[Federal Register Volume 62, Number 173 (Monday, September 8, 1997)]
[Proposed Rules]
[Pages 47240-47260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23613]
[[Page 47239]]
_______________________________________________________________________
Part II
Department of Commerce
_______________________________________________________________________
National Institute of Standards and Technology
_______________________________________________________________________
15 CFR Part 280
Procedures for Implementation of the Fastener Quality Act; Proposed
Rule
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 /
Proposed Rules
[[Page 47240]]
DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
15 CFR Part 280
[Docket No: 970724177-7177-01]
Procedures for Implementation of the Fastener Quality Act
AGENCY: National Institute of Standards and Technology, United States
Department of Commerce.
ACTION: Notice of proposed rulemaking; request for comments.
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SUMMARY: The Director of the National Institute of Standards and
Technology (NIST), United States Department of Commerce, and the Under
Secretary of the Bureau of Export Administration, United States
Department of Commerce, request comments on proposed changes to the
regulations found at 15 CFR part 280 pertaining to implementation of
the Fastener Quality Act (the Act). The proposed changes allow
accreditation of in-process inspection activities of qualifying
statistical process control manufacturing facilities, address the issue
of passing laboratory inspection and testing reports along the supply
chain to the fastener manufacturer, address the issue of significant
alteration by removal of manufacturer or grade identification markings
for decorative purposes at the customer's request, address the issue of
grandfathering fasteners, and revise definitions and related sections
for clarity and to correct editorial error. The proposed changes will
facilitate the implementation of the Act and regulations and will
better accommodate modern industry practices by incorporating them into
the Fastener Quality Act certification process.
DATES: Comments must be received no later than November 7, 1997.
ADDRESSES: Comments on the proposed revisions must be submitted to: Dr.
Subhas G. Malghan, FQA Program Manager, Technology Services, National
Institute of Standards and Technology, Building 820, Room 306,
Gaithersburg, MD 20899, telephone number (301) 975-5120.
FOR FURTHER INFORMATION CONTACT: Dr. Subhas G. Malghan, FQA Program
Manager, Technology Services, National Institute of Standards and
Technology, Building 820, Room 306, Gaithersburg, MD 20899, telephone
number (301) 975-5120.
SUPPLEMENTARY INFORMATION:
Background
The Fastener Quality Act (the Act) protects the public safety by:
(1) Requiring that certain fasteners which are sold in commerce conform
to the specifications to which they are represented to be manufactured,
(2) providing for accreditation of laboratories engaged in fastener
testing; and (3) requiring inspection, testing and certification, in
accordance with standardized methods, of fasteners covered by the Act.
The Secretary of Commerce, acting through the Director of the
National Institute of Standards and Technology (NIST), published final
implementing regulations on September 26, 1996, establishing
procedures, under which: (1) Laboratories in compliance with the Act
may be listed; (2) laboratories may apply to NIST for accreditation;
(3) private laboratory accreditation entities (bodies) may apply to
NIST for approval to accredit laboratories; and (4) foreign
laboratories accredited by their governments or by organizations
recognized by the NIST Director under section 6(a)(1)(C) of the Act can
be deemed to satisfy the laboratory accreditation requirements of the
Act. The regulation also established, within the Patent and Trademark
Office (PTO), a recordation system to identify the manufacturers or
distributors of covered fasteners to ensure that the fasteners may be
traced to their manufacturers or private label distributors. In
addition, the regulations contained provisions on testing and
certification of fasteners, sale of fasteners subsequent to
manufacture, record keeping, applicability of the Act, enforcement,
civil penalties, and hearing and appeal procedures.
Those regulations became effective on November 25, 1996, and were
to apply to fasteners manufactured on or after May 27, 1997, the
``implementation date''. On April 18, 1997, pursuant to Section 15 of
the Fastener Quality Act, NIST announced a one year extension in the
implementation date of the regulations on grounds that there were an
insufficient number of accredited laboratories to conduct the volume of
inspection and testing required by the Act and regulations (62 Fed.
Reg. 19041 (1997)). NIST believes that it will have completed the
approval/accreditation of a sufficient number of accreditation bodies/
laboratories to implement the Act by May 26, 1998.
Following issuance of the final regulations on September 26, 1996,
the automobile industry approached the Department and expressed its
concerns that the Act and implementing regulations do not recognize the
use of modern manufacturing methods using prevention-based quality
assurance systems employing statistical process controls (SPC). During
the period of September 1996 to January 1997, the Department worked
with the automobile industry (domestic and foreign) to develop further
information about the extent of the problem. On February 4, 1997, a
Public Workshop was held at the National Institute of Standards and
Technology (NIST) to solicit information from the automobile,
aerospace, construction, and fastener industries on the use of
prevention-based quality assurance systems employing SPC in the
manufacture of fasteners. On the basis of this meeting and many
discussions with the concerned industries, the Department is proposing
amendments to the implementing regulations that will recognize the use
of prevention-based quality assurance systems under the Act and
regulations. These amendments are discussed in detail in Part 1 of this
proposed rule.
In addition to the above, the Department collaborated with industry
in conducting eleven Fastener Quality Act Workshops in various parts of
the United States, Europe, and Asia during the period from September
1996 to February 1997. The workshops attracted over 2,500 industry
participants who asked hundreds of questions of the Department on the
Act and regulations. As a result of those workshops and the great deal
of information provided by the industry participants on the impact of
the Act and regulations, the Department assembled evidence of need for
several possible amendments to the regulations. These amendments are
discussed in detail in Part 2 of this proposed rule.
Part 1: Summary of Proposed Amendments on Statistical Process Control
Background & Definition of the Issue
Ford, General Motors, and Chrysler Corporation established a
Supplier Quality Requirements Task Force in the 1980s to develop
quality system requirements (QS-9000) for their suppliers of materials
and parts. Initially, each company developed its own expectations for
supplier quality systems. In 1988, emphasis was placed on standardizing
the requirements, and in 1992 this was largely accomplished. The goal
of QS-9000 is the development of fundamental quality assurance systems
(QAS) that provide for continuous improvement, emphasizing
[[Page 47241]]
defect prevention and the reduction in variation and waste in the
supply chain.
QS-9000 employs statistical process control (SPC) in ensuring the
quality of parts. Suppliers must demonstrate process capabilities which
will yield a given quantity of parts with a minimum specified number of
defects. Depending upon the fastener type and auto maker, the maximum
allowable defective Parts Per Million (PPM) ranges between 15 and 125
PPM.
The heart of the QS-9000 system is the Control Plan which each
company must develop and have approved by Ford, GM, or Chrysler as part
of their adherence to QS-9000. The Control Plan is a comprehensive
documentation of product/process characteristics, process controls,
tests, and measurement systems that will occur during mass production.
It will normally also specify how much in-process or final testing and
inspection will be carried out by the supplier company. This
determination is based upon demonstrated process capabilities,
experience with the supplier, etc. QS-9000 implies that, through
continuous improvement, a supplier company may ultimately be able to
demonstrate a capability of producing millions of parts with zero
defects by continuously monitoring and controlling the production
process rather than relying upon the inspection and testing of the
physical attributes of the manufactured product. Given the above, the
automotive industry asserts that the Fastener Quality Act's reliance on
lot control and final inspection of fasteners does not recognize the
reality of modern mass production using statistical process control.
As present, the FQA and implementing regulations, rely on the use
of accredited laboratories for inspection, testing, and certification
of fasteners to applicable standards and specifications. Sections 5 of
the Act and 280.5 of the regulations are very specific that a
manufacturer of a lot of fasteners shall cause a representative sample
of the fasteners in the lot to be inspected and tested by an accredited
laboratory, and a test report must be produced which indicates that the
fasteners tested are in conformance with all of the provisions of the
standards and specifications used by the manufacturer in the production
of the fasteners. The end result, and the cornerstone on which the Act
is based, is that every lot of fasteners is certified by the
manufacturer as conforming to a given standard and specification, and
the paperwork relating to such certification (e.g., certificates of
conformance and test reports) is maintained on file and available at
the purchaser's request.
In the case of fastener manufacturers supplying the automobile
industry, Ford, GM, and Chrysler, as major end users of the fasteners,
have established QS-9000 as a means of achieving the same end. Their
suppliers are required to: (1) Establish a control plan under which
they will produce fasteners to the auto industries standards and
specifications; (2) submit evidence in the form of production data that
they can produce fasteners under a specified defect rate; and (3)
perform continuous monitoring and tests to maintain control of the
production process and to assure that the final product will be in
conformance with fastener standards and specifications. The difference
between the previously published regulation and the QS-9000 approach is
that the regulation assures end users that fasteners meet standards and
specifications by relying upon the inspection and testing of fasteners
by accredited laboratories. Under QS-9000, the end users (Ford, GM, and
Chrysler) recognize the fastener manufacturer's entire production
process as a means of ensuring conformance to these end users standards
and specifications. Consequently, ensuring adherence to standards and
specifications, is equivalent under the QS-9000 approach to end product
testing. However, the automobile industry believes that reliance on QS-
9000, which is based upon continuous monitoring and improvement of the
manufacturing process, is more efficient and cost effective than
traditional manufacturing regimens of final inspection and testing of
the end product, and represents the direction in which manufacturing
technology is evolving in this country and abroad.
