ASTM F2688-2008(2014) 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的标准指南》.pdf

1、Designation: F2688 08 (Reapproved 2014)Standard 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 y

2、ear 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.1. Scope1.1 This guide establishes recommended system-based pro-cedures to assist fastener manufacturers and alteration dis

3、tribu-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 Documents2.1 ASTM Standards:2F1469 Guide for Conduc

4、ting 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-cedureF1789 Terminology for F16 Mechanical Fastener

5、sF2282 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 Assurance Requirements for Fastener Test-ing Laboratori

6、es2.4 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)2.6 ISO Standard:ISO 16426 FastenersQuality Assuran

7、ce 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 Use4.1 A need exists for a Quality Systems Guide th

8、at 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 manufactur-ers who are not required to have such certifica

9、tion.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.5.2 Quality ManualThe management commitment shallbe fully supported by a

10、 quality manual which shall be underperiodic review.5.3 Personnel TrainingManagement shall assume respon-sibility for providing appropriate training for all companypersonnel.Appropriate training shall include, but not be limitedto, job skills, process knowledge, quality training, environmen-tal issu

11、es, and safety skills for all organizational processstreams.1This guide is under the 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. Origin

12、allyapproved in 2008. Last previous edition approved in 2008 as F268808. DOI:10.1520/F2688-08R14.2For 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 Docum

13、ent Summary page onthe ASTM website.3Available from American Society of Mechanical 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

14、 http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States16. Inquiries and Quotation6.1 Review of Drawings and SpecificationsAll drawingsand specifications that are applicable to a given inquiry shall bereviewed prior to is

15、suance 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 ReviewThe activity specified in 6.1 shall besubject

16、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 year. The results of the review shall be reported to

17、 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 and packaging, were based uponestablished requirements

18、 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 define all fea-tures and characteristics of the faste

19、ner. 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/Configuration ControlA documentedprocedure shall exist for c

20、ontrolling 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-cess for procurement of fastener materials, services,com

21、ponents, 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 manufacturer and alteration distributor shall havean

22、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 Approvals and ControlsThe organization shallformally au

23、dit 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 quality assurance, engineering, materials,processing

24、 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 evaluations shall be current and on-siteaudits shall

25、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 ResponsibilitiesA production proceduremanual shall establish a

26、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 defining all elements of produc-tion which shall includ

27、e 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 CapabilityThe manufacturer or altera-tion distributor

28、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 a systemexists for the design, purchase, inventory,

29、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 place aprogram for preventative maintenance of manufac

30、turing 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 schedule the manufacturing or alteration capacityto

31、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, and the sequence of operations in-cluding outsource

32、 services. Process Flow Diagrams are helpfulin documenting these requirements.9.2.8 Lot Control/SegregationThere shall be in place asystem to identify product in-process by lot identifiers trace-able to the mill heat of raw material from which it ismanufactured.9.2.9 InspectionsIn-process inspection

33、 testing, and finalverification shall be in place in accordance with requirementsfor in-process control (10.14.1), and verification (10.14.2).F2688 08 (2014)210. Quality Assurance Program/System Elements10.1 Quality System OrganizationThe organizationalstructure, functional responsibilities, levels

34、 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 includes:10.1.1 Ensuring those processes needed for this stan

35、dard 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 throughout the organization.10.2 Quality System Self AuditTher

36、e 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 shall be performedin accordance with written procedures or

37、 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 conducted at leastannually in accordance with the provisio

38、ns 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 be specified, prepared, and maintained. Records shall b

39、elegible, identifiable, and retrievable. Records shall be protectedagainst damage, alteration, deterioration, or loss. Requirementsand responsibilities for record transmittal, distribution,retention, maintenance, and disposition shall be established anddocumented.10.4 Document ControlThe manufacture

40、r 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 theassignment of responsibility for preparing, review

41、ing,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 to applicable standards and specificationsshall be cont

42、rolled 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 internationalstandard exists. Such equipment shall be uniquely numbered/id

43、entified 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 necessary, identify and retrieve material or productfou

44、nd 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 Control and TraceabilityThe raw ma-terial requirements

45、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 specification and manufacturing process.All raw material

46、s 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 sys-tem shall be in place that maintains product trac

47、eability 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 events.10.8 Finished Product Lot Control and Identific

48、ationAsystem 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 toshipment of said product to their customer.10.9 Packagi

49、ng 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 fasteners in each respective container.10.9.3 There shall be in pl