manual procedures 2

8/8/2019 Manual Procedures 2

1/56


2/56

Page: 2

By

Wes Westberg

Page: 111

Status reports on actions from previous ManagementReviewsIdentification of any strategic or operations changes that

affect the SystemIdentification of any policy issues requiring reviewStatus reports on progress towards meeting specificimprovement objectives:

y Customer Satisfactiony Supplier Performancey Overall System effectiveness including evidence of

repeat audit findings or other repeat problems

y Overall operational efficiency including an evaluation ofthe cost ofpoor quality

y Manufacturingprocess effectiveness and efficiencyincludingperformance against customer specified (orother targets for productivity, process capability and cost

y Overallproduct performance including an analysis ofactual andpotential field failures and their impact onquality, safety, or the environment

y Overallproduct quality includingperformance againstcustomer specified (or other) targets related to productquality

y Overall effectiveness of training completed includingskills training, on-the-job training, and employeeawareness and effectiveness of employee motivation

y Recommendations for improvement andplans


3/56


4/56

Page: 4 Page: 109

13.The quality inspector performs part inspection andlooks for(see boundary sample):

y Correct Colory No Forming Flaws (I.E., Excess Carpet, Carpet

Wrinkles)

y Clean Trim Edge No Fuzz Or Debrisy Hole Clean No Slugsy Cut or punched clean Slots and any additional cutouts.y Overall Appearance Good

14.The quality inspector records the findings (If needed followSOP 8.3 Nonconformingproduct)

15.The quality inspector also checks for container quantity andcorrect label

Rework Instructions:

If the tool in the press does not punch the required holes inthe S197 Deck Lid remove the part to designated reworkarea.

Rework the part by manuallypunching the holes usingcorrect size punch 3/16 for the two holes on each side ofthe release trunk slot and 5/16 for the remaining holes.

Revision History


5/56


6/56

Page: 6

y ISO/TS 16949 Automotive Certification Scheme-Rulesfor Achieving IATF Recognition and all relateddocuments

y ISO 14001 EnvironmentalManagement SystemsRequirements and all relateddocuments

y Customer-specific requirements and guidancedocuments

Company Background

The Company, established in XXXX, and the headquarters islocated at XXX Some Street, City, State, zip.

The Company currently supplies to the followingmanufacturers:

y XXXX,y XXXX

Where possible we integrated the quality system and theenvironmental management system to ensure that operations arecost effective and environmentally responsible.TheCompanys Quality and Environmental Policy are availableupon request.

APPLICATION

Our Quality/Environmental Systems comply with all applicablerequirements contained in ISO/TS 16949:2002, covers thedesign andprovision of all companyproducts, and encompassesall operations at both of our facilities. The following tableidentifies the requirements not applicable to our organizationandprovides a brief narrative justifying their exclusion from thescope of our Quality/Environmental Systems:

Page: 107

WORK INSTRUCTIONS

WI-DL-6.2.2

General Safety NotesPPE:

y Safety Glassesy Kevlar Glovesy Kevlar Sleevesy Knife

General Notes

Setup includes:

y Press (See Setup Sheet)y Check Fixturey Burnishing Tabley Final PackContainer

Material Needed:

y Carpet Milliken -62 rollStage Material for production:

The team leader ensures that the proper tenor frames areavailable at the beginning of the shift and will check

throughout the shift.

The material handler:

y Brings carpet to the press and helps the operator toload the carpet onto carpet feeder


7/56

Page: 106

3. Attach both tenor frames to the carpet and cut the carpetbetween them

4. Raise carpet to the cutter and cut the carpet just above thetenor frames

5. Place the both tenor frames central over the cavities (onetenor frame per two cavities)

6. The operator cycles the press bypressing the two blackpalm buttons simultaneously

7. When the press finishes its cycle, the operator removes theparts and the left over material

8.

The operator then places the part on ov

er bend fixture andthe waste material into the compactor andpresses the greenpalm buttons simultaneously

9. The quality inspector performs 1st piece inspection, atbeginning of shift, and after the removal of the part fromthe over bend fixture

10.The operator then places the finishedparts into a shippingcontainer

11.When the container is full, the operator calls the materialhandler to remove the container and bring an empty one

12.The material handler puts a shippinglabel on container andmoves the container to the inspection holding area

13.Part inspection14.Pack andlabelRevision History

Page: 7

1. Reference DocumentsThe following externaldocuments contain provisions, which,through reference in this manual, constitute provisions of our