Parallels to QS-9000 are being used in other countries including
Japan, and in other industries. For example, the U.S. aerospace
industry employs statistical process control in much the same way that
the automobile industry does. That is, major end users of aerospace
fasteners are beginning to require their fastener suppliers to comply
with comparable quality assurance programs as a condition to supplying
them.
When the Fastener Quality Act was signed into law in 1990, QS-9000
was in the early stages of development, and its full implication for
the industry was not well known. There is some evidence in the history
of the Act that Congress was informed of the need to consider OEM based
quality assurance systems for procuring fasteners (e.g., Statement of
Donald Keil, Assistant Director of Quality, Caterpillar Inc., during
the Hearing on H.R. 3000 before the Committee on Commerce, Science, and
Transportation, United States Senate, S.Hrg. 101-509, November 20,
1989). However, the Act did not directly recognize major end user
quality system requirements for satisfying testing, inspecting and
certification provisions under section 5 of the Act. Similarly, in
August 1992, NIST published draft implementing regulations for public
comment. As a result of the public comment process, letters were
received from General Motors and Nissan Corporation calling attention
to quality assurance programs they had in place to qualify fastener
suppliers; they indicated that the Act would require some redundant
testing. However, no recommendations were made at that time to permit
recognition of QS-9000 type systems.
The discussions about the use of statistical process control within
the automobile industry, did not lead to specific recommendations for
treating SPC under the Act or regulations. However, the issue was
raised at a meeting of the Fastener Advisory Committee in May 1996. At
that meeting a member of the Advisory Committee raised the issue of
problems that fastener suppliers would face in meeting the inspection,
testing, and certification requirements of the Act and regulations.
Accordingly, a proposal was introduced to exempt from the regulations
the automotive fasteners produced to the standards of a major end user
such as GM, Ford, and Chrysler. Since May of 1996, the Department has
had many discussions of these issues with representatives of the
automobile industry (U.S. and foreign) and with fastener manufacturers
who supply such industries. On February 4, 1997, NIST held an open
meeting to solicit industry views on the use of SPC in the manufacture
of fasteners under the Act. The purpose of the meeting, attended by
some 150 industry representatives and Department officials, was to
determine the impact that inspection, testing, and certification
requirements of the Act and regulations would have on fastener
manufacturers who use SPC and to identify ways in which the
requirements of the Act and regulations might be met by prevention-
based QAS using SPC.
A report of the meeting was published in April 1997, NISTIR 6001--
``Summary of Public Meeting, Use of Quality Assurance Systems in the
Fastener Industry,'' and may be obtained from NIST. The report included
proposed regulatory language being considered at that time by the
Department for resolving the issues identified during the meeting. As
part of the report, the
[[Page 47242]]
Department invited industry to provide input on the suggested
regulatory approach. Some 30 letters were received by NIST, commenting
on the report and the proposed regulatory language. The vast majority
of these focused on the SPC issue, suggesting solutions ranging from
exempting the automobile industry from the Act and regulations to
incorporating SPC in the regulatory scheme. Many proposed specific
amendments to the regulations that would incorporate SPC. The
Department appreciates the spirit with which the automobile industry
has responded and had considered all comments received. It is believed
that the amendments proposed in this notice best achieve the
incorporation of SPC in the regulatory scheme.
The Proposed Solution to the QAS/SPC Issue
The Director of NIST is today proposing that a fastener
manufacturing facility employing a fastener quality assurance system
(QAS) as defined in the regulations may be deemed to be an accredited
laboratory for purposes of the Act and regulations if such facility has
been formally registered by a NIST-recognized quality systems
registrar.
NIST wishes to make it clear that recognition of facilities that
employ fastener QAS as accredited laboratories within the meaning of
the Act and regulations is an alternative to final inspection and
testing of fasteners that is still carried out by many fastener
manufacturers. Both approaches to meeting the requirements of the Act
and regulations are equally valid. Adoption of these proposed
amendments will enable the use of QAS in fastener manufacturing in a
manner consistent with the requirements of the Act by ensuring that
every lot of fasteners is sampled and examined to ensure conformance
with applicable standards and specifications. Manufacturers must follow
the requirements of the fastener standards and specifications, as
published by a consensus standards organization or a major end user.
For example, a fastener manufacturer cannot unilaterally decide to
replace final inspection and testing with a QAS unless the designated
standards or specifications provide for this as an alternative to final
inspection and testing.
A definition of ``Fastener Quality Assurance System (QAS)'' is
proposed as part of the amendments. In developing the QAS definition,
NIST feels it is important to provide guidance to the industry as to
the minimum elements a fastener manufacturer's QAS should contain to be
eligible for recognition as an accredited laboratory within the meaning
of the Act and regulations. These elements have been included in the
definition.
The Department believes that the proposed amendments resolve
industry's concerns that the Act and regulations should recognize the
use of modern manufacturing methods. Proposed procedures for applying
for NIST/ABEP recognition of registrar accreditation bodies that
accredit quality systems registrars, which are based upon international
standards, are included as subparts I through L.
Part 2: Summary of All Other Proposed Amendments
Since September 1996, eleven Fastener Quality Act Workshops have
been conducted in seven cities in the U.S. (Chicago [2], Cleveland,
Columbus, Houston, Newark, Atlanta, and Los Angeles), and in Taiwan and
the U.K. (two were held in London). Over 2,500 industry participants
attended the workshops. These included fastener manufacturers,
distributors, and importers, and representatives of industries such as
automotive, aerospace, construction, heavy machinery, etc., that
purchase and use high strength fasteners. At the workshops,
representatives of BXA, NIST, and the Patent and Trademark Office (PTO)
presented information on the Act and implementing regulations. In
addition, members of the Public Law Task Force (PLTF), a nine member
industry committee representing fastener manufacturers, distributors,
and importers, provided an industry perspective on the impact of the
Act and regulations. Over the course of the workshops some 450
questions from the participants were documented by the Department, with
the understanding that answers would be published as interpretive
opinions of the Department as soon as practicable.
During the course of the workshops a great deal of practical
information was exchanged among the participants on the impact of the
Act and regulations on daily commerce in fasteners. This information
has been analyzed by the Department and translated into proposed
amendments which are discussed below. Comments from the public are
requested on these proposed amendments.
1. Significant Alterations of Fasteners
Under section 280.2 of the regulations, ``significantly alter''
means to alter a fastener in a manner which could weaken or otherwise
materially affect the performance or capabilities of the fastener as it
was originally manufactured, grade or property class marked, tested or
represented. The term does not include the application of adhesives or
sealants, locking elements, provisions for lock wires, coatings and
platings of parts having a specified Rockwell C hardness of less than
32, or cutting off of fasteners. In the reference to Rockwell C
hardness, an editorial error was made in the September 26, 1996
issuance of the final regulations in that the word ``minimum'' was to
appear before the word ``specified'' so that it reads ``minimum
specified Rockwell C hardness of less than 32 * * * '' in section 280.2
and in section 280.11 (b) of the regulations. The Department proposes
amendments to these sections to correct this error.
2. Removal of Head Markings
Questions were raised during each of the workshops about specialty
fasteners and the practice of shaving or polishing of fastener heads to
remove all markings for decorative purposes. The cases mentioned were
of manufacturers of motorcycles and pianos which frequently special
order fasteners that will be subject to the Act and regulations without
any head markings on them because they do not want the markings to show
in the final product. However, the Department also recently received a
letter from the Association of International Automobile Manufacturers
(AIAM) indicating that some of its members produce company standards
which may reference consensus standards for certain requirements for
fasteners but which do not reference requirements for including the
manufacturer's insignia on the head of the fastener. AIAM asserts that
such practice is consistent with the Act and regulations and that the
manufacturer of the fastener may supply the fasteners to these
automobile manufacturers without any head markings. The issue is
whether a fastener manufacturer is in violation of the Act and
regulations if he/she fills such an order from a customer. Put another
way, how much flexibility does a customer have in requesting that
covered fasteners be supplied to them without the required headmarkings
if they are going to use the fasteners in their products and possibly
even sell them for repair and replacement parts?
The Department has studied this issue and is proposing to amend the
regulations by adding a new section 280.11(c) to allow a fastener user
or purchaser to special order fasteners covered under the Act and
regulations without the required manufacturer or grade identification
markings under certain conditions. The existing sections
[[Page 47243]]
280.11(c) and (d) are proposed to be redesignated as sections 280.11(d)
and (e). The new section 280.11(c) requires that: (1) The fasteners be
manufactured to an OEM or major end-user standard which does not
require such markings; or (2) the customer request in writing that
manufacturer or grade identification markings be removed for decorative
purposes and certifies that such fasteners will not be held out or sold
as meeting the requirements of a consensus standard which requires
manufacturer or grade identification markings.
