Company: Prepared By: Date: Changes from previous version highlighted in yellow. Paragraph Element Objective Evidence 2.1 Objective of Quality Assurance Program 2.2 Applicability and Scope 2.3 QA Program and Manual Requirements 2.4 Management Responsibility 2.5 Production, Inspection, and Test Planning 2.6 Corrective and Preventative Actions 2.7 Document Control 2.8 Measuring and Testing Equipment 2.9 Purchasing and Contracting 2.10 Incoming Inspection 2.11 In-Process Inspection 2.12 Final Inspection 2.13 Inspection Status 2.14 Identification and Traceability 2.15 Process Control 2.16 Preservation, Packaging and Shipping 2.17 Quality Records 2.18 Nonconformance Control 2.19 Quality Program Review and Manual Revision 2.20 Process Capability/Statistical Methods 2.21 Internal Quality Audits 2.22 Training 2.23 Contract Review 2.24 Design Control Page 1
2.1 2.1.1 2.1.2 Has the contractor established a quality assurance program that includes all elements of the AAR M-1003 specification? Is it established and maintained by the contractor for the purpose of ensuring that materials, products, and services conform to contract requirements? 2.1.2.1 Are all specified requirements fulfilled? Are nonconforming items prevented, detected early, and properly 2.1.2.2 disposed? Is there evidence of continuous improvement of the items 2.1.2.3 produced, the processes producing them and/or the services provided? Does the documentation sufficiently outline requirements affecting quality in activities covered by this standard in order to verify that 2.1.3 materials, products, and services meet contract, statutory, and regulatory requirements? 2.2 2.2.1 2.2.2 OBJECTIVE of the QUALITY ASSURANCE PROGRAM Are the principal objectives of a quality program addressed as follows: APPLICABILITY and SCOPE Does the contractor's quality assurance program apply throughout all areas of contract performance including, as appropriate, the procurement, identification, stocking, inspection, and issuing of material; the entire process of manufacture including design control, fabrication, processing, inspection, and assembly; and the packaging, storing, and shipping of material; and the maintenance of equipment that affects quality? Does the program provide that measures be implemented to plan work and prevent defects? Does the program identify nonconformances and initiate corrective action to eliminate their causes and potential for reoccurrence as early in the process as possible? Page 2
2.3 2.3.1 2.3.2 Does the contractor establish, implement, and maintain a quality assurance program according to the requirements of this specification? Does the contractor prepare a quality assurance manual covering the requirements of this specification? Does the quality assurance manual: 2.3.2.1 Include or make reference to the quality program s procedures? Outline the structure of the documentation used in the quality 2.3.2.2 program to plan and perform work so that nonconformities are prevented and those that do occur are detected and resolved? 2.3.2.3 Provide the means for its effective implementation and continuous improvement of the quality program? 2.3.3 Does a senior management official approve the QA Manual, and is this approval documented? 2.3.4 Does the quality assurance manual contain, at a minimum: 2.3.4.1 A description of the organization? 2.3.4.2 An inspection and test plan in accordance with paragraph 2.5? 2.3.4.3 A statement for reviewing and updating the manual? 2.3.4.4 2.3.5 QUALITY ASSURANCE PROGRAM and MANUAL REQUIREMENTS System function descriptions for paragraphs 2.6 through 2.24 that document purpose (intent of what is expected to be accomplished), scope (what activities and processes are included), and an outline of what shall be done? Does the contractor maintain a current subscription to AAR Circular Letters or demonstrate a system that provides access to current AAR Circular Letter information as it pertains to the contractor's operation? 2.3.6 Does the contractor maintain a current copy of AAR Specification M-1003? Page 3
2.4 2.4.1 2.4.1.1 2.4.1.2 2.4.1.3 2.4.1.4 2.4.2 2.4.2.1 2.4.2.2 2.4.2.3 2.4.2.4 2.4.2.5 MANAGEMENT RESPONSIBILITY Policy and Objectives Does the contractor: Define and document the organization's policy for quality, including objectives for quality and its commitment to quality? Ensure that this policy is understood, implemented, and maintained at all levels of the organization? Ensure that quality assurance requirements are not subordinated to manufacturing or construction? Define the responsibility, authority and interrelationship of personnel who manage, perform and verify work affecting quality? Is this personnel interrelationship shown on organization charts or clearly described in writing? Responsibility and Authority Does the contractor appoint a management representative who, irrespective of other responsibilities, has the responsibility, organizational freedom and authority to: Ensure that a quality program is established, implemented, and maintained in accordance with specification M-1003? Periodically review the performance of the quality program with senior management as a basis for improvement of the program? Initiate action to prevent the occurrence of any nonconformities relating to product, process, and quality program? Identify and record any problems relating to the product, process, and quality program? Initiate or recommend solutions to problems through designated channels? 2.4.2.6 Verify the implementation of solutions? 2.4.2.7 Control further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected? Page 4
