00-qm-01 quality manual rev. 17...• graphic products: graphic overlays, labels, and nameplates....

QUALITY MANUAL

SECTION 1: SIGNATURE PAGE

00-QM-01 Rev. 17 PAGE 1 of 34

APPROVALS: (Approvals are electronically recorded in the eQMS.)

CEO/President – California Division: Bruce Cleckley President – Washington Division: Brad Root President – North Carolina Division: Jack Sharrett President – Elite Plastics, Oregon Division: Dan Thurmond Corporate Director of Quality & Regulatory Affairs: Martin Espinola Corporate Quality Systems Manager: Autumn Santa Ana DESCRIPTION OF CHANGES FROM LAST REVISION: (Revision history is electronically recorded in the eQMS.)

Section 4.0:

• Added a company introduction section.

• Changed scope statement.

• Clarified application and exclusions.

• Excluded 7.3 Design and development.

Section 4.1:

• Added …“customer, statutory, regulatory requirements…” to first paragraph.

• Changed ‘Typical Process Flow’ to ‘GMN Core Processes’ and ‘GMN Process SIPOC’.

Section 5.4.1:

• Added Corporate Quality oversight structure.

Section 7.1.3:

• Clarified that the customer has responsibility for configuration management.

Section 7.3:

• Removed section 7.3 from the QMS, including reference to 00-QP-7.3 from section 7.0 reference documents section.

QUALITY MANUAL

SECTION 2: TABLE OF CONTENTS

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Section Page

1 SIGNATURE PAGE………………………………………………………………1

2 TABLE OF CONTENTS………………………………………………………….2

3 QUALITY POLICY.………………………………………………………….……3

4 QUALITY MANAGEMENT SYSTEM…………………...…………….…....…..4

5 MANAGEMENT RESPONSIBILITY…………………………...…………..….10

6 RESOURCE MANAGEMENT………………………………………...….…....16

7 PRODUCT REALIZATION…………………………………………...…….…..18

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT………………………29

QUALITY MANUAL

SECTION 3: QUALITY POLICY

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GM Nameplate Quality Policy

The quality policy of GM Nameplate is to provide products that meet or exceed customer expectations, comply with all regulations, continually improve in everything we do, and maintain the effectiveness of the quality management system.

What our quality policy means to us:

• We provide products that meet or exceed customer expectations by using the ISO 9000

family of standards as our benchmarks. We employ proven quality management principles within the framework of our quality management system to enhance customer satisfaction and continually improve our performance and capabilities.

• We comply with all regulations by using our quality management system as a tool to

promote ethical compliance to applicable statutes, regulations, and industry standard requirements.

• We continually improve in everything we do through our commitment to maintaining the

effectiveness of our quality management system.

QUALITY MANUAL

SECTION 4: QUALITY MANAGEMENT SYSTEM

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4.0 General

Introduction

GM Nameplate (GMN) is a custom manufacturer with over 60 years of experience serving nearly

every industry with world-class customer service, ingenious solutions, and supply chain stability.

GMN provides product development assistance and a broad range of manufacturing capabilities

to take customer projects from inspiration through implementation. Our core competencies

include:

• Electronics & user interface technologies: Backlighting, elastomer keypads, front panel integration & bonding, membrane switches, and printed circuit boards.

• Graphic products: Graphic overlays, labels, and nameplates.

• Functional products: die-cut components, optical encoders, and printed electrodes.

• Production services: Engineering, rapid prototyping, research & development, testing, and value-added assembly.

We serve a diverse variety of industries including: Aerospace, Appliance, Automotive, Cosmetics,

Electronics, Heavy Equipment, Industrial Controls, Medical, and Wine and Spirits labeling.

