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Business Model - Fisher Regulators Also known as the Quality Manual, this document addresses requirements from ISO 9001:2000 and fulfills 4.1, 4.2.1b, 4.2.2c [sequence and interaction described throughout], & 5.4.2a). While this is nice, the really important thing is to recognize it is our "Business Model". This means we are focused on our business first, with ISO 9001:2000 serving as a platform to make sure we have covered all the bases as it relates to business performance.

Revision: 6/25/2007 (Description of changes: updated objectives to current year objectives and changed customer property section, pointing to customer related processes instead of returned

goods)

Typical process flow and for the most part processes directly interacting w th one another. iClick here for a printer friendly version of this document.

The Master Control Plan serves as a table of contents for all of the documents that can be accessed directly through this site. All other documents are

controlled by e-Docs or Prime.

SCOPE 4.2.2a

Design (McKinney & Shanghai) and manufacture of industrial and commercial regulators and valves and provide regulator solutions for all applications (natural gas, propane, air, etc.), assembly of equipment for control and monitoring products used on remote systems (Fromex) as well as assembly of combustion

analyzers and continuous monitoring systems (Fromex).

QUALITY POLICY 4.2.1a, 5.1b & 5.3

We will foster an environment of continuous improvement and will strive to constantly improve our products, processes, and people. We recognize that everything we do can and must be improved. We will provide customers with the most innovative, highest quality, and superior performance products, services,

and solutions. Exceeding customer expectations is a way of life at Fisher. To achieve a high level of performance excellence, we will provide training, skill development, and education for our employees.

QUALITY OBJECTIVES 4.1e, 4.2.1a, 5.1c, 5.4.1, & 8.4

OBJECTIVE

KEY PERFORMANCE MEASUREMENTS

DIRECTLY IMPACTED BY

IN-DIRECTLY IMPACTED BY

Drive Growth Through Technology and Market Leadership

a) New Products as % of Sales b) Sales Growth in Emerging Marketsc) Service Sales Growth d) Marquee account participation % e) Tescom and Jeon vs Board Plan

Upper Management, Engineering, and Marketing

All Employees

Improve Systems and Processes to Drive Improved Customer Service and Operational Performance

a) Compliance Violations

b) Customer Survey Results

Oracle Implementation, Quality, Engineering, Customer Service, Supplier Quality, and Finance

All Employees

Develop and Strengthen The Organization

a) Leadership Turnover %

Management and HR

All Employees

Achieve Operational Excellence

a) On-Time Delivery b) Quality c) Supplier Performance d) Inventory Turns e) Profitability f) Localization of Supplier Base (Shanghai) g) Material Containment

Material Management, Manufacturing Engineering, Design Engineering, Quality, Production, Customer Service, and Sales Shanghai Procurement

All Employees and Suppliers

Team (f)

The reports and/or charts covering specific measurements for each of these objectives includes the goals and/or targets used to ensure the business model (QMS) is effective. See the Monitoring & Measurement section of this document to understand how we use these measurements to ensure the filter (policy) is driving behavior.

MONITORING & MEASUREMENT

(Beyond The Daily Grind) 8.1a-c, 8.2.3, 8.4a, 8.4b & 8.4c

Modeled after Deming's Plan, Do, Check, Act

STUDY Management, responsible for fulfilling the activities related to the measurements shown, assesses the results to confirm we are heading in the right direction and/or to identify the actions needed to right the ship and to identify improvement opportunities.

ACTION Establish action items using a closed-loop process (having a built in memory jogger for follow-up). These can involve things like action item lists or memos maintained by management and/or those mechanisms called for in Improvement Systems and/or Product Realization & Quality Planning. Remember: things that get measured get done!

Things to think about as part of "STUDY": - What does each measurement tell us? - Why does it say that? - What makes us think it will be okay if we leave it alone? - What are we doing about it, if we decide something needs to be done?

Charts & reports should include the

reason the results look they way they do and what has been done to

improve or sustain them so management

can assess and determine if further

action is needed.

FOLLOW-UP Using the closed-loop process employed in the "ACTION" section, follow-up on the action items raised to make sure they are staying on track, to provide direction, and to verify the action taken worked. REMEMBER TO ALLOW ENOUGH TIME FOR EFFECTIVE IMPLEMENTATION (in-place and working long enough to prove it will meet the desired result now and in the future). In some cases, we find what we are trying to do is not working. When this is the case, try taking it in another direction to resolve the issue. It is okay to abandon a cause, as long as it will not have an adverse effect on us or the customer and we realize resolution is not feasible.

VALIDATION Management, responsible for fulfilling the activities related to the measurements shown, summarizes the issues identified, actions taken, and results of follow-up for upper management. Upper management assesses the effectiveness of actions taken and determines if more action is needed and if what was learned can be applied in other areas. Those needing further attention are re-introduced into this process at the "ACTION" step.

MANAGEMENT'S "BIG PICTURE" PERSPECTIVE (Management Review, Auditing, Data Analysis, & Improvement)

NOTES: (related to Management's "Big Picture" Perspective I. Management review is an assessment of the actions (summary or highlights of departmental data as described in the "validation" section of Monitoring & Measurement) taken by area management to determine if further action is necessary. Management review occurs at least once per year as defined in Management Review. II. The internal audit process (defined in the Audit Procedure) tells us how effective our business model is. Auditors work with area personnel to identify which documents are driving behavior and which ones need to be improved so we can be more effective as an organization. III. The types of data analyzed at Fisher Regulators and what we do with it is described in the objectives section and in Management Review. Corrective Action, Preventive Action, and Continual Improvement processes are described in the Improvement Systems procedure.

COMMUNICATION & FOCUS 5.1a, 5.2 & 5.5.3 Management ensures personnel understand the importance of (are focused on) meeting customer requirements by posting the objectives or through employee meetings and by ensuring product is produced to meet customer requirements outlined in the order and/or drawing(s). In other words, customer requirements are determined (Customer-Related Processes), conveyed to our work force (order and/or drawing), and met (product produced to those requirements) with the aim of enhancing customer satisfaction. Management also ensures personnel are aware of any applicable statutory/regulatory requirements. Employee meetings, training courses, and/or memos addressing these types of issues are the means used for communicating with the employees. The effectiveness of the management system (Business Model and supporting documents) is communicated to employees through postings and/or through employee meetings.

CUSTOMER CONFIDENCE 5.2, 7.2.3d, 8.1b, 8.1c, 8.2.1, & 8.4a Complaints are handled through the FIX system and/or by issuing a corrective or preventive action (see Improvement Systems). Customer satisfaction data is obtained through meetings held with Reps and distributors (reporting both on our ability to meet their needs and those of their customers [end users]. The data is analyzed, with action items established as part of the process and/or as part of management review. This may be further supported by methods defined in the applicable Customer Related Process.

MAINTENANCE 6.3, 6.4, & 7.5.1c For the most part handled by the maintenance department as defined in the Production Process Overview. Maintaining the computer system, including back-ups is handled by the IT department.

MONITORING AND MEASUREMENT DEVICES 7.5.1d & 7.6 Selection and use is facilitated by the process calling for monitoring or measurement, with the Production Process Overview pointing out those processes and calibration is handled per Monitoring & Measuring Devices - Calibration.

VALIDATION OF PROCESSES 7.5.2 Those processes where we cannot or do not verify the product produced meets requirements is considered to be a "special

CUSTOMER PROPERTY 7.5.4 For the most part, it is treated like everything else. With the necessary controls facilitated by Customer Related Processes and the Customer Owned Property Log referenced in that process. Bologna receives customer

process and requires validation. Click here to see which process are special and/or how to validate a process when we find one that is special.

returns (property) and maintains control through the Returned Goods Authorization process and Receiving process.

And Now, Things We Have To Deal With Because They Makes Sure We Can Sustain Our Business Model

(maintaining our quality management system)

MANAGEMENT REPRESENTATIVE 5.5.2 The ISO Management Representative (person designated as such on the Organization Chart) has been given the responsibility and authority by management to: - ensure an effective quality management system is in place (this Business Model and supporting documentation) and is being maintained (through internal audits and by measuring key performance objectives); - report to top management on the performance of this system and any need for improvement (management review and reporting on the objectives); and - ensure personnel are aware of customer requirements (see Communication & Focus in this document).

While each site may have an ISO Management Representative, the management rep in McKinney is the person maintaining the corporate level documentation and assists each site as needed.

REQUIRED PROCEDURES 4.2.1c There are six documented procedures required by ISO 9001:2000 and we have covered them all. Document Control (4.2.3 as described in the Document Control section above), Records Control (4.2.4 as described in the Records Control section above), Internal Audits (8.2.2 with relational perspective provided in note II of Management's Big Picture Perspective above), Control of Nonconformance (8.2.3), Corrective Action (8.5.2 with relational perspective provided in note III of Management's Big Picture Perspective above), and Preventive Action (8.5.3 with relational perspective provided in note III of Management's Big Picture Perspective above).

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Nonconformance Control" box (shown above) with "8.1b & 8.3" referenced. This means the notes or documents referenced, address the requirements of 8.1b & 8.3 of ISO9001:2000. It should also be noted that, hyperlinked, italicized, and/or blue words are references to documents describing a particular process in greater detail.

THE STUFF WE LEFT OUT! 4.2.2a (exclusions) As a whole, there are no exclusions at Fisher Regulator. All requirements are applicable, but may not all be applied at each site (i.e., Customer Owned Property [7.5.4] and Validation of Processes...[7.5.2] are not applicable in Shanghai as the Shanghai facility does not have to deal with customer property and all product can be and is verified as meeting all requirements through monitoring and/or measurement. The only thing we left out completely was Servicing, as we do not perform servicing at any of our sites.

THE LAST WORD ON THE QUALITY MANAGEMENT SYSTEM 4.1 & 4.2.1d This quality manual (Business Model) and the documents that support it (referenced in this document or in those that support it and/or those documents included in the Master Control Plan) are the processes needed for the quality management system (QMS) at Fisher Regulator. These documents define or make reference to the sequence and interaction of our processes, the criteria/methods needed to ensure effective operation and control of these processes, and the resources/information needed (including the

provision of additional resources as needed) to operate and monitor these processes. This QMS includes the monitoring, measurement, and analysis activities necessary to ensure our processes will achieve the desired results now, looking for and acting on continual improvement opportunities as they arrive. Simply put, the documents we need to effectively plan, operate, and control our processes are in place.

ISO 9001:2000 Through The Eyes Of Fisher Regulator Division & Fisher Regulator Division Through The Eyes Of ISO 9001:2000.

Revision: 11/17/20 6 0(initial release)

While we recognize the traditional approach to documenting a management system is to follow the flow of the standard, we also recognize the standard does not on its own drive Fisher Regulator Division towards effectiveness. As a result, we chose to develop a "Business Model". This model is helping us understand Fisher Regulator as it relates to ISO 9001 (i.e., "ISO 9001:2000 through the eyes of Fisher Regulator Division") and more importantly is helping us define the Fisher Regulator Division Way. If you would like to see a matrix showing Fisher Regulator Division through the eyes of ISO 9001:2000 (i.e., clause by clause in the order of the standard), you can do so by clicking the link below. There is also a link to a mini tutorial on "The Big Picture" (document used to show the standard clause by clause.

Fisher Regulator Division Through The Eyes of ISO 9001:2000 The Big Picture

Tutorial On Using The Big Picture

http://www.an-answer.com/emerson/index.htm

http://www.an-answer.com/emerson/ISO9001AtFisher.XLS




Customer Related Processes (5.2, 7.2, 7.5.4, and 8.2.1) Use the following links to see the customer-related processes for each site.

Revision: 6/25/2007(Description of changes: added considerations concerning customer property)

Customer Related Processes - Industrial & Natural Gas - McKinney

Customer Related Processes - Propane - McKinney

In McKinney, when Customer Property (material or equipment the customer retains ownership of while it is in our possession) is involved the Customer Owned Property Log facilitates receipt and control of these items. Any loss,

damage, or unsuitable situations involving customer property are brought to Customer Service's attention and are noted in the Customer Owned Property Log.

Customer Related Processes - Bologna

Customer Related Processes - FROMEX

Customer Related Processes - Shanghai

Customer-Related Processes – Industrial & Natural Gas - McKinney 7.2, 8.2.1, & 8.4a

Revision: 3/26/2006(description of changes - change "FIX" to "CSN" & added Customer Service Activities)

THINGS WE THINK ABOUT & ADD TO OUR QUOTES, ORDERS & CHANGES TO ORDERS WHEN IT MAKES SENSE TO DO SO 7.2.1 - Customer expectations (products to be delivered & requirements to be lived up to) 7.2.1a ; - Things we know are needed (based upon our experience) that the customer may have left out 7.2.1b; - Legal or regulatory issues, related to the product or service, that have to be complied with (may come from the customer, a regulatory body/industry standard, or us) 7.2.1c; & - General rules (product features/options, lead time, etc.) that apply to the Emerson way of doing business. 7.2.1d COMMUNICATING WITH THE CUSTOMER & CUSTOMER SATISFACTION 7.2.3, 8.2.1 & 8.4a - Product information is communicated to the customer when we inform them of the types of products or services we provide and/or when we provide them order specific status information (per their request). 7.2.3a - Communication related to quotes, orders or amendments to orders is facilitated by the activities described in this document. 7.2.3b - Customer satisfaction/feedback (complaints or other feedback [positive and negative]) are determined (Customer Service Network [CSN] & Local Business Partner [LBP] meetings), collected (CSN and LBP meeting summaries), and analyzed (as part of review of the CSN data and LBP meeting reviews). The information is used to determine opportunities for improvement as defined in Improvement Systems. 7.2.3c, 8.2.1, & 8.4a

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Request for quote (RFQ)" parallelogram with "7.2.1 & 7.2.2a" referenced. This means the notes or documents referenced, address the requirements of 7.2.1 & 7.2.2a of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

NOTES: 1. For the most part, pricing is already established. When special pricing or terms are requested, this process is followed. Requests may be verbal or hard copy. In either case the requirements are understood (confirmed) when we document them in a quote. The "THINGS WE THINK ABOUT & ADD TO OUR QUOTES, ORDERS & CHANGES TO ORDERS WHEN IT MAKES SENSE TO DO SO" section of this document is considered as part of this process. 2. CRITERIA: - A product we (Fisher Regulator) already can or do make (will actually work as a product)? - Are we willing to accept any terms/specifications they have indicated? 3. Resolution at this stage would be: - Working with Engineering to determine the feasibility of a design change (see Design & Development); - Working through issues related to terms or credit issues with the customer; and/or - Informing the customer of our inability to meet their request. 4. A quote is generated by outside sales, representatives, or management, covering the pricing and other considerations requested by the customer, and is submitted to the customer. This is the record (results of review and necessary actions) of the quote. 5. The Rep and/or Order Entry handles new orders and changes to orders. The orders and changes to orders may be verbal or hard copy, with the order entered in the system serving to ensure all order requirements are understood (confirmed). The "THINGS WE THINK ABOUT & ADD TO OUR QUOTES, ORDERS & CHANGES TO ORDERS WHEN IT MAKES SENSE TO DO SO" section of this document is considered as part of this process. 6. CRITERIA: (Some of these are for new orders, some are for changes to existing orders, and some work with both) - A product we (Fisher Regulator) already make (will actually work as a product)? - Are we willing to accept any terms/specifications, changes to terms/specifications, or changes to orders they have indicated? - Can we pull back the existing order and make the changes? (for changes to existing orders) - Not on credit hold? 7. Resolution at this stage would be: (Some of these are for new orders, some are for changes to existing orders, and some work with both) - Working with Engineering to determine the feasibility of a design change (see Design & Development); - Working through issues related to special requests, terms, credit issues, and or changes to existing orders with the customer; and/or - Informing the customer of our inability to meet their request. 8. The order and/or changed order entered into the system is the record (results of review and any necessary actions) of review. When a change to an order is involved, the affected documents (work order [if production is involved] or shipping paperwork [if the item is distribution only or already in shipping] and/or any other documents related to the change) are updated and management for the area(s) affected by the change are notified so the change can be fully implemented. 9. A written acknowledgment or electronic update is provided to the customer.

Customer-Related Processes – Propane - McKinney 7.2, 8.2.1, & 8.4a

Revision: 11/12/2004

THINGS WE THINK ABOUT & ADD TO OUR QUOTES, ORDERS & CHANGES TO ORDERS WHEN IT MAKES SENSE TO DO SO 7.2.1 - Customer expectations (products to be delivered & requirements to be lived up to) 7.2.1a ; - Things we know are needed (based upon our experience) that the customer may have left out 7.2.1b; - Legal or regulatory issues, related to the product or service, that have to be complied with (may come from the customer, a regulatory body/industry standard, or us) 7.2.1c; & - General rules (product features/options, lead time, etc.) that apply to the Emerson way of doing business. 7.2.1d

COMMUNICATING WITH THE CUSTOMER & CUSTOMER SATISFACTION 7.2.3, 8.2.1 & 8.4a - Product information is communicated to the customer when we inform them of the types of products or services we provide and/or when we provide them order specific status information (per their request). 7.2.3a - Communication related to quotes, orders or amendments to orders is facilitated by the activities described in this document. 7.2.3b - Customer satisfaction/feedback (complaints or other feedback [positive and negative]) are determined (FIX &/or Distributor meetings), collected (FIX or Distributor meeting summaries), and analyzed (as part of review of the FIX data and/or Distributor meeting reviews). The information is used to determine opportunities for improvement as defined in Improvement Systems. 7.2.3c, 8.2.1, & 8.4a

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Request for quote (RFQ)" parallelogram with "7.2.1 & 7.2.2a" referenced. This means the notes or documents referenced, address the requirements of 7.2.1 & 7.2.2a of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

NOTES: 1. For the most part, pricing is already established. When special pricing or terms are requested, this process is followed. Requests may be verbal or hard copy. In either case the requirements are understood (confirmed) when we document them in a quote. The "THINGS WE THINK ABOUT & ADD TO OUR QUOTES, ORDERS & CHANGES TO ORDERS WHEN IT MAKES SENSE TO DO SO" section of this document is considered as part of this process. 2. CRITERIA: - A product we already make? - Are we willing to accept any terms they have indicated? - Not on credit hold? 3. Resolution at this stage would be: - Working with Engineering to determine the feasibility of a design change (see Design & Development); - Working through issues related to terms or credit issues with the customer; and/or - Informing the customer of our inability to meet their request. 4. A quote is generated by Inside Sales, covering the pricing and other considerations requested by the customer, and is submitted to the customer. This is the record (results of review and necessary actions) of the quote. 5. The system and/or Customer Service handle new orders and changes to orders. The orders and changes to orders may be verbal or hard copy, with the order entered in the system serving to ensure all order requirements are understood (confirmed). The "THINGS WE THINK ABOUT & ADD TO OUR QUOTES, ORDERS & CHANGES TO ORDERS WHEN IT MAKES SENSE TO DO SO" section of this document is considered as part of this process. 6. CRITERIA: (Some of these are for new orders, some are for changes to existing orders, and some work with both) - A product we already make? - Are we willing to accept any terms, changes to terms, or changes to orders they have indicated? - Can we pull back the existing order and make the changes? (for changes to existing orders) - Not on credit hold? 7. Resolution at this stage would be: (Some of these are for new orders, some are for changes to existing orders, and some work with both) - Working with Engineering to determine the feasibility of a design change (see Design & Development); - Working through issues related to special requests, terms, credit issues, and or changes to existing orders with the customer; and/or - Informing the customer of our inability to meet their request. 8. The order and/or changed order entered into the system is the record (results of review and any necessary actions) of review. When a change to an order is involved, the affected documents (Manufacturing Order [MO] and/or any other documents related to the change) are updated and management for the area(s) affected by the change are notified so the change can be fully implemented. 9. At a minimum, a verbal order acknowledgment is provided to the customer, with the goal being to send an actual order acknowledgement (log sent each Monday) for each order (either by the system or an email or fax from Customer Service).

Customer-Related Processes – Bologna 7.2, 8.2.1, & 8.4a


Quotes And Orders

Changes To Orders

Customer Service's Role In Shipping Orders

Technical Review

Returned Goods Authorization (RGA)

THINGS WE THINK ABOUT & ADD TO OUR QUOTES, ORDERS & CHANGES TO ORDERS WHEN IT MAKES SENSE TO DO SO 7.2.1 - Customer expectations (products to be delivered & requirements to be lived up to) 7.2.1a ; - Things we know are needed (based upon our experience) that the customer may have left out 7.2.1b; - Legal or regulatory issues, related to the product or service, that have to be complied with (may come from the customer, a regulatory body/industry standard, or us) 7.2.1c; & - General rules (product features/options, lead time, etc.) that apply to the Emerson way of doing business. 7.2.1d

COMMUNICATING WITH THE CUSTOMER & CUSTOMER SATISFACTION 7.2.3, 8.2.1 & 8.4a - Product information is communicated to the customer when we inform them of the types of products or services we provide and/or when we provide them order specific status information (per their request). 7.2.3a - Communication related to quotes, orders or amendments to orders is facilitated by the activities described in this document. 7.2.3b - Customer satisfaction/feedback (complaints or other feedback [positive and negative]) are determined, collected, and analyzed (see Improvement Systems). 7.2.3c, 8.2.1, & 8.4a

Customer-Related Processes – Quotes & Order - Bologna 7.2.1, 7.2.2, 7.2.3a, & 7.2.3b

Revision: 11/23/2006(description of changes: added color code for folder in note 3)

NOTES: 1. For the most part orders received are faxes, emails, or printouts. Verbal orders may be received and are processed in the same way as all other orders (confirmed when entered into and accepted as an order in Galileo. 2. To enter a new customer in Galileo, the following customer information is needed and entered into the system. - Company name - Address - VAT (if part of the EU) - Payment terms - Any discounts granted by area management 3. Order types are as follows: A – Standard order for an assembly to be provided by Fisher Process B – Spare part or material order to be provided by Fisher Process C – Fast order for an assembly to be provided by Fisher Process K – Drop shipment order M – Order highlighting the need to ensure compliance with embargos or sanctions U – Orders Fisher Process enters into OPS on behalf of the customer, where no other action is needed (the site the order was placed with will manage the order) The pending orders are maintained in color-coded folders as follows:

• Red - Intercompany order • Yellow - Orders from embargoed or sanctioned countries • Green - Reps and Distributors

4. Customer code, request date, and reference are added to Galileo to keep track of the order. 5. CRITERIA: - Compliance determines the order can be accepted without compromising any embargo or sanction. 6. Customer Service works with the customer, Compliance, Sales, Customer Service, and/or Operations (as needed) to confirm the order can be processed or an alternate solution can be provided to the customer. If resolution is not possible. The order is cancelled in Galileo and associated documents (i.e., customer PO, email correspondence, etc.) are filed as a cancelled order. When the resolution is successful, the order returns to the process where the issue was raised and proceeds accordingly. 7. The order entered into and accepted by OPS is recognized as the record of the results the order for type U orders. 8. Completing the order in Galileo includes (as applicable and if not already there): - Date the order is entered as an order - Customer reference number - Consignee code (if different from the customer code and available) - Address the invoice will be sent to - Product code - Quantity - Price (if no default is shown or default is different from price we are charging) - Special instructions - End user and application (Sales orders only) - JD reference - Rep code and discount(s) - Freight forwarder contact details (if Rep or Distributor has made it available) - Indemnity statement (Rep or Distributor only) - Name of person entering the order - Shipping marks and shipping label information - Confirmation date (if different from the customer's request date) - The order entered into and accepted by Galileo is recognized as the record of the results the order for all orders except type U orders.

Most orders are entered as an “01” to acknowledge the order will work through warehouse location 100. Drop shipment orders are entered as “51” and a warehouse location of 300. This helps Galileo recognize which orders the MRP is to recognize for the sake of planning production and material needs. 9. CRITERIA (Assessed by Customer Service personnel trained to understand compliance considerations): - All of the results of the screen show there are no embargo or sanction issues affecting our ability to accept the order? 10. Customer Service tracks the order through shipment to be aware of the time when an invoice can be provided to the customer. 11. When a drop shipment is involved, the copy(s) go to Purchasing so they can match invoices received from other sites (for orders placed in OPS) with the orders in Galileo. This allows Fisher Process to ensure invoices paid to these internal vendors are correct. 12. Fisher Process does not provide quotes to customers, but does assist Sales with quote-related information. Delivery, pricing, and/or the source to be used for making the purchase is provided by Customer Service, project personnel, or operations management as needed.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Order received" parallelogram with "7.2.2a" referenced. This means the notes or documents referenced, address the requirements of 7.2.2a of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Customer-Related Processes – Change Orders - Bologna 7.2.1, 7.2.2, 7.2.3a, & 7.2.3b


NOTES: 1. Change orders received are faxes, emails, or printouts. 2. CRITERIA: - Order is still new enough that it has not been sent to Production, Purchasing, or the Warehouse? - Changes will not adversely affect price or committed to delivery? - We are willing to make the change because we have other orders that can use any excess material involved? - The change is an increase and we are capable of providing the product on-time? - Order is still new enough that making the change will have minimal impact on Production, Purchasing, or the Warehouse? 3. Customer Service works with the customer and those affected internally (Production, Purchasing, Engineering, etc.) to come up with the best solution. In some cases, the order is too far along to process the change and the customer takes it as is or cancels the order. 4. CRITERIA: - Costs incurred, needing cancellation charges or restocking fees?

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Change order received" parallelogram with "7.2.2a" referenced. This means the notes or documents referenced, address the requirements of 7.2.2a of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Customer Service's Role In Shipping – Bologna 7.5.1f


NOTES: 1. Shipping provides a copy of the order with the dimensions and weight of shipping container(s). 2. CRITERIA: - Customer Service has already done the screening. 3. Ensure Shipping has provided evidence of restricted party screening (orders from Sales, Reps, & Distributors) and a completed Order/Quote Screening Form (Rep & Distributor orders only), performing the screen as needed. 4. CRITERIA: - Courier or freight forwarder listed is the one the customer wanted? - We can ship the current method and still be on time? - There is no alternative that is less expensive and does not sacrifice quality over price?

5. The customer is contacted by Customer Service and shipping instructions are obtained. In most cases, Customer Service provides the customer with the shipping weight and dimensions to help the customer make a decision about the best way to ship the product. 6. At a minimum, a delivery note is prepared for orders within the European community. When exports are involved, the delivery note is accompanied by a copy of the invoice and the applicable export paperwork. The applicable export paperwork and other such notes are maintained in customer-specific files or are added to the order, as needed. 7. CRITERIA: - Order calls for certificates to be shipped with the product. 8. Certificates called for on the order are pulled and copies provided to the customer (see Certs - Bologna).

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "7.5.1f" referenced in the document title. This means this document and any documents or notes referenced throughout this document, address the requirements of 7.5.1f of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Technical Review – Bologna 7.1 & 7.2.2

Revision: 10/12/2006(description of changes: changed note 7, removing reference to OPS and recognizing the project plan as the record of review for orders of this type)

NOTES: 1. The order is provided to Engineering for the sake of understanding the requirements, verifying we can meet the need, providing alternatives when necessary, and establishing the plan needed to fulfill requirements. Planning Considerations may be used to facilitate effective product realization. 2. CRITERIA: - The order matches the correct order type as defined in “Customer-Related Processes – Quotes & Order – Bologna”. 3. Engineering may provide Customer Service with alternatives for the customer to consider. If we are unable to resolve the issue, the order would simply be cancelled as described in “Customer-Related Processes – Quotes & Order – Bologna”. 4. CRITERIA (While there may be other types of special requirements, those shown below are the most common): - Special paint? - Special testing? - Change in material? - Non-standard option? 5. CRITERIA (Guideline to consider, not requirement to live up to) - Key customer? - Order valued at around or greater than $50k? - Order presented as part of a project. 6. Engineering and/or project management personnel assemble a team, consisting of representatives from Engineering, Production, Project Management, and/or others as needed. 7. A project plan is established and includes the following, as deemed appropriate by the project team. - Inspection &/or test plans - Welding certifications/procedures needed - Quality plan - Special handling and/or paint requirements - Process definition - BOM development 8. Folders in use are: - Fast Order (Red Folder) – Order taken with the intent we would process it with the utmost urgency. - Standard (Yellow Folder) – Order reflecting we have enough lead time built in to let the job run the normal course, without any special attention or heightened awareness. - Embargo or Sanctioned Order (Blue Folder) – Order needing attention to ensure we do not involve parties (people or countries) where it is illegal for that party to do business with or in the country that is the end destination - Special Order/Project (Green) – Requires special attention due to the need for special paint, special testing, etc. and/or is a project (i.e., key customer order needing special attention, > $50K, requires project management due to complexity, etc.) 9. Examples of special requirements include: - Test report - Material certifications - Type of Material 10. CRITERIA: - If we wait for the MRP run, will there still be enough time to complete the order?