Quality/Environmental Systems:

y ISO 9000:2005, Quality management systems Fundamentals andvocabulary

y ISO 9001:2000, Quality management systems Requirements

y ISO 9004:2000, Quality management systems Guidelines for performance improvements

Customer Specific Requirements:y ISO/TS 16949:2002, Quality management systems

particular requirements for the application of ISO9001:2000 for automotive production and relevantservice part organizations

y CSR-Ford, FordMotor CompanyCustomer-SpecificRequirements for Use with ISO/TS 16949:2002

y CSR-GM, GeneralMotors Customer SpecificRequirements - ISO/TS 16949:2002

y CSR-DC, DaimlerChrysler (Chrysler Group)Customer-Specific Requirements for Use withISO/TS 16949:2002

Customer Reference Manuals:y APQP-2, Advanced Product Quality Planning &

Control Plan (APQP)

y FMEA-3, Potential Failure Mode and EffectsAnalysis (FMEA Third Edition)

y PPAP-4, Production Part Approval Process (PPAPFourth Edition)


8/56

Page: 8

y SPC-3, Statistical Process Control (SPC) Note:1. The SPCReference Manual, Second Edition, has

an improved flow and

2. R

einforces the need for a systemic approach toanalysis ofvariation in data3. Addresses additional control chart methods and

tools

y MSA-3, Measurement Systems Analysis (MSA)y TS-QSA2, Quality System Assessment Checklist,

Checklist to ISO/TS 16949:2002 TS-GS, IATFGuidance to ISO/TS 16949:2002

2. Terms and DefinitionsOur Quality/Environmental Systems uses the sameinternationally recognized terms, vocabulary, anddefinitionsgiven in ISO 9000 as supplemented by terms defined inISO/TS 16949:2002, Section 3. Acronyms, terms,vocabulary, anddefinitions unique to our organization,

customers, industry, and region and referenced throughoutour Quality/Environmental Systems are contained inAppendix A, Terms and Definitions.

3. Quality Management SystemGENERAL REQUIREMENTS

The responsibility belongs to TopManagement for defining

the organizations quality and environmentalpolicy and toensure the documented, communicated, andunderstoodthroughout the organization.

Management review meetings, include the Quality andEnvironmentalpolicies and objectives for continuingsuitability.

Page: 105

WORK INSTRUCTIONS

WI-SB-5.2.2

Important General Safety NotesPPE:

y Safety glassesy Gloves

Important General Notes

Setup includes:

y Pressy Carpet Cuttery Over Bend fixturey Check Fixturey Final PackContainer

Stage Material for production:

1. Material handler brings material to conveyor and setup inproper position for conveyor load

2. Material handler brings carpet to the press to be loaded ontocarpet cutter

3. Provide shipping container4. Two frames are requiredProcess:

1. The material is automaticallyloaded onto conveyor and intooven while the operator prepares the carpet for insertioninto the press

2. The operator uses the controls to roll out the carpet longenough to place the tenor frames on the carpet


9/56

Page: 104

Work Instructions

This booklet contains sample WorkInstructions. They are very generic innature.

Page: 9

Our Quality/Environmental Systems is part of our overallmanagement system, which establishes documents andimplements our qualitypolicy, and relatedprocesses forprovidingproducts and services, which meet or exceedcustomer requirements, and satisfies Quality/Environmental Systems requirements of ISO900/14001.

We have adopted the process approach advocated by ISO9000, bydefining and managing:

y Process inputs, controls, and outputs to ensure desiredresults are achieved, and

y Interfaces between interrelatedprocesses to ensuresystem effectiveness.Specific responsibilities for and the sequence and interactionof our key Quality/Environmental Systems processes aredetailed in the StandardOperating Procedures (SOPs), manyof which contain or reference deployment flow chartsdepicting the process or procedure described in the narrativeSOP. Appendix A contains a List ofKey Quality/

Environmental Systems Documents, including all SOPs andother key Quality/Environmental Systems documents.

GENERAL REQUIREMENTS SUPPLEMENTAL

We also recognize the significant role that subcontractorsplay in achievingdesired results and recognize that we mustensure proper control over outsourced Quality/

Environmental Systems processes (Section 7). Ourflowcharts depict outsourcedprocesses andproceduresdescribe the governing of their management in documentsreferenced in applicable SOPs.


10/56

Page: 10

DOCUMENTATION REQUIREMENTS

GENERAL

The Management, through the Management Team, isresponsible to implement and maintain a quality andenvironmental management system, and continuallyimprove its effectiveness.

