ASTM F2688-2008 Standard Guide for System-Based Customer-Centered Quality Plan for Manufacturers《系统为基础、以客户为中心的制造质量计划的标准指南》.pdf

1、Designation: F 2688 08Standard Guide forSystem-Based, Customer-Centered Quality Plan forManufacturers1This standard is issued under the fixed designation F 2688; 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 (e) 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 distribu-tors in t

3、he 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:2F 1469 Guide for Conducting a Repeata

4、bility and Repro-ducibility Study on Test Equipment for NondestructiveTestingF 1470 Guide for Fastener Sampling for Specified Mechani-cal Properties and Performance InspectionF 1503 Practice for Machine/Process Capability Study Pro-cedureF 1789 Terminology for F16 Mechanical FastenersF 2282 Specific

5、ation for Quality Assurance Requirementsfor Carbon and Alloy Steel Wire, Rods, and Bars forMechanical Fasteners2.2 ASTM Manual:Manual 22 Total Quality Management-Guiding Principlesfor Application22.3 IFI Standard:IFI-139 Quality Assurance Requirements for Fastener Test-ing Laboratories2.4 ASME Stand

6、ards: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 Assurance System4NOTE 1

7、There is no direct relationship of this standard to an ISOcounterpart. However, several elements of this guide may be found inISO 16426.3. Terminology3.1 Terms shall be defined in accordance with TerminologyF 1789.4. Significance and Use4.1 A need exists for a Quality Systems Guide that may bedeploy

8、ed 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 certification.5. Managem

9、ents 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 quality manual

10、 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 issues, and safety

11、skills for all organizational processstreams.6. Inquiries and Quotation6.1 Review of Drawings and SpecificationsAll drawingsand specifications that are applicable to a given inquiry shall be1This guide is under the jurisdiction of ASTM Committee F16 on Fasteners andis the direct responsibility of Su

12、bcommittee F16.93 on QualityAssurance Provisionsfor Fasteners.Current edition approved Jan. 1, 2008. Published January 2008.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, r

13、efer to the standards Document 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.,4t

14、h Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.reviewed prior to issuance of a quotation. This review shallinclude engineering, manufacturing, production materials, pro-cesses, quality

15、 assurance, cost accounting and outside sourcingas applicable to ensure that all of the customers requirementscan be met.6.2 Ongoing 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 accu

16、ratemanner. 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 andreviewed by management.7. Engineering7.1 Specification RequirementsFor products defined byrecognized standards,

17、 there shall be evidence that the appli-cable specifications for material, configuration, processing,finishing, inspection testing and packaging, were based uponestablished requirements specified in these standards and arerelated to fit, form, and function. Unless otherwise specified inthe contract

18、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 fastener. The use of informalsketches, uncontrolled drawings, and red lined changes todrawings, specifications, and proc

19、ess documents shall not bepermitted in the purchasing, fabrication, process, test, orinspection operations.7.3 Design Change/Configuration ControlA documentedprocedure shall exist for controlling and authorizing thedevelopment, release, change, use, and control of designdocuments. The procedure shal

20、l 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, compo-nents, and assemblies shall be formally planned, documented,and controlled. The authority and responsibility of

21、 the organi-zations involved in interaction with the control of suppliersshall be established by management and documented. Thefastener manufacturer and alteration distributor shall have anactive documented system to verify the performance of sup-pliers.8.2 Supplier EvaluationThe appropriate represe

22、ntativesfrom all segments of the organization shall participate, asneeded, for approval of sources of materials and services.8.3 Source Approvals and ControlsThe organization shallformally audit on-site the suppliers or sources capability tofurnish conforming materials and/or services relevant to su

23、p-ply, manufacture, processing, or alteration of fasteners. Thisaudit shall be documented with procedures that include input asrequired, from quality assurance, engineering, materials, pro-cessing, and procurement. Subsequently, the suppliers orsources shall be evaluated on the basis of on-site surv

24、eys,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 be conducted at least once every four years.8.4 Technical RequirementsSpecifications, drawings, andpurch

25、ase orders shall define and communicate applicablerequirements to the supplier of materials and services.9. Production9.1 Production ResponsibilitiesA production proceduremanual shall establish a controlled approach for productquality in production encouraging interaction with engineering,procuremen

