AS9100 QMS Process Manual
AS9100 QMS Process Manual
AS9100 QMS Process Manual
GEN-QMS9100, Revision D 1 of 33
TABLE OF CONTENTS
Par. Description Sheet
1.0 1.1 1.2 2.0 3.0 4.0 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.3 5.0 5.1 5.1.1 5.2 5.2.1 5.2.2 5.3 5.4 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3 5.6 6.0 6.1 6.2 6.2.1 6.2.2 6.2.3 6.3 6.4 7.0
SCOPE General Application NORMATIVE REFERENCE TERMS AND DEFINITIONS QUALITY MANAGEMENT SYSTEM General Documentation Documentation Requirements Quality Manual Document Control Record Control Configuration Management MANAGEMENT RESPONSIBILITY Management Commitment Executive Management Customer Focus Determination and Compliance Customer Satisfaction Assessment Quality Policy Planning Quality Objectives QMS Planning Responsibility, Authority and Communication Executive Management Representative Functional Management Internal Communication Management Review RESOURCE MANAGEMENT Provision of Resources Human Resources Competency, Awareness and Training Position Descriptions Personnel Reviews and Appraisals Infrastructure Work Environment PRODUCT REALIZATION
4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 7 7 7 7 7 7 7 8 8 8 8 8 9 9 9 9 9 10 10 10 10 GEN-QMS9100, Revision C 2 of 33
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7.1 7.2 7.2.1 7.2.2 7.3 7.4 7.4.1 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 8.0 8.1 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5 8.5.1 8.5.2 8.5.3
Planning of Product Realization Customer-Related Processes Determination and Review of Requirements Customer Communication Design and Development Purchasing Purchasing Process Production and Service Provision Control of Production and Service Provision Validation of Processes for Production and Service Provision Identification and Traceability Customer Property Preservation of Product Control of Monitoring and Measuring Devices MEASUREMENT, ANALYSIS, AND IMPROVEMENT General Planning and Implementation of Measurement, Analysis and Improvement Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring and Measurement of Processes Monitoring and Measurement of Product Control of Nonconforming Product Analysis of Data Improvement Continual Improvement Corrective Action Preventive Action
10 10 11 11 11 11 11 12 12 13 13 13 13 13 14 14 14 14 14 14 15 15 15 15 15 16 16
Appendix
A B
Title
Overview of Process Sequence and Interactions (Figures 1 through 11) Overview of Documents Required to Ensure Effective: Planning Operation and Control of Fairchild Processes (Figures 12 & 13)
Sheet
17
29 32
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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.
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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, reapproval, 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.
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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 GENQAI1602. 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.
Fairchilds 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. c. d. e. Defines Quality Policy and assures it is appropriate to the company by Executive Management approval. Ensures that the framework for Quality Objectives is established and remains suitable at all levels throughout the company, see 5.1.4 Quality Objectives. Ensures the availability of adequate resources through periodic manpower reviews. 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. g. Ensures the integrity of the QMS is maintained at all times through an aggressive Internal Audit Program and Management Review. Ensures that Functional Management communicates applicable responsibility and authority within the company through position descriptions and organization charts.
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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.
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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;
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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.
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 GENQAI1801, 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.
