as9100 qms process manual

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TABLE OF CONTENTS Par. Description Sheet

1.0 SCOPE 4

1.1 General 4

1.2 Application 4

2.0 NORMATIVE REFERENCE 4

3.0 TERMS AND DEFINITIONS 4

4.0 QUALITY MANAGEMENT SYSTEM 5

4.1 General 5

4.2 Documentation 5

4.2.1 Documentation Requirements 5

4.2.2 Quality Manual 5

4.2.3 Document Control 5

4.2.4 Record Control 6

4.3 Configuration Management 6

5.0 MANAGEMENT RESPONSIBILITY 6

5.1 Management Commitment 6

5.1.1 Executive Management 6

5.2 Customer Focus 7

5.2.1 Determination and Compliance 7

5.2.2 Customer Satisfaction Assessment 7

5.3 Quality Policy 7

5.4 Planning 7

5.4.1 Quality Objectives 7

5.4.2 QMS Planning 7

5.5 Responsibility, Authority and Communication 8

5.5.1 Executive Management Representative 8

5.5.2 Functional Management 8

5.5.3 Internal Communication 8

5.6 Management Review 8

6.0 RESOURCE MANAGEMENT 9

6.1 Provision of Resources 9

6.2 Human Resources 9

6.2.1 Competency, Awareness and Training 9

6.2.2 Position Descriptions 9

6.2.3 Personnel Reviews and Appraisals 10

6.3 Infrastructure 10

6.4 Work Environment 10

7.0 PRODUCT REALIZATION 10


TABLE OF CONTENTS (Continued) Par. Description Sheet

7.1 Planning of Product Realization 10

7.2 Customer-Related Processes 10

7.2.1 Determination and Review of Requirements 11

7.2.2 Customer Communication 11

7.3 Design and Development 11

7.4 Purchasing 11

7.4.1 Purchasing Process 11

7.5 Production and Service Provision 12

7.5.1 Control of Production and Service Provision 12

7.5.2 Validation of Processes for Production and Service Provision 13

7.5.3 Identification and Traceability 13

7.5.4 Customer Property 13

7.5.5 Preservation of Product 13

7.6 Control of Monitoring and Measuring Devices 13

8.0 MEASUREMENT, ANALYSIS, AND IMPROVEMENT 14

8.1 General Planning and Implementation of Measurement,

Analysis and Improvement 14

8.2 Monitoring and Measurement 14

8.2.1 Customer Satisfaction 14

8.2.2 Internal Audit 14

8.2.3 Monitoring and Measurement of Processes 14

8.2.4 Monitoring and Measurement of Product 15

8.3 Control of Nonconforming Product 15

8.4 Analysis of Data 15

8.5 Improvement 15

8.5.1 Continual Improvement 15

8.5.2 Corrective Action 16

8.5.3 Preventive Action 16

Appendix Title Sheet

A Overview of Process Sequence and Interactions 17

(Figures 1 through 11)

B Overview of Documents Required to Ensure Effective:

Planning Operation and Control of Fairchild Processes 29

(Figures 12 & 13)

C Organization Chart 32

(Figure 14)


1.0 SCOPE

1.1 General

This Quality Manual describes Fairchild Controls Corporation (Fairchild) Quality Management

System (QMS) and the methods by which it complies with the requirements of SAE International

Aerospace Standard, AS9100, without exclusions.

Fairchild is committed to meeting customer needs by supplying quality products and/or services

on schedule and at a competitive cost.

The management and employees of Fairchild are dedicated and committed to maintaining the

Quality Policies and Procedures as outlined herein and attaining the goals set forth as Quality

Objectives. Fairchild management ensures that the Quality Policies, Procedures and Objectives

are understood, implemented and maintained at all levels throughout the organization.

Fairchild management has empowered and encourages each employee to continually improve

their processes, emphasizing prevention rather than reaction.

1.2 Application

This Quality Management System Manual is applicable to all personnel and processes that

have an impact on the quality of the product or service being provided by Fairchild.

2.0 NORMATIVE REFERENCE

AS9100 Quality Systems Aerospace Model for Quality Assurance in Design,

Development, Production, Installation and Servicing (SAE International

Aerospace Standard)

ISO9001 American National Standard, Quality Management Systems -

Requirements

ISO9000 American National Standard, Quality Management Systems –

Fundamentals & Vocabulary

3.0 TERMS AND DEFINITIONS

For the purpose of the Quality Manual the terms and definitions given in ISO9000 apply.


4.0 QUALITY MANAGEMENT SYSTEM

4.1 General (See Appendix B, Figure 13, Section 4.1)

The processes necessary to implement the Fairchild Quality Management System (QMS) are

defined herein and provide for the criteria and methods to ensure:

Operation and controls are effective

Availability of resources and information

Methods of monitoring, measurement and analysis

The actions to achieve planned results and continual improvement

“Appendix A” provides an overview of pertinent process sequence and interactions.

4.2 Documentation (See Appendix B, Figure 13, Section 4.2)

4.2.1 Documentation Requirements

Quality Policy is defined in Fairchild Policy & Procedure 701 - Section II, and Policy & Procedure

1011 - Section II. Provisions for Quality Objectives are defined in Fairchild Policy & Procedure

701 - Section III A, Policy & Procedure 1011 - Section I, and Sections 1.0 and 5.0 herein.

Specific Quality Objectives are defined throughout Fairchild documentation.

4.2.2 Quality Manual

This Quality Manual outlines all of the requirements and documents needed to implement the

QMS throughout Fairchild and delineates all applicable requirements imposed by Customer

and/or Regulatory Authorities. An overview of the documents required to ensure the effective

planning, operation and control of Fairchild processes is provided in “Appendix B”. QMS

procedures are available universally to personnel via a read-only computer network system.

Fairchild makes this information available for Customer and/or Regulatory Agency review.

4.2.3 Document Control

Fairchild QMS document controls include, but are not limited to, review, approval, update, re-

approval, change, identification of status, availability at points of use, legibility, control of

documents of external origin, control of obsolete documents, and personnel familiarization of the

QMS documentation system. Current revision status is available to all employees in the

electronic data System to preclude the use of obsolete or non-applicable documents. Also see

paragraph 4.3 below.

