Definitions contained in the above mentioned Specifications and Industry Standards are applicable herein.

Transcription

1 1. SCOPE Quality Specification TEC Jul 11 Rev C All Paragraphs Revised Global Quality Management System Supplement for the Aerospace Industry Model, AS 9100 (C) 1.1. Content This specification defines the aerospace industry Quality Management System requirements in accordance with AS 9100 (C), Quality Management Systems Aerospace-Requirements. The Aerospace Standard may also be identified as SAE / AS / EN / or SJAC In addition, this document is a supplement to Quality Specification in providing criteria for compliance to aerospace industry requirements. Alignment to Quality Specification is achieved through the ISO 9001:2008 paragraph tables which address each additional AS 9100 (C) requirement Application This specification is applicable to all TE Connectivity business organizations. In recognition of the varying organizational structures and needs, business organizations may develop and use support specifications and/or procedures. However, such supporting documentation shall not conflict with or supersede this specification. 2. APPLICABLE DOCUMENTS The following documents constitute a part of this specification to the extent specified herein. Unless otherwise specified, the latest edition of the document applies Specifications A. Global Quality Management System B. TEC-1003 Supplier Performance Reporting and Continual Improvement Process C. TEC-1005 TE Total Quality Management Requirements for Suppliers D. TEC-1006 Approval of Suppliers E. TEC LEANPD Development Execution 2.2. Forms D Corrective Action Worksheet (TECHS) 2.3. Industry Standards A. AS 9100 (C) Quality Management Systems Requirements for Aviation, Space, and Defense Organizations B. AS 9101 (D) Quality Management Systems Audit Requirements for Aviation, Space, and Defense Organizaitons C. AS 9102 (A) First Article Inspection D. ISO 9001:2008 Quality management systems Requirements E. ISO 10007:2003 Quality management systems Guidelines for configuration management 3. DEFINITIONS Definitions contained in the above mentioned Specifications and Industry Standards are applicable herein. On all subsequent pages, Bold Text in the right hand column represents TE commentary Tyco Electronics Corporation, a TE Connectivity Ltd. Company All Rights Reserved Indicates Change *Trademark. TE Connectivity, TE connectivity (logo), and TE (logo) are trademarks. Other logos, product and/or Company names may be trademarks of their respective owners. 1 of 31 LOC B

2 4. QUALITY MANAGEMENT SYSTEM (QMS) 4.1. QMS General Requirements 4.1 General Requirements The organization s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements. Documented customer, statutory, and regulatory requirements applicable to the TE Quality Management System will be controlled in accordance with established and documented procedures defining the manner of control for documents of external origin. Customer, statutory and regulatory requirements related to product design and performance may be incorporated into TE product specifications, which will include the applicable version of the external requirement Documentation Requirements Documentation Requirements General Quality Manual Document and Data Control Initial Issue Changes Drawings, Standards, and Specifications 4.2. Documentation Requirements General The organization shall ensure that personnel have access to, and are aware of, relevant quality management system documentation and changes. Management will implement processes and controls ensuring that all TE associates are aware of and have ready access to documentation pertinent to their assignments. This may be accomplished through access to electronic mediums or the controlled distribution of hard copies. As requested, customers and regulatory authority representatives will be granted access to relevant quality management system documentation. This documentation should be classified as non-confidential classified per defined TE policy Control of Quality Records Control of Records The documented procedure shall define the method for controlling records that are created by and/or retained by suppliers. Quality management system procedures define the manner for retaining documentation with specific information on record types, retention intervals, and responsibilities. Record retention requirements relative to documentation created by and/or retained by suppliers is defined procedurally with specific record types and retention interval. These procedures shall be in accordance with TE record management policies. Rev C 2 of 31

