KEVLIN CORPORATION DIVISION OF COBHAM DEFENSE ELECTRONIC SYSTEMS

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1 1.doc KEVLIN CORPORATION DIVISION OF COBHAM DEFENSE ELECTRONIC SYSTEMS QUALITY POLICY MANUAL QPM Lowell St Methuen, MA USA

2 2.doc TABLE OF CONTENTS Clauses Procedure Description of Contents Page # I --- Revision History 3 II --- Introduction 4 III --- Organizational Chart Purpose Scope Quality Commitment Quality Management System General Requirements Doc. Control Procedure Documentation Requirements Doc. Control Procedure/Records Control Procedure Control of Quality records ENG22 & ENG10 Configuration Management 9 5. Management Responsibility Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority and Communication Mgt. Review Procedure Management Review 6. Resource Management 6.1 Provision of Resources 6.2 Human Resources Training Matrix 6001 Competence, Awareness and Training Infrastructure Work Environment Design Procedure Product Realization Design Procedure Planning of Realization Process Customer Service Procedure Customer-related Processes Design Procedure Design and Development Purchasing Procedure Purchasing Prod. Control/Mfg. Procedure Control of Production and Service Provision Supplier Eval./Purchasing Procedure Validation of Processes for Production and Service Prod. Control/Mfg. Procedure Identification, Traceability and Status Repair Procedure/ Control of Cust/Gov. Property Customer Property Receiving & Shipping/ Handling & Storage Proc. Preservation of Product Calibration Procedure Control of Monitoring and Measuring Devices Measurement Analysis and Improvement , Cust. Service Procedure/ Customer Contact Reports General & Customer Satisfaction Internal Auditing Procedure Internal Audits Manufacturing Procedure Monitoring and Measurement of Process Incoming and Final Inspection Procedure Monitoring and Measurement of Product Nonconformance and Corrective Action Procedure Control of Nonconforming Product Management Review Procedure Analysis of Data Management Review Procedure Continual Improvement , Mgt. Review, Nonconf. & C/A, Preventive Action Corrective Action and Preventive Action 30 Procedure Appendix A Responsibility and Authority Matrix 31 Appendix B Management Representative Appointment letter 32 Appendix C Flow Chart of Process Interactions and Sequence 33 2

3 3.doc I REVISION HISTORY REVISION DESCRIPTION of CHANGE APPROVALS DATE 9 Initial Release of Updated AS9100 Manual 10 Updated Table of Contents (page 2, and Responsibility Matrix (page 31) Updated entire document per SGS CAR1 of AS9100 Audit of 3/07 APP 2/12/07 SOD 3/2/07 APP/SOD 4/13/07 Approval Signature _Andrew P.Pellerin 2/12/07_ President 3

4 4.doc II INTRODUCTION () was incorporated in 1947 as a tool and die maker and a precision machine shop. In 1962, entered the microwave industry by manufacturing passive devices and rotary couplers to customer specifications (build to print). Since then, has established itself as industry s rotary coupler technological leader and has provided rotary couplers and other components for numerous ground, shipboard, submarine, aircraft, and space applications. has expanded it s repair and refurbishment capabilities to include all microwave components, whether or not we are the original manufacturer. Additionally, serves as a depot repair facility for many Government agencies and prime contractors. In 1996, was acquired by Cobham, Plc. Cobham is a UK based company specializing in the design, development and manufacture of airborne antennas and electronic communication equipment. It is currently part of the CDES, Cobham Defense Electronic Systems Division. 4

5 5.doc III ORGANIZATIONAL CHART 5

6 6.doc 1. SCOPE This outlines the requirements for a Quality Management System where KEVLIN CORPORATION demonstrates its ability to provide product consistently that meets customer and applicable regulatory requirements, as well as addressing customer satisfaction through the effective application of designs, manufacturing and servicing of complex -mechanical and microwave components and sub-systems. specializes in microwave, and electro-mechanical rotating devices. These include rotary couplers and pedestals used in military, air traffic control radars and telecommunications systems, including processes for continual improvement and the prevention of nonconformity. This AS 9100 Aerospace compliant Quality Management System is in effect (February 1, 2007) and all prior records, systems, policies, and procedures are not applicable. 2. PURPOSE The requirement of the applies to all aspects of KEVLIN CORPORATION Quality Management System; this manual is divided into five (5) main areas: Quality Management System Management Responsibility Resource Management Product realization Measurement Analysis Improvement 3. QUALITY COMMITMENT The President of KEVLIN CORPORATION is committed to Quality. All employees are responsible and participate in the quality improvement activities of this company. In doing so, the following policy for quality has been implemented under the signature of the president. KEVLIN CORPORATION Quality Policy: The company is committed to supplying it s customers with product and services that meet or exceed their expectations, and by continuing to improve it s Quality Management System. s strategy for achieving and maintaining this goal includes partnerships with our customers and suppliers. By investing in the training and education of it s employees, makes a strong commitment to continuous improvement in all areas of the business. It is the responsibility of every employee to adhere to the defined processes of their job, to initiate action to prevent occurrence of product nonconformity and to strive for continuous improvement. establishes quality objectives for the company and will continually improve the effectiveness of the quality system in order to achieve those objectives. 6