Quality/EnvironmentalManagement System processes,including their sequence and interaction with otherprocesses, we identify anddocument in this Quality/EnvironmentalManual, and managed in accordance withISO and customer requirements. Management reviews theidentified anddocumented indicators for measurement andanalysis to assure effectiveness and efficiency.

The Management ensures that adequate resources andinformation necessary to support the operation, monitoring,measuring, and analysis of these processes is made availableand actions necessary to achieve planned results and support

continuous improvement.Each Department Manager is responsible for evaluating andadjusting resource requirements to efficiently executeassignments and accomplish goals defined in the businessplan, including the implementation and control of theEnvironmentalManagement System. Management givesindividuals total support and the necessary authority toperform the assigned tasks.

The Company recognizes that control of any outsourcedprocesses is necessary in order to ensure the productconforms to customer requirements.

Quality/Environmental Systems documents anddata maybe in hard copy or electronic media. This quality manual,SOPs, and other internal and externaldocuments anddata

Page: 103

We retain all forms used in the corrective andpreventiveaction procedure for active life of the product forreference to prevent reoccurrence.

Analysis of customer returned rejects begins upon receiptof the defective material. We will make records of theanalysis available upon request. If a corrective action isinitiated because of the analysis will be tracked throughthe corrective action format.

We initiate Preventive Actions because of, TPM activities;lessons learned followup, the APQP process, Leanactivities, or technology changes. We trackpreventiveactions on the Preventive Action Log.

We reviewpreventive actions during regular managementreview meetings.

Revision History


11/56


12/56

Page: 12

Quality and Environmental records are legible, readilyavailable and retained for a specifiedperiod in QualityRecordMatrix. Record retention must satisfy bothregulatory and customer requirements, as well as ISO or TSrequirements. When we reach retention time, records shouldbe disposed of accordingly.

The information QualityManager has overall responsibilityfor ensuring that all Quality/Environmental Systemsdocuments, below includes forms used to create controlledquality records as detailed in procedure SOP 4.2.3:

a) Approve documents for adequacyprior to issue.b) Review, update as necessary, and re-approve

documents.

c) Identify the current revision status ofdocuments.d) Ensure that relevant versions of applicable documents

are available at points ofuse.

e) Ensure that documents remain legible, readilyidentifiable, and retrievable

f) Ensure that identified externaldocuments (includingcustomer-engineering standards/specifications) havecontrolleddistribution

g) Prevent the unintended the use of obsoletedocuments, and to apply suitable identification tothem if they are retained for anypurpose.

ENGINEERING SPECIFICATIONSThe Program Manager oversees our process for assuring thetimely review, distribution, and implementation of allcustomer-engineering standards/ specifications and changesbased on customer-required schedule; The Companyuses aProduct Data Management system to manage and controlengineering records anddata (see SOP 4.2.3).

Page: 101

CORRECTIVE AND PREVENTIVEACTION

SOP 8.5.2/8.5.3

1.0 Purpose

This procedure provides a systematic means in whichqualityproblems will be eliminated.

2.0 Application

This procedure applies to all qualityproblems, including

internal rejections, problems from subcontractors andcustomer complaints.

3.0 Definitions

Not applicable

4.0 Responsibility

It is the responsibility of the QualityManager to managethe corrective/preventative action. The format utilized willbe an 8D, unless otherwise directed by the customer.

The TopManagement Team is responsible for analysis ofcustomer-rejected material.

5.0 Associated Materials

FOCAR8.5.2 Concern Report (MCR)FOMCRLOG MaterialConcern Report Tracking LogSOP 8.3 Control of Nonconforming Product

ProcedureFOPARLOG Preventative Action Log


13/56


14/56


15/56


16/56

Page: 16

method by which we accomplish this: by continuallyimprovingprocesses, products, and services to ensure theyconsistently meet or exceed requirements. Moreover, ourqualitypolicy statement acts as a compass in providing thedirection and a framework for establishing key corporatelevelperformance measures and related improvementobjectives. (Section 5)

y We ensure that our qualitypolicy is communicated andunderstood at alllevels of the organization throughdocumented training, regular communication, andreinforcement during annual employee performance

rev

iews (Section 6).y We control our qualitypolicy statement by including it in

this manual, and along with allpolicies contained in thismanual, is reviewed for continuing suitabilityduringmanagement review meetings (Section 5).

QUALITY/ENVIRONMENTAL POLICY

Management re

v

iew meetings checks the Quality andEnvironmentalpolicies and objectives for continuing suitability.

