ASTM F3205-2016 Standard Practice for Independent Audit Program for Light Aircraft Manufacturers《轻型航空器制造商独立审计计划的标准实施规程》.pdf

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1、Designation: F3205 16Standard Practice forIndependent Audit Program for Light AircraftManufacturers1This standard is issued under the fixed designation F3205; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revisio

2、n. 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 practice establishes a minimum set of requirementsfor a Manufacturer Assessment Independent Audit Program incompliance with P

3、ractice F2839.1.2 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2

4、. Referenced Documents2.1 ASTM Standards:2E2659 Practice for Certificate ProgramsF2839 Practice for Compliance Audits to ASTM Standardson Light Sport Aircraft2.2 ISO Standard:3ISO 9001 Quality Management SystemsRequirements2.3 DNV GL Standard:4AS/EN 9100 Aerospace Quality Management3. Terminology3.1

5、 Definitions:3.1.1 factory assessment auditan audit of an aircraftmanufacturer and its associate facilities to determine compli-ance with CAA-accepted consensus standards, and proceduresestablished to meet those requirements.3.1.2 findinga non-fulfillment of a requirement that mayaffect the ability

6、of the aircraft manufacturer to comply withthe provisions for compliance of the relevant CAA.4. Significance and Use4.1 This practice establishes the minimum set of require-ments for an independent factory assessment audit program foraircraft manufacturers. The intended use is to provide mini-mum re

7、quirements for an initial assessment of manufacturersbringing a new aircraft model to market, or for periodic reviewof an existing manufacturers operations if required by relevantCivil Aviation Authority (CAA).4.2 Compliance to this practice would ensure that the auditprogram and those who execute i

8、t meet the consensus set ofminimum requirements and qualifications.4.3 This practice does not mandate independent factoryassessment audits.4.4 Independent audits are to be conducted only at therequest of the manufacturer or relevant CAA.5. Audit Criteria5.1 Initial AssessmentWhen performing an initi

9、al assess-ment audit of an aircraft manufacturer, the auditor(s) shallreview compliance to the consensus standards for the aircraftbeing produced.5.1.1 The auditing entity shall verify that the referencedconsensus standards are appropriate and accepted by therelevant CAA.5.1.2 At a minimum, the audi

10、tor(s) shall assess complianceto the following processes as applicable to the category ofaircraft being produced:5.1.2.1 Aircraft Design and Performance;5.1.2.2 Aircraft Operating Instructions;5.1.2.3 Aircraft Maintenance and Inspection Procedures;5.1.2.4 Aircraft Flight Training Supplement (as appl

11、icable);5.1.2.5 Manufacturers Quality Assurance System;5.1.2.6 Manufacturers Continued Operational Safety Pro-gram;5.1.2.7 Any specific requirements mandated by relevantCAA.5.1.3 Assessment of compliance shall be comprehensiveand verifiable.NOTE 1Assessment of compliance to applicable standards does

12、 notrequire a determination of technical or design merit to be made by theauditing entity.1This practice is under the jurisdiction of ASTM Committee F37 on Light SportAircraft and is the direct responsibility of Subcommittee F37.70 on Cross Cutting.Current edition approved Oct. 1, 2016. Published Oc

13、tober 2016. DOI: 10.1520/F3205-16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from Internation

14、al Organization for Standardization (ISO), ISOCentral Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.4Available from DNV GL, 1400 Ravello Dr., Katy, TX 77449, https:/www.dnvgl.us.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C7

15、00, West Conshohocken, PA 19428-2959. United States15.2 Periodic ReviewWhen conducting a periodic reviewaudit, the auditing entity may vary the audit scope to assesscompliance to the same standards as an initial assessment auditat a reduced level of review. For example, the audit scope mayinclude on

16、ly selected audit criteria, selected period underreview, or selected portions of the facility or organization.6. Audit Program Personnel and Responsibilities6.1 GeneralThe auditing entity is responsible to conductthis audit program in accordance with the requirements givenin Practice F2839.6.2 Perso

17、nnelThe Audit Program consists of the follow-ing personnel:6.2.1 Lead Auditor;6.2.2 Audit Team members, as needed, to conduct the audit;and6.2.3 Support personnel as required.6.2.4 The responsibilities and qualifications of these person-nel are defined in Practice F2839. Auditors and any supportpers

18、onnel must be familiar with the content of all applicablestandards before performing or supporting an audit.6.3 TrainingAuditing personnel must have successfullycompleted, with documented records, a standards certificationtraining program within the preceding four years. The trainingprogram must lea

