GM NAMEPLATE, INC. QUALITY MANUAL · GM NAMEPLATE, INC. QUALITY MANUAL ... the standard AS9100 Revision C. The ... GM NAMEPLATE, INC. QUALITY MANUAL Management

GM NAMEPLATE, INC. QUALITY MANUAL

DOCUMENT NUMBER 00-QM-01 REVISION LEVEL 14 PAGE 1 of 38

SIGNATURE APPROVAL:

___________________________________________________________ _______________

APPROVE: (CHAIRMAN) DON ROOT DATE

___________________________________________________________ _______________

APPROVE: (CEO) (PRESIDENT – CALIFORNIA) BRUCE CLECKLEY DATE

___________________________________________________________ _______________

APPROVE: (PRESIDENT – WASHINGTON) BRAD ROOT DATE

___________________________________________________________ _______________

APPROVE: (PRESIDENT – NORTH CAROLINA) JACK SHARRETT DATE

___________________________________________________________ _______________

APPROVE: (PRESIDENT – ELITE PLASTICS) DAN THURMOND DATE

___________________________________________________________ _______________

APPROVE: (CORPORATE DIRECTOR OF QUALITY AND DATE

REGULATORY AFFAIRS) MARTIN ESPINOLA

DOCUMENT CHANGE RECORD:

Rev. Date Description of Change

14 10/28/13 2588-Update 4.0 scope to reference 01-QM-MED

13 02/19/13 1535-Add Elite Plastics to AS9100C certification, update organization chart and

change number formatting to align with AS9100C

12 04/02/12 1458-Update for AS9100C

11 05/07/10 1248-Change 5 references of ISO9001:2000 to ISO9001:2008

10 04/16/10 1209-Add justification for exclusion of service provision, add flowchart for

interaction of QMS processes and revise management responsibility and

authority.

9 06/05/08 1027-Removed QS9000, add scope, change AS9100 rev A to rev B, integrate

AS9100 requirements, add sub-contract of internal audits, update

organizational chart, minor update to improve clarity

8 06/09/04 427-Update for AS9100, Risk Management & Intellectual property policies

7 10/15/03 336-Revised and updated for ISO 9001

6 04/15/02 924-Added supplemental sections 210 & 220 and updated organizational chart

5 02/15/01 844-Updated section 40 for QS-9000 requirements & update org chart

4 01/18/00 699-Removed cross reference index & reformatted document header and footer

3 12/15/99 698-Added QS-9000 requirements

2 07/07/99 624-Added GM Asia PTE LTD to company organizational chart

1 01/06/97 197-Revised sections 01, 80 & 02

NONE 05/01/96 NEW-Creation of Quality Manual

COPY DISTRIBUTION UNCONTROLLED

SECTION 1

SIGNATURE PAGE



Section # Name Page

1 SIGNATURE PAGE 1

2 TABLE OF CONTENTS 2

3 INTRODUCTION 3

4 QUALITY MANAGEMENT SYSTEM 4

5 MANAGEMENT RESPONSIBILITY 9

6 RESOURCE MANAGEMENT 15

7 PRODUCT REALIZATION 17

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 32

9 CROSS REFERENCE TO QUALITY PROCEDURES 38

SECTION 2

TABLE OF CONTENTS



OUR QUALITY POLICY

The Quality Policy of GM Nameplate is to provide products and services that meet or exceed customer

expectations every time and to continually improve in everything we do.

Using the ISO 9001:2008 Quality Management System Standard, and where applicable, Aerospace

Standard AS9100C, as our benchmarks, we employ proven quality management principles to enhance

customer satisfaction and continually improve our performance and capabilities.

Each of us will be a trained, involved and effective employee. Each of us is empowered with the

responsibility and authority to resolve issues that in any way compromise the quality of our products

and services.

We are committed to the prosperity of our customers, fellow employees, our community and our

company; we must build strong partnerships with all of them.

Using our Total Quality Management System as a tool, GM Nameplate’s management promotes ethical

compliance to applicable statutes and regulations.

SECTION 3

INTRODUCTION



General

Scope

GM Nameplate’s Quality Management System described by this Quality Manual covers the design

and manufacture of nameplates, graphic overlays, labels, panels and switches for Automotive,

Aerospace, Computer, Medical and Industrial Applications.

GM Nameplate’s Quality Management System is based on the ISO 9001:2008 standard, and where

applicable as defined in this Quality Assurance Manual, the standard AS9100 Revision C. The

requirements unique to AS9100 are denoted in this Quality Manual with the use of italic type.

Our Quality Management System is applicable as follows:

ISO 9001:2008 based requirements are applicable to our Washington, California, North

Carolina Divisions;

AS9100C based requirements are applicable to our Washington & Elite Plastics Divisions;

Design requirements are applicable to our Washington Division;

Parts Manufacturer Approval (PMA) under 14 CFR 21.303 is applicable to our Washington

Division.

Quality management issues pertaining to medical product manufacturing are covered in

the GM Nameplate medical quality system manual 01-QM-MED for Seattle Division only

and are based on specific customer requirements and not as a regulatory requirement.

As a component manufacturer with no serviceable consumer products, GM Nameplate excludes Service

Provision and Service Operations from our Quality Management System.

4.1 General Requirements

GM Nameplate has identified, established and applied the processes necessary throughout the

organization to ensure the effectiveness and continual improvement of the Quality Management

System. The control and support of these processes are assured by:

a) Determine the processes needed for the quality management system and the application throughout

the organization.

b) Determine the sequences and interactions (see process flow on following page),

c) Determine the criteria and methods to ensure operation and control of the process are effective,

d) Availability of resources and information,

e) Defined monitoring, measuring and analysis,

f) Implementation of actions necessary to achieve the planned results and to drive continual

improvement,

g) Implementation of the controls of outsourced processes that affect product quality.

SECTION 4

QUALITY MANAGEMENT SYSTEM



SECTION 4



PAGE 5 of 38



4.2 Documentation

4.2.1 General

GM Nameplate has established a comprehensive Quality Management System for the purpose of assuring the achievement of its quality policy and objectives. A five level documentation system is used to clearly communicate quality requirements.

QUALITY MANAGEMENT

SYSTEM

DOCUMENTATION

The Quality Policy is a statement of our commitment to our customers and is a driving force of our

Quality Management System. Quality Objectives are statements of measurable goals to support our

Quality Policy.

4.2.2 The Quality Manual is a brief, clear description of the Quality Management System requirements.

As a corporate document, the Quality Manual conveys quality policy to the specified divisions. The

manual provides reference to the procedures established for the Quality Management System.