7 7.doc 4.1 General requirements 4. Quality Management System KEVLIN CORPORATION will establish, document, implement, maintain and continually improve a quality management system in accordance with the requirements of the International Standard ISO 9001:2000 and the AS 9100 Aerospace Standard. To implement the quality management system, KEVLIN CORPORATION will: a) Identify the processes needed for the quality management system and their application throughout the organization b) Determine the sequence and interaction of these processes (Appendix C ) c) Determine criteria and methods required to ensure the effective operation and control of these processes are effective d) Ensure the availability of information necessary to support the operation and monitoring of these processes e) Measure, monitor and analyze these processes f) Implement action necessary to achieve planned results and continual improvement of these processes. Where KEVLIN CORPORATION chooses to outsource any process that affects product conformity with requirements KEVLIN CORPORATION will ensure control over such processes. Reference Purchasing procedure PURCH.doc KEVLIN CORPORATION will manage these processes in accordance with the requirements of the ISO 9001:2000 and AS 9100 Standards. 4.2 General documentation requirements Reference Document Control Procedure DOCCONT.doc, Records Control Procedure QOP19, ECO Procedure ENG10.doc, and ECO Procedure ENG10.doc The quality management system documentation will include: a) Documented statements of a Quality Policy (see page 6) and Quality Objectives. b) Documented procedures required by the ISO 9001:2000/AS 9100 Standard; are clearly identified in the quality manual. c) Documents required by KEVLIN CORPORATION to ensure the effective planning, operation and control of its processes. d) Quality records required by the ISO 9001:2000/AS 9100 standard. e) Any quality management system requirements imposed by the applicable regulatory authorities 7

8 8.doc KEVLIN CORPORATION ensures that personnel have access to quality management system documentation and personnel are aware of relevant procedures. Customers and/or regulatory authority s representative have access to quality management system documentation Control of documents Documents required for the quality management system will be controlled. Quality records are a special type of document and will be controlled according to the requirements given in A documented procedure will be established: a) to approve documents for adequacy prior to issue b) to review, update as necessary and re-approve documents c) to ensure that changes and the current revision status of documents are identified d) to ensure that relevant versions of applicable documents are available at points of use e) to ensure that documents remain legible, readily identifiable f) to ensure that documents of external origin are identified and their distribution controlled g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. KEVLIN CORPORATION always coordinates any documented changes with customer and/or regulatory authorities in accordance with their requirements. Reference Configuration Control Process Control of quality records Reference Purchasing procedure PURCH.doc, QC Purchase Order Clauses Form QC1053, and Records Control Procedure QOP19.doc Quality Records will be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Quality records will be legible, readily identifiable and retrievable. A documented procedure will be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of quality records. Records that are created by suppliers such as certifications and test records are controlled according to the Purchasing procedure KEVLIN CORPORATION will make available any records requested by customers and regulatory authorities in accordance with contract or regulatory requirements. 4.3 Configuration Management Reference Configuration Management ENG22.doc KEVLIN CORPORATION will establish, document and maintain a configuration management process, appropriate to the product. Currently all configuration is maintained controlled by the Configuration Management Procedure. 8