Returned Goods Authorization (RGA) – Bologna 7.2.3c, 8.2.1, & 8.4a


NOTES: 1. CRITERIA: - Product has not been obsoleted? - Age of unit does not indicate parts with a limited-life have exceeded their shelf-life? - Customer confirms the product has been stored in an environment that will not lead to deterioration? 2. CRITERIA: - Can we resell it easily? - Is the order a mistake that Sales made and we have to eat it? 3. Information needed to decide the action to be taken is: - Order # - Item # &/or Serial # - Problem encountered - Whether the unit has or has not been used (including how long it has been in use) 4. CRITERIA: - Comparing today's date with the ship date, the order is still within the warranty period? 5. CRITERIA: - Recognize this as a recurring problem with this product or material? - We realize the problem is due to our actions? - Customer is a top customer and we decide to take care of them? 6. Data collected in the RGA Table is used to analyze customer feedback and as a means for determining customer satisfaction. The information is summarized and discussed as part of management review. DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Customer requests return" parallelogram with "7.2.3c" referenced. This means the notes or documents referenced, address the requirements of 7.2.3c of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Customer-Related Processes – FROMEX 7.2, 8.2.1, & 8.4a


NOTES:

To be determined

Customer-Related Processes – Shanghai 7.2, 8.2.1, & 8.4a

Revision: 8/9/2006(Description of the latest change - Added embargo considerations to note 6)

Transfer order(PO with Kanban)

7.2.2a

Can we deliver on-time?

7.2.1 & 7.2.2c

Sales Order or Kanban entered into

JDE7.2.2 (record)

Resolve with site requesting the

transfer7.2.2b

Work order generated by the system

7.5.1a & 7.5.1b

Intercompany order

(PO from Sales)

7.2.2a

Price okay & we can deliver on-time?

7.2.1 & 7.2.2c

Resolve with Sales7.2.2b

Trade order(OPSF &

DADF from Sales)

7.2.2a

Price okay, we can deliver on-time, & authorization is

okay?7.2.1 & 7.2.2c

Kanban cards released to suppliers

7.4.2Kanban item?

NO

MC checking material status for an order

Pre-alert from Material

Handling

Kanban card turned in

Safety stock report shows need

Material need

realized

MC generates PO in JDE & fax/email approved PO to

suppliers7.4.2

YES

NO

See note 1.

See

not

e 2.

See note 3.

YES YES

NO

See note 5.

See note 6.

Transfer orderchange

requested7.2.2a

Can we make the change?

7.2.1 & 7.2.2c

Production &/or suppliers notified

7.2.2 (relevant personnel made aware)

YES

NO

Sales orderchange

requested7.2.2a

Can we make the change?

7.2.1 & 7.2.2c

MC informs Sales or customer we

cannot meet their request

7.2.2b

Involve cancellation

charges or price adjustments?

Prepare adjustments and update orderIf affected

YES

YES

NO

NO

YES

NO

Supplier on Approved Supplier List?

7.4.1

Supplier Selection7.4.1

YES

NO

This is Purchasing

See note 4.

See note 4.

NOTES: 1. The Material Coordinator (MC) will contact the affected site and inform them of our commit date. 2. The order (Kanban or sales order) entered into and accepted by JDE serves as the results of our review and the workorder generated is the actions arising from that review (record of review). It should also be noted the sales order number (SO) and workorder number (WO) are the series number. The series for each order type are as follows:

• 9055000 - Transfer Order • 9056I00 - Intercompany Order • 9051I06 - Trade Order

3. The Materials group manages the system as it relates to material needs and makes the necessary adjustments (i.e., increase or decrease to safety stock, react to pre-alerts or fluctuations in orders, etc.). 4. The purchasing document describes (as applicable) the material needed, qualifications required, quality management system requirements that must be lived up to, and/or the need for source inspection/the method of release once source inspection is complete (when and if source inspection is required). Evidence the purchasing document (Kanban, PO, etc.) has been reviewed for adequacy prior to communication to the supplier occurs when the PO or Kanban is entered into and accepted by the system and is released, faxed, email to the supplier. 5. The Material Coordinator (MC) works with sales personnel and/or the customer to resolve the issue at hand, entering the order in the system once everything is worked out. In the event there is an issue that cannot be resolved, Sales or the customer is notified and the order is cancelled. 6. Trade orders require and Order Process System Form (OPSF) and a Discount Authorization Deviation Form (DADF) with the level of authorization maintained by Finance. “Check on website https://online2.openharbor.com/fui/ to assure end user on Order Screening Form is not embargo and print the accept screen. If the end user is embargo, the order will be rejected” CLARIFICATION: What about quoting? We do not perform quoting functions in Shanghai, but we do support the quoting efforts of those who do (sales personnel, reps, etc.) and is mainly related to projected lead times. As these are not quotes in the traditional sense (not a tender), but a support effort for those doing quotes, we do not keep records of these activities. The Material Coordinator (MC) handles all of the activities related acceptance of an order and material related issues, facilitating the answering of questions (when other sites, sales personnel, or customers have questions or we need to resolve issues raised) and will involve other members of Shanghai’s team (Quality, Production Management, Finance, etc.) as needed.

THINGS WE THINK ABOUT & ADD TO OUR ORDERS & CHANGES TO ORDERS WHEN IT MAKES SENSE TO DO SO 7.2.1 - Customer expectations (products to be delivered & requirements to be lived up to) 7.2.1a ; - Things we know are needed (based upon our experience) that the customer may have left out 7.2.1b; - Legal or regulatory issues, related to the product or service, that have to be complied with (may come from the customer, a regulatory body/industry standard, or us) 7.2.1c; & - General rules (product features/options, lead time, etc.) that apply to the Emerson way of doing business. 7.2.1d

COMMUNICATING WITH THE CUSTOMER & CUSTOMER SATISFACTION 7.2.3, 8.2.1 & 8.4a - Product information is communicated to the customer when we inform them of the types of products or services we provide and/or when we provide them order specific status information (per their request). 7.2.3a - Communication related to orders or amendments to orders is facilitated by the activities described in this document. 7.2.3b - Customer satisfaction/feedback (complaints or other feedback [positive and negative]) are determined (FIX reports and customer feedback), collected (FIX or Quality's summary of customer feedback), and analyzed (as part of review of the FIX data and/or Quality's summary of customer feedback). The information is used to determine opportunities for improvement as defined in Improvement Systems. 7.2.3c, 8.2.1, & 8.4a

Customer Owned Property Log

Suitable for use?

Y or N(If N [no], note in Action Taken...)

Accepted by

(initials)

Date Received Customer Name

Description(what is it and/or what does it go with?)

Location 7.5.4

(where do we keep it, ensuring protection and safeguarding)

Action Taken to Protect and/or Safeguard, and/or the Record of Loss, Damage, or Unsuitability of

Customer Property7.5.4 (protect and safeguard, and where needed a place to note the action taken when loss,

damage, or unsuitability [found or done here] occurs)

1

2

3

4

5

6

7

8

9

10

11

Criteria: Not lost, damaged, or unsuitable for use 7.5.4 (verify).

Customer property tends to arrive with some form of identification (we can tell it belongs to them because it is marked or labeled). When it is not marked or labeled, we label or mark the item(s) to ensure everyone will know it is customer property. If loss, damage, or unsuitability of customer property (whether it arrived that way or we did something to it) is encountered, we let Customer Service know so they can

call the customer to report it. The incident is recorded in this form.

Customer Owned Property Log Revision: 11/1/2004 Page 1 of 1

Fisher Controls International, Inc. © Fisher Controls 2006

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Printed: 01/27/06 Confidential / Do Not Reproduce Page 1 of 29

Engineering Standard EST 9 Revision M

CONFIDENTIAL: This document, including the information it bears, is the property of Fisher Controls and must be held in strict confidence and properly safeguarded by the recipient at all times. It may not be copied or reproduced, or provided or revealed to any other party, except with the prior written authorization of Fisher Controls, and any authorized copy or reproduction must include this legend. The recipient may use the same only for the purpose for which Fisher Controls has provided it to the recipient, and it must be returned to Fisher Controls, along with all copies and reproductions, upon request. By accepting this document, the recipient agrees to the forgoing.

USE OF THIS DOCUMENT

The master copy of this document resides in electronic format. Printed copies of this document are for convenience only. Verify that the revision of this printed document matches the current revision of the electronic master before use. Ownership of this document may be

determined by viewing the electronic master.

New Product Development and

Design Control Requirements for

Fisher Regulator Division Products

Engineering Standard

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TABLE OF CONTENTS

1. SCOPE ........................................................................................................................................... 3

2. REFERENCES............................................................................................................................... 3

3. DEFINITIONS ............................................................................................................................. 4

4. NEW PRODUCT DEVELOPMENT PROCESS................................................................... 11

5. DESIGN INPUTS...................................................................................................................... 13

6. PROJECT INPUT DOCUMENTATION .............................................................................. 13

7. DESIGN STANDARDS........................................................................................................... 16

8. DESIGN PROCESS................................................................................................................... 16

9. DESIGN VERIFICATION AND VALIDATION ............................................................... 18

10. DESIGN OUTPUT .................................................................................................................... 19

11. PROCUREMENT OF SUBCONTRACTED SERVICES.................................................... 19

12. INTERFACE CONTROL ......................................................................................................... 19

13. DESIGN REVIEW..................................................................................................................... 20

14. DESIGN DOCUMENTS.......................................................................................................... 20

15. PRODUCTION RELEASE....................................................................................................... 21

16. DOCUMENT CONTROL........................................................................................................ 21

17. DESIGN CHANGE CONTROL ............................................................................................ 21

TABLE OF FIGURES

APPENDIX 1:

NPD PHASE DELIVERABLES ........................................................................................................ 23

APPENDIX 2:

GATE APPROVAL FORM................................................................................................................ 26


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1. SCOPE

1.1 This document provides New Product Development and Design Control requirements for the design, maintenance, and application of Fisher Regulator Division products. These requirements are in conformance with ISO 9001.

1.2 The requirements of this standard apply to all design work required to develop and maintain a new product, a redesigned product, or a product component that is released to production and offered for sale.

1.3 The requirements of this standard do not apply to research or project work that does not result in a product or product component that is released to production and offered for sale, such as feasibility studies and technology development work. However, the documentation requirements of this standard should generally be applied, as appropriate, so as to provide adequate control and documentation of the work performed.

1.4 Design Control in accordance with this standard begins with an approved product marketing requirement, when customer order requirements are received by Engineering, or when Engineering initiates a project for a minor product improvement where a Marketing evaluation is not necessary.

2. REFERENCES

(a) ES 2, Method of Revising Drawings and Other Engineering Documents

(b) ES 26, Guidelines for Making Changes to Engineering Documentation that affects Interchangeability

(c) ES 192, Engineering Change Request Procedure

(d) ES 242, Controlled Documents and Data

(e) ES 264, Product Safety Responsibility for the Fisher Regulator Division

(f) ES 250 Product Assignment – Designated Engineer List

(g) EST 4, Project Numbers

(h) EST 7, Project and Product Record Files

(i) EST 8, McKinney, Texas Design Review Committee

(j) EST 10, Engineering Hold

(k) EST 24, Design Audits for McKinney Projects


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(l) EST 47, Making and Filing Calculations

(m) FGS 15A8, Statistical Process Control Charting For Variable Data

(n) ISO 9001, Quality Systems - Model for Quality Assurance in Design/Development, Production, Installation and Servicing.

The latest edition and addenda or revision of these documents applies unless otherwise specified for a particular customer order.

3. DEFINITIONS

3.1 Alternatives Analysis

An assessment of other ways to meet the project goals. This could be different designs, approaches, adaptations to existing products, repositioning existing products, foregoing the market opportunity, etc.

3.2 Alternative Technologies Assessment

An analysis of the relative advantages and disadvantages of utilizing technologies different than those of the proposed product concept.

3.3 Appropriation Request (AR)

A written request used to purchase or lease a fixed tangible or intangible asset; for the transfer, disposal, and/or retirement of capital assets; for the purchase of professional services; and for project pre-approvals.

3.4 Competitive Assessment

An analysis of competitive product offerings, their strengths, weaknesses, key features and benefits, pricing, costs estimates, market penetration, product positioning strategies, sales channels, etc.

3.5 Competitor Technology Assessment

An analysis of the technologies utilized by competitive offerings, including their overall performance, strengths, weaknesses, and costs.

3.6 Concept Validation Testing

Testing and/or analysis of the proposed product concept performed to sufficient rigor in order to ensure the project objectives will be met within acceptable risks.

3.7 Cost Containment Assessment

Identification of components requiring price negotiations, sourcing actions, etc to reduce costs within project targets. Cost Containment is the execution of plans developed from these assessments


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3.8 Customer Analysis

An assessment of key users and/or customers, their purchase volumes, current prices, key values, unmet needs, etc.

3.9 Customer Field Tests

Tests of prototypes or production samples in end user installations in order to validate product performance and/or the effectiveness of laboratory evaluations.

3.10 Detail Drawings, Specifications, and BOM (Bill of Material)

Part and product design information including solid models, 2-D details drawings, material and processing specification, materials lists, rules for applying options, etc.

3.11 Design

The term "Design" includes all the work necessary to develop and maintain a product for sale. It includes all the work necessary to manage an engineering project; to design, develop, and prepare a new product for production; to modify or redesign an existing product; to generate product data and project file records; and to generate product application information and documentation.

3.12 Design Audit

A detailed audit of the design activities by an Engineer outside the core project team.

3.13 Design Calculations and Computer Analysis

Methodologies utilized to assess design compliance with Marketing and Technical Specifications without building prototypes. These include hand calculations, calculations made by equation solver or spreadsheet programs, and computer simulations with software tools such as Finite Element Analysis (FEA) or Computational Fluid Dynamics (CFD).

3.14 Design Documents

Design documents define the technical characteristics of products and components and are illustrated by samples listed in Section 14.

3.15 Design Inputs

Those technical requirements such as owner's design specification, customer order information, technical specification, regulatory requirements, codes, standards, or marketing requirements upon which final design is based.

3.16 Design Review

A technical review of the proposed design by an Engineering Committee comprised of senior engineers outside the core project team.


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3.17 Design Review for Sourcing

A review of the expected product design based upon supplier abilities to produce required component parts as well the degree to which multiple global sources are available. Special consideration must be given to the ability to source components in low cost countries. Key strategic suppliers should be included in these reviews whenever possible.

3.18 Development Plan and Level of Effort

A detailed listing of the key Engineering activities necessary to develop the proposed product concept, including human resource and skills requirements

3.19 Exhibit 10M

An Emerson Electric financial exhibit that tracks key project metrics.

3.20 Fabricated and Tested Prototypes

Prototypes simulating the commercialized product that have been constructed and submitted to laboratory evaluations in order to validate project objectives will be met within acceptable risks.

3.21 Feasibility Analysis and Technology Development Needs

An assessment of the likelihood the product concept will meet performance and cost objectives. It also includes an analysis of key technologies that must be developed or acquired to commercialize the product concept.

3.22 Financial Analysis

A written financial evaluation of the proposed product to be developed. It estimates the return on investment and payback period for all product development expenses and capitalized costs that will be incurred by Engineering, Manufacturing, and Marketing in relation to forecasted product sales and associated profits

3.23 FMEA (Failures Modes and Effects Analysis)

A systematic analysis of all possible product or process failures, their causes, likelihood of occurrence, severity, and possible ways to prevent, eliminate, or reduce their severity.

3.24 Intellectual Property/Patent Analysis

An assessment of existing intellectual property (IP) relevant to the proposed design, the degree the proposed design may infringe with existing IP, IP generated by the new design, and the status of effort to protect any new IP.


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3.25 Inventory Plan

A detailed plan that identifies the inventory ramp down for the product being replaced, as well as the inventory ramp-up for the new product. It should include estimates for obsolete inventory write-off's, historic inventory turns for the legacy product, inventory turn objectives for the new product, as well as part by part material flow methodologies such as reorder point, MRP, or Kanban signaling.

3.26 Key Supplier Identification

Identification of suppliers that will produce critical components as determined by the design team. A suggested approach is to segment components into three categories: Category 1 where the component is so critical to the success of the project that a partner supplier or supplier must be identified in the concept feasibility phase, Category 2 where the part is of a less critical nature where multiple supplier partners are needed in the concept development phase with the final production award based upon electronic quoting or other competitive tensioning means, and Category 3 where the parts are non-critical commodities so that suppliers may be determined in the product development phase by various competitive tensioning means.

3.27 Key Supplier Engagement

Involvement of Key Suppliers in the product development process

3.28 Manufacturing Feasibility Assessment

An analysis of the likelihood that project manufacturing objectives can be achieved such as labor and overhead costs, customer lead-times, quality targets , etc.

3.29 Manufacturability Design Review

A review of the proposed product and manufacturing process designs for their ability to meet cost and quality objectives. Particular attention should be given to Lean Process design techniques and metrics.

3.30 Manufacturing Process Design

Design of the product assembly, test, material storage and flow, and any other production processes.

3.31 Manufacturing Review and Release

Review of the final manufacturing process design and pilot manufacturing results by appropriate Operations Senior Management. Release grants authorization to begin production pending Gate 5 approvals.


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3.32 Manufacturing Strategy

A document describing the manufacturing systems required to meet the Market Requirements and Technical Specifications.

3.33 Manufacturing Work Instructions

Detailed documents describing process, assembly, and/or testing instructions such as a Fisher Manufacturing Procedure Texas (FMPT)

3.34 MARCOM

Marketing communications materials such as brochures, CD’s, web pages, bulletins, instruction manuals, etc.

3.35 Market Assessment

An analysis that defines the overall market size as wells as key segments according to geographic location, user type, application, etc. This analysis may include additional data such as price levels, competitiveness, entry barriers, etc.

3.36 Marketing Requirements Specification (MRS)

A controlled document that identifies key market and product attributes to be addressed by the new product design and manufacturing systems.

3.37 Pilot Production Build and Verification

Preproduction testing of the assembly and test processes to validate their ability to meet operational objectives. This is typically accomplished by building a typical production lot of products and then verifying the degree to which the processes and manufactured products comply with manufacturing, quality, and technical requirements.

3.38 Process Quality Control Plan

The methods by which the product quality objectives will be met and verified.

3.39 Procurement Feasibility Assessment

An analysis of the likelihood that project material flow objectives can be achieved such as inventory turns, obsolete material write-offs, material costs, supplier availability, etc.

3.40 Procurement Strategy

A written document that describes the material supply chain required to meet the Market Requirements Specification, Technical Specification, and Manufacturing Strategy.


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3.41 Product Cost Estimate

A projection of the expected Product Standard Cost (PSC) including a breakdown of fixed and variable costs according to material, labor, freight, duties, overheads, etc.

3.42 Product Engineer

A person selected from the engineering staff that has primary engineering responsibility for designated products as specified in ES 250. The primary responsibility of a Product Engineer is to perform support engineering for Sales, Order Entry, Manufacturing, and general customer service. A Product Engineer may also perform product line extension development and minor product redesign engineering work.

3.43 Product Lifecycle and Phase-out Plan

A plan that identifies the expected volume ramp-up of new products and ramp-down of existing products in both units and timing. The plan must include an obsolescence forecast for products being replaced.

3.44 Project Budget

A listing of expected project expenditures for human resources, travel, prototypes, capital equipment, etc.

3.45 Project Engineer

A person selected from the engineering staff whose primary responsibility is to perform new product development or major product redesign engineering work.

3.46 Project Evaluation

A post project review of the project results and development processes. The review should identify best practices, improvement opportunities, and corrective actions to improve future NPD projects.

3.47 Project Manager

A person selected by Division Management with overall responsibility to coordinate all the activities of a new product development or major product redesign project.

3.48 Project Timeline

A plan that identifies key project activities, their duration, resource requirements, and their interrelationships. The timeline should provide an estimate of completion dates for key activities and project phases.

3.49 Prototype Design

A product design that simulates the production concept.


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3.50 Qualification and FA Approvals

Verification of supplier capabilities to meet all component part specifications and dimensional requirements. These qualifications may include First Article (FA) inspections and supplier pilot runs.

3.51 Resource Plan

A listing of key human resource needs by functional area, number of resources needed for each function and resource assignments against those needs.

3.52 Risk Analysis and Mitigation Plan

An assessment of all reasonable financial, schedule, technical, market, etc risks. The risk analysis should include an assessment of both the likelihood and potential impact of the identified risks. Methodologies to prevent, eliminate, or reduce the impact of each risk should be identified.

3.53 Safety Review

A review of the proposed product design for end user and manufacturing safety. This activity may be completed in conjunction with the Safety Audit and/or Technical Review

3.54 Sales Forecast

Projects sales volumes for the new product and its associated product options. The sales forecast should provide sufficient unit volume and price detail to enable purchase of raw materials and component parts as well as financial budgeting.

3.55 Technical Specification

Written translation of market requirements into detailed product technical requirements including materials, strength, orientation, etc. The technical specification must include verification to ensure the end design meets the technical and marketing requirements.

3.56 Test Fixtures and Equipment

All equipment and tools required to assemble, test, and otherwise manufacture the product.

3.57 Third Party Approvals Design approval by an external, non-customer agency such as Underwriters Laboratories, Canadian Standards Association, Bureau Veritas, Factory Mutual, etc.


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3.58 Validation Testing on Pilot Production Units

Laboratory testing and/or customer field testing of first production samples performed with sufficient rigor to validate compliance with Marketing and Technical Specifications.

3.59 Value Based Pricing

The price level of the new product is set relative to competitive offerings based upon the economic value derived by the customer. Value based pricing is a direct outflow from the value proposition.

3.60 Value Proposition

Identifies the key value(s) the new product provides for end users and/or customers. The value proposition should differentiate the new product from competitive offerings and translate the differentiation into economic value.

4. NEW PRODUCT DEVELOPMENT PROCESS

4.1 New Product Development (NPD) will be accomplished by cross-functional teams. Division Management shall determine team membership such that the following functional areas are appropriately represented: Project Management, Marketing, Engineering, Manufacturing, Procurement & Materials, Finance, Quality, and Sales.

4.2 NPD projects shall be executed in series of discreet phases, with each phase concluding in a gate review by Division Management. Some phases and gate reviews may be combined with Division Management Approval.

Phase 1: Market Research & Idea Generation Gate 1: Idea

Phase 2: Concept Feasibility Gate 2: Feasibility

Phase 3: Concept Development & Project Planning Gate 3: Planning

Phase 4: Design & Development Gate 4: Design

Phase 5: Pilot Manufacture & Ramp-up Gate 5: Launch

Phase 6: Launch & First Production Gate 6: Review


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FIGURE 1: New Product Development Process

4.3 Approval Process

Each project phase shall comprise the completion of key deliverables by a cross-functional project team. Key deliverables by project phase and functional area are found in Appendix 1. Appendix 1 identifies minimum project requirements. It does not prohibit completing deliverables earlier than indicated or additional deliverables as the project team or Division Management deems necessary. Division Management will review these deliverables at each gate and either approve progression to the next project phase, continue the project in its current phase pending completion of specific action items, or cancel the project. Gate approval shall be documented using the form found in Appendix 2.

Stable Production

Gate 1 Idea

Market Research

Concept Development

& Project Planning

Design & Development

Pilot Manufacture & Ramp-up

Concept Feasibility Idea

Generation Launch &

First Production

Gate 2 Feasibility

Gate 3 Planning

Gate 4 Design

Gate 5 Launch

Gate 6 Review


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5. DESIGN INPUTS

5.1 New Product Development

Design input information for all new product development projects is contained in the Marketing Requirements Specification.

5.2 Modifications to Existing Products

Existing product modifications are normally implemented to accommodate changes in customer requirements or technological advances. Whenever Marketing evaluations are done, Marketing will provide a written statement of product Marketing Requirements per Section 6.1. For minor product improvements to existing products, where Marketing evaluations are unnecessary, Engineering will provide design input requirements in place of the Marketing Requirements.

5.3 Customer Orders

The design information for special ordered products is provided by the customer’s design specification and/or order information. All customer orders requiring design activity are forwarded to the appropriate Engineering personnel in accordance with Order Entry procedures.

6. PROJECT INPUT DOCUMENTATION

6.1 Marketing Requirements Specification (MRS)

6.1.1 Marketing shall lead the process of establishing product requirements. These Marketing Requirements provide a preliminary set of specifications as the basis for subsequent design work.

This process shall:

(a) Determine the need for a product or service.

(b) Define the market need and extent of the market so as to provide a basis for establishing the product or service grade, quantity, price, and development timing.

(c) Determine customer requirements and provide an assessment of any unstated customer expectations or biases.

(d) Communicate all customer requirements clearly by providing a formal statement of the product or service requirements.

(e) Provide financial objectives including product cost, market price, price discount structure, and profit margin targets.


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6.1.2 These requirements shall be documented by a Marketing representative in an MRS and approved, signed, and dated by Marketing, Engineering, Sales, and Manufacturing senior management.

6.1.3 The MRS shall be revised as necessary to be kept current during the design process. Each revision shall also be approved, signed, and dated by those senior management functions approving the original specification. The MRS shall be identified and included in the product development project file along with all revisions and the reasons for all revisions.

6.2 Product Development Financial Evaluation

All NPD projects shall have a financial evaluation of the proposed product to be developed. Approval from the Regulator Division President authorizes the financial expenditures to develop the product. This financial evaluation may be incorporated with other project documents such as the MRS or AR. The financial evaluation shall be identified and included in the product development project file along with all revisions and the reasons for all revisions.

6.3 Technical Specification

At the beginning of NPD projects, a Technical Specification shall be established that translates the Marketing Requirements into technical requirements. It shall typically include the following:

(a) Performance characteristics

(b) Installation configuration or fit

(c) Attribute features

(d) Expected operating conditions

(e) Applicable codes, standards, third party approvals, and statutory regulations

(f) Durability, reliability, maintainability, and environmental requirements under the expected storage and operating conditions.

(g) Test and verification plan

(h) Acceptance and rejection criteria

(i) Design review requirements per EST 8


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(j) Safety review requirements per ES 264

6.3.1 The Technical Specification shall be of sufficient detail to permit the design activity to be carried out in a correct manner and to provide a consistent basis for making design decisions, for making design changes, and to be used as the design verification checklist. It shall be developed, approved, signed, and dated by both Marketing and Engineering senior management. The Technical Specification shall be revised as necessary to be kept current during the design process. Each revision shall also be approved, signed, and dated by both Marketing and Engineering senior management. The Technical Specification shall be identified and included in the product development project file along with all revisions and the reasons for all revisions.

6.4 Manufacturing Strategy

6.4.1 A manufacturing strategy describing the manufacturing systems required to meet the Market Requirements and Technical Specifications will be developed by the Manufacturing team member. In particular, the manufacturing strategy shall provide the methodologies, logistical systems, and processes required to meet customer quality and delivery needs, as well as product cost and technical requirements.

6.4.2 The manufacturing strategy will be approved, signed, and dated by Manufacturing, Marketing, and Engineering senior management. The Manufacturing Strategy shall be revised as necessary to be kept current during the design process. Each revision shall also be approved, signed, and dated by Manufacturing, Marketing, and Engineering senior management. The Manufacturing Strategy shall be identified and included in the product development project file along with all revisions and the reasons for all revisions.

6.5 Procurement Strategy

6.5.1 A Procurement Strategy will be developed that describes the material supply chain required to meet the Market Requirements Specification, Technical Specification, and Manufacturing Strategy. In particular, the Procurement Strategy shall identify key commodity classifications, target vendors, and material quality validation processes necessary to meet component technical, quality, delivery, and cost requirements. It will also identify material flow and inventory systems required to meet working capital utilization objectives.