The Quality Manual shows the relationship between the procedures and the requirements of the

Quality Management Standards.

Procedures are documents used to define in further detail the principles and strategies used to support

the elements of the Quality Management System. Procedures are used for groups of people allowing a

clear definition of responsibility and interfaces.

Work Instructions are the documents that provide the detailed instructions for a single operation.

They define what tasks are involved, how they are to be performed, and what reference

documentation is needed to perform the task.

Reference Documentation and

Quality Records

Work Instructions

Procedures

Quality Manual

Quality

Policy and

Objectives

SECTION 4




Reference Documentation is the documentation that needs to be consulted in order to follow a

procedure or work instruction. The most common reference documentation used at GM Nameplate is

the work order ticket (job ticket) which contains the specific requirements for each order, including

the part number, materials, specifications, drawings, schedule, stations sequences, ship date and

method, etc.

Records show evidence of meeting quality requirements and the effectiveness of the Quality

Management System.

Quality System Requirements Imposed by Regulatory Authorities are documented at divisional level

quality management system documentation as applicable to industries and customers served.

GM Nameplate personnel have access to quality management system documentation and are made

aware of procedures including changes and revisions needed to carry out their responsibilities.

Customer and regulatory authorities representatives are allowed access to GM Nameplate Quality

Management System documentation.

4.3 Control of Documents

GM Nameplate has established and maintains documented procedures to control and distribute all documents and data that relate to the Quality Management System documentation as defined in the Quality Manual. This includes controls for engineering drawings of internal origin and controls for documents of external origin such as industry and international standards, customer specifications, and customer supplied drawings. Where such documents have been determined to be necessary for the planning and operation of the quality management system.

The Quality Management System documentation is reviewed, approved, issued, maintained, and distributed in a controlled manner. This control includes:

a) Review of documents for adequacy, and approval by authorized personnel before issue,

including updates of documents,

b) A master list or equivalent document control procedure to identify the distribution and current

revision status of documents,

c) Identification of changes to documents,

d) The availability of relevant versions of applicable documents at the appropriate points of use,

e) Legibility and easy identification,

f) Prompt removal of obsolete documents from all points of issue or use, or suitably identify

and assure against unintended use.

SECTION 4




4.3.1 Control of Records

GM Nameplate establishes, maintains and controls records to provide evidence of conformance to

requirements and evidence of the effective operation of our quality management system. Documented

procedures have been established to ensure that:

a) Records are legible, readily identifiable and retrievable,

b) Controls are defined for the identification, storage, protection, retrieval, and disposition of

records,

c) PMA records will be retained for a minimum of 5 years, all other records are retained for a minimum of 3 years, or as otherwise specified by contract.

d) Where required contractually or by regulatory requirements, quality records are made available

for review by our customers and regulatory authorities.

e) Methods are defined for controlling records that are created by and/or retained by suppliers.

When forms are used as quality records, the forms shall be identified with a title, form number, revision date and/or number when applicable, or be pictured within a procedure or work instruction.

SECTION 4




5.0

5.1 Management Commitment

GM Nameplate executive management is committed to the development, implementation and

continual improvement of the Quality Management System by:

a) Communicating to all members of the organization the importance of meeting customer, statutory

and regulatory requirements,

b) Establishing the quality policy,

c) Ensuring that quality objectives are established,

d) Conducting management reviews of the Quality Management System,

e) Ensuring that the necessary resources are available.

5.2 Customer Focus

Executive management ensures that customer requirements are determined and met with the goal of

increasing customer satisfaction. Customer requirements are determined and satisfaction is measured

through our product realization and measurement, analysis and improvement processes and

procedures.

Executive management shall ensure that product conformity and on-time delivery are measured and

that appropriate actions are taken if planned results are not or will not be, achieved.

5.3 Quality Policy

Our quality policy expresses our commitment to meet or exceed customer requirements and

expectations, and to continually improve the quality of our products and services. The policy

establishes a framework by which we establish and review quality objectives, and is periodically

reviewed by executive management to ensure its continuing suitability. Executive management

ensures that the policy is communicated and understood throughout the organization.

5.4 Planning

Executive management ensures that quality objectives are established and that the Quality

Management System is planned to ensure that the quality objectives are met.

SECTION 5

MANAGEMENT RESPONSIBILITY



5.4.1 Quality Objectives

Measurable quality objectives are established at the appropriate functions throughout the organization

that are relevant in supporting the quality policy, meeting the requirements for products and

processes, improving quality and performance, and maintaining and enhancing customer satisfaction

Quality objectives include:

a) Policy objectives: These are strategic objectives that provide direction to the organization. Policy

objectives are established by top management and are communicated in the quality policy or

other policy statements.

b) Quality Management System objectives: These objectives set targets for processes and

performance of the Quality Management System. Quality Management System objectives are

established within the management review process.

c) Product quality and process performance objectives: These objectives set targets for performance

in meeting product quality requirements and for process operational performance. Product quality

and process performance objectives are initially established within the processes for product

realization. Objectives for improvement of quality and process performance are established

within the management review process.

5.4.2 Quality Management System Planning

The Quality Management System is planned to define the processes needed to meet the quality

objectives and support the quality policy. The output of Quality Management System planning

includes the Quality Assurance Manual, and the associated documented procedures and other

referenced documents.

Quality Management System planning includes:

a) Planning of the general Quality Management System. Significant changes to the Quality

Management System will be evaluated within the management review process to ensure that the

integrity of the system is maintained,

b) Planning for product realization. Responsibilities and processes for the planning of the

realization, verification, validation, monitoring and inspection of specific products are identified

in the documented quality procedures for product realization,

c) Planning for measurement and analysis. Responsibilities and processes for the planning of

measurement and analysis of product and of the Quality Management System are identified in the

documented quality procedures for measurement and analysis,

d) Planning for improvement. Responsibilities and processes for the planning of improvement

activities are identified in the documented quality procedures for continual improvement.

SECTION 5




5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

The CEO delegates to each Division President the ongoing responsibility for ensuring that the Quality Management System for each division satisfies the requirements of the appropriate Quality Management System Standard(s).

The President of each division delegates to the Quality Assurance Manager the responsibility to

maintain total compliance with the Quality Management System as well as monitor and control

product quality.

Each manager, as defined in the Organizational Structure, is responsible for the applicable quality

requirements as detailed in this manual.

The Quality manager will coordinate with Customer and regulatory authorities representative to allow

access to GM Nameplate Quality Management System, to include inspection of the Quality

Management System, facilities, technical data and any manufactured articles and witness any test

include any inspection or test at a suppliers facility necessary to determine compliance of the product

being manufactured.