QUALITY OBJECTIVE

Our objective is to satisfy all of our customers with qualityproducts and services.

QUALITYPOLICY

We will Accomplish Our Objective through CustomerSatisfaction by Providing:

1. Make statement2. Make another statement

Page: 97

y On-The-Job training is provided for allpersonnel,including contract or service personnel, in any newor modified job.

Determine Effectiveness of TrainingOne or more of the followingdetermines trainingeffectiveness:

y Review of Salaried andHourly Evaluationsy Post-training tests, when applicabley Employee on the job performance

Revision History


17/56


18/56


19/56


20/56

Page: 20

RESPONSIBILITY, AUTHORITY, ANDCOMMUNICATION

The Managing Director (MD), with the help ofdepartment

managers, sets direction and ensures the success of our businessthrough the clear definition and communication ofQuality/Environmental Systems responsibilities and authorities.Other members of TopManagement include:

y The Operations Managing andy The Human Resource Director

The interrelationship of TopManagement and other key

personnel is depicted our Organization Chart.

RESPONSIBILITY FORQUALITY

Overall Quality/Environmental Systems responsibility andauthority is as follows:

TOP MANAGEMENT

Members of TopManagement are ultimately responsible for thequality ofThe Companysproducts and services since theycontrol the systems andprocesses accomplished work. TopManagement is responsible for Business Planning, developmentand communication of our qualitypolicy,Quality/Environmental Systems Planning including theestablishment anddeployment of objectives (Section 5), theprovision of resources needed to implement and improve

Quality/Environmental Systems and management reviews(Sections 5 and 6).

MANAGEMENT

All managers are responsible for execution of the Business Planand implementation of the policy, processes, and systems

Page: 93

7.0 RecordsManagement review records must be as comprehensive aspossible. They will be the sole evidence that the agenda of

the rev

iew was completely cov

ered, and concluded thereview with appropriate decisions and actions.

We document the Management Review output in theManagement ReviewReport based on form MRR5.6.1.The report is prepared by the QualityManager and isdistributed to the attending and, if any, absent participants.Operational Procedure SOP 4.2.4, Control ofRecordsThe location, and retention period for management review

records.

8.0 Referenced Documents5.6.1 Management ReviewReport Form

SOP 4.2.4 Operational Procedure, Control ofRecords

SOP 8.5.2 Operational Procedure, Corrective andPreventive Action

9.0 Associated RecordsManagement ReviewReport: Record of the managementreview meeting, to include presented anddiscussed topicsand issues; conclusions, policies and changes; and anyactions initiated to implement the conclusions andpolicies. Management ReviewReport Documentedusingform FO-MRR-5.6.1,

Quality Objectives Matrix:We document Record of established quality objectivesonthe title page of the Management ReviewReport (MRR5.6)

Revision History


21/56


22/56


23/56


24/56


25/56

Page: 88

MANAGEMENT REVIEW

SOP 5.6

1.0 PurposeThe purpose of this procedure is to provide for a systemand instructions, and to assign responsibilities forscheduling, conducting, and recording managementreviews of the quality management system.

2.0 ApplicationThis procedure applies to all activities comprising the

quality system, and in particular, those named in Section 4,Review Input, of this procedure.

3.0 DefinitionsNone

4.0 ProcedureFrequency and SchedulingQualityperformance and the quality management systemand reviewed at least once a year. We conduct the annualreview in March.

For the first two years (i.e., through the maturation phaseof the quality system), management reviews are conductedtwice a year. We conduct the additional review in

September. In response to changing or special conditionsand events, the Operations Manager may call forunscheduled extraordinary reviews.

Page: 25

management reviews (and/or specified in our Business Plan)and reviewed for status and continuing suitability.

REVIEW INPUT SUPPLEMENTAL.

In addition, The Program Manager provides an analysis of actualandpotential field-failures and their impact on quality, safety orthe environment as an input to the management reviewprocess.

REVIEW OUTPUT

At a minimum, outputs from management review meetingsinclude new/revised corporate level improvement objectives

and any related actions required for improvement of theQuality/Environmental Systems and its processes, improvementofproduct related to customer requirements, andprovision ofresource needs. Per SOP 5.6, we record the results ofmanagement review meetings and the ISOManagementRepresentative maintains the records.

RESOURCE MANAGEMENT

PROVISION OF RESOURCES

The Company, through the Management team, determinesits resource needs andprovides the resources to implementand maintain the quality management system and continuallyimprove its effectiveness, and to enhance customersatisfaction by meeting customer requirements.

