SAE AS 9017-2009 Control of Aviation Critical Safety Items《航天临界安全装备的控制》.pdf

1、_6$(7HFKQLFDO6WDQGDUGV%RDUG5XOHVSURYLGHWKDW7KLVUHSRUWLVSX EOLVKHGE6$(WRDGYDQFHWKHVWDWHRIWHFKQLFDO and engineering sciences. The use of this report is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising therefrom, LVWKHVROHUHVSRQ

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4、il: CustomerServicesae.orgSAE WEB ADDRESS: http:/www.sae.orgSAE values your input. To provide feedback on thisTechnical Report, please visithttp:/standards.sae.org/AS9017AEROSPACESTANDARDAS9017Issued 2009-11Reaffirmed 2017-03Control of Aviation Critical Safety ItemsRATIONALEAS9017 has been reaffirme

5、d to comply with the SAE Five-Year Review policy.FOREWORDTo assure customer satisfaction, aerospace industry organizations must produce and continually improve safe, reliable products that meet or exceed customer and applicable statutory and regulatory authority requirements. The globalization of th

6、e aerospace industry and the resulting diversity of regional/national requirements and expectations have complicated this objective. Organizations have the challenge of purchasing products from suppliers throughout the world and at all levels of the supply chain. Suppliers have the challenge of deli

7、vering products to multiple customers having varying quality requirements and expectations. Industry has established the International Aerospace Quality Group (IAQG), with representatives from companies in the Americas, Asia/Pacific, and Europe, to implement initiatives that make significant improve

8、ments in quality and reductions in cost throughout the value stream. This standard has been prepared by the Americas Aerospace Quality Standards Committee (AAQSC). This document standardizes, to the greatest extent possible, minimum requirements for the control of aviation Critical Safety Items (CSI

9、s) throughout the supply chain. The establishment of common requirements, for use at all levels of the supply-chain, by organizations should result in improved quality and safety, and decreased costs, due to the elimination or reduction of organization-unique requirements and the resultant variation

10、 inherent in these multiple expectations. TABLE OF CONTENTS 1. SCOPE 31.1 General . 31.2 Application . 32. NORMATIVE REFERENCES . 33. TERMS AND DEFINITIONS . 33.1 Aviation Critical Safety Item (CSI) . 33.2 Critical Characteristic 33.3 Critical Items . 43.4 Critical Safety Item (CSI) Failure Conseque

11、nce . 43.5 Customer . 43.6 End Customer . 43.7 Failure, Modes, and Effects Analysis (FMEA) 43.8 Failure, Modes, Effects, and Criticality Analysis (FMECA) . 43.9 Frozen Planning 43.10 Sub-Tier Source 44. QUALITY MANAGEMENT SYSTEM 44.1 Documentation Requirements 44.1.1 Control of Documents . 45. PRODU

12、CT REALIZATION 55.1 Planning of Product Realization 55.1.1 Control of Work Transfers . 55.2 Review of Requirements Related to the Product 55.3 Customer-Related Processes . 55.3.1 Customer Communication 55.4 Design and Development 55.4.1 Design and Development Planning 55.5 Purchasing 65.5.1 Purchasi

13、ng Process 65.5.2 Purchasing Information . 65.6 Production and Service Provision . 65.6.1 Control of Production and Service Provision 65.6.2 Production Process Verification 85.6.3 Control of Production Process Changes . 85.6.4 Post-Delivery Support . 95.6.5 Identification and Traceability . 95.6.6 P

14、reservation of Product 96. MEASUREMENT, ANALYSIS, AND IMPROVEMENT . 96.1 Monitoring and Measurement . 96.1.1 Internal Audit . 96.1.2 Monitoring and Measurement of Product 96.2 Control of Nonconforming Product . 107. NOTES 10SAE INTERNATIONAL AS9017 Page 2 of 10_1. SCOPE 1.1 General 1.1.1 This docume

15、nt is intended to prescribe consistent requirements for CSI management for organizations and suppliers who perform work for prime contractors receiving direct contracts from U.S. government agencies (i.e., first-tier or prime suppliers). 1.1.2 The contractor, which receives the initial government co