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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)
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. b. c. d. e. Quality Objectives and requirements for the product. (See 5.4) The need to establish processes, documents, and provide resources specific to the product. (See 5.4, 6.1 & 6.2) Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance. (See 7.3 & 8.2) Records needed to provide evidence that the realization processes and resulting product meet requirements. (See 4.2.3) 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)
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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. b. c. d. e. Stated customer requirements including delivery and post-delivery activities. Unspecified customer requirements necessary for specified or intended use, where known. Statutory and regulatory product related requirements. Additional requirements determined by Fairchild. 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:
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Material Control GEN-OP1015 Purchasing Request Generation Procedure & GENOP5008 Production Order System Procurement Quality Assurance GEN-QAI0601 Procurement Document Review, GENQAI0602 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)
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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
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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 GENMET1102, and Metrology Historical Records GEN-QAI1101. (See Appendix A, Figure 7)
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 Fairchilds 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)
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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)
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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)
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Input Common to all Processes o o o o o o Quality Policy Quality Objectives & Measures Planning Communication Management Responsibility Resource Management
o Internal Audit
Procurement Process
Analysis of Data
Customer Satisfaction
Management Review Process
Continual Improvement
Fig 1
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Data Review GEN-CMI1003 GEN-CMI1005 Cost of Quality GEN-QAI2101 Qualification Reporting GEN-OP9001
Records GEN-QAI1601
Product & Method Improvement, Effectiveness of Product Improvements Policy & Procedure 1011
Fig 2
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Customer-Related Process
Customer Requirements
Proposals/Contract Submittal Product Support Orders Spares Maintenance Requests Regulatory & Statuatory Requirement
Quality Systems GEN-QMS9100 Sect. 4.0 Quality Program Planning GEN-QAI0101 Input
Contracts GEN-QMS9100, Sect. 7.2.1 GEN-QAI0301 Solicitation Review Reviews Operations Quality Assurance Programs Finance
Identify & Resolve Discrepencies Issue Sales Orders Records GEN-QAI1601 Finance - Issues Program Directive & Budgets Policy & Procedure 357
Output Sales Order Notification SF-CON004 Program Office Request for Program Directive Policy & Procedure 357
Product Deliverables
Fig 3
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Input
Design Control GEN-QMS9100, Sect. 7.3 GEN-QAI 0412 Document and Change Control GEN-QMS9100 Sect. 4.2 & 7.3 CMIXXXX Product Safety & Liability GEN-QAI2201 Software Design Control GEN-QAI04XX Design Notebooks Previous Similar Designs GEN-QAI1601
Output Records GEN-QAI1601 Qualification Procedures & Reports GEN-OP9001 Key Characteristics GEN-QAI2001 GEN-OP2001 Production & Service GEN-QAI0902
Fig 4
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Improvement Process