Seattle Quality Manger will notify the FAA in writing of any changes to the inspection, conformity, or

airworthiness of the delivery with a PMA designated product. Any changes to the Quality

Management System will be submitted to the FAA for review and approval.

Each employee of GM Nameplate is responsible for ensuring:

a) Applicable policies and procedures are followed within their work area,

b) Any process creating non-conforming product is stopped until corrective action is taken,

c) Procedures, which are undefined or fail to satisfy customer requirements are identified for

corrective action,

d) Principles and methods of continual improvement are regularly applied to processes.

SECTION 5




SECTION 5


Corporate

Director of Quality

GM NAMEPLATE

ORGANIZATIONAL CHART

Chairman

GMN Executive

Committee

OUR CUSTOMERS

CEO

Purchasing Manager

Quality Assurance

Manager /

Management

Representative

CFO

Process Engineering

Manager

Purchasing Manager

Production Manager

INTAQ Engineering

Manager

Customer Service

Manager

Process Engineering

Manager

Process Engineering

Manager

Production Manager

Purchasing Manager

Purchasing Manager

Customer Service

Manager

Engineering Manager

Tool Room Manager

President

Washington

Division

President

California

Division

President

North Carolina

Division

President

Elite Plastics

Division

Manufacturing Manager

Director of Quality

/ Management

Representative

Quality Assurance

Manager /

Management

Representative

General Manager

Customer Service

Manager

Customer Service

Manager

Vice President

Sales and

Marketing

Marketing Manager

Quality Assurance

Manager /

Management

Representative

Corporate HR

Manager

Human Resources Specialist

Human Resources Manager



Product Line Sales

Managers

General Manager



5.5.2 Management Representative

The Quality Assurance Manager of each division of GM Nameplate serves as management representative and has the responsibility and authority for:

a) Ensuring that the requirements of the GM Nameplate Quality Manual and the processes needed

for the quality management system are implemented and maintained,

b) Reporting on the performance of the Quality Management System to executive management for

review and as a basis for improvement of the Quality Management System,

c) Ensuring that awareness of customer requirements is promoted throughout the organization.

d) The organizational freedom and unrestricted access to top management to resolve matters

pertaining to quality.

5.5.3 Internal Communication

Executive management ensures that processes for communicating information concerning the

Quality Management System are established throughout the organization. Communication

includes information regarding:

a) Quality policies,

b) Quality objectives and requirement,

c) Effectiveness of the Quality Management System.

Communication between functions performing specific Quality Management System activities is

defined in the documented procedures for those activities. Communication methods also include:

a) Management-led employee meetings,

b) Training sessions,

c) Internal publications, bulletin boards, email.

SECTION 5




5.6 Management Review

5.6.1 General

The Quality Management System is reviewed by executive management on a continual basis through quality and performance reports and through management review meetings held at defined intervals sufficient to evaluate the status, suitability and effectiveness of the Quality Management System. Opportunities for improvement are reviewed and the Quality Management System, including the quality policy and quality objectives, will be reviewed for a need for change.

The assigned management representative for each division schedules and maintains records of

each Management Review Meeting.

Continual Management Review of quality and performance reports include the review of monthly product nonconformance reports, a Pareto analysis by reject category report, on-time delivery reports and customer complaint reports.

5.6.2 Inputs to the Management Review Meetings include information related to the following:

a) The results of internal quality audits,

b) The results of second and third party quality audits,

c) Customer feedback, including complaint reports and surveys,

d) Product quality and process performance,

e) Status of corrective and preventive actions,

f) Supplier performance,

g) On-time delivery performance,

h) Follow-up action items from previous meetings,

i) Opportunities and recommendations for improvement,

j) Any changes that could affect the Quality Management System.

5.6.3 Output of the management review meetings includes decisions and action items related to:

a) Improvement of the effectiveness of the Quality Management System, including objectives for

system and product quality and process performance,

b) Improvement of products in relation to customer requirements,

c) The need for resources to achieve objectives.

SECTION 5




6.0

6.1 Provision of Resources

GM Nameplate determines and provides the resources required to implement, maintain and

continually improve the Quality Management System and to enhance customer satisfaction by

meeting customer requirements.

6.2 Human Resources

All personnel performing work affecting conformity to product requirements shall be competent on

the bases of appropriate education, training, skills and experience as needed to successfully fulfill

their responsibilities.

Company-Wide Training

All employees receive an introduction to the GM Nameplate quality policy and company objectives

by a senior manager during New Employee orientation to train and motivate them. In addition,

intensive quality training sessions are presented during the orientation period covering topics such as:

The Quality Policy Why quality matters

What is a Quality Management System Employee involvement in quality

Internal and external customers Continual improvement

ISO 9001:2008, and where applicable, AS9100C requirements

Departmental Training

Each departmental supervisor or manager is responsible for identifying the training needs and

providing for training of all personnel performing activities affecting conformity to product

requirements.

Personnel performing specific assigned tasks are qualified by their managers based on the appropriate

education, training or experience, as required. A training certification process is used to train, certify

and record that employees have been properly trained to documented process and quality procedures

within the scope of the Quality Management System.

Training Effectiveness

Training is periodically evaluated to assess its effectiveness in meeting goals and requirements.

Methods used to evaluate training effectiveness include internal and external audits, employee

performance reviews, and quality and productivity data.

Records

The appropriate records of training, education, skills and experience are maintained by the Human

Resources Department.

SECTION 6

RESOURCE MANAGEMENT



6.3 Infrastructure

The infrastructure needed to assure conformance to quality requirements is determined, provided and

maintained. Infrastructure includes, as applicable:

a) Buildings, workspaces and associated utilities,

b) Process equipment (hardware and software),

c) Supporting services (communication, transport, etc.).

6.4 Work Environment

A suitable work environment is provided to ensure that conformity to product requirements are achieved.

Work environment requirements are established during product realization planning. Considerations are

given to both human and physical factors that can affect product conformity. Factors to be considered

include:

a) Safety rules, including the use of protective equipment,

b) Ergonomics,

c) Temperature, humidity, light, air flow, protection from ESD,

d) Cleanliness, pollution, noise, hazardous materials,

e) Compliance will all relevant standards, codes, laws,

f) Methods to enhance employee involvement, motivation and satisfaction, such as recognition

programs.