When applicable, document approval for initial release and any subsequent changes are

coordinated with customer and/or regulatory authorities.


4.2.4 Record Control

Responsibilities for identification, collection, maintenance, storage, protection, retrieval,

retention, disposition, and use of quality records essential to the effective operation of the

Fairchild QMS have been defined in individual procedures and in GEN-QAI1601 and GEN-

QAI1602. GEN-QAI0621 defines supplier record controls. Records are available for customer

and/or regulatory authority review in accordance with contract or regulatory requirements.

4.3 Configuration Management (See Appendix B, Figure 13, Section 4.3)

Control of Fairchild generated and/or customer furnished documents, both manually or

electronically generated, are defined within the series of General Configuration Management

Instructions, GEN-CMIXXXX.

5.0 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment (See Appendix B, Figure 13, Section 5.1)

Fairchild’s Top Management Team consists of its president and executive staff. The Top

Management Team (Executive Management) is responsible for developing and implementing

the QMS and continually improving its effectiveness.

5.1.1 Executive Management

Executive Management:

a. Communicates the importance of meeting customer, statutory and regulatory

requirements through Program Plans, Program Directives, performance metrics, and

training.

b. Defines Quality Policy and assures it is appropriate to the company by Executive

Management approval.

c. Ensures that the framework for Quality Objectives is established and remains suitable at

all levels throughout the company, see 5.1.4 Quality Objectives.

d. Ensures the availability of adequate resources through periodic manpower reviews.

e. Ensures customer requirements are determined and met with the aim of enhancing

customer satisfaction through solicitation and contract reviews, customer visits, program

status reviews, and technical reviews.

f. Ensures the integrity of the QMS is maintained at all times through an aggressive Internal

Audit Program and Management Review.

g. Ensures that Functional Management communicates applicable responsibility and

authority within the company through position descriptions and organization charts.


5.2 Customer Focus (See Appendix B, Figure 13, Section 5.2)

Executive Management ensures that customer requirements are met and that customer

satisfaction is continuously assessed for improvement. (See Policy & Procedures 402)

5.2.1 Determination and Compliance

Determination and compliance to customer requirements is achieved in accordance with

Section 5.6 and 7.0 of this Quality Manual.

5.2.2 Customer Satisfaction Assessment

Customer satisfaction is assessed in accordance with Section 5.6 and 8.0 of this Quality

Manual.

5.3 Quality Policy (See Appendix B, Figure 13, Section 5.3)

Executive Management ensures the Fairchild Quality Policy defines our business, espouses

conformance to requirements, prompts creation of objectives and continuous improvement, is

known and understood throughout the organization, remains current, and fully meets the

requirements of AS9100, SAE International Aerospace Standard. See Section 5.6 of this

Quality Manual.

5.4 Planning (See Appendix B, Figure 13, Section 5.4)

Executive Management ensures the planning of the QMS and Quality Objectives.

5.4.1 Quality Objectives

Executive Management requires and ensures that Functional Management defines the Quality

Objectives pertaining to the essential elements of quality such as fitness for use, performance,

safety, and reliability. Functional Management establishes Quality Objectives that are realistic,

measurable, and add value. Special departmental Quality Objectives are reviewed for their

consistency with other Corporate Objectives. This is accomplished by Program Plans, Strategic

Initiatives, and review of individual performance goals.

5.4.2 QMS Planning

Executive Management ensures that the integrity of the QMS is continually evaluated via

Management Review and metrics selection. Resources are evaluated and acquired when

needed to enable each department to perform its function in a cost-effective manner while

achieving the stated Quality Goals and Objectives for both the company and its customers.

Changes to the QMS are reviewed by Quality Management to maintain system integrity.


5.5 Responsibility, Authority, and Communication (See Appendix B, Figure 13, Section 5.5)

Executive Management ensures that responsibilities and authority are defined and

communicated throughout the organization through organizational charts (see appendix C) and

position descriptions.

5.5.1 Executive Management Representative

The Director of Quality Assurance is appointed by Executive Management and reports directly

to the President of Fairchild. The QA Director chairs the Executive Quality System

Management Review, has the organizational freedom to resolve matters pertaining to quality,

and is delegated the responsibility of implementing and maintaining the Fairchild QMS.

5.5.2 Functional Management

Functional Management is defined as a person who is appointed by Executive Management

and has a position title of Vice President, Director, Manager, or Supervisor. A Functional

Manager has the authority and responsibility for implementing Quality Policies, Objectives, and

Procedures; ensuring that all personnel reporting to them understand the Corporate Quality

Policy as it applies to their position, and ensuring that all aspects of the QMS relevant to their

areas of responsibility are available, implemented, and maintained. Functional Managers

ensure that personnel in positions affecting quality have the freedom and authority to

recommend, initiate, and provide solutions to improve their processes.

Functional Management periodically evaluates procedures and instructions for continued

compliance with the Quality Policy.

5.5.3 Internal Communication

Executive Management ensures that appropriate communication processes are established

within the organization and that communication takes place regarding the effectiveness of the

QMS by posting summary and trend data of non-proprietary or sensitive metrics in the

manufacturing areas, holding operation reviews with employees, issuing newsletters, and

periodically issuing and analyzing employee surveys to determine the effectiveness of the

communication processes.

5.6 Management Review (See Appendix B, Figure 13, Section 5.6)

Executive Management meets quarterly to review inputs related to, as a minimum, internal and

external audit results; customer feedback; process performance and product conformity; status

of preventive and corrective actions; follow-up actions from previous management reviews;


changes that could affect the QMS; and recommendation for improvement. Inputs are outlined

in the Management Review Meeting Table of Contents. The chairperson maintains records of

Management Review, including actions assigned and completion status. A summary report of

the review is issued to Executive Management containing, as a minimum, decisions and actions

regarding improvement in the effectiveness of the QMS and its processes; improvement of

product related to customer requirements; and needed resources. Appropriate information is

then communicated through Functional Management to all levels, see 5.5.3 Internal

Communication.