9 9.doc 5 Management Responsibility 5.1 Management commitment Reference Management Review Procedure MGTREV.doc, Quality Objectives Form 1004 and Management Review Minutes Form 1006 s Top Management will provide evidence of its commitment to the development and improvement of the quality management system and continually improving its effectiveness by: a) communicating to the organization the importance of meeting customer as well as regulatory and regulatory requirements b) establishing the quality policy c) ensuring that quality objectives are established d) conducting management reviews e) ensuring the availability of necessary resources. 5.2 Customer focus s Top Management will ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction. 5.3 Quality policy (Documented on page 6) s Top Management will ensure that the quality policy: Is appropriate to the purpose of KEVLIN CORPORATION a) includes a commitment to comply with requirements and to continually improve the effectiveness of the quality management system b) provides a framework for establishing and reviewing quality objectives c) is communicated and understood within the organization d) is reviewed for continuing suitability. KEVLIN CORPORATION will meet customer requirements and all statutory, regulatory, and legal requirements and continually improve the quality management system 5.4 Planning Reference Management Review Procedure MGTREV.doc, Quality Objectives Form 1004, and Management Review Minutes Form Quality objectives s Top Management will ensure that quality objectives including those needed to meet requirements for product are established at relevant functions and levels within KEVLIN CORPORATION The quality objectives will be measurable and consistent with the quality Policy. 9

10 10.doc Quality Management System planning s Top Management will ensure that the planning of the Quality Management System is carried out in order to meet the requirements given in 4.1, as well as the quality objectives. The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication Responsibility and authority s Top Management will ensure that the responsibilities, authorities and their interrelation are defined and communicated within KEVLIN CORPORATION Responsibility and authority for the implementation of each policy identified in this manual can be found in the responsibility matrix (see Appendix A ) Management representative s Top Management will appoint (see Appendix B ) a member(s) of the management who, irrespective of other responsibilities, will have responsibility and authority that includes: a) ensuring that Processes needed for the quality management system are established implemented and maintained b) reporting to top management on the Performance of the quality management system, including needs for improvement c) ensuring the promotion of awareness of customer requirements throughout the organization d). The management representative will have the necessary authority and organizational freedom to resolve matters pertaining to quality Internal communication s Top Management will ensure that appropriate communication processes are established within KEVLIN CORPORATION and that communication takes place regarding the effectiveness of the quality management system. 5.6 Management review Reference Management Review Procedure MGTREV.doc, Quality Objectives Form 1004, and Management Review Minutes Form General s Top management will review the quality management system, at planned intervals, to ensure it s continuing suitability, adequacy and effectiveness. The review will include assessing opportunities for improvement and the need for changes to the quality management system, 10

11 .doc including quality policy and quality objectives Review input Inputs to management review will include information on: a) results of audits b) customer feedback c) process performance and product conformance d) status of preventive and corrective actions e) follow-up actions from earlier management reviews f) planned changes that could affect the quality management system g) recommendations for improvement Review output The outputs from the management review will include any decisions and actions related to: a) improvement of the quality management system and its processes b) improvement of product related to customer requirements c) resource needs. 6 Resource Management 6.1 Provision of resources Reference Management Review Procedure MGTREV.doc, and Management Review Minutes Form 1006 KEVLIN CORPORATION will determine and provide the resources needed a) to implement and maintain the quality management system, and continually improve its effectiveness b) to enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources Reference Training Procedure TRAIN.doc and Training Matrix Form General Personnel performing work affecting product quality will be competent on the basis of appropriate education, training, skills and experience Competency, Awareness and Training KEVLIN CORPORATION will: a) determine the necessary competency for personnel performing activities affecting quality

12 12.doc b) provide training or take other actions to satisfy these needs c) evaluate the effectiveness of the actions taken d) ensure that its employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives e) maintain appropriate records of education, training, skills and experience (see 4.2.4). 6.3 Infrastructure Reference Machine Shop Process machshop.doc, Management Review Procedure MGTREV.doc, Management Review Minutes Form 1006, and Safety Committee Meeting Minutes KEVLIN CORPORATION will determine, provide and maintain the infrastructure needed to achieve the conformity to product requirements. Infrastructure includes for example: a) buildings, workspace and associated utilities b) process equipment, both hardware and software c) supporting services such as transport or communication. 6.4 Work Environment Reference Handling, Storage, and Delivery Procedure QOP09, ESD Control Procedure ENG41, Calibration and Control of Measuring Equipment QOP02, and Foreign Object Damage MFG103 KEVLIN CORPORATION will determine and manage the work environment needed to achieve conformity to product requirements. The factors that may affect the conformity of the product include temperature, humidity, and cleanliness. 7 Product Realization 7.1 Planning of realization processes Reference Production Control Procedure prodcont.doc and Engineering Design guideline Procedure design.doc KEVLIN CORPORATION will plan and develop the processes needed for product realization. Planning of product realization will be consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization KEVLIN CORPORATION will determine the following as appropriate: a) quality objectives and requirements for the product b) the need to establish processes documents, and provide resources specific to the product c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance d) records needed to provide evidence that the realization processes and resulting product to fulfill requirements (see 4.2.4) 12