3. Supplying Originals vs Copies of Test Reports
In all of the workshops, especially those held in Asia and in
Europe, concerns were expressed about the potential paperwork burden on
raw materials manufacturers in meeting the requirements of section
280.15 of the regulations. Raw materials manufacturers (domestic and
foreign) assert that the requirement for ``originally signed'' test
reports to accompany shipments of raw materials and finished fasteners
will be a significant burden to them.
In the case of raw material suppliers, the raw material purchased
by the fastener manufacturer typically goes through as many as four
processors, each performing a different operation that does not affect
the steel's chemical characteristics. In addition, distributors may be
involved in these transactions. Under one scenario, the following
successive processors/distributors transform the ingot/bloom to
fasteners:
Steel mill or melter or ingot producer irod produceri wire or rod
produceri distributori fastener producer
Current industry practice is that the steel mill is the primary
source at which the chemical characteristic certification is produced
and passed down to the first processor or distributor to whom it sells
the steel. All other subsequent processors, distributors and fastener
manufacturers in the above mentioned chain, produce their own
certification based on the results contained in the original chemical
certificate of the steel mill. This certificate consists of relevant
information such as the name of steel melter, steel mill
identification, heat number, and chemical analysis data. Therefore,
current industry practice is for everyone in the chain except the
original steel melter to reference the original chemical certification
data instead of passing on a certified copy of the chemical
characteristics certificate down the chain to the fastener
manufacturer. The primary reason for this practice is that from a
single heat number of steel, thousands of lots of fasteners can be
manufactured by an unknown number of fastener manufacturers. Moreover,
the steel mill would not know in advance the name of fastener
manufacturers who would purchase steel from a given heat number or the
number of certificates required from a heat number of the steel.
To comply with the Act and current regulations, either copies of
the laboratory report of chemical characteristics, certified by the
laboratory, must be passed down the supply chain ``through the metal
manufacturer'' or the fastener manufacturer must be responsible for
contacting the laboratory that performed the chemical tests to obtain a
certified copy directly. Since the metal manufacturers do not know how
many fastener manufacturers will acquire part of a particular heat or
coil, they do not know how many certified copies to request from the
laboratory at the time they obtain the original test report. The
fastener manufacturers feel it is burdensome for them to obtain
certified copies from the laboratories, and it is extremely burdensome
for the laboratories to have to retrieve reports and create certified
copies whenever requested by fastener manufacturers.
A solution that works for both fasteners of foreign origin and
domestically-produced fasteners is to allow copies of laboratory
testing reports of chemical characteristics only to be certified by
either the laboratory or the metal manufacturer. The definition of
``original laboratory testing report'' in section 280.2 is proposed to
be amended to allow metal manufacturers, as well as laboratories, to
certify copies of laboratory testing reports of chemical
characteristics.
4. Laboratory Test Reports
Several steel producers raised another issue with respect to the
chemistry certificate during the workshops. It deals with a discrepancy
in the language used in reporting of alternative chemical
characteristics, as follows:
1. Section 5(d)(3)of the Act requires reporting the, ``chemical
characteristics of such coil or heat number;''
2. Section 280.6(b)(5)(ii) of the regulations requires, ``test
results for each sample;'' and
3. Section 280.15(b) returns to the requirement for reporting,
``chemical characteristics of such coil or heat number.''
The chemical characteristics data required to be reported in
section 280.6(b)(5)(ii) is not the same as the other two sections
mentioned above. Currently, steel manufacturers use test reporting
methods that conform to section 5(d) of the Act, and section 280.15 of
the regulations. The reporting of the ``heat number analysis'' is well
defined in existing steel making practices and consensus standards. A
``heat number analysis'' consists of derived values for each element
from one or more samples taken from either molten metal or solid steel.
Overall, this method best describes the chemical characteristics of the
steel.
If section 280.6(b)(5)(ii) is not changed to make it in agreement
with other sections of the Act and regulations, several problems may
occur:
1. Steel suppliers will be forced to use their best judgement in
interpreting the Act, and proper methods of reporting of chemical
analysis;
2. Variations in interpretations will lead to serious disputes
between steel suppliers and their customers; and
3. Steel suppliers will be forced to change reporting methods to
those described in section 280.6(b)(5)(ii), which will result in
unnecessary costs to the industry.
Accordingly, the Department is proposing for public comment an
amendment to section 280.6(b), which is proposed to be redesignated as
section 280.6(c), which requires the reporting of test results for such
coil or heat number chemical analysis.
5. New Definition of ``Lot Number''
It was pointed out during the workshops that ``lot number'' as
defined in section 280.2 of the definitions means a number assigned to
the lot by a manufacturer, and that it is fairly common for
distributors and importers to assign their own unique lot number to
fasteners in addition to the number assigned by the manufacturer.
Further, section 280.11 of the regulations dealing with significant
alterations requires that significant alterors assign their lot numbers
to significantly altered fasteners. Accordingly, the Department is
proposing to amend the definition of lot number found in section 280.2
to include a number assigned by a manufacturer, importer, distributor,
or significant alterer to the lot. The amendment further stipulates
that a lot number assigned by an importer, distributor, or significant
alterer shall be traceable to a manufacturer's single, unique lot
number.
6. Grandfathered Fasteners Issue
Section 15 of the Act provides that the Act is applicable only to
fasteners manufactured after the implementation date of the Act.
Section 280.12(c) of the
[[Page 47244]]
regulations further states that nothing in the Act or in the
regulations prohibits selling finished fasteners manufactured prior to
the implementation date of the Act, or representing that such fasteners
meet standards and specifications of a consensus standards organization
or a government agency. Additionally, this section of the regulations
states that fasteners manufactured prior to the implementation date of
the Act may not be represented as being in conformance with the Act or
the regulations.
It is clear that Congress, in enacting section 15 of the Act,
intended only to cover those fasteners produced after the
implementation date of the Act so as not to impose a hardship on the
industry by having existing product retested and certified. However,
representatives of the fastener industry met in January 1997 with
representatives of NIST and proposed that section 280.12(c) of the
regulations be amended by moving the last sentence of the section,
which states that fasteners manufactured prior to the implementation
date of the Act may not be represented as being in conformance with the
Act or the regulations, to section 280.602, Violations. This sentence
is moved to the violations section because as a prohibition on certain
specific conduct, it more appropriately belongs there.
Request for Public Comment: Persons interested in commenting on the
proposed regulations should submit their comments in writing to the
above address. All comments received in response to this notice will
become part of the public record and will be available for inspection
and copying at the Department of Commerce Central Reference and Records
Inspection facility, room 6228, Hoover Building, Washington, DC 20230.
Additional Information
Executive Order 12866
This rule has been determined not to be significant under section
3(f) of Executive Order 12866.
Executive Order 12612
This rule does not contain policies with Federalism implications
sufficient to warrant preparation of a Federalism assessment under
Executive Order 12612.
Regulatory Flexibility Act
Regulatory Flexibility Analysis of Procedures for Implementation of the
Fastener Quality Act
This proposed rule has been determined to be not significant for
the purposes of E.O. 12866.
The Assistant General Counsel for Legislation and Regulation of the
Department of Commerce certified to the Chief Counsel for Advocacy, the
Small Business Administration that this proposed rule, if adopted,
would not have a significant economic impact on a substantial number of
small entities as follows:
The proposed rule includes changes that allow accreditation of in-
process inspection activities of qualifying statistical process control
(SPC) manufacturing facilities, address the issue of passing laboratory
inspection and testing reports along the supply chain to the fastener
manufacturer, address the issue of significant alteration by removal of
manufacturer or grade identification markings for decorative purposes
at the customer's request, address the issue of grandfathering
fasteners, and revise definitions and related sections for clarity and
to correct editorial error. The proposed changes will facilitate the
implementation of the Fastener Quality Act (FQA) and regulations and
will better accommodate modern industry practices by incorporating them
into the FQA certification process. However, of all these proposed
changes, the major change covered here is that which allows
accreditation of in-process inspection activities of qualifying
statistical process control manufacturing facilities. The remaining
changes are relevant to the existing regulations that became effective
on November 25, 1996, and their impact on the fastener industry already
has been presented. Therefore, in this analysis, the issues relevant to
manufacturing of fasteners using only SPC or quality assurance systems
(QAS) are covered.
As presently constructed, the FQA and implementing regulations,
rely on the use of accredited laboratories for inspection, testing, and
certification of fasteners to applicable standards and specifications.
Sections 5 of the Act and 280.5 of the regulations are very specific
that a manufacturer of a lot of fasteners shall cause to be inspected
and tested a representative sample of the fasteners in the lot by an
accredited laboratory, and a test report must be produced which
indicates that the fasteners tested are in conformance with all of the
provisions of the standards and specifications used by the manufacturer
in the production of fasteners. The end result, and the cornerstone on
which the law is based, is that every lot of fasteners is certified by
the manufacturer as conforming to a given standard and specification,
and the paperwork relating to such certification (e.g., a certificate
of conformance and test reports) is maintained on file and available at
the purchaser's request.
