16949 manual procedures

8/8/2019 16949 Manual Procedures

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TABLE OF CONTENTS

Quality/Environmental Manual ......... 4

Documentation Requirements .......... 93

Control of Documents ...................... 96

Control of Records ......................... 100

Management Review ...................... 103

Competence Awareness & Training 111

Control of Nonconforming Product . 116

Corrective and Preventive Action .... 120

Work Instructions ......................... 124

Work Instructions ......................... 127

Management Review FC-MR-5.6 .... 131


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QUALITY/ENVIRONMENTAL MANUAL

SOP 4.2.2

1. ScopeGeneral

The Company is a design-responsible supplier of (name

your product here). Our products (name your market

here) and therefore the quality and environmental

management system adhere to the current ISO/TS 16949

and ISO 14001 standards, andThe Companys quality

and environmental policies.

The Company has based the Quality Environmental

Management System described in this manual to

demonstrate our capability (see Section 5) to provide

products and services that meet customer and applicableregulatory requirements, and to operate with increased

effectiveness and efficiency with the overall aim of

enhancing customer satisfaction consistently.

We developed Quality/Environmental Systems in

accordance with the following four additional types of

documents containing recommended automotive industrypractices, examples, illustrations, and explanations, to

smooth the progress of continual improvement by

emphasizing defect prevention and the reduction of

variation and waste:

y International Automotive Task Force (IATF)Guidance to ISO 9001 and all related documents

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Status reports on actions from previous Management

Reveiws

Identification of any stratigic or operations changes

that could affect the SystemIdentification of any policy issues requiring review

Status reports on progress towards meeting specific

improvement objectives:

y Customer Satisfactiony Supplier Performancey Overall System effectiveness including evidence

of repeat audit findings or other repeat problems

y Overall operational effedciency including anevaluation of the cost of poor quality

y Manufacturing process effectivness and efficiencyincluding performance against customer specified

(or other targets for productivity, process

capability and costy Overall product performance including an

analysis of actual and potential field failures and

their impacton on quality, safety, or the

environment

y Oerall product qualtiy including performanceagainst customer spcified (or other) targets related

to product qualityy Overall effectiveness of training completed including

skills training, on-the-job training, and employeeawareness and effectiveness of employee motivation

y Recommendations for improvement and plans

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y Quality System Assessment Checklist to ISO 9001and all related documents

y ISO/TS 16949 Automotive Certification Scheme-Rules for Achieving IATF Recognition and all

related documents

y ISO 14001 Environmental Management SystemsRequirements and all related documents

y Customer-specific requirements and guidancedocuments

Company Background

The Company, established in XXXX, and the

headquarters is located 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 the

environmental management system to ensure that

operations are cost effective and environmentally

responsible.The Companys Quality and

Environmental Policy are available upon request.


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Application

Our Quality/Environmental Systems comply with all

applicable requirements contained in ISO/TS

16949:2002, covers the design and provision of all

company products, and encompasses all operations at

both of our facilities. The following table identifies therequirements not applicable to our organization and provides a brief

narrative justifying their exclusion from the scope of our

Quality/Environmental Systems:

Exclusion Table

Clause Exclusion Justification

2. Reference DocumentsThe following external documents contain provisions,which, through reference in this manual, constitute

provisions of our Quality/Environmental Systems:

y ISO 9000:2005, Quality management systems Fundamentals and vocabulary

y ISO 9001:2000, Quality management systemsRequirements

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

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MANAGEMENT REVIEW FC-MR-5.6

Assess Overall

System Effectiveness

Monitor Objedctives and

Operations

Plan & Schedule

ManagamentReview

Meetin

Significant

Impact on

System

Analyze Results & Trends

Issue Management

Review Agenda

Prepare Management

Review Inputs

Issue Management

Rewview Minutes

Review Inputs & Develop

Outputs

Monitor

Implementation of

ActionsResulting

from Management

Review

Assess Process for

Effectiveness

Action to improve Effectiveness

of the System & its processesActionss to improve products

Actions to provide nedded

resources

New or revised improment of

objectives


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Rework Instructions:

If the tool in the press does not punch the required

holes in the S197 Deck Lid remove the part to

designated rework area.

Rework the part by manually punching the holes

using correct size punch 3/16 for the two holes on

each side of the release trunk slot and 5/16 for the

remaining holes.

Revision History

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

systems particular requirements for theapplication of ISO 9001:2000 for automotive

production and relevant service part

organizations

y CSR-Ford, Ford Motor CompanyCustomer-Specific Requirements for Use with ISO/TS

16949:2002

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

y CSR-DC, DaimlerChrysler (Chrysler Group)Customer-Specific Requirements for Use with

ISO/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(PPAP Fourth Edition)

y SPC-3, Statistical Process Control (SPC)Note:

1. The SPCReference Manual, SecondEdition, has an improved flow and

2. Reinforces the need for a systemicapproach to analysis of variation in data


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3. Addresses additional control chartmethods and tools

y MSA-3, Measurement Systems Analysis(MSA)

y TS-QSA2, Quality System AssessmentChecklist, Checklist to ISO/TS 16949:2002

TS-GS, IATF Guidance to ISO/TS

16949:2002

3. Terms and DefinitionsOur Quality/Environmental Systems uses the same

internationally recognized terms, vocabulary, and

definitions given in ISO 9000 as supplemented by

terms defined in ISO/TS 16949:2002, Section 3.

Acronyms, terms, vocabulary, and definitions unique

to our organization, customers, industry, and region

and referenced throughout ourQuality/Environmental Systems are contained in

Appendix A, Terms and Definitions.

4. Quality Management SystemGeneral Requirements

Top Management is responsible to define theorganizations quality and environmental policy and

ensure that it is documented, communicated, and

understood throughout the organization.

Management review meetings, include the Quality and

Environmental policies and objectives for continuing

suitability.

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9. The quality inspector performs 1st piece inspection atbeginning of shift (If needed follow SOP 8.3

Nonconforming product), and records the

information

10.The operator then places the finished parts into ashipping container to packaging specifications

11.When the container is full, the operator has thematerial handler to remove the container and bring an

empty one as needed

12.The material handler puts a shipping label oncontainer and moves the container to the inspection

holding area

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 Slots and additional cutouts are cut or punched

clean.y Overall Appearance Good

14.The quality inspector records the findings (If neededfollow SOP 8.3 Nonconforming product)

15.The quality inspector also checks for containerquantity and correct label


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The material handler:

y Brings carpet to the press and helps theoperator to load the carpet onto carpet feeder

y Provides shipping containers as requiredduring the shift

Process:

1. The operator uses pre-cut carpet and the operatorattaches the tenor frame to the carpet

2. The operator raises the carpet to the cutter and cutsthe carpet just above the tenor frame

3. The operator then places the tenor frame central overthe tool

4. The operator cycles the press by pressing the twoblack palm buttons simultaneously

5. When the press finishes its cycle, the operatorremoves the parts and the left over material

6. The operator then places the waste material into thecompactor

7. The operator inspects the part to verify 15 holes, oneslot, and 3 additional cutouts are clean with no slugs

or fabric strings or debris. If holes, slots, or cutouts

are not punched clean, followRework Instruction.

