ASTM F2688-08(2014)e1
(Guide)Standard Guide for System-Based, Customer-Centered Quality Plan for Manufacturers (Withdrawn 2019)
Standard Guide for System-Based, Customer-Centered Quality Plan for Manufacturers (Withdrawn 2019)
SIGNIFICANCE AND USE
4.1 A need exists for a Quality Systems Guide that may be deployed by small to larger manufacturers that give direction on development of process-based systems that drive quality and continuous improvement. This guide does not require third party regulation, thus making it attractive to those manufacturers who are not required to have such certification.
SCOPE
1.1 This guide establishes recommended system-based procedures to assist fastener manufacturers and alteration distributors in the development of process controls which are intended to produce quality products in a cost effective manner. These recommended system-based procedures allow an organization to continually improve operational effectiveness.
WITHDRAWN RATIONALE
This guide establishes recommended system-based procedures to assist fastener manufacturers and alteration distributors in the development of process controls which are intended to produce quality products in a cost effective manner. These recommended system-based procedures allow an organization to continually improve operational effectiveness.
Formerly under the jurisdiction of Committee F16 on Fasteners, this guide was withdrawn in August 2019. This standard is being withdrawn without replacement due to its limited use by industry.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
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Designation: F2688 − 08 (Reapproved 2014)
Standard Guide for
System-Based, Customer-Centered Quality Plan for
Manufacturers
This standard is issued under the fixed designation F2688; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—10.16 was editorially corrected in May 2016.
1. Scope 2.4 ASME Standards:
B18.18.1Inspection and Quality Assurance for General
1.1 This guide establishes recommended system-based pro-
Purpose Fasteners
cedurestoassistfastenermanufacturersandalterationdistribu-
B18.18.2 Inspection and Quality Assurance for High-
torsinthedevelopmentofprocesscontrolswhichareintended
Volume Machine Assembly Fasteners
to produce quality products in a cost effective manner. These
2.5 NIST Program:
recommended system-based procedures allow an organization
Malcolm Baldrige Criteria for Excellence(www.nist.gov)
to continually improve operational effectiveness.
2.6 ISO Standard:
2. Referenced Documents
ISO 16426Fasteners—Quality Assurance System
2.1 ASTM Standards:
NOTE 1—There is no direct relationship of this standard to an ISO
F1469Guide for Conducting a Repeatability and Reproduc-
counterpart.However,severalelementsofthisguidemaybefoundinISO
ibility Study on Test Equipment for Nondestructive Test-
16426.
ing
3. Terminology
F1470Practice for Fastener Sampling for Specified Me-
chanical Properties and Performance Inspection
3.1 Terms shall be defined in accordance with Terminology
F1503Practice for Machine/Process Capability Study Pro-
F1789.
cedure
4. Significance and Use
F1789Terminology for F16 Mechanical Fasteners
F2282SpecificationforQualityAssuranceRequirementsfor
4.1 Aneed exists for a Quality Systems Guide that may be
Carbon and Alloy Steel Wire, Rods, and Bars for Me-
deployed by small to larger manufacturers that give direction
chanical Fasteners
on development of process-based systems that drive quality
2.2 ASTM Manual:
andcontinuousimprovement.Thisguidedoesnotrequirethird
Manual 22Total Quality Management-Guiding Principles
party regulation, thus making it attractive to those manufactur-
for Application
ers who are not required to have such certification.
2.3 IFI Standard:
5. Management’s Role
IFI-139Quality Assurance Requirements for Fastener Test-
ing Laboratories
5.1 Executivemanagementshallberesponsibleforcommit-
ment to a company-wide quality policy. The Quality Policy
This guide is under the jurisdiction ofASTM Committee F16 on Fasteners and
shall be published, maintained, understood and implemented
isthedirectresponsibilityofSubcommitteeF16.93onQualityAssuranceProvisions
by all company operation groups.
for Fasteners.
Current edition approved April 1, 2014. Published April 2014. Originally
approved in 2008. Last previous edition approved in 2008 as F2688–08. DOI:
10.1520/F2688-08R14E01. Available from American Society of Mechanical Engineers (ASME), ASME
For referenced ASTM standards, visit the ASTM website, www.astm.org, or International Headquarters, Three Park Ave., New York, NY 10016-5990, http://
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.asme.org.
Standardsvolume information,referto thestandard’sDocumentSummary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2688 − 08 (2014)
5.2 Quality Manual—The management commitment shall 8.2 Supplier Evaluation—The appropriate representatives
be fully supported by a quality manual which shall be under from all segments of the organization shall participate, as
periodic review. needed, for approval of sources of materials and services.