13 13.doc e) the identification of resources to support operation and maintenance of the product. The output from this planning is in a form suitable for KEVLIN CORPORATION methods of operation. 7.2 Customer-related processes Reference Engineering Design Procedure DESIGN.doc, and Sales Order Processing Procedure SALES.doc Determination of requirements related to the product KEVLIN CORPORATION will determine: a) requirements specified by the customer, including the requirements for delivery and post-delivery activities b) requirements not specified by the customer but necessary for specified use or known and intended use c) statutory and regulatory requirements related to the product d) any additional requirements determined by KEVLIN CORPORATION Review of requirements related to the product KEVLIN CORPORATION will review the requirements related to the product. This review will be conducted prior to KEVLIN CORPORATION commitment to supply a product to the customer (e.g. submission of a tender (quote), acceptance of a contract or order) and will ensure that: a) product requirements are defined b) contract or order requirements differing from those previously expressed are resolved c) KEVLIN CORPORATION has the ability to meet defined requirements d) Risks will be evaluated during the quoting process. Where the customer provides no documented statement of requirement, the customer requirements are confirmed by KEVLIN CORPORATION before acceptance. Where product requirements are changed, KEVLIN CORPORATION will ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements Customer communication Reference Customer Service Procedure CUSTSERVE.doc, Sales Order Processing Procedure SALES.doc, and Customer Contact Procedure QOP12 13

14 14.doc KEVLIN CORPORATION will determine and implement effective arrangements for communicating with customers in relation to: a) product information b) enquiries, contracts or order handling, including amendments c) customer feedback, including customer complaints. 7.3 Design and development Design and Development Planning Reference Design Procedure DESIGN.doc, Engineering Type A, ENG44 and Engineering Type B, ENG45 KEVLIN CORPORATION will plan and control Design and Development of product. During the design and development planning KEVLIN CORPORATION will determine: a) the design and development stages -- in respect of KEVLIN CORPORATION, task sequence, mandatory steps, sufficient stages and method of configuration control b) the review, verification, and validation that are appropriate to each design and development stage c) the responsibilities and authorities for design and development. Where appropriate, due to the complexity, KEVLIN CORPORATION will give consideration to the following activities: Structuring the design effort into significant elements For each element, analyzing the tasks and the necessary resources for its design and development. This analysis will consider an identified responsible person, design content, input data, planning constraints, and performance conditions. The input data specific to each element will be reviewed to ensure consistency with requirements Interfaces between different groups will be effectively managed Planning output will be updated as appropriate, as the design and development progresses The different design and development tasks to be carried out will be defined according to specific safety or functional objectives of the product in accordance with customer and /or regulatory authority requirements Design and Development inputs Reference Design Procedure DESIGN.doc, Engineering Type A, ENG44 and Engineering Type B, ENG45 Inputs relating to product requirements will be determined and records maintained. These inputs will include: 14

15 15.doc a) functional and performance requirements b) applicable statutory and regulatory requirements c) where applicable, information derived from previous similar designs d) other requirements essential for design and development. These inputs will be reviewed for adequacy, and incomplete, unambiguous or conflicting requirements will be resolved Design and Development outputs Reference Design Procedure DESIGN.doc, Engineering Type A, ENG44 and Engineering Type B, ENG45 The outputs of design and development will be provided in a form that enables verification against the design and development input and will be approved prior to release. Design and Development outputs will: a) meet the input requirements for design and development b) provide appropriate information for purchasing, production and for service provision c) contain or reference product acceptance criteria d) specify the characteristics of the product that are essential for its safe and proper use e) identify key characteristics, when applicable, in accordance with design or contract requirements. All pertinent data required to allow the product to be identified, manufactured, inspected, used and maintained will be defined by KEVLIN CORPORATION Design and Development review Drawings, part lists, specifications A listing of those drawings, parts lists, specifications, necessary to define the configuration and the design of the product. Information on material, processes, type of manufacturing and assembly of the product necessary to ensure the conformity of the product. At suitable stages, systematic reviews of design and development will be performed with planned arrangements. a) to evaluate the ability of the results of design and development to meet requirements b) to identify any problems and propose necessary actions c) authorize progression to the next stage 15