3 5. MANAGEMENT RESPONSIBILITY Management Commitment Customer Focus Quality Policy Planning Quality Objectives QMS Planning Responsibility, Authority and Communication Responsibility and Authority Management Representative Internal Communication Management Review General Review Input Review Output 5.2. Customer Focus Top management shall ensure that product conformity and ontime delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved. Product conformity and on-time delivery performance are key TE Global Quality Measurements that are tracked, reported, reviewed, and acted upon throughout all organizational levels including top management. These measurements are reviewed monthly with the reviews posted on the TE intranet Management Representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes: The organizational freedom and unrestricted access to top management to resolve quality management issues. TE, business organization, and facility top management shall appoint representatives who, irrespective of other responsibilities, shall have the responsibility and authority for ensuring that the requirements of the quality management system defined in, and supplemented by this document, are established, implemented, and maintained. Additionally, these representatives shall have unrestricted access to top management and be granted the freedom and authority to resolve issues pertaining to quality management including identifying and resolving problems and conditions adverse to quality, verification of problem resolutions, and the authority to withhold from continued production or release for shipment, products not in conformance with acceptance criteria. Rev C 3 of 31

4 6. RESOURCE MANAGEMENT Provision of Resources Human Resources General Competence, Training, and Awareness Human Resources Function Qualification Training Training Effectiveness Infrastructure Work Environment Rev C 4 of 31

5 7. PRODUCT REALIZATION Planning of Product Realization New Product Introduction Disaster Recovery Planning 7.1. Planning of Product Realization In planning for product realization, the organization shall determine the following, as appropriate: Quality objectives and requirements for the product; Quality objectives and requirements for the product include consideration of aspects such as Product and personal 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. Product requirements and quality objectives are determined and established through the different design and development tasks detailed in Section 7.3 (Design and Development) and in related quality specifications. Design and development is carried out based on product requirements and quality objectives in accordance with customer, statutory, and regulatory requirements. Product requirements and quality objectives shall include applicable safety and reliability parameters. Design and development planning shall consider the ability to produce, inspect, test and maintain product and any requirements relative to product disposal. In planning for product realization, the organization shall determine the following, as appropriate: Configuration management appropriate to the product; Configuration management is maintained through the utilization of engineering change control and through the control of process documentation. In planning for product realization, the organization shall determine the following, as appropriate: Resources to support operation and maintenance of the product. Rev C 5 of 31

6 It is the responsibility of Management to ensure that the resources essential to product support and maintenance throughout product realization are identified during the planning processes. Resource planning may occur during the budgeting process and be adjusted during the year in response to sales growth, profit plans, capacity constraints, changing customer requirements, and other internal needs Project Management As appropriate to the organization and the product, the organization shall plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints. The management of product realization projects shall use a disciplined approach that includes the development of project plans ensuring successful project completion, specific project objectives, defined roles and responsibilities, and a defined end point. These disciplines shall be used for all products at all levels from proposal through delivery ensuring product quality, on-time delivery, acceptable risk, and resource availability. Project management principles shall be deployed for all product design and development projects. New product development project plans shall be prepared and identify the functional responsibilities for each design and development activity. The plans shall be updated and communicated to the appropriate individuals as each design evolves. The plans shall describe or reference the following activities, as applicable; organizational and technical interfaces between different groups (internal and external) shall be identified and the necessary information documented, transmitted, and reviewed; project roles and responsibilities; project reporting requirements, including tracking and resolving open issues; performance, safety, security, and other critical requirements; any project specific training requirements; and usage or licensing rights. Project management principles shall also be deployed for all TEOA related and other QMS process improvement projects involving product realization processes. Project plans shall identify associated risks, resources, and schedules Risk Management The organization shall establish, implement and maintain a process for managing risk to the achievement of applicable requirements, that includes as appropriate to the organization and the product Assignment of responsibilities for risk management, Definition of risk criteria (e.g., likelihood, consequences, risk acceptance), Rev C 6 of 31

7 Identification, assessment and communication of risks throughout product realization, Identification, implementation and management of actions to mitigate risks that exceed the defined risk acceptance criteria, and Acceptance of risks remaining after implementation of mitigating actions. Risk management methods shall be implemented throughout all product realization processes as a proactive measure to mitigate undesirable situations or circumstances that have a likelihood of occurring with a potentially negative consequence. The risk management processes shall include: risk management responsibility, risk criteria definition, risk identification, assessment, and communication, risk mitigation, and risk acceptance. The primary TE risk management process involves failure mode and effects analysis (FMEA). The FMEA process as defined in Standard Operating procedure TEC , LEANPD Development Execution includes the following risk management processes. BFMEA Business Failure Mode and Effects Analysis: Implemented at the product development project Definition Phase. Identifies potential risks related to successful introduction of the product or service. May include certain customer related requirements and supplier selection. RFMEA Requirements Failure Mode and Effects Analysis: Implemented at the product development project Concept Phase. Identifies potential risks related to specific customer or market requirements and technologies and processes with unproven capabilities. DFMEA Design Failure Mode and Effects Analysis: Implemented at the product development project Design Phase. Identifies potential risks related to product design objectives by analyzing the product s design characteristics relative to their intended function. PFMEA Process Failure Mode and Effects Analysis: Implemented at the product development project Design Phase. Identifies potential risks related to product manufacturing processes that may prevent the product design from meeting it s design objectives by recognizing potential process variables. Other processes used to mitigate risk may involve project management plans. Rev C 7 of 31