6.0 RESOURCE MANAGEMENT

6.1 Provision of Resources (See Appendix B, Figure 13, Section 6.1)

Executive and Functional Management identify the need for and provide the resources to

implement and maintain the QMS, continually improve its effectiveness, and enhance customer

satisfaction by meeting customer requirements. This is accomplished through periodic

manpower and facilities reviews held to assess company needs by program and/or task.

6.2 Human Resources (See Appendix B, Figure 13, Section 6.2)

6.2.1 Competency, Awareness and Training

Employee competency, awareness, specialized skills, training and development is the

responsibility of Human Resources and Functional Management. Training is outlined in GEN-

QAI1801, GEN-OP5016, and applicable formal and informal training plans.

6.2.2 Position Descriptions

Position descriptions are approved by Functional Management and Human Resources, and

include approval dates to show control of the content. Employee training, development, and

performance records are maintained, as appropriate, by Human Resources and Functional

Management.

Functional Management is responsible for determining and taking the necessary actions to

assure the level of competence, experience and training required for personnel performing

quality related tasks and for follow-up to evaluate the effectiveness of any required actions.


6.2.3 Personnel Reviews and Appraisals

Executive Management and Functional Management perform employee reviews and appraisals

on each direct report employee. Personnel are made aware of the relevance and importance of

their activities and how they contribute to achieving the quality objectives.

6.3 Infrastructure (See Appendix B, Figure 13, Section 6.3)

Executive and Functional Management are responsible for the design, development, and

maintenance of the manufacturing facility, associated utilities, environmental controls, process

equipment (both hardware and software), and supporting services to provide a suitable

workspace. These activities are outlined in Fairchild Policies and Procedures, Facility and

Maintenance Procedure GEN-OP1014, and Environmental Guidelines for Manufacturing Areas

GEN-OP5000.

6.4 Work Environment (See Appendix B, Figure 13, Section 6.4)

See Section 6.3 above.

7.0 PRODUCT REALIZATION

7.1 Planning of Product Realization (See Appendix B, Figure 13, Section 7.1)

Fairchild plans and develops processes needed for product realization. Planning of product

realization is consistent with the requirements of the other QMS processes. (See 4.1) These

plans are specified by Contract and in supporting documentation such as Program Quality

Plans, Engineering requirements, drawings, specifications, and test requirements.

In planning product realization, Fairchild determines the following, as appropriate:

a. Quality Objectives and requirements for the product. (See 5.4)

b. The need to establish processes, documents, and provide resources specific to the

product. (See 5.4, 6.1 & 6.2)

c. Required verification, validation, monitoring, inspection and test activities specific to the

product and the criteria for product acceptance. (See 7.3 & 8.2)

d. Records needed to provide evidence that the realization processes and resulting product

meet requirements. (See 4.2.3)

e. The identification of resources to support operation and maintenance of the product is

planned during the proposal phase as labor cost input. (See 6.1, 6.3 & 7.2.1 d & e)

7.2 Customer-Related Processes (See Appendix B, Figure 13, Section 7.2)


7.2.1 Determination and Review of Requirements

Prior to submission of a Request for Proposal (RFP), Request for Quotation (RFQ) and prior to

the acceptance of a contract or order from a potential customer, the contract, order, or any

modifications or amendments to existing contracts or orders, are reviewed by Fairchild in

accordance with GEN-QAI0301, Contracts Procedure for Contract Review. (See Appendix A,

Figure 3) Responsibility and authority for determining and recording the following are defined

therein:

a. Stated customer requirements including delivery and post-delivery activities.

b. Unspecified customer requirements necessary for specified or intended use, where

known.

c. Statutory and regulatory product related requirements.

d. Additional requirements determined by Fairchild.

e. Risks and ability to meet the requirements.

7.2.2 Customer Communication

Fairchild maintains effective communication with customers related to product information,

inquiries, contracts, order handling, amendments, customer feedback, and complaints as

defined in section 7.2.1 above, GEN-QAI0412 Design Control, and GEN-QAI1402 Processing

Customer Concerns.

7.3 Design and Development (See Appendix B, Figure 13, Section 7.3)

Design Engineering has responsibility and authority for the Design and Development (D&D)

process. The requirements for D&D Planning, Inputs, Outputs, Review, Verification & Validation

(V&V), V&V Documentation, V&V Testing, and D&D Changes are defined in GEN-QAI04XX and

GEN-CMIXXXX instructions. Also see Appendix A, Figure 4.

7.4 Purchasing (See Appendix B, Figure 13, Section 7.4)

7.4.1 Purchasing Process

Fairchild ensures that purchased product conforms to specified requirements. Material Control,

Procurement Quality Engineering, Procurement, Quality Assurance, and Program Quality

Engineering have responsibility and authority for managing the quality of all products purchased

from suppliers, including customer-designated sources. The process includes control of

suppliers, generating Purchase Orders, and verification of product. This process is

implemented and maintained by the functions listed above in accordance with the following

procedures:


Material Control – GEN-OP1015 Purchasing Request Generation Procedure & GEN-

OP5008 Production Order System

Procurement Quality Assurance – GEN-QAI0601 Procurement Document Review, GEN-

QAI0602 Supplier Source Delegation Procedure, & GEN-QAI0621 Supplier Approval

and Control

Procurement – GEN-PPM1001 Procurement Procedures Manual & Purchase Order

Terms and Conditions

Quality Assurance – GEN-QAI1002 Receiving Inspection

Program Quality Engineering – GEN-QAI1305 Test Failure Reporting & GEN-QAI1307

Material Reject Report

Also see Section 8.5 and Appendix A, Figure 11.