16 16.doc Participants in such reviews will include representatives of functions concerned with design and development stage(s) being reviewed. Records of the results of the review and any necessary actions will be maintained Design and Development verification Reference Design Procedure DESIGN.doc, Engineering Type A, ENG44 and Engineering Type B, ENG45 Verification will be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the result of the verification and any necessary actions will be maintained Design and Development validation Reference Design Procedure DESIGN.doc, Engineering Type A, ENG44 and Engineering Type B, ENG45 Design and Development validation will be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Whenever practicable, validation will be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions will be maintained Documentation of design and/or development verification and validation At the completion of design and/or development, KEVLIN CORPORATION will ensure that reports, calculations, test results, etc. demonstrate that the product definition meets the specification requirement for all identified operational conditions Design and/or development verification and validation testing Where tests are necessary for verification and validation, these tests will be planned, controlled, reviewed, and documented to ensure and prove the following: a) Test plans or specifications identify the product being tested and the resources being used, define test objectives and conditions, parameters to be recorded, and relevant acceptance criteria b.) Test procedures describe the method of operation, the performance of the test, and the recording of the results c.) The correct configuration standard of the product is submitted for the test d.) The requirements of the test plan and the test procedures are observed e.) The acceptance criteria are met. 16

17 17.doc Control of Design and Development changes Reference ECO Procedure ENG10.doc, Configuration Management ENG22.doc, and Configuration Control Categories through -4 Design and Development changes will be identified and records maintained. The changes will be reviewed, verified and validated, as appropriate, and approved before implementation. The review of Design and Development changes will include evaluation of the effect of the changes on constituent parts and product already delivered. KEVLIN CORPORATION change control process will provide for customer and/or regulatory authority approval of changes, when required by contract or regulatory requirements. Records of the results of the review of the changes and any necessary actions will be maintained. 7.4 Purchasing Reference Purchasing Procedure PURCH.doc, Supplier Evaluation Procedure SUPPEV.doc QC Clause Categories PU001.doc, and QC Purchase Order Clauses Form QC Purchasing control KEVLIN CORPORATION will ensure that purchased product conforms to specified requirements. The type and extent of control applied to the supplier and the purchased product will be dependent upon the effect of the purchased product on subsequent realization or the final product. The quality of all purchased products or service is verified, including customer-designated sources. KEVLIN CORPORATION. will evaluate and select suppliers based on their ability to supply product in accordance with KEVLIN CORPORATION requirements. Criteria for selection, evaluation, and re-evaluation will be established. Records of the results of evaluations and any necessary actions will be maintained (see 4.2.4). To ensure where required that both KEVLIN CORPORATION and all subcontractors use customer- approved special process sources To ensure that the function for having responsibility for approving the subcontractor(s) Quality systems have the authority to disapprove the use of sources Periodically review subcontractor performance. KEVLIN CORPORATION will maintain records of these reviews and used them as a basis for establishing the level of controls to be implemented KEVLIN CORPORATION will maintain procedures that define the necessary actions to take when dealing with subcontractors which do not meet requirements A list of approved subcontractors will be maintained and will specify the scope of approval. 17

18 18.doc Purchasing information Purchasing information will describe the product to be purchased, including where appropriate: a) requirements for approval of product, procedures, processes, and equipment b) requirements for qualification of personnel c) quality management system requirements KEVLIN CORPORATION will ensure the adequacy of specified requirements prior to their communication to the supplier. The purchasing data will include when required the: Design, test, examination, inspection and customer acceptance requirements and any related instructions and requirements Right of access by the purchaser, their customer and regulatory authorities to all facilities involved in the order and all applicable quality records Requirements for test specimens (production methods, number, storage conditions etc.) for design approval, inspection, investigation or auditing Requirements relative to the notification of anomalies, changes in definition and the approval of their processing. Requirements to flow down to sub-tier suppliers the applicable requirements in the purchasing documents, including key characteristics where required Verification of purchased product Reference Incoming and Final Inspection Procedure INSPECT.doc, Raw Material Stock Control Procedure QOP1, and QC Purchase Order Clauses Form QC1053 KEVLIN CORPORATION will establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where KEVLIN CORPORATION or its customer intends to perform verification at the supplier's premises, KEVLIN CORPORATION will state the intended verification arrangements and method of product release in the purchasing information. KEVLIN CORPORATION will implement procedures to verify purchased products. These may include: Obtaining objective evidence of the quality of the product from subcontractors (e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control). 18