8. The operator burnishes the part edges of extra fuzz (ifnecessary).

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Our Quality/Environmental Systems is part of our

overall management system, which establishes

documents and implements our quality policy, and

related processes for providing products and services,which meet or exceed customer requirements, and

satisfies Quality/ Environmental Systems

requirements of ISO9001/ 14001.

We have adopted the process approach advocated by

ISO 9000, by defining and managing:

y Process inputs, controls, and outputs to ensuredesired results are achieved, and

y Interfaces between interrelated processes toensure system effectiveness is achieved.

Specific responsibilities for and the sequence and

interaction of our key Quality/EnvironmentalSystems processes are detailed in the Standard

Operating Procedures (SOPs), many of which contain

or reference deployment flow charts depicting the

process or procedure described in the narrative SOP.

Appendix A contains a List of Key Quality/

Environmental Systems Documents, including all

SOPs and other key Quality/Environmental Systemsdocuments.

General requirements Supplemental

We also recognize the significant role that

subcontractors play in achieving desired results and

recognize that we must ensure proper control over


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outsourced Quality/ Environmental Systems

processes (Section 7). Outsourced processes are also

depicted in our flowcharts; procedures governing

their management are described in documentsreferenced in applicable SOPs.

Documentation requirements

General

The Management, through the Management Team, is

responsible to implement and maintain a quality andenvironmental management system, and continually

improve its effectiveness.

Quality/Environmental Management System

processes, including their sequence and interaction

with other processes, have been identified and

documented in this Quality/ Environmental Manual,

and are managed in accordance with ISO and

customer requirements. Management reviews the

identified and documented indicators for

measurement and analysis to assure effectiveness and

efficiency.

The Management ensures that adequate resources and

information necessary to support the operation,monitoring, measuring, and analysis of these

processes is made available and actions necessary to

achieve planned results and support continuous

improvement.

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WORK INSTRUCTIONS

WI-DL-6.2.2

General Safety Notes

PPE:

y Safety Glassesy Kevlar Glovesy Kevlar Sleevesy Knife

General Notes

Setup includes:

yPress (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

are available at the beginning of the shift and will

check throughout the shift.


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11.When the container is full, the operator calls thematerial handler to remove the container and bring an

empty one

12.The material handler puts a shipping label oncontainer and moves the container to the inspection

holding area

13.Part inspection14.Pack and labelRevision History

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Each Department Manager is responsible for

evaluating and adjusting resource requirements to

efficiently execute assignments and accomplish goals

defined in the business plan, including theimplementation and control of the Environmental

Management System. Management gives individuals

total support and the necessary authority to perform

the assigned tasks.

The Company recognizes that control of any

outsourced processes is necessary in order to ensure

the product conforms to customer requirements.

Quality/Environmental Systems documents and data

may be in hard copy or electronic media. This quality

manual, SOPs, and other internal and external

documents and data needed to manage, perform, or

verify work affecting product quality. We use SOPs

and flow charts to document and define the key

Quality/Environmental Systems processes. We also

issue and control work instructions, job descriptions,

and other internal and external documents and data as

appropriate and needed to manage our systems

(Section 4).

Quality manual

This manual is that part of our

Quality/Environmental Systems defines the scope of

our Quality/Environmental Systems and documents

the policy, procedures, and processes needed to

implement our quality policy and achieve our quality


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objectives. This manual also shows our justification

for any exclusion from ISO/TS 16949:2002

requirements (Section 1) and defines the overall

sequence of between our key Quality/EnvironmentalSystems processes.

Control of documents

Quality/Environmental records represent

information that demonstrates conformity to

Quality/Environmental Systems requirements and

effective operation ofThe Companys Quality andEnvironmental system. Pertinent records from our

subcontractors are an element of this.

Each Process Owner is responsible for identifying

which records they consider quality/environmental

records and for collection, storage, protection,

retrieval, and the retention and disposition of theserecords

Quality/Environmental records are legible, readily

available and retained for a specified period in Quality

Record Matrix. Record retention must satisfy both

regulatory and customer requirements, as well as

ISO/TS requirements. Once retention time is met,records should be disposed of accordingly.

The information Quality Manager has overall

responsibility for ensuring that all

Quality/Environmental Systems documents, below

includes forms used to create controlled quality

records as detailed in procedure SOP 4.2.3:

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Process:

1. The material is automatically loaded onto conveyorand into oven while the operator prepares the carpet

for insertion into the press

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

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

4. Raise carpet to the cutter and cut the carpet justabove the tenor frames

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

6. The operator cycles the press by pressing the twoblack palm buttons simultaneously

7. When the press finishes its cycle, the operatorremoves the parts and the left over material

8. The operator then places the part on over bendfixture and the waste material into the compactor and

presses the green palm buttons simultaneously

9. The quality inspector performs 1st piece inspection,at beginning of shift, and after the removal of the part

from the over bend fixture

10.The operator then places the finished parts into ashipping container


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WORK INSTRUCTIONS

WI-SB-5.2.2

Important General Safety Notes

PPE:

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 andsetup in proper position for conveyor load

2. Material handler brings carpet to the press to beloaded onto carpet cutter

3. Provide shipping container4. Two frames are required

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

documents.

c) Identify the current revision status ofdocuments.

d) Ensure that relevant versions of applicabledocuments are available at points of use.

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

f) Ensure that identified external documents(including customer-engineering

standards/specifications) have controlled

distribution

g) Prevent the unintended the use of obsoletedocuments, and to apply suitable identificationto them if they are retained for any purpose.

Engineering specifications

The Program Manager oversees our process for

assuring the timely review, distribution, and

implementation of all customer-engineeringstandards/ specifications and changes based on

customer-required schedule; The Company uses a

Product Data Management system to manage and

control engineering records and data (see SOP 4.2.3).


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The Company considers reviews timely if performed

within two working weeks of receipt. When a change

involves standards or specs that are reference on

design records, or they affect PPAP documents, wesubmit an updated PPAP.

(Section 7)

Master Lists

Requirements for the establishment and maintenance

of Master Lists of internal and external

Quality/Environmental Systems documents aredefined in SOP 4.2.3.

Control of records

Quality/Environmental records represent

information that demonstrates conformity to

Quality/Environmental Systems requirements and

effective operation ofThe Companys Quality and

Environmental system. Pertinent Records from our

sub-contractors are an element of this. Records may

be in the form of hard copy or electronic media. SOP

4.2.4 details procedures necessary to control

Quality/Environmental Systems records that, as a

minimum, are prepared to document:a) Results of processes performed, including

identification of the individual performing the

activity.

b) Product/process evaluation/acceptance criteria

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Work Instructions

This booklet contains sample Work Instructions. Theyare very generic in nature and would need to be added toor changed for a real company.


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The corrective action is monitored for thirty days to

assure that the action taken has been successful.

Statistical methods (i.e. diagrams, x-bar and r charts,

etc.) are used when applicable. All corrective actionsare to be reviewed during management review

meeting.

If the action is successful, appropriate documents

(procedures, work instructions, etc.) are updated to

permanently implement the changes required by the

corrective or preventive action.

All forms used in the corrective and preventive

action procedure are retained for active life of the

product for reference to prevent reoccurrence.

Analysis of customer returned rejects will begin

upon receipt of the defective material. Records of

the analysis will be made available upon request. If acorrective action is initiated because of the analysis

will be tracked through the corrective action format.

Preventive Actions may be initiated because of,

TPM activities, lessons learned follow up, the

APQP process, Lean activities or technology

changes. Preventive actions will be tracked on the

Preventive Action Log.