7.5 Production and Service Provision (See Appendix B, Figure 13, Section 7.5)

7.5.1 Control of Production and Service Provision

Manufacturing Operations and Quality Assurance have responsibility for implementation and

control of production and service processes. Production and service processes are planned

and carried out under controlled conditions. These conditions include, but are not limited to,

consideration for key characteristics, in-process verification points, and required tooling for

variable measurements. Implementation includes applicable information, work instructions,

suitable equipment, provisions for monitoring and measurement, accountability and status,

foreign object control, environment and facility control, and clearly defined criteria for

workmanship. With respect to Post Delivery Servicing, Fairchild provides for an adequate

logistic back-up including technical device, spares or parts supply, and competent servicing.

Servicing responsibility is agreed upon and documented between Fairchild, suppliers, and

customers.

Controls are outlined in approved documentation and include, but are not limited to, process

changes, non-program and programmable equipment, handling and storage, outside

processing, and service operations.

Planning, implementation and controls are defined in General Operating Procedures, General

Process Procedures, and General Quality Assurance Instructions (see 7.1 and Appendix A,

Figures 7, 8 & 10, and Appendix B, Figures 12 & 13)


7.5.2 Validation of Processes for Production and Service Provision

Special Processes are defined by General Process Procedures. These procedures are

qualified and approved prior to issue for use and upon change. These controls delineate all

required equipment, personnel qualification, methods and procedures, parameters, records, and

revalidation procedures. (See Appendix B, Figures 12 & 13)

7.5.3 Identification and Traceability

Product identification and traceability requirements defined by contract or regulatory authority

are implemented via Fairchild procedures, drawings and work instructions. The contract review,

design & development, quality program planning processes and production order system

provide for required identification (including configuration) throughout product life, traceability for

raw materials, and traceability of components to the next higher assembly. Product status and

sequential production records are maintained throughout product realization. Status is recorded

on receiving documents and manufacturing orders. The acceptance authority media is defined

in Control and Usage of Stamps GEN-OP1000.

7.5.4 Customer Property

Customer Furnished Property (CFP) and Government Furnished Property (GFP) are the

responsibility of Quality Assurance, Manufacturing Operations, and Program Management.

Controls for CFP and GFP are defined by Fairchild procedures GEN-QAI0701, GEN-GPP1001,

and GEN-GPP1002.

7.5.5 Preservation of Product

Preservation is the responsibility of Manufacturing Operations and includes product

identification, handling, packaging, storage and protection. Preservation requirements are

defined and implemented in Handling Procedure GEN-HP1000, Inventory Material Manual

GEN-IMM1000, Production Order System GEN-OP5008, Process Specification for Object and

Debris Removal GEN-PS1009, Handling of Electrostatic Sensitive Devices GEN-GR7000,

Age/Use Sensitive Materials GEN-QAI1011 and applicable Fairchild process procedures,

drawings and specification.

7.6 Control of Monitoring and Measuring Devices (See Appendix B, Figure 13, Section 7.6)

Control of the monitoring and measuring process, including applicable computer software, is the

responsibility of Quality Assurance. Measurement and Test Equipment (M&TE) needed is

determined and the extent of monitoring and measurement is established to ensure product

conformity. (See 7.2.1) Control of the monitoring and measuring process, including provisions


for the identification of all product and/or equipment affected by nonconforming M&TE is defined

in Metrology GEN-MET1101, Personnel Qualification for Controlled Metrology Functions GEN-

MET1102, and Metrology Historical Records GEN-QAI1101. (See Appendix A, Figure 7)

8.0 MEASUREMENT, ANALYSIS, and IMPROVEMENT

8.1 General Planning and Implementation of Measurement, Analysis and Improvement

Measurement, analysis and improvement are the responsibility of all employees at Fairchild

however the primary responsibility rests with Manufacturing Operations and Quality Assurance.

These processes are performed to demonstrate conformity of product, ensure conformity of the

QMS and continually improve the effectiveness of the QMS by the application of planned

methods and when appropriate statistical techniques. Planned methods include, but are not

limited to, customer satisfaction evaluation, Internal Audit, Receiving/In-Process/Test/FAI/ Final

Inspection, Records, Control of Nonconforming Material, Data Collection and Analysis,

Continual Improvement, Corrective Action, and Preventive Action. (See Appendix A, Figure 1,

2, 3, 5, 8, & 9 and Appendix B, Figure 13, Section 8.1)

8.2 Monitoring and Measurement (See Appendix B, Figure 13, Section 8.2)

8.2.1 Customer Satisfaction

Fairchild Management is responsible for determining customer satisfaction. (See 5.2)

The methods for obtaining and using information related to customer perception and Fairchild’s

ability to meet customer requirements are defined in Policy and Procedure 402.

8.2.2 Internal Audit

The internal audit process is deployed utilizing all functional disciplines throughout Fairchild.

Oversight and control of the internal audit process is the responsibility of Quality Assurance and

is implemented in accordance with Quality Auditing GEN-QAI1701 and, when applicable,

contract and/or regulatory requirements.

8.2.3 Monitoring and Measurement of Processes

QMS processes are monitored and, when applicable, measured to demonstrate the ability to

achieve planned results. In the event of process nonconformity, nonconforming product is

identified and controlled while appropriate corrective action is taken to ensure product

conformity. (See 8.3 and Appendix A, Figure 1, 2, & 8)


8.2.4 Monitoring and Measurement of Product

The monitoring and measuring of product characteristics and service is planned and carried out

at appropriate stages of the realization process and include, when applicable, key

characteristics. Monitoring and measurement is planned at Receiving Inspection, In-Process

Manufacturing and Assembly, First Article Inspection, In-Process Inspection, Test, Final

Manufacturing and Assembly, Final Inspection prior to delivery. Methods utilized in the process

include, but are not limited to, acceptance sampling to statistically valid and customer approved

sampling plans, nonconformance control, control of product or service prior to release or

delivery, documented evidence of conformity, and control of records. Process controls are

defined in the procedures outlined in Appendix B, Figure 13, Section 8.2.

8.3 Control of Nonconforming Product (See Appendix B, Figure 13, Section 8.3)

Responsibility and authority for control of nonconforming product is defined in Fairchild Material

Review System procedures, GEN-QAI13XX. These procedures include requirements for the

identification and control of all nonconforming products and include preventing unintended use

or delivery, re-verification after correction to demonstrate conformity, assessment and customer

notification when applicable, and any customer contract/regulatory requirements and/or

approvals. See Appendix A, Figure 9 and Appendix B, Figure 13, Section 8.3.

