quality management system manual qm-qua-001 · n 03/28/07 remove revisions from text for as9100 and...

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Quality Management System Manual QM-QUA-001

Nelson-Miller Inc. Wilson-Hurd 2800 Casitas Avenue 311 Winton Street, Los Angeles, Ca 90039 Wausau, Wisconsin

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Revision Date Description of the Change

N/C 10/10/79 Initial release of documented inspection system A 07/22/80 Deleted Chief Inspector from Executive

Staff B 10/01/84 Changes made in Executive Staff C 01/10/87 Completely rewritten

D 01/17/89 Completely rewritten

E 07/14/92 Completely rewritten

F 05/07/98 Rewritten to reflect NNP’s Quality Improvement Process (QIP) and Systems

G 8/10/99 Process revisions made to Sections: 1, 2, 4, & 11; Deleted Section 15 and renumbered the following sections

H 7/31/00 Rewritten to comply with ISO 9002

I 10/20/00 Section 8: “Substrates” to “Metal and adhesives.” Page VI: “...all existing & new employees.” to “. . . all employees. ”Section 1: “15 steps” to “14 steps” APPENDIX A: Deleted

J 03/14/01 Quality Policy: Added “during” to training description. Section 2: Clarified scope of quality system. Section 9: Added Mil-A-8625 Type II compliance to special processes. Section 11: Clarified calibration source approval requirements. Section 17: Changed assessment schedule release period from July to the first quarter of each year. Section 18: Change “Personnel” to “Human Resources.”

K 11/19/01 Revised to comply with AS9100. L 10/27/03 Revised to comply with ISO 9001 and AS9100

M 06/05/06 Changed “ECR” to “OFI”. Added exclusions to the Scope of the Quality System as recommended during the 2004 TUV audit report (Opportunity for Improvement) – page 7.

N 03/28/07 Remove revisions from text for AS9100 and ISO based on TUV audit report

O 04/02/09 Modified Section 3, added “..as it is not required for our products..” is Section 7.5, and added Team Functions to Diagram #2.

P 09/24/09 Modified Section 5.3.

Q 01/05/10 Revised to reflect ISO 9001: 2008

R 11/01/2011 Revised to reflect name change, current practices and compliance to AS9100 revision C

S 01/12/12 Revised to improve conformance to AS9100 standard

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Revision Date Description of the Change T 02/15/13 Removed Section 7.5.1.4 from exception list and

updated 7.5.1.4 to show “not applicable “at this time or where the action is addressed for each reference statement.

U 7/16/15 Update Org. Chart; update QMS referenced documents as part of QMS documentation review/update.

V 8/26/15 Section 5.6 Management review 5.6.1 General - updated frequency for Management Review from “Semi-annually” to “annually”.

W 2/09/16 Changed Quality Policy. Y 2/2/18 Update Manual to align with AS9100D and

ISO9001:2015 requirements

TABLE OF CONTENTS

TITLE REFERENCE PAGE Cover Page 1

Revision History 2

Table of Contents 3

Introduction Nelson-Miller Organization Chart 8

Section 1 Scope 9

Section 1.1 General 9

Section 1.2 Application 9

Section 2 Normative Reference 11

Section 2 .0 Quality Management System References 11

Section 3 Terms and Definitions 12

Section 3.0 Quality Management System Definitions 12

Section 4 Context of the Organization 13

Section 4.1 Understanding the Organization and Its Context 13

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TITLE REFERENCE PAGE

Section 4.2 Understanding the Needs and

Expectations of Interested Parties 13

Section 4.3 Determining the scope of the quality

management system 13

Section 4.4 Quality management system and its processes 14

Chart Identification and interaction of Processes 15

Section 5 Leadership 16

Section 5.1 Leadership and commitment 16

Section 5.1.2 Customer Focus 16

Section 5.2 Policy 16

Section 5.3 Organizational Roles, Responsibilities and Authorities 17

Section 6 Planning 19

Section 6.1 Actions to address risks and opportunities 19

Section 6.2 Quality objectives and planning to achieve them 19

Section 6.3 Planning of changes 19

Section 7 Support 21

Section 7.1 Resources 21

Section 7.1.1 General 21

Section 7.1.2 People 21

Section 7.1.3 Infrastructure 21

Section 7.1.4 Environment for the operation of processes 21

Section 7.1.5 Monitoring and measuring resources 21

Section 7.1.5.2 Measurement Traceability 22

Section 7.1.6 Organizational Knowledge 22

Section 7.2 Competence 22

Section 7.3 Awareness 23

Section 7.4 Communication 23


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Section 7.5 Documented information 24


Section 7.5.2 Creating and updating 25

Section 7.5.3 Control of documented Information 25

Section 8 Operation 27

Section 8.1 Operational planning and control 27

Section 8.1.1 Operational risk management 28

Section 8.1.2 Configuration Management 28

Section 8.1.3 Product Safety 29

Section 8.1.4 Prevention of Counterfeit Parts 29

Section 8.2 Requirements for products and services 29

Section 8.2.1 Customer communication 29

Section 8.2.2 Determining the Requirements for Products

And services 30

Section 8.2.3 Review of the requirements for products

And services 30

Section 8.2.4 Changes to requirements for products and

Services 30

Section 8.3 Design and Development of Products and

Services 31

Section 8.4 Control of externally provided processes,

products and services 31


Section 8.4.2 Type and Extent of Control 31

Section 8.4.3 Information for external providers 32

Section 8.5 Production and service provision 32

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Section 8.5.1 Control of production and Service provision 32

Section 8.5.1.1 Control of Equipment, tools and software programs 34

Section 8.5.1.2 Validation and control of special processes 34

Section 8.5.1.3 Production Process Verification 34

Section 8.5.2 Identification and traceability 34

Section 8.5.3 Property belonging to customers or external

Providers 35

Section 8.5.4 Preservation 35

Section 8.5.5 Post-delivery activities 36

Section 8.5.6 Control of Changes 36

Section 8.6 Release of products and services 36

Section 8.7 Control of nonconforming outputs 37

Section 8.7.2 The organization shall retain documented

information that 37

Section 9 Performance evaluation 40

Section 9.1 Monitoring, measurement, analysis and evaluation 40


Section 9.1.2 Customer Satisfaction 40

Section 9.1.3 Analysis and evaluation 41

Section 9.2 Internal Audit 41

Section 9.3 Management review 42


Section 9.3.2 Management Review inputs 42

Section 9.3.3 Management Review outputs 42

Section 10 Improvement 44

Section 10.1 General 44


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Section 10.2 Nonconformity and corrective action 44

Section 10.3 Continual Improvement 45

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Nelson-Miller Responsibilities and Organizational Structure


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Section 1: Scope

1.1 General

Nelson-Miller Company’s mission is to provide total customer satisfaction with quality products leading to long term partnerships. The QMS is established to improve our operational effectiveness, and enhancing customer satisfaction by consistently providing products that meet customer and applicable regulatory requirements, while continually improving the QMS.