2.4.3 2.4.3.1 Management? 2.4.3.2 Performance of work? 2.4.3.3 Verification activities, including internal quality audits? 2.4.3.4 Training? 2.4.4 2.4.4.1 Resources Does the (contractor's) organization ensure that adequate resources are identified and provided, including the assignment of trained personnel for the following: Management Review Does the contractor's management holding executive responsibility: Review the quality program at least annually to ensure its continuing suitability and effectiveness in satisfying the requirements of this specification and the contractor s quality policy and objectives? Does the review include at least the following: 2.4.4.1.1 Internal and External quality audits? 2.4.4.1.2 Internal and external nonconformances and/or Chapter 7 criteria? 2.4.4.1.3 Corrective and Preventative Actions? 2.4.4.1.4 Previous management review and action items? 2.4.4.1.5 Changes to the quality system? 2.4.4.1.6 Inspection results for example scrap rates, rework status, inspection data, and on-time delivery? 2.4.4.2 Have records of such reviews been maintained? Page 5
2.5 2.5.1 2.5.1.1 Plan the production activities? 2.5.1.2 Plan the inspection and test activities? 2.5.1.3 Develop an inspection and test plan in accordance with paragraph 2.5.2? 2.5.1.4 Update the plan to reflect inspection and test revision? 2.5.2 2.5.2.1 2.5.2.2 2.5.2.3 2.5.2.4 2.5.2.5 2.5.2.6 PRODUCTION, INSPECTION, and TEST PLANNING Does the contractor do the following: The inspection and test plan may be of any format to suit the contractor s program as long as all criteria from incoming inspection through packaging and shipping are addressed. Does it do at least the following: Indicate each inspection and test point and its relative location in the processing cycle, including incoming inspection, preservation of items, packaging, and site inspection and testing? The contractor may include additional in-process inspection points for its own evaluation of quality. Identify the characteristics to be inspected, examined, and tested at each point & specify acceptance criteria to be used? Identify inspection and test points where measurement and test records are maintained so that assessments required by paragraph 2.8.7 can be met? Indicate mandatory hold points that require witnessing or verification of selected characteristics of an item or process, and beyond which the work shall not proceed? Define or refer to sampling plans and statistical process control, including the criteria for selection, if proposed, and indicate where they will be used? Define or refer to how verification of compliance to process procedures will be accomplished and documented? 2.5.2.7 Where applicable, specify where lots or batches will be used? 2.5.2.8 Indicate where subcontractor services will be employed? Page 6
2.6 2.6.1 2.6.2 2.6.2.1 2.6.2.2 2.6.2.3 2.6.2.4 2.6.2.5 2.6.2.6 2.6.3 2.6.3.1 2.6.3.2 2.6.3.3 2.6.4 CORRECTIVE and PREVENTATIVE ACTION Does the contractor continuously improve the effectiveness of the quality program through the use of corrective action, preventive action internal audit results (refer to 2.21) and actions resulting from management reviews (refer to 2.4.4)? Has the contractor implemented procedures for corrective action that include the following: Handling of customer complaints and reports of product/service nonconformance? Investigation of the root cause of the nonconformity relating to product, process, and quality program and recording of the results of the investigation? Determination of the corrective action needed to permanently eliminate the root cause of the nonconformity? Documenting assignment of responsibility to ensure corrective actions are implemented? Assignment and tracking of expected completion dates for corrective actions? Application of controls to ensure that corrective action is taken and is effective? Has the contractor implemented procedures for preventive action that include the following: The use of appropriate sources of information, such as process and work operations, that affect product quality, concessions, audit results, quality records, service reports, and customer complaints to detect, analyze, and eliminate causes of potential nonconformity? Initiation of preventive action and application of controls to ensure that the procedure is effective? Confirmation that relevant information on actions taken is submitted for management review? Have records of corrective and preventive actions been maintained? Page 7