8.4 Analysis of Data (See Appendix B, Figure 13, Section 8.4)

Fairchild determines, collects and analyses appropriate data to demonstrate the suitability,

effectiveness, and continual improvement of the QMS. This process includes data collected

and analyzed to determine customer satisfaction, conformity to product requirements, process

characteristics and trends, opportunities for preventive action, and supplier performance. See

Appendix A, Figure 2.

8.5 Improvement (See Appendix B, Figure 13, Section 8.5)

8.5.1 Continual Improvement

Fairchild continually improves the effectiveness of the QMS as defined by the Quality Policy and

Quality Objectives. (See 5.3 and 5.4.1) Methods for determining improvement include, but are

not limited to, internal audits, analysis of data, corrective and preventive actions and the

management review process. (See 8.2.2, 8.4, 8.5.2, 8.5.3 & 5.6 and Appendix A, Figures 2 & 5)


8.5.2 Corrective Action

Quality Assurance is responsibility for the implementation of the corrective action process and

for assuring that corrective action is appropriate to the effects of the nonconformities

encountered. The requirements are defined in Preventive and Corrective System procedures

GEN-QAI1401 and Processing Customer Concerns GEN-QAI1402, and include review,

determination of root cause, evaluation of proposed corrective action plans for adequacy,

maintaining records, assuring follow-up, flowing down corrective action requirements to

suppliers, monitoring the timeliness of the process, and taking appropriate action if timely and/or

effective corrective action is not achieved. (See Appendix A, Figure 5 & 9)

8.5.3 Preventive Action

Quality Assurance is responsibility for the implementation of the preventive action process and

for assuring that preventive action addresses the cause of potential nonconformities in order to

prevent their occurrence and determine that actions are appropriate to the effects of potential

problems. The requirements are defined in Preventive and Corrective Action System procedure

GEN-QAI1401, and include review, determination of potential nonconformities and their cause,

evaluating the need for preventive action, review of proposed preventive action plans for

adequacy, assuring follow-up and effectiveness, maintaining records, monitoring the timeliness

of the process, and taking appropriate action if effective preventive action is not achieved. (See

Appendix A, Figure 2, 5, & 6)


Appendix A

Overview of Process Sequence and Interactions

Quality Mgt Sys Process Interrelationship

Customer Input

Customer Requirements

Input Common to all Processes Design, Development& Configuration Control

o Quality Policyo Quality Objectives & Measureso Planningo Communicationo Management Responsibilityo Resource Management

o Internal Audit Procurement

Process

Production & Service Provisions

Control of Nonconforming Control of Monitoring &

Product Measuring Devices

Monitoring &

Measuring

Analysis of Data

Management ReviewProcess

Customer Related Processes

Continual Improvement

Customer Satisfaction

Fig 1


Analysis of Data Process

Management ResponsibilityGEN-QMS9100 Quality Policy & Objectives

Sect 5.0 Policy & Procedures 1011Product Verification

GEN-QAI1002GEN-QAI1003GEN-QAI1004

Process Capability Data Test ProceduresGEN-OP2001 Preventive Action

GEN-QAI1401

Corrective Action

& Follow-up

GEN-QAI1401Internal Audits Recommendations forGEN-QAI1701 Process Improvements

Policy & Procedure1011

Quality SystemsGEN-QMS9100Sect. 4.0

Management ReviewData Review GEN-QMS9100, Sect. 5.6

Trend Analysis GEN-CMI1003 GEN-QAI2101 Supplier Review BoardGEN-QAI1301 GEN-CMI1005 GEN-QAI0621

Cost of Quality Trend Analysis Process ControlGEN-QAI2101 GEN-QAI1301 GEN-QAI0902

GEN-QAI1303Qualification Reporting Program ReviewGEN-OP9001 Policy & Procedure

401 & 402

Material Review Board Failure Review BoardRecords GEN-QAI1301 GEN-QAI1303GEN-QAI1601

Corrective Action &Follow-UpGEN-QAI1401

Customer SatisfactionPolicy & Procedure

Required Resources 402GEN-QMS9100

Sect. 6.0

Preventive ActionProduct & Method Improvement, GEN-QAI1401Effectiveness of Product

Quality System ImprovementsInitiatives & Plans Policy & Procedure 1011

Customer Data

Policy & Procedure 402

Output

Input

Fig 2


Customer-Related Process

Regulatory & StatuatoryRequirement

Proposals/Contract SubmittalProduct Support Orders Spares Maintenance Requests

Internal Audits Other Customer Interface

GEN-QAI1701 Policy & Procedure402

Management ResponsibilityGEN-QMS9100Sect. 5.0

Quality Systems

GEN-QMS9100Sect. 4.0

Quality Program PlanningGEN-QAI0101

ContractsGEN-QMS9100, Sect. 7.2.1

GEN-QAI0301Review Solicitation Review

Contract vs Proposal Reviews Customer Support Operations GEN-OP1007 Quality Assurance

Interpreting Customer Programs

Requirements Finance Product ServicingGEN-QAI1901

Identify & Resolve Discrepencies

Issue Sales Orders

Records

GEN-QAI1601

Finance - IssuesProgram Plans Program Directive & Budgets(Data Items) Policy & Procedure 357

Sales Order NotificationSF-CON004

Program OfficeRequest for Program Directive Design & Development Customer Satisfaction

Product Policy & Procedure 357 Plannng Policy & ProcedureDeliverables Procurement 402

Customer Requirements

Output

Input

Fig 3


Design & Development Process

Management Responsibility

GEN-QMS9100 Program DirectiveSect. 5.0 Policy & Procedure 357

Customer Satisfaction Contract ReviewPolicy & Procedure 402 GEN-QAI0301

Internal Audits Customer Requirements

GEN-QAI1701 Statutory & Regulatory Requirements

Producibility

Quality Systems ReviewGEN-QMS9100 GEN-QMS9100, Sect. 6.1

Sect. 4.0 Mfg. Eng.