19 19.doc Inspection and audit at source Review of the required documentation Inspection of products at delivery Delegation of verification to the subcontractor, or subcontractor certification. When delegation is used KEVLIN CORPORATION will define the requirements for delegation and maintain a list of delegations. Purchased product is not used or processed until it has been verified as conforming to specified requirements unless it is released under positive recall. KEVLIN CORPORATION utilizes test reports and verifies acceptability per applicable specifications. Raw material test reports are checked against the applicable specifications. Material test reports are validated by an outside facility at least once each quarter. KEVLIN CORPORATION does not delegate any verification activities. If specified in the contract, the customer or the customer s representative is given the right to verify at the supplier s or KEVLIN CORPORATION premises that the product conforms to specified requirements. Verification by the customer is not used by KEVLIN CORPORATION as evidence of effective control of quality by the supplier and does not absolve KEVLIN CORPORATION of the responsibility to provide acceptable product, nor does it preclude subsequent rejection by the customer. 7.5 Production and service operations Reference Production Control Procedure PRODCONT.doc, Manufacturing Procedure MFT.doc, and Manufacturing Documentation MFG-100, Workmanship Manual Control of production and service operations KEVLIN CORPORATION develops a router for each part number detailing the process plan and including as applicable: Process controls and development of control plans when key characteristics have been identified The identification of in-process verification points when adequate verification of conformance cannot be performed at a later stage of production The design, manufacture, and use of tooling so that variable measurements can be taken, particularly for key characteristics Special processes are listed in section KEVLIN CORPORATION carries out production and service provisions under control conditions. Those controlled conditions will include as applicable: 19

20 20.doc a) the availability of information that describes the characteristics of the product b) the availability of work instructions c) the use of suitable equipment d) the availability and use of monitoring and measuring devices e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and applicable post-delivery activities g) the accountability for all product during production h) evidence that all manufacturing and inspection operations have been completed as planned i) provisions for the prevention, detection and removal of foreign objects j) monitoring and control of utilities and supplies such water, compressed air, electricity and chemical products to the extent they affect product quality k) criteria for workmanship will be stipulated in the clearest practical manner Production Documentation Production operations are carried out using routers, sketches, and schedules approved by Management and Quality control. The information may contain: Drawings, parts list, process flow charts including inspection operations, production documents (e.g., manufacturing plans, traveler, router, work order, process cards); and inspection documents A list of specific or non specific tools and numerical control (NC) machine programs Documents associated with specific tools enabling the tools to be designed, produced, validated, controlled, used and maintained Control of Production Process Changes: Changes affecting processes, production equipment, tools and programs are documented. Proposed changes to routers are submitted using the document change process per MFG- 100, MFG-001, OR ENG10.WPD. The results of changes to production processes will be assessed to confirm that the desired effect has been achieved without adverse effects to product quality. The Engineering Manager and/or the Production Manager has the overall responsibility for 20

21 21.doc approving all changes relating to the production process Control of Production Equipment, Tools, and Numerical Control (NC) Machine Programs Reference Machine Shop Process MACHSHOP.doc, First Piece Inspection Procedure QOP24, and MOP101, MOP102, MOP103, MOP104 Production equipment, tools and programs will be validated prior to use, maintained and inspected periodically according to documented procedures. Validation prior to production use will include verification of the first article produced to the design data/specification. Storage requirements, including periodic preservation/condition checks, will be established for production equipment or tooling in storage. Equipment is required to be checked once a year, or prior to use Control of Work Transferred, on a Temporary Basis, Outside the Organization s Facility When planning to carryout work at a location other than its normal facilities, KEVLIN CORPORATION will define the process to validate the process and control the work by defining it in the Purchase Order (Reference Purchasing procedure PURCH.doc) Control of Service Operations Where Service is a specified requirement, service operation processes will be provided for: A method of collecting and analyzing in-service data Actions to be taken where problems are identified after delivery, including investigation and reporting activities including actions on service information consistent with contractual and/or regulatory requirements The control and updating of technical documentation The approval, control and use of repair schemes The controls required for off site work (e.g. KEVLIN CORPORATION work undertaken at the customer s facilities) Validation of processes for production and service provision Reference Design Procedure DESIGN.doc, Purchasing Procedure PURCH.doc, Supplier Evaluation Procedure SUPPEV.doc, and QC Purchase Order Clauses Form QC1053 KEVLIN CORPORATION will validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies may become apparent only after the product is in use or the service has been delivered. Validation will demonstrate the ability of the processes to achieve planned results. KEVLIN CORPORATION will establish arrangements for these processes including as applicable: 21