6.5.2 The procurement strategy will be approved, signed, and dated by Procurement, Manufacturing, Marketing, and Engineering senior


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management. The Procurement Strategy shall be revised as necessary to be kept current during the design process. Each revision shall also be approved, signed, and dated by Procurement, Manufacturing, Marketing, and Engineering senior management. The Procurement Strategy shall be identified and included in the product development project file along with all revisions and the reasons for all revisions.

6.6 Project Plan

A plan shall be written that covers the detailed aspects of the project. It shall include the following at minimum:

(a) List of assigned Project Engineers and Project Team members.

(b) An outline or listing of the design and development activities required to accomplish the project objectives. This may be in the form of a PERT, GANT, or other useful charting means.

(c) An outline or listing of the verification activities required to assure conformance to all specifications.

(d) Identification of responsibilities for each design, development, and verification activity.

The Project Plan shall be reviewed and updated as NPD work progresses.

7. DESIGN STANDARDS

7.1 Design standards consist of Drafting Manual, Drafting Standards (DS), Engineering Standards (ES), Engineering Practices (EP), and McKinney Engineering Standards (EST). The purpose of these standards is to:

(a) Describe process procedures.

(b) Provide consistent design practices.

(c) Provide proper and consistent interpretation of national and international codes and standards, as applicable to Fisher products, where necessary.

7.2 These Fisher design standards shall apply, as applicable, to all product development, product redesign, and product support activities. Any deviation from this practice shall be documented in the Project File records or the Product Record File per EST 7, with specifically stated reasons for the deviation.

8. DESIGN PROCESS

8.1 General


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8.1.1 Design activities shall be documented in the product development project file per EST 7 to the level of detail necessary to permit the design process to be carried out correctly and to permit verification that the final design meets the design input requirements.

8.1.2 The product file shall contain sufficient detail to ensure traceability of the final product documents (EM's, drawings, etc.) to the design input and verification documents.

8.1.3 All new and revised standards go into effect at the date of release. All active product development project files shall be updated as necessary to be in compliance with the standards that are current at the time of product release to production, unless there is practical reason to deviate from this practice. Any deviation from this practice shall be documented in the project file records with specifically stated reasons for the deviation.

8.1.4 At the conclusion of the product development work, the project file will be put into proper form, per EST 7, and closed in accordance with the requirements of EST 7. The project file will then be labeled and permanently retained.

8.2 Design Calculations and Analyses

Design calculations and analyses shall be performed in a planned, controlled, and correct manner as delineated in EST 47. Calculations shall be retained in the project files per EST 7.

8.3 Material Selection

Material selection shall be based on suitability of materials as determined from the design inputs and design analyses. The basis for their selection and the material identification shall be clearly documented.

8.4 Purchased Parts Selection

The selection of purchased parts shall be based on their suitability as determined from the design inputs and design analyses. A description of the parts and the basis for their selection shall be clearly documented. When necessary to control quality, acceptable suppliers and any special processing requirements shall be specified on drawings or in Engineering purchasing specifications, such as the FMS's or FGS's.

8.5 Purchased Products Selection


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The selection of purchased products as OEM products for resale or as a special product to meet the requirements of a specific customer order shall be based on the appropriate design inputs and design analyses. A description of the products and the basis for their selection shall be clearly documented. When necessary to control quality, special processing requirements shall be specified on drawings or in Engineering purchasing specifications, such as the FMS's or FGS's.

9. DESIGN VERIFICATION AND VALIDATION

Products are designed according to marketing specifications developed from marketing research and planning. This market research establishes a range of application conditions and related requirements, which are intended to satisfy a wide variety of customer needs. These marketing specifications are then translated into measurable Technical Specifications which become the basis for the product design. Although there is some overlap in design verification and validation procedures, especially in the area of field testing, these activities are accomplished as outlined below.

9.1 Design Verification

9.1.1 Design verification is the process of reviewing, confirming, or substantiating the design by one or more methods to provide assurance that the design meets the specified design input requirements. When it is determined that the functionality of the product under actual process or service conditions cannot be adequately duplicated in laboratory tests, field evaluations are performed.

9.1.2 Each project resulting in a new or substantially modified product must undergo third party design audits per EST 24 and safety audits per ES 264. These audits should be completed after design activities are substantially complete for each project phase and prior to design reviews.

9.2 Design Validation

Design validation is the process of ensuring that the developed product conforms to defined user needs and/or requirements. This validation process is accomplished in the following manner. Application guidelines, developed by Engineering, are utilized to ensure that the customer's intended use falls within the capability of the product. In addition, each product, once it's released for production and sale, is assigned to a Product Engineer who is responsible for technical support of that product. This transfer of responsibility from the Project Engineer to the Product Engineer typically occurs within one to two years of production release. ES 250 defines the Product Engineering responsibility for each active McKinney Regulator product. The Project and


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Product Engineers ensure validation for customer intended use in a number of ways, including, but not limited to one or more of the following: consultation with Sales and/or the customer at the time of quotation; product revisions and/or retrofits due to Field Service Reports; on-site problem solving and consulting when the customer experiences an application problem with the product, and revision or modification of product application guidelines based on customer experience.

10. DESIGN OUTPUT

10.1 The design output shall be expressed in terms of requirements, calculations, and analyses and shall be documented in a Project file, in accordance with EST 7, which shall be permanently retained. The design output shall:

(a) Document compliance with the Technical Specification requirements.

(b) Contain or reference product production performance testing and inspection requirements along with the acceptance criteria.

(c) Show conformance to appropriate regulatory requirements whether or not these have been stated in the input information.

(d) Identify those characteristics of the design that are crucial to the safe and proper functioning of the product, such as product rating and application service limitations.

(e) Include or reference design documents as noted in Section 14.

10.2 Statistical Process Control (SPC) will be specified by Engineering on the drawing when it has been determined as the only way to produce a required feature. When it is determined that certain part dimensions must be controlled by the SPC process, the requirements shall be specified on the part drawing in accordance with the requirements of FGS 15A8. Manufacturing is required to use SPC on all part dimensions where it is specified, but may also use SPC, at their option, on any other dimensions that are not specified as requiring SPC.

11. PROCUREMENT OF SUBCONTRACTED SERVICES

11.1 The engineering for any or all parts of a component may be subcontracted; however, the Project Engineer is responsible for reviewing and approving all such subcontracted engineering. All communications with the subcontractor shall be handled in accordance with Section 12.

12. INTERFACE CONTROL


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12.1 Interface controls apply to Engineering communications with organizations performing work that affects design quality. Externally, this includes organizations such as customers, vendors, and subcontractors that provide criteria, designs, specifications and technical direction. Internally, this applies to organizational units outside Engineering NPD team members.

12.2 Lines of communication shall be established with each organization for the controlled transfer of design information. Preferably, only one individual per organization will be involved. All communications shall be made between these individuals and the Project or Product Engineer or other authorized person(s).

12.3 Design information transmitted to or from outside organizations shall be identified and documented in a transmittal letter. For design documents the document number and revision level may be sufficient. For other types of information a description of the information shall be provided. Where it is necessary to initially transmit design information orally or by other informal means, the transmittal shall be confirmed promptly by letter or other means that satisfies the above requirements. Copies of all written communications and notes of oral communications shall be retained in the Project File.

13. DESIGN REVIEW

All new designs or major modifications to existing designs shall undergo technical review prior to each gate in accordance with EST 8.

14. DESIGN DOCUMENTS

14.1 Design documents are used to define the technical characteristics of component parts and assemblies. Except in the case of special customer designs, the following design documents are required for all products that are released to production. It should be noted some of the required design documents, such as FFS's and FMS's, may already exist and do not need to be duplicated for each product.

(a) Drawings. Drawings refer to both assembly and detail drawings.

(b) Engineering Master (EM). EM's are lists of the various material and functional combinations available for a specific product. Including the parts list or bill of material required for specific product constructions.

(c) Product Rating. Product Ratings delineate limitations, such as pressure and temperature, for the various material combinations available for a specific product. For pressure vessels they also include the hydrostatic test pressure and duration.


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(d) Fisher Finishing Specification (FFS). FFS's are used to specify surface finishes, such as platings, painting, etc. that are not covered in the Material Reference Number specification data. These specifications are not required if the needed information is provided elsewhere, such as on the drawings.

(e) Assembly and Test Specifications. These are used to specify methods and procedures for general product manufacture.

(f) Fisher Material Specification (FMS). FMS's are used to specify material specifications and heat-treatment conditions not covered by industry specifications (ASME, ASTM, SAE, etc.) in the required detail.

(g) Instruction Manual Assembly and Operating Instructions. These special instructions may include descriptions of the assembly, installation, disassembly, inspection, and maintenance of components.

14.2 Pertinent parts of the following documents are used in the preparation, review and approval, issuance and distribution, storage and control, and revision of design documents:

(a) Drafting Manual

(b) Drafting Standards

(c) Engineering Standards

(d) Engineering Practices

(e) Engineering Standards McKinney

15. PRODUCTION RELEASE

Production is authorized for all new or substantially modified products upon Gate 5 – Launch approval by Division Management.

16. DOCUMENT CONTROL

Publications such as codes, standards, and specifications (ASME, ANSI, ASTM, API, DIN, etc.) and Fisher standards (ES's and DS's) used in the design process shall be identified and controlled in accordance with ES 242.

17. DESIGN CHANGE CONTROL


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17.1 All design changes identified in this section should be reviewed and approved by the same individual or group that reviewed and approved the original design documents. If product responsibility has been transferred, the newly designated individual or group shall have access to pertinent background information, have demonstrated competence in the specific design area of interest, and have an adequate understanding of the requirements and intent of the original design.

17.2 Design changes, including those made by the Product Engineer during the product support phase, and non-conforming items dispositioned "use-as-is" shall be justified and subject to design control measures commensurate with those applied to the original design. These measures shall include assurance that the design analyses for the structure, system, or components are still valid.

17.3 If calculation errors are discovered in the project record files, the Project or Product Engineer responsible for the product shall revise the calculations and document the revision in the Project file.

17.4 All changes to Engineering documentation shall be processed in accordance with the change procedures established in ES 2 and ES 192.

17.5 Special parts that are modifications of existing parts may be made for special customer application and approved by the Engineer responsible for the particular product without further supporting documentation other than the drawings, provided that the original Project File design documents contain appropriate design verification documentation applicable to the special modified parts. If the original product development records do not contain appropriate design verification documentation, then the necessary verification shall be performed and permanently filed with the original Project File design documents in the Product Record File per EST 7.

17.6 Once a product Design or Type number has been assigned and the product is released to production, the product design is considered to be fixed. Any revisions to the product are then limited such that interchangeability of form, fit, and function in accordance with ES 26 is maintained.

17.7 Additions to a product, by additional drawings, may be made such as the following:

(a) Special body end-connections.

(b) Special trim designs such as special flow characteristics, noise control, or cavitation control.

(c) Special part materials.


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(d) Special bonnet designs such as to accommodate special packing arrangements.

(e) Special brackets for pilot or instrumentation mounting.


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APPENDIX 1: NPD Phase Deliverables

Market Research & Idea Generation Concept Feasibility

Concept Development &

Project Planning



Launch & First Production

Project Timeline (estimate of next

phase)

Updated Timeline (estimate next phase)

Updated Timeline (estimate of remaining

phases)

Updated Timeline (estimate of remaining

phases)

Resource plan Updated resource plan Updated resource plan Updated resource plan

Project Budget Updated project budget Updated project budget Updated project budget

Risk analysis & mitigation plan

Updated risk analysis & mitigation plan



Product cost estimate Updated product cost estimate

Updated product cost estimate

Final product costs Product cost management

Draft AR Approved ARComparison of financial

forecast to actual results

Alternatives analysis Updated alternatives analysis

Updated alternatives analysis

Updated alternatives analysis

Project evaluation

Exhibit 10M Updated Exhibit 10M Updated Exhibit 10M Updated Exhibit 10M Updated Exhibit 10M Updated Exhibit 10M

A. Project Management



Project Planning




Market Assessment Updated Market Assessment

Updated Market Assessment

Updated Market Assessment

Preliminary Marketing Requirements

Secification

Updated Marketing Requirements Specification

Updated Marketing Requirements Specification

Final Marketing Requirements Specification

Value proposition Updated value proposition

Value based pricing strategy and plan

Updated value based pricing plan

Final value based pricing Price Management

Competitive assessment

Updated Competitive assessment



Customer analysis Key Customer Agreements MARCOM strategy MARCOM

Product lifecycle and phase out plan

Updated Product lifecycle and phase out

plan


plan


planProduct lifecycle plan

Preliminary sales forecast Updated sales forecast Updated sales forecast Updated sales forecast Final sales forecast Forecast managemnt

Marketing


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Project Planning




Feasibility analysis & technology dev. needs Prototype design

Detail drawings, specifications, and

BOMCustomer field tests

Preliminary Technical Specification

Updated Technical Specification

Updated Technical Specification

Updated Technical Specification Third party approvals

Competitor technology assessment

Updated competitor technology assessment

Concept validation testing

Fabricated and tested prototypes

Validation tests on pilot production units

Preliminary Design FMEA Updated FMEA Updated FMEA

Preliminary design caculations and

computer analysis

Final design caculations and

computer analysisAlternative

technologies assessment

Development plan and level of effort Safety reviews

Concept design reviews & audits

Development design reviews & audits

Final design reviews & audits

Intellectual property analysis Patent analysis Patent status review Patent status review Patent status review

Engineering



Project Planning




Procurement strategy Updated procurement strategy

Updated procurement strategy

Updated procurement strategy

Preliminary inventory plan Updated inventory plan Updated inventory plan Updated inventory plan Final inventory plan Inventory management

Procurement feasibility assessment

Design review for sourcing

Qualification and FA approval for all parts

Key supplier identification

Key supplier engagement

Identify suppliers for non-key component

partsPurchased material and supplier tooling

cost estimates

Updated purchased material & supplier

tooling cost estimates

Updated purchased material & supplier

tooling cost estimates

Final purchased material costs

Cost containment assessment Cost containment

Procurement & Materials


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Project Planning




Manufacturing strategy Updated manufacturing strategy

Updated manufacturing strategy

Updated manufacturing strategy

Manufacturing work instructions

Manufacturing feasibility assessment

Manufacturability design review

Process quality control plan

Test fixtures and equipment

Preliminary manufacturing process

design

Final manufacturing process design

Pilot production build & verification

Volume production start-up

Preliminary Process FMEA Final Process FMEA

Manufacturing review and release

Manufacturing



Project Planning




Design review for quality



Assessments to product quality plans

Updated Quality assessments

Product quality specifications

Confirmation of Product quality specifications

Assessments to material quality plans

Quality verification plan Supplier and material quality plans

Assessments to process quality plans

Preliminary financial analysis

Updated financial analysis




Product cost evaluations and project

costs audit


costs audit


costs audit


costs audit


costs audit

Customers for field testing Updated sales plans Customer introductions

Sales order process Sales automation tools

Field sales training plan Field sales training

Quality

Finance

Sales


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Gate 1 Idea

Market Research

Concept Development

& Project Planning

Design & Develop-

ment

Pilot Manufac-

ture & Ramp-up

Concept Feasibility Idea

Generation

Launch & First

Production

Gate 2 Feasibility

Gate 3 Planning

Gate 4 Design

Gate 5 Launch

Gate 6 Review

Stable Production

APPENDIX 2: GATEKEEPERS/SIGNOFFS Gate ____ Decision & Metrics

� Project Leader:

� Product Description:

� Gate Schedule vs. Plan:

� FINANCIAL ANALYSIS:

� Risk Assessment ( High – Red, Medium – Yellow, Low – Green )

Gatekeepers/Sign-offs President Date

VP Finance Date

VP Business Unit Date

VP Engineering Date

VP Operations Date � Issues:

VP Materials Date � Funding Committed:

Idea Feasibility Planning Design Launch Review Original: / / / / / / / / / / / / Previous: / / / / / / / / / / / / Current: / / / / / / / / / / / /

Idea Feasibility Planning Design Launch Review Total Sales: Total COGS: Incremental Sales: Incremental COGS: Gross Profit: SGA: Project Expense: Operating Profit: Other Income (Deductions): Capital Investment: Depreciation: Increase (Decrease) in Working Capital: Cumulative Cash Flow NPV

Risk Status Mitigation Plan

� Advance the Project to the Next Phase – Go

� Complete Additional Action Items

� Discontinue the Project


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VP Sales Date � # of Resources Needed for Phase :

� Target Date for Gate :


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RELEASE/REVISION RECORD

Release/Revision: A

Date: 12-19-83

Written by: Jim B. Griffin

Approved: Don Rice

Date Approved: 12-1983

Department: Engineering

Revision: M

Date Revised: 27 January 2006

Revised by: Marla Newman

Checked by: Dave Woollums

Date Checked: 27 January 2006

ECRN: 060128

Reason: Update to reflect phase gate new product development process.

Product Realization & Quality Planning Use the following links to understand what should be considered when launching a product, process, or significant project

Planning Considerations

Technical Review (Bologna)

Launching A Product In Shanghai

Updating A Product Line In Shanghai

Planning Considerations 4.1 (including control of outsourced processes), 5.4.2, 6.1, 6.3, 6.4, 7.5.1c (ensuring equipment is suitable), 7.1, 7.5.2 (establishing special processes), 7.6 (measuring device needs identified), & 8.1 (establishing statistical techniques)

Revision: 6/30/2005

DEFINITIONS: Process - A series of events or planned arrangements intended to produce a desired result. An example of this is the process employed for producing a product or the Manufacturing Order (MO) or Rework Order (RO). The Manufacturing Order or Rework Order outlines the materials/equipment needed and any operating parameters to be used to produce the product. Product/Part - Any item produced to meet Fisher Regulator and/or customer requirements. Project - A significant event that needs to be planned for the sake of ensuring a successful outcome will be achieved. Projects may involve the introduction of new processes or products.

PURPOSE: To understand the activities needed to successfully plan for the identification, application, sequence/interaction, implementation, and fulfillment of the business model (a.k.a., quality management system or QMS), products, processes, and projects needed to meet customer requirements and continually improve the effectiveness of Fisher Regulator's QMS.

NOTES: 1. The planning activities in this flowchart are the considerations we need to evaluate each time we develop a new product, introduce a new/modify an existing process, outsource a process affecting product or service quality, or try to implement a significant project (ISO, facility moves or expansions, new computer systems, etc.) at Fisher Regulator, ensuring the integrity of the QMS throughout the process. If we fail to plan, then we should plan on failing. 2. When we establish a plan, it needs to be documented (output of planning) so we can understand what the product, process, or project is supposed to look like when it is done (quality objectives/product requirements), including the recognition of sequence/interactions of processes, as necessary. Manufacturing Order (MO), Rework Order (RO), quality/control plans (when required), timelines, flowcharts, Quality Planning Worksheet, and/or checklists are a few of the ways we can document a plan. Whichever we use, allow for updates so we can see where we are and what is left. 3. CRITERIA: (as applicable) - Do we understand and have we established the process? - Do we have the equipment and/or tooling needed to do the job? - Do we have what it takes to verify (inspect or test) the results? - Do we have the right people for the job (skills, education, training, or experience)? 4. CRITERIA: - Will the absence of documented procedures detailing the activities to be performed have an adverse affect on quality, reliability, and/or our ability to meet requirements? - Will the process require validation because we cannot completely ensure the product will meet all requirements through the inspections or tests we perform (special process)? If the answer to the second question is "Yes," refer to the "Establishing a Special Process" flowchart included in this document. 5. Items included in a documented process are shown throughout this flowchart. Additional considerations are shown in the Quality Planning Table included in this document. 6. The "Resource Management" section of this procedure describes the considerations and methods used to identify and provide for resources. If the resource involves new personnel, make sure we have a job description/training plan describing the need so we can hire someone with the right education, experience, training, and skills. 7. CRITERIA: (ensuring the integrity of the QMS is maintained) - Can we introduce this new product without having an adverse effect on existing products? - Can we introduce this new process without having an adverse effect on existing processes or products? - Can we introduce this new equipment or software without having an adverse effect on existing equipment, software, or products? 8. When introducing a new product, process, piece of equipment, or software causes a conflict with what we already have or do, we need to try to understand this ahead of time and work on a solution before it becomes a problem. In some cases, it causes us to rethink the allocation of resources. Exploiting our weaknesses before they exploit us!

9. CRITERIA: - Will existing inspection and/or testing methods provide a means for verifying the desired results have been achieved? - Do we have the necessary measuring and monitoring equipment for the inspections and/or tests to be performed? - Have we determined when an inspection and/or test is to be performed and have we established methods for ensuring it will be performed at the appropriate time? - Have we decided to do 100% inspection or testing instead of using statistical techniques such as sample plans or control charts (SPC)? - Do we have documented acceptance criteria? - Have we determined how we will demonstrate (prove) conformance to specified requirements (acceptance criteria) or show (prove) our business model (QMS) is operating effectively? If the answers to either the first or second question is "No," and we are not going to be able to put these things in place, refer to the "Establishing a Special Process" flowchart included in this document. 10. Based upon the types of shortcomings derived from the series of questions in note 9, develop the necessary inspection/test methods, inspection or test stages, acceptance criteria (including clarification of those that are subjective), and the records to prove we have fulfilled requirements. Three things to keep in mind when assessing and fulfilling these needs: - When determining the inspection or test to be used, new instrumentation (testers, measuring or monitoring devices, etc.) may be needed, - If we are not doing 100% inspection or test or are instituting statistical process control (SPC), the techniques used (sample plans, control charts, etc.) need to be defined and implemented so they are consistently applied, and - Sometimes there is no known method or instrument currently available for the inspection or test being performed. When we don't have the capability (or it does not currently exist), we have to figure out what the appropriate method or instrument is and acquire it in time to be able to verify we have achieved the desired results for the new product, process, or project. 11. When the planning process is complete (typically when the product, process, or project is finished), file the records per requirements outlined in the records section of the Master Control Plan. When this involves products or projects, we are showing we met desired results. For equipment and/or processes, we are showing it is approved for use.

QUALITY PLANNING TABLE

Along with the considerations described in this procedure, the following items should be considered and addressed, as applicable, when developing documentation associated with planning activities for

products, processes, or projects.

PRODUCTS (Items needing to be addressed in the Manufacturing Order (MO) or Rework Order (RO), as

applicable.) • Determine if existing methods for identifying product (including those related to preservation)

are sufficient or if the customer has additional requirements. • If traceability is a specified requirement (and exceeds our current method of traceability),

include provisions that ensure we will live up to the expectation. • Include references to requirements that must be lived up to and are not part of the drawings or

specifications. • Establish steps for inspections or tests to be performed at the necessary stages. • Include any special handling, protection, and shipping (including packing, packaging, marking,

and delivery) requirements. • Determine if any new production processes are required that will need to be designed,

implemented, and validated. Also consider preventive maintenance and process control requirements.

In some cases, it makes more sense to address these items in process documentation (see the

Processes & Projects section of this table).

PROCESSES & PROJECTS (May be addressed in a business model documentation (QMS), timeline, Quality Planning Worksheet,

flowchart, or other means of expressing the plan.) • Establish revision control for any documents developed that should be included in the business

model (when the absence of that detail could have an adverse effect on quality). • Determine if existing methods for identifying process or project outputs (may be product) are

sufficient. • Consider special requirements imposed on us by the customer and/or any regulatory or legal

requirements. • If a process or project has special traceability requirements (typically involves products),

include provisions that ensure we will live up to the expectation. • Ensure any equipment introduced as a result of the new process or project is suitable, used in

a suitable environment, and have established and implemented maintenance requirements. • Ensure compliance with reference standards/codes, quality plans, and/or documented

procedures. • Determine and implement the methods needed to monitor and control process parameters

and/or product characteristics.

Establishing a Special Process 7.5.2

NOTES: A. A special process is any process where it cannot be proven that Fisher Regulator has met applicable requirements (customer, legal, regulatory, etc.) by verifying the resulting output. When this is the case, we have to know the process employed, the equipment used, and the people performing the task are capable of achieving the desired results. In other words, when we cannot prove we have met the applicable requirements because we cannot inspect or test the item in a way to prove it, we have to know (prove) the process, the equipment, and the people can do it without the proof of a definitive inspection or test. B. As we begin to develop a process, we need to define the criteria to be used to review and approve the process. These includes: - approving the equipment, - qualifying the people, and - approving any methods/procedures. In essence, we need to provide a basis for saying each of the items is valid and will ensure we meet the requirements. C. Equipment approval may be through calibration of settings and/or by producing a test piece and having it validated (i.e., sending the test piece out for testing). D. Personnel qualifications can be achieved through an internally established testing process that coincides with methods used for equipment approval. When this is not the case, industry-related certifications tend to be the methods used. E. Methods are the types of processes employed, the equipment needed, and the series of events sequenced. Procedures are the documents developed to address these issues, ensuring we have the information needed to consistently apply the methods. F. Records need to be maintained showing the methods and equipment used and the people using those methods and equipment are qualified. We make sure those records are included in the records section of the Master Control Plan. G. Revalidation needs to be performed within a timeframe allowing us to prove the methods, equipment, and people involved are still capable. While we get to set the timeframe, we need to make sure we have systems in place to see it through. These items can be added to the maintenance schedule, calibration schedule, or can be maintained by the affected manager.

NOTES: 1. Management utilizes the following sources of information to assess the need for additional resources and to determine the types of resources needed to enhance customer satisfaction by meeting customer requirements: - Customer-Related Processes, - growth projections, - preventive/corrective actions, - area management insight, and - quality/delivery issues. 2. Informing upper management of a need is typically verbal, but may be a memo or plan (see page 1) justifying the need, if deemed necessary. The process stops here if management says "no." If considered to be a capital expenditure, executive management would validate the need. 3. CRITERIA: - Can someone already here meet the need? - Can we afford to move someone here without sacrificing our existing process? 4. Moving internal human resources may or may not require replacement. If replacement is needed, complete the process. 5. CRITERIA: - Are we going to use a temporary agency to fill the need? If yes, follow the connector to Purchasing. This is where we make sure the temporary agency is an approved vendor. 6. Hired employees are located by and employed through: - word of mouth - walk-ins - employee referrals - temp-to-hire - advertising Once the need is met, identify and provide training per the Training procedure. This procedure also

addresses responsibility and authority.

7. Purchasing activities are typically accomplished by following the Purchasing procedure. However, where arrangements exist, we may simply be invoiced by a Temp Agency based upon the terms of the contract noting the number of hours their Temporary worked. Remember to follow the Training procedure, if we are bringing in a temporary employee or implementing additional equipment. 8. Don't forget about the considerations included throughout this document when introducing new equipment, facilities, or processes. 9. All maintenance activities are facilitated by Maintenance. When service agreements are involved, make sure the service provider is listed as an approved vendor (see Purchasing) if the service affects product quality or delivery.

Launching A Product - Shanghai 4.1, 5.4.2, & 7.1

Revision: 6/30/2005

NOTES: 1. May be a new product from Design or a transfer of a product line from another facility. 2. Planning Considerations may be used to facilitate effective product realization. 3. This includes the development of process documentation (work instructions, forms for verification, etc.) on the line and any product specific objectives. If this involves a line transfer, the layout would generally mirror that of the layout from the location the line was transferred from and the process documentation from the other site is translated and updated to fit the process we will employ. 4. While it is possible for process related documents to be approved as a quality management system document (i.e., in the same way as the other procedures, work instructions, and forms), we tend to approve documents directly related to a product line as part of approving the product line. See note 7 to understand how document control is maintained. 5. For the most part, this is through an operator certification that we develop during the initial set-up but it can be through the other methods for providing training defined in the Training procedure. 6. See the “verification” section of Design & Development. 7. The release meeting include the part approvals of Manufacturing Engineering, Manufacturing, and Materials at a minimum. This approval includes the approval of process documentation (work instructions, forms, illustrations, etc.) that are part of the layout of the line. Review occurs as part of internal audits (see Auditing), with any changes handles as described in Updating A Product Line (including re-approval and identification of the changes). Revision status of these documents is based on the fact that they are the only ones in existence and are part of the line (this also makes sure the documents are available at points of use). Legibility and identifiability are maintained through internal audits (see Auditing). Obsolete versions are removed and discarded. If obsolete documents are retained, they are marked as obsolete to prevent from unintended use. 8. Manufacturing management takes into consideration maintenance recommendations from the manufacturer of equipment, developing preventive maintenance activities and records as deemed necessary.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "PFMEA" box "7.1b" & "7.1c" referenced. This means the notes or documents referenced, address some or all of the requirements in 7.1b & 7.1c. Blue, hyperlinked, &/or italicized words are referencing other documents.