Procurement

Specifications

Data Item GEN-QAI0420 Software Design Control

GEN-QAI04XX

& Part Lists Design Notebooks

GEN-CMI1002 Product Safety & Liability Previous Similar Designs

GEN-QAI2201 GEN-QAI1601

Records Production & Service

GEN-QAI1601 GEN-QAI0902

QualificationProcedures & Reports

GEN-OP9001

Key Characteristics

GEN-QAI2001Procurement Acceptance Test Procedures GEN-OP2001

Specifications GEN-QAI0901

GEN-QAI0420

CMIXXXX

Design Control

GEN-QMS9100, Sect. 7.3

Program Documents, Drawing Sect. 4.2 & 7.3

Change ControlGEN-CMI2001Document and

GEN-QMS9100

GEN-QAI 0412

Output

Input

Fig 4


Improvement ProcessManagement ResponsibilityGEN-QMS9100, Sect. 5.0

Continuous Improvement ProducibilityPolicy & Procedures 1011 Dept 311 Process Improvement

TeamsPolicy & Procedures1011

Router Improvement Integrated Product TeamsForm SF-QA006 Policy & Procedure

1011

Cost of QualityGEN-QAI2101 Performance Goals Variation Reduction

GEN-OP2001

Internal AuditsEmployee Suggestions GEN-QAI1701Policy & Procedures

211

Customer Input Supplier Review BoardPolicy & Procedure 402 GEN-QAI0621

GEN-QMS9100Sect. 5.2 Management Review

GEN-QAI1401Expense & Capital BudgetDevelopment

Performance GoalsProduct Deficiency Review

Tactical Strategic Nonconforming Mat'lReview

Resource Allocation Corrective & Preventive GEN-QAI1301Action System Gen-QAI1305

Records GEN-QAI1401GEN-QAI1601GEN-QAI1602

Capital Expenditures/FacilityUpgrades

Product Design ChangesMethods Improvements GEN-QAI0412

Process ChangesPerformance Reporting GEN-QAI0902

Output

Input

Fig 5


Management Review Process

Supplier PerformanceGEN-QAI0621


Internal Audits Continuous ImprovementGEN-QAI1701 Policy & Procedures 1011

Variation ReductionGEN-OP2001

Realization Performance

GEN-QAI1303GEN-QAI1013

Nonconforming Material Quality RecordsGEN-QAI1305 GEN-QAI1601GEN-QAI1307

Cost of QualityGEN-QAI2101

Management ReviewMetrics and Company Performance GoalsGEN-QMS9100

Quality System Management ReviewGEN-QAI1401

Preventive ActionRecordsGEN-QAI1601GEN-QAI1602

Continuous Improvement Tactical & Strategic Goals,Policy & Procedures 1011 Other Action Items


Output

Input

Fig 6


Metrology ProcessManagement ResponsibilityGEN-QMS9100Sect. 5.0

Contract ReviewGEN-QAI0301

Document ControlGEN-QMS9100, Sect. 4.2 & 7.3

Configuration ControlGEN-CMIXXXX

Quality Program PlanningGEN-QAI0101

Quality SystemsGEN-QMS9100Sect. 4.0 Control of Hard Tooling

GEN-OP5118

Internal AuditingGEN-QAI1701

Measurement & Test EquipmentGEN-MET1101

Metrology

GEN-MET1101

ESDS Workstations Training GEN-GR7001 GEN-QAI1801

Records Handing ESDSGEN-QAI1101 GEN-GR7000GEN-QAI1601

Product Process ControlGEN-QAI0902

Manufacturing, Assembly & Test

GEN-OP5008 Receiving InspectionGEN-QAI1002

Statistical Sampling for Acceptance In-Process InspectionGEN-IP1000 GEN QAI1003

Creating ATP Final Inspection GEN-QAI0901 GEN-QAI1004

Calibration Supplier ApprovalGEN-QAI0621

.Metrology Personnel QualificationsGEN-MET1102

Output

Input

Fig 7


Monitoring & Measurement ProcessFor Product & Processes

Corrective Action SystemQuality Systems

Management Responsibility PlanningGEN-QMS9100 GEN-QMS9100 Program Directive Sect. 5.0 Sect. 5.4.2 Policy & Procedure 357

Customer ConcernsGEN-QAI1402

Audits Inventory ControlGEN-QAI1701 Receiving

GEN-IMM1000

Manufacturing OrderSystemGEN-OP5008

Customer SatisfactionPolicy & Procedure

402

Metrology Product VerificationGEN-MET1101 Receiving Inspection GEN-QMS9100

GEN-QAI1002 Sect. 7.0 & 8.0 Product Support

In-Process Inspection First Article InspectionGEN-QAI1003 Statistical Sampling for Acceptance GEN-QAI1013

GEN-IP1000Final Inspection TrainingGEN-QAI1004 GEN-QAI1801

QA Test Surveillance Completed Mat'l ProcessingGEN-QAI1010 Repair Station for Acft Industry

GEN-OP1012 GEN-OP1007Records GEN-OP1017GEN-QAI1601GEN-QAI1602

Reject & Failure ReportingGEN-QAI1307GEN-QAI1305

Quality Data SystemGEN-QAI1303

Management Review Data Continual ImprovementGEN-QMS9100 Policy & Procedure

Sect. 5.6 1011

IRB & FRBGEN-QAI1401

Output

Input

Fig 8


Nonconforming Material Control Process

Management ResponsibilityGEN-QMS9100 Quality Policy & Objectives Program Directive Sect. 5.0 Policy & Procedures 1011 Policy & Procedure

357 Product RejectionGEN-QAI1002GEN-QAI1003

Process Performance GEN-QAI1004GEN-OP2001 Product Realization GEN-QAI1901GEN-IP1000 GEN-OPXXXX