22 22.doc a) defined criteria for review and approval of the processes - qualification and approval of special processes b) approval of equipment and qualification of personnel c) use of specific methods and procedures - control of the significant operations and parameters of special processes in accordance with documented process specifications and changes thereto d) requirements for records (see 4.2.4) e) revalidation Identification and traceability Reference Receiving and Shipping Procedure RECSHIP.doc, Manufacturing Procedure MFT.doc, Production Control Procedure PRODCONT.doc, Incoming and Final Inspection Procedure INSPECT.doc, and QC Inspector Stamps QOP06 Where appropriate KEVLIN CORPORATION will identify the product by suitable means throughout production realization. KEVLIN CORPORATION will maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration. KEVLIN CORPORATION will identify the product status with respect to monitoring and measurement requirements. All employees authorized to accept product can either sign or place their initials as evidence of acceptance. Where traceability is a requirement, KEVLIN CORPORATION will control and record the unique identification of the product. According to the level of traceability required by contract, regulatory, or other established requirement, the organization shall provide for: Identification to be maintained throughout the product life All the products manufactured from the same batch of raw material or from the same manufacturing batch to be traced, as well as the destination (delivery, scrap) of all products of the same batch For an assembly, the identity of its components and those of the next higher assembly to be traced For a given product, a sequential record of its production (manufacture, assembly, inspection) to be retrieved The supplier will maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration Customer property Reference Receiving and Shipping Procedure RECSHIP.doc, Government Property Control System QOP07, and Repair Procedure REPPROC.doc 22

23 23.doc KEVLIN CORPORATION will exercise care with customer property while it is under the company s control or being used by the company. KEVLIN CORPORATION will identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use it will be reported to the customer and records maintained. Customer property can include intellectual property Preservation of Product Reference Receiving and Shipping Procedure RECSHIP.doc, Handling, Storage and Delivery Procedure QOP09, Manufacturing Procedure MFT.doc, ESD Control Procedure ENG41.doc, and FOD Procedure MFG103 KEVLIN CORPORATION will preserve conformity of product during internal processing and delivery to the intended destination. This preservation will include identification, handling, packaging, storage, and protection. Preservation will also apply to the constituent parts of a product. Preservation of product will include where applicable in accordance with product specifications and/or applicable regulations, provisions for requirements for: Cleaning Prevention, detection and removal of foreign objects Special handling for sensitive products Marking and labeling including safety warnings Shelf life control and stack rotation Hazardous material 7.6 Control of measuring and monitoring devices Reference Calibration Procedure CALIB.doc, and Calibration and Control of Measuring Equipment QOP2 KEVLIN CORPORATION will determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide conformity of product to determined requirements. KEVLIN CORPORATION will establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. As part of the monitoring KEVLIN CORPORATION maintains a listing of the devices which identifies the type of equipment, location, frequency of checks, check methods, and acceptance criteria; this includes test hardware, test software and automated test equipment if applicable. KEVLIN CORPORATION also ensures the environmental conditions are suitable for the inspections, calibrations, measurements, and tests carried out.. Where necessary to ensure valid results, measuring equipment will: 23

24 24.doc a) be calibrated or verified at specified intervals or prior to use against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification will be recorded b) be adjusted or re-adjusted as necessary c) be identified to enable the calibration status to be determined d) be safeguarded from adjustments that would invalidate the measurement result e) be protected from damage and deterioration during handling, maintenance and storage f) recalled to a defined method when requiring calibration In addition, KEVLIN CORPORATION will assess and record the validity of previous measuring results when the equipment is found not to conform to requirements. KEVLIN CORPORATION will take appropriate action on the equipment and any product affected. Records of the results of calibration and verification will be maintained. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application will be confirmed. This will be undertaken prior to initial use and reconfirmed as necessary. 8 Measurement, analysis and improvement 8.1 General Reference Management Review Procedure MGTREV.doc, Design Procedure DESIGN.doc, KEVLIN CORPORATION will plan and implement the monitoring, measurement, analysis and improvement Processes needed to demonstrate conformity of the product; a. to ensure and demonstrate conformity of the quality management system, and b. to continually improve the effectiveness of the quality management system c. Process Controls d. Selection and inspection of key characteristics e. Process capability measurement f. Statistical process control g. Design of experiment h. Inspection - matching sampling rate to the capability of the product and to the process capability i. Quality management; use of statistical techniques to determine required improvement activities j. Failure mode and effect analysis This will include determination of applicable methods, including statistical techniques, and the extent of their use 24