Updating A Product Line - Shanghai 4.1, 5.4.2, & 7.1

Revision: 6/30/2005

NOTES: 1. CRITERIA: - Will we need to change the process or equipment on the line? - Will the updating of process documents (work instructions, illustrations, forms, etc.) change the expected outcome of the process? 2. Simply means the change will not affect process performance (e.g., a change to a work instruction is only to make the work instruction more accurately reflect what we do) and we need do nothing more than acknowledge the change. 3. Includes adjustments to Kanbans (internal and those with suppliers) and the development of process documentation (work instructions, forms for verification, etc.) on the line and any product specific objectives. as needed. Planning Considerations may be used top facilitate effective product realization. 4. While it is possible for process related documents to be approved as a quality management system document (i.e., in the same way as the other procedures, work instructions, and forms), we tend to approve documents directly related to a product line as part of approving the product line. See note 7

to understand how document control is maintained.

5. For the most part, training is through an existing operator certification that we update during the set-up but it can be through the other methods for providing training defined in the Training procedure. 6. See the “verification” section of Design & Development. 7. The release meeting includes the part approvals of Manufacturing Engineering, Manufacturing, and Materials, as applicable to the need for approval (at Manufacturing Engineering’s discretion). This approval includes the re-approval of process documentation (work instructions, forms, illustrations, etc.) that are part of the layout of the line. For the most part changes are identified through training personnel to the updated document, but may simply be letting them know we made the change when the change is only to make the document reflect what they are already doing. Revision status of these documents is based on the fact that they are the only ones in existence and are part of the line (this also makes sure the documents are available at points of use). Obsolete versions are removed and discarded. If obsolete documents are retained, they are marked as obsolete to prevent from unintended use. 8. Manufacturing management makes adjustments to maintenance activities in place as needed, taking into consideration maintenance recommendations from the manufacturer of equipment and developing preventive maintenance activities and records as deemed necessary.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Update Control Plan" box with "7.1a" & "7.5.1a" referenced. This means the notes or documents referenced, address some or all of the requirements in 7.1a & 7.5.1a. Blue, hyperlinked, &/or italicized words are referencing other documents.

Document & Records Control 4.2.3, 4,2,4, & 5.4.2b

Revision: 3/26/2006(description of changes - Added reference to ES-242 for control of external documents)

DOCUMENT CONTROL 4.2.3 (required procedure 4.2.1c)

With respect to quality management system (QMS) documents (this manual and associated procedures), the document control flow shown in this document and the Master Control Plan (a master list of documents noting the revision status) cover document control requirements. While the main documents defining the QMS are controlled as defined above, additional QMS documents and Engineering documents (such as those beginning with letters designating what they are for, like "FMPT", "FGS", or "EST") documents are controlled through E-Docs per ES2 (Method of Revising Drawings and Other Engineering Documents), DS 40 (Drafting Standard) and ES192 (Engineering Change Request Procedure). Control of localized documents (typically those maintained in a book in the area) are handled through Document Control & Approval - Area Specific Instructions. When the process is documented by the way it is laid out, including illustrations, the control of documents and the process may be based on the approval of the line (E-Docs in McKinney and Launching A Product and Updating A Product Line for Shanghai). External documents are controlled as defined in ES-242.

RECORDS CONTROL 4.2.4 (required procedure 4.2.1c)

While the records section of the Master Control Plan addresses the procedural aspects of records, there are a few other things that need to be considered. - A record is evidence we maintain to show conformance to a requirement and/or to show our system (this Business Model and supporting documents) is operating effectively. - When completing a record, we need to make sure we write clearly. If the record is not legible (readable), then it will not be able to act as the evidence it is intended to be. - We also need to be able to identify the records (i.e., understand they are records) and retrieve them. The records section of the Master Control Plan is the road map to all records (including those called for throughout ISO 9001:2000). From this list, we are able to identify which documents are records. This, coupled with the fact the records section of the Master Control Plan includes our method of indexing each record and who we should see if we need access to them (retrievability), ensures we are in control as it relates to records.

This flow covers the controls associated with quality management system documents (manual, procedures, etc.) not already controlled through E-DOCS and may include some external documents (such as ISO 9001:2000 or other reference standards directly related to the quality management system). All other documents are controlled as defined above.

CLARIFICATIONS: Adequate (as it relates to internal documents) - The document says what we do, addresses requirements we are trying to live up to, does not contradict or negatively affect the integrity of the quality management system, and all references and titles match up (congruency). Adequate (external documents) - We understand how the document relates to us, are willing and able to live up to the requirements, and the document clearly identifies itself. MCP - Master Control Plan. New or updated - In most cases, new or updated is referring to documents we create or change. When an external document is involved, we simply need to recognize the need to deal with the external document. Record - We use the information collected (recorded) to prove we are living up to an expectation. Review (4.2.3b), available (4.2.3d), legible and readily identifiable/retrievable (4.2.3e & 4.2.4) - We review documents (ensuring continuing suitability, adequacy, and effectiveness) and assess whether personnel can find those documents and records they are supposed to have or maintain (available and identifiable) and if the same documents and records can be read (legible) as part of internal audits (see Audit Report Summary). Syscopy - Syscopy stands for system copy and means the current document on the system is the latest and greatest document.

DocumentControlApproval Revision: 11/11/2004 Page 1 of 1

PURPOSE: To ensure that all area-specific documents are controlled.DEFINITIONS:Adequacy - Says what is necessary to meet the requirements of the standard, our customers &/or the Fisher Regulator way of doing business; is achievable & does not contradict other documents (maintains the integrity of the system).NOTES:1. Area management or designee maintains a master copy of the area-specific documents (standard operating procedures, forms, etc.). This "master copy" includes a completed copy of this document.2. Approval (see adequacy) occurs when a document is inserted into the "master copy." Revision control is two fold. All of the documents in the "master copy" on the day of approval are the current version. When a change occurs after approval and prior to the annual audit (review and re-approval), they are noted on this document and inserted into the "master copy."3. Distribution to other books in the area is noted on this document.4. Review is an annual process and follows the activities described in the "Annual Audit" section of this form. Upon successful completion, a new copy of this form is inserted into the "master copy" and the form showing the audit as complete is filed as a record. 5. When changes are necessary (documents do not reflect what we do or are supposed to do), documents are updated and re-distributed to those listed below. Changes are also noted below.6. When updating a document, make sure that obsolete copies are discarded or are suitably identified (i.e. obsolete, down rev, or some other intuitively obvious marking on the document).

4.2.3f of ISO9001:2000 is not applicable to this page, as we are not speaking of external documents.

See note 1.

Master copy of area-specific documents

Approval & revision control

by area management or

designee4.2.3a-c & 5.4.2b

Issue document4.2.3d

Document review (internal audits)

4.2.3b & 4.2.3e

Changes required?

4.2.3b

Update documents & ID

changes in master copy4.2.3b & 4.2.3c

Deal with obsolete

documents4.2.3g

YES

NO

See note 2.

See note 3.

See note 4.

See note 5.

See note 6.

DID YOU KNOW!

Numbers shown throughout this document are clause numbers from ISO9001:2000 that are being fulfilled by the activities

related to the step or note that is referencing the clause. An

example of this would be the "Issue document" box with

"4.2.3d" referenced. This means that the notes or documents

referenced, address requirements related to 4.2.3d

of ISO9001:2000.

COMPLETED FORM TO BE KEPT IN THE "MASTER COPY."Remember to train affected personnel to the change when a change in behavior is expected.

Area:________________________________ Date of Approval/Re-approval:_______________________

Description of Changes (note the title of the document that changed and what changed):

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

Hard copy(s) distributed to the following areas, ensuring availability (as needed):

________________________________________ ________________________________________

________________________________________ ________________________________________

________________________________________ ________________________________________

________________________________________ ________________________________________

ANNUAL AUDIT (done at least once every 13 months)A. Using the "master copy," verify that the distributed copies match the "master copy" by randomly sampling (compare approximately 5 documents at each distribution point) with the "master copy to ensure that they match.B. Using the "master copy," verify that any changes (noted above) have been distributed and that the distributed copies match the "master copy."C. While reviewing documents at the distribution points, verify that the documents reviewed were readily identifiable (easy to find) and legible (easy to read).

Audit-related Comments (including actions taken to resolve problems, when they arise):

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

Completed by:________________________________________ Audit Date:______________________

Use

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or a

dditi

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pag

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for a

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Try

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Document Control & Approval – Area Specific Instructions 4.2.3 & 5.4.2b

Current as of:

PROTECTION

INDEX ACCESS FILE STORE MAINTAIN RETENTION DISPOSITION

Document Description/Title (Primary Recognition) also known as Process Name and/or Records Identification

Distribution is for the most part controlled electronically (online). Distribution of an individual document (where we are maintaining copies) is included as an embedded

"comment" in the description for that document.

Revision If we are only controlling the

document as a record (typically the case for

records from subcontractors), the

revision is N/A.

Document ApprovedInitials of IM

Rep Is it

a R

ecor

d?

What is the order in which these records are indexed?

Who has primary

respon. for controlling

access to/retrieval of

these records?

In what physical area

are these records filed?

(short-term filing)


are these records

stored? (long-term storage).

How are these records

protected? (filed hard

copies, system backed-up files, etc.)

How long are these records kept in long-

term storage? (min time)

What is to be done with the records when the retention time expires?

ISO 9001:2000 (industry standard/external document) 12/13/2000 DVK

A Brief Look At Using This Audit System 2/20/2004 DVK

Audit Procedure 10/13/2004 DVK

Audit Report - Customer Property 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Customer-related Processes 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Design & Development 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Document & Records Control 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Improvement Systems 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Internal Audit System 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Maintaining Calibration 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Management Commitment 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

CORPORATE (McKinney)

This section tends to serve as the list of controlled Quality Management System (QMS) documents (those documents developed to explain our company in relation to ISO9001:2000), but can be used to list records

where we do not control the format. In other words, evidence we have to maintain but do not have complete control over the way it is formatted is also listed to recognize how we identify the fact it is a record and needs

to be controlled.STORAGERETRIEVAL

Master Control Plan - McKinney6/25/07 2:49 PM

Document List Records Controls

Italicized font = Relational perspective to ISO9001:2000 4.2.4

MasterControlPlan Revision: 7/14/2004 1 of 16

Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Audit Report - Nonconformance Control 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Production & Service Provision 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Purchasing 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Quality Management System 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Realization Planning 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Special Processes 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report - Training 2/12/2004 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Audit Report Summary 2/12/2004 DVK *Audit Report Supplemental 3/6/2006 DVK *

Audit Schedule - Annual Plan 2/12/2004 DVK * Year Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies Current Year Discard

Audit Schedule - Team Audit of Entire System 2/16/2004 DVK * Event Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 6 months Discard

bill of lading System Copy DVK

Business Model (Quality Manual) 6/25/2007 DVK

business performace review (inputs to management review) N/A DVK * Date Corporate Staff Network Network Backed-up electronically 1 Year Delete

As an attachment to the Audit Report

As an attachment to the Audit Report


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














business system software System Copy DVK * Data tables Area of responsibility System System Backed-up

electronically until updated Overwrite

Brazing 5/3/2006 DVK

Calibration Methods Tables System Copy DVK

Calibration records from vendors N/A DVK * Device number Quality Calibration Lab Archive Filed Hard Copies 5 Years Discard

Certs (the process) 11/19/2004 DVK

Certs - Product System Copy DVK * Shipper Number Quality Tech Quality Office Archive Filed Hard

Copies 10 Years Destroy

Certs - Vendor N/A DVK * Foundry Number Quality Tech Quality Office Archive Filed Hard


CMTR Request Form Initial Release DVK *Corrective Action Report System Copy DVK *

Corrective/Preventive Action Request (MCK 2148) November '03 DVK * Number Quality Quality Quality Filed Hard Copies 3 Years Destroy

Customer Owned Property Log 11/1/2004 DVK * Date Return Goods Returned Goods

Returned Goods

Filed Hard Copies 1 Year Discard

Customer Property 3/18/2006 DVK

Customer Related Processes 6/25/2007 DVK

Customer-Related Processes - Industrial & Natural Gas - McKinney 3/26/2006 DVK

As and attachment to the MO


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Customer-Related Processes - Propane - McKinney 11/12/2004 DVK

Customs - Trade Partnership Against Terrorism Initial Release DVK

Daily Control Log 11/11/2004 DVK * Date Paint Paint Paint Filed Hard Copies 1 Year Destroy

Design & Development 7/19/2005 DVK

design records (product development project file) N/A DVK * Project Project Manager

Project Manager Office Archive Filed Hard


Document Control & Records Control 3/26/2006 DVK

Document Control & Approval - Area Specific Instructions 11/11/2004 DVK * Area Area Mgt Area Area Filed Hard Copies Each Audit Discard

E-Docs System Copy DVK

employee based training records N/A DVK * Employee HR &/or Area Mgt

HR or Area Mgt Office Archive Filed Hard

Copies7 Years or until

updated Destroy

Engineering Change Request Notice (ECRN) System Copy DVK * ECRN # Engineering On-line On-line Backed-up electronically 20 Years Delete

event based training records N/A DVK * Event HR &/or Area Mgt

HR or Area Mgt Office Archive Filed Hard

Copies7 Years or until

updated Destroy

Exporting - McKinney 3/16/2006 DVK

First Article Inspection July '02 DVK * Part # QA QA QA Filed Hard Copies 5 Years Destroy

FIX System/Report System Copy DVK * Fix # Return Goods On-line On-line Backed-up electronically 3 Years Delete


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Flow Group Supplier Quality Manual Folder Maintained as its own system DVK

GagePack System Copy DVK * Device number Quality Quality Quality Backed-up electronically 3 Years Delete

Global Consistency 4/10/2006 DVK

Improvement Systems 6/5/2005 DVK

Improvement Systems - McKinney 5/3/2006 DVK

Machine Shop 11/22/2004 DVK

Management Review 10/12/2005 DVK

Management Review Marix 10/14/2005 DVK * Date Management Quality Quality Filed Hard Copies 1 Years Destroy

Management Summary 2/17/2004 DVK *

Manufacturing OrderControlled as part

of business system software

DVK * Date Shipping Shipping Archive Filed Hard Copies 2 Years Destroy

Monitoring & Measurement Devices (Calibration) 2/7/2006 DVK

Nonconformance Control 6/23/2007 DVK

Opening Closing Meeting Attendance Sheet 2/12/2004 DVK

Operation Skills Matrix System Copy DVK * Employee Mfg Mgmt Network Network Backed-up electronically until updated Updated

Attachment to Management Review


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Order - Industrial & Natural Gas - McKinney System Copy DVK * Order # Customer Service System System Backed-up

electronically 1 Year Delete

Order - Propane - McKinney System Copy DVK * Order # Customer Service System System Backed-up


Order Acknowledgement - Industrial & Natural Gas - McKinney System Copy DVK * Order # Customer

Service System System Backed-up electronically 1 Year Delete

Order Acknowledgement - Propane - McKinney System Copy DVK * Order # Customer Service System System Backed-up


Organization Chart System Copy DVK

Packing slip N/A DVK * Vendor Finance Finance Finance Filed Hard Copies 6 Months Discard

Paint 12/3/2004 DVK

Paint Log Initial Release DVK * Date Paint Paint Paint Filed Hard Copies 1 Year Destroy

Paint Quality Checklist (MCK 2057) April '01 DVK * Date Paint Paint Paint Filed Hard Copies 1 Year Destroy

Part Approval Process 4/10/2006 DVK

Parts To Outside Vendors 2/12/2005 DVK

Parts Warehouse 3/18/2006 DVK

Planning Considerations 6/30/2005 DVK

PO receipt in the Business SystemControlled as part


DVK * PO # Receiving On-line On-line Backed-up electronically 2 Years Delete


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Pressure Equipment Directive 5/27/1997 DVK

Production Process Overview - McKinney 6/23/2007 DVK

Pull Sheet System Copy DVK

Purchase Order (Bellweather, Datapoint, etc.) System Copy DVK * Vendor Purchasing Area Archive Filed Hard Copies 5 Years Destroy

Purchasing 5/3/2006 DVK

Quality Planning Worksheet (and other quality planning records) 1/5/2005 DVK * Project Project

ManagerProject

Manager OfficeProject

Manager OfficeFiled Hard

Copies 1 Year Destroy

Quote - Industrial & Natural Gas - McKinney System Copy DVK * Email Regional Sales Manager Email Email Backed-up


Quote - Propane - McKinney N/A DVK * Customer LP Customer Service Office Office Filed Hard

CopiesAfter order is

entered Discard

Receiving - McKinney 6/25/2007 DVK

Receiving Inspection Log Oct '00 DVK

Regulator & Pilots 6/23/2007 DVK

Returned Goods 3/18/2006 DVK

Rework OrderControlled as part


DVK * RO #P & IC, JIT, or

Returned Goods

On-line On-line Backed-up electronically 1 Year Delete

Scrap Report (McKinney) System Copy DVK * Report Number QA On-line On-line Backed-up electronically 1 Year Delete


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Scrap Report (vendor) MCK 01165A April '97 DVK * Scarp Ticket # QA System System Backed-up electronically 1 Year Delete

shipper in the business system software N/A DVK * Order # Shipping System System Backed-up electronically 1 Year Delete

Shipping 3/16/2005 DVK

Supplier Approval Process 5/3/2006 DVK

Supplier Business Reviews 4/10/2006 DVK

Supplier Corrective Action Requests 4/10/2006 DVK * Series # Quality Quality Quality Filed Hard Copies 3 Years Destroy

Supplier Development 4/10/2006 DVK

Supplier Gated Process 4/11/2006 DVK

Supplier Leadership System 2/4/2006 DVK

Supplier Quality System Audit Checklist Form b Rev 1 DVK * Vendor Procurement Procurement Procurement Filed Hard Copies 5 Years Destroy

Supplier Preaward Survey Form A Rev 1 DVK * Vendor Procurement Procurement Procurement Filed Hard Copies 5 Years Destroy

Supplier Report Cards 4/10/2006 DVK

The Big Picture Audit Report 7/12/2005 DVK * Audit Mgt Rep Mgt Rep Office Mgt Rep Office Filed Hard Copies 1 Year Discard

Torque Verification-Responsibilities List 1/6/2006 DVK * Date QA QA QA Filed Hard Copies 2 Years Destroy


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Training 10/7/2005 DVK

TravelerControlled as part


DVK * Vendor Display Coordinator Shipping Shipping Filed Hard

Copies 6 Months Destroy

Action Item List 12/13/2005 GG * Date Quality Quality Quality Filed Hard Copies 2 Years Discard

audit results (may be based on a form called for by the system or any document addressing the requirements layed out in the procedure)

N/A GG * Date Quality Network Network Backed up copy 3 Years Delete

Calibration records (Qualibus) Syscopy GG * Equipment ID Quality Network Network Backed up copy 3 Years Delete

calibration records from vendors n/a GG * Device Quality Quality Quality Filed Hard Copies 2 Years Discard

Cert record (Buono di Versamento) - Also serving as record of testing Syscopy GG * Serial Number Customer

ServiceCustomer

Service Back-upBacked-up Electronic

Copy3 Years Delete

Certs - Bologna 12/13/2005 GG

certs from vendors N/A GG * Vendor Purchasing Network NetworkBacked-up Electronic

Copy3 Years Delete

Customer-Related Processes 10/11/2005 GG

Customer-Related Processes - Quotes & Orders- Bologna 11/23/2006 GG

Bologna


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Customer-Related Processes - Changes To Orders - Bologna 10/11/2005 GG

Customer Service's Role In Shipping - Bologna 10/11/2005 GG

Customs - Imports- Bologna 10/12/2005 GG

Gallileo (business system software) Syscopy GG * By categoryDepends on information

neededNetwork Back Up Backed-Up

Copy 5 Years Deleted

import spreadsheet N/A GG * SPDF Purchasing Purchasing Archive Filed Hard Copies 5 Years Discard

Improvement Systems - Bologna 10/11/2005 GG

maintenance records N/A GG * Date Purchasing Purchasing Purchasing Filed Hard Copies 1 Year Discard

Opportunities & Incidents 10/11/2005 GG * Date Quality Quality Quality Filed Hard Copies 2 Years Discard

order in Gallileo Syscopy GG

order (completed and invoiced copy maintained as histroy with supporting documents) N/A GG * Invoice # Customer

ServiceCustomer

Service Archive Filed Hard Copies 5 Years Shred

Order/Quote Screening Form A GG * Invoice # Customer Service

Customer Service Archive Filed Hard

Copies 5 Years Shred

Organization Chart Syscopy GG

Production Process Overview - Bologna 11/23/2006 GG

Project Plan N/A GG * Customer Project personnel Network Network Backed-up

copies 5 Years Destroy


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Purchasing - Bologna 10/12/2005 GG

Purchase Order (includes receiving record) Syscopy GG * PO Number Purchasing Purchasing Archive Filed Hard Copies 5 Years Discard

Purchase Order in OPS Syscopy GG * PO Number Purchasing Purchasing Archive Filed Hard Copies 5 Years Discard

Qualibus Syscopy GG * By Sort Need Quality Network Back-upBacked-up Electronic

Copy3 Years Delete

Receiving - Bologna 10/13/2005 GG

receiving inspection record N/A GG * Date Tartarini Inspector

Tartarini Incoming Inspection

Tratarini Incomoing Inspection

Filed Hard Copies 3 Years Discard

Returned Goods Authorization (RGA) - Bologna 10/11/2005 GG

RGA Table Syscopy GG * RGA # Customer Service Network Backed-up

copyBacked-up

copy 3 Years Delete

Shipping - Bologna 10/11/2005 GG

Technical Review 10/12/2006 GG

training records (hardcopy) N/A GG

training records (Qualibus) Syscopy GG

Work Order (also serving as the record of inspection) Syscopy GG * Date Production Management Production Archive Filed Hard

Copies 2 Years Dispose

DOCUMENTS SPECIFIC TO SHANGHAI


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Action Item List 6/28/2005 DVK * Incident Office Staff Office Office Filled Hard Copies 1 year Discard

Approved Vendor List File Copy EN * Vendor Supplier Quality System System Electronic

Copy (back-up) Until Updated Delete

Address Book/Change Form 2 EN * Date Finance Finance Finance Filed Hard Copy 5 Years Destroy

Assembly Daily Inspection 67 A EN * Date Maintenance Maintenance Archive Filed Hard Copy 1 Year Discard

Assembly Daily Inspection Compact A EN * Date Maintenance Maintenance Archive Filed Hard Copy 1 Year Discard

Assembly Daily Inspection HSR/R600 A EN * Date Maintenance Maintenance Archive Filed Hard Copy 1 Year Discard

Breakdown Analysis A EN * Date Maintenance Maintenance Archive Filed Hard Copy 1 Year Discard

Calibration Log System Copy EN * Device Quality Network Network Electronic Copy (back-up) Until Updated Overwrite.

Calibration Record Subcontractors N/A N/A * Device Quality Quality Quality Filed Hard Copy 15 Years Destroy

Certs EN

Cert Form System Copy EN * SO Production Production Production Filed Hard Copy 10 Years Delete

Certs - Supplier N/A N/A * PO MC Office Office Filed Hard Copy 10 Years Destroy

Customer-Related Processes - Shanghai 8/9/2006 EN


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Customer - Imports - Shanghai 7/1/2005 EN

Discount Authorization Deviation Form (DADF) N/A N/A * Date or Order # MC/OA Office Office Filed Hard

Copy 10 Years Destroy

Exporting - Shanghai 6/30/2005 EN

Finished Goods Audit (FGA) Compact Regulator A/0 EN * Date Quality Quality Quality Filed Hard Copy 6 months Destroy

Finished Goods Audit (FGA) HSR A/0 EN * Date Quality Quality Quality Filed Hard Copy 6 months Destroy

Finished Goods Audit (FGA) R600 A/0 EN * Date Quality Quality Quality Filed Hard Copy 6 months Destroy

Finished Goods Audit (FGA) 67 A/0 EN * Date Quality Quality Quality Filed Hard Copy 6 months Destroy

First Article Inspection (Maintained @ Shanghai) System Copy EN * FA # Quality Network NetworkBacked-up Electronic

Copy10 Years Delete

First Article Inspection (Maintained @ Shanghai) A EN * FA # Quality Qualiy Network Filed Hard Copy 5 Years Delete

First Part Process Verify Record Compact Regulator A EN * Date Quality Quality Quality Filed Hard Copy 1 Year Destroy

First Part Process Verify Record 67 B EN

First Part Process Verify Record HSR A EN

First Part Process Verify Record R600 B EN

Import Records N/A EN * PO I/E Clerk Materials Materials Filed Hard Copy 3 Years Destroy


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Improvement Systems - Shanghai 7/16/2005 EN

Launching A Product In Shanghai 6/30/2005 EN

Nonconforming Report A/0 EN * Part Number Quality Network NetworkBacked-up Electronic

Copy1 Year Delete

Order (SO or KanBan) sys copy EN * Customer Material Coordinator Network Network

Backed-up Electronic

Copy3 Years Delete

Organizational Chart sys copy EN

Part Approval - Shanghai 8/4/2005 EN

Pilot Run Form A/0 EN * Series # Quality Quality Quality Filed Hard Copy 5 Years Destroy

Process Inspection 67 A/0 EN * Date Quality Quality Quality Filed Hard Copy 1 Year Destroy

Process Inspection Compact A/0 EN * Date Quality Quality Quality Filed Hard Copy 1 Year Destroy

Process Inspection HSR A/0 EN * Date Quality Quality Quality Filed Hard Copy 1 Year Destroy

Process Inspection R600 A/0 EN * Date Quality Quality Quality Filed Hard Copy 1 Year Destroy

Purchase Order (P O) Receiver System Copy EN * Part Number Finance Finance Archive Filed Hard Copy 15 Years Destroy

Corrective Action form (Process Improvement Report) B/1 EN * Series # Quality Quality Quality Filed Hard Copy 1 Year Destroy

Production Process Overview - Shanghai 7/30/2005 EN


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














production release System Copy N/A * Line Mfg Eng Mfg Eng Mfg Eng Filed Hard Copy 5 Years Destroy

Purchasing Document (KanBan PO) System Copy EN * Part Number MC Office Office Filed Hard Copy 3 Years Destroy

Receiving 7/30/2005 EN

receiving inspection plan and form System Copy EN * Part Number Quality Network NetworkBacked-up Electronic

Copy1 Year Delete

Scrap Log System Copy EN * Date Quality Network Network Filed Hard Copy 15 Years Destroy

Shipping 7/30/2005 EN

Supplier Selection - Shanghai 7/1/2005 EN

Training Records (Employee Specific) N/A EN * Employee HR Office Office Filed Hard Copy

1 Year after employment Destroy

Training Records Event Based (Training Log) N/A EN * Event HR Office Office Filed Hard Copy 5 Years Destroy

Updating A Product Line In Shanghai N/A EN

Vendor Choice Record Form 6/30/2005 EN * Payment # Finance Finance Finance Filed Hard Copy 15 Years Destroy

Vendor Packing List (Delivery Notes) N/A EN * Invoice # Finance Finance Finance Filed Hard Copy 15 Years Destroy

Vendor selection N/A EN * Vendor Procurement Procurement Procurement

Backed-up Electronic

Copy& Filed Hard copy

2 Years after eliminated Delete


Current as of:

PROTECTION








revision is N/A.


Rep Is it

a R

ecor

d?


Who has primary



these records?



(short-term filing)


are these records














Work Order sys copy EN * WO # Finance Finance Finance Filed Hard Copy 15 Years Destroy


Training 5.5.1, 5.3d & 6.2

Revision: 10/7/2005 (latest change - added Bologna)

See note 13.

See note 6.

YES

NO

NO

See note 5.

NO

See notes 1, 2, & 20.

See note 7.

See note 3 & 4.

New employee

Employee orientation and

training plan 5.3d, 6.2.2a & 6.2.2d

Proficient?

Continue training6.2.2b & 6.2.2c

Sign-off and file training records

6.2.2e

Position training on-the-job

6.2.2a, 6.2.2b & 6.2.2c

Training effective?

6.2.2c

Continue training until proficient

6.2.2c

Sign-off and file records

6.2.2e

New document / equipment

Identify those needing training

6.2.2a

Train to document or equipment

6.2.2b

Changed document /

process

Identify those needing training

6.2.2a & 4.2.3c

See note 8. See note 9.

