ASTM F3205-2017 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 16F3205 17Standard 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

2、 revision. 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 requirements for a Manufacturer Assessment Independent Audit Program incomplian

3、ce with Practice F2839.1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine theapplicability of r

4、egulatory limitations prior to use.1.3 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Or

5、ganization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E2659 Practice for Certificate ProgramsF2839 Practice for Compliance Audits to ASTM Standards on Light Sport Aircraft2.2 ISO Standard:3ISO 9001 Quality Management SystemsRequirements2.3 DNV GL Standard:

6、4AS/EN 9100 Aerospace Quality Management3. Terminology3.1 Definitions:3.1.1 factory assessment auditan audit of an aircraft manufacturer and its associate facilities to determine compliance withCAA-accepted consensus standards, and procedures established to meet those requirements.3.1.1 findinga non

7、-fulfillment of a requirement that may affect the ability of the aircraft manufacturer to comply with theprovisions for compliance of the relevant CAA.3.1.2 independent auditan audit of an aircraft manufacturer and its associate facilities by an external auditing entity todetermine compliance with C

8、AA-accepted consensus standards, and procedures established to meet those requirements.4. Significance and Use4.1 This practice establishes the minimum set of requirements for an independent factory assessment audit program for aircraftmanufacturers. The intended use is to provide minimum requiremen

9、ts for an initial assessment of manufacturers bringing a newaircraft model to market, or for periodic review of an existing manufacturers operations if required by relevant Civil AviationAuthority (CAA).operations.4.2 Compliance to this practice would ensure that the audit program and those who exec

10、ute it meet the consensus set ofminimum requirements and qualifications.4.3 This practice does not mandate manufacturer independent factory assessment audits.1 This practice is under the jurisdiction of ASTM Committee F37 on Light Sport Aircraft and is the direct responsibility of Subcommittee F37.7

11、0 on Cross Cutting.Current edition approved Oct. 1, 2016Dec. 1, 2017. Published October 2016December 2017. Originally approved in 2016. Last previous edition approved in 2016 asF3205 16. DOI: 10.1520/F3205-16.10.1520/F3205-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or co

12、ntactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have b

13、een made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official docume

14、nt.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.4 Independent audits are to be conducted only at the request of the manufacturer or relevant CAA.5. Audit Criteria5.1 Initial AssessmentWhen performing an initial assessment audit o

15、f an aircraft manufacturer, the auditor(s) shall reviewcompliance to the consensus standards for the aircraft being produced.5.1.1 The auditing entity shall verify that the referenced consensus standards are appropriate and accepted by the relevant CAA.5.1.2 At a minimum, the auditor(s) shall assess

16、 compliance to the following processes as applicable to the category of aircraftbeing 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 applicable);5.1.2.5 Ma

17、nufacturers Quality Assurance System;5.1.2.6 Manufacturers Continued Operational Safety Program;5.1.2.7 Any specific requirements mandated by relevant CAA.5.1.3 Assessment of compliance shall be comprehensive and verifiable.NOTE 1Assessment of compliance to applicable standards does not require a de

18、termination of technical or design merit to be made by the auditingentity.5.2 Periodic ReviewWhen conducting a periodic review audit, the auditing entity may vary the audit scope to assesscompliance to the same standards as an initial assessment audit at a reduced level of review. For example, the a

19、udit scope mayinclude only selected audit criteria, selected period under review, or selected portions of the facility or organization.6. Audit Program Personnel and Responsibilities6.1 GeneralThe auditing entity is responsible to conduct this audit program in accordance with the requirements given

20、inPractice F2839.6.2 PersonnelThe Audit Program consists of the following 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 personnel are defined in Practice F2839. Aud

21、itors and any supportpersonnel must be familiar with the content of all applicable standards before performing or supporting an audit.6.3 TrainingAuditing personnel must have successfully completed, with documented records, a standards certificationtraining program within the preceding four years. T

22、he training program must leave the auditor(s) with an understanding of:TheLead Auditor must have a current certification from an accredited quality auditor certification training program.6.3.1 Whether there is adequate substantiation to show compliance to the applicable requirements.6.3.2 The requir