In the case of fastener manufacturers supplying the automobile
industry, the industry has established QS-9000 as a means of achieving
the same end. That is, they qualify their suppliers by requiring them
to: (1) Establish a control plan under which they will produce
fasteners to their standards and specifications; (2) submit evidence in
the form of production data that they can produce fasteners under a
specified defect rate; and (3) perform continuous monitoring and tests
of the production process to maintain control of the process and to
assure that the final product will be in conformance with fastener
standards and specifications. The difference between the regulation as
it exists and the QS-9000 approach is that the regulation assures end
users that fasteners meet standards and specifications by relying upon
the inspection and testing of fasteners by accredited laboratories.
Under QS-9000, the end users (Ford, GM, and Chrysler) recognize the
fastener manufacturer's entire production process as a means of
assuring conformance to their standards and specifications. The end
result, that of assuring adherence to standards and specifications, is
the same under the QS-9000 approach as with end product testing.
However, the automobile industry believes that reliance on QS-9000,
which is based upon continuous monitoring and improvement of the
manufacturing process, is more efficient and cost effective than
traditional manufacturing regimens of final inspection and testing of
the end product, and represents the direction in which manufacturing
technology is evolving in this country and abroad.
To the extent the FQA permits flexibility in developing these draft
regulations, the Department has sought advice from the fastener and
end-user industries (automotive, aerospace, etc.) to maximize the cost-
effectiveness of the proposed rule. Those recommendations presented by
the industry at the February 4, 1997 meeting and at site visits to
industry have been incorporated in this proposed rule to assist
industry in implementing this rule, if accepted, in a cost-effective
manner.
It is difficult to estimate the total number of fastener
manufacturers in the U.S. because there are too many that do not belong
to any professional organization and operate very small shops. Some
estimate this number to be in excess of one thousand. However, based on
an estimate from the Industrial Fastener Institute, 80% of the U.S.
fastener production capacity is served
[[Page 47245]]
by approximately 120 major manufacturers. Of these, nearly 50%, or 60
manufacturers, supplying fasteners to the auto and aerospace industries
could be using the QAS included in this rule. A large majority of these
60 manufacturers could be classified as small businesses employing less
than 750 employees (as defined at 13 CFR 121.201).
We believe the overall effect on the fastener industry of
adopting this proposed rule will be highly beneficial. No negative
effects are envisioned at this time. In fact, as we look into the
future, we believe market forces (improved quality and decreased
cost) will push the remaining manufacturers not currently using QAS
to adopt the QAS standards. This proposed rule, if adopted, would
allow these manufacturers to do so without incurring additional
costs to comply with the FQA. We believe this proposed rule, if
adopted, would benefit the industry in, at least, the following
ways:
1. Ability to use modern manufacturing technology to conform
with the law without a need to make any changes;
2. Ability to use just-in-time delivery and other advancements
to avoid production delays and reduce inventory costs; and
3. Overall improvement in the fastener quality at a lower
production cost.
Registration cost per facility will vary with scope (the number
of procedures and products, the number of sampling locations, etc.)
as in the case of laboratory accreditation. Based on the laboratory
accreditation carried out by NVLAP during the past nine months, we
estimate the annual cost of registration will run between $5,000 and
$15,000 per facility which is the same as the cost of laboratory
accreditation. Since most facilities are likely to adopt one of the
approaches, this will not be an additional cost. Moreover, most
facilities seeking registration have already obtained registration
under either ISO-9000 or QS-9000. Therefore, additional cost savings
may result because fastener manufacturers do not have to spend
resources solely for conforming with the FQA.
It is not expected that any manufacturing facility practicing
QAS will cease to operate; suffer a significant loss in gross
revenue; or have increased compliance costs because of this proposed
rule, if adopted.
We seek public comment providing data on impact for use in
determining the appropriateness of this certification for purposes
of a final rule. Moreover, within one to two years of the initial
implementation period, if adopted, we should have sufficient data to
assess impact for purposes of determining the necessity for review
under 5 U.S.C. Sec. 610(c).
The requirements for laboratory accreditation and registration
of manufacturing facilities under this rule are in accordance with
the established international standards, thus promoting uniformity
in the evaluation process. The rule allows the fastener manufacturer
and testing laboratories to decide which approach to choose for
seeking accreditation.
This rule contains a collection-of-information requirement
subject to the Paperwork Reduction Act. However, that requirement
involves paperwork already being produced by fastener manufacturers.
The only additional requirement is to prepare a synopsis of the
testing and inspection results in the form of a test report. This
requirement is proposed to facilitate enforcement actions of the
Bureau Of Export Administration (BXA), which has the enforcement
authority granted under the Fastener Quality Act.
As a result, no initial regulatory flexibility analysis has been
prepared.
Paperwork Reduction Act
Notwithstanding any other provision of the Act, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with a collection-of-information, subject to the
requirements of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.,
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) control number.
This proposed rule revises an existing collection of information
subject to the requirements of the Paperwork Reduction Act that was
previously approved by the Office of Management and Budget under the
control number 0693-0015. The revision is applicable to persons
requiring approval of the Accreditation Body Evaluation Program (ABEP)
at NIST to register quality system registrars who would in turn
register fastener manufacturing facilities.
The collection of information requirement is applicable to persons
requiring approval of the Accreditation Body Evaluation Program (ABEP)
at NIST to accredit quality system registrars who would register
fastener manufacturing facilities. The public reporting burden per
respondent for the collection of information contained in this rule is
estimated to average 4 hours annually. This estimate includes the time
for reviewing instructions, searching existing information, gathering
and maintaining the information needed, and completing and reviewing
the collection of information.
Comments are requested concerning: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of NIST's burden estimate; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on the respondents, including the use of automated
collection techniques or other forms of information technology.
Comments should be addressed to the Office of Information and
Regulatory Affairs, Office of Management and Budget, Washington, D.C.
20503; and to NIST (Attn.: ABEP Program Manager, NIST, Building 820,
Room 306, National Institute of Standards and Technology, Gaithersburg,
MD 20899).
National Environmental Policy Act
This rule will not significantly affect the quality of the human
environment. Therefore, an environmental assessment or Environmental
Impact Statement is not required to be prepared under the National
Environmental Policy Act of 1969.
List of Subjects in 15 CFR Part 280
Business and industry, Fastener industry, Imports.
Dated: August 13, 1997.
Robert E. Hebner,
Acting Director, National Institute of Standards and Technology.
Dated: August 21, 1997.
William A. Reinsch,
Under Secretary for Export Adminstration.
For reasons set forth in the preamble, it is proposed that Title 15
of the Code of Federal Regulations be amended as follows:
PART 280--FASTENER QUALITY
1. The authority for part 280 continues to read as follows:
Authority: Section 13 of the Fastener Quality Act (Pub.L. 101-
592, as amended by Pub.L. 104-113).
2. Section 280.1 is amended by adding paragraph (d) to read as
follows:
Sec. 280.1 Purpose/description of rule.
* * * * *
(d) Delegations of authority. The Secretary of Commerce has
delegated authority to the Director, National Institute of Standards
and Technology to promulgate regulations in this part under sections 5
through 8 of the Fastener Quality Act (15 U.S.C. 5404-5407). In
addition, the Secretary of Commerce has delegated concurrent authority
to the Under Secretary for Export Administration to amend the
regulations issued under sections 5 through 7 of the Act, regarding
enforcement. The Secretary of Commerce had also delegated concurrent
authority to amend the regulations issued under section 8 of the Act,
regarding recordal of insignias, to the Assistant Secretary and
[[Page 47246]]
Commissioner of Patents and Trademarks.
3. Section 280.2 is amended by revising the definitions for
accreditation, lot number, original laboratory testing report, and
significantly alter and adding the remaining definitions as set forth
below:
Sec. 280.2 Definitions.
* * * * *
Accreditation for purposes of the Act and this part means
accreditation of a testing laboratory or the registration of a fastener
manufacturing facility employing a quality assurance system (a
Facility).
* * * * *
Accreditor means a registrar accreditation body that meets the
requirements of subpart K of this part, is recognized by NIST, and
appears on the Accreditors List described in Sec. 280.810(a).
* * * * *
Facility means a fastener manufacturing facility implementing a
quality assurance system as defined in this part, that has been
registered by a Registrar and appears on the Facilities List described
in Sec. 280.810(c).
* * * * *
Fastener Quality Assurance System (QAS). (1) Fastener Quality
Assurance System (QAS) means a fastener manufacturing system that has
as a stated goal the prevention of defects through continuous
improvement, and which seeks to attain that goal by incorporating:
(i) Advanced quality planning;
(ii) Monitoring and control of the manufacturing process;
(iii) Process inspection embodied in a comprehensive and written
control plan for product/process characteristics, process controls
(including statistical process control), tests, and measurement systems
that will occur during mass production; and
(iv) The creation, maintenance, and retention of electronic,
photographic, or paper records, available for inspection during the
periods required by section 10 of the Act and Sec. 280.7 of this part,
regarding the inspections, tests, and measurements required by or
performed pursuant to the control plan.