8 Configuration Management The organization shall establish, implement and maintain a configuration management process that includes, as appropriate to the product Configuration management planning, Configuration identification, Change control, Configuration status accounting, and Configuration audit. See ISO for guidance. The TE configuration management plan is established and maintained through various documented procedures where responsibilities and authorities are outlined. These responsibilities and authorities include required customer approvals. The scope of the configuration management process includes: Document and data control which addresses the identification, protection, approval, and availability of current issues of all pertinent product and project related documents including designs, specifications, plans, and schedules. Design changes which require that each design change be traceable to an appropriate source and approval. Product identification and traceability which requires that each version of a configuration item be identified by some appropriate means including component parts. Inspection and test status which requires procedures to identify what verification steps and tests have been achieved by the product or product components at each phase in the defined life cycle. Nonconforming product control which requires procedures to ensure that untested, defective, or incorrect versions of the product are not inadvertently used Control of Work Transfers The organization shall establish, implement and maintain a process to plan and control the temporary or permanent transfer of work (e.g., from one organization facility to another, from the organization to a supplier, from one supplier to another supplier) and to verify the conformity of the work to requirements. TE shall establish and maintain a manufacturing location change process that includes a manufacturing location change model, general requirements and responsibilities, checklists, and specific requirements. Rev C 8 of 31

9 Customer Related Processes Determination of Product Related Requirements Review of Product Related Requirements Customer Service Customer Specification Review Customer Communication Design and Development Design and Development Planning Project Planning Review of Requirements Related to the Product The organization shall review the requirements related to product. This review shall be conducted prior to the organization s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that Special requirements of the product are determined, and Risks (e.g., new technology, short delivery time scale) have been identified (see 7.1.2). In cases where the TE part number is confirmed, the customer service representative shall review the order to confirm the pricing and delivery requirements. If any risks or discrepancies are observed, the order is reconciled within the business organization and transmitted to the customer service representative. Booking the order is confirmation that there are no known risks or discrepancies between the customer request and the ability to meet the request. In cases where the customer order or request does not confirm to an established TE part number or special product requirements are determined, appropriate action shall be initiated to eliminate risks and resolve differences to ensure satisfaction of contractual requirements before acceptance of the order. This verification shall include a consideration of verbal and electronic ordering methods as well as a means to convey changes to existing order requirements. Amendments to contracts shall be reviewed and appropriate actions shall be initiated to resolve any differences Design and Development Planning Where appropriate, the organization shall divide the design and development effort into distinct activities and, for each activity, define the tasks, necessary resources, responsibilities, design content, input and output data and planning constraints. The different design and development tasks to be carried out shall be based on the safety and functional objectives of the product in accordance with customer, statutory and regulatory requirements. Design and development planning shall consider the ability to produce, inspect, test and maintain product. Project plans shall be prepared that identify the responsibility, budgets, staffing and schedules for each design and development activity. The plans shall be updated and communicated to the appropriate individuals as each design evolves. The plans shall describe or reference the following activities, as applicable: Organizational and technical interfaces between different groups (internal and external) shall be identified and the necessary information documented, transmitted, and reviewed; Project roles and responsibilities; Design content, input and output data, and planning Rev C 9 of 31