See note 10.

See note 11.

See notes 12 & 20.

See note 14.

YES

YES

Performance assessment / Recurring

training

Training needed?

6.2.2a

ID source & obtain training

6.2.2b & 6.2.2e

See notes 15 & 20.

See notes 16 & 17.

See note 18.

See notes 19 & 20.

RESPONSIBILITY & AUTHORITY: (5.5.1) Responsibility and authority is defined through training to a process, embedded in documents, and/or in a job description. Communication of these responsibilities and authorities is through training and/or by making employees aware of (distributing) documents related to the processes they are involved with.

NOTES: NOTES: McKinney Shanghai Bologna

1 New employees receive an orientation covering applicable statutory/regulatory requirements, general practices, and the significance (relevance and importance) of their role at Fisher Regulators in relation to fulfilling the Quality Policy and Objectives (included in the Business Model). This training includes a review of the Business Model (Quality Management System) ensuring they understand who their internal vendors are (those employees affecting them) and who their internal customers are (those employees they affect).

2 Management assigns the employee to a training plan (which may be nothing more than a copy of the applicable job description or an outline of expectations) applicable to his/her job title.

The job description, operator certification, and/or a training record defining the training to processes related to the tasks to be performed by each employee serve as the training plan(s).

3 The employee receives on-the-job training for the duties and responsibilities outlined where they are not already competent (sometimes they arrive ready to hit the ground running). This equips the employee with the skills and understanding necessary to perform the job.

4 The documents in the Master Control Plan (maintained by the ISO Management Representative) applicable to the new employee's position are determined (typically, with area management). The new employee is trained to these documents, ensuring he/she understands the procedures by observing him/her perform the tasks outlined in the document.

5 CRITERIA: - Is the employee recognized as proficient (competent) in all items? The employee's education, skills, training, and experience are assessed (by manager or supervisor) as required for the position defined in the job description, process related documentation, and/or training plan. Records of this training (may be a signed off job description, attendee log, or some other entry in the employees training files) are maintained per the Records Controls outlined in the Master Control Plan.

6 If any of the employee's education, skills, training, and experience (assessed by management) are deemed incomplete and/or do not meet requirements (and we are choosing not to dismiss them), the entry in the applicable training record is left open until they are seen as competent. For all items assessed as complete and/or meet or exceed requirements, an entry is signed off or a record is completed. On-the-job-training (OJT) continues for the incomplete areas until the next assessment. Completed training records are controlled as records per the controls defined in the records section of the Master Control Plan.

7 If all the employee's education, skills, training, and experience assessed (by management) as defined in the applicable training record are deemed complete and/or meet or exceed requirements, all of the entries on the training record are signed off. Optionally, additional skills are added to the applicable record for future reference. The trainer or a member of management completes the training record. Once the trainee is

competent, the completed record is turned in for filing. Completed training records are controlled as records per the controls defined in the records section of the Master Control Plan.

8 CRITERIA: - Can the employee follow the process and complete the applicable tasks effectively? - Can the employee demonstrate the knowledge obtained is being applied?

9 On-the-job-training (OJT) continues until the employee is proficient (or in some cases terminated for lack of proficiency). The training record is stored and maintained per the Master Control Plan. Management and/or the ISO Management Representative is responsible for working with area management to facilitate assessment/re-assessment of employee proficiency (competence) and to determine the re-evaluation date. This cycle continues until the employee is proficient (or other action is taken). For documents, procedures, and equipment, employee training continues until he/she can perform the outlined task(s) effectively. The ISO Management Representative and/or area management are responsible for ensuring each employee understands the documents, procedures, and equipment associated with his/her job.

On-the-job-training (OJT) continues until the trainer or management determines the employee to be proficient (or in some cases terminates the employee). The training record is stored and maintained per the Master Control Plan. Management and/or HR is responsible for working with area management to facilitate assessment/re-assessment of employee proficiency (competence) and to determine the re-evaluation date. This cycle continues until the employee is proficient (or other action is taken). For documents, procedures, and equipment, employee training continues until he/she can perform the outlined task(s) effectively. Area management is responsible for ensuring each employee understands the documents, procedures, and equipment associated with his or her job.

On-the-job-training (OJT) continues until the employee is proficient (or in some cases terminated for lack of proficiency). The training record is stored and maintained per the Master Control Plan. Management and/or the ISO Management Representative is responsible for working with area management to facilitate assessment/re-assessment of employee proficiency (competence) and to determine the re-evaluation date. This cycle continues until the employee is proficient (or other action is taken). For documents, procedures, and equipment, employee training continues until he/she can perform the outlined task(s) effectively. The ISO Management Representative and/or area management are responsible for ensuring each employee understands the documents, procedures, and equipment associated with his/her job.

10 Once the employee completes, meets, or exceeds requirements, all the requirements outlined in the applicable training record will be signed off and the record(s) turned it

Once the employee completes, meets, or exceeds requirements, all the requirements outlined in the applicable job description, certification program, or other training records will be signed

Once the employee completes, meets, or exceeds requirements, all the requirements outlined in the applicable training record will be signed off and the record(s) turned it in to

in to management for filing. A copy of any certificates of training/attendance for employee-based training (involving individual employees) may also be retained as records of training. When certificates from outside parties (seminars, training courses, etc.) are involved, those sending the employee for the training will discuss what was learned with the employee to assess the effectiveness of the training, making notes of that assessment on the back of the certificate (record) and present it for filing. In any case, all of the records described herein are controlled per the controls outlined in the records section of the Master Control Plan.

off and the record(s) turned it in to HR for filing. A copy of any certificates of training/attendance for employee-based training (involving individual employees) may also be retained as records of training. When certificates from outside parties (seminars, training courses, etc.) are involved, those sending the employee for the training will discuss what was learned with the employee to assess the effectiveness of the training, making notes of that assessment on the back of the certificate (record) and present it for filing. In any case, all of the records described herein are controlled per the controls outlined in the records section of the Master Control Plan.

management for filing. A copy of any certificates of training/attendance for employee-based training (involving individual employees) may also be retained as records of training. When certificates from outside parties (seminars, training courses, etc.) are involved, those sending the employee for the training will discuss what was learned with the employee to assess the effectiveness of the training, making notes of that assessment on the back of the certificate (record) and present it for filing. In any case, all of the records described herein are controlled per the controls outlined in the records section of the Master Control Plan.

11 A new document is added to the Quality Management System by the ISO Management Representative or new equipment is added by management impacting product quality.

12 The ISO Management Representative works with the management team to determine who needs to be trained to the document and facilitates training. Area management determines who needs to be trained to the equipment and facilitates training.

13 The employee(s) affected by the document or equipment are trained. Each employee is observed to ensure he/she understands how to perform the task(s) outlined in the document or equipment operating instructions.

14 The existing document and/or process is changed.

15 The ISO Management Representative identifies those to be re-trained to the changed document and/or process (typically, by reviewing the names of those recognized as trained to the previous version or process). This re-training is a means of ensuring changes to

The ISO Management Representative in Shanghai identifies those to be re-trained to the changed document and/or process (typically, by reviewing the names of those recognized as trained to the previous version or process). This re-training is a means of ensuring changes to documents and/or

The ISO Management Representative identifies those to be re-trained to the changed document and/or process (typically, by reviewing the names of those recognized as trained to the previous version or process). This re-training is a means of ensuring changes to documents and/or processes

documents and/or processes are identified and implemented.

processes are identified and implemented.

are identified and implemented.

16 Performance assessment may occur as part of an annual performance review or may simply be recognized as part of day-to day operations and internal audits. When additional skills are required (to fulfill new processes/requirements), the job descriptions of the positions affected may be updated and trained to. In either case, management makes the call.

An annual performance appraisal (see the Manager and Non-Manager performance appraisals) is used to assess the continued effectiveness of training provided and to ensure proficiency (competence is maintained. When additional skills are required (to fulfill new processes/requirements), the job descriptions of the positions affected may be updated and trained to or a training plan is established.

Performance assessment may occur as part of an annual performance review or may simply be recognized as part of day-to day operations and internal audits. When additional skills are required (to fulfill new processes/requirements), the job descriptions of the positions affected may be updated and trained to. In either case, management makes the call.

17 Recurring training may be required as part of an annual training/refresher program administered by HR, upper management, or area management.

18 CRITERIA: - Is additional training (besides the training already provided) needed to ensure competence, compliance, or to advance the employee's skills, training, education, or experience?

19 Utilizing both internal or external sources, training that will meet the need is identified. The need is clearly defined and the evidence needed to show proficiency is also noted on the associated training record (job description, training attendance log, certificate of training/attendance, etc.).

20 The attendance log may also be used to facilitate training activities, including the evaluation of effectiveness. Event and/or employee based training records are maintained as a record per the controls outlined in the Master Control Plan.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Training Needed" diamond with "6.2.2a" referenced. This means the notes or documents referenced, address the requirements in 6.2.2a of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Supplier Selection 7.4.1, 4.1 (control of outsourced processes related to product quality), & 8.4d Use the following links to see the supplier selection processes for each site.

McKinney

Bologna

FROMEX

Shanghai

Supplier Leadership System 7.4.1, 4.1 (control of outsourcing), & 8.4d

Revision: 2/4/2006(updated to supplier leadership system)

Supplier Gated Process 7.4.1, 4.1 (control of outsourcing), & 8.4d

Revision: 4/11/2006(description of significant changes - added reference to procurement network hard drive, updated gate 3 approval, performance metrics are now suggested instead of required, moved technical review to gate 2, updated

gate 1 deliverables, added pre-bid technical review to major tasks of gate 2, updated gate 2 deliverables)

While the goal is to see all of the gates fulfilled, we recognize that projects can be terminated at any time. Also, the primary storage of documentation will be on the procurement network hard drive.

PURPOSE This procedure defines the minimum requirements for tracking strategic procurement supplier projects for Fisher Controls – Regulator Division.

SCOPE Commodity managers across the division will manage their supplier projects in accordance with this procedure. Types of projects are defined as:

• Containment – project in support of offsetting inflation. • Performance – project in support of transitioning parts from a poor performing supplier • Cost Reduction – project in support of generating savings as a function of “re-design” (tolerancing, materials, etc.) • New Product/Part Development – project in support of any new product development or the design of a new part

RESPONSIBILITY The Vice President, Materials is responsible for this process. Approval authorization for containment, performance, localization and cost reduction projects is as follows: Gate 1, 2 and 5:

• Project < $200K of current spend – Global Commodity Manager • Project > $200K and < $750K of current spend – Global Commodity Manager, Business Group Leader, Strategic Procurement

Manager, VP Materials • Project > $750K of current spend – Global Commodity Manager, Business Group Leader, Strategic Procurement Manager, VP

Materials, President Regulator Division

Gate 3:

• Approval occurs when the contract is signed

Gate 4:

• Approval by Global Commodity Manager required

PERFORMANCE METRICS (can include)

• Velocity – number of days from Project Idea Phase to Project Completion Phase • Gate Scheduling Performance – variance between planned date and actual date

• Supplier Performance – quality and on-time delivery • Project Objectives – agreed upon at the Idea Gate

REFERENCES

• Flow Group Supplier Quality Manual • Gated Process Tracking Spreadsheet

PROCEDURE

Project Idea Gate (1) • Major Objectives

Project alignment with global commodity manager’s strategy Project alignment with business objectives Ensure adequate planning/preparation of project

• Major Tasks:

Complete the appropriate information identified on the Gated Process Tracking Sheet Identify project support team (SQE, Engineering, Tactical Purchasing, Operations, etc.)

• Gate 1 deliverables:

• Project Objective

• Proposed/Estimated Results • Estimated capital costs • Total cost analysis • Estimated expenses (travel, testing, etc.) • Estimated resources (people, time, lab work, etc.) • Estimated timeline • High-level transition strategy (“cut-over”, % transition, etc.) • Priority of parts (if necessary) • Current supplier(s) performance (PPM, delivery) • Major issue(s) with any specific part number (if necessary) • Current number of suppliers for the commodity • Appropriate risk assessment (business, quality, customer, etc.)

Completed Gated Process Tracking Sheet Approval requirements – in accordance with responsibility defined for gate 1.

Evidence gate 1 is completed is the completed Gate 1 Idea Submission form.

Project Quoting Gate (2)

• Major Objectives

Identify potential supplier(s) Maintain business alignment as defined at Gate 1

• Major Tasks

Supplier self-surveys complete prior to quoting Complete confidentiality agreements with supplier prior to quoting Obtain quotes from an adequate number of suppliers Supplier selection process Analysis of potential suppliers (total cost, tooling, logistics, etc) Capacity and initial capability review Supply chain analysis (length, geography, customs, etc.) Update Gated Process Tracking Sheet Collect and store bid data Pre-Bid Technical Review

Gate 2 deliverables:

Project Objective

• Completed Gated Process Tracking Sheet w/ updated Gate 1 information • Initial transition plan • Supplier Identified with documented evidence (completed survey, audits, etc.) • Identify supplier development needs (as needed) • Planned date for Technical Review • Total cost analysis (price, transport, customs, etc)


Evidence gate 2 is completed is the completed Gate 2 Supplier Approval form.

Project Award Gate (3)


Verify supplier is aware of all part specifications Verify supplier is aware of all part approval requirements Insure supplier understands contract terms

• Major Tasks:

Conduct Technical Review with the supplier Finalize capacity review Identify dates for part approval process Update Gated Process Tracking Sheet Review contract with supplier


Project Objective

• Documented successful completion of technical review • Dates for all first article submittals • Contract signed by all required parties • Completed Gated Process Tracking Sheet w/ updated Gate 1 and Gate 2 information • Verify supplier understanding of all commercial and communication expectations


Project Part Approval and Transition Gate (4)

• Major Objectives:

Insure parts meet Fisher specifications Transition parts to new supplier with no disruption to manufacturing operations

• Major Tasks

Execute Fisher part approval process Manage submission of approval samples Update Gated Process Tracking Sheet Finalize transition plan Execute transition in accordance with approved plan


Project Objective

• Parts must successfully complete part approval process with all required documentation • Transition of all parts in the project must be complete • Determine date for project completion gate


Project Completion Gate (5)


Validate project objectives Formal “close-out” of project

• Major Tasks Quality performance assessment of supplier Delivery performance assessment of supplier Assessment of other project objectives Document lessons learned (if necessary) Completed Gated Process Tracking Sheet


Project Objective


Evidence gate 1 is completed is the completed Gate 5 Project Closeout form.

Supplier Selection, Evaluation, & Re-Evaluation For Non-Product Service Providers Affecting Product Quality & Emergency Part/Material Suppliers Or Product Service Providers

GRANDFATHERED SUPPLIERS Suppliers in good standing at Emerson Process Regulator Division (those in the system prior to July 1st, 2005) are recognized as approved for use due to our determination that they are acceptable at this time. While there may be some additional information to base our assessment of these suppliers, it is for the most part based on first hand knowledge of their performance.

NOTES: 1. New non-product specific service affecting product quality (i.e., calibration subcontractor, process related equipment maintenance service provider, etc.) needed, problem with existing supplier and an emergency supplier is needed, or supplier is needed to fulfill an order where there are limits as to who can be involved for legal reasons (e.g., issues involving orders where an embargo or government sanctions limit participation from citizens or countries where such activity would be illegal) are needed. These suppliers included organizations who provide a service that directly affects product quality (calibration service providers, outsourced equipment maintenance, etc.). Unless the supplier is a single source, sole source, or is already approved by another Emerson site, we tend to obtain pricing for 3 sources and select the least expensive (good price, we believe they will deliver what we need, and good service). In emergency situations, we simply rely on the evaluation of site Engineering and/or Purchasing calling on sources they find to be reputable (past experience, recognized in the industry, etc.) 2. While suppliers can come from a wide variety of sources, we tend to rely on the following: - Internet - Exhibitions - References from those we respect - Yellow Pages - Industry magazines and other such sources - Suppliers already approved by another Emerson site. 3. CRITERIA: (as applicable) - Calibration house is capable of verification, with traceability of standards to national or international standards? - Personnel performing service are qualified based on a certification or years of experience leading you to believe the person(s) is qualified? - Cost and ability to perform the service in a time frame meeting our needs? - Supplier provides examples (physical or verbal) of like products or services we believe will meet the need? - Audit (on-site or through a survey) verifying the supplier is capable of providing the needed product or service found the supplier to be acceptable? 4. Evidence a supplier is approved occurs when the supplier is added to the business system software (Oracle, JDE, Gallileo, etc.) vendor section. 5. Supplier Management involves the following, as applicable. Part/Material or Product Service Provider Supplier: - Suppliers are sent PPM and OTD data monthly. - CARs are followed up on. - Business review with important suppliers (volume of work or criticality of part) at least once per year. While corrective action requests may be issued (see SCAR) or we may look at designing around the problem, we may simply have to identify measures internally (increased inspection/sorting, carrying additional inventory to overcome the level of variation, etc.). Non-Product Specific Service Provider Affecting Product Quality: - Re-evaluation occurs as situation requiring corrective action arise, and are handled through the corrective action process (see SCAR). While corrective action requests may be issued (see SCAR) or we may look at designing around the problem, we may simply have to identify measures internally (increased inspection/sorting, carrying additional inventory to overcome the level of variation, etc.).

Global Consistency 7.4.1 (type & extent of control)

Revision: 4/10/2006

• Engage in supplier development across the division o Improve quality, delivery, lead time, cost o Quarterly supplier development project reviews

• Standard supplier process across the division o Supplier Leadership System o Flow Group Supplier Quality Manual

• Global reporting structure o See the entire global supplier base

• Web-based supplier quality management system o Communication across geographical and current information system boundaries. o Globally manage/track audits, part approvals, supplier corrective actions, etc.

• Training o Develop internal expertise o Assist suppliers with their training needs for continuous improvement

Supplier Development 7.4.1 (actions arising from review) & 8.5.1

Revision: 4/10/2006

• Identify Key Suppliers o Key suppliers may be chosen using the following criteria:

Total spend Criticality of parts Potential long-term relationships Other special needs

o Identification of key suppliers allows us: to focus and measure suppliers critical to our business develop key relationships work with suppliers on development projects

• Supplier Summits o Annual event targeted at key suppliers o Provide information on the Regulator Division Business o Provide general information on supplier performance o Receive feedback from suppliers o Build customer-supplier relationship

Supplier Feedback Loops 7.4.1 (re-evaluation) & 8.4d

Focus is primarily on key suppliers (see Supplier Development), with re-evaluation of all other suppliers being passive (the supplier is on the "Top 5" monthly review for those contributing to issues with PPM)

Supplier Business Reviews

Supplier Report Cards

Supplier Corrective Action Requests

Supplier Business Reviews 7.4.1 (re-evaluate) & 8.4d

Revision: 4/10/2006

• Objective o Engage key suppliers annually in a formal discussion on performance and business o Build customer-supplier relationship o Provide feedback to the supplier

• Proposed Agenda o Open Actions from Last Meeting o Supplier Business Review

Current Organization Chart(s) Market Conditions Capital Investment Plans Status on New Product Development Parts (FA, Tooling, etc.) Supplier Containment Projects Supplier Continuous Improvement Projects

o Regulator Division Business Review Current Organization Chart(s) General Business Directions (EPM & Regulator Division)

o Supplier Performance Review o Customer Service Support o Commercial Issues o Opportunities for Improvement o Action Items

Supplier Report Cards 7.4.1 (re-evaluate) & 8.4d

Revision: 4/10/2006

• Monthly distribution to key suppliers • OTD (combined, kanban, non-kanban, & PPM)

Below is an example of a typical supplier report card.

Supplier Corrective Action Requests 7.4.1 (actions arising from evaluations) & 8.5.1

Revision: 4/10/2006

• Focus on providing adequate information to suppliers • Supplier must focus on containment, root cause analysis, and preventive actions • "Top 5" monthly review for the top contributing parts to supplier PPM metric.

Overview of corrective action process is embedded in Improvement Systems.

Part Approval Process 7.4.1 (evaluate and select)

Revision: 4/10/2006

Supplier Approval Process 7.4.1 (evaluate and select)

Revision: 5/3/2006(updated to include the use of C-TPAT as described in note 1)

NOTES: 1. The C-TPAT (Customs - Trade Partnership Against Terrorism) must be completed (if we do not already have one on file for that supplier) when the supplier will be importing items into the United States.

2. Pre-Bid Technical Review (with appropriate engineers, resource engineer, and supplier quality engineers)

Identify special manufacturing requirements Identify material requirements Identify criticality of parts and approval requirements Identify third party requirements (UL, PED, CSA, etc.) Conduct review with appropriate business group strategic material

manager Choose level 1, 2, or 3 in accordance with the Flow Group Supplier

Quality Manual

3. Conduct a quality system audit (see Supplier Quality System Audit Checklist or Emerson Supplier Audit Checklist). Management may choose to use the Quality Planning Worksheet, allowing the supplier or a member of the Regulator Division's Supplier Quality to facilitate an assessment in relation to minimum acceptable requirements (see Planning Considerations).

4. Risk assessment based on current performance and an analysis of capacity.

5. CRITERIA: (assessed by SQE and Commodity Manager)

• Meets requirements in the Flow Group Supplier Quality Manual? • Action plans lead us to believe the supplier is or will soon be able to sustain effective practices

(we are working to develop them)?

6. Business awarded tentatively to the supplier, pending part approval process.

Supplier Selection - Shanghai 7.4.1, 4.1 (control of outsourcing), & 8.4d

Revision: 7/1/2005

GRANDFATHERED SUPPLIERS Suppliers in good standing at Fisher Regulators Shanghai (those on the Approved Vendor List prior to July 1st, 2005) are recognized as approved for use due to our determination that they are acceptable at this time. While there may be some additional information to base our assessment of these suppliers, it is for the most part based on first hand knowledge of their performance.

NOTES: 1. New product or service needed, problem with existing supplier, or product line is being transferred to China and local suppliers are needed. 2. While suppliers can come from a wide variety of sources, we tend to rely on the following: - Internet - Exhibitions - APPO (Asia Pacific Procurement Office) - Yellow Pages - Industry magazines and other such sources - Suppliers already approved by another Emerson site. 3. Supplier Quality meets with Engineering, Quality, and Materials to discuss the results, using the Supplier Pre-Award Survey, Supplier Quality System Audit Checklist, and any other information collected that may be related to commodity. From this review, the supplier is: - Approved (issues identified (if any) are opportunities for improvement we would like to see from the supplier; - Conditionally approved (while there are issues we need the supplier to take action on, we feel we can or need to work with this supplier [i.e., they are sole or single source, they are local and developing them makes good business sense, etc.); or - Disapproved (the issues identified lead us to believe the supplier will take more effort that we are willing to give in developing them. 4. Evidence a supplier is approved occurs when the Address Book Entry/Change Form and Vendor Choice Record Form are completed and submitted to Finance (by the department responsible for deciding to use the supplier). Finance adds the supplier to the Approved Vendor List. 5. Supplier Management involves the following: - Suppliers are sent PPM and OTD data monthly. - CARs are followed up on. - Quarterly business review with important suppliers (volume of work or criticality of part). - Suppliers are divided into 3 grades. A – PPM is below the target Delivery is >95% B – PPM is between 1 and 2 times the target Delivery is 85% to 95% C – PPM is more that 2 times the target Delivery is less than 85% While the goal is to have all suppliers to at least the grade of B, we recognize that a "C" may be what we have to live with. An example of this would be a sole source who has what we need and we cannot get the part, material, or service from another source. While corrective action requests may be issued (see Improvement Systems) or we may look at designing around the problem, we may simply have to identify measures internally (increased inspection/sorting, carrying additional inventory to overcome the level of variation, etc.). 6. These suppliers included organizations who provide a service that directly affects product quality (calibration service providers, outsourced equipment maintenance, etc.). Unless the supplier is a single source, sole source, or is already approved by another Emerson site, we obtain pricing for 3 sources and select the least expensive (good price, we believe the will deliver what we need, and good service). 7. CRITERIA: (as applicable) - Calibration house is capable of verification, with traceability of standards to national or international standards? - Personnel performing service are qualified based on a certification or years of experience leading you to believe the person(s) is qualified? - Cost and ability to perform the service in a time frame meeting our needs?

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Qualified" diamond with "7.4.1" referenced. This means the notes or documents referenced, address some or all of the requirements in 7.4.1. Blue, hyperlinked, &/or italicized words are referencing other documents.

Purchasing 7.4.2 Use the following links to see the purchasing processes for each site.

McKinney

Bologna

FROMEX

Shanghai (see "Material Need Identified" embedded in

Customer-Related Processes - Shanghai)

Purchasing - McKinney 7.4, 4.1 (control of outsourcing), & 8.4d

Revision: 5/3/2006(changed note 3 to point to Supplier Leadership System, which is used to evaluate and select suppliers and updated note 6 to reflect the supplier feedback

activities)

For items needing to be sent to outside vendors, see Parts To Outside Vendors.

NOTES: 1. For the most part the need is generated weekly by the requirements planning portion of our business system software. This system automatically generates orders for “policy 2” orders (those set-up in the system to need no intervention because lead times, inventory turns, and/or economic order quantities are such that the system can flag concerns), unless the item is a “policy 1” (no forecast, no vendor, or a system flag has been activated) or “policy 5” (items being phased out or requiring a “hands on approach” to inventory management evaluated and released [email, phone call, etc. to the applicable buyer] by P&IC as they deem it to be necessary. Other product-related items are purchased through Bellweather as needed, with those affected or responsible for watching inventory make the call by entering the item into Bellweather or providing a paper version of a purchase order (PO) to someone who can enter the order into Bellweather. 2. Existing vendors (a.k.a. suppliers) are selected because the system recognizes them. In other words, the system will not let someone make a product-related purchase unless a designation of “product” is shown in the system. While there are some instances where “non-product” designated items affect the product, vendors in good standing are in Bellweather, with those not in good standing “discontinued” in the system when the need arises.

3. New vendors are evaluated and selected by Supplier Quality, including evaluation of controls for outsourced processes to ensure the requirements of our quality management system will be maintained (see Supplier Leadership System). Those selected are added to our system (record of evaluation and actions taken as a result of the evaluation). The system also flags items received if the item is new or a new vendor is used and routes the item to receiving inspection for a First Article Inspection. Issues raised are provided to Purchasing and resolution occurs immediately. A first article requirement would be required until the item passed. 4. The purchase order entered into our business system software is our purchasing document. Requirements for approval, qualification of personnel, and any requirements needing to be lived up to by the supplier to fulfill requirements related to our quality management system are included in or referenced by the purchase order. Adequacy of the purchase order, prior to communication with the supplier, occurs when the order is entered into and accepted by the system. If we or our customer are going to perform a source inspection on the item at our vendor’s site, this expectation and the method of release (what is allowing them to ship the item to us) is included in the purchasing document. 5. Receiving and receiving inspection are defined in Receiving. 6. Re-evaluation is facilitated by data collected in the system as it relates to quality and delivery (see the Supplier Feedback Loops section of the Supplier Leadership System). This information is monitored, with records of re-evaluation and actions taken maintained as records per the Master Control Plan. Actions taken can be to recognize the part as a certified pass through (no inspection required because inspections performed have shown the vendor and part to meet requirements over time), to require inspection on every lot received (including removing someone or a part from certified pass through), request corrective or preventive action from the supplier (see the Supplier Corrective Action Requests [embedded in Improvement Systems] and as called for in the Supplier Feedback Loops), or change a supplier status in the system to prevent future purchases. Additionally, the system ensures each part is inspected at least once per year (or the next time the need arises) by flagging items received for inspection when it has been more than year since the last inspection.

DEFINITION: Type and extent of control (7.4.1) - “The type and extent of control applied to the vendor and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.” This refers to the impact a problem with something purchased (material, product, service, etc.) would have on the product or service it is used for or with (constituent parts). The greater the impact of failure to control the vendor or the thing being purchased, the more control you need. “Type” is what you will do to ensure success (evaluate and select good vendors, perform an assessment on samples of the material before introducing it into your product, inspect/test material upon arrival, etc.). “Extent” tends to be criteria, or a reflection of frequency or degree of control (i.e., obtain and review the vendor’s reports from their registrar, audit the vendor, report on vendor performance, clearly describing the purchase in a PO, etc.). “Extent” also includes any actions taken as a result of evaluation or re-evaluation, such as adding vendors to our system to reflect approval, deleting or flagging poor performers, etc.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Receiving" box "7.4.3" & "8.2.4" referenced. This means the notes or documents referenced, address some or all of the requirements in 7.4.3 & 8.2.4. Blue, hyperlinked, &/or italicized words are referencing other documents.