Preventive actions will be reviewed during regular

management review meetings.

Revision History

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c) Procedures, drawings, or instructions used toperform an activity, including revision or date of

document.

d) Identification of material, parts, or equipmentused in the making of the product

e) Personnel, material or equipment qualificationsf) Pertinent technical records from sub-contractors

Records Retention

SOP 4.2.4 contains related procedures and responsibilities

to ensure:

y Record controls established satisfy all regulatoryand customer requirements.

y Records controlled include customer-specifiedrecords.

y Disposition of records also includes theirdisposal.

y Management Responsibilityy Management commitment

The Managing Director, along with the management

team, is responsible to communicate the importance ofmeeting customer as well as statutory and regulatory

requirements. We provide evidence of commitment to

the development, implementation, and improvement of

our Quality/ Environmental Systems in very tangible

ways:


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Our quality policy statement (Section 5) documents and

communicates the importance of meeting or exceeding all

applicable requirements (including customer, regulatory

and legal requirements) through continual improvementof our processes, products, and services.

We ensure understanding, implementation, and

maintenance of our quality policy at all levels of the

organization through widespread printed distribution of

our quality policy statement, through periodic

management review of the quality policy statement, and

corporate level improvement objectives. We

communicate and deploy our quality policy and objectives

throughout the organization through individual

performance objectives established and reviewed during

employee performance reviews (Section 5 and 6).

y All managers demonstrate their commitment to thedevelopment and improvement of the Quality/

Environmental Systems through the provision of

necessary resources (Section 6), through their

involvement in the internal audit process, and

through their proactive involvement in our

continual improvement activities (Section 8).

Emphasis is placed on improving both effectiveness

and efficiency of our key Quality/Environmental

Systems processes.

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SOP 8.3 Control of Nonconforming

Product Procedure

FOPARLOG Preventative Action Log

6.0 Procedure

An immediate (possibly temporary) fix is developed

and implemented with documentation, within

twenty-four hours of the receipt of the notice of

concern.

All suspect parts are inspected and inventoried. The

quantity checked, the quantity defective, and

disposition of stock are determined and recorded.-

If future shipments are to be certified a method and

duration must be established by Manufacturing,

Quality, and the customer (if applicable).

The root cause of the problem is established anddocumented after the initial write up.

Corrective/Preventative action reports must be

complete through interim corrective action within

three days of issuance. Permanent corrective action

is to be determined by the team within 7 days of

issuance. The time frame to verify the effectivenessof the corrective action is to be determined by the

corrective action team. The team will utilize

mistake-proofing methodology to the degree

appropriate to the magnitude of the problems and

commensurate with the risks encountered.


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CORRECTIVE AND PREVENTIVE ACTION

SOP 8.5.2/8.5.3

1.0 Purpose

This procedure provides a systematic means in

which quality problems will be eliminated.

2.0 Application

This procedure applies to all quality problems,including internal rejections, problems from

subcontractors and customer complaints.

3.0 Definitions

Not applicable

4.0 Responsibility

The Quality Manager is responsible for ensuring

that the corrective/preventative action is managed

effectively. The format utilized will be an 8D, unless

otherwise directed by the customer.

The Top Management Team is responsible for

analysis of customer rejected material.

5.0 Associated Materials

FOCAR8.5.2 Concern Report (MCR)

FOMCRLOG Material Concern Report Tracking

Log

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Process efficiency

Top management reviews product realization and support

processes to assure both effectiveness and efficiency

during management reviews (Section 5).

Customer focus

Customer requirements are determined during Quoting

and Contract review processes. Top Management ensures

that we meet these requirements with the aim of

enhancingC

ustomer Satisfaction, throughC

ustomerfeedback and the following activities:

y The Company continually monitors and measurescustomer complaints and other customer input/

feedback to identify opportunities for improvement

(Section 8).

y These customer focused communications andinteractions ultimately yield clear, explicit customer

requirements and expectations in the form of a

contractual agreement or customer order; the

Managing Director has overall responsibility for

ensuring that specified and unspecified

requirements are determined, understood, and

converted into requirements (Section 7).

y Our quality policy statement indicates ourcommitment and focuses on what is important to

us as an organization: achieving customer

satisfaction; and it prescribes the method by which

we accomplish this: by continually improving


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processes, products, and services to ensure they

consistently meet or exceed requirements.

Moreover, our quality policy statement acts as a

compass in providing the direction and aframework for establishing key corporate level

performance measures and related improvement

objectives. (Section 5)

y We ensure that our quality policy is communicatedand understood at all levels of the organization

through documented training, regular

communication, and reinforcement during annual

employee performance reviews (Section 6).

y Our quality policy statement is controlled byinclusion in this manual, and along with all policies

contained in this manual, is reviewed for continuing

suitability during management review meetings

(Section 5).

Quality/Environmental Policy

Management review meetings checks the Quality andEnvironmental policies and objectives for continuingsuitability.

Quality Objective

Our objective is to satisfy all of our customers with

quality products and services.

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y Acceptable Product - some reworknecessary with written instructions &

records.

y Unacceptable Product (placed in redSCRAP container / on rack)

y Questionable Product (QA dispositionrequired)

Quality disposes of questionable product and

records the final counts and outcomes. No rework

shall be visible on the exterior of the product.

A Quality representative records the results of the

inspection and rework on the Material Concern

Report listing the method of rework, number of

acceptable/ unacceptable parts, date, employee

responsible for reprocessing, etc.

The material is re-inspected by the designatedQualityRepresentative. Conforming materials are

removed from the container and returned to

production flow. Nonconforming materials are

scrapped or reworked accordingly. Scrapped

material is recorded in the Scrap Log and the

Material Concern Report.

All material shipped under a customer concession

or deviation will be identified as required by the

customer. Records of the quantity and expiration

date shall be maintained.

Revision History


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SOP 8.5.2 Corrective/Preventive Action

Procedure

FO 8.3 Quarantine Area Record

FO 8.3 Scrap Log

6.0 Procedure

When material is found to be nonconforming, the

container(s) is identified by a Quality representative

or production supervisor with an initial Material

Concern Report. (If material is part of an

accumulation, a Material Concern Report will beissued at the time of occurrence)

The non-conforming material is moved to the

Quarantine Area and a member of the quality

department or Production Supervision, up to the

disposition section, completes the Quarantine Area

Record.

The Production Supervision and Quality Manager

determine the disposition of the non-conforming

material and record it on the Quarantine Area

Record. Production personnel complete sort or

rework. Quality or a member of management will

provide written instructions to the employeeconducting these activities. There are four possible

determinations of inspected product:

y Acceptable Product green check mark

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Quality Policy

Our Objective Will Be Accomplished Through Customer

Satisfaction by Providing:

1. Make statement2. Make another statement

Planning

Quality objectives

The Managing Director and Operations Manager ensures(established at relevant functions and levels within the

organization) that quality and environmental objectives

and measures are documented in a business plan,

including those needed to meet product requirements.

The Companys Management Team annually reviews

business plan and revises, as appropriate, to encourage

customer satisfaction and overall growth of the

organization. The business plan includes short and long-

term goals relating to quality and environmental policy

objectives, and defines timeframes to achieve each goal.

We also have methods to track update and revise fall

under the Continuous Improvement Process.