Nelson-Miller Inc. has implemented a Quality Managment System (QMS), that documents the company’s best business practices, to better satisfy the requirements and expectations of its internal and external customers, and to continuously improve the overall managment of the company.

This quality manual outlines the policies, procedures and requirements of the QMS. The system is structured to comply with the conditions set forth in the International Standard AS9100D, ISO 9001:2015, and ISO 13485:2016.

This manual is divided into ten sections that best correlate with the QMS sections of the AS9100, ISO 9001. This manual is used internally to guide the company’s employees through the various requirements of the ISO standards that must be met and maintained in order to ensure customer satisfaction, continuous improvement, and provide the necessary instructions that create an empowered workforce.

This manual is used externally to introduce our QMS to our customers and other external organizations. This manual is used to familiarize those individuals with the controls Nelson-Miller has implemented. It also assures them that the integrity of the QMS is maintained and that we are focused on customer satisfaction and continuous improvement.

1.2 Application 1. Nelson-Miller QMS, meets the requirements of AS9100D, ISO 9001:2015, and ISO

13485:2016. This manual applies to Wilson-Hurd, a division of Nelson-Miller. Locations listed below:

Location Applicable Standard(s) Site

2800 Casitas Ave. Los Angeles, CA. 90039

AS9100D and ISO9001:2015

Nelson-Miller, Inc. Corporate Office

311 Winton Street, Wausau, Wisconsin

ISO9001:2015 & ISO13485:2016

Electronic Control Products – Wilson-Hurd Division of Nelson-Miller

202 S. Johnson Street, Berlin, Wisconsin.

AS9100D and ISO9001:2015

Core Products – Wilson-Hurd Division of Nelson-Miller

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The following table identifies ISO 9001:2015 and ISO 13485:2016 exclusions from each of its sites: EXCLUSION TABLE

Location Clause or Sub-clause Exclusion Justification

Los Angeles, CA. 8.3 Design Controls & ISO 13485:2016

Product is manufactured using the customer drawings.

Wausau, WI N/A Design Controls Product is manufactured using customer drawings

Berlin, WI 8.3 Design Controls & ISO 13485:2016

Standard applicable only to the Wausau site


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Section 2: Normative Reference

2.0 Quality Management System References The following documents were used as reference during the preparation of the Quality Management System:

▪ SAE AS9101 Rev D (2016) - Quality Management Systems – Audit Requirements for Aviation, Space and Defense Organizations

▪ SAE AS9102 (B) Aerospace First Article Inspection Requirement

▪ ISO 9000-2015, Quality Management Systems - Vocabulary.

▪ ISO 9001-2015, Quality Management Systems – Requirements

▪ ISO 9004-2005, Quality Management Systems – Guidelines for performance Improvements

▪ ISO 13485:2016, Medical Devices – Quality Management Systems –Requirements for Regulatory Purposes

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Section 3: Terms and Definitions 3.0 Quality Management System Definitions

Containment - Action to control and mitigate the impact of nonconformity and to protect the customer’s operation includes correction, immediate corrective action, immediate communication, and verification that the nonconforming situation does not further degrade.

Counterfeit Part - An unauthorized copy, imitation, substitute, or modified part (e.g., material, part, component), which is knowingly misrepresented as a specified genuine part of an original or authorized manufacturer.

NOTE: Examples of a counterfeit part can include, but are not limited to, the false identification of marking or labeling, grade, serial number, date code, documentation, or performance characteristics.

Critical items - Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product and services; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, key characteristics, etc.

Customer owned property - Any type of instrumentation, accessories or manuals that belongs to a customer.

Customer supplied product - Any type of material supplied to be utilized in the manufacture, modification or repair of customer-owned property.

Documented Information – information required to be controlled and maintained by the organization in the medium on which it’s contained. This refers to related processes, procedures and work instructions, including records that serve as evidence of results achieved.

Interested Parties – Person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity. For Example: Customers, owners, people in an organization, providers, bankers, regulators, unions, partners or society that can include competitors or opposing pressure groups.

Key Characteristics - An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life or producibility, that requires specific actions for the purpose of controlling variation.

Objective Evidence Record (OER) - A document recording objective evidence of the audit findings, including reference to the reviewed or observed procedures, records, products, processes, and associated NCR’s and opportunities for improvement.

Product & Services– The end item result of meeting all contract terms and conditions. (eg: manufactured goods, etc.)

Product Safety – The state of which a product is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.

Quality Records – Documentation of those activities wherein records of said activities must be maintained will be specified in the procedure or work instruction level documents, as applicable. Also referred as documented information.


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Risk - An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.

Special requirements - Those requirements identified by the customer, or determined by the organization, which have high risks to being achieved, thus requiring their inclusion in the operational risk management process. Factors used in the determination of special requirements include product or process complexity, past experience and product or process maturity. Examples of special requirements include performance requirements imposed by the customer that are at the limit of the industry's capability, or requirements determined by the organization to be at the limit of its technical or process capabilities.

Section 4 – Context of the organization

4.1 Understanding the Organization and Its Context Nelson-Miller’s internal business context is comprised of our company’s quality policy, strategic objectives, internal and external resources, fostering a diverse culture, and striving for customer excellence.

4.2 Understanding the Needs and Expectations of Interested Parties Nelson-Miller have defined our relevant interested parties, as our employees, customers, community, suppliers/partners, regulatory agencies, and our investors. We are committed in striving to achieve their expectations by understanding their needs, and aligning our overall business objective and goals, to ensure those needs are met.

Interested party information is reviewed through the QMS process to ensure Information is reviewed and monitored to relevant requirements.

4.3 Determining the Scope of the Quality Management System This Quality Manual has been prepared to describe Nelson-Miller's Quality Management System (QMS). This Quality Manual is applicable to all three (3) new locations. Each location may have its own set of relevant work instructions and applicable forms relevant to its site.

The scope and permissible exclusions of the QMS are described in section one of this manual. Each section of the manual references documented QMS procedures relating to the requirements outlined in that section. The Process Flow Diagram provides a description of the interaction between the processes of the QMS system. The relationship between the AS9100 REVISION D, ISO 9001:2015 standards and documented procedure has been indicated by use of a numbering system that correlates to these standards.

Nelson-Miller manufactures various types of products; metal and plastic nameplates, membrane switches, graphic overlays products, and sub-assemblies, contract

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manufacturing services with our off-shore partners for various types of customers in different type of industries.

4.4 Quality management system and its processes Nelson-Miller has established, documented, and implemented a Quality Management System (QMS) in accordance with the requirements of AS9100 REV. D, ISO 9001:2015.