Purchasing - Bologna 7.4.1 (supplier performance and some selection), 7.4.2, 7.4.3 (related to source inspections), 4.1 (control of outsourcing), & 8.4d,


NOTES: 1. For the most part the need is generated weekly by the requirements planning portion of our business system software. When the need is immediate, Operations Management informs Purchasing (email, phone call, etc.) of the need. 2. CRITERIA: - Order can be pulled in without sacrificing other commitments? - While the pull in will sacrifice other commitments, management chooses to proceed and will facilitate informing affected parties? - Cost of expediting (including shipping costs) is not considered excessive by management and/or the need is greater to meet the delivery date for the customer where the pull-in exists? 3. MRP is run at least once each week, but may be done more frequently as needed. 4. CRITERIA: - Listed in Galileo as the source for an item? - Recognized as an approved source by another Emerson Process Management Site? - Is capable of providing the need (i.e. calibration subcontractor whose calibration/verification is performed with standards traceable to a national or international standards, someone or an organization qualified or certified to perform maintenance on the compressor, etc.). See Supplier Selection, if more information is needed. 5. The Purchase Order (PO), prepared by Purchasing, ensures the purchasing requirements are adequately defined, including as applicable: - what was ordered (description), quantity, and price, - quality-system requirements needing to be lived up to (including CofC, certified maintenance technicians, pertinent controls/specifications for outsourced processes, etc.), and - if a source inspection is to be performed, the vendor is made aware of the requirement and the terms for releasing the product (explicitly described in the PO). - when a first article inspection (FAI) is required (new machined or cast part, machined or cast part from a new supplier, machined or cast part in a different material than the existing FAI), Purchasing notes the need for an FAI on the PO. 6. Evidence the PO has been reviewed and approved for adequacy (clearly describes the requirements) is accomplished when the PO is entered into and accepted by Galileo. Remember: if the process is being outsourced, we need to make sure the vendor of choice has controls in place to ensure we will be able to get product that meets all requirements. Much of this is based upon the certifications they supply and/or inspections or tests we perform on the product when it is submitted to us, but can be based upon our knowledge of the vendor's capability (history/reputation) and recognition of their performance as part of the evaluation process (current and future). Planning Considerations serves as a guideline for ensuring processes address all of the pertinent requirements and can be used to evaluate whether our vendors have the needed controls. 7. CRITERIA: - Clearly describes what we expect the vendor to provide and live up to? - Provides the level of information needed for receiving and/or receiving inspection to be able to verify all requirements were met as part of receiving inspection. 8. Delivery and/or quality issues are dealt with as they arise, with a summary of issues maintained by Purchasing. 9. When it is determined there is need for action, a supplier corrective action is issued per the Supplier Corrective Action Request procedure. 10. While we are primarily focused on the suppliers of products or services that become the product, some of our suppliers for services that can have a direct positive or negative impact on suppliers (i.e. those providing calibration, maintenance, etc.) also need to be maintained,

CLARIFICATION: Type and extent of control (7.4.1) - “The type and extent of control applied to the vendor and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.” This refers to the impact a problem with something purchased (material, product, service, etc.) would have on the product or service it is used for or with (constituent parts). The greater the impact of failure to control the vendor or the thing being purchased, the more control you need. “Type” is what you will do to ensure success (evaluate and select good vendors, perform an assessment on samples of the material before introducing it into your product, inspect/test material upon arrival, etc.). “Extent” tends to be criteria, or a reflection of frequency or degree of control (i.e., obtain and review the vendor’s reports from their registrar, audit the vendor, report on vendor performance, clearly describing the purchase in a PO, etc.). “Extent” also includes any actions taken as a result of evaluation or re-evaluation, such as adding vendors to our system to reflect approval, deleting or flagging poor performers, etc.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Approved Supplier" diamond with "7.4.1" referenced. This means the notes or documents referenced, address some or all of the requirements in 7.4.1 & 8.2.4. Blue, hyperlinked, &/or italicized words are referencing other documents.

Customs - Imports Use the following links to see the processes for handling imports at each site.

Bologna

FROMEX

Shanghai

Customs - Imports - Bologna 7.5.1f


NOTES: 1. Purchasing creates instructions (see import spreadsheet) for customs clearance. 2. CRITERIA: - Did the shipment come from a developing country? - Does the documentation provided by the supplier prove the goods were completely produced in a developing country?


Customs - Import Fromex

To be developed

Customs - Imports - Shanghai 7.5.1f

Revision: 7/1/2005

NOTES: 1. The Material Coordinator provides the Import/Export Clerk with the RM information (normal trading/logbook parts, Import RM number, and quantity). Make sure the information on the PO is accurate. For Duty-free RMs, the Logbook needs to be applied for prior to importing cargo. 2. The import/Export Clerk prepares: - Invoice - Original D/N - Bill way of landing - Logbook (if needed) 3. The Cargo Agent follows up on the whole import process with customs including the KSD order entry, cargo propagation/sanitation, commercial inspection, verification of cargo by Customs, etc.). 4. The Cargo Agent arranges for transportation of the Cargo to the Shanghai facility.


Receiving 7.4.3, 7.5.4, 7.5.5, 7.6 (select and use of monitoring & measurement devices), 8.1 (statistical techniques), & 8.2.4 Use the following links to see the receiving and receiving inspection processes for each site.

McKinney

Bologna

FROMEX

Shanghai

Receiving 7.4.3, 7.5.4, 7.5.5, 7.6 (select and use of monitoring & measurement devices), 8.1 (statistical techniques), & 8.2.4

Revision: 6/25/2007(description of changes - updated rubber part cure date table and added new note one, moving all other notes accordingly)


Click here for a printer friendly version of this document.

NOTES: 1. Customer Property is submitted to Customer Service. 2. CRITERIA: - Paperwork with the item shows it is an authorized return good? - Packing slip does not include a purchase order number and/or the item is coming from a customer? 3. CRITERIA: (found by pulling up the PO) - Routing in the system notes it is for FROMEX? 4. Complete a FROMEX Manifest form. 5. CRITERIA: - Part or material that is or will become the product? 6. CRITERIA: - Number of boxes and/or the label quantity and what is in the box match match the packing list? - PO or KanBan number provided matches the system? - Condition of packaging does not lead to a belief that the item being received is damaged? If rubber parts are involved and the item will not be going to Receiving Inspection, receiving personnel verify the cure date is within the required range for the item (see Rubber Part Cure Date Summary), ensuring the item is labeled with the cure date. Evidence the item passed this level of “inspection” is the receipt in the system. Unauthorized material will be reported to the buyer(s). If contraband or suspicious material is discovered, report this material immediately to a Supervisor/Manager, the Safety Manager, and the Compliance Manager. 7. CRITERIA: - Already known to be nonconforming (not something we are still working out the details on) and in need of disposition? 8. Complete a Discrepancy Sheet and place with the product, emailing the buyer to notify them (may also include a copy of the email with the discrepancy sheet). Place the item on the discrepancy shelf with a copy (may be the original) of the discrepancy sheet and wait for the response. Receiving works with Purchasing to resolve the issue (may require tracking progress of items on the shelf), which may include a shipping authorization to return the item (or over shipments) to the vendor. Based on Purchasing's response, the incident is resolved and the product or material is allowed to proceed or is recognized as nonconforming and handled as nonconforming product. 9. Evidence (record of inspection) the initial receiving inspection (receiving the item in) is the receipt in the system and printing of the Traveler. 10. Parts awaiting receiving inspection are found in the Inspection Aisle (for bulk items) or the inspection rack (small parts). Receiving inspection verifies the product is per the print and/or specification(s) to the extent a feature affects our ability to use the item as part of an assembly (threads and basic dimensions are correct, surface finish is per need, etc.) and signs off the Traveler as evidence of the inspection. If the item is new, from a new vendor, or an engineering change affects manufacturability/assembly (here or at the vendor) has occurred, a first article is performed. The first article covers all dimensions and requirements outlined in the drawing and/or specification, with the results noted in the First Article Inspection record. If the item is part of a family (same part but different sizes or material), a first article may be waived after one member of the family is approved. If rubber parts are involved, Quality personnel verify the cure date is within the range for that type of rubber per the cure date summary, ensuring the item is labeled with the cure date. The Receiving Inspection Log (MCK2023) is completed to track completion of jobs by Receiving Inspection. 11. CRITERIA: - Product or material matches the requirements? 12. Typically routed by the person completing the step on the Traveler, but may be JIT personnel. 13. Enter into the system and submit to the area of need or stock location

Rubber Part Cure Date Summary (per FGS 8A31 Revision N) Table 2 summarizes the information in section 7 of this specification

Table 2: Allowable Shelf Life per Fisher Shelf Life Statements

Elastomer Category Shelf Like per PSCD-062 and PSCD-069 Shelf Life per PSCD-131**

Category 1 AU, EU, CSM, ECO, NR, NR, PUR, SBR, any elastomer not otherwise listed

2 years from shipment or 6 years from cure date

4 years from shipment date 8 years from cure date

Category 2 ACM, CR, EPDM, HNBR, MQ, PMQ, PVMQ, VMQ



Category 3 FKM, FFKM, FVMQ, TFE/P No shelf life limit No shelf life limit

**Note - Requires hand picked parts with latest cure date and 27°C (80°F) maximum storage temperature.

7.5.3 Identification, Status, and Traceability What it is (identification), what is its state of existence (status), and where did it come from/where did it go (traceability)? IDENTIFICATION: Purchased Item - Part number and/or description of the item. Customer-Owned Property (equipment or material) – Packing Slip or labeled as such Returned Good – RGA or FIX number STATUS: Purchased Item - For the most part by area (i.e., inspection shelf, discrepancy shelf, etc.), but may be by documentation (Traveler, nonconformance form, etc.) with the item. Customer Owned Property & Returned Goods – By area (moved to Returned Goods area) and/or paperwork. TRACEABILITY: When traceability is required, certs received are given to Quality so they can be related to an order (record of traceability) when the situation arises. 7.5.5 Preservation of Product Preservation issues related to: Identification - When there is concern about a product's ability to survive to the point of use, product tends to arrive with labels or instructions noting what needs to be done (i.e., sealed items intended to maintain cleanliness with a label noting handling requirements) to ensure the requirement will be lived up to. When this is not the case and the Traveler or a localized instruction describes some form of labeling, Receiving personnel follow those instructions. Handling - For the most part, handling issues are based upon the weight of the item (things greater than 40 pounds are handled with hoists or on carts). The key to using a hoist is ensuring the item is adequately secured before use. The only other handling consideration involves parts with oxygen service, ensuring the unit remains sealed. All other handling is obvious, as the type of part and the potential for damage dictate the actions of the person handling the item. Packaging - For the most part items arrive in packaging that will work in our environment, keeping the item safe until it is introduced into or becomes the product. When this is not the case or when the way it is packed affects productivity on the line, we may re pack it or place the item in shelves or drawers set up to accommodate the item in question. In the end, the goal is to make sure the item will survive to the point of use. Storage - Items are stored in inventory locations throughout the facility, with these locations ensuring the product is protected.

Protection – Ensuring the date for limited life items are not passed due and the use of inventory control methods such as FIFO (first-in-first-out) are the controls related to Receiving. 7.6 Selection & Use Of Monitoring & Measurement Devices When a device is used for monitoring or measurement of a product or process, we make sure it is capable of an accurate measurement and is used correctly. Correct use is based upon training provided (see training records). Selection is ensuring the device is capable of accurately measuring in the specified range or accurately demonstrating required specifications are being met. The other important thing to recognize is the need to report damaged devices or those not reading accurately to Quality. This will allow us to resolve any problem/potential problem. 8.1 Statistical Techniques Related To Product & Service Provision Receiving Inspection uses level 10.0 of the C = 0 sampling plan shown below. Tighter levels would only be used if management or engineering identifies a need to do so. Table number 1-a is as follows.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Receive in customer property" box with "7.5.4 (identify & verify)" referenced. This means the notes or documents referenced, address the requirements to identify and verify customer property as called for in 7.5.4 of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Receiving - Bologna 7.4.3, 7.5.4, 7.5.5, 7.6 (select and use of monitoring & measurement devices), 8.1 (statistical techniques), & 8.2.4

Revision: 10/12/2006(description of changes: updated traceability to reflect Purchasing as the receiver of certs from suppliers)

NOTES: 1. CRITERIA: - Paperwork with the item shows it is an authorized return good? - Packing slip does not include a purchase order number and/or the item is coming from a customer? 2. CRITERIA (for condition): - Arrived without damage and/or in a condition suitable for us to take action? 3. Customer Service contacts the customer and notes the incident and action taken in the RGA Tables (this is the record for reporting lost, damaged, or unsuitable property to the customer). 4. Production management evaluates the returned item(s) and determines what is needed to deal with the product. If the item is a return that does not involve some sort of defect, the item may be returned to stock in the system. If defective or there is a question as to whether the item is in good enough condition to return to stock, Nonconformance Control is followed. In either case, Production management works with Customer Service to keep the customer informed and to resolve the situation with the customer (i.e., repair, replace, credit, etc.).

5. CRITERIA: - Number of boxes and/or the label quantity and what is in the box match match the packing list? - PO number provided matches the system? - Condition of packaging does not lead to a belief that the item being received is damaged? - Limited life (or shelf life) items are not past due and will not become past due before we use the item? If rubber parts are involved, receiving personnel verify the cure date is within the required range for the item (see Rubber Part Cure Date Summary), ensuring the item is labeled with the cure date. A cursory review for surface finish may also be done, as designated by management. 6. Completely at Purchasing discretion and tends to involve things like the need for material certs, the need to correct import documents to match shipments, etc.). While Purchasing is working on the issue, the items in question are retained in Receiving. 7. Purchasing acknowledges receipt and enters any cert numbers related to material received into Galileo. 8. CRITERIA: - Item received is from a supplier other than an Emerson Process Management company or suppliers recognized as “pass through”? When an additional inspection is required the parts or material that are not part of the sample, but are part of the lot being inspected, are maintained in Receiving or in a hold are until inspection has been completed and the product is accepted. 9. Inspected to ensure all of the dimensions identified on the drawing are within requirements. Rubber Part Cure Date Summary Parts received should to have a cure date no older than the number of years listed below from the date of receipt (i.e., item received on 10/04 with a cure date of 09/00 where the requirement is 3 years would be out of date due to the length of time being 4 years and 1 month). Part number or description will include these names or designators as applicable. Nitrile (acrylonitrile, NBR) and Neoprene – Three (3) years. Elastomer (ACM, CR, ECO, EPDM, FKM, FVMQ, VMQ, and TFE/P) – Packing Slip or labeled as such up to 5 years old from cure date. Perfluoroelastomers (FFKM) – Have no shelf life limits. While these are the guidelines, the condition of the material and the conditions under which the item was maintained and/or is to be used (i.e. nuclear jobs require tighter control) can allow for management to accept items not per these requirements (unless the customer requirements would be violated) without it being considered nonconforming product. This would be noted as a comment in the system and/or manufacturing order. 7.5.3 Identification, Status, and Traceability What it is (identification), what is its state of existence (status), and where did it come from/where did it go (traceability)? IDENTIFICATION: Purchased Item - Part number and/or description of the item. STATUS: Purchased Item - For the most part by area (i.e., inspection area or shelf, discrepancy area or shelf, etc.), but may be by documentation (PO, nonconformance form, etc.) with the item. TRACEABILITY: When traceability is required, certs received are given to Purchasing so they can be related to an order (record of traceability) when the situation arises.

7.5.5 Preservation of Product Preservation issues related to: Identification - When there is concern about a product's ability to survive to the point of use, product tends to arrive with labels or instructions noting what needs to be done (i.e., sealed items intended to maintain cleanliness with a label noting handling requirements) to ensure the requirement will be lived up to. When this is not the case, a localized instruction describes some form of labeling, Receiving personnel follow those instructions. Handling - For the most part, handling issues are based upon the weight of the item. The key to using a hoist is ensuring the item is adequately secured before use. All other handling is obvious, as the type of part and the potential for damage dictate the actions of the person handling the item. Packaging - For the most part items arrive in packaging that will work in our environment, keeping the item safe until it is introduced into or becomes the product. When this is not the case or when the way it is packed affects productivity on the line, we may re pack it or place the item in shelves or drawers set up to accommodate the item in question. In the end, the goal is to make sure the item will survive to the point of use. Storage - Items are stored in inventory locations throughout the facility, with these locations ensuring the product is protected. Protection – Ensuring the date for limited life items are not passed due and the use of inventory control methods such as FIFO (first-in-first-out) are the controls related to inventory management. 7.6 Selection & Use Of Monitoring & Measurement Devices When a device is used for monitoring or measurement of a product or process, we make sure it is capable of an accurate measurement and is used correctly. Correct use is based upon training provided (see training records). Selection is ensuring the device is capable of accurately measuring in the specified range or accurately demonstrating required specifications are being met. The other important thing to recognize is the need to report damaged devices or those not reading accurately to Quality. This will allow us to resolve any problem/potential problem. DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Nonconformance Control" box "8.3" referenced. This means the notes or documents referenced, address the requirements of 8.3 in ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Receiving - Shanghai 7.4.3, 7.5.4, 7.5.5, 7.6 (select and use of monitoring & measurement devices), 8.1 (statistical techniques), & 8.2.4

Revision: 7/30/2005(description of latest change - added "For the industrial line?" decision point to the flow chart)

NOTES: 1. CRITERIA: - Goods received matches the PO and delivery notes or packing list? - The count or weight and condition of the goods is acceptable? - The Kanban was followed?

2. The Material Coordinator (MC) is notified and resolves the matter (i.e., accepts by actual, notifies the supplier of the need for action, etc.). While most corrections involve adjustments to transactions in JDE, the MC can work with management to decide to resolve part/material problems in-house rather than send it back to the supplier (especially if we are talking about items having to leave the country). When this is the case, Nonconformance Control would be followed. 3. Receiving inspection verifies the product is per the inspection plan (may be the print and/or specification or a plan based on these requirements) and signs off the PO Receiver as evidence of the inspection. If the item is new, from a new vendor, an engineering change affecting manufacturability/assembly (here or at the vendor), and has not already had a first article here or at another facility, a first article is performed. The first article covers all dimensions and requirements outlined in the drawing and/or specification, with the results noted in the First Article Inspection record. If the item is part of a family (same part but different sizes or material), a first article may be waived after one member of the family is approved. If rubber parts are involved, Quality personnel verify the cure date is within the range for that type of rubber per the cure date summary, ensuring the item is labeled with the cure date. Rubber Part Cure Date Summary Parts received should to have a cure date no older than the number of years listed below from the date of receipt (i.e., item received on 10/04 with a cure date of 09/00 where the requirement is 3 years would be out of date due to the length of time being 4 years and 1 month). Part number or description will include these names or designators as applicable. Nitrile (acrylonitrile, NBR) and Neoprene – Three (3) years. Elastomer (ACM, CR, ECO, EPDM, FKM, FVMQ, VMQ, and TFE/P) – Packing Slip or labeled as such up to 5 years old from cure date. Perfluoroelastomers (FFKM) – Have no shelf life limits. While these are the guidelines, the condition of the material and the conditions under which the item was maintained and/or is to be used (i.e. nuclear jobs require tighter control) can allow for management to accept items not per these requirements (unless the customer requirements would be violated) without it being considered nonconforming product. This would be noted as a comment in the system and/or manufacturing order. 7.5.3 Identification, Status, and Traceability What it is (identification), what is its state of existence (status), and where did it come from/where did it go (traceability)? IDENTIFICATION: Purchased Item - Part number and/or description of the item. STATUS: Purchased Item - For the most part by area (i.e., inspection area or shelf, discrepancy area or shelf, etc.), but may be by documentation (PO Receiver, nonconformance form, etc.) with the item. TRACEABILITY: When traceability is required, certs received are given to Quality so they can be related to an order (record of traceability) when the situation arises.

7.5.5 Preservation of Product Preservation issues related to: Identification - When there is concern about a product's ability to survive to the point of use, product tends to arrive with labels or instructions noting what needs to be done (i.e., sealed items intended to maintain cleanliness with a label noting handling requirements) to ensure the requirement will be lived up to. When this is not the case, a localized instruction describes some form of labeling, Receiving personnel follow those instructions. Handling - For the most part, handling issues are based upon the weight of the item (things greater than 40 pounds are handled with hoists or on carts). The key to using a hoist is ensuring the item is adequately secured before use. All other handling is obvious, as the type of part and the potential for damage dictate the actions of the person handling the item. Packaging - For the most part items arrive in packaging that will work in our environment, keeping the item safe until it is introduced into or becomes the product. When this is not the case or when the way it is packed affects productivity on the line, we may re pack it or place the item in shelves or drawers set up to accommodate the item in question. In the end, the goal is to make sure the item will survive to the point of use. Storage - Items are stored in inventory locations throughout the facility, with these locations ensuring the product is protected. Protection – Ensuring the date for limited life items are not passed due and the use of inventory control methods such as FIFO (first-in-first-out) are the controls related to Receiving. 7.6 Selection & Use Of Monitoring & Measurement Devices When a device is used for monitoring or measurement of a product or process, we make sure it is capable of an accurate measurement and is used correctly. Correct use is based upon training provided (see training records). Selection is ensuring the device is capable of accurately measuring in the specified range or accurately demonstrating required specifications are being met. The other important thing to recognize is the need to report damaged devices or those not reading accurately to Quality. This will allow us to resolve any problem/potential problem.

8.1 Statistical Techniques Related To Product & Service Provision Receiving Inspection uses level 10.0 of the C = 0 sampling plan shown below. Tighter levels would only be used if Quality, Management or Engineering identifies a need to do so. Table number 1-a is as follows.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Count/weight & condition okay?" diamond with "7.4.3" & "8.2.4" referenced. This means the notes or documents referenced, address the requirements of 7.4.3 & 8.2.4 in ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Production Process Overview Use the following links to see the production processes for each site.

McKinney

Bologna Production (Assembly)

Parts or Material Order Fulfillment (included in Shipping)

FROMEX

Shanghai

Production Process Overview - McKinney 4.1, 5.4.2, 6, 7.1, 7.5.1, 7.5.2, 7.5.3, 7.5.5, 7.6 (sel. & use of calibrated devices), 8.1 (statistical techniques), 8.2.3, & 8.2.4

Revision: 6/23/2007Description of changes: Removed brazing from process flow and added note 7

NOTES: 1. For the most part product lines define the process, including the necessary tests. FMPTs (Fisher Manufacturing Procedure Texas) and/or localized instructions (torque range charts, sample plans, etc.) are also used to define and/or support the process. 2. Manufacturing Engineering develops the process, including any necessary fixturing and test equipment, working with manufacturing to create and/or update FMPTs (Fisher Manufacturing Procedure Texas) as needed. Product Realization & Quality Planning serves as a memory jogger, providing considerations and insight into things we may need to put in place to successfully launch a process, project, or product line. 3. If processing is needed (hydro, paint, etc.), P&IC, a member of production management, or JIT Rep generates a rework order (RO). This facilitates the action to be taken. Codes to be used for Rework Orders are as follows: Type 101 - Correct Fisher Error Type 102 - Per Customer Request Type 103 - Change One Part To Another Type 104 - Sort/Correct Vendor Error Type 150 - Route incoming receipts through the processing department Type 201 - Tear-down due to cancellation Type 202 - Tear-down due to Fisher Error Type 205 - Returned Goods, Return To Customer or Customer Scrap Type 206 - Returned Goods Return To Sock Type 301 - Tear-down A Special Type 302 - Tear-down a part or FS in stock Type 401 - OSV Rework To Correct Fisher Error Type 402 OSV Rework Per Customer Request Type 403 OSV Rework Convert One Product To Another Type 404 OSV Rework Vendor Error Type 501 - Rework With No Pull Sheet/Product Structure 4. The Manufacturing Order (MO) is released by Production & Inventory Control (P&IC), with a pull sheet. In some cases, a Pressure Equipment Directive (PED) may also be included in the package. The sleeve the MO is maintained in defines the priority of the job and/or special considerations as follows: - Fast Order (Green sleeve) - Order taken with the intent we would process it with the utmost urgency. - Hot Order (Red sleeve) - Order considered to be a priority over all use, unless a Fast Order (Green sleeve) is in the area. - Export Order - (Yellow sleeve) - Need to get this order type out as soon as possible to allow for enough time to complete export paperwork. - Special Order (Blue sleeve) - Requires special attention due to the need for special paint, oxygen service, PMI testing, or other such special situations. - Normal Order (Clear sleeve) - Order reflecting we have enough lead time built in to let the job run the normal course, without any special attention or heightened awareness. 5. While it is preferred to have the shipping labels generated here, it may be done during the processing of the job (E-Regs). The operator processing the job assumes responsibility for the shipping labels need to be produced as part of the process when no labels are provided or would inform management of the need for labels if he or she was not able to produce shipping labels. The need for stamping is based upon a review of the Pull Sheet (looking for tags) generated as part of the Manufacturing Order. Stamping is completed as defined in the Nameplate Stamping Procedure (FMPT13A5 and/or FMPT13A2) Upon completion, stamping personnel initial or sign the MO as evidence of completion of the step and to status the order 6. Typically done by a person assigned to pulling jobs, but may be done by area leadership or an Operator needing work. In any case, the items needed to produce the job are pulled from the applicable inventory locations.

7. Painting is performed by an outside vendor per the purchasing process or by Fromex (facilitated by planning). References to documented instructions beginning with "FMPT", "FGS", "ES", or "EST" These references involve engineering documents that can be found in E-DOCS, the online engineering document control system available on our intranet.

4.1 Control of Outsourced Processing In some cases, we outsource some of the activities required to produce product. When this is the case, vendors used are evaluated and selected as described in Purchasing. 7.5.1c, 6.3 & 6.4 Use of Suitable (including maintained) Equipment In A Suitable Environment Equipment is considered to be suitable if it is capable of producing the part to requirements and is in good working order. Suitability of the work environment is addressed in the documents related to process where such considerations exist. Preventive maintenance activities are subcontracted out to vendors recognized as approved suppliers, when the maintenance activity can affect our ability to meet customer requirements. Corrective maintenance activities are facilitated by our business system software and handled by Maintenance. 7.5.4 Customer Owned Property For the most part customer owned property is dealt with like it was our own. The only thing different is to introduce it into Fisher Regulator through Returned Goods and if customer property is lost, damaged, or unsuitable for use, we let Returned Goods know so they can deal with the situation per the Returned Goods process. 8.1 Consistently Applying Statistical Techniques The only statistical techniques used in Production involve sample plans and charts or reports where data is analyzed. Sample plans are controlled by the process they are used for (posted in the area or referenced in the applicable process documents). Charts are controlled by the equations embedded in the program used to produce the chart or report.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Stamping & Labeling" box with "7.5.3" referenced. This means the notes or documents referenced, address the requirements of 7.5.3 of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Production Process Overview - Bologna 4.1, 5.4.2, 6, 7.1, 7.5.1, 7.5.2, 7.5.3, 7.5.5, 7.6 (sel. & use of calibrated devices), 8.1 (statistical techniques), 8.2.3, & 8.2.4

Revision: 11/23/2006 (description of changes: added inspection record definition to note 4)

NOTES: 1. CRITERIA: - Order will need to be produced in less than the current standard lead time? 2. For the most part units are assembled by operator who are recognized as competent to produce a particular assembly (i.e., an operator competent to produce a type 95 is capable of producing any and all of the type 95 units). When this is not the case or when the operator needs information to jog his or her memory, assembly illustrations or instructions may be used. 3. In some cases, received items do not go to our production area (i.e., they were purchase as a complete unit and only need “Further activities…”). Additionally, items that have already been processed through production and are returning from outside processing return to “Further

activities required” so they can be completed and shipped. 4. Inspection is a cursory review of the product for anything that may be obviously wrong. Tags and labels are called for by the order and/or BOM. Records of inspection/testing are as follows (unless other wise noted):

• Work order pick ticket signed/initialed by the person completing the assembly to signify product was produced and verified as acceptable in relation to the applicable specifications. In other words, the signed/initialed work order is evidence of conformity (signature reflecting the unit passed (was produced to the specifications) and the name of the person (signature or initials) to show the name of the person authorizing release.

