ASTM F2688-2008(2014)e1 Standard Guide for System-Based Customer-Centered Quality Plan for Manufacturers《以体系为基础 以顾客为中心的制造商质量计划标准指南》.pdf

1、Designation: F2688 08 (Reapproved 2014)1Standard Guide forSystem-Based, Customer-Centered Quality Plan forManufacturers1This standard is issued under the fixed designation F2688; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the

2、year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTE10.16 was editorially corrected in May 2016.1. Scope1.1 This guide establishes recommended system-based pro-cedures t

3、o assist fastener manufacturers and alteration distribu-tors in the development of process controls which are intendedto produce quality products in a cost effective manner. Theserecommended system-based procedures allow an organizationto continually improve operational effectiveness.2. Referenced D

4、ocuments2.1 ASTM Standards:2F1469 Guide for Conducting a Repeatability and Reproduc-ibility Study on Test Equipment for Nondestructive Test-ingF1470 Practice for Fastener Sampling for Specified Me-chanical Properties and Performance InspectionF1503 Practice for Machine/Process Capability Study Pro-c

5、edureF1789 Terminology for F16 Mechanical FastenersF2282 Specification for QualityAssurance Requirements forCarbon and Alloy Steel Wire, Rods, and Bars for Me-chanical Fasteners2.2 ASTM Manual:Manual 22 Total Quality Management-Guiding Principlesfor Application22.3 IFI Standard:IFI-139 Quality Assur

6、ance Requirements for Fastener Test-ing Laboratories2.4 ASME Standards:B18.18.1 Inspection and Quality Assurance for GeneralPurpose Fasteners3B18.18.2 Inspection and Quality Assurance for High-Volume Machine Assembly Fasteners32.5 NIST Program:Malcolm Baldrige Criteria for Excellence (www.nist.gov)2

7、.6 ISO Standard:ISO 16426 FastenersQuality Assurance System4NOTE 1There is no direct relationship of this standard to an ISOcounterpart. However, several elements of this guide may be found in ISO16426.3. Terminology3.1 Terms shall be defined in accordance with TerminologyF1789.4. Significance and U

8、se4.1 A need exists for a Quality Systems Guide that may bedeployed by small to larger manufacturers that give directionon development of process-based systems that drive qualityand continuous improvement. This guide does not require thirdparty regulation, thus making it attractive to those manufact

9、ur-ers who are not required to have such certification.5. Managements Role5.1 Executive management shall be responsible for commit-ment to a company-wide quality policy. The Quality Policyshall be published, maintained, understood and implementedby all company operation groups.1This guide is under t

10、he jurisdiction of ASTM Committee F16 on Fasteners andis the direct responsibility of Subcommittee F16.93 on QualityAssurance Provisionsfor Fasteners.Current edition approved April 1, 2014. Published April 2014. Originallyapproved in 2008. Last previous edition approved in 2008 as F268808. DOI:10.15

11、20/F2688-08R14E01.2For 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 American Society of Mechani

12、cal Engineers (ASME), ASMEInternational Headquarters, Three Park Ave., New York, NY 10016-5990, http:/www.asme.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Bo

13、x C700, West Conshohocken, PA 19428-2959. United States15.2 Quality ManualThe management commitment shallbe fully supported by a quality manual which shall be underperiodic review.5.3 Personnel TrainingManagement shall assume respon-sibility for providing appropriate training for all companypersonne

14、l.Appropriate training shall include, but not be limitedto, job skills, process knowledge, quality training, environmen-tal issues, and safety skills for all organizational processstreams.6. Inquiries and Quotation6.1 Review of Drawings and SpecificationsAll drawingsand specifications that are appli

15、cable to a given inquiry shall bereviewed prior to issuance of a quotation. This review shallinclude engineering, manufacturing, production materials,processes, quality assurance, cost accounting and outsidesourcing as applicable to ensure that all of the customersrequirements can be met.6.2 Ongoing

16、 ReviewThe activity specified in 6.1 shall besubject to a periodic internal audit/review which will evaluateits ability to respond to the purchaser in a timely and accuratemanner. Frequency of the internal audit/review shall be deter-mined on past audit/reviews, but shall be conducted at leastonce a