5.3 Personnel Training—Managementshallassumerespon- 8.3 Source Approvals and Controls—The organization shall
sibility for providing appropriate training for all company
formally audit on-site the supplier’s or source’s capability to
personnel.Appropriatetrainingshallinclude,butnotbelimited furnish conforming materials and/or services relevant to
to,jobskills,processknowledge,qualitytraining,environmen-
supply,manufacture,processing,oralterationoffasteners.This
tal issues, and safety skills for all organizational process auditshallbedocumentedwithproceduresthatincludeinputas
streams.
required, from quality assurance, engineering, materials,
processing, and procurement. Subsequently, the suppliers or
6. Inquiries and Quotation
sources shall be evaluated on the basis of on-site surveys,
physical audits, or current quality history. Such evaluations
6.1 Review of Drawings and Specifications—All drawings
shall be conducted on an ongoing basis, but no less than
andspecificationsthatareapplicabletoagiveninquiryshallbe
annually. Evidence of evaluations shall be current and on-site
reviewed prior to issuance of a quotation. This review shall
audits shall be conducted at least once every four years.
include engineering, manufacturing, production materials,
processes, quality assurance, cost accounting and outside
8.4 Technical Requirements—Specifications, drawings, and
sourcing as applicable to ensure that all of the customer’s
purchase orders shall define and communicate applicable
requirements can be met.
requirements to the supplier of materials and services.
6.2 Ongoing Review—The activity specified in 6.1 shall be
subject to a periodic internal audit/review which will evaluate 9. Production
its ability to respond to the purchaser in a timely and accurate
9.1 Production Responsibilities—A production procedure
manner. Frequency of the internal audit/review shall be deter-
manual shall establish a controlled approach for product
mined on past audit/reviews, but shall be conducted at least
qualityinproductionencouraginginteractionwithengineering,
once a year. The results of the review shall be reported to and
procurement,materials,processing,andqualityassurance.The
reviewed by management.
manufacturer or alteration distributor shall have in place a
productionproceduresmanualdefiningallelementsofproduc-
7. Engineering
tion which shall include as a minimum the elements listed
7.1 Specification Requirements—For products defined by
under 9.2.
recognized standards, there shall be evidence that the appli-
9.2 Production and Planning Elements :
cable specifications for material, configuration, processing,
9.2.1 Capacity—The manufacturer or alteration distributor
finishing, inspection testing and packaging, were based upon
shall have evidence that production is related to his manufac-
established requirements specified in these standards and are
turing or alteration capacity.
related to fit, form, and function. Unless otherwise specified in
9.2.2 Equipment Capability—The manufacturer or altera-
the contract or purchase order, the latest revision of any cited
tiondistributorshallhaveevidencethatcapabilitystudieshave
or applicable specification shall be used.
been conducted to verify ability to manufacture or alter and to
7.2 Drawing Requirements—Drawings shall define all fea-
processfastenerstospecificationrequirements.PracticeF1503
tures and characteristics of the fastener. The use of informal
may be used for these studies.
sketches, uncontrolled drawings, and red lined changes to
9.2.3 Tooling—Evidence shall be present that a system
drawings, specifications, and process documents shall not be
exists for the design, purchase, inventory, and control of
permitted in the purchasing, fabrication, process, test, or
perishable and nonperishable tooling.
inspection operations.
9.2.4 Equipment Operators—There shall be evidence that
7.3 Design Change/Configuration Control—A documented
equipment operators have appropriate training in accordance
procedure shall exist for controlling and authorizing the with their specific responsibilities.
development, release, change, use, and control of design
9.2.5 Repair and Maintenance—There shall be in place a
documents.Theprocedureshallbeadequatetopreventtheuse program for preventative maintenance of manufacturing and
of obsolete design documents.
processing equipment. Maintenance shall be performed at
prescribed intervals. Records shall be maintained of mainte-
8. Procurement
nance and repair on manufacturing and processing equipment.
8.1 Responsibilities of Procurement—The system and pro- 9.2.6 Scheduling—There shall be in place a system to
evaluate and schedule the manufacturing or alteration capacity
cess for procurement of fastener materials, services,
components, and assemblies shall be formally planned, to meet stated customer requirements, including timeliness.
documented, and controlled. The authority and responsibility 9.2.7 Production Planning—Production shall be carried out
of the organizations involved in interaction with the control of in accordance with a production plan of the process. This
suppliersshallbeestablishedbymanagementanddocumented. controlled approach should include tooling, material,
The fastener manufacturer and alteration distributor shall have processes, specifications, and the sequence of operations in-
an active documented system to verify the performance of cludingoutsourceservices.ProcessFlowDiagramsarehelpful
suppliers. in documenting these requirements.