(2) A Fastener Quality Assurance System contains the following
elements at a minimum:
(i) A documented quality management system that satisfies the
requirements of ISO-9001 ``Quality Systems--Model for quality assurance
in design, development, production, installation and servicing,'' ISO-
9002 ``Quality Systems--Model for quality assurance in production,
installation and servicing,'' or other quality system standards that
incorporate ISO-9001 or ISO-9002 (e.g. QS-9000, ARD-9000, etc.);
(ii) A requirement that raw material certification supplied to the
fastener manufacturer shall be traceable to that of a mill heat of
material that has been tested by a laboratory on the Accredited
Laboratory List;
(iii) A requirement that subcontracted processes, including plating
and heat treating, are controlled by the manufacturer, and performed by
a Facility on the Facilities List described in Sec. 280.810 or tested
by a Laboratory on the Laboratories List described in Sec. 280.101, to
avoid product lot contamination, and that finished lots of fasteners
shall be traceable to subcontracted processes;
(iv) A QAS plan, requiring that the fastener manufacturer fully
document fastener sampling and inspection points and an in-process
control plan that emphasizes defect prevention, relates frequency of
inspection, corrective action for nonconforming characteristics, and
sampling frequency and sample size; a requirement that the control plan
be made available to the customer upon request and shall identify those
standards and specifications upon which the plan is based; and
(v) A requirement that the in-process control plan include those
characteristics specified by the QAS standard, characteristics
specifically indicated by applicable fastener standards or
specifications (consensus or major end-user standards as defined by the
Act and this part), or those characteristics appropriate for evaluating
product functionality.
* * * * *
Lot number means a number assigned by a manufacturer, importer,
distributor, or significant alterer to the lot. A lot number assigned
by an importer, distributor, or significant alterer shall be traceable
to a manufacturer's single, unique lot number.
* * * * *
Original laboratory testing report means:
(1) In general, a laboratory testing report which is originally
signed by an approved signatory or is a copy thereof, certified by the
laboratory that conducted the test; or
(2) For purposes of the alternative procedures for chemical
characteristics described in section 5(d) of the Act and Sec. 280.15 of
this part only, a laboratory testing report which is originally signed
by an approved signatory or is a copy thereof, certified by the
laboratory that conducted the test or by the metal manufacturer.
* * * * *
Registrar means a quality systems registrar that meets the
requirements of subpart L of this part, is accredited by an Accreditor
as defined in this part, and appears on the Registrars List described
in Sec. 280.810(b).
* * * * *
Registration means evaluation and certification of a manufacturing
facility as competent to carry out and conforming to the applicable
requirements of a Fastener Quality Assurance System when such
evaluation and certification is performed by a Registrar as defined in
this part.
* * * * *
Significantly alter means to alter or take any other action which
could weaken or otherwise materially affect the performance or
capabilities of the fastener as it was originally manufactured, grade
or property class marked, tested, or represented. The term does not
include the application of adhesives or sealants, locking elements,
provisions for lock wires, coatings and platings of parts having a
minimum specified Rockwell C hardness of less than 32, or cutting off
of fasteners. The cutting of finished threaded rods, bars or studs to
produce individual smaller length threaded studs for resale is not a
significant alteration. However, cut threaded studs, rods, and bars
offered for sale shall be individually marked with the grade or
property class identification marking appearing on or accompanying the
original threaded studs, rods, and bars from which the fasteners were
cut.
* * * * *
4. Section 280.6 is amended by redesignating paragraphs (b) and (c)
as paragraphs (c) and (d) respectively, adding new paragraphs (b) and
(e), and revising redesignated paragraph (c)(5)(ii) to read as follows:
Sec. 280.6 Laboratory Test Reports.
* * * * *
(b) When performing tests for which they are registered under this
part, each facility registered under Subpart I or J of these
regulations and currently listed in the Facilities List shall issue
test reports of its work which accurately, clearly, and unambiguously
present a synopsis of test results, and all information required by
this section. In addition, the facilities shall attach reports of
chemical characteristics and any report of the tests conducted in a
laboratory under the accredited laboratories list. All
[[Page 47247]]
reports must be in English or be translated into English, must be
signed by an approved signatory, must be protected by a tamper
resistant system, and contain the following information:
(1) Name and address of the facility;
(2) Unique identification of the test report including date of
issue and serial number, or other appropriate means;
(3) Name and address of client, if applicable;
(4) Fastener Description, including:
(i) Manufacturer (name and address);
(ii) Product family (screw, nut, bolt, washer, or stud), drive and/
or head configurations as applicable;
(iii)Date of manufacture;
(iv) Head markings (describe or draw manufacturer's recorded
insignia and grade identification or property class symbols);
(v) Nominal dimensions (diameter; length of bolt, screw or stud;
thickness of load bearing washer); thread form and class of fit;
(vi) Product standards and specifications, if any, related to the
facility in writing by the manufacturer, importer or distributor;
(vii) Lot number;
(viii) Specification and grade of material;
(ix) Coating material and standard and specification as applicable;
(5) Sampling information:
(i) Standards and specifications or reference for sampling scheme;
(ii) Production lot size and the number sampled;
(iii) Name(s) and affiliation of person performing the lot
sampling;
(6) Test Results:
(i) Actual tests required by the standard and specification;
(ii) Test results;
(iii) All deviations from the test method;
(iv) All other items required on test reports according to the test
method;
(v) Where the report contains results of tests performed by sub-
contractors, these results shall be clearly identified along with the
name of the laboratory/facility and accreditation/registration
information listed in paragraph (b)(10) of this section.
(vi) A statement that the samples tested either conform or do not
conform to the fastener standards and specifications or standards and
identification of any nonconformance;
(7) A statement that the report must not be reproduced except in
full;
(8) A statement to the effect that the test report relates only to
the item(s) tested;
(9) Name, title and signature of approved signatory accepting
technical responsibility for the tests and test report;
(10) The name of the registrar which registered the facility, and
code number assigned to the facility by the registrar, and the
expiration of registration.
(c) * * *
(5) * * *
(ii) Test results for such coil or heat number chemical
characteristics;
* * * * *
(e) For tests carried out by a Facility registered pursuant to
subpart I or J, the facility shall maintain laboratory test reports in
the forms of electronic, photographic, or paper records, available for
inspection during the periods required by section 10 of the Act and
Sec. 280.7, regarding the inspections, tests, and measurements required
or performed pursuant to the QAS control plan.
5. Section 280.7 is amended by revising paragraph (a)to read as
follows:
Sec. 280.7 Recordkeeping Requirements.
(a) Each laboratory accredited under subparts C, D, or E or
Sec. 280.104 of this part shall retain for 5 years after the
performance of a test all records pertaining to that test concerning
the inspection and testing, and certification, of fasteners under the
Act and this part. The final test report or the test records maintained
by the laboratory shall contain sufficient information to permit the
test to be repeated at a later time if a retest is necessary. The
laboratory shall maintain the test report and a record of all original
observations, calculations, and derived data. The records shall include
the identity of personnel involved in sample preparation and testing.
Procedures for storage and retrieval of records must be documented and
maintained in the laboratory's quality manual.
* * * * *
6. Section 280.10 is revised to read as follows:
Sec. 280.10 Sampling.
In the event that the standard or specification to which a
manufacturer represents the fasteners in a particular sample to have
been manufactured does not provide for the size, selection or integrity
of the sample to be inspected and tested, inspections and tests under
section 5 of the Act shall be carried out using ASME/ANSI B18.18.2M,
Inspection and Quality Assurance For High-Volume Machine Assembly
Fasteners; ASME/ANSI B18.18.3M, Inspection and Quality Assurance for
Special Purpose Fasteners; or ASME/ANSI B18.18.4M, Inspection and
Quality Assurance for Highly Specialized Engineering Applications--
Fasteners, or a sampling plan provided by a Fastener Quality Assurance
System or by standards and specifications intended for use with a
Fastener Quality Assurance System, as appropriate.
7. Section 280.11 is amended by redesignating paragraphs (c) and
(d) as paragraphs (d) and (e) respectively, adding new paragraph (c),
and revising paragraph (b) and redesignated paragraph (d) to read as
follows:
Sec. 280.11 Significant Alterations of Fasteners.
* * * * *
(b) If the significant alteration is only electroplating of
fasteners having a minimum specified Rockwell C hardness of 32 or
above, the requirements set forth in paragraphs (a)(2) and (a)(3) of
this section shall not apply, but the alterer shall assign a new lot
number as set forth in paragraph (a)(1) of this section and shall test
the electroplated fasteners as required by the plating standards and
specifications.
(c) If the significant alteration is only the removal of
manufacturer or grade identification markings for decorative purposes
at the customer's request, the requirements set forth in paragraph
(a)(2) of this section shall not apply, but the alterer shall assign a
new lot number as set forth in paragraph (a)(1) of this section and
shall either test the fasteners or provide a written statement
disclosing the alteration as set forth in paragraph (a)(3) of this
section. Along with such an order the fastener manufacturer must
require a written certification from the customer stating that
fasteners from the altered lot will not be held or sold as meeting the
requirements of a consensus standard which requires manufacturer or
grade identification markings.