10 constraints; Project reporting requirements, including tracking and resolving open issues; Performance, safety, security, and other critical requirements; Any project specific training requirements, and Usage or licensing rights Design and Development Inputs Customer Input Design and Development Outputs Design and Development Outputs Design and development outputs shall: Specify, as applicable, any critical items, including key characteristics, and specific actions to be taken for these items. The design output shall be documented and expressed in terms of requirements, calculations and analyses, and shall: Identify those characteristics of the design that are crucial to the safe and proper functioning of the product. () These characteristics shall include any design or contract required key characteristics and any actions related to these items. The organization shall define the data required to allow the product to be identified, manufactured, inspected, used and maintained; including for example The drawings, parts lists and specifications necessary to define the configuration and the design features of the product, and The material, process, manufacturing and assembly data needed to ensure conformity of the product. The design output shall be documented and expressed in terms of requirements, calculations and analyses, and shall: Meet the design input requirements; Provide the information required for manufacturing the product including any purchasing information; Define the acceptance criteria; Conform to documented industry, safety and regulatory requirements, where appropriate; Identify those characteristics of the design that are crucial to the safe and proper functioning of the product; Result from a process that makes appropriate use of the basic and advanced quality tools (such as design of experiments (DOE), failure mode and effects analysis (FMEA), statistical tolerance analysis, CDOV, etc.). () Rev C 10 of 31

11 Design and Development Review Design and Development Review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) To authorize progression to the next stage Design and Development Verification Design and Development Validation Design and development reviews shall be documented with records of activities, resulting actions, and approvals to progress to the next design and development stage maintained Design and Development Verification and Validation Testing Where tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed and documented to ensure and prove the following Test plans or specifications identify the product being tested and the resources being used, define test objectives and conditions, parameters to be recorded and relevant acceptance criteria, Test procedures describe the method of operation, the performance of the test and the recording of the results, The correct configuration of the product is submitted for the test, The requirements of the test plan and the test procedures are observed, and The acceptance criteria are met. Product design verification and validation testing is performed to a planned, established, controlled, reviewed, and documented test plan to ensure and prove the following: A defined test scope with product descriptions, corresponding part numbers, and the latest versions of design objectives, product specifications, and needed test resources; Test specimens are identified and representative of normal production lots with Certificates of Conformance required for design validation/product qualification testing; A test sequence is defined including the order of tests, examinations, and groupings; A description of each test with defined acceptance criteria; A description of test methods including references to applicable external requirements and recording of results. The acceptance criteria are met Design and Development Verification and Validation Documentation At the completion of design and/or development, the organization shall ensure that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions. Rev C 11 of 31

12 Following completion of design and/or development verification and validation, reports of results shall be prepared with any differences between established specification requirements and report data reconciled and documented. These reports shall include verification and/or validation to all specified operational conditions. Records of verification and validation reports, calculations, and test results and any necessary actions shall be maintained Control of Design and Development Changes Control of Design and Development Changes Design and development changes shall be controlled in accordance with the configuration management process (see 7.1.3) Purchasing Purchasing Process New Suppliers Supplier Performance The TE configuration management plan is established and maintained through various documented procedures where responsibilities and authorities are outlined. The scope of the configuration management process includes design changes which require that each design change be traceable to an appropriate source and approval Purchasing Process The organization shall be responsible for the quality of all products purchased from suppliers, including product from sources defined by the customer. One factor that can be used during supplier selection and evaluation is supplier quality data from objective and reliable external sources, as evaluated by the organization (e.g., information from accredited quality management system or process certification bodies, organization approvals from government authorities). Use of such data would be only one component of an organization s supplier control process and the organization remains responsible for verifying that purchased product meets specified purchase requirements. The organization shall: Maintain a register of its suppliers that includes approval status (e.g., approved conditional, disapproved) and the scope of the approval (e.g., product type, process family); Per the criteria in Quality Specification TEC-1006, Approval of Suppliers, suppliers are approved and identified in the TE Database (TED) and in the Purchasing Module of the various TE Enterprise Requirements Planning software such as SAP and the Purchasing On-Line Information System (POLIS). A supplier s approval scope provides a list of materials and products and limits what may be purchased from a particular supplier. The organization shall: Periodically review supplier performance; the results of Rev C 12 of 31