Management Responsibility GEN-QMS9100, Sect. 5.0 Continuous Improvement Policy & Procedures 1011 Producibility Dept 311 Process Improvement Teams Policy & Procedures 1011 Integrated Product Teams Policy & Procedure 1011
Performance Goals
Supplier Review Board GEN-QAI0621 Management Review GEN-QAI1401 Expense & Capital Budget Development Performance Goals Product Deficiency Review Tactical Strategic Resource Allocation Corrective & Preventive Action System GEN-QAI1401 Nonconforming Mat'l Review GEN-QAI1301 Gen-QAI1305
Methods Improvements
Performance Reporting
Fig 5
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Realization Performance GEN-QAI1303 GEN-QAI1013 Nonconforming Material GEN-QAI1305 GEN-QAI1307 Quality Records GEN-QAI1601
Input
Quality System Management Review GEN-QAI1401 Preventive Action Records GEN-QAI1601 GEN-QAI1602
Output
Fig 6
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Metrology Process
Management Responsibility GEN-QMS9100 Sect. 5.0
Contract Review GEN-QAI0301 Document Control GEN-QMS9100, Sect. 4.2 & 7.3 Configuration Control GEN-CMIXXXX Quality Program Planning GEN-QAI0101 Quality Systems GEN-QMS9100 Sect. 4.0 Internal Auditing GEN-QAI1701
Measurement & Test Equipment GEN-MET1101 Calibration Supplier Approval GEN-QAI0621 Metrology GEN-MET1101 .Metrology Personnel Qualifications GEN-MET1102 Training GEN-QAI1801 Handing ESDS GEN-GR7000
Product Process Control GEN-QAI0902 Manufacturing, Assembly & Test GEN-OP5008 Statistical Sampling for Acceptance GEN-IP1000 Creating ATP GEN-QAI0901
Receiving Inspection GEN-QAI1002 In-Process Inspection GEN QAI1003 Final Inspection GEN-QAI1004
Fig 7
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Metrology GEN-MET1101
Receiving Inspection GEN-QAI1002 In-Process Inspection GEN-QAI1003 Final Inspection GEN-QAI1004 QA Test Surveillance GEN-QAI1010
Product Verification GEN-QMS9100 Sect. 7.0 & 8.0 Product Support First Article Inspection GEN-QAI1013 Training GEN-QAI1801 Completed Mat'l Processing for Acft Industry GEN-OP1007
Output
Fig 8
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Customer Requirements & Customer Concerns GEN-QAI1402 Internal Audits GEN-QAI1701 Recommendations for NC Process Improvements Policy & Procedure 1011 Quality Systems GEN-QMS9100 Sect. 4.0 Control of Nonconforming Material GEN-QAI1301 Customer Field Reports Policy & Procedure 402 GEN-QAI1901 Trend Analysis GEN-QAI1301 Software Problem Reporting GEN-QAI1310 Test Failure Reporting GEN-QAI1305 Material Review Board GEN-QAI1301 Standard Repair GEN-QAI1309 Records GEN-QAI1601 Preventive Action GEN-QAI1401 Corrective Action & Follow-up GEN-QAI1401 Improved Supplier Perfirmance GEN-QAI0601 GEN-QAI0602 GEN-QAI0621 Failure Review Board GEN-QAI1303 Control of Nonconforming CFE/GFE & CFP/GFP GEN-QAI0701 GEN-GPP1001 & 2 Statutory/Regulatory Requirements GEN-QAI0301 SF-QA001
Input
Output
Conforming Product
Fig 9
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Customer Satisfaction
Policy & Procedures 402
Program Management Policy & Procedures 401 Contract Review GEN-QAI0301 SF-QA001 Internal Audits GEN-QAI1701
Variation Reduction GEN-OP2001 Management Responsibility GEN-QMS9100 Sect. 5.0 Human Resources Policy & Procedures 205 Design Control GEN-QAI0412 Input Quality Systems GEN-QMS9100 Sect. 4.0
Training GEN-QAI1801
Records GEN-QAI1601
Fig 10
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Procurement Process
Management Responsibility GEN-QMS9100, Sect. 5.0 Contract Review GEN-QAI0301 SF-QA001 Quality Systems GEN-QMS9100 Sect. 4.0 Program Directive Policy & Procedure 357 Quality Program Planning GEN-QAI0101
Program Quality Plan Example: N01-QPP1000 Document Control GEN-QMS9100, Sect. 4.2 & 7.3 Configuration Control GEN-CMIXXXX Audits GEN-QAI1701 Input
Production Order Sys GEN-OP5008 Outside Processes PR Generation GEN-OP1015 Supplier Approval GEN-QAI0621 PR Approval GEN-QAI0601 .Source Delegation Process GEN-QAI0602
Fig 11