2.7 2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.7.4.1 2.7.4.2 2.7.4.3 2.7.4.4 DOCUMENT CONTROL Has the contractor done the following: Establish and maintain documented procedures to control all documents affecting quality, including, to the extent applicable, documents of external origin such as standards and customer drawings? Establish and maintain a master list or equivalent documentcontrol procedure identifying the current revision status of documents? (This list or procedure must be available to preclude the use of invalid and/or obsolete documents.) Have documents been reviewed and approved for adequacy by authorized personnel prior to use? Does the contractor establish controls to ensure the following: That the applicable issues of appropriate and understandable documents are available at all functional areas and inspection and test points where operations essential to the effective functioning of the quality program are performed? Applicable standards, internal procedures, and forms necessary to demonstrate compliance with this specification and any related technical requirements must be maintained in English, as well as the appropriate language for the user. Per Appendix C: M-1003 Certified companies are required to maintain current English language versions of applicable standards, internal procedures, and forms used in the quality program. With respect to completed forms, inspection and test results need not be translated into both English and the appropriate language; however, a blank form in English must be available for use by the auditor. That invalid and/or obsolete documents are promptly removed from all points of issue or use or otherwise assured against unintended use? That any obsolete documents retained for legal and/or reference purposes shall be suitably identified and assured against unintended use? Page 8
2.7.5 When changes are made to documents, does the contractor do the following: 2.7.5.1 2.7.5.2 2.7.5.3 2.7.6 2.7.7 Ensure that changes to documents receive the same level of authorization as the original documents? Process all changes in writing so they are acted on promptly at the specified locations? Maintain a record of changes and, where practical, identify the nature of the changes? Are written notes on documents made by authorized persons according to established procedures? Does the contractor revise and reissue documents after a practical number of changes have been issued? Page 9
2.8 2.8.1 2.8.2 2.8.3 2.8.4 Does the contractor establish and maintain documented procedures to control, calibrate, and maintain all measuring and test equipment and devices used to verify item quality and to monitor special processes? Does the contractor, at prescribed intervals or prior to use, calibrate and adjust measurement and test equipment against certified equipment having a known valid relationship to nationally recognized standards? Where no national standard exists, does the contractor document the basis employed for calibration? This can include industry or user standards. Does the contractor maintain calibration documents that include the following: 2.8.4.1 Date of the calibration? 2.8.4.2 Reference to standard applied? 2.8.4.3 Equipment type? 2.8.4.4 Identification number? 2.8.4.5 Location? MEASURING AND TEST EQUIPMENT 2.8.4.6 Frequency of checks? 2.8.4.7 Description of check method? 2.8.4.8 Acceptance criteria? 2.8.4.9 Action to take when results are unsatisfactory? Page 10
2.8.5 2.8.6 2.8.7 2.8.8 2.8.9 2.8.10 Does the contractor identify measuring and testing equipment with a tag, sticker, or other suitable indicator to show the calibration status? Does the contractor maintain calibration records for measuring and test equipment? Does the contractor assess and document the validity of previous inspection and test results when measuring and test equipment are found to be out of calibration? Does the contractor ensure that environmental conditions are suitable for calibrations being carried out? Does the contractor ensure that the handling, storage, and preservation of measuring and testing equipment is such that the accuracy and fitness for use are maintained? Does the contractor safeguard all measuring and testing equipment from adjustments that would invalidate the calibration setting? Page 11
2.9 2.9.1 PURCHASING AND CONTRACTING Does the contractor do the following: 2.9.1.1 Identify products to be purchased or subcontracted? 2.9.1.2 2.9.1.2.1 Does the contractor determine for those subcontracted items and purchased products an appropriate method of verifying that the products/services conform to specified requirements? Typical methods include but are not limited to: Inspection by subcontractor. 2.9.1.2.2 Source inspection by contractor. 2.9.1.2.3 Incoming inspection. 2.9.1.2.4 Objective evidence, such as certificates of compliance. 2.9.1.2.5 Surveillance of subcontractor. Evaluate and select subcontractors based on documented 2.9.1.3 assessments of their ability to meet contract and quality requirements? Survey and audit subcontractor's verification of quality at the 2.9.1.4 Subcontractor s plant or the site of processing as and when required? 2.9.1.5 Maintain quality records of acceptable subcontractors? 2.9.2 2.9.2.1 2.9.2.2 Do purchasing documents contain data clearly describing the items ordered, including the following, where applicable: The type, class, grade, or other precise identification, including AAR specification, drawings, or other technical specifications? The title or other positive identification, and applicable issues, of specifications, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of items, procedures, process equipment, and personnel? 2.9.2.3 The title, number, and issue of the quality standard to be used? 2.9.2.4 The verification arrangements and method of product release? Page 12