(d) Any person who knowingly sells a significantly altered fastener
as described in paragraph (a) of this section, and who did not alter
such fastener, shall provide to the purchaser a copy of the statement
required by paragraph (a)(3) of this section; unless the significant
alteration is only electroplating of the fastener, as described in
paragraph (b) of this section or removal of manufacturer or grade
identification markings, as described in paragraph (c) of this section.
* * * * *
8. Section 280.12 is revised to read as follows:
Sec. 280.12 Applicability.
(a) The requirements of the Fastener Quality Act and this part
shall be applicable only to fasteners manufactured on or after May 26,
1998.
(b) Metal manufactured prior to May 26, 1998 may not be used to
[[Page 47248]]
manufacture fasteners subject to the Act and this part unless the metal
has been tested for chemistry pursuant to Sec. 280.15 of this part by a
laboratory accredited under the Act and this part and the chemical
characteristics of the metal conform to those required by the standards
and specifications.
(c) Nothing in the Act and this part prohibits selling finished
fasteners manufactured prior to May 26, 1998 or representing that such
fasteners meet standards and specifications of a consensus standards
organization or a government agency.
9. Section 280.104 is added to subpart B to read as follows:
Sec. 280.104 Accreditation of Certain Manufacturing Facilities as
Laboratories
(a) Subject to the limitations contained in paragraphs (b), (c),
and (d) of this section, registration of a fastener manufacturing
facility employing a fastener quality assurance system shall be deemed
to meet the requirements of accreditation of a laboratory for purposes
of the Act and this part. The independent third-party registrar
registering such facility under this section shall comply with all
procedures set forth in subparts I through L of this part. Records
documenting the inspection and testing of a lot of fasteners performed
by such an accredited laboratory shall be maintained by the facility in
accordance with the requirements of Secs. 280.6 and 280.7.
(b) In any instance where a Facility accomplishes any in-process
inspection and testing by performing laboratory tests on a sample of
fasteners at any stage in the manufacturing process, those tests must
be conducted by a laboratory on the Accredited Laboratory List. Such a
laboratory may be located on the same premises as a fastener
manufacturing facility if the laboratory is separately accredited
pursuant to a provision of this part other than Sec. 280.104(a).
(c) Any laboratory tests performed outside the Facility's in-
process inspection and testing must be conducted by a laboratory on the
Accredited Laboratory List.
(d) Chemical testing and raw material testing must be performed by
a laboratory on the Accredited Laboratory List.
10. Section 280.602 is amended by revising paragraphs (e)(2), (h),
and (j) and adding paragraphs (k), (l), (m), and (n) to read as
follows:
Sec. 280.602 Violations.
* * * * *
(e) Misrepresentation and concealment of facts * * *
(2) In connection with the preparation, submission, use,
maintenance of a laboratory test report, certificate of conformance as
described in Secs. 280.5 and 280.6 of this part or any quality
assurance system document required by this part or;
* * * * *
(h) Falsification of Documents Relating to Accreditation of
Laboratories or Registrars or Approval or Recognition of Accreditors or
Accreditation Bodies. No person shall falsify or make any false or
misleading statement on or in connection with any document relating to
laboratory accreditation or approval or recognition of accreditation
bodies, Accreditors or Registrars as required by section 6(a) or 6(b)
of the Act or this part.
* * * * *
(j) Falsification of Laboratory Accreditation, Accreditation Body
or Accreditor. No person shall falsely claim to be an accredited
laboratory or approved or recognized accreditation body or Accreditor
as described in section 6 of the Act or subparts B, C, D, E, I and J of
this part.
(k) Sale of fasteners manufactured prior to the implementation date
as compliant with the Act. No person shall represent, sell, or offer
for sale fasteners manufactured prior to May 26, 1998 as being in
conformance with the Act or this part.
(l) Failure to Assign lot number traceable to Manufacturer's
single, unique lot number: No importer, distributor, or significant
alterer shall assign a lot number unless the assigned lot number is
traceable to a manufacturer's single, unique lot number.
(m) Falsification of Documents relating to the registration of
Fastener Manufacturing Facilities as accredited laboratories,
accreditation of Registrars or recognition of Accreditors. No person
shall falsify or make any false or misleading statement on or in
connection with any document relating to the registration of Fastener
Manufacturing Facilities as accredited laboratories, accreditation of
Registrars or recognition of Accreditors as required by Subparts I, J,
K, and L of this part.
(n) False claim of registration of Fastener Manufacturing
Facilities as accredited laboratories, accreditation of Registrars, and
recognition of Accreditors. No person shall falsely claim to be a
registered Fastener Manufacturing Facility, an accredited Registrar, or
a recognized Accreditor as described by Subparts I, J, K, and L of this
part.
11. Subparts I through L are added to read as follows:
Subpart I--Special Rule for the Accreditation of Certain Fastener
Manufacturing Facilities, Whose Implemented Fastener Quality
Assurance Systems Meet Defined Requirements, as Laboratories
Sec.
280.800 Introduction.
280.801 Application.
280.802 Review and decision process.
280.803 Criteria for recognition.
280.804 Maintaining recognized status.
280.805 Voluntary termination of recognition.
280.806 Involuntary termination of recognition by NIST.
280.807 Subcontracting.
280.808 Reports.
280.809 Recordkeeping.
280.810 Listing of recognized accreditors, accredited registrars,
and registered facilities.
280.811 Removal from a list.
280.812 Appeal.
Sec. 280.800 Introduction.
(a) This special rule applies to those fastener manufacturers,
employing a fastener quality assurance system (QAS) as defined in this
part, who wish to seek accreditation of the particular manufacturing
facility employing the QAS as a laboratory within the meaning of the
Act. This rule consists of this subpart, and subparts J, K, and L. The
rule adopts the view that a fastener manufacturing facility is deemed
to be an accredited laboratory for purposes of the Act and this part if
such facility employs a fastener quality assurance system (QAS) that
has been formally registered by a NIST-recognized quality systems
registrar. The rule applies only to facilities manufacturing fasteners;
raw materials for fastener manufacture must be tested and certified by
a laboratory listed on the Accredited Laboratory List. This subpart
sets out the full process that NIST requires for the accreditation of a
fastener manufacturing facility employing a QAS in the United States: a
fastener manufacturing facility employing a QAS (a ``Facility'') will
be deemed to be an accredited laboratory if it is registered by a
Quality Systems Registrar (a ``Registrar'') that in turn has been
accredited by a Registrar Accreditation Body (an ``Accreditor'') that
has been recognized by NIST. Subpart J provides for foreign Accreditors
to be recognized and to recognize Registrars under the same procedures.
(b) A chain is thus established to assure the proper regulation of
[[Page 47249]]
Facilities: NIST recognizes Accreditors that meet the requirements of
subpart K, which is based upon ISO Guide 61; the NIST-recognized
Accreditors may, in turn, accredit Registrars that meet the
requirements of Subpart L, which is based upon ISO Guide 62. The
Registrars, in turn, may register Facilities that satisfy the elements
of a fastener quality assurance system (QAS), as defined in this part.
(c) Within this subpart, Secs. 280.801 through 280.809 contain the
procedures that NIST uses to process requests from Accreditors for
recognition by NIST. Section 280.810 establishes three lists that NIST
will maintain: Sec. 280.810(a) provides for a list of Accreditors that
have been recognized by NIST; Sec. 280.810(b) provides for a list of
Registrars that have been accredited by Accreditors listed according to
Sec. 280.810(a); and Sec. 280.810(c) provides for a list of Facilities
that have been registered by Registrars listed according to
Sec. 280.810(b). The remainder of this subpart, Secs. 280.811 and
280.812, contain procedural provisions related to the lists established
by Sec. 280.810.
Sec. 280.801 Application.
(a) Application must be made by Accreditors to NIST for recognition
to accredit Registrars under the Act. Upon request, NIST will provide
application forms and instructions. The applicant shall complete the
application in English and may provide whatever additional enclosures,
attachments or exhibits the applicant deems appropriate.
(b) Application packages may be obtained from: Manager, FQA
Accreditation Body Evaluation Program, NIST, Bldg. 820, Room 282,
Gaithersburg, Maryland, 20899. Requests may be made by mail or by FAX
to: (301) 963-2871.
(c) The applicant shall reimburse NIST for all costs incurred in
the evaluation of its accreditation program and subsequent costs
incurred in ensuring the continued compliance of its program.
Reimbursement shall be in accordance with the fee schedule established
by NIST for this purpose.
(d) An application may be revised by an applicant at any time prior
to the final decision by NIST. An application may be withdrawn by an
applicant, without prejudice, at any time prior to the final decision
by NIST.
Sec. 280.802 Review and decision process.
(a) Applications submitted by Accreditors will be accepted by NIST
and their receipt acknowledged in writing. The applications will be
reviewed by NIST against the criteria specified in this subpart and in
subpart K of this part. NIST may request additional information as
needed from the applicant.
(b) NIST shall conduct on-site assessments of the facilities of the
applicant including all of the applicant's organizational units and
locations covered by the application.