25 25.doc 8.2 Monitoring and Measurement Customer satisfaction Reference Customer Service Procedure CUSTSERV.doc, and Customer Contact Procedure QOP12 As one of the measurements of performance of the quality management system, KEVLIN CORPORATION will monitor information relating to customer perception as to whether KEVLIN CORPORATION has fulfilled customer requirements. The methods for obtaining and using this information will be determined Internal audit Reference Internal Auditing Procedure AUDITS.doc KEVLIN CORPORATION will conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned requirements (see 7.1), to the requirements of the AS 9100 International Standard and to the quality management system requirements established by KEVLIN CORPORATION b) is effectively implemented and maintained. An audit program will be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods will be defined. Selection of auditors and conduct of audits will ensure objectivity and impartiality of the audit process. Auditors will not audit their own departments and/or job responsibilities. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) will be defined in a documented procedure. Management responsible for the area being audited will ensure actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities will include the verification of the actions taken and the reporting of verification results (8.5.2). Detailed tools and techniques have been developed such as audit check sheets, process flow charts and similar methods to support audit of the quality management system requirements. The acceptability of the selected tools will be measured against the effectiveness of the internal audit process and overall organization performance. Internal audits will also meet contract and/or regulatory requirements Monitoring and measurement of processes Reference Manufacturing Procedure MFT.doc and Non-conformance and Corrective Action Procedure NONCONF.doc 25

26 26.doc KEVLIN CORPORATION will apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods will demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action will be taken, as appropriate, to ensure conformity of the product. In the event of process non-conformity KEVLIN CORPORATION will: take appropriate action to correct the non-conforming process evaluate whether the process non-conformity has resulted in product non-conformity Identify and control the non-conforming product in accordance with Nonconformance and Corrective Action Procedure Nonconf.doc Monitoring and measurement of product Reference Incoming and Final Inspection Procedure INSPECT.doc, Statistical Sampling Procedure QOP05, First Article Inspection Procedure QOP22, Manufacturing Procedure MFG.doc KEVLIN CORPORATION will monitor and measure the characteristics of the product to verify that product requirements are fulfilled. This will be carried out at appropriate stages of the product realization process in accordance with the planned arrangements: When Key characteristics have been identified and require monitoring When KEVLIN CORPORATION uses sampling inspection as a means of product acceptance, the plan will be statistically valid The plan will preclude the acceptance of lots whose sample have known nonconformities When required the plan will be submitted to the customer for approval. All product will be held until it has been inspected or other wise verified as conforming to specified requirements, except under a positive recall procedure pending completion of all required measurement and monitoring activities. Evidence of conformity with the acceptance criteria will be maintained. Records will indicate the person(s) authorizing release of product (see 4.2.4). Product release and service delivery will not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer Inspection Documentation All measurements required for product acceptance are documented: The documentation identifies the criteria for acceptance and/or rejection The sequence where the measurement and testing operations was performed A record of the measurement result The type of measurement instrument required and any specific instructions associated with their use The test results will show actual test results data when required by the specification or acceptance test plan 26

27 27.doc All records when required will indicated the evidence the product meets the defined requirements First Article Inspection KEVLIN CORPORATION provides a process for the inspection, verification, and documentation of a representative item from the first production run of a new part, or following any subsequent change that invalidates the previous first article inspection result. 8.3 Control of nonconforming product Reference Non-conformance and Corrective Action Procedure NONCONF.doc, and Inspector s Data Entry Procedure QOP16 KEVLIN CORPORATION will ensure that product which does not conform to product requirements is identified and controlled to prevent unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product will be defined in a documented procedure. NONCONFORMANCES AND CORRECTIVE ACTION PROCEDURE NONCONF.doc defines the responsibility for review and the authority for the disposition of non-conforming product including the process for approving personnel making these decisions. KEVLIN CORPORATION will deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer c) by taking action to preclude its original intended use or application. KEVLIN CORPORATION prevents disposition of Use-As-Is or repair, unless specifically authorized by the customer, if the product is produced to the customers design, or the nonconformity results in a departure from the contract requirement (Unless otherwise restricted by the contract). All products that are dispositioned for scrap are processed according to NONCONFORMANCES AND CORRECTIVE ACTION PROCEDURE. (ref; NONCONF.DOC) Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, will be maintained (see 4.2.4). When nonconforming product is corrected it will be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, KEVLIN CORPORATION will take action appropriate to the effects, or potential effects of the nonconformity. : 27

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