2.9.3 Does the contractor review and approve purchasing documents for adequacy of the specified requirements prior to release? 2.9.4 When specified in the contract, are the contractor's customers afforded the right to verify at the subcontractor's plant and on the contractor's premises that subcontracted items conform to specified requirements? Verification by the customer shall not absolve the contractor of the responsibility to provide acceptable service, nor shall it preclude subsequent rejection by the customer. Page 13
2.10 2.10.1 INCOMING INSPECTION Does the contractor inspect, test, and identify incoming items as required by the inspection and test plans? 2.10.2 2.10.3 2.11 2.11.1 2.11.2 2.11.3 Does the contractor check the objective evidence provided by subcontractors and suppliers as a means of verifying quality per the requirements of paragraph 2.10.1? Does the contractor hold incoming items until the required inspection and tests are completed or the necessary inspection and test reports are received and verified (except when items are released under positive recall)? IN-PROCESS INSPECTION Does the contractor inspect, test, and identify items as required by the inspection and test plan? Where inspection is not feasible, does the contractor monitor process methods? Does the contractor hold items until the required inspections and tests are complete or necessary reports are received and verified (except when items are released under positive recall)? Release under positive recall shall not preclude inspection, testing and identification as specified in paragraph 2.11.1. 2.11.4 Does the contractor identify nonconforming items? 2.11.5 2.11.6 Does the contractor maintain documented procedures for the verification, storage, and preservation of the customer-supplied part(s)? Are any customer-supplied part(s) that are lost, damaged, nonconforming, or otherwise unsuitable for use recorded and reported to the customer? Page 14
2.12 FINAL INSPECTION 2.12.1 2.12.2 Does the contractor inspect, test, and identify the final items as required by the inspection and test plan? Does the contractor review all inspection and test records and verify that the item has been inspected at all points shown in the inspection and test plan and that these records are complete? 2.12.3 2.13 2.13.1 Does the contractor retain all inspection records as specified in paragraph 2.17? INSPECTION STATUS Does the contractor provide means for ensuring that required inspections and tests are performed and that the acceptability of items with regard to inspections and tests performed is known throughout processing? 2.13.2 Does the contractor establish and maintain a system for tags or stamped impressions on the item or its container or other physical means that indicates final acceptance of items? Final acceptance indicators, in-process indicators, and incoming inspection indicators must not be identical. 2.13.3 Does the contractor show the identity of the contractor and its inspector on any inspection stamps used? 2.13.4 Does the contractor provide measures for controlling status indicators, including the authority for application and removal of tags, stamps, or other physical means of indicating the inspection status? Page 15
2.14 2.14.1 2.14.2 2.15 IDENTIFICATION and TRACEABILITY Where appropriate, does the contractor establish and maintain systems that identify each item (lot, component, or part) to the applicable drawing, specification, or other technical document, from receipt through processing and shipping? Where traceability is specified, does the contractor assign to each item a unique identification that shall distinguish those items that are otherwise identical but that have been processed in separate batches? Does the contractor record this identification on all process, inspection, and test records? PROCESS CONTROL 2.15 Does the contractor identify and plan the production, installation, and servicing processes that directly affect quality and ensure that these processes are conducted under controlled conditions? 2.15.1 2.15.2 2.15.3 2.15.4 Adhering to documented procedures defining the work process where the absence of such procedures could adversely affect quality? Employing suitable process equipment in a suitable working environment? Complying with applicable codes, standards, specifications, documented procedures, and/or inspection and test plans (Paragraph 2.5)? Monitoring and control applicable process parameters and product characteristics? 2.15.5 Approving procedures, processes, and equipment? 2.15.6 2.15.7 Do controlled conditions include, but are not limited to, the following: Establishing workmanship criteria in the clearest appropriate manner (written/reference standards, pictures, etc.)? Maintaining equipment with documented preventative maintenance to ensure continuing conformity to product requirements? Page 16