13 these reviews shall be used as a basis for establishing the level of controls to be implemented; Per the definitions in Quality Specification TEC-1003, Supplier Performance Reporting and Continual Improvement Process, the primary source for supplier performance data will be information maintained in the TE Database (TED). This data will be used to monitor continual improvement of a supplier s performance and continual improvement of commodities managed by procurement. Periodic supplier performance reviews shall be conducted at a business organization, regional, and global level. At least one review shall be conducted annually for key suppliers. Performance reviews for nonstrategic suppliers will be conducted on an as-needed basis. The organization shall: Define the necessary actions to take when dealing with suppliers that do not meet requirements; Per the requirements of Quality Specification TEC-1003, Supplier Performance Reporting and Continual Improvement Process, issues regarding unacceptable quality and delivery performance of the nonstrategic supply base will be monitored and addressed on a case by case basis by purchasing and quality personnel. The course of action taken by the business organization purchasing department representatives for nonstrategic suppliers will depend upon the effect of the purchased product on subsequent product realization or the final product. The course of action taken for unacceptable quality or delivery performance of nonstrategic suppliers will range from: 1. Continue to conduct business while monitoring improvement of the supplier. 2. Limit the supplier to fulfilling only existing orders. 3. Limit the supplier to processing existing product. New business will not be given to this supplier until quality and delivery performance improves. 4. Remove the supplier from the approved supplier list. The organization shall: Ensure where required that both the organization and all suppliers use customer-approved special process sources; In the event an external customer has an approved subcontractor list, the responsible business organiztion must coordinate with Purchasing to make sure that those suppliers are included in the TE supply base. TE is responsible for products and services purchased from customer designated suppliers. Optionally, the business organization may work with the customer to have the TE supplier added to their list of approved suppliers. () The organization shall: Define the process, responsibilities and authority for the approval status decision, changes of the approval status Rev C 13 of 31

14 and conditions for a controlled use of suppliers depending on the supplier s approval status. Per the requirements of Quality Specification TEC-1003, Supplier Performance Reporting and Continual Improvement Process, business organization purchasing department representatives, in conjunction with Supplier Quality and Global Procurement have the authority and responsibility for classifying suppliers, reviewing supplier performance data, and changing the approval status of suppliers. The organization shall: Determine and manage the risk when selecting and using suppliers (see 7.1.2). Risk management requirements for supplier selection and retention shall be determined and documented per Quality Specification TEC-1006, Approval of Suppliers. Records resulting from supplier selection risk management activities shall be maintained in accordance with the corporate records retention schedule Purchasing Information Purchasing Information Purchasing information shall describe the product to be purchased, including where appropriate: The identification and revision status of specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data, Requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance by the organization, and as applicable critical items including key characteristics, Requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection/verification, investigation or auditing, Purchase orders placed with suppliers shall define the product, the revision level and any additional quality assurance requirements beyond those established in Quality Specification TEC-1005, TE Total Quality Management Requirements for Suppliers. Requirements regarding the need for the supplier to: o Notify the organization of nonconforming product, o Obtain organizational approval for nonconforming product disposition, Per the requirements of Quality Specification TEC-1005, TE Total Quality Management Requirements for Suppliers, if a non-conformance is discovered by the supplier, the supplier shall be responsible for notifying the respective TE buyer/authorized purchasing personnel of non-conforming material and any already shipped non-conforming material to ensure containment of the entire lot or order of material. Rev C 14 of 31

15 In addition, Quality Specification TEC-1005 details supplier responsibilities relative to coordinating the containment and disposition of suspect nonconforming material with TE Quality and Materials department personnel. o Notify the organization of changes in product and/or process, changes of suppliers, changes of manufacturing facility location and, where required, obtain organizational approval, and Per the requirements of Quality Specification TEC-1005, TE Total Quality Management Requirements for Suppliers, TE must ensure that its customers receive product that is consistent with drawings, product specifications, and inherent performance requirements. To facilitate this requirement for consistency, TE requires that the supplier provide prior written notice to the Purchasing and/or TE business organization when supplier, product, process or manufacturing location changes are proposed. The responsible buyer/authorized purchasing personnel must be contacted prior to any changes being implemented as the requirements vary for the different TE individual business organizations. o Flow down to the supply chain the applicable requirements including customer requirements, Per the requirements of Quality Specification TEC-1005, TE Total Quality Management Requirements for Suppliers, the supplier shall flow down quality requirements to subcontractors to the extent necessary to ensure that characteristics not verifiable upon receipt are controlled by the sub-contractor. Records retention requirements, and Per the requirements of Quality Specification TEC-1005, TE Total Quality Management Requirements for Suppliers, suppliers are responsible for maintaining specified records for each production part number manufactured or provided for a designated duration. These include specific inspection records, material certificates, laboratory analyzes, applicable SPC data, purchase and change orders, deviations, calibration records, corrective actions, applicable PPAP records, environmental records, IMDS registrations, production records, shipping records, and equipment maintenance records. Right of access by the organization, their customer, and regulatory authorities to the applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records Per the requirements of Quality Specification TEC-1005, TE Total Quality Management Requirements for Suppliers, the supplier shall include right of entry provisions in subcontracts and purchase contracts, allowing the TE, TE Rev C 15 of 31