GEN-PSXXXX

Customer Requirements &

Statutory/Regulatory Requirements

GEN-QAI0301Internal Audits SF-QA001GEN-QAI1701

Recommendations forNC Process ImprovementsPolicy & Procedure

1011Quality SystemsGEN-QMS9100Sect. 4.0

Control of Nonconforming MaterialGEN-QAI1301

Customer Field ReportsPolicy & Procedure 402 Trend Analysis Test Failure ReportingGEN-QAI1901 GEN-QAI1301 GEN-QAI1305

Software Problem Material Review Board Failure Review BoardReporting GEN-QAI1301 GEN-QAI1303GEN-QAI1310

Standard Repair Control of NonconformingGEN-QAI1309 CFE/GFE & CFP/GFP

Preventive Action GEN-QAI0701Records GEN-QAI1401 GEN-GPP1001 & 2GEN-QAI1601 Corrective Action

& Follow-upGEN-QAI1401

ImprovedSupplier PerfirmanceGEN-QAI0601

Required Resources Customer Satisfaction GEN-QAI0602GEN-QMS9100 Policy & Procedure GEN-QAI0621 Sect. 6.0 402

Product Improvement Design ChangesCost of Quality Data Policy & Procedure 1011 GEN-CMI1003

GEN-QAI2101SCRAPProcessing Conforming ProductGEN-QAI1308

Customer Concerns

GEN-QAI1402

Output

Input

Fig 9


Production & Service ProvisionProgram Directive

Policy & Procedure 357 Corrective Action SystemGEN-QAI1401 Policy & Procedures 402

Program Management

Policy & Procedures 401 Continual ImprovementContract Review Policy & Procedures 1011GEN-QAI0301SF-QA001

Cost of QualityInternal Audits GEN-QAI2101

GEN-QAI1701 Configuration Management

CMIXXXVariation ReductionGEN-OP2001 Management

Review

Management Responsibility Quality Systems GEN-QMS9100GEN-QMS9100 GEN-QMS9100 Sect. 5.6Sect. 5.0 Sect. 4.0

Human ResourcesPolicy & Procedures 205

Training

Design Control GEN-QAI1801GEN-QAI0412

Quality Program Planning Production Order SystemGEN-QAI0101 GEN-OP5008

Work Instructions

Machining, Assembly, & Test Statistical TechniquesGEN-OPXXXX's GEN-QAI2001

GEN-PSXXXX's GEN-OP2001ATP's

Field ReturnsInventory Management GEN-QAI1901

Records Receiving, Stockroom, & Shipping

GEN-QAI1601 GEN-IMM1000

Monitoring & MeasuringContinual Improvement Processes

Policiy & Procedure DELIVERABLES1011 Hardware & Service


Output

Input

Fig 10


Procurement ProcessManagement ResponsibilityGEN-QMS9100, Sect. 5.0

Quality SystemsContract Review GEN-QMS9100GEN-QAI0301 Sect. 4.0SF-QA001

Program Directive Policy & Procedure 357

Quality Program PlanningGEN-QAI0101 Design Control

GEN-QAI0412

Design Procurement SpecificationGEN-QAI0420

Program Quality PlanExample:N01-QPP1000

Document ControlGEN-QMS9100, Sect. 4.2 & 7.3

AuditsConfiguration Control GEN-QAI1701

GEN-CMIXXXX

Production Order SysGEN-OP5008Outside Processes

PR GenerationGEN-OP1015

PR ApprovalGEN-QAI0601

PO GenerationGEN-PPM1000

RecordsGEN-QAI1601GEN-QAI1602

Produce ReceiptGEN-IMM1000

Receiving InspectionGEN-QAI1002

Stock Room Quality Data ReportingGEN-IMM1000 GEN-QMS9100, Sect 5.6

Supplier ApprovalGEN-QAI0621

.Source Delegation ProcessGEN-QAI0602

Output

Input

Fig 11



Appendix B

Overview of Documents Required to Ensure Effective:

Planning Operation and Control of Fairchild Processes

o Quality Mgt. System Directiveo Quality Policy and Continuous Improvement Philosophyo Signed by President

Level 1 Documentso Directive Policieso Includes Cost of Quality & Product Safety/Liability

Level 2 Documentso "How To" Documentso Define Responsibilities for Applicable Departmentso Deploy Level 1 Requirementso Specific Process or Task Orientedo Identify Quality Records

o Route Product Through a Level 3 Documents Production Process

o Refer to Other Documents as Applicableo Provide Evidence of Processing & Servicing

Guidelines for Document Structureo General Procedures GEN-CMI1000o Test Procedures GEN-QAI0901o Qualification Test Reports GEN-OP9001

Fig 12 QMS Definition o Product Work Instructions GEN-OP5008

(OP)

ProcessSpecifications

(PS)

TestProcedures

(QAI)

Other

(CMI)

Operating ProceduresInstructions

Configuration Mgt.

AS 9100 SAE International Aerospace Standard

Records - Level 4 Documents


Quality Manual (GEN-QMS9100)


Procedures(GEN-XXXXXX)

Drawings & Work Instructions

Quality AssuranceInstructions


4.0 QUALITY MANAGEMENT SYSTEM 7.0 PRODUCT REALIZATION

4.1 General Requirements 7.1 Planning of Product RealizationGEN-QMS9100, Section 4.0 GEN-QMS9100, Section 7.0

GEN-QAI01014.2 Document Requirements GEN-OPXXXX, GEN-PSXXXX

P&P 1011 MPS XXX, SF XXXGEN-QMS9100, Section 4.0GEN-QAI0201, GEN-QAI1601 7.2 Customer Related ProcessesGEN-CMIXXXX P&P 402

GEN-QMS9100, Section 7.04.3 Configuration Management GEN-QAI0101, GEN-QAI0201

GEN-QMS9100, Section 4.0 GEN-QAI0301, GEN-OP1007, GEN-OP1012GEN-CMIXXXX

7.3 Design and Development5.0 MANAGEMENT RESPONSIBILITY GEN-QMS9100, Section 7.0

GEN-QAI04XX, GEN-QAI0901, GEN-QAI16015.1 Management Commitment GEN-QAI2202, GEN-CMIXXXX