The QMS is maintained and continually improved through the use of the Quality Policy, Quality Objectives, audit results, analysis of data, corrective and preventive action and management review. Our organization utilizes Quality Procedures (PR) and Work Instructions (WI) to provide our employees and external providers (Suppliers), with detailed instructions and requirements. The documents support the achievement of quality compliance for each of the process steps. We retain Quality Forms (FO) which provide documented information substantiating the process inputs and outputs have been accomplished as planned.

In the event that our organization elects to outsource any processes that affect the product conformity to the requirements, the process is controlled via the purchasing process.

Nelson-Miller has addressed the following:

Determined the processes, sequence and interactions needed for the QMS and their application throughout the organization and illustrated in the Process Flow Diagram "Interaction of QMS Processes".

Determined criteria and methods needed to ensure that the operation and control of the processes are effective, and documented.

Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes

Responsibilities and authorities for the QMS processes have been assigned, in the organizational chart

Established a process for the identification and review of risks and opportunities

Established systems to monitor, measure and analyze these processes, and

Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes


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Key Processes Related to Product Realization

Related Procedures

Document # Procedure Title ISO9001:2015/AS9100D

QM-QUA-001 Quality Manual 4.4 Quality management system and its processes

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Section 5 – Leadership

5.1 Leadership and commitment Senior Management is actively involved in the implementation of the Quality Management System (QMS). It has provided the vision and strategic direction for the growth of the QMS, and established quality objectives and the quality policy, PR-QUA-014. Senior Management at Nelson-Miller demonstrate leadership and commitment to the QMS and to the continuous improvement activities by:

▪ Taking accountability for the effectiveness of the QMS.

▪ Establishing the quality objectives, and the quality policy, that are ccompatible with the context and the Nelson-Miller strategic direction.

▪ Ensure the integration of the QMS requirements into the organizations business processes.

▪ Promote the use of process approach and risk-based thinking.

▪ Ensuring the availability of resources, and engaging, directing and supporting persons to contribute to the effectiveness of the QMS.

▪ Communicating the importance of effective quality management, by meeting customer, statutory, and regulatory requirements.

▪ Ensuring the QMS achieves its intended results

▪ Engaging, directing and supporting employees to contribute to the effectiveness of the QMS

▪ Promoting continuous improvement

▪ Supporting other relevant management roles to demonstrate their leadership as is applies to their areas of responsibilities.

5.1.2 Customer focus Nelson-Miller strive to identify current and future customer needs, to meet customer requirements and exceed customer expectations See WI-QUA-026. Top managment ensures that customer requirements are understood and met. The risks and opportunities that can affect conformity of products and services, and the ability to enhance customer satisfaction are determined, addressed and communicated to the appropriate people in the organization.

Management also ensures that product and service conformity, and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be achieved.

5.2 Policy Nelson-Miller quality policy is appropriate to the purpose and context of our organization and our business strategic direction. Senior Management ensures that the quality policy is communicated to all employees see PR-QUA-015. The Policy is


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included in new employee training and training on the QMS, and is posted in prominent places throughout the facility to maintain high standards within our organization. The quality policy is documented in this quality manual which is available upon request to our interested parties. Management reviews the quality policy at each management review meeting to determine the policy’s continuing suitability for our organization.

Quality Policy

Nelson-Miller is committed in understanding our customer’s expectations, to provide

quality products and services delivered on time, and in compliance with customer and regulatory requirements.

We continually strive to improve our processes and services, With the intent to surpass our Customers’ Expectations

5.3 Organizational Roles, Responsibilities and Authorities

The organizational chart defines the basic management structure and shows the interrelation of personnel in the organization. In all cases, the appropriate person has been granted both the responsibility and authority for their position's duties, which are further defined within position specific job descriptions. The organizational chart is reviewed and approved by company CEO, for adequacy. These documents are available throughout the organization to help employees understand responsibilities and authorities.

Management representative The Management Representative is responsible for the reporting of the overall Quality Management System, the Quality Director has been appointed by the CEO as management representative. Management representative will have the responsibility and authority for the following:

▪ Ensure that processes needed for the quality management system are established and implemented.

▪ Report to Management Review on the performance of the quality management system, and note needed improvements.

▪ Promote awareness of customer requirements throughout the organization.

▪ Act as a liaison with external parties such as customers or auditors on matters relating to the QMS and

▪ Resolve matters pertaining to quality issues ▪ Organizational freedom and unrestricted access to management to resolve

matters pertaining to quality.

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Related Procedures:


PR-QUA-036

Process for Internal

Communications with

Employees

5 Leadership

PR-QUA-015 Training Procedure

5.1 Leadership and commitment

PR-QUA-014 Management Review Procedure

5.2 Policy

5.3 Organizational roles, responsibilities

and authorities


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6. Planning

6.1 Actions to address risks and opportunities Nelson-Miller determine actions to address risks and opportunities, the causes of potential nonconformities in order to prevent their occurrence. Prevent or reduce undesired effects.

A documented procedure PR-QUA-003 defines requirements for:

Determining potential nonconformities and their causes

Evaluating the need for actions to prevent occurrence of nonconformities

Determining and implementing action needed

Records of results of action taken

Reviewing the effectiveness of the action taken to achieve improvement

6.2 Quality objectives and planning to achieve them 6.2.1 Nelson-Miller has established Quality Objectives at relevant functions, levels,

and processes needed for the QMS, such as quality, delivery, and customer satisfaction.

These objectives are established to be consistent with our quality policy, and relevant to the conformity of products and services, and enhancement of customer satisfaction. The quality objectives are communicated, measured, and reviewed at a minimum annually for suitability.

Quality objectives are monitored and measured, and reviewed against performance goals at each MIT quarterly meetings and during management review meeting. Objectives are updated as appropriate. Metrics are addressed in PR-QUA-014.

6.2.2 Management is responsible to determine the actions required, resources needed, assigning responsibilities, monitoring periods, and how the results will be evaluated.

6.3 Planning of changes The quality system has been planned and implemented to meet our quality objectives and the requirements of AS9100D standard and the ISO 9001:2015 Standard. Quality planning takes place as changes that affect the quality system are planned and implemented.

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Consideration is taken on the purpose of the change(s) and their potential consequences, the integrity of the QMS, the availability of resources, and the allocation of responsibilities and authorities.

Related Procedures:


PR-QUA-014

Management Review Procedure

6 Planning 6.1 Actions to Address risks and opportunities 6.2 Quality Objectives and Planning to Achieve Them


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Section 7 – Support

7.1 Resources:

7.1.1 General Nelson-Miller has implemented a Quality Management System that complies with the AS9100D standard and ISO 9001:2015 standard. This implementation was achieved with management commitment and with sufficient resources for the implementation. To effectively maintain and continually improve the system, management determines and provides necessary resources, as required.