16 customers and regulatory agencies access to all applicable work areas at any supply chain level and records to verify the quality of work and materials and to verify conformance to contract requirements Verification of Purchased Products Verification of Purchased Product 1 Customer verification activities performed at any level of the supply chain should not be used by the organization or the supplier as evidence of effective control of quality and does absolve the organization of its responsibility to provide acceptable product and comply with all requirements. TE assumes the responsibility for the quality of product supplied by contracted vendors including agreed upon customer designated sources. 2 Verification activities can include: Obtaining objective evidence of the quality of the product from the supplier (e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control records), Inspection and audit at supplier s premises, Review of the required documentation, Inspection of products upon receipt, and Delegation of verification to the supplier, or supplier certification. It shall be the responsibility of the business organization to determine the means of verifying that suppliers meet their contractual obligations related to the quality of the procured items. This can be accomplished by one of five methods: Stock as Received (SAR) following receipt of the material, it can be placed directly into stores without any receiving inspection activity. Material may be designated Stock as Received based on supplier or part number certification as administered through Purchasing / Supplier Quality Assurance or as approved by the business organization. Purchasing /Supplier Quality Assurance is responsible for periodic assessments of certified suppliers. Supplier warrants or Certificate of Analysis (C of A), with test results, submitted with the material. Incoming inspection each lot of received material shall be inspected to confirm conformance to specifications. Inspection strategy plan lots inspected using a specified pattern of planned inspection cycles. Product is evaluated and reported as acceptable by an accredited supplier or test laboratory. Rev C 16 of 31

17 Where purchased product is released for production use pending completion of all required verification activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements Production and Service Processes Control of Production and Service Processes The responsibility for implementing a recall process for product released to production prior to conformance verification will be maintained by the local receiving inspection function. Local procedures shall include, as a minimum, the manner for identifying product released prior to conformance verification, the control of released product discovered to be nonconforming, and the requirements that product incorporating such components and materials not be shipped to external customers. Where the organization delegates verification activities to the supplier, the requirements for delegation shall be defined and a register of delegations maintained. The local purchasing function, in conjunction with the supplier quality organization, shall maintain the responsibility for establishing and maintaining a register of product verification activities delegated to suppliers. This register of delegations may be maintained in electronic supplier management and purchase order programs Control of Production and Service Provision The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable The availability of information that describes the characteristics of the product, This information can include drawings, parts lists, materials and process specifications. Identification and planning of production and service processes that directly affect quality shall ensure that these processes are carried out under controlled conditions in accordance with documented procedures. Production functions shall ensure that: Product characteristics are adequately defined. () The availability of work instructions, as necessary, Work instructions can include process flow charts, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards) and inspection documents. Identification and planning of production and service processes that directly affect quality shall ensure that these processes are carried out under controlled conditions in accordance with documented procedures. Production functions shall ensure that: Rev C 17 of 31