19、ve the auditor(s) with an understanding of:6.3.1 Whether there is adequate substantiation to showcompliance to the applicable requirements.6.3.2 The requirements to obtain certification, inclusive ofdesign, performance, quality, and continued operational safety.6.3.3 The responsibilities and duties

20、of an aircraft manufac-turer as defined by the audited standards.6.4 Acceptable means of compliance to these requirementsare:6.4.1 The Light Sport Aircraft course and personnel certifi-cate training program offered by ASTM International.6.4.2 Another training program, either internal or external,mee

21、ting the requirements of Practice E2659 and the require-ments given in this section and audited by an accredited thirdparty.6.4.3 Another program equivalent to 6.4.1 or 6.4.2.NOTE 2Equivalency per 6.4.3 may include programs such as: (1)Internal training programs embedded within an ISO 9001 or AS/EN

22、9100approved system; (2) training programs developed under the supervisionof a relevant CAA.7. Selection and Scheduling of Factory Assessment Audits7.1 Audit Schedule NotificationUnless directed by rel-evant CAA to address potential safety of flight concerns, thefacility to be audited shall receive

23、notification at least 30calendar days before the start of the audit.7.2 Selection of AuditorsThe audit team should consist ofauditors who are competent, objective, and independent asdefined in Practice F2839.8. Audit Process8.1 Audit Preparation:8.1.1 Before the start of an audit, an audit plan will

24、 bedeveloped in accordance with Practice F2839.8.1.2 Lead Auditor ResponsibilitiesThe lead auditor coor-dinates with:8.1.2.1 A representative of the facility to be audited toensure administrative and logistical arrangements for itemssuch as unrestricted access, escorts, meeting rooms, and safetyand

25、security requirements are complete; and8.1.2.2 Audit Team members and CAAs as needed tofacilitate administrative and logistical travel and audit prepa-ration information.8.1.3 The lead auditor and all team members meet beforestarting the audit, usually at the facility to be audited. Thispre-audit te

26、am meeting is the forum for the lead auditor toreview team assignments and supplement them if necessary.8.2 Executing the Audit:8.2.1 Audit communications and data gathering protocolsshall be conducted in accordance with Sections 7 and 8 ofPractice F2839.8.2.2 Any findings will be documented before

27、the conclu-sion of the audit in accordance with Section 9 of PracticeF2839.8.3 Post-Audit Reporting Activities:8.3.1 Corrective Action and Follow-Up:8.3.1.1 Post-Audit LetterThe audited entity will receive apost-audit letter indicating the results of the audit activity. Theletter should include comm

28、unicating any findings which mayimpact the aircraft manufacturers ability to complete andcertify aircraft.8.3.1.2 Request for Corrective ActionThe post-audit re-port will request corrective action for any findings.8.3.1.3 The post-audit letter should be delivered within 30calendar days of the audit,

29、 or within the timeline agreed uponin the audit plan.8.3.1.4 Verification of Corrective ActionsOnsite verifica-tion of corrective actions may occur when it is not possible toconfirm corrective actions via written, electronic, or othercorrespondence.8.3.1.5 Final Audit ReportOnce findings and correct

30、iveactions have been resolved, a letter will be sent to themanufacturer confirming completion of the audit and commu-nicating the manufacturers completion of the audit and reso-lution of any findings. This should be completed within 90calendar days of the on-site audit and may be extended ifcorrecti

31、ve actions need additional time to complete.8.3.1.6 Courtesy copies of the final audit report may beprovided to the appropriate CAA office by the audited entity.These evaluations, when shared with the relevant CAA, may beused as the basis for product or production approval.8.3.2 Lead Auditor Correct

32、ive Action Responsibilities:8.3.2.1 Coordinates all follow-up actions and correspon-dence with the manufacturer and any involved CAA geo-graphic office or delegate.8.3.2.2 Generates and issues corrective action requests andfollow-up correspondence.8.3.2.3 Coordinates, as required, on-site follow-up

33、activitiesand verification of corrective actions.8.3.3 Audit Records:8.3.3.1 Audit records will be managed in accordance withSection 10 of Practice F2839.F3205 1629. Keywords9.1 aircraft; audit; CAA; compliance; corrective actions;findings; manufacturerASTM International takes no position respecting

34、 the validity of any patent rights asserted in connection with any item 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 standar

35、d is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International

36、 Headquarters. Your comments will receive careful consideration at a 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.Thi

37、s standard is copyrighted by ASTM International, 100 Barr Harbor Drive, 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:/ 163