17、 year. The results of the review shall be reported to andreviewed by management.7. Engineering7.1 Specification RequirementsFor products defined byrecognized standards, there shall be evidence that the appli-cable specifications for material, configuration, processing,finishing, inspection testing a

18、nd packaging, were based uponestablished requirements specified in these standards and arerelated to fit, form, and function. Unless otherwise specified inthe contract or purchase order, the latest revision of any citedor applicable specification shall be used.7.2 Drawing RequirementsDrawings shall

19、define all fea-tures and characteristics of the fastener. The use of informalsketches, uncontrolled drawings, and red lined changes todrawings, specifications, and process documents shall not bepermitted in the purchasing, fabrication, process, test, orinspection operations.7.3 Design Change/Configu

20、ration ControlA documentedprocedure shall exist for controlling and authorizing thedevelopment, release, change, use, and control of designdocuments. The procedure shall be adequate to prevent the useof obsolete design documents.8. Procurement8.1 Responsibilities of ProcurementThe system and pro-ces

21、s for procurement of fastener materials, services,components, and assemblies shall be formally planned,documented, and controlled. The authority and responsibilityof the organizations involved in interaction with the control ofsuppliers shall be established by management and documented.The fastener

22、manufacturer and alteration distributor shall havean active documented system to verify the performance ofsuppliers.8.2 Supplier EvaluationThe appropriate representativesfrom all segments of the organization shall participate, asneeded, for approval of sources of materials and services.8.3 Source Ap

23、provals and ControlsThe organization shallformally audit on-site the suppliers or sources capability tofurnish conforming materials and/or services relevant tosupply, manufacture, processing, or alteration of fasteners.Thisaudit shall be documented with procedures that include input asrequired, from

24、 quality assurance, engineering, materials,processing, and procurement. Subsequently, the suppliers orsources shall be evaluated on the basis of on-site surveys,physical audits, or current quality history. Such evaluationsshall be conducted on an ongoing basis, but no less thanannually. Evidence of

25、evaluations shall be current and on-siteaudits shall be conducted at least once every four years.8.4 Technical RequirementsSpecifications, drawings, andpurchase orders shall define and communicate applicablerequirements to the supplier of materials and services.9. Production9.1 Production Responsibi

26、litiesA production proceduremanual shall establish a controlled approach for productquality in production encouraging interaction with engineering,procurement, materials, processing, and quality assurance. Themanufacturer or alteration distributor shall have in place aproduction procedures manual de

27、fining all elements of produc-tion which shall include as a minimum the elements listedunder 9.2.9.2 Production and Planning Elements :9.2.1 CapacityThe manufacturer or alteration distributorshall have evidence that production is related to his manufac-turing or alteration capacity.9.2.2 Equipment C

28、apabilityThe manufacturer or altera-tion distributor shall have evidence that capability studies havebeen conducted to verify ability to manufacture or alter and toprocess fasteners to specification requirements. Practice F1503may be used for these studies.9.2.3 ToolingEvidence shall be present that

29、 a systemexists for the design, purchase, inventory, and control ofperishable and nonperishable tooling.9.2.4 Equipment OperatorsThere shall be evidence thatequipment operators have appropriate training in accordancewith their specific responsibilities.9.2.5 Repair and MaintenanceThere shall be in p

30、lace aprogram for preventative maintenance of manufacturing andprocessing equipment. Maintenance shall be performed atprescribed intervals. Records shall be maintained of mainte-nance and repair on manufacturing and processing equipment.9.2.6 SchedulingThere shall be in place a system toevaluate and

31、 schedule the manufacturing or alteration capacityto meet stated customer requirements, including timeliness.9.2.7 Production PlanningProduction shall be carried outin accordance with a production plan of the process. Thiscontrolled approach should include tooling, material,processes, specifications

32、, and the sequence of operations in-cluding outsource services. Process Flow Diagrams are helpfulin documenting these requirements.F2688 08 (2014)129.2.8 Lot Control/SegregationThere shall be in place asystem to identify product in-process by lot identifiers trace-able to the mill heat of raw materi

33、al from which it ismanufactured.9.2.9 InspectionsIn-process inspection, testing, and finalverification shall be in place in accordance with requirementsfor in-process control (10.14.1), and verification (10.14.2).10. Quality Assurance Program/System Elements10.1 Quality System OrganizationThe organi