P&P 1011GEN-QMS9100, Section 5.0 7.4 Purchasing

GEN-QMS9100, Section 7.0, T&C's Clause 165.2 Customer Focus GEN-QAI0101, GEN-QAI0420, GEN-QAI0601

P&P 402, P&P 1011 GEN-QAI0602, GEN-QAI0621, GEN-QAI0901GEN-QMS9100, Section 5.0 GEN-QAI1002, GEN-MM1000, GEN-OP1015, GEN-OP5032

5.3 Quality Policy 7.5 Production and Service ProvisionP&P 1011 GEN-QMS9100, Section 7.0

GEN-QAI0101, GEN-QAI0201, GEN-QAI06015.4 Planning GEN-QAI0701, GEN-QAI0901, GEN-QAI10XX

GEN-QMS9100, Section 5.0 GEN-QAI1601, GEN-QAI1701, GEN-QAI1901GEN-QAI1401 GEN-CMIXXXX, GEN-GPP10XX, GEN-GR7000

GEN-IMM1000, GEN-HP1000, GEN-IP1000, GEN-MET11XX5.5 Responsibility, Authority & Communication GEN-OPXXXX, GEN-PSXXXX, SF XXX, Routers

GEN-QMS9100, Section 5.0GEN-QAI0101, GEN-QAI1401 7.6 Control of Monitoring & Measuring Devices

GEN-QMS9100, Section 7.05.6 Management Review GEN-QAI0101, GEN-QAI1002, GEN-MET11XX

GEN-QMS9100, Section 5.0 GEN-IP1000, GEN-OP5000, Dwgs, SpecsGEN-QAI1401

8.0 MEASUREMENT, ANALYSIS & IMPROVEMENT6.0 Resource Management

8.1 General6.1 Provision of Resources P&P 1011

P&P 1011 GEN-QMS9100, Section 8.0GEN-QMS9100, Section 6.0 GEN-QAI0402, GEN-OP2001

6.2 Human Resources 8.2 Monitoring and MeasuringGEN-QMS9100, Section 6.0 P&P 402, GEN-QMS9100, Section 8.0GEN-QAI1601 GEN-QAI0406, GEN-QAI0420GEN-QAI1801 GEN-QAI0601, GEN-QAI0901, GEN-QAI2001

GEN-QAI1002, GEN-QAI1003, GEN-QAI10046.3 Infrastructure GEN-QAI13XX, GEN-QAI1401, GEN-QAI1601

P&P 901 GEN-QAI1701, GEN-QAI1901, GEN-CMI1005GEN-QMS9100, Section 6.0 GEN-IP1000, GEN-OP1012, GEN-OP2001GEN-QAI0101 GEN-OP5008, GEN-OP5032, GEN-OP5033GEN-OP1014

8.3 Control of Nonconforming Product6.4 Work Environment GEN-QMS9100, Section 8.0

GEN-QMS9100, Section 6.0 GEN-QAI1002, GEN-QAI1003, GEN-QAI1004GEN-OP1014, GEN-OP5000 GEN-QAI13XX, GEN-QAI1901GEN-PS1009, GEN-GR7000

8.4 Anslysis of DataGEN-QMS9100, Section 8.0, GEN-QAI0621GEN-QAI1303, GEN-QAI1401, GEN-QAI1402GEN-QAI1701, GEN-QAI1901, GEN-QAI2101

8.5 ImprovementP&P 1011, GEN-QMS9100, Section 8.0

Fig 13 GEN-QAI1401



Appendix C

Organization Chart

FAIRCHILD CONTROLS CORPORATION

CEO &*PRESIDENT

HUMAN RESOURCES*DIRECTOR

PROGRAM MANAGEMENT

*VICE PRESIDENT

CTO/ADVANCED PRODUCTS

*VICE PRESIDENT

*EXECUTIVE MANAGEMENT POSITIONS

INTEGRATED SUPPLY CHAIN

*VICE PRESIDENT

PROCUREMENT & SUBCONTRACTS

MANAGER

ENGINEERING *VICE PRESIDENT

ELECTRICALDESIGN

DIRECTOR

MECHANICALDESIGN

DIRECTOR

MECHANICALCHIEF

ENGINEER

PROJECT/TESTENGINEERING

DIRECTOR

ELECTRONICSCHIEF

ENGINEER

SOFTWARE& CONTROLS

CHIEF ENGINEER

CHIEF FINANCIAL OFFICER

*VICE PRESIDENT

CONTRACTS MANAGER

ACCOUNTINGDIRECTOR

INFORMATION TECHNOLOGY

MANAGER

FINANCIALPLANNING &

ANALYSISDIRECTOR

QUALITY AND RELIABILITY ASSURANCE*DIRECTOR

QUALITY AND RELIABILITY

ENGINEERING MANAGER

QUALITY SYSTEMSAND SUPPLIER

QUALITY ASSURANCE

QUALITY CONTROL

SUPERVISOR

CONFIGURATION& DATA MGT

MANAGER

METROLOGYSUPERVISOR

CUSTOMER SUPPORT & SERVICES

*DIRECTOR

PRODUCT SUPPORT

ADMINISTRATION

OTHER PROGRAM

MANAGERS

SOFTWAREENGINEERING

DIRECTOR

MANUFACTURINGOPERATIONS

DIRECTOR

OPERATIONS PLANNING & STRATEGIC SOURCING DIRECTOR

MATERIALSMANAGER

MANUFACTURING ENGINEERING

MANAGER

PRECISIONMACHININGMANAGER

REPAIR STATION & MANUFACTURING

SUPERVISOR

PROGRAM CONTROLMANAGER

ENGINEERINGLAB

MANAGER

PROJECTENGINEERING

BUSINESSDEVELOPMENT

SYSTEMS &TECHNOLOGY

ELECTRONICOPERATIONS

DIRECTOR

PRINTED DOCUMENT IS FOR REFERENCE ONLY. GEN-QMS9100, Revision D VERIFY CURRENT REVISION WITH ON-LINE SYSTEM. 33 of 33