16、ntract, will receive their CSI requirements directly from the U.S. government agency and will be required per those contracts to maintain a CSI management system that ensures compliance to all requirements. 1.1.3 The flow down of this document shall be in addition to any specific contract clauses (e

17、.g., Federal Acquisition Regulations, Defense Federal Acquisition Regulations) required by the government to be flowed by contract to sub-tier sources. 1.2 Application 1.2.1 This standard will be auditable with the expectation that the prime contractor will flow CSI requirements to the supply chain

18、and periodically assess, audit, validate, and recognize compliance to AS9017 per their own processes.1.2.2 All manufacturers of CSIs shall comply with the requirements of SAE AS9100 or a technically equivalent quality management system standard. Special process suppliers may meet this quality manage

19、ment system requirement through their Nadcap certification. 1.2.3 Any operation, process, or other action associated with the new manufacture/production of any CSI, shall only be performed by sources meeting the applicable requirements of this document. 2. NORMATIVE REFERENCES This standard shall be

20、 used in conjunction with: SAE AS9100 “Quality Management Systems Requirements for Aviation, Space and Defense Organizations”, or a technically equivalent quality management standard. U.S. Public Law 108-136 “National Defense Authorization Act for Fiscal Year 2004”; Section 802, “Quality Control in

21、Procurement of Aviation Critical Safety Items and Related Services”. 3. TERMS AND DEFINITIONS 3.1 Aviation Critical Safety Item (CSI) A part, an assembly, installation equipment, launch equipment, recovery equipment, or support equipment for an aircraft or aviation weapon system that contains a char

22、acteristic which failure, malfunction, or absence of could cause a catastrophic or critical failure resulting in the loss of or serious damage to the aircraft or weapon system, an unacceptable risk of personal injury or loss of life, or an un-commanded engine shutdown that jeopardizes safety. 3.2 Cr

23、itical Characteristic Any feature throughout the life cycle of a critical item (e.g., dimension, tolerance, finish, material or assembly, manufacturing or inspection process, operation field maintenance, depot overhaul requirement) that if nonconforming, missing, or degraded may cause the failure or

24、 malfunction of the critical item. SAE INTERNATIONAL AS9017 Page 3 of 10_3.3 Critical Items Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product (including safety, performance, form, fit, function, prod

25、ucibility, service life, etc.) thatrequire specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc. 3.4 Critical Safety Item (CSI) Failure Consequence Catastrophic A fa

26、ilure that could result in death, permanent total disability, and/or financial loss exceeding a defined contractual limit. Critical A failure that could result in permanent partial disability and/or injuries or occupational illness resulting in hospitalization of at least three personnel. 3.5 Custom

27、er The organizations immediate contract source; this may be a prime/first-tier supplier or subsequent contractor in the supply chain who flows this document to their suppliers as a requirement. 3.6 End Customer All aviation CSIs controlled in accordance with U.S. Public Law 108-36, Section 802 origi

28、nate from a U.S. Government controlled entity (e.g., U.S. Air Force, U.S. Army, U.S. Navy). The originating agency is considered the “end customer”. 3.7 Failure, Modes, and Effects Analysis (FMEA) A process for analysis of potential failure modes within a system for classification by severity or det

29、ermination of the effectof failures on the system. 3.8 Failure, Modes, Effects, and Criticality Analysis (FMECA) An extension of FMEA. In addition to the basic FMEA, it includes a criticality analysis which is used to chart the probability of failure modes against the severity of their consequences.