Resource requirements identifiedduring the Business PlanProcess, Quotingprocess, and advanced Quality/Environmental Planning. We accomplish verification ofwork through budget comparisons, capital expenditurereview, performance measurements, as well as through theresults of internal audits of the quality and environmental


26/56

Page: 26

provided through our budgeting and other businessmanagement processes including:

SUBJECT

y Quality/Environmental Planningy Business Planningy Human Resource Planningy Plant, Facility, Equipment and other Infrastructure

Planningy Contingency Planningy Work Environment, and Safety Planningy

Product Quality Planning (including Adv

ance ProductQuality Planning)y Planning ofCustomer-related Processesy Product andManufacturing Process Design and

Development Planningy Planning of Purchased Product (Materials, Services and

Vendors)y Production, and Service Provision Planningy

Measurement Systems Planning (including the conductofMSA)y Measurement, Analysis, and Improvement Planning

(including the use of SPC)y OrganizationalContinual Improvement Planningy Manufacturing Process Continualy Improvement Planning

The MD, with input from other responsible managers, monitors

and measures overall operational efficiency (including the costofpoor quality) andprovides related input andrecommendations that may affect Quality/ EnvironmentalSystems effectiveness to TopManagement for review andaction. (Section 5)

Page: 87

Obsolete documents, other than production partapprovals, tooling records, purchase orders andamendments, we shall maintain them for the length oftime established by the corresponding Department

Manager and in accordance with minimum customerrequirements.

Revision History


27/56

Page: 86

The Materials Manager and Accountingdepartment areresponsible for ensuring the proper retention of customerrelatedpurchase orders and amendments.

5.0 Associated Materials AIAG APQP Advanced Product Quality Planning

Manual

AIAG FMEA Failure Mode Effect Analysis Manual

AIAG MSA Measurement Systems Analysis Manual

AIAG SPC Statistical Process ControlManual

AIAG PPAP Production Part Approval Process

SOP 5.6 Management Review Procedures

SOP 7.2 Contract Review Procedures

SOP 8.2.2 Internal Audit Procedure

FO 4.2.4 QR QualityRecords List

6.0 ProcedureThe responsible personnel and

/or departments ensurethe validity and completeness, anddetermine the filing

and storage method (for retrieving andpreventingdamage) and the retention duration (conforming to TS-16949 requirements) for quality records. The retentionduration listed is a minimum retention. We might retainthe records longer for reference at the discretion of theresponsible party. The status of archived records is

determined and appropriate records are disposed ofannually.

The Quality Department retains supersededpartdocuments used for newpart qualification.

The Quality Department ensures quality records areavailable for evaluation by the customer for the statedperiod.

Page: 27

HUMAN RESOURCES

GENERAL

The Company ensures that all employees who perform activ

itiesthat may affect product quality or have significant impact on theenvironment have the appropriate training, skills, experience andcompetence. We utilize a mentor system for the first of fourphases with an experienced operator working with a newpersonand the work instructions of the particular process. In thesecondphase, the experiencedperson or member ofmanagement continues to observe the newperson. In the third

phase, we deem the newperson competent to work on his orher own. Some persons may move on to the fourth stage andwe deem them an expert allowing them to train others orassume other responsibilities.

COMPETENCE, AWARENESS, AND TRAINING

The Company maintains a Training/Competence Matrix forpersonnel by job description. It is a four-quadrant system. It is

which visuallydisplays the capabilities of the person accordingto which of the quadrants have been achieved. ThisCompetencyMatrix is available to persons assigning work. Allpersonnelunderstand the importance of their activities and theircontribution to the achievement of the quality andenvironmental objectives. (SOP 6)


28/56

Page: 28

NEED DETERMINATION

Department managers and supervisors are responsible toidentify required training and competency for personnel in theirrespective areas and to coordinate training and follow throughwith evaluations for competencies. Our TrainingCoordinator isresponsible to analyze effectiveness of training and competence,andupdate of hourly employee Training/Competence Matrixrecords.

The Human Resource Department, with input from responsiblemanagers, evaluates and qualifies applicants for specific jobopenings based on documented or demonstrated competencies.

Where possible, we help existing employees qualify fornew/changed jobs through the provision of appropriateeducation and training, including on-the-job-training (OJT).

PRODUCT DESIGN SKILLS

The Program Manager ensures that personnel with product ormanufacturingprocess design responsibility (Section 7) are

competent to achiev

e design requirements and are skilled indesign methods (Section 7) needed to achieve desired results.