2.15.8 2.15.9 Ensuring that special processes (including but not limited to welding, heat treating, plating, and non-destructive testing) are performed under controlled conditions in accordance with applicable codes, standards, specifications, and governmental and contractual requirements by qualified personnel using qualified equipment and procedures? Ensuring that the qualification of personnel, procedures, and equipment complies with the requirements of applicable codes, standards, and specifications? 2.15.10 2.15.11 2.15.12 Ensuring that documentation for currently qualified personnel, processes, or equipment is maintained in accordance with the requirements of pertinent codes, standards, & specifications? Defining those special processes not covered by applicable codes, standards, or specifications? Where item quality requirements exceed the requirements of established codes, standards, and specifications, describe the necessary qualifications of personnel, procedures, and equipment? Ensuring that any required AAR or other technical requirements have been obtained and understood and are maintained. This includes verification that the requirements of applicable AAR standards, specifications, recommended practices, or other technical requirements are being met. Page 17
2.16 2.16.1 2.16.2 PRESERVATION, PACKAGING, AND SHIPPING Does the contractor establish and maintain documented procedures for handling, storage, preservation, and delivery of product? Does the contractor provide methods of handling and storing product that prevent damage? Does the contractor control packing, packaging, storing, shipping and marking processes? 2.16.3 2.16.4 2.16.5 Do procedures apply to ensure conformance to specified requirements, including, as applicable, materials used, rotation of dated materials, consideration of environmental factors affecting product, and technical requirements? Does the contractor apply appropriate methods for preservation and segregation of product when the product is under contractor control? Does the contractor arrange for the protection of the quality of the product after final inspection and test? Where contractually specified, is this protection extended to include delivery to destination? Page 18
2.17 2.17.1 2.17.1.1 2.17.1.2 2.17.1.3 2.17.2 2.17.2.1 QUALITY RECORDS Does the contractor maintain quality records as evidence of the following: The item or material meets this standard and contractual requirements? Personnel, procedures, and equipment for special processes are qualified as required by paragraph 2.15.10? Selection and surveillance of subcontractors are met as required by paragraph 2.9.1? Does the contractor include in paragraph 2.17.1 inspection and test records that identify the following: Either the reference drawing number and revision number or part number of the item? 2.17.2.2 Applicable requirements? 2.17.2.3 Specific inspections performed and results obtained? (If measurements are not required, include the basis of acceptance.) 2.17.2.4 Nonconformance reports (see paragraph 2.18.4)? 2.17.2.5 The date of inspection or test? 2.17.2.6 The identity of the inspector or data recorder? 2.17.3 2.17.3.1 Make quality records available for analysis and review? 2.17.3.2 Identify, index, and file quality records for easy retrieval? 2.17.3.3 2.17.3.4 Does the contractor do the following: Retain quality records for as long as necessary; at a minimum ensure compliance to applicable contractual, legal and/or technical specification requirements? Provide suitable environment for records to minimize deterioration or damage and to prevent loss? If electronic records are used does the contractor address, at a minimum, frequency of backups, type of media to be used for backups, and storage requirements? Page 19
2.18 2.18.1 2.18.2 Does the contractor control nonconforming conditions and continuously improve the effectiveness of the quality program? 2.18.2.1 Define the responsibility and authority of those who dispose of nonconforming items? 2.18.2.2 Detect and record nonconformance? 2.18.2.3 Identify and hold nonconforming items for evaluation? 2.18.2.4 Develop a disposition that has the concurrence of all responsible parties? 2.18.2.5 Implement accepted disposition? 2.18.2.6 Provide requirements for reinspecting and retesting repaired and reworked items? 2.18.2.7 2.18.3 2.18.4 2.18.5 NONCONFORMANCE CONTROL Does the contractor establish and maintain measures for controlling nonconforming items that do the following: Advise the initiator and the AAR through the online AAR material nonconformance reporting website at http://aar.iirx.net of the final disposition of returned/recalled materials identified as nonconforming to preclude unauthorized use as per Chapter 7? Is the contractor complying with all Chapter 7 requirements of AAR M-1003? Is the contractor properly using Forms QA-7.1, QA-7.2 and QA-7.3 as detailed in Chapter 7 of AAR M-1003? Are records of this activity maintained for three years as required by Chapter 7 of AAR M-1003? Does the contractor designate a Chapter 7 nonconformance reporting contact? Does the contractor provide holding areas or methods for segregating nonconforming items to prevent unauthorized use, shipment, or mixing with conforming items? Where physical segregation is not practical, tagging, marking or other positive means of identification are acceptable. Does the contractor maintain records identifying nonconforming items, the nature and extent of nonconformance, its disposition, and objective evidence that repaired and reworked items have been reinspected or retested according to applicable documented procedures? Page 20
