ASTM F2688-08(2014)
(Guide)Standard Guide for System-Based, Customer-Centered Quality Plan for Manufacturers
Standard Guide for System-Based, Customer-Centered Quality Plan for Manufacturers
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.
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
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.
1. Scope B18.18.2 Inspection and Quality Assurance for High-
Volume Machine Assembly Fasteners
1.1 This guide establishes recommended system-based pro-
cedurestoassistfastenermanufacturersandalterationdistribu- 2.5 NIST Program:
torsinthedevelopmentofprocesscontrolswhichareintended Malcolm Baldrige Criteria for Excellence(www.nist.gov)
to produce quality products in a cost effective manner. These
2.6 ISO Standard:
recommended system-based procedures allow an organization 4
ISO 16426Fasteners—Quality Assurance System
to continually improve operational effectiveness.
NOTE 1—There is no direct relationship of this standard to an ISO
counterpart.However,severalelementsofthisguidemaybefoundinISO
2. Referenced Documents
16426.
2.1 ASTM Standards:
F1469Guide for Conducting a Repeatability and Reproduc-
3. Terminology
ibility Study on Test Equipment for Nondestructive Test-
3.1 Terms shall be defined in accordance with Terminology
ing
F1789.
F1470Practice for Fastener Sampling for Specified Me-
chanical Properties and Performance Inspection
4. Significance and Use
F1503Practice for Machine/Process Capability Study Pro-
cedure
4.1 Aneed exists for a Quality Systems Guide that may be
F1789Terminology for F16 Mechanical Fasteners
deployed by small to larger manufacturers that give direction
F2282SpecificationforQualityAssuranceRequirementsfor
on development of process-based systems that drive quality
Carbon and Alloy Steel Wire, Rods, and Bars for Me-
andcontinuousimprovement.Thisguidedoesnotrequirethird
chanical Fasteners
party regulation, thus making it attractive to those manufactur-
2.2 ASTM Manual: ers who are not required to have such certification.
Manual 22Total Quality Management-Guiding Principles
for Application 5. Management’s Role
2.3 IFI Standard:
5.1 Executivemanagementshallberesponsibleforcommit-
IFI-139Quality Assurance Requirements for Fastener Test-
ment to a company-wide quality policy. The Quality Policy
ing Laboratories
shall be published, maintained, understood and implemented
2.4 ASME Standards:
by all company operation groups.
B18.18.1Inspection and Quality Assurance for General
5.2 Quality Manual—The management commitment shall
Purpose Fasteners
be fully supported by a quality manual which shall be under
periodic review.
This guide is under the jurisdiction ofASTM Committee F16 on Fasteners and
5.3 Personnel Training—Managementshallassumerespon-
isthedirectresponsibilityofSubcommitteeF16.93onQualityAssuranceProvisions
sibility for providing appropriate training for all company
for Fasteners.
personnel.Appropriatetrainingshallinclude,butnotbelimited
Current edition approved April 1, 2014. Published April 2014. Originally
approved in 2008. Last previous edition approved in 2008 as F2688–08. DOI:
to,jobskills,processknowledge,qualitytraining,environmen-
10.1520/F2688-08R14.
tal issues, and safety skills for all organizational process
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
streams.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standardsvolume information,referto thestandard’sDocumentSummary page on
the ASTM website.
Available from American Society of Mechanical Engineers (ASME), ASME
International Headquarters, Three Park Ave., New York, NY 10016-5990, http:// Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
www.asme.org. 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
F2688 − 08 (2014)
6. Inquiries and Quotation processing, and procurement. Subsequently, the suppliers or
sources shall be evaluated on the basis of on-site surveys,
6.1 Review of Drawings and Specifications—All drawings
physical audits, or current quality history. Such evaluations
andspecificationsthatareapplicabletoagiveninquiryshallbe
shall be conducted on an ongoing basis, but no less than
reviewed prior to issuance of a quotation. This review shall
annually. Evidence of evaluations shall be current and on-site
include engineering, manufacturing, production materials,
audits shall be conducted at least once every four years.
processes, quality assurance, cost accounting and outside
sourcing as applicable to ensure that all of the customer’s
8.4 Technical Requirements—Specifications, drawings, and
requirements can be met.
purchase orders shall define and communicate applicable
6.2 Ongoing Review—The activity specified in 6.1 shall be requirements to the supplier of materials and services.
subject to a periodic internal audit/review which will evaluate
its ability to respond to the purchaser in a timely and accurate 9. Production
manner. Frequency of the internal audit/review shall be deter-
9.1 Production Responsibilities—A production procedure
mined on past audit/reviews, but shall be conducted at least
manual shall establish a controlled approach for product
once a year. The results of the review shall be reported to and
qualityinproductionencouraginginteractionwithengineering,
reviewed by management.
procurement,materials,processing,andqualityassurance.The
manufacturer or alteration distributor shall have in place a
7. Engineering
productionproceduresmanualdefiningallelementsofproduc-
7.1 Specification Requirements—For products defined by
tion which shall include as a minimum the elements listed
recognized standards, there shall be evidence that the appli-
under 9.2.
cable specifications for material, configuration, processing,
9.2 Production and Planning Elements :
finishing, inspection testing and packaging, were based upon
established requirements specified in these standards and are 9.2.1 Capacity—The manufacturer or alteration distributor
related to fit, form, and function. Unless otherwise specified in
shall have evidence that production is related to his manufac-
the contract or purchase order, the latest revision of any cited turing or alteration capacity.
or applicable specification shall be used.