TRAINING

Responsible managers identify training needs for theiremployees and achieve competence of allpersonnelperformingactivities affectingproduct quality. Personnelperformingspecific assigned tasks are qualified, as required, with particular

attention to the satisfaction of customer requirements(application ofdigitized mathematically baseddata, e.g.).

ON-THE-JOB-TRAINING

Responsible managers ensure on the job training (OJT) isprovided for personnel in any new or modified job affecting

Page: 85

CONTROL OF RECORDS

SOP 4.2.4

1.0 PurposeThis procedure provides a method of maintaining qualityrecords consisting of identification, collection, indexing,filing, storage, anddisposal.

2.0 ApplicationThis procedure applies to alldepartments responsible for

the maintenance of quality records.

3.0 DefinitionsNone

4.0 ResponsibilityEach Department Manager is responsible for records theirdepartment creates and for their maintenance, protection,

availability, anddisposal.

The QualityManager is responsible for ensuring theproper retention ofproduction part approvals, qualityperformance records, internal quality system audits, andmanagement review.

The Program Manager and/or designee are responsiblefor ensuring the proper retention of appropriate tooling

records. This is inclusive of allprints.

Accountingdepartment and the Materials Manager areresponsible for ensuring the proper retention ofsubcontractor purchase orders and amendments.


29/56

Page: 84

ensuring the identification and/or disposition of obsoletecopies.

The Plant Supervisor is responsible for ensuring themaintenance of records for Total Preventive Maintenanceactivities.

The Program Manager is responsible for ensuring alllevelsofdocuments and subordinate documents (such as controlplan, first piece, and in-process and operator instructions)and that they agree with each other.

Department Managers are responsible for reviewing allof their applicable documents within their departmentsat a minimum of annually to insure relevance andconformance.

5.0 Associated Materials

SOP 4.2.4 Control of QualityRecords Procedure

SOP 7.3 Advanced Quality-Planning Procedure

WI 4.2.3 Documentation Writing Procedures andWork Instructions

Revision History

Page: 29

product quality, including agency or contract employees.Responsible managers ensure that employees are aware of therelevance and importance of their activities and contributions tothe achievement of our objectives.

EMPLOYEE MOTIVATION ANDEMPOWERMENT

The management team is responsible to motivate employees toachieve quality objectives, to make continual improvements andto create an environment to promote innovation.

The Company carries out periodic audits with employees to

determine their awareness of the relevance and importance oftheir activities and contribute to the achievement of the qualityand environmental objectives.

We conduct Annual employee reviews to give one on oneinteraction of communication employee withThe CompanyManagement.

PROVISIONWe utilize the employee performance reviewprocess tomotivate employees to achieve individual or functionalperformance objectives that support achievement of ourcorporate objectives (Section 5). We use employee performancereviews and the internal audit process (Section 8) to promoteand assess the extent of quality and technological awarenessthroughout our organization. Responsible managers, officers,

and supervisors re-evaluate employee competencies and evaluateemployee performance against established objectives throughour employee performance reviewprocess.


30/56


31/56

Page: 82

CONTROL OF DOCUMENTS

SOP 4.2.3

1. Purpose

This procedure describes the responsibilities for receipt,review, anddistribution ofdrawings anddocuments,includingdocuments of external origin.

2. Application

This procedure applies to statutory & regulatoryrequirements the drawings specifications anddocumentsthat explain the engineering requirements, manufacturingprocesses, assembly methods, test procedures, workinstructions and inspection instructions related todeliverable goods and our processes.

3. Definitions

y QualityManager is the Document Control Specialisty ControlledCustomer ownedproduct relatedprints &

specifications are located on the X drive and areavailable to Engineering Quality &Manufacturingpersonnel

y AIAG Automotive Industry Action Group4.0 Responsibility

The Department Managers are responsible for ensuringthat the Quality System Procedures have the appropriatecontrols in place to ensure that current issues are availablein alllocations as required.

Page: 31

equipment (hardware and software as necessary); and anysupporting services that are needed, such as transportation orcommunication.

We use a multi-disciplinary approach to developplant, facility,processes, and equipment. In addition, we detail methods toevaluate and monitor the effectiveness of existing operations inSOP 7.5.1.4 and SOP 5.6.