SECTION 6

RESOURCE MANAGEMENT



7.0

7.1 Planning of Product Realization / Project Management

GM Nameplate plans and develops processes for the realization of our products. In planning product

realization, the following are determined:

7.1.1

a) The quality requirements and objectives for the product,

Note: This includes consideration of aspects such as;

Product and personnel safety,

Reliability, availability and maintainability,

Producibility and inspectability

Suitability of parts and materials used in the product,

Selection and development of embedded software, and

Recycling or final disposal of the product at the end of its life

b) The processes and resources needed for the product. This includes any supporting processes and

resources needed, such as training, maintenance and information management.

c) The verification, validation, monitoring, inspection and test activities and the acceptance criteria

required to assure the quality of the product,

d) The documentation needed to define the quality requirements and support and control the

processes,

e) The records needed to provide evidence that the processes and the product meet the

requirements,

f) Configuration management appropriate to the product.

g) Where required by contract, the identification of resources to support operation and

maintenance of the product.

The primary output of product realization planning is the work order job ticket, which includes the basic

manufacturing and quality plan. Output may also include additional work instructions, inspection and test

plans, project plans and control plans.

7.1.2 Risk Management

GM Nameplate maintains a policy to ensure the active identification, analysis, control and

monitoring of business risks, and to develop proactive avoidance/mitigation plans. This policy

applies to both strategic and individual project levels.

At the strategic level, a formal assessment of business risks is performed during the course of the

annual meeting of the Executive Committee, and during monthly Division President meetings. The

Executive Committee and the Division Presidents are responsible for identifying, analyzing,

controlling and monitoring business risks

SECTION 7

PRODUCT REALIZATION



At the individual project level, each project is assessed for risks during the quoting and planning

stages by engineering and other functions as required. Each GM Nameplate division maintains

procedures that define responsibilities for identifying, analyzing and acting on risks associated with a

project.

7.1.3 Configuration Management

Configuration management is controlled through drawings and revision levels, and through

processes for product/lot identification and traceability, change control, and records of the

differences between the actual and the planned configuration.

7.1.4 Control of work Transfers

The process for work transferred outside of GM Nameplate’s facilities is defined to control the work

and to validate the conformity of the work.

7.2 Customer-Related Processes

Systems and processes are maintained to ensure that requirements related to the product are

determined and reviewed, and that customer communication is effective.

7.2.1 Determination of Requirements Related to the Product

Requirements related to the product are determined during Request for Quotation (RFQ) and Contract

Review processes, involving Sales, Design Engineering, Process Engineering, Customer Service and

other functions as appropriate. Identified are:

a) Requirements specified by the customer, including delivery and post-delivery requirements,

b) Requirements not specified by the customer but necessary for the specified or intended use of

the product,

c) Requirements related to statutory and regulatory requirements,

d) Any additional requirements identified by GM Nameplate.

SECTION 7

PRODUCT REALIZATION



7.2.2 Review of Requirements Related to the Product

Requirements related to the product are reviewed during Request for Quotation and Contract Review

processes prior to our commitment to supply a product to the customer. The Customer Service

organization is responsible to review or coordinate the review of request for quotations, purchase orders

and contracts. The Contract Review process will ensure that:

a) Customer and product requirements are adequately defined and documented. Where no written

statement of requirement is available, GM Nameplate will ensure that the order requirements are

confirmed and agreed before acceptance,

b) Any differences in the requirements are resolved,

c) GM Nameplate has the capability to meet contractual requirements,

d) Special requirements of the product are determined,

e) Risks have been evaluated (e.g., new materials, processes, technology; short time schedules),

Records of contract review are maintained.

When product or contract requirements are changed, amendments are made to the relevant documents and

are transferred to the concerned functions within the organization. These processes are defined in

documented procedures.

7.2.3 Customer Communication

GM Nameplate establishes effective methods of communication with our customers, including

determining customer requirements, product information, handling of customer inquiries, orders and

contracts, and customer feedback including customer complaints.

Customer Intellectual Property Rights

GM Nameplate maintains polices that protect against infringement on intellectual property rights. Our

policies include:

a) Before any order is accepted, a thorough background check of the customer is made.

b) No product is built for anyone other than the original ordering customer without written consent

from the ordering customer.

c) No artwork paid for by one customer can be used by any other customer without written consent

from the original ordering customer.

d) No customer can order a product built with another company’s logo or design without written

consent from that company.

SECTION 7

PRODUCT REALIZATION



e) All plants have controlled access utilizing a security badge system. Entrance by other than an

authorized employee is attained by going through the receptionist. Guests permitted in the plant

must register and be escorted.

f) We regularly sign confidentiality agreements with customers wishing confidentiality on specific

or all projects, and then do what is required to ensure that confidentiality.

g) Our patent and intellectual property attorney reviews any new product in development. Any time

we have reason to question potential intellectual property matters they are our advisors.

h) In addition to all of the above, orders are accepted only on the basis that the customer guarantees

the legal propriety of all matters submitted and will indemnify GM Nameplate against all claims

and responsibility arising from the manufacture of such matters.

7.3 Design and Development

General

GM Nameplate receives product requirements from customers in the form of completed drawings

and specifications for many of the parts we manufacture. For electronic touch devices, however,

identified as the INTAQ product line, product requirements are supplied partially in terms of

drawings and specifications, and partially in terms of performance criteria. This leaves the

responsibility for creating a complete, final design to the INTAQ design function. An emphasis on

customer satisfaction, delivering a superior design at an acceptable price, and the allowance for a

satisfactory return for the company has directed the establishment of systems and procedures for

design and development.

The Design Engineering Manager is responsible to establish and maintain documented procedures for

design and development.

7.3.1 Design and Development Planning

Design and development projects are planned and controlled. Design and development planning

includes determination of the following:

a) The design and development stages needed for the project,

b) The review, verification and validation that are appropriate to each design and development

stage,

c) The responsibilities and authorities for design and development.

SECTION 7

PRODUCT REALIZATION



d) For complex projects, consideration is given to:

Structuring the design project into significant elements,

For each element, analyzing the tasks and the necessary resources for its design and

development. The analysis considers the identification of a responsible person, design content,

input data, planning constraints, and performance conditions. The input data specific to each

element is reviewed to ensure consistency with requirements.

The interfaces between the different groups involved in the design and development processes are

defined in the design and development procedures to ensure effective communication and clear

assignment of responsibility.

Design and development plans are updated as appropriate as the design and development project

evolves.

The different design and development tasks are defined according to the specified safety or functional

objectives of the product in accordance with any customer or regulatory authority requirements.

Design and development planning shall consider the ability to produce, inspect and maintain the

product.

7.3.2 Design and Development Inputs

Design inputs related to product requirements are identified, documented and reviewed for accuracy.

Any incomplete, ambiguous or conflicting requirements are resolved with those responsible for

imposing the requirements. Design inputs include:

a) Functional and performance requirements,

b) Statutory and regulatory requirements,

c) Any applicable information from previous similar designs,

d) Other requirements essential for design and development.