7.1.2 People Adequate number of personnel is provided for the effective implementation of our quality management system and for the continuous operation and control of our processes and services.

7.1.3 Infrastructure To meet quality objectives and product requirements Nelson-Miller has determined the infrastructure needed per PR-QUA-006. The infrastructure has been provided, and includes buildings, workspace, utilities, process equipment, transportation services, information and communication technology, and supporting services. As new infrastructure requirements arise, they will be communicated in staff meetings, and documented during management reviews. Existing infrastructure is maintained to ensure product and service conformity. Maintenance requirements are documented in:

Preventive maintenance documented records

Applicable preventive maintenance procedures as necessary

7.1.4 Environment for the Operation of Processes A suitable, non-discriminatory, safe, and clean work environment is established, provided and maintained for achieving product and service conformance described in PR-QUA-006. Requirements are determined during initial planning and may be documented in the management review results. The work environment is managed for continuing suitability. Data from the quality system is evaluated to determine if the work environment is sufficient for achieving product conformance, or if corrective actions related to the work environment are required.

7.1.5 Monitoring and Measuring Resources Nelson-Miller determine and provide measuring resources to ensure valid and reliable conformity results are: PR-QUA-004

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Suitable for monitoring and measuring activities.

Maintained and Retained to ensure continuing fitness for purpose

7.1.5.2 Measurement Traceability Nelson-Miller ensure that when measurement traceability is a requirement, or is considered to be an essential part of providing confidence in the validity of measurements results, measuring equipment is: ▪ calibrated, verified or both at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards. When no such standards exist, the basis used for calibration or verification is retained as documented information.

▪ adjusted or re-adjusted as necessary

▪ identified to enable the calibration status to be determined

▪ safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement result

▪ recalled and assessed if the validity of the previous measuring results has been adversely affected when measuring equipment is found not to conform to requirements. Appropriate actions will be taken.

▪ Calibration or verification of monitoring and measuring equipment are carried out under suitable environmental conditions.

Nelson-Miller maintain a register of the monitoring and measuring equipment(s). The equipment list defines equipment type, unique NM identification number(s), location, calibration or verification method, frequency, and acceptance criteria.

7.1.6 Organizational Knowledge Organizational Knowledge is gained through internal and external sources. Internal sources can include knowledge gained through Quality Awareness training resulting from the investigations of internal nonconformances and customer returns, including improvement projects from processes and product and services.

External sources may include knowledge of regulatory requirements and standards, relevant training conferences, and or obtaining knowledge from customer or external providers.

This knowledge is maintained and is made available to the extent necessary to achieve our organizational objectives.

Changing needs and trends are considered and evaluated to determine if additional knowledge or updates are necessary.

7.2 Competence To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications required for each position that affects the performance


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and effectiveness of the QMS. Qualifications include requirements for education, skills and experience.

Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a position change. The Human resource function maintains records of employee qualifications. If any differences between the employee’s qualifications and the requirements for the job are found, training or other action is taken to provide the employee with the necessary competence for the job. The results are then evaluated to ensure that the competence has been achieved. Training and evaluation are conducted according to Training procedure PR-QUA-015.

All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.

Job descriptions and training records are maintained as evidence of competence. Competence of personnel can be evaluated during internal audits,

7.3 Awareness Personnel is made aware of the quality policy and the importance of ethical behavior during hiring process. The quality policy can be found posted throughout the facility, and is part of the job travelers.

Quality objectives are communicated by management during employee meetings. Employees are made aware of the importance and the benefits of their contribution to the overall effectiveness of the quality managment, product and service conformity, and product safety.

Awareness training is conducted and information is communicated to employees on the implications of not conforming with the quality management system requirements, as well as any changes to the quality system.

7.4 Communication Processes are established for communication within the organization. Methods of communicating the effectiveness of the QMS include department and management meetings, management review, production meetings, staff meetings, and/or other routine business communication.

7.5 Documented information

7.5.1 General Nelson-Miller maintains all required documented information to effectively sustain its quality management system. Management is responsible for implementation of documented information (procedures & records) in their areas as required by the quality management system. The quality system documentation is comprised of a hierarchy of documents that flow from AS9100 REVISION D, ISO 9001:2015 and this quality manual.

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QMS Documentation Scheme

Nelson-Miller maintains a secure intranet that allows authorized users to access documents as needed throughout the facility. Obsolete documents are identified as such and stored separately to prevent unintended use. Documents and records determined to be necessary for effective planning, operation, and control of processes, unless otherwise directed by customer requirements are as follows: This Quality Manual Documented Procedures Customer Contract/Purchase Order Engineering Data Nelson-Miller's Job Traveler Quality / Inspection Records Records required by statutory and regulatory authorities Vendor/Seller specifications

Senior Management ensures that personnel have access to quality management system documentation and are aware of relevant procedures. While providing customer or statutory and regulatory authorities’ access to quality management system documentation.

Customer & Regulatory Requireme

Quality Policies / Objectives

QMS Manual

Standard Operating Procedures Process Flows

Work Instructions / Process Specifications /

Visual / Checking Aids

Documents & Compliance Records Performance Data

Level I

Level II

Level III

Level IV


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7.5.2 Creating and updating

When creating an updating documented information, Nelson-Miller ensures:

That documented information is identified and described with applicable document title, date(s), author, and reference number.

Format (e.g. language, software version, graphics) and media (e.g. paper, electronic); and

Are reviewed and approved for suitability and adequacy by authorized personnel.

7.5.3 Control of Documented Information

Documented information is maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. The records, including those created by or maintained by suppliers, are maintained according to the Document and Data and Quality Records Control Procedure PR-QUA-001.

This procedure requires that documented information is available and suitable for use where and when needed, and are adequately protected. Documented information, is to remain legible, readily identifiable and retrievable. The procedure defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of documented information.

▪ Approving documents for adequacy prior to issue

▪ Reviewing and updating as necessary and re-approving documents

▪ Ensuring that changes and current revision status of documents are identified

▪ Ensuring that relevant versions of applicable documents are available at points of use

▪ Ensuring that documents remain legible and readily identifiable

▪ Ensuring that documents of external origin are identified and their distribution controlled

▪ Preventing the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose and

▪ Obtaining customer / regulatory agency approvals when required by contract or statutory and regulatory requirements

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Related Procedures:


PR-QUA-015

Training Procedure

7.1.1 General

7.2 Competence

7.3 Awareness

PR-QUA-006

Planning of Product

Realization Procedure

7.1.3 Infrastructure

7.1.4 Environment for the operation

of processes

7.5 Documented information

PR-QUA-001

Document and Data Control and Quality Records

Control Procedure

7.5.1 General

7.5.2 Creating and updating

7.5.3 Control of documented information

PR-QUA-036

Process for Internal Communications with Employees

7.4 Communication

PR-QUA-004

Control of Monitoring and Measuring Equipment

7.1.5 Monitoring and Measuring resources

7.1.5.2 Measurement traceability


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Section 8 Operation

8.1 Operational Planning and Control In planning the processes for product realization PR-QUA-006, management has ensured that the processes and services are consistent with the requirements of the other processes and services within the quality system. Planning includes the following: ▪ Personnel and product safety: Nelson-Miller provides adequate resources to support the use and maintenance of the product and services. ▪ Producibility and inspectability: verification, validation, monitoring, measurement,

inspection, and test and acceptance activities specific to the product and services.