2.19 2.19.1 2.19.1.1 2.19.1.2 2.19.2 2.20 QUALITY PROGRAM REVIEW and MANUAL REVISION Does the contractor review the quality assurance program and manual at least annually? Does the contractor maintain a completed Quality Assurance System Evaluation (QASE) Checklist, identifying the corresponding line item from their program that addresses each requirement in the current Specification M-1003? Following the review does the contractor update the quality assurance program and manual accordingly to reflect current quality assurance practices? Does the contractor submit revisions to the quality assurance program and manual to the AAR QA Program Coordinator or agent prior to 60 days before a scheduled M-1003 audit? Does the contractor prepare and submit more frequent upgrades in procedures and clarity in accordance with these specifications when deficiencies are identified and documented by the Quality Assurance Committee? PROCESS CAPABILITY/STATISTICAL METHODS 2.20.1 2.20.2 2.20.3 Does the contractor use statistical methods to evaluate and control the variability of processes that may include rework/repair, status, scrap rates, and inspection data? If not what do they do? Does the contractor use statistical process control to evaluate the capability and capacity to ensure materials, products, and services conform to contract requirements? If not what do they do? Does the contractor identify where statistical methods are used for control and continuing improvement of key product/process characteristics? (Suppliers shall then identify and classify product, process, and service characteristics for which statistical techniques will be used as a basis for the assurance and control of quality and acceptance or rejection of lots.) Page 21
2.20.4 2.20.4.1 Evaluate and control the variability of processes? 2.20.4.2 Control key product/process characteristics for continuous improvement? 2.20.4.3 Measure key performance indicators of the quality program? 2.20.5 2.21 2.21.1 2.21.2 Does the contractor maintain documented procedures to implement and control the application of the statistical methods? Does the contractor carry out internal quality audits to verify compliance with Specification M-1003 and the contractor s current quality assurance practices? Does the contractor schedule audits as follows: 2.21.2.1 On the basis of the status and importance of the activity? 2.21.2.2 They occur minimally once per year? They encompass a review of all 24 elements contained in Chapter 2.21.2.3 2 of this specification within a 12-month period? Are audits performed in accordance with documented procedures (using appropriate checklists) by trained personnel who have the 2.21.3 organizational freedom to record results and deficiencies as they are required? Are audit results recorded and do they include evidence of 2.21.4 conformance or nonconformance of a product, process or procedure to specified requirements? 2.21.5 Does the contractor identify the need for the application of statistical methods to accomplish the following: INTERNAL QUALITY AUDITS Are the results of audits documented and brought to the attention of the personnel having responsibility in the area audited? 2.21.6 2.21.7 Does management personnel responsible for audited areas with noted nonconformances take timely corrective action (paragraph 2.6.2) on the deficiencies found by internal audits? Do follow-up activities verify and record the implementation and effectiveness of the action taken? Page 22
2.22 2.22.1 2.22.2 2.22.3 2.22.4 2.22.5 2.22.6 TRAINING Does the contractor establish and maintain approved procedures for identifying training needs, providing the training, and evaluating the effectiveness of that training of all personnel involved in activities affecting quality? Does the contractor create and maintain job descriptions? Are basic job responsibilities and qualification requirements defined? Do personnel involved in special or key processes (including, but not limited to, welding, heat treating, painting, coating, pressure treating, product inspection, internal quality auditing, etc.) have both function-specific training and applicable work experience to be considered qualified? Are training records maintained for qualified personnel as long as they remain qualified or as required by other regulatory requirements? Does the contractor define the measures to ensure that personnel are aware and knowledgeable of their specific responsibilities for quality? Does the contractor provide the necessary instruction and means whereby those personnel can develop, achieve, and maintain proficiency? Page 23