7.3.3 Design and Development Outputs

Completed design and development outputs consist of drawings, specifications and instructions for

the detail requirements including material, manufacturing and operational characteristics, which allow

verification against the design and development inputs. The outputs are approved prior to release.

Design and development outputs:

a) Meet the input requirements for design and development,

b) Provide appropriate information for purchasing, production and service provision (if required),

SECTION 7

PRODUCT REALIZATION



c) Contain or reference acceptance criteria,

d) Specify the characteristics of the product that are essential for its safe and proper use,

e) Identify critical items including key characteristics, in accordance with design or contract

requirements and specific actions to be taken for these items.

f) Define the pertinent data required to allow the product to be identified, manufactured,

inspected, and if required by contract, used and maintained. These data may typically include:

Drawings, component lists and specifications,

A listing of those drawings, component lists and specifications necessary to define the

configuration and the design features of the product,

Information on material, processes, type of manufacturing and assembly of the product to

ensure the conformity of the product to the requirements.

7.3.4 Design and Development Review

At appropriate stages, systematic reviews of design and development are performed in accordance

with the design and development plan. Design and development reviews include representatives of all

functions concerned with the design and development stage being reviewed. Design and development

reviews will:

a) Evaluate the ability of the results of design and development to meet the requirements,

b) Identify any problems and propose necessary actions,

c) Authorize progression to the next stage.

Records of design and development reviews and any necessary actions are maintained

7.3.5 Design and Development Verification

During the design and development process, verification is performed according to the design and

development plan to ensure that the design and development outputs meet the input requirements.

Verification is performed by design engineering, the customer and other functions as appropriate.

Records of the results of the design and development verification and any necessary actions are

maintained.

SECTION 7

PRODUCT REALIZATION



7.3.6 Design and Development Validation

Design and development validation is performed according to the design and development plan to

ensure that the resulting product is capable of meeting the requirements for the specified application

or use. Since the conditions of use and applications of product vary beyond GM Nameplate’s control,

our customers typically perform design validation to determine the suitability of the product for their

specific applications. Design validation of INTAQ products is normally accomplished as part of a

prototype approval process or a first article approval process where the customer validates the design

and GM Nameplate warrants that the product conforms to its written and/or published specifications.

Product for validation purposes is made available to the customer when specified in purchase order or

contract requirements. Where possible, validation will be completed prior to the delivery or

implementation of the product. Records of design and development validation and any necessary

actions are maintained.

Design and Development Verification and Validation Testing

Where tests are necessary for design and development verification and validation, they are planned,

controlled, reviewed and documented to ensure and prove the following:

a) Test plans or specifications identify the product being tested and the resources being used,

define test objectives and conditions, parameters to be recorded, and relevant acceptance

criteria,

b) Test procedures describe the method of operation, the performance of the test, and the recording

of the results,

c) The correct configuration standard of the product is submitted for the test,

d) The requirements of the test plan and the test procedures are observed,

e) The acceptance criteria are met.

Documentation of Design and Development Verification and Validation

Upon completion of design and development projects, all reports, calculations, test results and other

documentation are reviewed to ensure that the product design meets the specifications for all

operational conditions.

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PRODUCT REALIZATION



7.3.7 Control of Design and Development Changes

Documented procedures are maintained for the identification, documentation, review, verification,

validation as appropriate, and approval of design and development changes. The review of design and

development changes includes evaluation of the effect of the changes on component parts and on

product already delivered.

When required by contract or regulatory requirements, changes are approved by customer and/or

regulatory authority.

Records of the results of changes and actions are maintained.

7.4 Purchasing

7.4.1 Purchasing Process

GM Nameplate ensures that all purchased goods and services utilized in the manufacture of GM

Nameplate products conform to specified requirements. Through a controlled purchasing process and

close working relationships with our key suppliers, materials are purchased at the best possible

quality, cost and delivery.

Suppliers are selected on the basis of their ability to meet specified requirements, including quality

requirements. The criteria for selection, evaluation and re-evaluation are established, with input from

Design Engineering, Process Engineering and Quality Assurance required for major commodity

supplier-base changes or additions, as appropriate. Records of the results of evaluations and any

necessary actions are maintained. Purchasing and Quality Assurance maintain procedures for routine

supplier rating and take appropriate actions when supplier performance improves or declines. Such

action may be reduced or increased appraisals, audits of the supplier Quality Management System, or

disqualification of the supplier.

GM Nameplate is responsible for the quality of all products purchased from suppliers, including

customer-designated sources.

Purchasing maintains a list of suppliers, including each supplier’s approval rating and performance

record. The scope of a supplier’s approval is defined through approval levels by part number.

Purchasing and Quality Assurance periodically review supplier performance. Records of the reviews

to provide a basis for establishing the level of controls required.

Purchasing and Quality Assurance maintain procedures that define actions to be taken when supplier

performance does not meet requirements. Authorities responsible for approving suppliers have the

authority to disapprove the use of suppliers.

Process Engineering and Purchasing maintain procedures that ensure that where required,

customer-approved suppliers are used, including special process sources.

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PRODUCT REALIZATION



Define the process, responsibility and authority for approval status decision, changes of the approval

status and conditions for controlled use of suppliers depending on the suppliers approval status

Determine and manage the risk when selecting and using suppliers

7.4.2 Purchasing Information

Purchasing documents contain the information necessary to describe the product to be purchased, and

are reviewed for adequacy prior to their communication to the supplier. Purchasing information

includes, where appropriate:

a) Requirements for the approval of product, procedures, processes and equipment,

b) Requirements for qualification of personnel,

c) Quality Management System requirements.

d) Identification and revision status of the product, and all applicable specifications, drawings and

other relevant data,

e) Requirements for design, test, inspection, verification, statistical techniques and related

instructions required for acceptance, and as applicable critical items and key characteristics.

f) Requirements for test samples, for design approval, inspection/verification, investigation or

auditing.

g) Requirements regarding the need for the supplier to notify GM Nameplate of;

nonconforming product, including arrangements for approval of supplier nonconforming

product,

Obtain approval for nonconforming product disposition

Requirements for supplier notification of GM Nameplate of changes in product or process,

change of suppliers, change if manufacturing location and where necessary, obtaining

approvals,

Requirements for the supplier to flow down the applicable requirements to sub-tier suppliers.

h) Record retention requirements

i) The right of access by GM Nameplate, our customers, and regulatory authorities to the

supplier’s and all sub-tier suppliers facilities and all records involved in the order,

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PRODUCT REALIZATION



7.4.3 Verification of Purchased Product

Purchased product is verified to ensure that it meets the specified purchase requirements. Verification

may include inspection, review of data, and other activities on the part of the GM Nameplate or our

supplier. Where GM Nameplate or our customer intends to perform verification at the supplier’s

premises, the intended verification arrangements and methods are stated in the purchase order.