• The cert record (Buono di Versamento) is signed/initialed to note the person authorizing release of the product to Shipping because the unit(s) passed the test (evidence of conformity is the signature/initials noting the test passed and the name shown in the initials/signature indicate who authorized release).

5. CRITERIA: - Is the job finished or is there more to be done, including possibly a next higher assembly? 6. CRITERIA: - Does the order call for a process that we outsource? 7. Inspect or test per the customer’s requirements. Inspection or test records (signed/initialed work order [Production's verification] and the cert record - Buono di Versamento [Testers results] are include and serve as the evidence of conformity/the name of the person authorizing release. 4.1 Control of Outsourced Processing In some cases, we outsource some of the activities required to produce product. When this is the case, vendors used are evaluated and selected as described in Purchasing and/or Supplier Selection. 7.5.1d & 7.6 Related To Selection & Use Of Such Devices When a device is used for monitoring or measurement of a product or process, we make sure it is capable of an accurate measurement and is used correctly. Correct use is based upon training provided (see training records). Selection is ensuring the device is capable of accurately measuring in the specified range or accurately demonstrating required specifications are being met. The other important thing to recognize is the need to report damaged devices or those not reading accurately to Quality. This will allow us to resolve any problem/potential problem. 7.5.3 Identification, Status, and Traceability What it is (identification), what is its state of existence (status), and where did it come from/where did it go (traceability)? IDENTIFICATION: Raw Material - Part number and/or description of the item. Work-In-Process (WIP) - By association with the WO. Finished Goods - Part number on unit or label on container noting part number or description. STATUS: Raw Material - For the most part by area, but may be by documentation with the item. WIP - The station the product is at defines the status of WIP. Finished Goods - By area (i.e., in packaging or shipping), the completed WO, or because it is packed up and awaiting shipment. TRACEABILITY: When required, the need for traceability is identified on the order. The certifications for units and the parts used are maintained with the completed order paperwork (record of traceability) and

can be used to identify affected orders when necessary. 7.5.1c, 6.3 & 6.4 Use of Suitable (including maintained) Equipment In A Suitable Environment Equipment is considered to be suitable if it is capable of producing the part to requirements and is in good working order. Suitability of the work environment is addressed in the documents related to process where such considerations exist. Preventive maintenance activities are are facilitated by logs or schedule or are subcontracted out to vendors recognized as approved suppliers, when the maintenance activity can affect our ability to meet customer requirements. Corrective maintenance activities are facilitated by production management. 7.5.5 Preservation of Product Preservation issues related to: Identification - When required, identification has been for the most part established as part of the process. When there is concern about a product's ability to survive to the point of shipment, the product is labeled "do not stack," "fragile" or other means of identification as deem necessary. Packaging - For the most part packaging is based on information provided in the order. When this is not the case, standard sized containers are used with items shipped in those containers per fit. Things like blocking and strapping a unit to a platform, using a wooden crate when there is concern about the product being affected by the shipping method are common practices for larger assemblies. Ensuring the unit is not against the edge to reduce the possibility of damage is also considered. Packaging in boxes, with paper, corrugated cardboard packing, and/or bubble packing may also be used. Items were a surface can be damaged by coming in contact with other surfaces (i.e. orifices or seat rings, plug valves, etc.), would be individually packed to maintain usefulness. In the end, the goal is to make sure the item will survive to the point of use. Storage - Raw material is stored in inventory locations throughout the facility, with these locations ensuring the product is protected. Work-in-Process (WIP) is stored on shelves, carts, or at the point of use. Finished goods are stored in inventory locations throughout the facility. Protection - For the most part, protection involves items with a limited life (i.e., glues, paints, epoxy, seals or other rubber parts with expiration dates), with the user ensuring the date is not past due prior to use. Other controls involve things like FIFO (first-in-first-out) and separating like parts on shelves to prevent mixing or misuse. DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Purchasing" box with "7.4" referenced. This means the notes or documents referenced, address the requirements of 7.4 ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Production Process Overview - Shanghai 4.1, 5.4.2, 6, 7.1, 7.5.1, 7.5.2, 7.5.3, 7.5.5, 7.6 (sel. & use of calibrated devices), 8.1 (statistical techniques), 8.2.3, & 8.2.4

Revision: 7/30/2005 (description of the latest change - Added maintenance considerations)

NOTES: 1. For the most part product lines define the process, including the necessary verifications and tests. Localized instructions (work instructions, illustrations, torque range charts, etc.) are also used to define and/or support the process. The workorder may include order specific instructions (job needs a cert, special handling requirements, etc.) needing to be fulfilled.

2. Production management receives the workorder, to verify the requirements are clearly understood and to insert the order into the appropriate line's production schedule (optimizing the line by putting like orders together, when it can be done). 3. Material Handlers load the product line with the correct materials for the build being set-up, making sure containers are clearly labeled and in the correct location on the line. When placing items on storage shelves in the are, Material Handlers tend to separate parts that have a similar look to reduce the possibility of pulling the wrong parts or mixing of parts. As part of loading the line, parts from the previous run tat are no longer needed are retruned to stock or placed back on the storage racks. 4. The Line Leader ensures the fixtures, line documentation, material on the line and tester are correct for the product to be produced, making adjustments as needed. 5. A line verification form is completed to reflect that the line has been verified. 6. Monitoring (inspections) and measurement (testing, torque verification) activities tend to be called out in the work instructions maintained as part of the line, but can be checks done by Quality (i.e., torque verification). Issues identified are brought to the Line Leader’s attention. The Line Leader corrects the issue and informs Quality of the need for corrective action when the issue is bad (catastrophic) or big (has happened a number of times in the past). Quality handles the need for action per Improvement Systems. Nonconforming product is dealt with as defined in Nonconformance Control. 7. Testing occurs as defined by the process or the line work instructions. The operator is authorized to release the product once the test has been satisfactorily completed, with evidence of completion being the application of the label on the unit. Nonconforming product is handled per Nonconformance Control. 8. 10 completed units (100% if the quantity is less than 10) are inspected by the Line Leader or a member of management per the Final Audit form for that line, with the signed off form serving as the record authorizing release of the product. Nonconforming product is handled per Nonconformance Control. 9. Shipping defines the shipping process and includes the handling of finished goods. References to documented instructions beginning with "FMPT", "FGS", "ES", or "EST" These references involve engineering documents that can be found in E-DOCS, the online engineering document control system available on our intranet. 4.1 Control of Outsourced Processing In some cases, we outsource some of the activities required to produce product. When this is the case, vendors used are evaluated and selected as described in Purchasing. 7.5.1d & 7.6 Related To Selection & Use Of Such Devices When a device is used for monitoring or measurement of a product or process, we make sure it is capable of an accurate measurement and is used correctly. Correct use is based upon training provided (see training records). Selection is ensuring the device is capable of accurately measuring in the specified range or accurately demonstrating required specifications are being met. The other important thing to recognize is the need to report damaged devices or those not reading accurately to Quality. This will allow us to resolve any problem/potential problem. 7.5.3 Identification, Status, and Traceability What it is (identification), what is its state of existence (status), and where did it come from/where did it go (traceability)? IDENTIFICATION: Raw Material - Part number and/or description of the item. Work-In-Process (WIP) - By association with the WO. Finished Goods - Part number on unit or label on container noting part number or description. STATUS: Raw Material - For the most part by area, but may be by documentation with the item. WIP - The station the product is at defines the status of WIP.

Finished Goods - By area (i.e., in packaging or shipping), the completed WO, or because it is packed up and awaiting shipment. TRACEABILITY: When required, the need for traceability is identified on the order. The certifications for units and the parts used are maintained with the completed order paperwork (record of traceability) and can be used to identify affected orders when necessary. 7.5.1c, 6.3 & 6.4 Use of Suitable (including maintained) Equipment In A Suitable Environment Equipment is considered to be suitable if it is capable of producing the part to requirements and is in good working order. Suitability of the work environment is addressed in the documents related to process where such considerations exist. Preventive maintenance activities are are facilitated by logs or schedule or are subcontracted out to vendors recognized as approved suppliers, when the maintenance activity can affect our ability to meet customer requirements. Corrective maintenance activities are facilitated by production management and a breakdown analysis is performed when corrective maintenance is an issue. 7.5.5 Preservation of Product Preservation issues related to: Identification - When required, identification has been for the most part established as part of the process. When there is concern about a product's ability to survive to the point of shipment, the product is labeled "do not stack," "fragile" or other means of identification as deem necessary. Handling - For the most part, handling issues are based upon the weight of the item (things greater than 40 pounds are handled with hoists or on carts). The key to using a hoist is ensuring the item is adequately secured before use. All other handling is obvious, as the type of part and the potential for damage dictate the actions of the person handling the item. Packaging - For the most part packaging is based upon standard sized containers with items shipped in those containers per fit. Things like blocking and strapping a unit to a platform, attaching corner posts to the cardboard tube, and attaching the card board tube to the platform are common practices for larger assemblies. Ensuring the unit is not against the edge to reduce the possibility of damage is also considered. Packaging in boxes, with paper, corrugated cardboard packing, and/or bubble packing may also be used. Items were a surface can be damaged by coming in contact with other surfaces (i.e. orifices or seat rings, plug valves, etc.), would be individually packed to maintain usefulness. In the end, the goal is to make sure the item will survive to the point of use. Storage - Raw material is stored in inventory locations throughout the facility, with these locations ensuring the product is protected. Work-in-Process (WIP) is stored on shelves, carts, or at the point of use. Finished goods are stored in inventory locations throughout the facility. Protection - For the most part, protection involves items with a limited life (i.e., glues, paints, epoxy, seals or other rubber parts with expiration dates), with the user ensuring the date is not past due prior to use. Other controls involve things like FIFO (first-in-first-out) and separating like parts on shelves to prevent mixing or misuse. DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Submit to Shipping" box with "7.5.1f & 7.5.5" referenced. This means the notes or documents referenced, address the requirements of 7.5.1f & 7.5.5 of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Monitoring & Measurement Devices (Calibration) 7.6

Revision: 2/7/2006(updated note 1 to recognize the need to allow for a grace period related to completion of calibration/verification by the due date)

NOTES: 1. Monitoring/measurement devices (things needing calibration or verification) are maintained by quality. GagePack (the calibration record in McKinney, but may be supported by vendor certs) or a calibration log (the calibration record in Shanghai and Bologna) is the schedule and is maintained by Quality. New monitoring/measurement devices are brought to Quality's attention when they arrive to determine if the device needs to be calibrated or verified prior to use (may simply accept the vendors cert if the cert provides insight into the calibration and maintains traceability). When pulling the device for calibration/verification, check to make sure it is being protected from damage or deterioration and has not been tampered with (safeguarded) in a way that could affect the device’s ability to provide accurate results. A calibration may be extended if the device has not been used since the last calibration or there is evidence showing use has been minimal. The extension and a justification would be included in the calibration record. It should also be noted that the goal is to complete the verification/calibration prior to the due date shown in the applicable schedule, but a grace period of 15 working days past the due date is acceptable to accommodate the need for the device and/or to allow time to complete all calibrations or verifications due at the time. Extending this time further may be done at management's discretion (typically in emergency situations), but should be noted as such in the schedule or in a memo. 2. We have used them before and no problems were encountered (see Purchasing for McKinney and Bologna or Supplier Selection for Shanghai). 3. Those providing calibration/verification are selected (criteria) on the basis of price and their ability to deliver. Evaluation criteria is simply that they are able to trace any calibration/verification performed back to NIST or other standard bodies and the standards have a capability that is greater than our

tightest tolerance. The record of evaluation is described in Purchasing. for McKinney and Bologna and Supplier Selection in Shanghai.

4. CRITERIA: - Outside Service - device is returned in a condition reflecting protection from damage or deterioration during calibration/verification and a review of the calibration/verification record provided by the supplier shows the device passed with traceability reflected and status (label on device or serial number that can be tied back to the record) clearly understood. - In-house - calibration/verification using traceable standards found the device to be in tolerance. Even if the device is within tolerance, we may choose to adjust or re-adjust the device to tighten the tolerance. The person performing calibration and/or the vendor working to calibrate the device would simply adjust/re-adjust the device and complete the calibration. 5. Devices that have been calibrated or verified may be labeled as such, but may be uniquely identified (i.e., name or number on the device) to allow for verification of status against the records. All devices are protected from damage or deterioration during handling and storage. This is also where we make sure settings that can be adjusted are safeguarded (tamper-proofed, sealed, etc.) to prevent tampering, when necessary. Records of the results of calibration/verification (internally and externally generated records) are maintained, include traceability, and filed per the records section of the Master Control Plan. 6. CRITERIA: - Is the device worth fixing (cheaper to repair than replace)? 7. If the item can be repaired (including adjustment/re-adjustment) in a cost effective manner (cheaper to repair than replace), it is repaired and re-calibrated/verified if it is such a device. Otherwise, the device is removed from service and a determination is made whether to purchase a replacement. An impact assessment (determining whether the device is out of tolerance within a range affecting our use of the device, review of customer complaints to see if an impact was realized and/or monitoring/measurement of product already checked with the device in question with a known good device) is undertaken by management from the area affected and/or Quality, to determine the validity of any measuring or monitoring done with the device. The results of this impact assessment are recorded on the calibration record. The assessment will include any action taken on the equipment (including increasing frequency of checks until once again confident) or affected product, as necessary. 8. In-house calibration/verifications are done per manufacturer’s recommendations or per check methods established by Quality (embedded in or referenced by the calibration record). Where feasible, calibration checks are done at 70 +/- 2 degrees Fahrenheit, with the unit under test and the test device together in this environment for at least 2 hours before and during the test. Where this is not feasible, ambient temperature, pressure and humidity is acceptable. The combination of these methods and ensuring traceability to NIST or other standard bodies is the process employed and is included in or referenced by the calibration record (GagePack for McKinney or the calibration certificate or calibration log in Shanghai and Bologna).

Determining monitoring and measurements to be undertaken, the devices needed, and ensuring the monitoring and measurement processes are fulfilling requirements (7.6) - Determination typically based upon the experience of the person performing the monitoring or measurement activity (see training records), but may be made by Quality or management as part of inspection or test procedures or work instructions and/or process specific procedures or work instructions.

Traceability of calibrations or verifications to NIST or other national/international bodies (7.6a) - All of the calibrations or verifications done at Fisher Regulator are traceable to the National Institute of Standards and Technology (NIST) or other standard bodies, as applicable. When there is no standard, the basis for the calibration or verification is recorded in this procedure, process-specific work instructions, and/or as part of the calibration record.

Software Confirmation - Software used for monitoring or measuring, that is not already confirmed as part of verifying a device, is confirmed as accurate to the needed capability prior to use and is re-confirmed as defined in the applicable calibration log.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Evaluate and select" box with "7.4.1" referenced. This means the notes or documents referenced, address the requirements of 7.4.1 of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Product Certification Use the following links to see the processes used for product certification at each site.

McKinney

Bologna

FROMEX

Shanghai

Certs 7.5.1a, 7.5.1b, & 7.5.1f


NOTES: 1. The Manufacturing Order (MO) defines the series of events needed to produce a product and includes the need for certifications (certs) related to a job. Certs referred to may be foundry certs or certs generated here to signify product was produced to requirements. 2. The heat number is the identifier used for foundry certs and is recorded on either the MO, CMTR Request Form, and/or in the business system software for parts requiring certs. If the heat number is hard to read or the product is a “Fast” part, the need for a cert and/or clarifying the heat number using existing certs may be requested from QA Technician. 3. For the most part the QA Technician identifies the need for certs by looking at what is in Shipping but not released as the MO is calling for certs, Shipping would identify the need when attempting to close out the order (both because either the system would point it out and/or the MO packet tends to contain an orange “Special Requirements” card to make it easier to see). Once the certs have been created they are mailed or sent electronically to the person or organization requesting the cert, with a copy maintained on file. 4. The product is released in the system for shipping. The MO is closed out by Shipping.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "MO calls for certifications" parallelogram with "7.5.1a, 7.5.1b, & 7.5.1f” referenced. This means the notes or documents referenced, address some or all of the requirements in 7.5.1a, 7.5.1b, & 7.5.1f. Blue, hyperlinked, &/or italicized words are referencing other documents.

Certs - Bologna 7.5.1a, 7.5.1b, & 7.5.1f


NOTES: 1. Certificates to signify product was manufactured to requirements (certificate of conformance) are provided for all products produced here (created at order entry). Material certs and certs related to items purchased from other sites are obtained when the order identifies this as a requirement. In either case, Production management and/or Customer Service obtain the necessary certs. 2. Record the information into Galileo and create a certificate from Fisher Process. 3. Production logs cert information on the cert log (form provided by Galileo, serving as a temporary record until the information is entered into Galileo). 4. CRITERIA: - Certs called for by the order exist and are here? 5. In some cases the product is already shipped. When this is the case, we obtain the information from the customer and work with the vendor to obtain the cert.

6. A review of shipping documents identifies orders needing certs sent to customers. Certs are printed and mailed or placed on the server for the customer to download as needed.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Certifications required" parallelogram with "7.5.1a, 7.5.1b, & 7.5.1f” referenced. This means the notes or documents referenced, address some or all of the requirements in 7.5.1a, 7.5.1b, & 7.5.1f. Blue, hyperlinked, &/or italicized words are referencing other documents.

Certs - Shanghai 7.5.1a, 7.5.1b, & 7.5.1f

Revision: 6/30/2005

NOTES: 1. The workorder defines the series of events needed to produce a product and includes the need for certifications (certs) related to a job. Certs referred to may be foundry certs or certs generated here to signify product was produced to requirements.

Exporting 7.5.1f Use the following links to see the way we handle exports at each site.

McKinney

Bologna (included in "Customer Service's Role In Shipping")

FROMEX

Shanghai

Exporting - McKinney 7.5.1f

Revision: 3/16/2006

Notes: 1. CRITERIA:

• Shipping document is a Shipping Authorization (SA) to an address that is unfamiliar (non-Fisher or Emerson location)?

• Management has asked for a screen?

Exporting - Shanghai 7.5.1f

Revision: 6/30/2005

NOTES: 1. Materials coordinator provides the Import/Export Clerk with SO information (Normal Export/Logbook/N-C logbook/Local Sales, FG part no. description, Qty, cargo weight, invoice, etc.). 2. For export cargos of non-corresponding logbook, there is a need to apply for Cargos supplementation to Foreign Economics Trade Commission & Customs ahead of cargo export 3. The Import/Export Clerk prepares: Logbook/Invoice/SO/Export Documentation/Picking list/Clearance list.

Shipping 7.5.1f & 7.5.5 Use the following links to see the way we ship product at each site.

McKinney

Bologna

FROMEX

Shanghai

Shipping 7.5.1f (release activities), 7.5.3, 7.5.5 (handling, storage, and protection), & 8.2.4 (verifying all monitoring & measurement activities have been done)

Revision: 3/16/2005 (description of latest changes - updated flow to account for exporting & added approach for shipping other types of shipments)

Click here for a printer friendly version of this document.


NOTES: 1. Parts are considered ready for shipping when they have been moved into the area and the Manufacturing Order (MO) shows all previous steps are complete. Shipping personnel perform this verification, with the system identifying that shipper as being the one closing out the order (record of inspection) 2. CRITERIA: - A review of the MO conducted by shipping identifies the need for special requirements (i.e. certs needing to be shipped with the job)? 3. The system will automatically print out the shipper if the manufacturing order is fulfilling a complete order. 4. CRITERIA: - The manufacturing order only covers part of a customer order? - The manufacturing order is the rest of an order where some or all of the items are in stock, awaiting the arrival of that order? 5. The appropriate freight area is for the most part designated by the shipper, with weight, size and shape being used to decide the method when needed and/or when the shipping method is not already defined. 6. CRITERIA: - The order in the system does not restrict a partial shipment? 7. CRITERIA: - The requirement is something that can be taken care of right away and there is no need to delay. 8. The RGA, shipping authorization, debit, and/or manifest may be used as a bill of lading. 9. The Shipping Authorization Form (see MCK 2144, found in R:\shipping_authorization\shipping_auth_std.doc "form 2144"). If the shipment is non product and going to FROMEX, a non product invoice is needed and can be obtained from Finance. Product going to FROMEX requires transfers generated by P & IC.

7.5.3 Identification, Status, and Traceability What it is (identification), what is its state of existence (status), and where did it come from/where did it go (traceability)? IDENTIFICATION - Identified by association with the order and/or the labeling on the product, shipping label, and/or Bill of Lading (BOL). STATUS - Typically, based upon location, but may also be statused by the shipping label and/or BOL. TRACEABILITY: - When required, the need for traceability is identified on the order (special requirements). The certifications for units and the parts used are maintained with the completed order paperwork (record of traceability) and can be used to identify affected orders when necessary. 7.5.5 Handling, Storage, & Preservation What we in shipping make sure of so the product will survive to the point of use by the customer. HANDLING – For the most part, handling is intuitively obvious and involves movement of product using a forklift, floor jack, cart, or some other moving equipment, but may simply be by

http://www.an-answer.com/emerson/Shipping-PrinterFriendly.doc

http://www.an-answer.com/emerson/Shipping-PrinterFriendly.doc

hand if the item is less than 40 pounds. STORAGE – Maintained by designated freight area and/or through inventory locations in our racks and our business system software. PROTECTION – Covered by the shipping method selected, ensuring the product will survive to the point of use.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Parts ready for shipping" parellellogram with "8.2.4" referenced. This means the notes or documents referenced, address the requirements called for in 8.2.4 of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Shipping - Bologna 7.5.1f (release activities), 7.5.3, & 7.5.5 (identification, handling, storage, packaging, and protection)


NOTES: 1. In some cases, an order is for parts and/or material only, other times an order is completed by Production and shipping the order is all that is needed, and still other times an assembly is

produced and parts and/or material are called for to be shipped with the assembly. In all cases, the expectations related to an order are included in the order from Customer Service. 2. CRITERIA: - Is the order from an Emerson Process Management Sales person or group? 3. The form should be with the order received from Customer Service, with their portion already filled out. If not, work with Customer Service to obtain the form. Complete the Shipping portion of the form. If issues arise, work with Customer Service to resolve. While it is possible for an order to be cancelled at this point (resulting in a return to stock of items pulled for shipping and the need for a disposition of completed assemblies), it is not likely. 4. The copy with the weights, dimensions of shipping container, and courier is given to Customer Service, while a copy of the order is maintained with the product (shipping container).

7.5.3 Identification, Status, and Traceability What it is (identification), what is its state of existence (status), and where did it come from/where did it go (traceability)? IDENTIFICATION - Identified by association with the order and/or the labeling on the product, shipping label, and/or delivery notes. STATUS - Typically, based upon location, but may also be statused by the shipping label and/or delivery notes. TRACEABILITY: - When required, the need for traceability (normally material traceability for the certs) is identified by the order. The certifications for units and the parts used are maintained with the completed order paperwork (record of traceability) and can be used to identify affected orders when certs are called for. 7.5.5 Identification, Handling, Storage, Packaging, & Preservation What we in shipping make sure of so the product will survive to the point of use by the customer. IDENTIFICATION - Labeling requirements related to preserving the product to the point of use, tend to be included in the order. When Shipping personnel determine there is a need to label a shipping container to ensure protection (such labels discouraging stacking), a label is created and applied to the container(s) HANDLING - For the most part, handling is intuitively obvious and involves movement of product using a forklift, floor jack, cart, or some other moving equipment, but may simply be by hand if the item is of a weight that is safe. STORAGE - Maintained by area and/or through inventory locations in our racks and our business system software. PACKAGING - For the most part packaging is based on information provided in the order. When this is not the case, standard sized containers are used with items shipped in those containers per fit. Things like blocking and strapping a unit to a platform, using a wooden crate when there is concern about the product being affected by the shipping method are common practices for larger assemblies. Ensuring the unit is not against the edge to reduce the possibility of damage is also considered. Packaging in boxes, with paper, corrugated cardboard packing, and/or bubble packing may also be used. Items were a surface can be damaged by coming in contact with other surfaces (i.e. orifices or seat rings, plug valves, etc.), would be individually packed to maintain usefulness. In the end, the goal is to make sure the item will survive to the point of use. PROTECTION - Covered by the shipping method selected, ensuring the product will survive to the point of use. Protection also involves items with a limited life (i.e., glues, epoxy, seals or other rubber parts with expiration dates), with the user ensuring the date is not past due prior to

use. Other controls involve things like FIFO (first-in-first-out) and separating like parts on shelves to prevent mixing or misuse.

DID YOU KNOW! The little numbers shown in the title and throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the section entitled "7.5.3 Identification, Status, & Traceability". This means this section and any notes or documents referenced, address the requirements called for in 7.5.3 of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Shipping - Shanghai 7.5.1f (release activities), 7.5.3, 7.5.5 (handling, storage, and protection), & 8.2.4 (verifying all monitoring & measurement activities have been done)

Revision: 7/30/2005 (description of latest change - moved arrow from "Shipping to address..." so it ends at "MC prints delivery notes...")

NOTES: 1. Parts are considered ready for shipping when they have been moved into the area and the Workorder (WO) is closed.

7.5.3 Identification, Status, and Traceability What it is (identification), what is its state of existence (status), and where did it come from/where did it go (traceability)? IDENTIFICATION - Identified by association with the order and/or the labeling on the product, shipping label, and/or Bill of Lading (BOL). STATUS - Typically, based upon location, but may also be statused by the shipping label and/or BOL. TRACEABILITY: - When required, the need for traceability is identified on the workorder or order. The certifications for units and the parts used are maintained with the completed order paperwork (record of traceability) and can be used to identify affected orders when certs are called for. 7.5.5 Handling, Storage, & Preservation What we in shipping make sure of so the product will survive to the point of use by the customer. HANDLING – For the most part, handling is intuitively obvious and involves movement of product using a forklift, floor jack, cart, or some other moving equipment, but may simply be by hand if the item is less than 40 pounds. STORAGE – Maintained by designated freight area and/or through inventory locations in our racks and our business system software. PROTECTION – Covered by the shipping method selected, ensuring the product will survive to the point of use.

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Parts ready for shipping" parellellogram with "8.2.4" referenced. This means the notes or documents referenced, address the requirements called for in 8.2.4 of ISO 9001:2000. Blue, hyperlinked, &/or italicized words are referencing other documents.

Nonconformance Control 8.3 Use the following links to see the way we deal with nonconforming product at each site.

McKinney

Bologna

FROMEX

Shanghai

Nonconformance Control 8.3

Revision: 6/23/2007Description of changes: Added note one to recognize the change out parts are not considered nonconforming product

NOTES: 1. Change out parts (i.e., parts being removed and replaced with a different part on existing units or kits) are not considered to be a nonconforming product and are not controlled as such. In essence, change out parts are either discarded or reintroduced as stock as applicable. 2. Actions may include completion of a Scrap Report, creation of a rework order, and/or a supplier CAR. 3. CRITERIA: - Do we believe the nonconformance involves more than just the item we are dealing with (i.e., more of a particular lot is in our inventory or out in the field)? There are instances where items not meeting requirements are backed out of the system (not really here) and are re-entered or returned to the vendor. These instances are not considered to be a nonconformance, unless they require action on our part. If they require action, a Scrap Report is generated and a debit is entered. They are placed in a hold area until the decision is made. A hold tag may also be used to identify issues where product is not truly nonconforming, but the situation suggests the need to be cautious. The tag is there to inform the person producing product of the need to look into something. If the situation is later found to be nonconforming, a scrap report is generated. 4. Quality &/or a member of management determines what is affected and where it is, to the extent they deem necessary, working with Applications Engineering (AE) to implement any course of action when necessary. 5. The responsibility and authority for disposition of nonconforming product lies with Quality, production management and/or Applications Engineering (AE). The actual disposition is noted on the Scrap Report (record of the nature of the nonconformity, and in some instances the record of actions taken and concessions obtained) or Supplier CAR, with the rework order serving as the record of the actions taken, and concessions obtained, as appropriate. 6. Affected parties include production and/or inventory control, as needed. 7. The goal is to rework the product or to salvage anything that can be returned to inventory. This would include inspection and/or testing to prove any reworked product was per requirements, using the same inspections and/or tests as were used for production. A record of the inspection and/or test, including the name(s) of the person authorizing release, is included in the rework order. 8. CRITERIA: - The nonconformance was an actual or potentially catastrophic event (amount or affect was or could have been BAD)? - Cumulative data tells us this issue is or will likely recur too frequently for us to ignore (quantity over time tells us this is or could be BIG)? - The circumstances are such that we can come up with a solution making our processes more effective (saving or positioning ourselves to be better)? A more thorough explanation of B3 can be found in Improvement Systems. 9. Scrap reports are accumulated and analyzed to identify and/or predict trends, with action taken as defined in Improvement Systems, when deemed necessary.