2.23 2.23.1 2.23.1.1 2.23.1.2 2.23.1.3 2.23.2 2.23.3 CONTRACT REVIEW Does the contractor establish and maintain documented procedures for contract review such that, before submission of an offer by the contractor, or at the acceptance of a contract or order (statement of requirement), the offer, contract, or order is reviewed by the contractor to ensure the following: The requirements are adequately defined and documented? Where no written statement of requirement is available for an order received by verbal means, does the contractor ensure that the order requirements are agreed to before their acceptance? Any differences between the contract or accepted order requirements and those in the offer are resolved? The contractor has the capability to meet the contract or accepted order requirements? When servicing is specified in the contract or order, has the contractor established and maintained documented procedures for performing, verifying, and reporting that the servicing meets the specified requirements? Does the contractor identify how an amendment to a contract is made and correctly transferred to the responsible personnel within the contractor's organization? 2.23.4 Does the contractor maintain records of contract reviews? Page 24
2.24 2.24.1 2.24.2 2.24.3 DESIGN CONTROL Does the contractor establish and maintain documented procedures to control and verify the design and development planning of the product in order to ensure that the specified requirements are met? Where product design, redesign, or modifications are not usually performed, do the design procedures address how adherence to existing design criteria is maintained? Where product design, redesign, or modifications are not usually performed, does the contractor define the procedure when a design change is required? Does the contractor prepare plans for each design and development activity? Do the plans include the review, verification and validation requirements that are appropriate to each design and development activity? Do the plans describe or reference these activities and define responsibility for their implementation. Are the design and development activities assigned to qualified personnel equipped with adequate resources? Are the plans updated as the design evolves? Are organizational and technical interfaces between different groups who contribute to the design process defined and the necessary information documented, transmitted, and regularly reviewed? Does the contractor manage the interfaces between the different groups to ensure effective communication and clear assignment of responsibility? Page 25
2.24.4 2.24.5 Are design and development input requirements relating to the product, including applicable statutory and regulatory requirements, functional and performance requirements and where applicable, information derived from previous similar designs and other requirements essential for design and development identified and documented and their selection reviewed for adequacy by the contractor? Are incomplete, ambiguous, or conflicting requirements resolved with those responsible for imposing these requirements? Does design input take into consideration the results of any contract review activities? Is planning output updated as appropriate, as the design and development activity progresses? Is design and development output documented and expressed in terms that can be verified against design input requirements and validated (see paragraph 2.24.9)? 2.24.5.1 Meet the design and development input requirements? 2.24.5.2 Contain or make reference to acceptance criteria? 2.24.5.3 2.24.5.4 2.24.6 Does design and development output do the following: Identify those characteristics of the design that are crucial to the safe and proper functioning of the product (e.g., operating, storage, handling, maintenance, and disposal requirements)? Provide appropriate information for purchasing, production, and servicing provision? Are design and development output documents reviewed before release? Page 26
2.24.7 At appropriate stages of design, are formal documented reviews of the design and development results planned and conducted, to evaluate the ability of the results to meet design and development input requirements? Does the review identify any problems and propose appropriate resolution actions? Do design reviews include representatives of functions concerned with the design and development stage(s) being reviewed? Are records of such reviews maintained? 2.24.8 2.24.9 2.24.9.1 2.24.9.2 2.24.10 2.24.10.1 2.24.10.2 Are necessary actions documented? At appropriate stages of design, is design verification performed to ensure that the design and development output meets the design and development input requirements? Are the design and development verification measures and any necessary actions recorded? Is design validation performed to ensure that product conforms to defined user needs and/or requirements? If specified application or intended use are known, is the resulting product capable of meeting the requirements of the intended use? Does the contractor do the following: Complete validation prior to the delivery or implementation of the product, wherever practicable? Maintain records of the results of validation and any necessary actions? Are all design and development changes and modifications identified, documented, reviewed, and validated as appropriate, and then approved by authorized personnel? Does the review include evaluation of the effect of the changes on constituent parts and product already delivered? Does the contractor maintain records of the review of changes and any necessary actions? Page 27