Purchasing and Quality Assurance maintain procedures to verify purchased product. Purchased

product is not used or processed until it has been verified as conforming to requirements, except

where released under positive recall procedure.

Where GM Nameplate delegates verification to the supplier, procedures will define the requirements

for delegation and include a list of delegations.

When required by contract, our customers or their representative are afforded the right to verify

product at our supplier’s facility and at our facility. Verification by our customer is not used by GM

Nameplate as evidence of effective control by the supplier, and does not absolve GM Nameplate of

the responsibility to provide acceptable product nor preclude rejection by our customer.

7.5 Production

GM Nameplate has developed processes and procedures to ensure that all aspects of production

activities are controlled and validated, and that product is properly identified and protected

throughout manufacturing and delivery.

7.5.1 Control of Production

Procedures are maintained for planning and carrying out production under controlled conditions,

including:

a) Product characteristics information is provided that describe the characteristics of the product,

b) Work instructions describing the performance of the process are available as necessary to ensure

safety, quality, and compliance with regulatory requirements,

c) Equipment suitable for the production of the product or performance is used,

d) Availability and use of monitoring and measuring equipment is used to monitor and measure

processes and product,

e) Implementation of monitoring and measuring equipment is used to monitor and measure

processes and product,

f) Release and delivery activities are defined for the release and delivery of the product, and where

applicable, post-delivery activities,

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PRODUCT REALIZATION



g) Accountability is maintained of all product during manufacturing,

h) Evidence that all production and inspection/verification operations have been completed as

planned, of as otherwise documented and authorized

i) Provisions for the prevention, detection and removal of foreign objects

j) Utilities, such as water, compressed air, electricity and chemical products, are monitored and

controlled where they affect product quality

k) Criteria for workmanship are provided in the clearest practical way,

Process controls and control plans are established where key characteristics have been

identified,

In-process verification points are identified when adequate verification of conformance

cannot be performed at a later stage of production,

Tooling is designed, manufactured and used so that variable measurements of the product

can be made, particularly for key characteristics,

Special processes, where the resulting output cannot be verified by subsequent monitoring

and measurement, are validated,

Product Process Verification

When GM Nameplate is required to demonstrate product qualification, records provide evidence that

the product meets the defined qualification requirements.

Processes are defined for the inspection, verification and documentation of a sample of the first

production run on a new part, and when changes are implemented that invalidate the previous first

article inspection result. First article inspection is performed in accordance with SAE AS9102 or

equivalent standard unless otherwise specified by the customer.

Control of Production Process Changes

Production Process Changes are controlled by documented procedures. These procedures identify those

personnel who are authorized to approve production processes changes, and define the documentation,

implementation and assessment of the effect on quality of process changes.

Where required by contract, GM Nameplate notifies our customer and obtains approval of process

changes prior to implementation of change.

Control of Production Equipment, Tool and Software Programs

Production Equipment, Tools and Numerical Control Machine Programs are validated before use. A

first article inspection process is used as a method of validation. Documented procedures define

periodic evaluation and maintenance requirements. Periodic checks are defined where production

equipment and tooling is kept in storage, storage requirements and periodic checks are defined.

Post-Delivery Support does not apply. GM Nameplate does not perform post-delivery support at this

time.

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PRODUCT REALIZATION



7.5.2 Validation of Processes

Processes where the output cannot be verified by subsequent monitoring or measurement are

validated. This includes any processes where defects become apparent only after the product is in use

or has been delivered. These processes are referred to as special processes.

Validation of special processes demonstrates the ability of the process to achieve the planned results.

Requirements for validation and operation of special processes include:

a) Defined criteria for the review and approval of special processes,

b) Approval of equipment and qualification of personnel

c) Use of specific methods and procedures,

d) Requirements for records,

e) Revalidation of the process as necessary.

7.5.3 Identification and Traceability

Product is identified and traceability maintained throughout the manufacturing cycle. Procedures are

maintained to provide for:

a) Identification of raw materials and purchased components, including those stored in inventory or

released to work orders. Traceability of key raw materials and purchased components, as defined

by GM Nameplate procedures, is maintained.

b) Identification of each production order with a unique number that serves as a lot number. The

product and its associated work order ticket are identified with this number throughout

production, inspection and test, packaging and shipment.

c) The status of product with respect to inspection and test requirements is maintained to ensure

that only product that has passed all of the planned inspection and test activities is available for

shipment,

d) Order tracking, accomplished with a barcode routing system recording order movement from

station to station,

e) Upon completion of production, products are packaged and identified by customer purchase

order number and part number.

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PRODUCT REALIZATION



f) Maintenance of the identification of the configuration of the product through work order tickets

and controlled drawings, specifications and other documentation. Records are maintained to

document any differences in the actual configuration and the agreed upon configuration.

g) Documented procedures and controls where acceptance authority media are used (stamps,

electronic signatures or passwords, etc.

According to the level of traceability required by contract, regulatory, or other established

requirement, GM Nameplate will also provide for the following levels of traceability:

h) Identification of the product so that the identification and traceability are maintained

throughout the product life,

i) Traceability of all of the products manufactured from the same batch, including the destination

(delivery, scrap) of all of the products from the same batch,

j) Traceability of components in an assembly,

k) A sequential record of the manufacturing and inspection processes used in the production of the

product.

7.5.4 Customer Property

GM Nameplate occasionally works with customer owned and supplied materials and equipment, and

also intellectual property (e.g., specifications, drawings, digital media and personal data). Customer

property is verified, stored and maintained as specified by the customer or, when not specified, in the

same manner as GM Nameplate property. Any property that is lost, damaged or otherwise found to be

unsuitable for use shall be reported to the customer and records maintained.

7.5.5 Preservation of Product

Procedures are maintained for preserving the quality of products from the time of receipt through

delivery to our customers.

Requirements for preservation of product are consistent with product specifications and contract

and regulatory requirement.

Procedures include provisions for:

a) Identification – Product will be identified as required to prevent damage and deterioration. This

will include appropriate identification of shelf life and expiration of age-sensitive products and

identification of ESD sensitive product.

Identification will also include any appropriate warnings to ensure the safety of personnel.

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PRODUCT REALIZATION



b) Handling – Use of appropriate methods and means of handling all products to prevent damage

and deterioration.