The quality manual documents the necessary processesthat define the planning process for

quality/environmental management system and

objectives.


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The Company benchmarks trends in quality;

productivity, efficiency, and effectiveness are, as

information is available. We accomplished Benchmarking

formally and informally via trade shows, reading material,customer feedback, and charting of performance

measures (Section 6).

Objectives may include the following possible measures

(Section 5):

y Customer Satisfaction: Managing Director(Section 8)

y Supplier Performance: Materials Manage(Section 7)

y Quality/Environmental Systems Effectiveness: ISOManagement Representative. (Section 8)

y Overall Operational Efficiency and ManufacturingProcess Efficiency (Section 5 and 6)

y Training Effectiveness and Employee Awareness:Human Resource Director (HRD) with input from

the Training Manager. (Section 6)

y Product Performance: Program Manager. (Section7)

y Effectiveness of Manufacturing Processes:Production Manager (Section 7)

y Product Quality: Quality Manager (Section 8)Page: 117

product which does not conform to specified

requirements. It is clearly (visually) identified and

quarantined or segregated to prevent inadvertent

use or installation. Material is reviewed anddisposition is determined by management and

quality. The Quality Department is responsible

for maintaining and analyzing data from NC

material activities.

The Program Manager/Production is responsible

for managing the customer authorization of

products or processes and the procurement of a

deviation or concession, including materials and

services provided by vendors, that differ from

those currently approved according to the

Production Part Approval Process Manual. This

managing includes the procurement of a deviation

or concession from the customer if changes to the

product differ.

4.3 The Quality Manager is responsible for

notifying the customer if non-conforming

material is detected after shipment has been made

or use has started. Actions will be taken such as

stock returns and replacement, sorting or even

sending a company representative to their site toprotect their interests.


FO 8.3 NCMRMaterial Concern Report


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CONTROL OF NONCONFORMING PRODUCT

SOP 8.3

1.0 Purpose

This procedure provides a method to control

nonconforming material at any location in the S

Group and to eliminate its potential for

unintended use or delivery.

2.0 Application

This procedure applies to, but is not limited to,

unidentified or suspect material, in-house

rejections, customer rejection / returns or

material received from a supplier.

3.0 Definitions

Nonconforming Product: Material (e.g., resin,

purchased components, work-in-progress, etc.)

that does not meet established parameters (e.g.,

melt flow, dimensions, visual, etc.)

Suspect Product: All material having the same lot

number as known nonconforming product.

4.0 Responsibility

The Production Supervision and Quality

Department are responsible for following

documented procedures and work instructions for

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Quality objectives Supplemental: Top management

utilizes the management review process (Section 5) to

define quality objectives and measurements to include in

ourB

usiness Plan and used to deploy our quality policy.We base specific measurable objectives on achievable

performance within a specified period, driven by the

following objectives we strive to achieve as a Full Service

Supplier (FSS) to the automotive industry:

a) Achievement of Zero Defects and 100% on timedelivery performance. (Section 7 and 8)

b) Manage and control facilities, processes, qualitysystems and personnel to consistently and cost

effectively produce products and furnish services

that meet customer needs (Section 7).

c) Develop and implement Advanced Product QualityPlanning (APQP) practices and procedures inaccordance with ISO/TS 16949:2002, including the

AIAG Advanced Product Quality Planning and

Control Plan reference manual, APQP-2, and

associated customer specific requirements

documents. (Section 7)

d) Provide objective evidence that all suppliedproducts and services satisfy all AIAG Production

Part Approval Process (PPAP) requirements,

PPAP-4 (Section 7) as required including

acceptable process capabilities for all

Special/Control Characteristics that have been

established. Note: In the absence of any specific


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instructions, we will default to a level 3 PPAP

submission. (Section 7)

e) Utilize appropriate statistical techniques for on-going process control and improvement as

established in the AIAG Statistical Process Control

(SPC) reference manual, SPC-3, and associated

customer specific requirements documents. (Section

8)

f) Be committed to continuous process improvementby emphasising reduction of part-to-part variationand the elimination of all waste. (Section 8)

g) Conduct operations in conformance with, or toexceed, all applicable environmental laws and

regulations of the jurisdictions in which we do

business (Section 6).

h) Meet customer requirements by controlling andusing returnable packaging, of. (Section 7).

Quality management system planning

The Quality/Environmental Systems planning process

involves the establishment and communication of our

quality policy and objectives through issuance of thismanual and its associated procedures, and through the

provision of resources needed for its effective

implementation. This manual constitutes our overall plan

for establishing, maintaining, and improving systems.

Page: 115

Determine Effectiveness of Training

One or more of the following determines training

effectiveness:

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

Revision History


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Orientation Manual

Job Descriptions

6.0 Procedure

Identify training needs.

The Company employees and their

manager/supervisor shall review the employees

training status to determine training needs. Thisreview occurs concurrently with the employees

performance evaluation or upon need.

Provide Training

One or more of the following provides formal

training:

y Identified The Company Trainersy Professional / Industry Organizations or

Societies

y Local Community and Trade Schoolsy College and University Sponsored Classesy On-The-Job training is provided for all

personnel, including contract or service

personnel, in any new or modified job.

Page: 23

Our management review process and internal audit

process ensure the integrity of our System is maintained

when significant changes are planned and implemented

that affect our key Systems. (Sections 5, 6, and 8)

The Quality Manager develops appropriate quality

planning documents for specific products, projects, or

contracts whenever customer requirements exceed the

capability or intent of the product/service realization and

support processes described in our

Quality/Environmental Systems (Section 7).

Responsibility, authority, and communication

Responsibility and authority

The Managing Director (MD), with the help of

department managers, sets direction and ensures the

success of our business through the clear definition and

communication of Quality/Environmental Systems

responsibilities and authorities. Other members of Top

Management include:

y The Operations Managing andy The Human Resource Director

The interrelationship of Top Management and other key

personnel is depicted our Organization Chart.

Responsibility for quality

Overall Quality/Environmental Systems responsibility

and authority is as follows:


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Top Management

Members of Top Management are ultimately responsible

for the quality ofThe Companys products and services

since they control the systems and processes

accomplished work. Top Management is responsible for

Business Planning, development and communication of

our quality policy, Quality/Environmental Systems

Planning including the establishment and deployment of

objectives (Section 5), the provision 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 Plan and implementation of the policy,

processes, and systems described in this manual. All

managers are responsible for planning and controllingQuality/ Environmental Systems processes within their

area(s) of responsibility, including the establishment and

deployment of operational level objectives (Section 5),

and the provision of resources needed to implement and

improve these processes. Managers also conduct

employee performance reviews (Section 6). Management

with responsibility and authority for corrective actionpromptly notifies employees of non-conformities (Section

8). Management ensures the staffing of all production

shifts with personnel in charge of, or delegated

responsibility for product quality (Section 7).

Page: 113

employees manager/supervisor in the performance

review process determines individual training needs.

Safety Training

All employees receive safety training

Specialized Training

Employees requiring specialized training in areas

affecting quality shall receive the training needed

per job description.

Evaluating Training

The training courses offered internally are

continually assessed by the Human Resource

Department. The content of the courses are

evaluated through a training feedback and

evaluation form, and an assessment test (if

applicable) is given upon completion of thecourse.