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Appendix B Overview of Documents Required to Ensure Effective: Planning Operation and Control of Fairchild Processes
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AS 9100 SAE International Aerospace Standard o Quality Mgt. System Directive o Quality Policy and Continuous Improvement Philosophy o Signed by President o Directive Policies o Includes Cost of Quality & Product Safety/Liability
Level 2 Documents o "How To" Documents o Define Responsibilities for Applicable Departments o Deploy Level 1 Requirements o Specific Process or Task Oriented o Identify Quality Records
Test Procedures
Level 3 Documents
o Route Product Through a Production Process o Refer to Other Documents as Applicable o Provide Evidence of Processing & Servicing
Guidelines for Document Structure o General Procedures GEN-CMI1000 o Test Procedures GEN-QAI0901 o Qualification Test Reports GEN-OP9001 o Product Work Instructions GEN-OP5008
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4.0
7.0
PRODUCT REALIZATION
7.1 Planning of Product Realization GEN-QMS9100, Section 7.0 GEN-QAI0101 GEN-OPXXXX, GEN-PSXXXX MPS XXX, SF XXX Customer Related Processes P&P 402 GEN-QMS9100, Section 7.0 GEN-QAI0101, GEN-QAI0201 GEN-QAI0301, GEN-OP1007, GEN-OP1012 Design and Development GEN-QMS9100, Section 7.0 GEN-QAI04XX, GEN-QAI0901, GEN-QAI1601 GEN-QAI2202, GEN-CMIXXXX Purchasing GEN-QMS9100, Section 7.0, T&C's Clause 16 GEN-QAI0101, GEN-QAI0420, GEN-QAI0601 GEN-QAI0602, GEN-QAI0621, GEN-QAI0901 GEN-QAI1002, GEN-MM1000, GEN-OP1015, GEN-OP5032 Production and Service Provision GEN-QMS9100, Section 7.0 GEN-QAI0101, GEN-QAI0201, GEN-QAI0601 GEN-QAI0701, GEN-QAI0901, GEN-QAI10XX GEN-QAI1601, GEN-QAI1701, GEN-QAI1901 GEN-CMIXXXX, GEN-GPP10XX, GEN-GR7000 GEN-IMM1000, GEN-HP1000, GEN-IP1000, GEN-MET11XX GEN-OPXXXX, GEN-PSXXXX, SF XXX, Routers Control of Monitoring & Measuring Devices GEN-QMS9100, Section 7.0 GEN-QAI0101, GEN-QAI1002, GEN-MET11XX GEN-IP1000, GEN-OP5000, Dwgs, Specs
4.2
7.2
4.3
7.3 5.0 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment P&P 1011 GEN-QMS9100, Section 5.0 Customer Focus P&P 402, P&P 1011 GEN-QMS9100, Section 5.0 Quality Policy P&P 1011 Planning GEN-QMS9100, Section 5.0 GEN-QAI1401 Responsibility, Authority & Communication GEN-QMS9100, Section 5.0 GEN-QAI0101, GEN-QAI1401 Management Review GEN-QMS9100, Section 5.0 GEN-QAI1401 8.0 6.0 Resource Management 8.1 6.1 Provision of Resources P&P 1011 GEN-QMS9100, Section 6.0 Human Resources GEN-QMS9100, Section 6.0 GEN-QAI1601 GEN-QAI1801 Infrastructure P&P 901 GEN-QMS9100, Section 6.0 GEN-QAI0101 GEN-OP1014 8.3 6.4 Work Environment GEN-QMS9100, Section 6.0 GEN-OP1014, GEN-OP5000 GEN-PS1009, GEN-GR7000 8.4 8.2 7.5
7.4
5.2
5.3
5.4
5.5
7.6
5.6
MEASUREMENT, ANALYSIS & IMPROVEMENT General P&P 1011 GEN-QMS9100, Section 8.0 GEN-QAI0402, GEN-OP2001 Monitoring and Measuring P&P 402, GEN-QMS9100, Section 8.0 GEN-QAI0406, GEN-QAI0420 GEN-QAI0601, GEN-QAI0901, GEN-QAI2001 GEN-QAI1002, GEN-QAI1003, GEN-QAI1004 GEN-QAI13XX, GEN-QAI1401, GEN-QAI1601 GEN-QAI1701, GEN-QAI1901, GEN-CMI1005 GEN-IP1000, GEN-OP1012, GEN-OP2001 GEN-OP5008, GEN-OP5032, GEN-OP5033 Control of Nonconforming Product GEN-QMS9100, Section 8.0 GEN-QAI1002, GEN-QAI1003, GEN-QAI1004 GEN-QAI13XX, GEN-QAI1901 Anslysis of Data GEN-QMS9100, Section 8.0, GEN-QAI0621 GEN-QAI1303, GEN-QAI1401, GEN-QAI1402 GEN-QAI1701, GEN-QAI1901, GEN-QAI2101 Improvement P&P 1011, GEN-QMS9100, Section 8.0 GEN-QAI1401
6.2
6.3
8.5 Fig 13
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BUSINESS DEVELOPMENT
ACCOUNTING DIRECTOR
QUALITY AND RELIABILITY ENGINEERING MANAGER QUALITY SYSTEMS AND SUPPLIER QUALITY ASSURANCE
ELECTRONICS CHIEF ENGINEER MECHANICAL DESIGN DIRECTOR MECHANICAL CHIEF ENGINEER SOFTWARE ENGINEERING DIRECTOR SOFTWARE & CONTROLS CHIEF ENGINEER PROJECT/TEST ENGINEERING DIRECTOR ENGINEERING LAB MANAGER
CONTRACTS MANAGER
PROJECT ENGINEERING
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