Special handling methods, cleaning, hazardous materials and for products that are

especially sensitive to damage and deterioration, including ESD sensitivity, are provided.

c) Storage - Designated storage areas and stock rooms are used, where required, to prevent damage

or deterioration of products pending use or delivery. Age sensitive products are identified,

rotated and periodically verified to prevent usage after the expiration date. The condition of

products in stock or storage is assessed at appropriate intervals to detect deterioration.

Where appropriate, cleaning procedures will be used to ensure the quality of the product.

d) Packaging - Control of the packaging process for products, including the use of specified

materials, markings and identification, and documented packaging methods.

e) Delivery – Assurance that the quality of all products continues to be adequately protected after

completion of manufacture. All products are adequately and appropriately packed and shipped to

protect them from damage or deterioration during delivery to their destination.

Procedures also ensure that documents required to accompany the delivered product are

present at delivery and are protected against loss and deterioration.

f) Provisions for prevention, detection and removal of foreign objects throughout the handling,

storage, packaging and delivery processes.

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PRODUCT REALIZATION



7.6 Control of Monitoring and Measuring Devices

Monitoring and measuring requirements, the monitoring and measuring devices needed to provide

evidence of conformity, and the methods for carrying out monitoring and measurement activities

consistent with the requirements are determined during planning of product realization.

Equipment that is controlled includes equipment that is employee owned or customer supplied. It also

includes equipment such as fixtures and templates.

A list of the monitoring and measurement equipment is maintained, and the processes for calibration

are defined. These include details of the equipment type, unique identification, location, frequency of

checks, check method and acceptance criteria.

Procedures have been established to:

a) Ensure inspection, measuring and test equipment is capable of the accuracy and precision

necessary and is suitable for its intended use,

b) Calibrate or verify inspection, measuring and test equipment at specified intervals, or prior to

use, and adjust if necessary. Where feasible, equipment is calibrated to known standards,

traceable to the National Institute of Standards and Technology (NIST) or equivalent. Where no

such standards exist, the basis used for calibration is documented.

c) Identify each item of inspection, measurement and test equipment, including a unique

identification number and the calibration status,

d) Safeguard inspection, measurement and test equipment from adjustments that would invalidate

the measurement results,

e) Protect inspection, measurement and test equipment from damage and deterioration during

handling, maintenance and storage,

f) Ensure that computer software used to monitor and measure specified requirements has the

ability to meet its intended application. This is confirmed prior to initial use and reconfirmed as

necessary to ensure continued ability.

g) Assess and document the validity of product tested with equipment found to be out of

calibration, and take corrective action, as required.

h) Provide for records of calibration.

i) Ensure that environmental conditions are suitable for calibrations, inspections, measurements

and tests,

j) Define the method for recall of inspection, measuring and test equipment when requiring

calibration.

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PRODUCT REALIZATION



8.0

8.1 General

The appropriate processes and methods for monitoring, measurement and analysis are determined

during product realization and improvement processes, including the use of statistical techniques, to:

a) Demonstrate the conformance of product requirements,

b) Ensure the conformance of our Quality Management System,

c) Continually improve the effectiveness of the Quality Management System.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

GM Nameplate monitors information related to our customer’s perception as to whether we have met

their requirements. Documented procedures define the methods for obtaining and using this

information. Methods include:

a) Customer surveys. Corporate Sales and Marketing coordinates with each division of GM

Nameplate to perform annual customer surveys,

b) Customer feedback and complaints. A customer comment form is maintained on the GM

Nameplate website. Customer complaints received through other means are recorded in a

customer complaint log,

c) Rates of customer-returned product,

d) Customer-supplied performance reports.

8.2.2 Internal Audit

Internal audits are conducted to determine if the Quality Management System conforms to the

requirements of the ISO 9001:2008 quality standard, to the AS9100C quality standard where

applicable, to the plans for product realization, and to the defined GM Nameplate Quality

Management System requirements; and to determine if it is effectively implemented and maintained.

Internal audits will also meet any additional contract or regulatory requirements.

Audits are conducted to determine compliance to the Quality Manual requirements. In addition, audit

plans and schedules are also based on considerations of the importance of processes to the objectives

of GM Nameplate, and the results of previous audits.

Audits are carried out by competent, trained personnel who are not directly responsible for the audited

activity. Auditors do not audit their own work. The Quality Assurance Manager may delegate an audit to

any responsible employee of the company. The Quality Assurance Manager may also subcontract internal

audits to a qualified third party organization.

SECTION 8

MEASUREMENT, ANALYSIS AND IMPROVEMENT



The Quality Assurance Manager is responsible to establish and maintain documented procedures to

define the planning, performance, reporting and recording of internal audits and internal audit

corrective actions.

Departmental managers are responsible for the timely corrective action of any deficiencies found by

the internal audits.

8.2.3 Monitoring and Measurement of Processes

Quality Management System processes are monitored and measured. Monitoring and measurement

demonstrate the ability of the processes to achieve the planned results. Methods used to monitor and

measure processes include:

a) Customer satisfaction measurements,

b) Internal audits,

c) Product quality performance measurements,

d) Process efficiency measurements,

e) On-time delivery performance.

Corrections and corrective actions are taken commensurate to the effect of the process

nonconformance on the conformity of the product when the processes do not achieve the planned

results. Actions are addressed as defined in the corrective and preventive action and continual

improvement sections of this Quality Manual.

In the event of process nonconformity, actions are taken to correct the process, and determine,

identify and control any nonconforming product that has resulted.

Determine if process nonconformity is limited to a specific case or whether it could have affected

other process or product.

SECTION 8




8.2.4 Monitoring and Measurement of Product

Product characteristics are monitored and measured to verify that product requirements have been

met. An appropriate selection of both variable and attribute characteristics are monitored and

measured at locations established during the planning of product realization processes. Work

instructions specify inspection at each location. The work order ticket and part drawings convey

product specific inspection requirements.

Records are maintained as evidence of conformity with the acceptance criteria. The records clearly

show whether the product has been accepted or rejected by inspection or test according to the defined

acceptance criteria. Records identify the person authorizing release of the product.

Product is not released until all of the planned activities for product realization have been

satisfactorily completed, unless approved by a person with authority as specified by the Quality

Management System procedures. Where required by contract, customer approval will be obtained.

Where key characteristics have been identified, they are monitored and controlled.

Sampling inspection plans used for acceptance of product are statistically valid and are appropriate

for the application. Sampling plans do not allow acceptance of lots whose samples have known

nonconformities. When required by contract, sampling plans will be submitted to the customer for

approval.

Standard procedure is to verify that product meets specified requirements prior to use. In special

situations, product may be released prior to verification in accordance with documented positive

recall procedures pending completion of all required inspections.