Established in 1954, GMN is a privately owned corporation. The company employs over 1,000

individuals across North America and Asia at the following locations:

• Seattle, Washington Division - corporate headquarters

• Seattle, Washington Division - superGraphics*

• San Jose, California Division

• Beaverton, Oregon Division dba Elite Plastics

• Monroe, North Carolina Division

• Singapore Division*

• China Division*

*These divisions are not included in the scope of the quality management system defined in this quality manual. Scope

GM Nameplate’s quality management system is based on the ISO 9000 family of standards, including the current revisions of ISO 9001 and AS9100, where applicable. The requirements unique to AS9100 are denoted in this quality manual with the use of italic type. The scope of GM Nameplate’s quality management system described by this quality manual covers: the Manufacture and Value-Added Assembly of Graphic, Functional, Electronic, and User Interface Technology Products for Aerospace, Automotive, Medical, Computer, Industrial, and Other Industries.

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Application and Exclusions

Our quality management system application and exclusions are as follows:

• ISO 9001 requirements apply to all of our divisions.

• AS9100 requirements apply to our Washington, California, and Oregon divisions.

• Parts Manufacturer Approval (PMA) under 14 CFR 21.303 only applies to our Washington division.

GMN manufactures parts using existing customer designs and does not perform any product design activities; therefore all of §7.3 Design and development has been excluded from the quality system.

As a component-only manufacturer with no serviceable consumer products, GMN excludes the service provisions of §7.5.1 Production and Service Provision, and §7.5.2 Validation of Processes for Production and Service Provision. GMN also does not provide post-delivery support and has excluded §7.5.1.4 Post-Delivery Support from our quality management system. Quality management issues pertaining to medical product manufacturing are covered in the GM Nameplate medical quality system manual 00-QM-MED for those divisions certified to the ISO 13485 standard and are based on specific customer requirements and applicable regulatory requirements.

4.1 General Requirements

GM Nameplate has identified, established and applied the processes necessary throughout the organization to ensure that the quality management system addresses all applicable customer, statutory and regulatory requirements and is continually improved. Each GMN division has identified the process/documentation flow-down of quality procedures to work instruction by matrices for each division. The control and support of these processes are assured by:

a) Determining the processes needed for the quality management system and their application throughout the organization;

b) Determining the sequences and interactions (see process flow on following page);

c) Determining the criteria and methods to ensure operation and control of the processes are effective;

d) Providing necessary resources and information;

e) Defined monitoring, measuring and analysis;

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

improvement; and

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

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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 four level documentation system is used to clearly communicate quality requirements. Documents are approved electronically using an eQMS system.

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 the 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

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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 authority’s representatives are allowed access to GM Nameplate quality management system documentation.

4.2.3 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 electronically 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.

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4.2.4 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: Quality Management System Reference Documents 00-QP-4.1 Document Control 00-QP-4.2 Control of Records

QUALITY MANUAL

SECTION 5: MANAGEMENT RESPONSIBILITY

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5.0

5.0 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.

5.1 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.

5.2 Quality Policy

Our quality policy expresses our commitment to provide products that meet or exceed customer expectations, comply with all regulations, continually improve in everything we do, and maintain the effectiveness of the quality management system. 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.

5.3 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.

5.3.1 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. As quality objectives are specific to each division and subject to change, they are established by each division as appropriate to their needs, recorded and reported on during management review meetings.

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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.

5.3.2 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 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.

5.4 Responsibility, Authority and Communication

5.4.1 Responsibility and Authority

The CEO appoints the Corporate Quality Director with the overall responsibility and authority of establishing, implementing, and maintaining the corporate quality management system.

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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 corporate quality management system and appropriate quality management system standard(s). The local quality management system must align with corporate policies and be approved by the Corporate Quality Director.

The president of each division delegates to the respective quality assurance manager the responsibility to maintain total compliance with the local quality management system. The local quality management system must align with corporate policies and be approved by the Corporate Quality Director. The quality assurance manager is also responsible to 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 assurance manager coordinates with customer and regulatory authority representatives 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 supplier’s facility necessary to determine compliance of the product being manufactured.

The appropriate divisional quality assurance manager 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 by corporate quality management.

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.