(c) If the applicant's program is deemed by NIST to have met the
requirements for recognition, the applicant shall be notified by NIST
in writing. The recognition notice shall include the date when the
recognition begins and the scope of the recognition. The recognition
period shall be for as long as the Accreditor continues to satisfy the
requirements of Sec. 280.803. As part of maintaining its approved
status, each Accreditor shall agree to be reassessed by NIST every two
years following its initial notice of recognition. NIST will maintain
and make available to the public a list of recognized Accreditors.
(d) If the applicant does not meet the requirements for
recognition, the applicant shall be notified in writing, listing the
specific requirements from this subpart and subpart K of this part
which the applicant's program has not met. After receipt of such a
notification, and within the response period provided by NIST, the
applicant may:
(1) Submit additional information for further review. Reviewing the
new submission may involve additional on-site visits by NIST personnel.
Additional fees may be required. Or,
(2) Submit a request that the original application be reconsidered,
including a statement of reasons why the applicant should have been
recognized.
Sec. 280.803 Criteria for recognition.
An applicant for NIST recognition must demonstrate the ability to
operate a registrar accreditation program consistent with the
requirements of this subpart and subparts A and K of this part, and
accredit registrars of Facilities to requirements set out in subpart L
of this part.
Sec. 280.804 Maintaining recognized status.
(a) Accreditors shall continue to satisfy all the requirements of
recognition during the recognition period.
(b) Upon request, recognized Accreditors shall make available to
NIST and/or BXA all records and materials pertaining to the program.
(c) NIST has the right to participate as an observer during any on-
site visit to a Registrar being audited by a NIST-recognized
Accreditor, or a Facility being audited by an accredited Registrar, or
it may perform its own surveillance visit of such bodies at its
discretion.
(d) Neither the Accreditor, nor any Registrar it accredits, nor any
Facility registered under the Act and this part shall take any action
which states or implies the approval, or endorsement by NIST or any
other agency of the U.S. Federal Government of any product or report
pertaining to a product associated with any activities carried out
under the recognition. None of these entities may take any action which
states or implies that they are recognized or authorized by NIST to act
or perform in any area(s) beyond that which was specified in their
recognition under this part.
Sec. 280.805 Voluntary termination of recognition.
An Accreditor may voluntarily terminate its recognition by giving
written notice to NIST and to all Registrars accredited by that body
under its accreditation program. The written notice shall state the
date on which the termination will take effect.
Sec. 280.806 Involuntary termination of recognition by NIST.
(a) NIST may terminate or suspend its recognition of an Accreditor
if such an action is deemed to be in the public interest.
(b) Before terminating the recognition of an Accreditor, NIST will
notify the Accreditor in writing, giving it the opportunity to rebut or
correct the stated reasons for the proposed termination. If the
problems are not corrected or reconciled within 30 days, or such longer
time as NIST in its sole discretion may grant, the termination shall
become effective.
(c) An Accreditor may appeal a termination to the Director by
submitting a statement of reasons why the recognition should not be
terminated. NIST may, at its discretion, hold in abeyance the
termination action pending a final decision by the Director. Within 60
days following receipt of the appeal, the Director shall inform the
Accreditor in writing of his or her decision.
(d) Registrars and registered organizations which have been listed
by NIST in accordance with this subpart, based on their accreditation
by an Accreditor whose recognition has been terminated, shall be
removed from the list, unless an exception is granted by NIST.
Sec. 280.807 Subcontracting.
If a recognized Accreditor, an accredited Registrar, or a
registered Facility subcontracts any of its functions
[[Page 47250]]
to another entity it must place the work with another recognized
Accreditor, accredited Registrar, or registered Facility; inform the
client, before the fact, that subcontracting will be necessary, and
clearly indicate in all appropriate records, and reports to the client,
specifically what functions were subcontracted.
Sec. 280.808 Reports.
Reports and records shall be maintained in such a manner to
preserve original data, and be collected as required into a final form,
sufficient to satisfy customer and legal requirements. Such reports
shall be provided upon request to the Bureau of Export Administration,
to the National Institute of Standards and Technology, or to any other
agency of the federal government authorized to obtain such records
under this part.
Sec. 280.809 Recordkeeping.
Each recognized Accreditor, accredited Registrar, or fastener
manufacturer whose Facility has been registered shall retain all
applicable records required under the Act and this part for 5 years.
All records are subject to the requirements in Sec. 280.7 of this part.
Sec. 280.810 Listing of recognized accreditors, accredited registrars,
and registered facilities.
(a) List of Accreditors. NIST shall prepare and maintain a list of
Accreditors recognized under this subpart and subpart J.
(b) List of Registrars. NIST shall prepare and maintain a list of
Registrars accredited by Accreditors listed in accordance with
Sec. 280.810(a).
(1) Names and information regarding accredited Registrars may only
be included on the list from information submitted to NIST by an
Accreditor listed in accordance with Sec. 280.810(a) that submits the
listing fee established by NIST and the following information, in
English:
(i) The name of the Accreditor which granted the accreditation ;
(ii) The name and address of the Registrar affected by the
accreditation action;
(iii) The nature of the accreditation action (e.g., initial
accreditation, renewal of accreditation, etc.);
(iv) A copy of the Registrar's accreditation certificate and a
scope of accreditation which states the quality system standard(s) for
which the Registrar has been accredited for purposes of assessing and
registering a fastener manufacturer's Facility; and
(v) The name and telephone number of the accredited Registrar's
authorized representative(s), and information concerning the physical
locations of all organizational units involved in the accreditation
activities.
(2) All Accreditors listed by NIST in accordance with
Sec. 280.810(a) shall promptly notify NIST of each accreditation action
taken. Accreditation actions include initial accreditations, denials of
accreditation, renewals, suspensions, terminations, and changes in
scope. Notifications shall be filed with: Fastener Quality Act Program
Manager, Office of Standards Services, National Institute of Standards
and Technology, Gaithersburg, Maryland 20899.
(c) List of facilities. NIST shall prepare and maintain a list of
Facilities registered by Registrars listed in accordance with
Sec. 280.810(b).
(1) Names and information regarding registered Facilities may only
be included on the list from information submitted to NIST by
accredited Registrars listed in accordance with Sec. 280.810(b) that
submit the listing fee established by NIST, through their Accreditors,
and the following information:
(i) The name of the fastener manufacturer and the address of the
registered Facility;
(ii) The name of the authorized representative of the fastener
manufacturer whose Facility is registered;
(iii) The scope of registration, stating the quality system
standard(s) to which the Facility has been registered; and
(iv) The effective dates of the registration.
(2) All Registrars listed by NIST in accordance with
Sec. 280.810(b) shall promptly notify NIST of each registration action.
Registration actions include initial registrations, denials of
registration, renewals, suspensions, terminations, and changes in
scope. Notifications shall be filed with: Fastener Quality Act Program
Manager, Office of Standards Services, National Institute of Standards
and Technology, Gaithersburg, Maryland 20899.
(d) These lists will be readily accessible to the public. Only
entities listed by NIST are authorized to offer services which comply
with the Act and this part. NIST shall revise as appropriate all
listings when notified of applicable actions and shall take appropriate
steps to make changes promptly available to the public.
Sec. 280.811 Removal from a list.
NIST may remove from a list any listed entity if NIST deems such
action to be in the public interest. An entity may appeal the removal
or proposed removal from a list to the Director by submitting a
statement of reasons why it should remain on the list. NIST may, at its
discretion, hold in abeyance a removal action pending a final decision
by the Director. The Director shall inform the entity in writing of the
decision within sixty days following receipt of the appeal.
Sec. 280.812 Appeal.
An applicant Accreditor, Registrar, or fastener manufacturer whose
Facility has been registered may appeal the removal or proposed removal
from the Accreditors list, the Registrars list, or the Facilities list,
to the Director.
Subpart J--Recognition of Foreign Registrar Accreditation Bodies
Sec.
280.900 Introduction.
280.901 Recognition of foreign entities.
Sec. 280.900 Introduction.
In accordance with section 6(a)(1)(C) of the Act, this subpart sets
forth the conditions under which the recognition of foreign entities by
their governments, by organizations acting on behalf of their
governments, or by organizations recognized by the Director shall be
deemed to meet the requirements of the Act.
Sec. 280.901 Recognition of foreign entities.
Foreign Accreditors wishing to be recognized to accredit Registrars
must submit an application for evaluation to NIST according to subpart
I. NIST recognition is limited to bodies that accredit Registrars which
register Facilities producing fasteners covered by the Act. To be
recognized by NIST, Accreditors must meet conditions set out in
subparts I and K and accredit Registrars of Facilities to conditions
set out in subpart L.
Subpart K--Requirements for Registrar Accreditation Bodies
(Accreditors)
Sec.
General
280.1000 Introduction.
280.1001 Scope.
Requirements for Accreditors
280.1010 Accreditors.
280.1011 Accreditor personnel.
280.1012 Decision on accreditation.
280.1013 References to accredited status.
280.1014 Change in the accreditation.
280.1015 Appeals, complaints and disputes.
280.1016 Access to records of appeals, complaints and disputes.
Requirements for Assessment
280.1020 Application for accreditation.
[[Page 47251]]
280.1021 Preparation for assessment.
280.1022 Assessment.
280.1023 Assessment report.
280.1024 Surveillance and reassessment procedures.
General
Sec. 280.1000 Introduction.