It is the responsibility of the Manufacturing

Supervisor to inform personnel whose work

affect quality of the consequences to the customer

of nonconformity to quality requirements.

It is the responsibility of the TS-16949 ManagementRepresentative to measure the extent to which our

personnel are aware of the relevance and

importance of their activities and how they

contribute to the achievement of the quality

objectives.


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Training Records

Hourly Employees: Records of hourly training

needs and training received by active employees

performing activities affecting quality shall bemaintained by the Human Resource Department.

Each hourly employee has an individual training

record, which is maintained by the Human

Resource Department. These records include, but

are not limited to, training matrices and copies of

training certificates.

Salary Employees: Records of salary training needs

and training received by active employees

performing activities affecting quality shall be

maintained by the Human Resource Department.

Each salary employee has an individual training

record, which is maintained by the Human

Resource Department. These records include, butare not limited to, training matrices and copies of

training certificates.

Evaluating Training Needs

All employees (salaried and hourly) must complete

the specific orientation program administered by

the Human Resource Department. Personnelwhose work affects quality are informed about the

consequences to the customer of nonconformity to

quality requirements. All employees have training in

awareness, relevance, and importance of their

activities and how they contribute to the

achievement of our overall quality objectives. The

Page: 25

Employees

All employees are responsible for the quality of their

work and implementation of the policy and procedures

applicable to processes they perform. Personnelresponsible for product quality have the authority to stop

production to correct quality problems (Section 8).

Detailed responsibilities and authorities for Quality/

Environmental Systems implementation and

improvement are contained in lower level documents

referenced throughout this manual and otherQuality/Environmental Systems documents including

procedures, flow charts, job descriptions, work

instructions, etc.

Management representative

The Company has appointed Quality and Environmental

Management representatives for each system. The

management representatives have the responsibility and

authority to:

y Ensuring that the ISO/TS 16949:2002 processesneeded for quality and environmental management

systems are established, implemented, and

maintained in accordance with their respectivestandards

(Section 5).

y Ensuring the promotion of awareness of customerand environmental requirements throughout the

organization (Section 5)


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y The Environmental Management Representative isresponsible for documenting and responding to

relevant communication from external parties.

Customer representative

The Program Manager will ensure and address customer

requirements and will represent the needs of the customer

internal functions, from contract review through

production

Internal communication

The Company uses a variety of tools, including but not

limited to workplace meetings, memos, bulletins, new

employee orientation, and specific training sessions to

communicate internal information about the effectiveness

of our quality and environmental management system,

and its policies, objectives and significant environmental

aspects.

We communicate information regarding Quality/

Environmental Systems processes and their effectiveness

through documented training (Section 6), the internal

audit process (Section 8), continual improvement, and

corrective/ preventive action processes (Section 8), and

regular formal and informal communications as follows:

y The ISO Management Representative postsinformation on quality bulletin boards throughout

the facility to convey information regarding

customer requirements, and the status and

importance of quality activities.

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COMPETENCE AWARENESS & TRAINING

SOP 6.2.2

1.0 Purpose

The system described in this section is used to

ensure that all personnel performing activities

affecting quality shall have their training needs

identified and, as appropriate, the training provided.

2.0 Application

The scope of this procedure incorporates the

training of all employees performing quality related

activities.

3.0 Definitions

Not applicable

4.0 Responsibility

Job Description

Each position has a written job description

maintained by the Human Resources Department.

Each job description identifies the competence

level/ education, skills appropriate required for the

position.


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9.0 Associated RecordsManagement ReviewReport: Record of the

management review meeting, to include presented

and discussed topics and issues; conclusions,policies and changes; and any actions initiated to

implement the conclusions and policies.

Documented using form FO-MRR-5.6.1,

Management ReviewReport.

Quality Objectives Matrix: Record of established

quality objectives. Documented on the title page ofthe Management ReviewReport (MRR5.6).

Revision History

Page: 27

y The Company uses internal audits (Section 8) toreinforce or communicate appropriate information

to employees.

The Operations Manager posts information on safety

bulletin boards throughout the facility to convey

information regarding the status of the Safety and

Environmental Management Program, and related

statutory/regulatory requirements. The Human Resources

Department posts information on employee bulletin

boards throughout the facility to convey information

regarding employee benefits, programs, involvement

opportunities, and applicable statutory/regulatory

requirements.

All managers and supervisors, are responsible for

establishing internal communications as needed to convey

to their employees the relevance and importance of their

activities; typically this information is conveyed throughproduction team meetings and cross-functional

improvement projects (Section 8). Communications

regarding how employees contribute to the achievement

of objectives, which we convey and reinforce during

employee performance, reviews (Section 6).

Management review

Top Management conducts formal review meetings at

least quarterly to ensure the continuing suitability,

adequacy, and effectiveness of our

Quality/Environmental Systems in accordance with

procedures detailed in SOP 5.6. The Managing Director


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Page: 28

or designee chairs the corporate reviews and top

management from all relevant functions attends. (Section

8)

The Company record review results provide at aminimum, evidence of achievement of

quality/environmental objectives and customer

satisfaction. We retain meeting records.

(Section 5)

The Quality Manager ensures that review includes analysis

of actual and potential field failure and their impact onquality, safety, and environment. The primary output of

management review meetings are management actions

taken (Section 8) to make changes or improvements to

our Quality/Environmental Systems and the provision of

resources needed to implement these actions.

The Company holds review meetings at least monthly toreview plant specific data and process effectiveness

indicators, identifying opportunities for improvement and

corrective and preventative actions.

Quality system performance

Each management review includes all requirements of the

Quality/Environmental Systems including monitoring ofquality objectives (Section 5), regular evaluation of the

cost of poor quality (Section 8) , and an assessment of the

suitability and effective of support processes (i.e. plant,

facility and equipment, Section 6) as an essential part of

our continual improvement process (Section 8).

Page: 109

Resource needs for implementing improvement

actions are identified. These include assignment of

responsibility, time frame, and allocation of human,

equipment, technical knowledge, and other

necessary resources.

7.0 RecordsManagement review records must be as

comprehensive as possible. They will be the sole

evidence that the agenda of the review was

completely covered, and that the review wasconcluded with appropriate decisions and actions.

Management review output is documented in the

Management ReviewReport based on form MRR

5.6.1. The report is prepared by the Quality

Manager and is distributed to the attending and, if

any, absent participants. The location and retention

period for management review records are specified

in Operational Procedure SOP 4.2.4, Control of

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 and

Preventive Action


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6.0 Management review outputy Improvement of the quality management system,y Improvement of quality performance, andy Improvement of products and/or services to

better meet customer requirements and increase

customer satisfaction

These improvement actions are defined implemented as:

Management review actions

Documented in the Management ReviewReport(FO-MRR-5.6.1) in theActions, Assigned to, and Due

Datecolumns. This type of action is most suitable

for minor improvements that can be quickly

implemented, and which are not directly related to

product or process conformity.

Corrective or preventive actions

Documented in the Corrective Action Request

(CAR) form (FO-NCCAR-8.2.3) and processed in

accordance with procedure SOP 8.5.2, Corrective

and Preventive Actions. CARs are normally used

for improvements related to specific actual or

potential product or process nonconformities.

Quality objectives

Documented on the title page of the Management

ReviewReport (refer to Section 6 of this

procedure). This method is most suitable for

implementing long-term improvement goals.