26、t, materials, processing, and quality assurance. Themanufacturer or alteration distributor shall have in place aproduction procedures manual defining 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 manuf

27、acturer or alteration distributorshall have evidence that production is related to his manufac-turing or alteration capacity.9.2.2 Equipment CapabilityThe manufacturer or alter-ation distributor shall have evidence that capability studieshave been conducted to verify ability to manufacture or altera

28、nd to process fasteners to specification requirements. PracticeF 1503 may be used for these studies.9.2.3 ToolingEvidence shall be present that a systemexists for the design, purchase, inventory, and control ofperishable and nonperishable tooling.9.2.4 Equipment OperatorsThere shall be evidence that

29、equipment operators have appropriate training in accordancewith their specific responsibilities.9.2.5 Repair and MaintenanceThere shall be in place aprogram for preventative maintenance of manufacturing andprocessing equipment. Maintenance shall be performed atprescribed intervals. Records shall be

30、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 meet stated customer requirements, including timeliness.9.2.7 Production PlanningProduction shall be car

31、ried outin accordance with a production plan of the process. Thiscontrolled approach should include tooling, material, pro-cesses, specifications, and the sequence of operations includingoutsource services. Process Flow Diagrams are helpful indocumenting these requirements.9.2.8 Lot Control/Segregat

32、ionThere 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, testing, and finalverification shall be in place in accordance with requirementsfor in-process control

33、 (10.14.1), and verification (10.14.2).10. Quality Assurance Program/System Elements10.1 Quality System OrganizationThe organizationalstructure, functional responsibilities, levels of authority, andlines of communication for activities affecting quality shall bedocumented. Top management shall appoi

34、nt 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 standard areestablished, implemented and maintained,F268808210.1.2 Reporting to top management on the performance ofthe orga

35、nization to this standard, and any need for improve-ment, and10.1.3 Ensuring the promotion of awareness of customerrequirements throughout 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

36、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 checklists by person-nel who do not have direct responsibility or involvement forperforming the activities be

37、ing 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 provisions of the QualityAssurance Manual. Documented corrective and preventiveaction shall be taken, where indicated,

38、 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 belegible, identifiable, and retrievable. Records shall be protectedagainst damage, alteration, deterioration,

39、or loss. Requirementsand responsibilities for record transmittal, distribution, reten-tion, maintenance, and disposition shall be established anddocumented.10.4 Document ControlThe manufacturer or alterationdistributor shall have in place a system governing the prepa-ration, change and distribution,

40、 of documentation that specifiesdimensions, mechanical, chemical, and performance require-ments of the fastener. This system shall provide for theassignment of responsibility for preparing, reviewing, approv-ing, and issuing documents. Persons other than those sodesignated shall make no changes to a

41、ny documents.10.5 Testing Equipment, Measuring Devices, and GagesAll testing equipment, measuring devices, and gages used toverify conformance to applicable standards and specificationsshall be controlled and, at specified intervals, shall be cali-brated to maintain accuracy within necessary limits.

42、 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/identified and have a documented plan for maintenance,control, and repair actions. All testing equipment

43、, measuringdevices, and gages used in statistical quality control shall bequalified using Guide F 1469. A system shall be in place thatwill, if necessary, identify and retrieve material or productfound to be nonconforming because of equipment, measuringdevices, or gages out of calibration. For faste

44、ners that aresubject to the FQA, laboratory accreditation by an independentthird party shall serve as evidence of conformance.10.6 Raw Material Control and TraceabilityThe rawmaterial requirements shall be described by a document such asa recognized standard or specification such as SpecificationF 2

45、282. This description shall include size, type, chemistry,source, condition, and any other information deemed necessaryto satisfy the product specification and manufacturing process.All raw materials shall be fully traceable and accompanied bya mill test report. A system shall be in place to control

46、 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 traceability back tothe original mill heat of raw material. This system shall becapable of maintaining lot

47、 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 IdentificationAsystem shall be in place for the handling, storage, andidentification of finished products based

48、 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 Packaging and Inventory of Finished ProductLotpurity, lot identity, and traceability shall be maintainedthrou

49、ghout 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 place a system to accurately accountfor all products with respect to size, type, quantity, location,and lot