9.2.2 Equipment Capability—The manufacturer or altera-
7.2 Drawing Requirements—Drawings shall define all fea- tiondistributorshallhaveevidencethatcapabilitystudieshave
been conducted to verify ability to manufacture or alter and to
tures and characteristics of the fastener. The use of informal
sketches, uncontrolled drawings, and red lined changes to processfastenerstospecificationrequirements.PracticeF1503
drawings, specifications, and process documents shall not be may be used for these studies.
permitted in the purchasing, fabrication, process, test, or
9.2.3 Tooling—Evidence shall be present that a system
inspection operations.
exists for the design, purchase, inventory, and control of
perishable and nonperishable tooling.
7.3 Design Change/Configuration Control—A documented
procedure shall exist for controlling and authorizing the 9.2.4 Equipment Operators—There shall be evidence that
development, release, change, use, and control of design
equipment operators have appropriate training in accordance
documents.Theprocedureshallbeadequatetopreventtheuse with their specific responsibilities.
of obsolete design documents.
9.2.5 Repair and Maintenance—There shall be in place a
program for preventative maintenance of manufacturing and
8. Procurement
processing equipment. Maintenance shall be performed at
prescribed intervals. Records shall be maintained of mainte-
8.1 Responsibilities of Procurement—The system and pro-
nance and repair on manufacturing and processing equipment.
cess for procurement of fastener materials, services,
components, and assemblies shall be formally planned,
9.2.6 Scheduling—There shall be in place a system to
documented, and controlled. The authority and responsibility
evaluate and schedule the manufacturing or alteration capacity
of the organizations involved in interaction with the control of
to meet stated customer requirements, including timeliness.
suppliersshallbeestablishedbymanagementanddocumented.
9.2.7 Production Planning—Production shall be carried out
The fastener manufacturer and alteration distributor shall have
in accordance with a production plan of the process. This
an active documented system to verify the performance of
controlled approach should include tooling, material,
suppliers.
processes, specifications, and the sequence of operations in-
8.2 Supplier Evaluation—The appropriate representatives cludingoutsourceservices.ProcessFlowDiagramsarehelpful
in documenting these requirements.
from all segments of the organization shall participate, as
needed, for approval of sources of materials and services.
9.2.8 Lot Control/Segregation—There shall be in place a
system to identify product in-process by lot identifiers trace-
8.3 Source Approvals and Controls—The organization shall
able to the mill heat of raw material from which it is
formally audit on-site the supplier’s or source’s capability to
manufactured.
furnish conforming materials and/or services relevant to
supply,manufacture,processing,oralterationoffasteners.This 9.2.9 Inspections—In-process inspection, testing, and final
verification shall be in place in accordance with requirements
auditshallbedocumentedwithproceduresthatincludeinputas
required, from quality assurance, engineering, materials, for in-process control (10.14.1), and verification (10.14.2).
F2688 − 08 (2014)
10. Quality Assurance Program/System Elements devices, or gages out of calibration. For fasteners that are
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-
documented. Top management shall appoint a member of
terial requirements shall be described by a document such as a
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.
10.1.2 Reporting to top management on the performance of
All raw materials shall be fully traceable and accompanied by
the organization to this standard, and any need for
a mill test report. A system shall be in place to control the
improvement, and
identity, storage, and handling of raw material from receiving
10.1.3 Ensuring the promotion of awareness of customer
to the production operation.
requirements throughout the organization.
10.7 In-Process Material Control and Traceability—A sys-
10.2 Quality System Self Audit—There shall be in place a
temshallbeinplacethatmaintainsproducttraceabilitybackto
system for internal audits to ensure compliance with this
the original mill heat of raw material. This system shall be
standard to verify the presence of, the adequacy of, and
capable of maintaining lot identity with respect to factory
compliancewithallaspectsofthequalityassurancesystemand
order, part number, strength levels, manufacturing event, and
to determine its effectiveness. These audits shall be performed
all subsequent processing inspections and testing events.
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
action shall be taken, where indicated, in a timely manner.
10.9 Packaging and Inventory of Finished Product—Lot
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
documented. 10.9.2 When required, the manufacturer or alteration dis-
tributor shall be able to issue a certified test report for each lot
10.4 Document Control—The manufacturer or alteration
of fasteners in each respective container.
distributor shall have in place a system governing the
10.9.3 Thereshallbeinplaceasystemtoaccuratelyaccount
preparation, change and distribution, of documentation that
for all products with respect to size, type, quantity, location,
specifies dimensions, mechanical, chemical, and performance
and lot number.
requirements of the fastener. This system shall provide for the
assignment of responsibility for preparing, reviewing,
10.10 Product Conformance in Manufacturing, Processing
approving, and issuing documents. Persons other than those so
and Alteration (ppm)—In this standard, the quality of a
designated shall make no changes to any documents.
manufacturing or shipping lot is defined in terms of ppm.This
meansthatalotmaycontainnomorethanacertainnumberof
10.5 Testing Equipment, Measuring Devices, and Gages
nonconformities per million to be acceptable. In this standard
—All testing equipment, measuring devices, and gages used to
wedefineandcontrolppmthroughth
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