Page: 29

At a minimum, we use these results to demonstrate

achievement of the quality objectives in our Business Plan

and customer satisfaction with supplied product.

Review input

The management review meeting includes a review of our

quality policy (Section 5), all applicable requirements of

the QEMS, related performance trends, and opportunities

for improvement, follow-up actions from earlier

management reviews, results of self-assessments (Section

8), and strategic or operational changes that could affectthe QEMS.

At a minimum, corporate level, effectiveness and/or

efficiency improvement objectives (Section 5)

documented in prior 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 actual and potential field-failures and their impact on

quality, safety or the environment as an input to the

management review process.

Review output

At a minimum, outputs from management review

meetings include new/revised corporate level

improvement objectives and any related actions required

for improvement of the Quality/Environmental Systems

and its processes, improvement of product related to


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customer requirements, and provision of resource needs.

Per SOP 5.6, we record the results of management review

meetings and the ISO Management Representative

maintains the records.

5. Resource ManagementProvision of resources

The Company, through the Management team,

determines its resource needs and provides the

resources to implement and maintain the quality

management system and continually improve its

effectiveness, and to enhance customer satisfaction by

meeting customer requirements.

Resource requirements identified during the Business

Plan Process, Quoting process, and advanced

Quality/ Environmental Planning. We accomplish

verification of work through budget comparisons,capital expenditure review, performance

measurements, as well as through the results of

internal audits of the quality and environmental

provided through our budgeting and other business

management processes including:

Page: 107

and thus fulfill the quality policy and other

organizational goals and aspirations.

At the end of the meeting, Quality presents the

status of quality objectives established by theprevious review (those objectives are documented

on the title page of the Management Review

Report); and records their status in the Status Next

Management Review column.

When an objective is not achieved, the participants

decide whether to drop the objective, reduce itstarget value, or extend the target due date.

Objectives that have been achieved may be

discontinued or be retained with a higher target

value.

Any quality objectives that are carried on into the

next period and any new objectives established bythe review meeting are documented in the Quality

Objectives Matrix on the title page of the

Management ReviewReport.

The principal quality policy is reviewed to ensure its

continuing suitability. The policy is changed when

the goals expressed in the policy have been

achieved, or when changes within or outside the

company render the policy inadequate or

inappropriate.


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Changes and quality system planning

Quality highlights any product, process, capacity, or

other operational or organizational changes that

affect the quality system and proposes specificactions to update or modify the system in response

to these changing circumstances.

Recommendations for improvement

Quality concludes the input phase of the review

with recommendations for improvement.

In addition to the topics listed above, the

management review may also consider such issues

as cost of quality and non-quality; integration of

the quality system with other operations and

activities; market and customer response to the

quality effort; and any other such issues related to

the quality management system.

Following each presentation, the participants

discuss the issues, compare their status and

performance with preceding periods, and identify

areas where improvement is required.

5.0 Quality objectives and quality policyAn important role of management reviews is to

establish quality objectives and to review progress

toward achieving the objectives and fulfilling the

quality policy. Quality objectives are established to

improve performance and/or the quality system

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Subject

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

Infrastructure Planning

y Contingency Planningy Work Environment, and Safety Planningy Product Quality Planning (including Advance

Product Quality Planning)

y Planning ofCustomer-related Processesy Product and Manufacturing Process Design

and Development Planning

y Planning of Purchased Product (Materials,Services and Vendors)

y Production, and Service Provision Planningy Measurement Systems Planning (including the

conduct of MSA)

y Measurement, Analysis, and ImprovementPlanning (including the use of SPC)

y Organizational Continual ImprovementPlanning

y Manufacturing Process Continualy Improvement Planning

The MD, with input from other responsible managers,

monitors and measures overall operational efficiency

(including the cost of poor quality) and provides related

input and recommendations that may affect Quality/

Environmental Systems effectiveness to Top

Management for review and action (Section 5).


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Human resources

General

TheC

ompany ensures that all employees who performactivities that may affect product quality or have

significant impact on the environment have the

appropriate training, skills, experience and competence.

We utilize a mentor system for the first of four phases

with an experienced operator working with a new person

and the work instructions of the particular process. In the

second phase, the experienced person or member ofmanagement continues to observe the new person. In the

third phase, we deem the new person competent to

work on his or her own. Some persons may move on to

the fourth stage and we deem them an expert allowing

them to train others or assume other responsibilities.

Competence,Awareness, and Training

The Company maintains a Training/Competence Matrix

for personnel by job description. It is a four-quadrant

system. It is which visually displays the capabilities of the

person according to which of the quadrants have been

achieved. This Competency Matrix is available to persons

assigning work. All personnel understand the importance

of their activities and their contribution to the

achievement of the quality and environmental objectives.

(SOP 6)

Page: 105

abandoned. Reasons for the failure to implement

the action and any decisions regarding continuation

of the action are recorded in the Management

ReviewReport.

Process performance and product conformity

Quality presents quality performance data. This

includes rates of process and product

nonconformities, on-time delivery performance,

supplier quality performance, and productivity data.

Edit the scope of the quality performance data asappropriate, and coordinate with ISO/TS 16949

Element 8.4- Analysis of Data.

Corrective and preventive actions:

Quality presents the most important corrective and

preventive actions implemented through the period,

and the status of pending actions.

Customer feedback and complaints

Customer Service presents summaries of customer

feedback and customer complaints, including

analysis of trends.

Internal quality audits

Quality presents results of internal quality system

audits. This includes summaries of results for the

cycle, the frequency of audit findings against

particular elements of the quality system and

discussion of significant findings.


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Manager may call for unscheduled extraordinary

reviews.

Attendance

Management reviews are chaired by the Quality

Manager and are attended by Management,

Engineering, Production, and Purchasing.

Those managers who are unable to attend shall

receive minutes of the review meeting and, after

reviewing the minutes, may submit their input and

comments to the Quality Manager. No more thanone manager may be absent from the meeting. The

Operations Manager and Quality Manager must

always attend.

Agenda

The agenda for management review meetingscovers at least all items listed in Section 4 of this

procedure. The agenda is documented on the cover

page of the Management ReviewReport.

Management review input

At a minimum, the following information and data

are presented for review:

Follow-up actions from previous reviews

Quality reports on the status of action items from

the previous meetings. Actions which are not

completed may be extended with a new due date,

reassigned to another person/function, changed, or

Page: 33

Need Determination

Department managers and supervisors are responsible to

identify required training and competency for personnel

in their respective areas and to coordinate training andfollow through with evaluations for competencies. Our

TrainingCoordinator is responsible to analyze

effectiveness of training and competence, and update of

hourly employee Training/Competence Matrix records.

The Human Resource Department, with input from

responsible managers, evaluates and qualifies applicantsfor specific job openings based on documented or

demonstrated competencies. Where possible, we help

existing employees qualify for new/changed jobs through

the provision of appropriate education and training,

including on-the-job-training (OJT). At a minimum, these

include:

Product design skills

The Program Manager ensures that personnel with

product or manufacturing process design responsibility

(Section 7) are competent to achieve design requirements

and are skilled in design methods (Section 7) needed to

achieve desired results.

Training

Responsible managers identify training needs for their

employees and achieve competence of all personnel

performing activities affecting product quality. Personnel

performing specific assigned tasks are qualified, as


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required, with particular attention to the satisfaction of

customer requirements (application of digitized

mathematically based data, e.g.).

