ASTM F3246-2018 Standard Specification for Quality Assurance for Manufacturers of Aircraft Systems.pdf

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1、Designation: F3246 18Standard Specification forQuality Assurance for Manufacturers of Aircraft Systems1This standard is issued under the fixed designation F3246; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revi

2、sion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification establishes the minimum require-ments for a Quality Assurance System (QAS) for manufactur-ers of an aircraft

3、 article(s) that is covered by the scope ofCommittee F39 on Aircraft Systems.1.2 This specification applies to the manufacturing of air-craft articles or systems and provides information and de-scribes criteria for establishing and maintaining a qualitysystem.1.3 This standard does not purport to ad

4、dress all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.4 This international standard was dev

5、eloped in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Terminology2.

6、1 Definitions:2.1.1 article, na material, part, component, process, orappliance.2.1.2 direct to stock (DTS), nparts that are accepted intoinventory without inspection.2.1.3 manufacturers statement of conformity, na docu-ment certifying that the article meets the manufacturers designrequirements.2.1.

7、4 quality assurance manual (QAM), na document thatprovides an overview of the quality policies and key require-ments of the QAS. The QAM is a basic source of reference andoverview of the QAS.2.1.5 quality assurance record (QAR), nthe record show-ing compliance with the QAS for each article produced.

8、2.1.6 quality assurance system (QAS), na system of pro-cesses and controls used by a manufacturer to verify andvalidate that the article meets its specified requirement.2.2 Abbreviations:2.2.1 DTSDirect to Stock2.2.2 MRBMaterial Review Board2.2.3 QAQuality Assurance2.2.4 QAAQuality Assurance Adminis

9、tration3. Quality Assurance System3.1 A QAS shall ensure that each process and service isperformed in accordance with specifications containing defini-tive standards of quality. Manufacturers shall develop andimplement a QAS in accordance with the requirements estab-lished within this specification.

10、 The elements of the QASestablished herein include the following:3.1.1 Quality Assurance Manual (QAM),3.1.2 Document Control,3.1.3 Product Configuration Control,3.1.4 Supplier Control,3.1.5 Product Change Management,3.1.6 Calibration and Test Equipment,3.1.7 Material Control,3.1.8 Inspections,3.1.9

11、Identification and Handling of NonconformingMaterial,3.1.10 Assignment of QA Duties,3.1.11 Self Evaluation (Audit), and3.1.12 Quality Assurance Record (QAR).3.2 Quality Assurance Manual (QAM)Each manufacturershall document their QAS in the form of a QAM.3.2.1 The QAM includes the quality policy and

12、an overviewof the key requirements contained in 3.1.2 through 3.1.12.Itisthe source of reference for all matters dealing with the QAS.3.2.2 The manufacturer shall define the system and proce-dures for each key requirement of the QAS contained in 3.1.2through 3.1.12. The key requirements of the QAS m

13、ay be inseparate documents or may be contained in a single document.3.2.3 The QAM itself and each of the QAS elementsincluded or referenced shall be controlled as productiondocumentation in accordance with 6.6.1This specification is under the jurisdiction ofASTM Committee F39 on AircraftSystems and

14、is the direct responsibility of Subcommittee F39.04 on AircraftSystems.Current edition approved Dec. 1, 2018. Published January 2019. DOI: 10.1520/F324618.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was

15、developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.3 Quality As

16、surance Administration (QAA)The manu-facturers administration that is charged with the implementa-tion of the QAS may consist of one or more employees,officials or manufacturers agents, consultants, or assigns.3.3.1 The Accountable Executive is responsible for thequality of the product produced. The

17、se roles and responsibili-ties may be delegated. If Accountable Executive has beendelegated, then 3.3.2 and 3.3.3 are required. These roles maybe demonstrated in an org chart. The Accountable Executive isassumed to be owner/operator unless otherwise designated.3.3.2 The title of the individual(s) wh

18、o make up the QAAshall be identified within the QAM.3.3.3 The manufacturer shall maintain a roster of the mem-ber(s) of the QAA authorized to attest final conformity of thearticle to the design.4. Quality Assurance Record (QAR)4.1 QARs are the record(s) necessary to show compliancewith the organizat

19、ions QAS. The QAR includes (as appli-cable):4.1.1 The records required by the QAS.4.1.2 Individual article records shall consist of:4.1.2.1 Completed final records and inspections from themanufacturing and assembly operations.4.1.2.2 Test documentation from the production acceptancetesting procedure

20、s. This includes items such as checklists orsign-off sheets showing acceptance and completion of appli-cable production acceptance test requirements, or both.4.1.2.3 The configuration of each system at its point ofdelivery including associated parts lists and software, if appli-cable.4.2 All QARs sh

21、all be kept for a minimum of three yearsbeyond the date of sale.4.2.1 The records required by 4.1.2.3 shall be retained for aminimum of five years.5. Product Marking5.1 The article shall be marked with manufacturers name,trademark, or symbol; and part number. If the part or article istoo small or ot

22、herwise impractical to mark with any of theinformation required by this part, the manufacturer shall attachthat information to the part or its container. If an article has aserial number or other serialized code, this shall be included inthe part marking.6. Engineering, Design, and Manufacture6.1 Du

23、ring development and as required, manufacturer shallperform and record engineering design and development re-views.6.2 Record of ComplianceThe manufacturer shall keep arecord of the documentation used to show compliance of eachconforming aircraft articles or system produced to all appli-cable consen