▪ Reliability, availability, and maintainability: Configuration management appropriate to the products and services. ▪ Suitability of parts and materials used in the product ▪ Selection and development of embedded software ▪ Product obsolescence ▪ Prevention, detection, and removal of foreign objects ▪ Handling, packaging, and preservation ▪ Recycling or final disposal of the product at the end of its life ▪ Quality objectives and requirements for the product ▪ The need to establish processes and documents, and to provide resources specific

to the product and services ▪ Documented information needed to provide evidence that the realization

processes and resulting product and services meet requirements The output of the planning is the job traveler, related drawings, inspection packages, operator check sheets, and specifications that show dimensions, characteristics, tolerances, and any key characteristics identified by Nelson-Miller or the customer. Likewise, these instructions define any processes, documents or resource requirements specific to the product. Inspection, testing and other monitoring steps will also be defined in the shop traveler. Management assigns responsibility for project management and ensuring that product realization is planned and managed in a controlled manner, meeting requirements at acceptable risk, within resource and schedule constraints. When planning to temporarily transfer work Nelson-Miller defines the process to control and validate the quality of work per the customer requirements. ▪ The outsourced service provider must be an approved, evaluated supplier

according to the requirements of section 8.4 ▪ The supplier is required to notify Nelson-Miller of any process changes, any

nonconformity, or other issues.

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▪ The supplier will be subject to the corrective action system, as defined in section 9.0.

▪ Work must be conducted on the article(s) according to any specifications listed on the purchase order.

8.1.1 Operational risk management Risk management is essential in meeting customer requirements. Managers, or their delegates, communicate with customers, obtaining information that may not be stated in contracts or purchase orders. The information obtained is used in risk management. Management is responsible for risk management and taking action to mitigate risks. Factors such as labor, equipment, material, scheduling, and outside processing are identified throughout contract review, purchasing, planning, production, and inspection processes. Documents are created or revised, and meetings are held as needed to address and communicate risks that have been identified. Internal preventive and corrective action is closely integrated into risk management. As risks are identified these actions may be used to mitigate/resolve risks. See 10.2 and 6.1. Prior to acceptance of contract or purchase order, relevant risk criteria are assessed to identify risk and determine feasibility. Criteria may include but are not limited to: ▪ Engineering data (e.g., drawings, models, specifications, etc.) are made

available, ▪ Customer supplied quality requirements and/or vendor manual, ▪ Configuration plan, ▪ Quantity and delivery schedule, ▪ Requirement for customer approved suppliers, ▪ Lead time and cost for raw material and/or hardware items, ▪ Lead time and cost of outside processing (as required), ▪ Cost of any non‐recurring changes, if any, ▪ Labor hours and skill, ▪ Equipment (e.g., tooling, fixtures, and resources), ▪ Inspection and test plans, ▪ Any special requirements and expectations not stated in request. 8.1.2 Configuration Management Nelson-Miller maintains a cconfiguration management process as appropriate to the process, through the flow down of information on customers purchase orders, drawings, specifications, website or other provided media that addresses:

▪ Configuration management planning

▪ Configuration identification

▪ Change control

▪ Configuration status accounting

▪ Configuration audit


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Contracts for new products and changes to existing products are processed in accordance with section 8.2. Part configuration is provided in the customer’s blueprint or other specifications. Configuration is identified on the job traveler document. When the product requirements change, the manufacturing plan is revised and appropriate personnel are informed of the change. This process is further defined in section 8.5. Configuration is controlled through verification during manufacturing. Evidence of verification is recorded on job travelers and inspection records as defined in section 8.6.

8.1.3 Product Safety Parts are made to customer specification. During the planning phase, Nelson-Miller defines and reviews the criteria required to control the processes needed to assure product safety during the entire product life cycle at NM, as appropriate to the organization and the product. Any event which affects the safety of the product or the employee in regards to the product is reviewed by the cross functional Job Order Review team, and new safeguards are determined and implemented, as needed. Documentation will be updated, when necessary, and training will be provided to affected personnel.

8.1.4 Prevention of Counterfeit Parts Nelson-Miller has planned and implemented controls in our processes to ensure the prevention of counterfeit or suspect counterfeit part use and their inclusion in product(s) delivered to the customer. The processes include the use of GIDEP (Government‐Industry Data Exchange Program) and/or our customer’s Approved Processing Source Lists, parts obsolescence monitoring, and quarantine and reporting of suspect or detected counterfeit parts.

8.2 Requirements for Products and Services 8.2.1 Customer communication

Customer Service is a primary contact for customer communications. Nelson-Miller has determined and Implemented effective arrangements for communicating with customers in relation to: Product and service information, Enquiries, contracts or orders, including amendments, customer feedback, customer complaints, and Handling or controlling customer property. The Sales department coordinates customer feedback and Quality monitors customer complaints through the use of corrective actions when required, or by means of reports, or memos noting the customer concern and the response required. The Quality department also handles and controls customer property in the form of gages, mating parts, or other items required for confirming products/services meet customer requirements.

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8.2.2 Determining the Requirements for Products and Services During contract review at the Request‐for‐quote stage potential projects are checked to determine Requirements applicable to the product and services including: • Requirements specified by the customer, including any special requirements for delivery and post‐delivery applications of the product and service. • Requirements not stated by the customer but necessary for intended use, where known. • Any statutory and/or regulatory requirements applicable to the product. • Any additional requirements that Nelson-Miller may consider necessary.

Operational risks have been identified. • Any additional requirements that Nelson-Miller may consider necessary.

Customer requirements are determined according to PR-SLS-001.

8.2.3 Review of the requirements for products and services Nelson-Miller ensures we have the ability to meet the requirements for products and services to be offered to Customers. Customer Service and Quoting Eng. conduct a contract/product review prior to committing to supply products and services to a customer. The review process at a minimum includes:

• All product requirements are defined. • Any requirements on the current contract that differ from those previously expressed to Nelson-Miller are resolved. • Nelson-Miller has the ability to meet the defined requirements. • Any special requirements have been determined. • Nelson-Miller at this time also evaluates any risk associated with the contract in regard to subjects such as manufacturability, delivery schedules, and new technologies.