Nonconformance Control - Bologna 8.3

Revision: 7/30/2005(description of latest changes - added Non-Conforming Report to note 6)

NOTES: 1. Actions may include completion of a Nonconformance Disposition, creation of a rework order, a supplier CAR, customer documentation describing a nonconformance, or simply tagging/labeling the item with the problem. Segregation (placing the part in a location to prevent it from being mistaken for conforming product) may also be used to prevent unintended use. 2. CRITERIA: - Do we believe the nonconformance involves more than just the item we are dealing with (i.e., more of a particular lot is in our inventory or out in the field)? There are instances where items not meeting requirements are backed out of the system (not really here) and are re-entered or returned to the vendor. These instances are not considered to be a nonconformance, unless they require action on our part. If they require action, a Nonconformance Disposition is generated and a debit is entered. They may be placed in a hold area until the decision is made. Tagging or labeling may also be used to identify issues where product is not truly nonconforming, but the situation suggests the need to be cautious. The tag or label is there to inform the person producing product of the need to look into something. If the situation is later found to be nonconforming, a Nonconformance Disposition is generated. 3. A member of management determines what is affected and where it is, to the extent they deem necessary, working with Engineering to implement any course of action when necessary. 4. The responsibility and authority for disposition of nonconforming product lies with production management and/or Engineering. The actual disposition is noted on the Nonconformance Disposition (record of the nature of the nonconformity, and in some instances the record of actions taken and concessions obtained) or Supplier CAR, with the rework order serving as the record of the actions taken, and concessions obtained, as appropriate. 5. Affected parties include production and/or inventory control, as needed. If an item(s) is being returned to the vendor, Purchasing follows the vendor's process for returns and ensures accounting related activities (debits and credits) have been taken care of. 6. The goal is to rework the product or to salvage anything that can be returned to inventory. This would include inspection and/or testing to prove any reworked product was per requirements, using the same inspections and/or tests as were used for production. A record of the inspection and/or test, including the name(s) of the person authorizing release, is included in the Nonconformance Disposition or rework order. 7. CRITERIA: - The nonconformance was an actual or potentially catastrophic event (amount or affect was or could have been BAD)? - Cumulative data tells us this issue is or will likely recur too frequently for us to ignore (quantity over time tells us this is or could be BIG)? - The circumstances are such that we can come up with a solution making our processes more effective (saving or positioning ourselves to be better)? A more thorough explanation of B3 can be found in Improvement Systems. 8. Nonconformance records are accumulated (turned in to Production management) and analyzed to identify and/or predict trends, with action taken as defined in Improvement Systems, when deemed necessary.

Nonconformance Control - Shanghai 8.3

Revision: 7/30/2005(description of latest changes - added Non-Conforming Report to note 6)

NOTES: 1. Actions may include completion of a Non-Conforming Report, separating bad parts or material from good parts or material (i.e., use of yellow & red bins on product lines, designated areas for items considered to be non-conforming or on hold, label or tag as nonconforming, etc.), and/or a Supplier CAR. 2. CRITERIA: - Do we believe the nonconformance involves more than just the item we are dealing with (i.e., more of a particular lot is in our inventory or out in the field/at the customer)? There are instances where purchased items not meeting requirements are backed out of the system (not really here) and are re-entered or returned to the vendor. These instances are not considered to be a nonconformance, unless they require action on our part. If they require action, a Non-Conforming Report is generated and a debit is entered. They are placed in a hold area until the decision is made. A hold tag may also be used to identify issues where product is not truly nonconforming, but the situation suggests the need to be cautious. The tag is there to inform the person producing product of the need to look into something. If the situation is later found to be nonconforming, a Non-Conforming Report, Supplier Car, or the nonconforming item(s) is placed in a scrap container and noted as such in the scrap log. 3. Quality &/or a member of management determines what is affected and where it is, to the extent they deem necessary, working with Purchasing, Quality Quality, and Engineering to implement any course of action when necessary. 4. The responsibility and authority for disposition of nonconforming product lies with Quality, Management, Purchasing, Supplier Quality, and/or Engineering. The actual disposition is noted on the Non-Conforming Report, Supplier Car or scrap report (with the completed version of these forms serving as the record of the nature of the nonconformity the record of actions taken and concessions obtained). 5. Affected parties include production, supplier quality and/or materials management, as needed. 6. The goal is to rework the product or to salvage anything that can be returned to inventory. This would include inspection and/or testing to prove any reworked product was per requirements, using the same inspections and/or tests as were used for production. A record of the inspection and/or test, including the name(s) of the person authorizing release, is the workorder, Non-Conforming Report, or rework instruction (which may simply be a note or memo) and product test/inspection records normally associated with the product line. 7. CRITERIA: - The nonconformance was an actual or potentially catastrophic event (amount or affect was or could have been BAD)? - Cumulative data tells us this issue is or will likely recur too frequently for us to ignore (quantity over time tells us this is or could be BIG)? - The circumstances are such that we can come up with a solution making our processes more effective (saving or positioning ourselves to be better)? A more thorough explanation of B3 can be found in Improvement Systems. 8. Scrap reports are accumulated and analyzed to identify and/or predict trends, with action taken as defined in Improvement Systems, when deemed necessary.

Improvement Systems 8.5

Revision: 6/5/2005

McKinney (Corporate Site)

Bologna

FROMEX (Mexico)

Shanghai

Improvement systems is all about the systems we have in place to continually improve our business, suppliers and products in a closed-loop fashion. The information we collect (analysis of data from customers, products, processes, and suppliers, audit results, measurements related to our objectives, previously completed corrective/preventive actions and inputs to management review) lead to actions (corrective action, preventive action, opportunity for improvement, management review outputs, etc.) that will drive improvement. The actual methods used for facilitating improvement systems at each Fisher Regulator site can be found by clicking on the links shown above.

B3 Big, Bad, or Better 8.5 The decision to take action is based upon the size (magnitude) of the actual/potential problem or needed improvement (how big is it/how big can it get or how big of a difference can it make?), the impact (encountered risk) the problem had or could have (how bad is it/how bad can it get?), and/or increased effectiveness an improvement could have (how much better could we be for our customers [give the customer what they want and make money doing it]?). When the action we could take is not the result of either a big or bad problem (but instead a fluke) and will not make us more effective, we may choose to forgo the action. Coupled with the policy and objectives' ability to drive effectiveness, these actions are all considered to be continual improvement opportunities and are typically geared towards the quality management system (manual, procedures, etc.). The more effective we make the system, the more the system can and will drive our behavior toward good business sense. Continual improvement efforts can also be generated by finding ways to operate more effectively and by identifying cost reductions. In either case, we should all be looking for ways to make Fisher Regulator better.

IssueNeeding

Resolution

RootCause

Found?

Process Improvement Loop

Step 1:Record the Action

to be taken

Step 2:Take the Action

Step 4:Close-out and submit

to management review.

Step 3:Verify and record

the Action effectivelyimplemented.

Why

NO

YES

The 5 Why's Explained (Getting to the Heart of the Matter)

The 5 Why's is a problem solving technique used to gain a deeper understanding of a situation and to determine its underlying cause. Until the real cause is determined, an effective solution cannot be implemented. Here is how it works: - Ask "Why?" the condition/situation currently exists. - Each time the question "Why?" is answered, ask "Why?" again. - Continue to ask "Why?" until everyone involved is satisfied the real root cause (the actual reason) is determined (typically why is asked 5 times but may be more or less).

The Policy as an Improvement Tool 8.5.1 Our quality policy is intended to serve as a filter for making good decisions at Fisher Regulator. When the evidence or our actions show shortcomings not covered by the policy, we may choose to update the policy to ensure we are clearly setting expectations and are positioned to drive behavior. This is how we use the quality policy to continually improve our effectiveness.

Improvement Systems - McKinney 8.5

Revision: 5/3/2006(description of changes - removed FIX and replaced with Service Request, also integrated supplier corrective action process into this flow)

Notes: 1. Opportunities to improve our effectiveness come from the evidence generated by the system (audit results, measurements related to our objectives, and analysis of customer, process-related, product-related and supplier data [a.k.a trends or "Big"]) , significant events or the potential for significant events requiring immediate corrective or preventive action (a.k.a "Bad"), and/or action items from management review (see Management Review Matrix). These sources are also where we get system improvements geared towards making us "Better."

2. CRITERIA: - In need of formal action? See "B3 Big, Bad, or Better" to understand when formal action (corrective/preventive action, action items from management review, etc.) is needed. When formal action is not needed, we just deal with the incident and move on. If the action needed relates to a supplier, see Supplier Quality.

3. When deciding not to take any action, we should let those requesting the action know of our decision. This lets them know we gave it due diligence and could lead to them shedding new light (including a solution we had not thought of) on the subject.

4. Incidents tend to be entered into the system by quality, but can be derived by the system directly in some cases (e.g., because the system knows when an item is to be delivered and when it was received in, the system can report on-time delivery). Supplier Quality reviews the data and determines if we need to send a notice (when they decide the only thing needed is to make the supplier aware of the situation) or issue a SCAR (a problem or potential problem exists and a solution is needed).

5. A notice tends to be an email sent to the supplier describing the issue, but can be a phone call, fax, or any other type of communication.

6. While the activities described in this section tend to be addressed in the applicable form, this section and the following notes are an overview of how actionable items are handled to ensure a closed-loop process is used.

• The root cause is the real reason a potential problem can exist, a problem does exists, and/or an improvement opportunity should be pursued. It is the thing needing to be dealt with to prevent the problem from happening in the first place (preventive action), keep it from happening again (corrective action), and/or realize the improvement opportunity. The "5 Why's" (see "The 5 Why's Explained") and/or any other root cause methodology can be used when the root cause is not intuitively obvious.

• Facilitated by the Corrective Action Report, Corrective/Preventive Action Request, Service Request (SR) system, SCAR or management review action items (such as those found in the Management Review Matrix). These forms also serve as the records of the results of actions taken and are maintained as defined in Master Control Plan.

7. CRITERIA: - Did the action taken eliminate the potential/actual problem and/or promote continual improvement after it was effectively implemented (put to use)?

8. Corrective or Preventive actions need to be summarized for management review (see Management Review Matrix). This summary may be a review of the completed corrective/preventive actions, an overview of significant issues (deemed as such by the management representative) compiled from corrective/preventive actions or a status of open corrective/preventive actions. The key is to recognize the goal of management review, that being to assess what has been done to determine if further action will improve the organization's effectiveness.

9. CRITERIA: - Will trying something else help us or are we wasting time?

DID YOU KNOW! The little numbers shown throughout this document are clause numbers from ISO 9001:2000 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Record results of actions taken” box with "8.5.2e & 8.5.3d" referenced. This means the notes or documents referenced, address the requirements of 8.5.2e & 8.5.3d of ISO 9001:2000. Blue &/or italicized words are referencing other documents.

Improvement Systems - Bologna 8.5, with 7.2.3c, 8.2.1, & 8.4a


Notes: 1. Opportunities to improve our effectiveness come from the evidence generated by the system (audit results, measurements related to our objectives, and analysis of customer, process-related, product-related and supplier data [a.k.a trends or "Big"]) , significant events or the potential for significant events requiring immediate corrective or preventive action (a.k.a "Bad"), and/or action items from management review (see Management Review). These sources are also where we get system improvements geared towards making us "Better." If a customer complaint is received, and is not part of a return (see the returned good process), the incident needs to be included in the Action Item List or and Opportunities & Incidents form. This information is

summarized for management review.

2. CRITERIA: - In need of formal action? See "B3 Big, Bad, or Better" to understand when formal action (corrective/preventive action, action items from management review, etc.) is needed. When formal action is not needed, we just deal with the incident and move on. If the action needed relates to a supplier, see SCAR. 3. When deciding not to take any action, we should let those requesting the action know of our decision. This lets them know we gave it due diligence and could lead to them shedding new light (including a solution we had not thought of) on the subject. 4. The root cause is the real reason a potential problem can exist, a problem does exists, and/or an improvement opportunity should be pursued. It is the thing needing to be dealt with to prevent the problem from happening in the first place (preventive action), keep it from happening again (corrective action), and/or realize the improvement opportunity. The "5 Why's" (see "The 5 Why's Explained") and/or any other root cause methodology can be used when the root cause is not intuitively obvious. 5. Facilitated by the Action Item List, Opportunities & Incidents, FIX system or management review action items (such as those found in the Action Item List). These forms also serve as the records of the results of actions taken and are maintained as defined in Master Control Plan. If the action to be taken is related to a supplier, corrective action is as defined in SCAR. 6. CRITERIA: - Did the action taken eliminate the potential/actual problem and/or promote continual improvement after it was effectively implemented (put to use)? 7. Corrective or Preventive actions need to be summarized for management review (see Management Review). This summary may be a review of the completed corrective/preventive actions, an overview of significant issues (deemed as such by the management representative) compiled from corrective/preventive actions or a status of open corrective/preventive actions. The key is to recognize the goal of management review, that being to assess what has been done to determine if further action will improve the organization's effectiveness. 8. CRITERIA: - Will trying something else help us or are we wasting time?


Improvement Systems - Shanghai 8.5

Revision: 7/16/2005

Notes: 1. Opportunities occur when a problem or potential problem at incoming inspection (bad or potentially bad), the percentage of scrap or rework in production has or is believed that it will exceed acceptable limits (big or potentially big), or a fatal/near fatal discrepancy (bad or potentially bad) is found by the Inspectors or Production. Quality is informed of the actual (believed to need corrective action) or potential (believed that preventive action will keep a situation from getting out of hand) issue needing attention. Quality uses this information, audit results, the results of previously closed corrective and preventive actions, and the defects/measurements review to determine which issues need corrective action, preventive action, or continual improvement (something that will simply make us better). See "B3 Big, Bad, or Better" for a clearer understanding of when formal action (corrective action, preventive action, continual improvement, etc.) is needed. 2. CRITERIA: - A supplier discrepancy (bad and in need of corrective action)? - A trend in supplier-related data suggest the need for action (big and in need of corrective action) - On-line scrap exceeds the goal for the line (big and in need of corrective action) or a trend in scrap leads us to believe we will soon exceed goal for the line (potentially big and in need of preventive action)? - On-line rework exceeds the goal for the line (big and in need of corrective action) or a trend in rework leads us to believe we will soon exceed the goal or the line (potentially big and in need of preventive action)? - A fatal or potentially fatal discrepancy (bad an in need of corrective action or potentially bad and in need of preventive action)? - An opportunity for improvement would help us save money or position us to make more money (better and in need of action to see it effectively implemented)? - Results show a previously closed corrective action, preventive action or improvement opportunity did not work and more action is needed? If an existing corrective action, preventive action or improvement opportunity is in the process of being worked on, there is no need to write another. When formal action is not needed, we just deal with the incident and move on. 3. When deciding not to take any action, we should let those requesting the action know of our decision. This lets them know we gave it due diligence and could lead to them shedding new light (including a solution we had not thought of) on the subject. 4. Quality Engineering issues a SCAR to the supplier within 2 days and the supplier acknowledges the SCAR within 24 hours, taking temporary action during that time. A response (root cause/action taken) is provided by the supplier within 10 working days (unless they inform us it will take longer to see that the results show the action taken resolved the issue raised). 5. Supplier Quality either works with the supplier to resolve the issue (offering assistance as needed) or begins looking for a new supplier per our Purchasing process. 6. Quality or management issues a process improvement record or action item to the responsible area (engineering, production, etc.) within 2 days and the responsible area acknowledges the process improvement record or action item within 24 hours, taking temporary action during that time. A response (root cause/action taken) is provided by the responsible area within 10 working days (unless they inform us it will take longer to see that the results show the action taken resolved the issue raised). With respect to the root cause (the real reason a potential problem can exist, a problem does exists, and/or an improvement opportunity should be pursued), it is the thing needing to be dealt with to prevent the problem from happening in the first place (preventive action), keep it from happening again (corrective action), and/or realize the improvement opportunity. The "5 Why's" (see "The 5 Why's Explained" above) and/or any other root cause methodology can be used when the root cause is not intuitively obvious. In any case the process improvement record or action item form facilitates corrective action, preventive action, and continual improvement, and is the record of the results of actions taken. Corrective action, preventive action, and improvement opportunity records are

maintained as defined in Master Control Plan.

7. CRITERIA (assessed by Quality or Management): - Did the action taken eliminate the potential/actual problem and/or promote continual improvement after it was effectively implemented (put to use)? If the answer is yes, Quality or Management closes out the process improvement record or action item. 8. Corrective or Preventive actions need to be summarized for management review (see Management Review). This summary may be a review of the completed corrective/preventive actions, an overview of significant issues (deemed as such by the management representative) compiled from corrective/preventive actions or a status of open corrective/preventive actions. The key is to recognize the goal of management review, that being to assess what has been done to determine if further action will improve the organization's effectiveness. 9. CRITERIA (determined by Quality or Management): - Will trying something else help us or are we wasting time? If we believe something else will help, assess the action to be taken against the root cause and start over the new action to be taken. May involve the completion of a new form or may simply be added to the record you are currently working with.


Audit Procedure 8.2.2 (responsibilities & requirements for planning & conducting audits) and 8.2.3 (monitoring and measuring processes)

Revision: 11/22/2006 (description of changes: all new procedure to recognize alternate audit checklists/schedules and to promote performance-based auditing)

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PURPOSE: A how-to guide for conducting an audit (measuring quality management system [QMS] processes to demonstrate the ability of the processes to achieve planned results), verifying the QMS is who we are (planned arrangements), what we want to be (requirements established by the organization), fulfills the sections of ISO 9001:2000 called for by the applicable audit report or audit schedule, and ensures the system is driving our behavior (effectively implemented and maintained) in an objective and impartial manner (which is what this procedure does).

CLARIFICATIONS:

Audit Plan - Typically an Audit Report for the activity/area being audited and the Audit Report Summary, with additional questions/issues that are to be verified included in or attached to these documents as needed to ensure objectivity and impartiality. May also be a marked-up copy of the procedure, identifying evidence to be collected to verify conformance. In essence, it can be any audit report or checklist used to ensure the management system is effectively implemented and is addressing all of the applicable requirements of ISO 9001:2000.

Audit Coordinator - Person with responsibility/authority for scheduling audits, selecting Auditors (ensuring objectivity and impartiality), and ensuring issues raised are effectively addressed.

Auditor - Person responsible for and having the authority to live up to the expectations set in this procedure.

Effectiveness - The evidence, including the relationship with inputs and outputs for the process, shows the process is working and supporting the organization's policy and objectives (including profitability and sustainability).

Finding - An issue needing resolution. It could be an actual problem (something requiring corrective action), a potential problem (something requiring preventive action), or any other opportunity for improvement (including those making us better and/or helping us make more money or save money). Types of findings are:

• MAJOR = The evidence shows the problem to be systemic (very big or bad) and/or requirements from the applicable standard(s) are not addressed or adhered to;

• MINOR = The evidence shows a problem, in need of attention, but not one where the system is broken down (simply needs a little touch-up) and/or a requirement or two from the applicable standard(s) are not completely addressed or adhered to; and

• COMMENT = May be a praise or may be pointing out things that could use a little work (correction, preventive action, or opportunities for improvement).

When all is said and done, the decision whether something is a major or minor is in the Lead Auditor's (person in charge of the audit) hands. The tendency is to use "the benefit of doubt" (things start as a minor and escalate as supported by evidence) as the rule of thumb. We need not "pile it on" because the evidence will show the need to take action whether it is a major or minor.

Objectivity and Impartiality - An expectation of both Auditors and the process they employ. To be objective and impartial means to let the evidence speak for itself. Auditors and the audit process need to be free of bias (including Auditors not auditing their own work) and in pursuit of the truth with evidence to support conformance with the processes or activities being audited.

COMPETENCY/QUALIFICATION OF AUDITORS USED: Persons trained to this process or an Auditor training course may be assigned to perform an audit, unless the audit will involve their own work. If the audit involves their own work, someone else will perform the audit. This ensures the Auditor will maintain objectivity and impartiality. When training to this process or any other Auditor training program, familiarity with ISO 9001:2000 is important.

NOTES:

1. The audit schedule is maintained by the management representative and is included in the maintenance schedule. Audits are scheduled based on how well the area to be audited is doing (status), the effect a problem would have on the area if it was allowed to go on until a problem was detected (importance) and how well the area did on the last audit.

2. The audit criteria are the clauses or sections of the applicable standard and/or the documents defining the

processes being audited. Scope tends to be based upon the sections of the applicable standard in use, but may be based upon a defined area and/or process. Document review and audit planning may be accomplished prior to and/or during the audit. The auditor uses the documents to formulate the questions to be asked and evidence to be reviewed. This plan may be a documented plan (an audit checklist, a highlighted document depicting questions to be asked/evidence to be reviewed, etc.) or may simply be a copy of the applicable standard or management system document. In either case, the intent is for the auditor to familiarize himself/herself with the activities/processes to be audited. Obtain the documents associated with the activity/area being audited. These documents may include:

• The quality manual, • Procedures, work instructions, or forms that support the activity/area, and • Peripheral documents (standards, specifications, procedures, previous audit results,

corrective/preventive actions issued since the last audit, etc.), as needed. • Previous audit results and corrective/preventive actions related to the area since the last audit.

Review the relationship of the documents to make sure there are no contradictions, to ensure adequate coverage of the applicable requirements (ISO 9001:2000, customer specifications, etc.), and look at past performance information to get a feel for issues the area has had to overcome. In essence, the auditor is trying to understand whether the documentation provides a good road map and to identify what could be seen or needs to be verified as effectively resolved.

3. Greet area personnel, helping them feel comfortable with the audit process and powering down your notes. (example: "Hi, I am here to perform an audit of ____ and I need your help. What I mean by that is I need you to speak on behalf of the process because you know what really happens. This will help us make sure the procedures are right. I will be taking notes along the way. My notes are not about you, but about the process. If there are things that need to be fixed or improvement opportunities, I will be writing those down so we can give management the information they need to take action.") REMEMBER: you (the Auditor) are not there to resolve any issues so do not make promises as to how or what will be fixed.

4. ASK OPEN-ENDED QUESTIONS! We are looking for evidence related to performance and behavior. In order to find this and to make sure we are focused on what we need to see, open-ended questions help us ask the witness to show us how something works and what the results are. Also, make sure your questions are about the evidence that proves or disproves a process is working.

5. CRITERIA:

- ☺ means what we said in a document is actually happening, meets the requirements, and is effective. - means what we said in a document is not happening, the document does not meet all of the requirements, and/or is not effective. - means we are not sure how we feel about what we see and probably need to ask additional questions to be able to come to a conclusion.

REMEMBER: Avoid rabbit trails (issues involving processes other than the one the Auditor is currently auditing), staying away from discomforts not directly related to the audit, unless it is obvious a nonconformance or ineffective condition related to the area or process being audited exists.

6. Make sure any findings are based upon facts not assumptions. Make note of the condition, powering down your notes so the witness does not think it is about him/her.

7. Remember, if you see something positive that is noteworthy, write it down. This is the only time you write someone's name on your audit report (unless their name is the sample, such as those you sample for training records). If your note taking skills are good enough to capture the evidence of conformance, that is great! At a minimum, make sure your results reflect what you audited (with the assumption being that no findings means the area/process is conforming and effective).

8. Ask additional questions or ask to see more evidence that will allow you to deal with your discomfort. Make sure they understand what you are uncomfortable with. This may help them with the answer.

9. Be careful not to let your discomfort influence them into making process changes they do not need. REMEMBER: Make sure you are adding value, not imposing beliefs.

10. If your discomfort is something you feel will be an issue in the future, be sure to add it to your audit as a comment or observation. This will tell the next auditor what they should follow up on and may help area management recognize an opportunity for improvement, as any action they take would be preventive action.

11. Once you are finished understanding the evidence of the process and whether that evidence reflects sound business practices, review the documents defining the process to see if the match up with what was seen. Any variation needs to be understood and worked through with area management to determine where there is a need to update the document (if it is found that the other things included in a procedure are not needed or there are additional steps that are not in the document but are needed) or a need to work with area personnel to ensure we are following practices deemed important.

12. Work with affected personnel and area management to reach an agreement on the findings. While this may not be achievable (they do not like your results), try to obtain agreement, powering down the process along the way. If you still feel the finding is legitimate, there may be a need to agree to disagree with your findings continue to exist.

13. The auditor summarizes the audit and any findings, presenting the recorded results to area management and/or the management representative. If the results are presented to the management representative, he or she reports the results to area management.

14. CRITERIA:

- A nonconformance was identified and will require corrective action? - A potential problem was identified and needs preventive action? - An opportunity for improvement was identified that could make us better (make more money or

spend less money)?

If the issue(s) was able to be resolved before the end of the audit or it is believed the follow-up at the next audit will report on the results (Audit Report should be flagged to ensure follow-up), the audit may be closed out and the Audit Schedule is updated as needed (see note 1).

15. Records (audit results, including any records of follow-up) are maintained as defined in the Master Control Plan. The management representative summarizes the results of audits for management review (see the management review process in 5.6)

16. Area management facilitates corrective action, preventive action, and/or any other improvement opportunity per 8.5 in ISO 9001:2000. This would include actions taken by area management (without undue delay) and follow-up of action taken. The records generated as a result of corrective/preventive action are maintained as

http://www.an-answer.com/emerson/MasterControlPlan.xls

http://www.an-answer.com/emerson/MasterControlPlan.xls

defined in 4.2.4 of ISO 9001:2000 [Control of Records]. Also, work with area management to determine when to verify any actions taken (allowing enough time for effective implementation), closing out findings (reporting the results) that have been dealt with by auditing those issues in a manner similar to the original audit (follow the methods established).

Management Review 5.6 & 8.4

Revision: 10/12/2005(added Management Review Matrix as a means for presenting in note 2)

NOTES: 1. Business reviews occur both at the site level and as part of a corporate level review at least once per year, at management's discretion and per management's direction. The review tends to involve the President, his senior level management team, and the site's management, but can be accomplished by a member of senior level management for the business unit involved. 2. A presentation is developed for the review and includes (as applicable for that review):

• A summary of the results of follow-up of action items from the last review that have not already been closed out by management and any that need more discussion, as well as the status (how well we are closing the loop and any hinderances) of corrective/preventive actions. 5.6.2d & 5.6.2e

• Performance metrics related to the objectives and overall business performance and (process performance, product conformity, customer feedback, results of audits). 5.6.2a, 5.6.2b, & 5.6.2c

• Improvement opportunities in work or being realized and the expected effect (recommendations for improvement and changes affecting the management system) 5.6.2f & 5.6.2g

The goal in developing this presentation is to present the results in a way that helps management understand the bottom line and in many cases the decisions that were made causing the results to look the way they do. This provides management with the information needed to assess actions taken to date. In some cases, the presentation is a completed Management Review Matrix.

3. Business performance reviews are assessments of results that show action taken by management to effectively run the business are working, and to determine if more work is needed or would simply benefit the organization and drive continual improvement. In essence, this review is primarily to accept the results (decisions) showing the business model (management systems, policies and objectives) is suitable (fits our business plan), adequate (lives up to customer, corporate, industry, and legal requirements), and effective (results show the business model is driving our behavior). If action items are identified, these action items (once completed) serve to make the business model (system) more suitable, adequate, and effective. 5.6.1 & 5.6.3 (decisions) 4. CRITERIA:

• Results show there is a need to improve our processes, policies, or objectives/measurements (i.e. our management system)?

• Results show there is a need to improve products to further support customer requirements? • Resource needs have been identified or acknowledged?

5. The Action Item List is used to facilitate action items and fulfills all of the requirements for corrective action and preventive action as well. Improvement Systems provides further insight into the closed-loop processes employed. 6. Management maintains the records of management review (the presentation and Action Item List).

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