24、sus standards and regulatory requirements ineffect at the time of manufacture.6.3 Configuration Control and Change Management:6.3.1 Revisions to documentation affecting compliance shallbe tracked and the change process for developing, reviewing,and incorporating revisions to compliance documentation

25、 shallbe controlled.6.3.2 The manufacturer must ensure and verify the use ofthe proper revision of any compliance document.6.4 Production DocumentationThe manufacturer shallmaintain a record of all production documentation pertinent toproduct compliance, including revisions. Production documen-tatio

26、n shall include the following types of documents:6.4.1 Parts lists,6.4.2 Component and assembly engineering drawings (en-gineering definition),6.4.3 Manufacturing processes,6.4.4 Work instructions,6.4.5 Specifications,6.4.6 Specialty tooling and gauge identification (includingcalibrated tools and te

27、st equipment), and6.4.6.1 All items requiring calibration shall be calibratedannually or at manufacturers specified interval.6.4.6.2 A policy shall be in place for action to be taken ifcalibrated equipment is found to be out of calibration.6.4.7 Manufacturers statement of conformity, which is adocum

28、ent certifying that the supplied article meets the manu-facturers design requirements.6.5 A procedure shall be in place for nonconformingproduct, which includes addressing causes of nonconformity,action to eliminate nonconformity, and record of action taken.6.6 All records required in Section 6 shal

29、l be retained for aminimum of five years.NOTE 1Any document or information necessary to show complianceto any section of any consensus standard is pertinent to product compli-ance and is intended to be documented and controlled as compliance/production documentation in accordance with Section 6.7. M

30、aterial Control7.1 Material control procedures shall be established anddocumented to assure that materials, processes, andcomponents, including raw materials, are in accordance withthe manufacturers applicable specifications. The materialcontrol procedures shall include:7.1.1 Procurement procedures

31、to ensure that requirementsfor all items ordered are clearly specified.7.1.2 Receiving procedures for incoming material and com-ponents.7.1.3 Stock management procedures so that material instock can be properly identified for future use.7.1.4 For outsourced processes or manufacturing/fabrication, a

32、supplier management procedure to verify that thework or item meets the manufacturers specifications.7.1.5 Aprocedure for non-conforming materials disposition.8. Inspections8.1 Manufacturers shall implement and document a systemof inspections to verify conformity of product to all applicableengineeri

33、ng requirements and production specifications.F3246 1828.2 Conforming, nonconforming, in-process, and itemsawaiting inspection shall be separated or clearly distinguish-able.8.3 Receiving InspectionIncoming items provided by out-side vendors shall be inspected for conformity to applicablespecificati

34、ons.8.3.1 DTS, including standard parts, only requires verifica-tion of receipt of ordered part against a purchase order (orsimilar).8.3.2 Parts other than DTS parts shall be identified by themanufacturer and inspected as necessary.8.3.3 Conforming items shall be distributed, as required, forimmedia

35、te use or placed in storage for future use.8.3.4 Items found to be nonconforming shall either beevaluated by a MRB or rejected in accordance with 6.5.8.4 Sampling plans may be utilized so that full inspection ofevery part is not required, provided that adequate controls arein place on underlying pro

36、cesses or supply sources to provideassurance of conformity.8.5 Any individual authorized to perform inspections, iden-tified in accordance with 8.1, shall be familiar with theapplicable standards and with the inspection methods,techniques, practices, aids, equipment, and tools used todetermine confo

37、rmity of the article. The inspector must havean understanding of:8.5.1 Whether there is adequate substantiation to showcompliance with the article design.8.5.2 The requirements to declare compliance, inclusive ofdesign, performance, and quality.9. QA Duties and Responsibilities9.1 Manufacturers shal

38、l document all QAduties and respon-sibilities (by title) within the QAM. This includes a functional/organizational chart and individual authorizations to performinspections.9.1.1 Manufacturers may assign QAduties to outside partiesfor the purpose of establishing satellite manufacturing,assembly, dis

39、tribution facilities, contract manufacturing/processing, or combinations thereof.9.1.1.1 In the case of assignment, the manufacturer retainsoverall QA responsibility for the accomplishment of theseactivities.9.2 A procedure shall be in place for nonconformity of theQAS, which includes addressing cau

40、ses of nonconformity,action to eliminate nonconformity, and record of action taken.9.2.1 Records of 9.2 shall be retained for a minimum of fiveyears.10. Self Evaluations10.1 Manufacturers shall conduct a self evaluation or auditof their QAS. Internal QAA members, external customers, orcombinations t

41、hereof, may perform the required evaluations, solong as each element of the QAS is evaluated at least onceevery two years.10.2 A record of all evaluations or audits shall be main-tained for a minimum of three years.10.3 Any determination of noncompliance shall be resolvedand a revision to the QAS sh

42、all be made, if necessary, toaddress any anomalies found.11. Competence and Training11.1 Manufacturers shall ensure that all employees arecapable of performing their assigned tasks.NOTE 2There is no requirement to train personnel to validate everycompliance element of every article independent of th

43、eir responsibilities.11.2 Documented records of competency shall be main-tained as long as the individual is assigned to the task.12. Management Review12.1 Shall occur annually.12.2 Shall review quality policy, self-evaluation (audit)results, process performance, product conformity, correctiveaction

44、s, and follow-up actions from previous managementreview.12.3 Records from management reviews shall be main-tained for three years.13. Keywords13.1 compliance; quality; quality assuranceASTM International takes no position respecting the validity of any patent rights asserted in connection with any i

45、tem mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical co

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47、 meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Dri

48、ve, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 183