If, upon completion of the review, Nelson-Miller determines that some customer requirements cannot be met or can only partially be met, Nelson-Miller shall negotiate a mutually acceptable requirement with the customer. Nelson-Miller ensures contracts, purchase orders or other requirements differing from those previously defined, are reviewed and approved prior to incorporating into our business systems.

We retain applicable documented information of the initial review and on any new/revised customer or applicable external party requirements for the products and services provided as part of the documentation for the customer in accordance with our documentation retention procedure.

8.2.4 Changes to Requirements for Products and Services Nelson-Miller ensures that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.


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8.3 Design and Development of Product and Services

8.3.1 Design and Development has been excluded from the scope of the AS9100 Revision D, ISO 9001:2015 QMS System.

8.4 Control of externally provided processes, products and services

8.4.1 General

Documented procedure PR-PUR-002 is followed to ensure that purchased product conforms to the specified purchase requirements. PR-PUR-001 The procedure outlines the extent of control required for suppliers. Suppliers are evaluated and selected based on their ability to supply product in accordance with requirements.

Responsibilities and criteria for selection, evaluation and re-evaluation, status and status change and risk analysis are documented in PR-PUR-001. Records of the evaluation and any necessary actions are maintained as quality records. The organization is responsible for the quality of all products purchased from suppliers, including customer-designated sources.

8.4.2 Type and Extent of Control The type and extent of control required to be applied on the purchase product would depend on the effect of the purchased product on the subsequent product realization of the end product.

Purchased products are subject to inspection in accordance with Inspection and Testing procedures and Receiving Inspection work instructions to ensure purchase order requirements are met prior to release for use. Activities to verify conformance may include:

• Obtaining objective evidence of quality conformance from the supplier, such as inspection documentation, certificates of conformity, test reports and/or record of statistical process control.

• Inspection and audit at supplier’s facilities.

• Review and acceptance of required documentation.

• Inspection of product upon receipt.

• Certifying supplier as a delegate to determine verification of product or processing conformity. Test report data is verified against applicable specifications when used for applicable acceptance. Periodic third party testing is performed on raw materials to verify accuracy of supplied test reports in accordance with Receiving Inspection work instructions. Nelson-Miller will accommodate contract requirements by our customers to access our facility or our supplier’s facilities, as needed to verify product conformance.

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Unless otherwise authorized by our customers, any acceptance validation by customers is not used by Nelson-Miller as primary evidence of effective control of quality at this organization or our suppliers, nor considered to negate our responsibility to provide acceptable product or our customer’s right to later reject any product found to be nonconforming.

Where purchased product is released for production use pending completion of all required verification activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements. If Nelson-Miller elect to delegate acceptance authority to a supplier in the future, the requirements for that delegation shall be defined and a register of delegations shall be maintained.

8.4.3 Information for external providers All purchased materials and services for the manufacture of product will require purchase orders which are generated in our ERP system by purchasing department. Purchasing documents are reviewed for adequacy and approved by purchasing personnel prior to release. These will clearly describe quantities, part number and description of the purchased materials and are subject to Nelson-Miller specification and verified to ensure that it meets purchase requirements. Purchasing information describes the product to be purchased, including where appropriate:

• Requirements for approval of product, process and equipment; • Requirements for qualification of personnel; • Special requirements, critical items, or key characteristics; • Test, inspection, and verification (including production process verification); • The use of statistical techniques for product acceptance and related instructions for

acceptance by the organization; • QMS requirements outlined in the Purchasing procedure. • The right of access by Nelson-Miller, our customers, and regulatory authorities to the

`applicable areas of facilities and to applicable documented information, at any level of the supply chain;

• ensuring that their employees are aware of their contribution to product or service conformity, their contribution to product safety, and the importance of ethical behavior.

8.5 Production and service provision

8.5.1 Control of production and service provision

Nelson-Miller plans and carries out production and service provision under controlled conditions according to documented procedure PR-QUA-006. Controlled conditions include, as applicable:

▪ The availability of documented information, including customer drawings, parts lists, material, process specifications. etc. that describes the characteristics of the products produced, the services rendered or the activities to be performed

▪ The availability and use of suitable monitoring and measuring resources


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▪ The availability of work instructions can include production documents, process flow charts, manufacturing plans, Job Travelers, routers, inspection documents, etc. that show results achieved. evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized,

▪ The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services have been met.

The use of suitable infrastructure and environment for the operation of processes;

▪ Appointing competent, qualified and trained personnel.

▪ The validation and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, that are considered special processes, where the resulting output cannot be verified by subsequent monitoring or measurement.

o Validation of processes and product can be performed during the testing process, although the final validation of the product is performed by the customer since Nelson-Miller does not have in most cases a complete product in its final form.

▪ The implementation of actions to prevent human error; and The implementation of release, delivery and post-delivery activities

▪ The accountability for all products during manufacture (e.g., parts quantities, split orders, nonconforming product), part accountability to ensure bad parts have been destroyed

▪ The control and monitoring of identified critical items, including key characteristics in accordance with established of processes.

▪ Methods to measure variable data, such as selecting proper tooling, on-machine probing, inspection equipment, are determined

▪ The identification of in-process inspection/verification points when adequate verification of conformance cannot be performed at a later stage,

▪ The availability of evidence that all production and inspection/verification operations have been completed as planned or as otherwise documented and authorized.

▪ provision for the prevention, detection, and removal of foreign objects,

▪ monitoring and control of utilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product quality, and criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations).

▪ Maintain documented information for the identification and recording of products released for subsequent production use pending completion of all required

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measuring and monitoring activities, to allow recall and replacement if it is later found that the product does not meet requirements.

8.5.1.1 Control of Equipment, tools and software programs:

Production equipment, tools and software programs used to automate and control/monitor production processes are validated prior to use and maintained and inspected periodically according to documented PR-MNT-001. Validation prior to production use includes verification of the first article produced to the design data/specification. Tools are validated prior to use in production and tooling is sstorage is checked periodically for preservation and condition.

8.5.1.2 Validation and control of special processes

Where the output results cannot be verified by subsequent monitoring or measurement, establish arrangements for these processes including, as applicable; defining of criteria for the review and approval of the processes; determination of the conditions to maintain the approval; approval of facilities and equipment; qualification of personnel, use of specific methods and procedures for implementation and monitoring the processes; and the requirements for documented information to be retained.

8.5.1.3 Production Process Verification:

Production process verification activities are implemented to ensure the production process is able to produce products that meet requirements. These activities take into consideration risk assessments, capacity and capability studies, and control plans as applicable.

Production processes are verified via a First Article Inspection PR-QUA-012 using a representative item from the first production run of a new part or assembly to verify that the process, documentation, and tooling are capable of producing conforming parts. Verification is repeated when changes occur that could invalidate the original results. Documented information on the results of production process verification is maintained.