18 Needed work instructions are available. () The use of suitable equipment, Suitable equipment can include product specific tools (e.g., jigs, fixtures, molds) and software programs. Identification and planning of production and service processes that directly affect quality shall ensure that these processes are carried out under controlled conditions in accordance with documented procedures. Production functions shall ensure that: Suitable production equipment is used. () Accountability for all product during manufacture (e.g., parts quantities, split orders, nonconforming product), Evidence that all manufacturing and inspection/verification operations have been completed as planned, or as otherwise documented and authorized, Provision for the prevention, detection, and removal of foreign objects, Monitoring and control of utilities and supplies (e.g., water, compressed air, electricity, chemical products) to the extent they affect conformity to product requirements, and Criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations). Planned and implemented controlled production conditions include, as applicable, the establishment of control plans where key characteristics have been identified and the consideration of variable measurements throughout inprocess and final inspection/verification operations. In addition, controlled manufacturing conditions include, as applicable, product accountability throughout production; documenting the completion of established manufacturing and inspection operations; provisions for the prevention, detection, and removal of foreign objects; monitoring and control of utilities associated with manufacturing operations, and; stipulating product workmanship criteria in a clear and practical manner. Planning shall consider, as appropriate, Establishing, implementing and maintaining appropriate processes to manage critical items, including process controls where key characteristics have been identified, Designing, manufacturing and using tooling to measure variable data, Identifying in-process inspection/verification points when adequate verification of conformance cannot be performed at later stages of realization, and Special processes (see 7.5.2) Rev C 18 of 31

19 Planned and implemented controlled production conditions include, as applicable, the establishment of control plans to manage critical items where key characteristics have been identified and the design and implementation of tools used to verify variable measurements throughout in-process and final inspection/verification operations. In addition, special processes as defined in paragraph are considered in the production and service provision planning process Production Process Verification The organization shall use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, manufacturing process changes, tooling changes). This activity is often referred to as first article inspection. The applicable business organization shall adopt a process or procedure using a representative item from the initial production run of a new part number to assure that tooling and processes are capable of producing parts that are in conformance with the product drawing and specification requirements. This process shall include performing a new first article inspection when a change invalidates any previous first article inspection result Control of Production Process Changes Personnel authorized to approve changes to production processes shall be identified. The organization shall control and document changes affecting processes, production equipment, tools or software programs. The results of changes to production processes shall be assessed to confirm that the desired effect has been achieved without adverse effects to product conformity. Production process changes; including production process procedures, specifications, and instructions; production equipment and tools; and software programs; shall be authorized, identified, controlled, and confirmed to ensure that the changes don t have an adverse effect on product conformity. This confirmation may involve a first article or first piece inspection of the product. Records of production process changes shall be maintained. Rev C 19 of 31

20 Control of Production Equipment, Tools and Software Programs Validation of Production and Service Processes Process Monitoring and Operator Instructions Verification of Process Setups and Operational Changes First Article Examination Production equipment, tools and software programs used to automate and control/monitor product realization processes, shall be validated prior to release for production and shall be maintained. Production equipment, tools, and software programs used to automate, control, or monitor product realization processes are validated prior to the initial production order of a new part number through a first article inspection. Changes to a production process shall be confirmed. This confirmation may involve a first piece inspection of the product Post-Delivery Support Post delivery support shall provide as applicable for the Collection and analysis of in-service data, Actions to be taken, including investigation and reporting, when problems are detected after delivery, Control and updating of technical documentation, Approval, control and use of repair schemes, and Controls required for off-site work (e.g., organization s work undertaken at the customer s facilities). As appropriate for the products involved, in-service product performance data will be collected, analyzed, and internally reported. Product performance problems detected after delivery will be subject to a formal disciplined corrective action process that includes containment, investigation, solution implementation, and reporting. Aerospace related service operations, such FAA approved Repair Stations, shall utilize operational processes that are controlled in a manner consistent with controlled production processes. These repair operations will be conducted under controlled conditions in accordance with documented procedures Validation of Processes for Production and Service Provision These processes are frequently referred to as special processes. Rev C 20 of 31

21 Product Identification and Traceability Inspection and Test Status Control of Customer Property Identification and Traceability The organization shall maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration. Product configuration identification shall be maintained in order to identify any differences between the actual and agreed configurations. This is accomplished prior to, or during product manufacture through a documented deviation process that details any product configuration differences and requires approval for acceptance. Configuration identification is maintained throughout production on nondeviated product through the manufacturing process routing and indication of product status. When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), the organization shall establish and document controls for the media. Organizations and facilities performing product acceptance shall establish, document, and maintain controls relative to inspection identifiers and acceptance authority media such as inspection stamps and electronic signatures. Traceability requirements can include Identification to be maintained throughout the product life; The ability to trace all products manufactured from the same batch of raw material, or from the same manufacturing batch, to the destination (e.g., delivery, scrap); For an assembly, the ability to trace its components to the assembly and then to the next the next higher assembly; and For a product, a sequential record of its production (manufacture, assembly, inspection/verification) to be retrievable. As established through customer contracts or regulatory requirements: Product identification, within TE control, shall be maintained throughout the product life through product and packaging marking and labeling. Product traceability to raw material batches and assembly components will be maintained through manufacturing records that register raw material and component part numbers and manufacturer lot numbers and/or component manufacture work order numbers. Production records will be maintained demonstrating that the prescribed sequence of manufacturing operations and product acceptance activities were followed. Rev C 21 of 31