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F2688 − 08 (2014)
9.2.8 Lot Control/Segregation—There shall be in place a tional standards or special certified masters if no international
system to identify product in-process by lot identifiers trace- standard exists. Such equipment shall be uniquely numbered/
able to the mill heat of raw material from which it is identified and have a documented plan for maintenance,
manufactured. control, and repair actions. All testing equipment, measuring
9.2.9 Inspections—In-process inspection, testing, and final devices, and gages used in statistical quality control shall be
verification shall be in place in accordance with requirements qualified using Guide F1469. A system shall be in place that
for in-process control (10.14.1), and verification (10.14.2). will, if necessary, identify and retrieve material or product
found to be nonconforming because of equipment, measuring
devices, or gages out of calibration. For fasteners that are
10. Quality Assurance Program/System Elements
subjecttotheFQA,laboratoryaccreditationbyanindependent
10.1 Quality System Organization—The organizational
third party shall serve as evidence of conformance.
structure, functional responsibilities, levels of authority, and
lines of communication for activities affecting quality shall be 10.6 Raw Material Control and Traceability—The raw ma-
terial requirements shall be described by a document such as a
documented. Top management shall appoint a member of
management who, is independent of other responsibilities and recognized standard or specification such as Specification
shall have responsibility and authority that includes: F2282. This description shall include size, type, chemistry,
10.1.1 Ensuringthoseprocessesneededforthisstandardare source,condition,andanyotherinformationdeemednecessary
established, implemented and maintained, to satisfy the product specification and manufacturing process.
All raw materials shall be fully traceable and accompanied by
10.1.2 Reporting to top management on the performance of
a mill test report. A system shall be in place to control the
the organization to this standard, and any need for
identity, storage, and handling of raw material from receiving
improvement, and
to the production operation.
10.1.3 Ensuring the promotion of awareness of customer
requirements throughout the organization.
10.7 In-Process Material Control and Traceability—A sys-
temshallbeinplacethatmaintainsproducttraceabilitybackto
10.2 Quality System Self Audit—There shall be in place a
the original mill heat of raw material. This system shall be
system for internal audits to ensure compliance with this
capable of maintaining lot identity with respect to factory
standard to verify the presence of, the adequacy of, and
order, part number, strength levels, manufacturing event, and
compliancewithallaspectsofthequalityassurancesystemand
all subsequent processing inspections and testing events.
to determine its effectiveness. These audits shall be performed
in accordance with written procedures or checklists by person-
10.8 Finished Product Lot Control and Identification—A
nel who do not have direct responsibility or involvement for
system shall be in place for the handling, storage, and
performing the activities being audited. Audit results shall be
identification of finished products based on segregation by lot
documented, reported to, and reviewed by responsible man-
number. Distribution entities shall ensure lot control in their
agement. These internal audits shall be conducted at least
storage and movement operations from receipt of product to
annually in accordance with the provisions of the Quality
shipment of said product to their customer.
Assurance Manual. Documented corrective and preventive
10.9 Packaging and Inventory of Finished Product—Lot
action shall be taken, where indicated, in a timely manner.
purity, lot identity, and traceability shall be maintained
10.3 Quality System Records—Records that furnish docu-
throughout the entire operation in such manner to prevent
mentary evidence of product conformance and traceability
commingling.
shall be specified, prepared, and maintained. Records shall be
10.9.1 All products shall be packaged to prevent damage
legible,identifiable,andretrievable.Recordsshallbeprotected
during storage and/or shipment. Containers shall be labeled to
againstdamage,alteration,deterioration,orloss.Requirements
identify the contents, responsible party, country of origin, and
and responsibilities for record transmittal, distribution,
lot number.
retention,maintenance,anddispositionshallbeestablishedand
10.9.2 When required, the manufacturer or alteration dis-
documented.
tributor shall be able to issue a certified test report for each lot
of fasteners in each respective container.
10.4 Document Control—The manufacturer or alteration
distributor shall have in place a system governing the 10.9.3 Thereshallbeinplaceasystemtoaccuratelyaccount
for all products with respect to size, type, quantity, location,
preparation, change and distribution, of documentation that
specifies dimensions, mechanical, chemical, and performance and lot number.
requirements of the fastener. This system shall provide for the
10.10 Product Conformance in Manufacturing,
...
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