The measurement requirements for products are documented in the work instructions, work order or

other suitable media. The documentation includes criteria for acceptance and/or rejection, where in

the sequence the measurements are to be performed, records of the measurement results, and the type

of measurement instruments required and any specific instructions for their use.

Test records show actual test results when required by the specifications and test plans.

When GM Nameplate is required to demonstrate product qualification, records provide evidence that

the product meets the defined qualification requirements.

SECTION 8




8.3 Control of Nonconforming Product

Documented procedures define the control of product that is found nonconforming, detected at any

stage of manufacturing from incoming inspection through shipping, and product returned by the

customer. These procedures and controls prevent the unintended use or delivery of nonconforming

product, including raw materials, components, subassemblies and end items.

Documented procedures include requirements for the following:

a) Clear identification of product deemed to be nonconforming,

b) Defined responsibilities and authorities for review and disposition of nonconforming product,

c) Disposition options, in one or more of the following ways:

Taking action to eliminate the nonconformity,

Authorizing its use, release or acceptance under concession by the defined authority and,

where applicable, by the customer,

Taking action to prevent its original use or application,

By taking actions necessary to contain the effect of the product nonconformity on other

processes or product

Nonconforming product is not dispositioned use-as-is or repair when the product is produced

to customer design, or the nonconformance results in a departure from the contract, unless

authorized by the customer,

GM Nameplate-designed product which is controlled by a customer specification may be

dispositioned use-as-is or repair when the nonconformity does not result in a departure from

the customer-specified requirements,

Product dispositioned as scrap is conspicuously and permanently marked, or positively controlled,

until physically rendered unusable.

d) Considerations for any contractual obligations with the customer,

e) Reinspection of reworked product in accordance with documented procedures to verify that it

meets requirements,

f) Actions when nonconforming product is detected after delivery or use. Actions will be

appropriate to the effects and potential effects of the nonconformity, and in consideration of

customer requirements,

Delivered nonconforming product is reported to the customer in a timely manner. The notification

includes a description of the nonconformity, the parts affected, customer and/or GM Nameplate part

numbers, quantity and date(s) delivered.

g) Records of nonconformities and subsequent actions taken, including concessions obtained.

SECTION 8




8.4 Analysis of Data

Data is collected and analyzed to evaluate the suitability and effectiveness of the Quality

Management System and for identifying opportunities for preventive action and improvement.

Categories of data collected and analyzed include:

Product Quality – Quality Assurance ensures that quality data, including the costs of

nonconformance, are collected and reported. Quality reports are reviewed by executive and

departmental management. Quality data are also analyzed for trends and presented in Management

Review meetings by Quality Assurance.

Process Performance – Data related to process performance, including variations from planned

efficiencies and schedules, are collected and reviewed by department managers. Performance and

trends are compared to appropriate goals and company benchmarks. Department managers analyze

variances, identify problems and implement solutions to maintain performance goals and improve

performance.

Supplier Performance – Purchasing and Quality Assurance ensure that supplier performance data are

collected and reported. Performance data include on-time delivery and conformance to quality

requirements. Purchasing and Quality Assurance analyze supplier performance and take appropriate

actions to maintain and improve performance goals.

Customer Satisfaction – Data related to customer satisfaction levels and complaints are collected by

Sales and Marketing, Customer Service and Quality Assurance, and reviewed by executive

management.

8.5 Improvement

8.5.1 Continual Improvement

Continual improvement of the Quality Management System is driven through the quality policy and

quality objectives. Opportunities for improvement are identified through management review, audits,

corrective and preventive action processes, and analysis of the system. Improvements shall be

monitored and evaluated for effectiveness

8.5.2 Corrective Action

Corrective actions are taken to eliminate the cause of nonconformities in order to prevent recurrence.

The need for corrective action, actions considered and actions implemented are commensurate with

the magnitude and risks associated with the nonconformities.

Documented procedures for corrective action include the following areas:

Supplier Corrective Action – Procedures for supplier corrective action are used to coordinate

corrective action with suppliers when purchased product or service related nonconformities occur.

SECTION 8




Product Quality Corrective Action – Corrective action procedures are used to identify, and record

nonconformities as related to products and processes, including customer complaints.

Internal Quality Audit Corrective Action – As a result of internal quality audit findings, corrective

action procedures are used to record and correct nonconformities.

The procedures for corrective action define the following:

a) Determination of the cause of nonconformities relating to product, process, and Quality

Management System,

b) Evaluating the need for corrective action to ensure the nonconformities do not recur,

c) Determination and implementation of the corrective action,

d) Reviews to ensure that corrective action is taken and that it is effective,

e) Records of the results of the investigation and actions taken,

f) Flowing down corrective action requirements to suppliers, where the supplier is responsible for

the root cause,

g) Specific actions where timely and/or effective corrective actions are not achieved.

h) Determining if additional nonconforming product exists based on the causes of the

nonconformities and taking further actions when required

8.5.3 Preventive Action

Preventive actions are taken to prevent potential nonconformities. Actions taken are appropriate to the

effects of the potential problems. The determination of need for preventive action includes review and

analysis of processes, quality data, trends, customer complaints and feedback, and audit results.

Documented procedures for preventive action include:

a) Determining potential nonconformities and their causes,

b) Evaluating the need for action to prevent occurrence of nonconformities,

c) Determining and implementing action needed,

d) Records of the results and action taken,

e) Review of the effectiveness of the preventive action taken.

SECTION 8




QUALITY MANUAL QUALITY PROCEDURE

Section Number 40: Quality Management System QP-40.1 Document Control

QP-40.2 Control of Quality Records

QP-40.3, Parts Manufacturer Approval1

Section Number 50: Management Responsibility QP-50.1 Management Review

Section Number 60: Resource Management QP-60.1 Training and Awareness

Section Number 70: Product Realization QP-70.1 Product and Process Planning and Control

QP-70.2 Customer Requirements and Communication

QP-70.3 Design and Development

QP-70.4 Purchasing

QP-70.5 Identification and Traceability

QP-70.6 Customer Property

QP-70.7 Preservation of Product

QP-70.8 Control of Monitoring and Measurement

Devices

QP-70.9 Manufacturing Process and Specification

Change Control1

Section Number 80: Measurement, Analysis and

Improvement

QP-80.1 Customer Satisfaction

QP-80.2 Internal Quality Audits

QP-80.3 Monitoring and Measuring of Product

QP-80.4 Control of Nonconforming Product

QP-80.5 Continual Improvement

QP-80.6 Corrective and Preventive Action

1 Washington Division application only

SECTION 9

CROSS REFERENCE TO QUALITY PROCEDURES