30、 3.9 Frozen Planning A methodology by which organizations will control the manufacturing/production processes to achieve consistent results in the production of aviation CSI designated features/characteristics of parts and assemblies. This means “freezing” or prohibiting changes to the agreed proces

31、s plan without appropriate approval. 3.10 Sub-Tier Source An aviation CSI organizations manufacturing source, either for procurement of CSI(s) or for individual manufacturing or process operation(s) required to produce a CSI. 4. QUALITY MANAGEMENT SYSTEM 4.1 Documentation Requirements 4.1.1 Control

32、of Documents All documents applicable to aviation CSIs (e.g., engineering, manufacturing, procurement, quality, packaging) shall be clearly noted as such or otherwise traceable and controlled. SAE INTERNATIONAL AS9017 Page 4 of 10_5. PRODUCT REALIZATION 5.1 Planning of Product Realization The organi

33、zation shall submit a manufacturing plan to the customer for operations planned by the organization or to be performed by sub-tier sources, including special process sources. The manufacturing plan shall include engineering definition, manufacturing planning, and/or technique documentation. Subcontr

34、acted operations must include the name(s) and location(s) of sub-tier sources used. Special processes performed on aviation CSIs, as defined by the customer or organization, shall also be subject to the requirements of this document. 5.1.1 Control of Work Transfers Manufacturing operations for aviat

35、ion CSIs are to be performed by organizations meeting the requirements of this document. Any planning changes, additions, or use of sub-tier sources not identified on customer approved planning must be approved by the customer, unless delegated prior to incorporation of the change to the plan. The t

36、emporary or permanent transfer of manufacturing operations requires the same controls, as required for the qualification of an initial process, to be in place. 5.2 Review of Requirements Related to the Product Non-design responsible parties must have a process for ensuring identification of a custom

37、ers identified aviation CSIs during contract review and for ensuring that they are properly identified and controlled per this document throughout their manufacturing processes. 5.3 Customer-Related Processes 5.3.1 Customer Communication The organization shall provide notification to the customer, w

38、ithin the time frame specified per the contract, for any of the following changes the organization becomes aware of: revisions to drawings, specifications, or standards that differ from the revision cited in the acquisition identification description in the contract; a change in the organizations ma

39、nufacturing location; or a transfer of manufacturing facilities by the organization since last manufacture. 5.4 Design and Development 5.4.1 Design and Development Planning 5.4.1.1 Design responsible parties must have a process acceptable to the customer: a. To evaluate and assess the consequences o

40、f CSI failure during the design phase (e.g., FMEA, FMECA, fault tree analysis, hazard risk assessments) and for identification of CSIs based on those identified items having a consequence failure equating to “catastrophic” or “critical”. Determination should be focused on the lowest replaceable end

41、item that the end customer secures as a unit. The process should consider design redundancy, the potential for dependent failure, and the potential for a latent/hidden failure as influencing factors for determining consequence. SAE INTERNATIONAL AS9017 Page 5 of 10_ The process shall ensure that the

42、 design is analyzed to ensure that all critical characteristics are identified. The process shall ensure engineering traceability requirements (e.g., serialization, lot traceability) are defined and documented on applicable drawings and technical data. b. For reviewing identified CSIs with the custo

43、mer and/or end customer, as required, during significant phases of design review/approval (e.g., critical design review, critical test review, physical configuration audit) and a process for reaching agreement with the end customer on determination of CSIs. c. For ensuring CSIs are translated into a

44、ppropriate manufacturing plans that provide controls for managing variation of identified critical characteristics. d. For risk management to evaluate, mitigate, or accept the residual risk of at least those items assessed as having a consequence of “catastrophic” or “critical” identified during the

45、ir hazard risk assessment process. e. For evaluating design changes for potential impact to critical safety items and securing customer approval as required.5.4.1.2 For product designed by the customer, customer engineering shall determine the items to be controlled and the characteristics to be des

46、ignated as “critical”. 5.4.1.3 If design authority is delegated to the organization, the organizations engineering processes and associated documentation shall be approved by the customer. Subsequent changes to the process shall be resubmitted for approval.5.5 Purchasing 5.5.1 Purchasing Process 5.5

47、.1.1 When organizations responsible for the design and/or delivery of aviation systems, platforms, or equipment (e.g., aircraft, engines, electronics systems, test equipment) require a new CSI supplier, the customer responsible for design control will perform the same approval process for the potential new source that was required during the original qualification of the approved source(s). 5.5.1.2 Sub-tier sources shall be approved by t