On-the-job-training

Responsible managers ensure on the job training (OJT) is

provided for personnel in any new or modified job

affecting product quality, including agency or contract

employees. Responsible managers ensure that employees

are aware of the relevance and importance of their

activities and contributions to the achievement of ourobjectives.

Employee motivation and empowerment

The management team is responsible to motivate

employees to achieve quality objectives, to make

continual improvements and to create an environment to

promote innovation.

The Company carries out periodic audits with

employees to determine their awareness of the relevance

and importance of their activities and contribute to the

achievement of the quality and environmental objectives.

We conduct Annual employee reviews to give one on one

interaction of communication employee withThe

Company Management.

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MANAGEMENT REVIEW

SOP 5.6

1.0

Purpose

The purpose of this procedure is to provide for a

system and instructions, and to assign

responsibilities for scheduling, conducting, and

recording management reviews 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 Scheduling

Quality performance and the quality management

system are reviewed at least once a year. The annual

review is conducted in March.

For the first two years (i.e., through the maturation

phase of the quality system), management reviews

are conducted twice a year. The additional review is

conducted in September. In response to changing

or special conditions and events, the Operations


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6.0 ProcedureThe responsible personnel and/or departments

ensures the validity and completeness, and

determines the filing and storage method (forretrievability and preventing damage) and the

retention duration (conforming to TS-16949

requirements) for quality records. The retention

duration listed is a minimum retention. The

records may be retained longer for reference at

the discretion of the responsible party. The status

of archived records is determined and appropriaterecords are disposed of annually.

The Quality Department retains superseded part

documents used for new part qualification.

The Quality Department ensures quality records

are available for evaluation by the customer for

the stated period.

Obsolete documents, other than production part

approvals, tooling records, purchase orders and

amendments, shall be maintained for the length of

time established by the corresponding

Department Manager and in accordance with

minimum customer requirements.

Revision History

Page: 35

Provision.

We utilize the employee performance review process to

motivate employees to achieve individual or functional

performance objectives that support achievement of ourcorporate objectives (Section 5). We use employee

performance reviews and the internal audit process

(Section 8) to promote and assess the extent of quality

and technological awareness throughout our organization.

Responsible managers, officers, and supervisors re-

evaluate employee competencies and evaluate employee

performance against established objectives through ouremployee performance review process.

Effectiveness

The Company evaluates the effectiveness of all actions

taken to meet competency needs. We evaluate provided

training through immediate feedback from the employee

and the manager, or supervisor who identified the

training requirement.

The responsible manager collects the documents for

each training event. Responsible managers monitor and

measure the overall training effectiveness and to meet

competency needs and provides related recommendations

to Top Management for review and action (Section 5).

Employee Awareness

Through their activities and contributions, we ensure that

our employees are aware of customer requirements

(Section 5 and Section 5), the relevance, and importance


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achieving our quality policy (Section 5) and objectives

(Section 5). This is accomplished through awareness

training, employee performance reviews (Section 6), and

employee participation in our internal audit (Section 8)

and improvement (Section 8) processes.

Records

We maintain appropriate records of education, training,

skills, and experience in accordance with provision of

Section 4. Employee qualification/competency review

records and annual performance review results aremaintained by the Human Resources Department. The

Training Manager maintains records of all training

completed.

Infrastructure

The Company provides and maintains the infrastructure

needed to achieve conformity to product requirements,including buildings, workspace and associated utilities;

process equipment (hardware and software as necessary);

and any supporting services that are needed, such as

transportation or communication.

We use a multi-disciplinary approach to develop plant,

facility, processes, and equipment. In addition, we detailmethods to evaluate and monitor the effectiveness of

existing operations in SOP 7.5.1.4 and SOP 5.6.

The Company prepared contingency plans to satisfy

customer requirements in event of an emergency such as

Page: 101

Accounting department and the Materials Manager

are responsible for ensuring the proper retention of

subcontractor purchase orders and amendments.

The Materials Manager and Accounting departmentare responsible for ensuring the proper retention of

customer related purchase 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 Control

Manual

AIAG PPAP Production Part Approval

Process

SOP 5.6 Management Review Procedure

SOP 7.2 Contract Review Procedure

SOP 8.2.2 Internal Audit Procedure

FO 4.2.4 DD Destroyed Documents List

FO 4.2.4 QR QualityRecords List


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CONTROL OF RECORDS

SOP 4.2.4

1.0 PurposeThis procedure provides a method of maintaining

quality records consisting of identification,

collection, indexing, filing, storage, and disposal.

2.0 ApplicationThis procedure applies to all departments

responsible for the maintenance of quality records.

3.0 DefinitionsNone

4.0

Responsibility

Each Department Manager is responsible for

records their department creates and for their

maintenance, protection, availability, and disposal.

The Quality Manager is responsible for ensuring the

proper retention of production part approvals,

quality performance records, internal quality systemaudits, and management review.

The Program Manager and/or designee is

responsible for ensuring the proper retention of

appropriate tooling records. This is inclusive of all

prints.

Page: 37

utility interruptions, labor shortages, and key equipment

failure and quality issues. (SOP 6.3.2)

The Plant Supervisor has overall responsibility for

managing our Facilities and Equipment Maintenanceprograms in accordance with SOP 6.3; these programs

include:

y Facilities management, maintenance and repairy Housekeeping/custodial services managementy Process equipment management, maintenance and

repair

y Production tooling management, andy Transportation and material handling equipment

management, maintenance, and repair

Plant, facility, and equipment planning

The MD uses a multidisciplinary approach for developing

plant, facility, and equipment plans. The Program

Manager ensures plant layouts are designed and

continually evaluated through the application of lean

manufacturing principles (state your approach here) to

minimize material travel, handling and value-added use offloor space and facilitate synchronous material flow.

The Plant Supervisor develops and implements an

effective preventive maintenance program utilizing

predictive maintenance methods (Section 7) as

appropriate. The Information Systems Manager has


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overall responsibility for managing our automated data

processing and communications systems. Management

reviews the effectiveness of these efforts during

management review meetings (Section 5).

Contingency plans. The Quality Manager, in conjunction

with the Information Systems Manager and other

appropriate managers, ensures contingency plans are

documented in the Business Plan and implemented as

needed to satisfy customer requirements in the event of

an emergency such as utility interruptions, labor

shortages, and key equipment failure and field returns.

Work environment

We provide employee benefits, job and schedule

flexibility, interesting work, and involvement of our

employees in an empowered environment of continual

improvement (Section 6). We engender total participation

by involving employees in internal audit (Section 8) and

improvement (Section 8) activities. The Human

Resources Department has overall responsibility for

identifying, implementing, and maintaining effective

employee benefit and workforce involvement programs.

The Operations Manager has overall responsibility for

identifying, implementing, and maintaining safety andenvironmental management systems, processes and

controls needed to ensure product conformance and meet

customer, statutory or regulatory requirements. We

monitor and improve workplace safety, health, and

ergonomics by following proper manufacturing practices,

Page: 99

Department Managers are responsible for

reviewing all of their applicable documents within

their departments at a minimum of annually to

insure relevance and conformance.


SOP 4.2.4 Control of QualityRecords Procedure

SOP 7.3 Advanced Quality Planning Procedure

WI 4.2.3 Documentation Writing Procedures

and Work Instructions

Revision History

C l P d d E i i Ch d h h f i d i i (S i


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Control Procedure and EngineeringChange

Process.