The Company prepared contingencyplans to satisfy customerrequirements in event of an emergency such as utilityinterruptions, labor shortages, and key equipment failure andquality issues. (SOP 6.3.2)

The Plant Supervisor has overall responsibility for managing ourFacilities and Equipment Maintenance programs in accordancewith SOP 6.3; these programs include:

y Facilities management, maintenance and repairy Housekeeping/custodial services managementy Process equipment management, maintenance and repairy Production tooling management, andy Transportation and material handling equipment

management, maintenance, and repair

PLANT, FACILITY, AND EQUIPMENTPLANNING

The MD uses a multidisciplinary approach for developingplant,facility, and equipment plans. The Program Manager ensuresplant layouts are designed and continually evaluated through theapplication oflean manufacturingprinciples (state yourapproach here) to minimize material travel, handling andvalue-addeduse of floor space and facilitate synchronous materialflow.


32/56

Page: 32

The Plant Supervisor develops and implements an effectivepreventive maintenance program utilizingpredictivemaintenance methods (Section 7) as appropriate. TheInformation Systems Manager has overall responsibility for

managing our automateddata processing and communicationssystems. Management reviews the effectiveness of these effortsduring management review meetings (Section 5).

Contingencyplans. The QualityManager, in conjunction withthe Information Systems Manager and other appropriatemanagers, ensures contingencyplans are documented in theBusiness Plan and implemented as needed to satisfy customerrequirements in the event of an emergency such as utilityinterruptions, labor shortages, and key equipment failure andfield returns.

WORK ENVIRONMENT

We provide employee benefits, job and schedule flexibility,interesting work, and involvement of our employees in anempowered environment of continual improvement (Section 6).

We engender totalparticipation by involving employees ininternal audit (Section 8) and improvement (Section 8) activities.The Human Resources Department has overall responsibilityfor identifying, implementing, and maintaining effectiveemployee benefit and workforce involvement programs.

The Operations Manager has overall responsibility foridentifying, implementing, and maintaining safety andenvironmental management systems, processes and controlsneeded to ensure product conformance and meet customer,statutory or regulatory requirements. We monitor and improveworkplace safety, health, and ergonomics by followingpropermanufacturingpractices, and through safety team meetings andtraining (Section 6).

Page: 81

revisedpolicy, procedure, or instruction, the recipientupdates the manual.

Alldocuments usedduring, or forms generated before therevision process shall be considered grandfathered,acceptable to use as is due to unavailability of revisedforms or unacceptable costs which would be incurred bydisposing ofunused forms.

Revision History


33/56


34/56

Page: 34

e. The identification of any controls, processes, equipment(including inspection and test equipment),documentation, fixtures, training and skills needed toachieve the required quality and environmental

objectives and targets, including the prevention ofpollution

f. Identification of requiredverification, monitoring,measuring, inspection and test activities

g. Records are identified and kept as evidence that therealization processes and resultingproduct meetcompany and customer requirements per the quality andenvironmentalplans

h. Customer requirements and references to technicalspecifications are to be included in the qualityplan

3. The Companyuses the methods in the APQP, SPCPFMEA, and PPAP, MSA, andControl Plan manuals asrequired.

4. The qualityplan and relevant work instructions clearlydefine acceptance criteria and approved by the customer.

5. We maintain customer confidentiality for allproducts andprojects under development, and relatedproductinformation, including electronic data.

6. The Company assesses product and manufacturingprocesschanges that affect product realization. We confirm definedactivities to ensure compliance with customer requirements.When we receive the approval for any changes affecting

customer requirements, we notify the customer andv

alidatechanges before implementation.

Page: 79

DOCUMENTATIONREQUIREMENTS

SOP 4.2

1.0 PurposeThis procedure addresses the maintenance of qualitydocuments pertaining to customer requirements. Qualityreceives, prepares, revises, reviews, approves, andsystematically issues documents in a controlled manner.

2.0 ApplicationTo maintain designated securedlocations for originalpolicy, procedure, and instruction elements, drawings, andspecifications.

3.0 DefinitionsNot applicable

4.0

ResponsibilityThe Process Owners/Area Managers are responsible forcontrolling issuance and maintenance of quality/andenvironmental-relatedpolicies, procedures, and operatorinstructions.

One level above the author will be an approver forreviewing and approving companywide policies,

procedures, and operator instructions for original releaseand the release of changes.

The Program Manager and/or designee are responsiblefor controlling issuance and maintenance ofdrawings.

Department/Plant Supervisor are responsible forcontrolling issuance and maintenance of associated


35/56

Page: 78

PROCEDURES

This booklet contains sample procedures.

They arev

ery generic in nature.