22 Product Preservation Shelf-Life Preservation of Product Preservation of product shall also include, where applicable in accordance with product specifications and applicable statutory and regulatory requirements, provisions for: Cleaning; Prevention, detection and removal of foreign objects; Special handling for sensitive products; Marking and labeling including safety warnings; Shelf-life control and stock rotation; Special handling for hazardous materials. Production processes, including the handling and storage of materials and products, shall be in accordance with applicable product specifications and statutory and regulatory requirements for cleaning; foreign object prevention, detection, and removal; sensitive product handling; product marking and labeling; shelf-life control; stock rotation; and hazardous material handling Control of Inspection, Measuring, and Testing Equipment 7.6. Control of Monitoring and Measuring Equipment The organization shall maintain a register of monitoring and measuring equipment and define the process employed for their calibration/verification including the details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria. Monitoring and measuring equipment includes, but is not limited to: test hardware, test software, automated test equipment (ATE) and plotters used to produce inspection data. It also includes personally owned and customer supplied equipment used to provide evidence of product conformity. Each TE location using product inspection, measuring, and testing equipment shall maintain a register of equipment to ensure that all equipment used to verify product quality are uniquely identified and calibrated at prescribed intervals. The methods and acceptance criteria for performing equipment calibrations shall be defined. The organization shall ensure that environmental conditions are suitable for the calibration, inspection, measurement and testing being carried out. Conditions shall be established that provide a suitable environment for calibration and use of measuring equipment and that equipment is stored and handled in a way that maintains accuracy and fitness for use. The organization shall establish, implement and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification. Processes shall be developed for calibration and record collection with adequate controls that protect product quality. All measuring devices shall have an indication of Rev C 22 of 31

23 calibration status. If the calibration status indication is invalid, the measuring device shall not be used. () All product produced with suspect measuring equipment shall be segregated and audited. Customer notification and product recall shall be considered if suspect product was shipped. () Rev C 23 of 31

24 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT Measurement, Analysis, and Improvement General Statistical Techniques Monitoring and Measurement Customer Satisfaction Internal Assessments and Audits Manufacturing Process Audits External Assessments 8.1. General According to the nature of the product and depending on the specified requirements, statistical techniques may be used to support: Design verification (e.g., reliability, maintainability, safety), Process control including selection and inspection of key characteristics, process capability measurements, statistical process control, and design of experiment; Inspection, and Failure mode, effect and criticality analysis. Quality (or other designated function) shall identify the need for and use of statistical techniques required for design verification and establishing, controlling, and verifying processes that impact product characteristics and process capability. Statistical tools (as needed to assure robust processes) shall be determined during design and development or as a result of a continual improvement effort (e.g., Six Sigma, Lean, QOS reviews, corrective actions, etc.). Process measurements shall be implemented and monitored at the appropriate points to ensure continual product conformance and to promote increased effectiveness of the process Customer Satisfaction Information to be monitored and used for the evaluation of customer satisfaction shall include, but is not limited to, product conformity, on-time delivery performance, customer complaints and corrective action requests. Organizations shall develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results. Information related to the customer perception that TE has met customer requirements shall be included as a QMS performance measure. Trends in customer satisfaction and key indicators of customer dissatisfaction shall be documented and supported by objective information. As appropriate, these trends should be compared to those of competitors or benchmarks and reviewed by Top Management. Customer satisfaction data is received in a variety of methods, including: Feedback received in response to answers to customer complaints; Industry positioning surveys; Supplier report cards ; Meetings with customers; and Ship to customer request performance. () Rev C 24 of 31