The results of changes to production processes are assessed to confirm that the desired effect has been achieved without adverse effects to product quality. For changes that will have an impact to form, fit, and function of customer part, PR-QUA-039 will be followed.

8.5.2 Identification and traceability Nelson-Miller uses suitable means to identify outputs when it is necessary to ensure the conformity of products and services. ▪ Nelson-Miller maintains the identification of the configuration of the product and

services in order to identify any differences between the actual configuration and the agreed configuration see PR-SLS-001.

▪ Product is identified with respect to monitoring and measurement requirements per PR-QUA-013.


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▪ When acceptance authority media such as stamps, electronic signatures or passwords are used Nelson-Miller establish and documents controls for the media per PR-QUA-013 .

▪ According to the level of traceability required by contract, statutory and regulatory, or other established requirement, Nelson-Miller’s system provides for:

o Identification to be maintained throughout the product life

o All the products processed from the same batch of material or from the same manufacturing batch to be traced (if applicable), as well as the destination (delivery, scrap) of all products of the same batch;

o For an assembly, the identity of its components and those of the next higher assembly to be traced;

o For a given product, a sequential record of its production / processing to be retrieved.

8.5.3 Property Belonging to Customers or External Providers

Nelson-Miller exercise care with customers or external providers property while it is under the organizations control or being used. WI-QUA-027 outlines the controls, verification, protection and safeguarding of customer property provided for use. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records maintained.

Customer or external provided property can include materials, components, tools & equipment, intellectual property, including customer furnished data used for design, production and/or inspection.

8.5.4 Preservation

Nelson-Miller preserve the product during internal processing and delivery to the intended destination to ensure product conformity. This preservation includes identification, handling, contamination control, packaging, storage, during transit, and protection. Preservation also applies to the constituent parts of a product.

Preservation of product also includes, where applicable in accordance with product specifications and/or applicable regulations, provisions for:

▪ Cleaning;

▪ Prevention, detection and removal of foreign objects;

▪ Special handling and storage for sensitive products;

▪ Marking and labeling, including safety warnings and cautions;

▪ Shelf life control and stock rotation;

▪ Special handling and storage for hazardous materials.

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8.5.5 Post-Delivery Activities

Nelson-Miller meets requirements for post-delivery activities associated with the products and services. In determining the extent of post-delivery activities that are required, Nelson-Miller considers:

a) Statutory and regulatory requirements; b) The potential undesired consequences associated with its products and services; c) The nature, use and intended lifetime of its products and services; d) Customer requirements; and e) Customer Feedback.

Collection and analysis of in-service – Not applicable at this time. Control,updating and provision of technical of technical documentation –

Addressed as indicated in Section 7.5.3. Approval, control and use of repair schemes – Not applicable at this time. Controls required for off-site work – Not applicable at this time.

Product/customer support –

Actions to be taken, including investigation and reporting, when problems are detected after delivery – Addressed as indicated in Section 8.7.

8.5.6 Control of Changes Nelson-Miller review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

Documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review are retained.

8.6 Release of Products and Services

Nelson-Miller has implemented planned arrangements, at appropriate stages, to verify that product and service requirements have been met.

The release of products or services, are not used or processed until it has been verified as conforming to specified requirements; or otherwise approved by the relevant authority, and, when necessary by the customer.

When verification activities are delegated to the supplier the requirements are defined, and a register of delegations is maintained.

If Nelson-Miller or the customer performs verification at the supplier’s premises, the verification arrangements and method of product release are documented in the purchasing information. Where specified in the contract, the customer or the customer’s representative is given the right to verify at the suppliers premises and organization’s premises that product conforms to specified requirements


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Documented information is retained as evidence of conformity with the acceptance criteria, including the person authorizing release of product and service.

All documented information required to accompany the product and services prior to delivery will be assembled by Quality and Shipping department as outlined in PR-QUA-031.

8.7 Control of Nonconforming Outputs Nelson-Miller ensure the outputs which do not conform to requirements are identified and controlled to prevent their unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in the Control of Nonconforming Product procedure PR-QUA-018. This process includes:

Appropriate action are taken based on the nature of the nonconformity and its effect on the conformity of products and services. This also applies to nonconforming products and services detected after delivery of products, during or after the provision of services.

Nelson-Miller deal with nonconforming outputs in one or more of the following ways:

Correction;

Segregation, containment, return or suspension of provision of products and services;

Informing the customer; and Obtaining authorization for acceptance under concession by relevant authority and when applicable, by the customer.

Dispositions of Use-as-is (UAI) or repair for the acceptance of nonconformance products may only be implemented, after approval by the authorized representative of responsible for the design or by persons having delegated authority from the customer.

If the nonconformity is determined to not meet the contract requirements; product that is dispositioned as scrap shall be noticeably and permanently marked, controlled, until physically rendered unusable.

Counterfeit, or suspect counterfeit, are reported and controlled to prevent reentry into the supply chain.

Conformity to the requirements are verified when nonconforming outputs are corrected.

8.7.2 The organization shall retain documented information that: Nelson-Miller retains documented information that describes: a) The nonconformity;

b) The actions taken;

c) Any concessions obtained; and

d) Identifies the authority deciding the action in respect of the nonconformity.

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Related Procedures:



5.6 Management review 5.6.1 General 9.3.2 Management review

input 9.3.3 Review output 9.1.3 Analysis of Data

PR-QUA-006

Planning of Product Realization Procedure

8.1 Operational planning and control

8.1.2 Operational risk management

8.1.3 Configuration Management

8.1 Operational planning and control

PR-SLS-001 WI-QUA-027

Contract Review Procedure Control of Customer Supplied Property

8.2 Requirements for products and services

8.2.1 Customer Communication

8.2.2 Requirements related to products and services

8.2.3 Review of requirements related to product and services

8.5.1 Control of production and service provision

8.5.5 Post-delivery activities

PR-PUR-001

PR-PUR-002

Supplier Approval and Monitoring Procedure Purchasing Procedure

8.4 Control of externally provided processes, products and services

8.4.1 General

8.4.2 Type and extent of control 8.4.3 Information for external

providers 8.6 Release of products and

services

PR-MNT-001 Preventive Maintenance Planning of Product Realization Procedure Inspection and Test Procedure Changes to Work Orders Control of Customer Supplied Property

8.5 Production and

Service Provision PR-QUA-006

8.5.1 Control of Production and Service Provision

PR-QUA-012

8.5.1.3 Production Process Verification

WI-QUA-020 8.5.1 Operational planning and control

WI-QUA-027

8.5.1.1 Control of Production Equipment, Tools and Software Programs


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Document # Procedure Title ISO9001:2015/AS9100D PR-QUA-005 Material Handling and Storage

Procedure

Shipping Procedure

Packaging Procedure

Customer Change Notification (CCN) Procedure

8.5.5 Post-Delivery Activities

PR-QUA-031

8.5.1 Control of Production and Service Provision

PR-QUA-032

8.5.2 Identification and Traceability

PR-QUA-039

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

PR-QUA-004 Control of Monitoring and Measuring Equipment

8.6 Release of products and services

PR-QUA-018 Control of Non-Conforming Product

8.7 Control of nonconforming outputs

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Section 9 – Performance evaluation

9.1 Monitoring, Measurement, Analysis and Evaluation

9.1.1 General Nelson-Miller plans and implements the monitoring, measurement, analysis and evaluation processes as needed

▪ To demonstrate conformity of the product,

▪ To ensure conformity of the quality management system, and

▪ To continually improve the effectiveness of the quality management system.