Page: 35

PLANNING OF PRODUCT REALIZATION SUPPLEMENTAL

We reviewproprietarydesigns, impact use with the customer.(Section 7)

Our APQP/PPAP process, as detailed in SOP 7.1 provides aconsistent advancedproduct qualityplanningprocess acceptableto all of our customers. The APQP Team uses the APQPprocess:

y Develop a controlplany Develop/review failure modes and effects analysisy Setup actions to reduce potential failure modes with highrisky Report requireddeliverables (i.e. Tooling, Fixtures,

PFMEA, Control Plans, PPAP, Run @ Rate, etc.)

SpecialCharacteristics for inclusion in the controlplan complywith customer specifications (includingdrawings, FMEAs,operator instructions, etc.) that affect product characteristics

andprocess parameters.Production Part Approval Process (PPAP) (Section 7). TheAPQP Team Leader implements the PPAP recognized by ourcustomers, PPAP-4; see SOP 7.1) in the absence of any specificinstructions, we willdefault to a level 3 PPAP submission. Weobtain PPAP approvalprior to the first production shipment ofproduct (unless specifically waived by the customer).

The APQP Team Leader ensures:y Submissions for part approvalprior to the implementation

of changes, to determine the type of quality re-certificationrequired (PPAP documentation.)

y Production following any change in process or method ofmanufacture


36/56

Page: 36

y Change of source for subcontractedparts, materials, orservices (e.g. heat treating or plating)

y Product re-released after the tooling has been inactivefrom volume production for twelve months or more.

ACCEPTANCE CRITERIA

Acceptance criteria is approved by the customer, whererequired. For attribute data sampling, the acceptance level iszero defects (Section 8).

CONFIDENTIALITY

We ensure the confidentiality of customer-contractedproductsandprojects under development and relatedproductinformation (Section 7).

CHANGE CONTROL

The QualityManager obtains necessary customer approval ofqualityplans, acceptance criteria, product, and/or

manufacturingprocess, and all related changes that may affectproduct realization. For proprietydesigns, impact of form, fit,and function (includingperformance anddurability) andreviewed with the customer, so all effects can be properly.When required by the customer, we perform additionalverification and identification requirements, such as required fornewproduct introduction, validation, and SOP 7.1. (Section 7)

CUSTOMER-RELATED PROCESSES

Achieving our qualitypolicy to meet or exceed customerrequirements requires that we determine, understand, andconsistently meet or exceed our customers requirements andexpectations, and that we establish effective communicationsystems with our customers with regards to product

Page: 77


37/56

Page: 76

EMERGENCY RESPONSE

When appropriate, specific emergency response instructions areprepared to allow rapid and effective response to environmentalincidents. Procedures provide general guidelines to follow in the

event of an environmental accident or incident and referencesappropriate emergency response instructions, where they exist.

We conduct emergency response drills, as a minimum, annually.We review and revise procedures and instructions after drillsand after the occurrence of accidents or emergencies.

MONITORING AND MEASUREMENT

The Company shall establish and maintain documentedprocedures to monitor and measure, on a regular basis, the keycharacteristics of the operations and activities that can havesignificant impact on the environment. This will include therecording of information to trackperformance, relevantoperations controls, and conformance with objectives andtargets.

Page: 37

information, inquiries, contract or order handling and relatedchanges, and customer feedback, including complaints. (Section8)

DETERMINATION OF REQUIREMENTSRELATED TO THE PRODUCT

The Company maintains documentedprocedures for quotingand contract review and the coordination of these activities.When a request for quote is received, it is processed accordingto the Quoting Process to ensure that quality and environmentalrequirements adequatelydefine anddocument considerationsfor recycling, environmental impact, and identifiedcharacteristics (Section 7).

Requirements include those specified by the customer (includingdelivery andpost delivery requirements); requirements notstated by customer but are necessary for specified or intendeduse; applicable statutory, government, safety and environmentalregulations and requirements; and any additional requirementsdetermined by the Company.

The Company conforms to customer requirements fordesignation, documentation, and control of indentified specialcharacteristics that occur during the planningphase.

All applicable government, safety, and environmentalregulations applied to the acquisition, storage, handling,recycling, elimination, or disposal of materials.

REVIEW OF REQUIREMENTS RELATED TOTHE PRODUCT

During Quoting andContract Review, we review requirementsrelated to the product to ensure that product requirements aredefined, contract or order requirements differing from those


38/56


39/56


40/56


41/56


42/56


43/56


44/56


45/56


46/56


47/56


48/56


49/56


50/56


51/56


52/56


53/56


54/56


55/56


56/56