The Program Manager is responsible for receiving,

reviewing and retainingCAD/ Math data,Instructions and Test Procedures are available.

The Plant Supervisor is responsible for ensuring

current instructions are available at all work

instructions.

Department Managers are responsible for creating,

approving, and maintaining their individual

department work instructions.

All Department Managers listed above are also

responsible for making sure distributed and or

obsolete copies are retrieved and replaced with the

latest revision. Both the person receiving a copy of

a new or revised document and the persondistributing the document are responsible for

ensuring that obsolete copies are identified and/or

disposed of.

The Plant Supervisor is responsible for ensuring

records of Total Preventive Maintenance activities

are maintained.

The Program Manager is responsible for ensuring

all levels of documents and subordinate documents

(such as control plan, first piece, and in-process and

operator instructions) are in agreement.

Page: 39

and through safety team meetings and training (Section

6).

Personnel safety to achieve product quality: We design

and carry out production processes to ensure productsafety and minimize potential risks to employees as may

be identified during development of design FMEAs

(Section 7) and/or process FMEAs (Section 7) and

documented in work instructions located in process areas

(Section 7).

Cleanliness of premises

We provide and maintain a work environment in a state

of order, cleanliness, and repair consistent with the

product and manufacturing process needs (Section 6)

6. Product RealizationPlanning of product realization

1. The Company has implemented a Quality andEnvironmental-planning process to define and

document how the respective requirements will be

met (See SOP 7.1 & SOP 7.2). This planning process

is consistent with the requirements of the ISO/

TS16949 standard and sets the framework for all

Company processes of the quality/environmental

management systems.

2. For new projects, a cross functional team plans theprocesses with consideration given to, but not limited

to, the following:

Th lit / i t l bj ti d 4 0 R ibilit


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a. The quality/environmental objectives andrequirements for the product

b. Environmental aspects/impactsc. Product special characteristics, including safety

characteristics

d. Error proofing for processes, facilities,equipment, and tooling

e. The identification of any controls, processes,equipment (including inspection and testequipment), documentation, fixtures, training and

skills needed to achieve the required quality and

environmental objectives and targets, including

the prevention of pollution

f. Identification of required verification, monitoring,measuring, inspection and test activities

g. Records are identified and kept as evidence thatthe realization processes and resulting product

meet company and customer requirements per the

quality and environmental plans

h. Customer requirements and references totechnical specifications are to be included in thequality plan

3. The Company uses the methods in the APQP, SPCPFMEA, PPAP, MSA, and Control Plan manuals as

required.

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4.0 Responsibility

The Department Managers are responsible for

ensuring that the Quality System Procedures have

the appropriate controls in place to ensure thatcurrent issues are available in all locations as

required.

The Quality Manager and/or designee is

responsible for retaining master copies and assuring

current revision level of the AIAG reference

manuals:

y Advanced Product Quality Planning &Control Plan

y Fundamental Statistical Process Controly Measurement Systems Analysisy Potential Failure Mode and Effects Analysisy Product Part Approval Processy Quality System Requirements TS 16949y Environmental Mgmt. System, ISO 14001

The Program Manager is responsible for a timely

review of customer drawings and specifications.

The PM has 10 business days of receipt to

document the receipt of drawings and maintain the

engineering standards according to the Drawing

4 The quality plan and relevant work instructions


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CONTROL OF DOCUMENTS

SOP 4.2.3

1. Purpose

This procedure describes the responsibilities for

receipt, review, and distribution of drawings and

documents, including documents of external origin.

2. Application

This procedure applies to statutory & regulatory

requirements the drawings specifications and

documents that explain the engineering

requirements, manufacturing processes, assembly

methods, test procedures, work instructions and

inspection instructions related to deliverable goods

and our processes.

3. Definitions

y Quality Manager is the Document ControlSpecialist

y Controlled Customer owned product relatedprints & specifications are located on the X

drive and are available to Engineering Quality

&Manufacturing personnel

y AIAG Automotive Industry Action Group

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4. The quality plan and relevant work instructions,clearly define acceptance criteria and approved by the

customer.

5. We maintain customer confidentiality for all productsand projects under development, and related product

information, including electronic data.

6. The Company assesses product and manufacturingprocess changes that affect product realization. We

confirm defined activities to ensure compliance with

customer requirements. When we receive theapproval for any changes affecting customer

requirements, we notify the customer and validate

changes before implementation.

Planning of product realization Supplemental

We review proprietary designs, impact use with the

customer.. (Section 7)

Our APQP/PPAP process, as detailed in SOP 7.1

provides a consistent advanced product quality planning

process acceptable to all of our customers. The APQP

Team uses the APQP process:

y Develop a control plany Develop/review failure modes and effects analysisy Setup actions to reduce potential failure modes with

high risk

y Report required deliverables (i.e. Tooling, Fixtures,PFMEA, Control Plans, PPAP, Run @ Rate, etc.)

Special Characteristics for inclusion in the control plan 6 0 Procedure


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Special Characteristics for inclusion in the control plan

comply with customer specifications (including drawings,

FMEAs, operator instructions, etc.) that affect product

characteristics and process parameters.

Production Part Approval Process (PPAP) (Section 7).

The APQP Team Leader implements the PPAP

recognized by our customers, PPAP-4; see SOP 7.1) in

the absence of any specific instructions, we will default to

a level 3 PPAP submission. PPAP approval is obtained

prior to the first production shipment of product (unless

specifically waived by the customer).

The APQP Team Leader ensures:

y Submissions for part approval prior to theimplementation of changes, to determine the type

of quality re-certification required (PPAP

documentation.)

y Production following any change in process ormethod of manufacture

y Change of source for subcontracted parts, materials,or services (e.g. heat treating or plating)

y Product re-released after the tooling has beeninactive from volume production for twelve months

or more.

Acceptance criteria

Acceptance criteria is approved by the customer, where

required. For attribute data sampling, the acceptance level

is zero defects (Section 8).

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6.0 ProcedureAny member of staff, through their department

manager, may request document changes. If a

Quality System procedure needs to be changed,send a Quality Manual Change Request Form to the

Quality Manager describing the proposed change.

The changes become part of the revision history. If

not approved, the request form gives an explanation

and a copy returned to the originator. The Quality

Department files original form.

Where practical, the revision history identifies the

changes.

The quality department distributes a copy of the

new or revised policy, procedure, or instruction

according to the Quality Policy Manual, Procedure

Manual, and Operator Instructions Distribution

List. Upon receipt of the new or revised policy,

procedure, or instruction, the recipient updates the

manual.

All documents used during, or forms generated

before the revision process shall be considered

grandfathered, acceptable to use as is due to

unavailability of revised forms or unacceptablecosts which would be incurred by disposing of

unused forms.

Revision History

The Program Manager and/or designee are Confidentiality


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The Program Manager and/or designee are

responsible for controlling issuance and

maintenance of drawings.

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

manuals and data within their area of responsibility

as required, Reference 6.0.

The responsible Department ensures that

designated personnel receive approval, initial issue,

and amendments of all documents and data relatingto the requirements of the quality system, and for

the recall of obsolete documents. The responsible

Department ensures availability of appropriate

documents at all locations where the performance

of operations affect the quality system.

The A