Nelson-Miller applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes see PR-QUA-014. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product. In the event of process nonconformity, the organization follows the Control of Nonconforming Product procedure PR-QUA-018 and:

▪ Takes appropriate action to correct the nonconforming process,

▪ Evaluates whether the process nonconformity has resulted in product nonconformity,

▪ Determines the scope of the process nonconformity, and

▪ Identifies and controls the nonconforming product in accordance with clause 8.3. The process for identifying and carrying out the required monitoring and measuring of processes is documented in the Internal Audit procedures PR-QUA-019.

9.1.2 Customer Satisfaction As one of the measurements of the performance of the quality management system, Nelson-Miller monitors information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information are determined and outlined in WI-QUA-026. Nelson-Miller collects customer feedback using one or more of the following methods to monitor and measure customer satisfaction: ▪ corrective action requests ▪ customer complaints ▪ customer‐provided performance data ▪ on‐Time delivery ▪ product and service conformity Nelson-Miller has developed and implemented a plan for customer satisfaction improvement that addresses deficiencies identified by the above evaluations, and assesses the effectiveness of the results during Management Reviews.


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9.1.3 Analysis and Evaluation Nelson-Miller determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the quality management system can be made. The process for determining, collecting and analyzing this data is defined in the Management Responsibility procedure. Appropriate data includes data generated as a result of monitoring and measurement and from internal and external relevant sources.

The analysis of data provides information relating to:

▪ Conformance to product and services.

▪ Customer satisfaction

▪ Performance and effectiveness of the quality managment system. Effectiveness of planning

▪ Effectiveness of actions taken to address risks and opportunities

▪ Supplier (external providers) performance

▪ The need for improvements to the quality managment system.

9.2. Internal Audit Nelson-Miller conducts internal audits at planned intervals to determine whether the quality management system:

▪ Conforms to company’s planned arrangements, and the requirements of AS9100 and ISO 9001 International Standards and that,

▪ It is effectively implemented and maintained.

An audit program has been designed and implemented and identifies an audit schedule based on the importance of the areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency, methods, responsibilities and requirements for planning and conducting audits, and for reporting and maintaining results, are defined and documented in the Internal Audit procedure PR-QUA-019.

Internal Audit may be outsourced to a qualified QMS Auditing Group; Internal Process Audit may be performed by Nelson-Miller qualified auditors

The management responsible for the area being audited is responsible for ensuring that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results.

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9.3 Management review

9.3.1 General Senior Management reviews the QMS annually at management review meetings. This review assesses the continuing QMS suitability, adequacy and effectiveness, and strategic alignment of the organization. identifying opportunities for improvement and needed changes. Documented information is maintained for each management review meeting (see PR-QUA-014).

9.3.2 Management Review inputs Management review is planned and carried out taking into consideration the following:

Status of actions from previous reviews

Changes in external and internal issues that are relevant to the QMS

Information on the performance and effectiveness of the quality management system, including trends in:

Customer satisfaction and feedback from relevant interested parties;

The extent to which quality objectives have been met;

Process performance and conformity of products and services;

Nonconformities and corrective actions;

Monitoring and measurement results;

Audit results;

The performance of external providers;

On-time delivery performance

The adequacy of resources;

The effectiveness of actions taken to address risks and opportunities; and

Opportunities for improvement

9.3.3 Management Review outputs

During these review meetings, management will identify appropriate decisions and actions to be taken regarding the following issues:

Opportunities for improvement

Any changes needed to the QMS

Resource needs

Risks Identified

Responsibility for required actions is assigned to members of the management review team. Any decisions made during the meeting, assigned actions, and their due dates are recorded in the minutes of management review, as documented information


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Related Procedures:


WI-QUA-026 Process for

measuring Customer Satisfaction

9.1.2 Customer satisfaction

PR-QUA-019 Internal Audit Procedure 9.2 Internal Audit


9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.3 Management review 9.3.1 General 9.3.2 Management review

input 9.3.3 Management review

output

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10 Improvement

10.1 General Nelson-Miller determines and selects opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. This is done through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. Management monitors the implementation of improvement activities for products and services, and evaluates the effectiveness of results.

10.2 Nonconformity and Corrective Action

Nelson-Miller takes actions to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered. A documented procedure PR-QUA-003 defines requirements for

10.2.1 When a nonconformity occurs, including any arising from complaints, Nelson- Miller: Responds to the nonconformity and, as applicable:

Take necessary action(s) to control and correct it;

Deals with the consequences;

Evaluates the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:

Reviewing and analyzing the nonconformity;

Determining the causes of the nonconformity; including, as applicable, related human factors

Determines if similar nonconformities exist, or could potentially occur Implements any action needed;

Review the effectiveness of any corrective action taken; Updates risks and opportunities determined during planning, if necessary; and Make changes to the quality management system, if necessary.

Flow down corrective action requirement’s to an external provider (supplier) when it is determined that the external provider is responsible for the nonconformity.

Will take specific actions when timely and effective corrective actions are not achieved.

Documented information is maintained that defines the nonconformity and corrective action management processes.

10.2.2 Nelson-Miller retains documented information as evidence of:

The nature of the nonconformities and any subsequent actions taken; and


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The results of any corrective action.

10.3 Continual Improvement

Nelson-Miller continually strives to improve the suitability, adequacy and effectiveness of the quality management system, through the use of the quality policy, quality objectives, and audit results, analysis of data, corrective actions, and managment reviews. Additional continuous improvement opportunities can result from lessons learned, problem resolutions, and the benchmarking of best practices. All improvement activities are monitored for effectiveness and efficiency

Related Documents:

Document # Procedure Title ISO 9001:2008/AS9100C

PR-QUA-018 Control of Non- Conforming Product

8.7 Control of Nonconforming Product

PR-QUA-003 Corrective and Preventive Action

10.1 General 10.3 Continual Improvement 10.2 Nonconformity and corrective action 6.1 Actions to address risks and opportunities (see 6.1.1, 6.1.2)