23、ements to obtain certification, inclusive of design, performance, quality, and continued operational safety.6.3.3 The responsibilities and duties of an aircraft manufacturer as defined by the audited standards.6.4 Acceptable means of compliance to these requirements are:6.4.1 The Light Sport Aircraf

24、t course and personnel certificate training program offered by ASTM International.6.4.2 Another training program, either internal or external, meeting the requirements of Practice E2659 and the requirementsgiven in this section and audited by an accredited third party.6.4.3 Another program equivalen

25、t 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 orAS/EN 9100 approvedsystem; (2) training programs developed under the supervision of a relevant CAA.7. Selection and Scheduling of Factory AssessmentManufacturer

26、Independent Audits7.1 Audit Schedule NotificationUnless directed by relevant CAA to address potential safety of flight concerns, the facility tobe audited shall receive notification at least 30 calendar days before the start of the audit.7.2 Selection of AuditorsThe audit team should consist of audi

27、tors who are competent, objective, and independent as definedin Practice F2839.8. Audit Process8.1 Audit Preparation:8.1.1 Before the start of an audit, an audit plan will be developed in accordance with Practice F2839.8.1.2 Lead Auditor ResponsibilitiesThe lead auditor coordinates with:8.1.2.1 A re

28、presentative of the facility to be audited to ensure administrative and logistical arrangements for items such asunrestricted access, escorts, meeting rooms, and safety and security requirements are complete; andF3205 1728.1.2.2 Audit Team members and CAAs as needed to facilitate administrative and

29、logistical travel and audit preparationinformation.8.1.3 The lead auditor and all team members meet before starting the audit, usually at the facility to be audited. This pre-auditteam meeting is the forum for the lead auditor to review team assignments and supplement them if necessary.8.2 Executing

30、 the Audit:8.2.1 Audit communications and data gathering protocols shall be conducted in accordance with Sections 7 and 8 of PracticeF2839.8.2.2 Any findings willshall be documented before the conclusion of the audit in accordance with Section 9 of Practice F2839.8.3 Post-Audit Reporting Activities:

31、8.3.1 Corrective Action and Follow-Up:8.3.1.1 Post-Audit LetterThe audited entity will receive a post-audit letter indicating the results of the audit activity. The lettershould include communicating any findings which may impact the aircraft manufacturers ability to complete and certifyaircraft.fin

32、dings.8.3.1.2 Request for Corrective ActionThe post-audit report will request corrective action for any findings.8.3.1.3 The post-audit letter should be delivered within 30 calendar days of the audit, or within the timeline agreed upon in theaudit plan.8.3.1.4 Verification of Corrective ActionsOnsit

33、e verification of corrective actions may occur when it is not possible to confirmcorrective actions via written, electronic, or other correspondence.8.3.1.5 Final Audit ReportOnce findings and corrective actions have been resolved, a letter will be sent to the manufacturerconfirming completion of th

34、e audit and communicating the manufacturers completion of the audit and resolution of any findings.This should be completed within 90 calendar days of the on-site audit and may be extended if corrective actions need additionaltime to complete.8.3.1.6 Courtesy copies of the final audit report may be

35、provided to the appropriate CAA office by the audited entity. Theseevaluations, when shared with the relevant CAA, may be used as the basis for product or production approval.8.3.2 Lead Auditor Corrective Action Responsibilities:8.3.2.1 Coordinates all follow-up actions and correspondence with the m

36、anufacturer and any involved CAA geographic officeor delegate.8.3.2.2 Generates and issues corrective action requests and follow-up correspondence.8.3.2.3 Coordinates, as required, on-site follow-up activities and verification of corrective actions.8.3.3 Audit Records:8.3.3.1 Audit records will be m

37、anaged in accordance with Section 10 of Practice F2839.9. Keywords9.1 aircraft; audit; CAA; compliance; corrective actions; findings; manufacturerASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of

38、 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 committee and must be reviewed every five

39、 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 Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical com

40、mittee, 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 Drive, PO Box C700, West Conshohocken, PA 1

41、9428-2959,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

42、standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,Switzerland, http:/www.iso.org.4 Available from DNV GL, 1400 Ravello Dr., Katy, TX 77449, https:/www.dnvgl.us.F3205 173