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Corporate Director of Quality

GM NAMEPLATE

ORGANIZATIONAL CHART

Chairman

GMN Executive Committee

OUR CUSTOMERS

CEO

Purchasing Manager

Quality Assurance Manager /

Mgmt. Rep.

CFO

Process Engineering

Manager

Purchasing Manager

Production Manager

Electronic Product Design

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


Mgmt. Rep.

General Manager

Customer Service

Manager

Customer Service

Manager

Vice President

Sales &

Marketing

Marketing Manager


Mgmt. Rep.

Corporate HR

Manager

Human Resources Specialist

Human Resources Manager



Product Line Sales Managers

General Manager

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5.4.2 Management Representative

The quality assurance manager of each division of GM Nameplate serves as the site 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 for the site, and in compliance with the corporate quality management system,

b) Reporting on the performance of the quality management system to local executive management and corporate quality 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.

5.4.3 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.

5.5 Management Review

5.5.1 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.

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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, analysis by reject category report, on-time delivery reports and customer complaint reports.

5.5.2 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.

5.5.3 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: Management Responsibility Reference Documents 00-QP.5.1 Management Review of the Quality Management System

QUALITY MANUAL

SECTION 6: RESOURCE MANAGEMENT

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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, and where applicable, AS9100 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.

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SECTION 6: RESOURCE MANAGEMENT

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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) Support 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 Reference Documents 00-QP-6.1 Training and Awareness

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SECTION 7: PRODUCT REALIZATION

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7.0

7.1 Planning of Product Realization

GM Nameplate plans and develops processes for the realization of our products. In planning product realization, the following are determined:

7.1.1 Project Management 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 as controlled by the customer.

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.

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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

Product configuration identification is provided by the customer. Configuration changes are controlled by the customer and noted in GM Nameplate customer records. Configuration status accounting is the responsibility of the customer, and the current revision status of a part is noted in GM Nameplate records. Configuration audits are the responsibility of the customer, and may be conducted during customer site audits.

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.

7.2.2 Review of Requirements Related to the Product

Requirements related to the product are reviewed during RFQ 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,

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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.

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.

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7.3 Design and Development GM Nameplate does not design products; therefore this section has been excluded from the quality management system.

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.

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

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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, and

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.

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.

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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,

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,

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• 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.

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,

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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.

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.

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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.

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.

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f) Provisions for prevention, detection and removal of foreign objects throughout the handling, storage, packaging and delivery processes.

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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Section 7: Product Realization Reference Documents 00-QP-7.1 Product and Process Planning and Control 00-QP-7.2 Customer Requirements and Communication 00-QP-7.4 Purchasing 00-QP-7.5 Product Identification and Traceability 00-QP-7.6 Control of Customer Property 00-QP-7.7 Preservation of Product 00-QP-7.8 Control of Monitoring and Measuring Devices 00-QP-7.9 Manufacturing Process & Specification Change Control 00-QP-8.6 Corrective and Preventive Action 00-QA-20.2 Process Validation

QUALITY MANUAL

SECTION 8: MEASUREMENT, ANALYSIS, AND IMPROVEMENT

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8.0

8.0 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.

8.1 Monitoring and Measurement

8.1.1 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.

8.1.2 Internal Audit

Internal audits are conducted to determine if the quality management system conforms to the requirements of the ISO 9001 quality standard, to the AS9100 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.

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The divisional Quality 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.

8.1.3 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.

8.1.4 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

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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.

8.2 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,

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• 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,

• 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) Re-inspection 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.

8.3 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 analyzes supplier performance and takes 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.

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8.4 Improvement

8.4.1 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

8.4.2 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.

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

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8.4.3 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: Measurement, Analysis, and Improvement Reference Documents 00-QP-8.1 Customer Satisfaction 00-QP-8.2 Quality Audits 00-QP-8.3 Monitoring and Measuring of Product 00-QP-8.4 Control of Nonconforming Product 00-QP-8.5 Continual Improvement 00-QP-8.6 Corrective and Preventive Action