34、zationalstructure, functional responsibilities, levels of authority, andlines of communication for activities affecting quality shall bedocumented. Top management shall appoint a member ofmanagement who, is independent of other responsibilities andshall have responsibility and authority that include

35、s:10.1.1 Ensuring those processes needed for this standard areestablished, implemented and maintained,10.1.2 Reporting to top management on the performance ofthe organization to this standard, and any need forimprovement, and10.1.3 Ensuring the promotion of awareness of customerrequirements througho

36、ut the organization.10.2 Quality System Self AuditThere shall be in place asystem for internal audits to ensure compliance with thisstandard to verify the presence of, the adequacy of, andcompliance with all aspects of the quality assurance system andto determine its effectiveness. These audits shal

37、l be performedin accordance with written procedures or checklists by person-nel who do not have direct responsibility or involvement forperforming the activities being audited. Audit results shall bedocumented, reported to, and reviewed by responsible man-agement. These internal audits shall be cond

38、ucted at leastannually in accordance with the provisions of the QualityAssurance Manual. Documented corrective and preventiveaction shall be taken, where indicated, in a timely manner.10.3 Quality System RecordsRecords that furnish docu-mentary evidence of product conformance and traceabilityshall b

39、e specified, prepared, and maintained. Records shall belegible, identifiable, and retrievable. Records shall be protectedagainst damage, alteration, deterioration, or loss. Requirementsand responsibilities for record transmittal, distribution,retention, maintenance, and disposition shall be establis

40、hed anddocumented.10.4 Document ControlThe manufacturer or alterationdistributor shall have in place a system governing thepreparation, change and distribution, of documentation thatspecifies dimensions, mechanical, chemical, and performancerequirements of the fastener. This system shall provide for

41、 theassignment of responsibility for preparing, reviewing,approving, and issuing documents. Persons other than those sodesignated shall make no changes to any documents.10.5 Testing Equipment, Measuring Devices, and GagesAll testing equipment, measuring devices, and gages used toverify conformance t

42、o applicable standards and specificationsshall be controlled and, at specified intervals, shall be cali-brated to maintain accuracy within necessary limits. All cali-brations shall be traceable to applicable national or interna-tional standards or special certified masters if no internationalstandar

43、d exists. Such equipment shall be uniquely numbered/identified and have a documented plan for maintenance,control, and repair actions. All testing equipment, measuringdevices, and gages used in statistical quality control shall bequalified using Guide F1469. A system shall be in place thatwill, if n

44、ecessary, identify and retrieve material or productfound to be nonconforming because of equipment, measuringdevices, or gages out of calibration. For fasteners that aresubject to the FQA, laboratory accreditation by an independentthird party shall serve as evidence of conformance.10.6 Raw Material C

45、ontrol and TraceabilityThe raw ma-terial requirements shall be described by a document such as arecognized standard or specification such as SpecificationF2282. This description shall include size, type, chemistry,source, condition, and any other information deemed necessaryto satisfy the product sp

46、ecification and manufacturing process.All raw materials shall be fully traceable and accompanied bya mill test report. A system shall be in place to control theidentity, storage, and handling of raw material from receivingto the production operation.10.7 In-Process Material Control and TraceabilityA

47、 sys-tem shall be in place that maintains product traceability back tothe original mill heat of raw material. This system shall becapable of maintaining lot identity with respect to factoryorder, part number, strength levels, manufacturing event, andall subsequent processing inspections and testing

48、events.10.8 Finished Product Lot Control and IdentificationAsystem shall be in place for the handling, storage, andidentification of finished products based on segregation by lotnumber. Distribution entities shall ensure lot control in theirstorage and movement operations from receipt of product tos

49、hipment of said product to their customer.10.9 Packaging and Inventory of Finished ProductLotpurity, lot identity, and traceability shall be maintainedthroughout the entire operation in such manner to preventcommingling.10.9.1 All products shall be packaged to prevent damageduring storage and/or shipment. Containers shall be labeled toidentify the contents, responsible party, country of origin, andlot number.10.9.2 When required, the manufacturer or alteration dis-tributor shall be able to issue a certified test report for each lotof fastener