This subpart sets out organizational, operational and other
requirements that must be met by all Accreditors recognized by NIST
under subpart I or J of this part. This subpart also sets out the
requirements against which an Accreditor assesses the competence of an
applicant Registrar.
Sec. 280.1001 Scope.
These are general requirements for an Accreditor to follow if it is
to be recognized as competent and reliable in assessing and
subsequently accrediting Registrars.
Requirements for Accreditors
Sec. 280.1010 Accreditors.
(a) General provisions. (1) The policies and procedures under which
the Accreditor operates shall be non-discriminatory, and they shall be
administered in a non-discriminatory manner. Procedures shall not be
used to impede or inhibit access by applicant bodies other than as
specified in this part.
(2) The Accreditor shall make its services accessible to all
applicants whose activities fall within its declared field of
operation. There shall not be undue financial or other conditions.
Access shall not be conditional upon the size of the applicant body or
membership of any association or group, nor shall accreditation be
conditional upon the number of bodies already accredited.
(3) The accreditation criteria against which the competence of a
registrar is assessed shall be those outlined in subpart L of this
part. If an explanation is required as to the application of these
documents to a specific accreditation program, it shall be formulated
by relevant and impartial committees or persons possessing the
necessary technical competence, and published by the Accreditor.
(4) The Accreditor shall confine its requirements, assessment and
decisions on accreditation to those matters specifically related to the
scope of the accreditation being considered.
(b) Organization of a recognized Accreditor. The structure of the
Accreditor shall be such as to give confidence in its accreditations.
In particular, the Accreditor shall:
(1) Be impartial;
(2) Be responsible for its decisions relating to the granting,
maintaining, extending, reducing, suspending and withdrawing of
accreditation;
(3) Identify the management (committee, group or person) which will
have overall responsibility for all of the following:
(i) Performance of assessment and accreditation as defined in this
part;
(ii) Formulation of policy matters relating to the operation of the
Accreditor;
(iii) Decisions on accreditation;
(iv) Supervision of the implementation of its policies;
(v) Supervision of the finance of the Accreditor; and
(vi) Delegation of authority to committees or individuals, as
required, to undertake defined activities on its behalf.
(4) Have documents which demonstrate that it is a legal entity;
(5) Have a documented structure which safeguards impartiality,
including provisions to assure the impartiality of the operations of
the Accreditor; this structure shall enable the participation of all
parties significantly concerned in the development of policies and
principles regarding the content and functioning of the accreditation
system;
(6) Ensure that each decision on accreditation is taken by a person
or persons different from those who carried out the assessment;
(7) Have rights and responsibilities relevant to its accreditation
activities;
(8) Have adequate arrangements to cover liabilities arising from
its operations and/or activities;
(9) Have financial stability and resources required for the
operation of an accreditation system;
(10) Employ a sufficient number of personnel having the necessary
education, training, technical knowledge and experience for performing
accreditation functions relating to the type, range and volume of work
performed, under a responsible senior executive;
(11) Have a quality system, as outlined in Sec. 280.1010(d), giving
confidence in its ability to operate an accreditation system for
registration bodies;
(12) Have policies and procedures that distinguish between
accreditation and any other activities in which the Accreditor is
engaged;
(13) Together with its senior executive and staff, be free from any
commercial, financial and other pressures which might influence the
results of the accreditation process;
(14) Have formal rules and structure for the appointment and
operation of any committees which are involved in the accreditation
process; such committees shall be free from any commercial, financial
and other pressures that might influence decisions;
(15) Ensure that activities of related bodies do not affect the
confidentiality, objectivity or impartiality of its accreditations and
shall not offer or provide, directly or indirectly, those services that
accredit others to perform, consulting services to obtain or maintain
accreditation, or services to design, implement or maintain a
certification scheme;
(16) Have policies and procedures for the resolution of complaints,
appeals and disputes received from bodies or other parties about the
handling of accreditation of any related matters;
(17) Have a structure where members are chosen to provide a balance
of interest, where no single interest predominates; and
(18) Assure that other products, processes or services that may be
offered, directly or indirectly, do not compromise confidentiality or
the objectivity or impartiality of its accreditation process and
decisions.
(c) Subcontracting. (1) When an Accreditor decides to subcontract
work related to accreditation (e.g. audits) to an external body or
person, a properly documented agreement covering the arrangements,
including confidentiality and conflict of interest, shall be drawn up.
The Accreditor shall:
(i) Take full responsibility for such subcontracted work and
maintain its responsibility for granting, maintaining, extending,
reducing, suspending or withdrawing accreditation
(ii) Ensure that the subcontracted body or person is competent and
complies with the applicable provisions of this part, including
Sec. 280.807, and is not involved, either directly or through its
employer, with the design, implementation or maintenance of a
registration scheme in such a way that impartiality could be
compromised; and
(iii) obtain the consent of the applicant or accredited body.
(2) Requirements in paragraphs (c)(1) (i) and (ii) of this section
are also relevant, by extension, when an Accreditor uses, for granting
its own accreditation, work provided by another Accreditor with which
it has signed an agreement.
(d) Quality system. (1) The management of the Accreditor with
executive responsibility for quality shall define and document its
policy for quality, including objectives for quality and its commitment
to quality. The management shall ensure that this
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policy is understood, implemented and maintained at all levels of the
organization.
(2) The Accreditor shall operate a quality system in accordance
with the relevant elements of this part and appropriate to the type,
range and volume of work performed. This quality system shall be
documented, and the documentation shall be available for use by the
staff of the Accreditor.
(3) The Accreditor shall ensure effective implementation of the
documented quality system procedures and instructions.
(4) The Accreditor shall designate a person with direct access to
its highest executive level who, irrespective of other
responsibilities, shall have defined authority to ensure that a quality
system is established, implemented and maintained in accordance with
this part, and report on the performance of the quality system to the
management of the Accreditor for review and as a basis for improvement
of the quality system.
(5) The quality system shall be documented in a quality manual and
associated quality procedures, and the quality manual shall contain or
refer to at least the following: :
(i) A quality policy statement;
(ii) A brief description of the legal status of the Accreditor,
including the names of its owners, if applicable, and, if different,
the names of the persons who control it;
(iii) The names, qualifications, experience and terms of reference
of the senior executive and other accreditation personnel influencing
the quality of the accreditation function;
(iv) An organization chart showing lines of authority,
responsibility and allocation of functions stemming from the senior
executive and, in particular, the relationship between those
responsible for the assessment and those making decisions regarding
accreditation;
(v) A description of the organization of the Accreditor, including
details of the management (committee, group or person), its
constitution, terms of reference and rules of procedure;
(vi) The policy and procedures for conducting management reviews;
(vii) Administrative procedures including document control;
(viii) The operational and functional duties and service pertaining
to quality, so that the extent and limits of each person's
responsibility are known to all concerned;
(ix) The policy and procedures for the recruitment and training of
Accreditor personnel (including auditors) and monitoring their
performance;
(x) A list of its subcontractors and details of the procedures for
assessing, recording and monitoring their competence;
(xi) Its procedures for handling nonconformities and for assuring
the effectiveness of any corrective actions taken;
(xii) The policy and procedures for implementing the accreditation
process, including:
(A) The conditions for issue, retention and withdrawal of
accreditation documents
(B) Checks of the use and application of documents used in the
accreditation
(C) The procedures for assessing and accrediting applicants; and
(D) The procedures for surveillance and reassessment of accredited
bodies.
(xiii) The policy and procedures for dealing with appeals,
complaints and disputes; and
(xiv) The procedures for conducting internal audits based on
appropriate international documentation.
(e) Conditions for granting, maintaining, extending, reducing,
suspending and withdrawing accreditation. (1) The Accreditor shall
specify the conditions for granting, maintaining, extending and
reducing accreditation, and the conditions under which accreditation
may be suspended or withdrawn, partially or in total, for all or part
of the accredited body's scope of accreditation. In particular, the
Accreditor shall require the accredited body to notify it promptly of
any intended changes to the quality system or other changes which may
affect conformity.
(2) The Accreditor shall have procedures to grant, maintain,
withdraw and suspend accreditation; to extend or reduce the scope of
accreditation; and to conduct reassessment in the event of changes
significantly affecting the activity and operation of the accredited
body (such as change of ownership, changes in personnel or equipment),
or if analysis of a complaint or any other information indicates that
the accredited body no longer complies with the requirements of the
Accreditor.
(f) Internal audits and management reviews. (1) The Accreditor
shall conduct periodic internal audits covering all procedures in a
planned and systematic manner, to verify that the quality system is
being implemented and is effective. The Accreditor shall ensure that
personnel responsible for the area audited are informed of the outcome
of the audit; corrective action is taken in a timely and appropriate
manner; and the results of the audit are documented.
(2) The top management of the Accreditor shall review its quality
system at defined intervals sufficient to ensure its continuing
suitability and effectiveness in satisfying the requirements of this
part and the stated quality policy and objectives. Records of such
reviews shall be maintained.
(g) Documentation. (1) The Accreditor shall document, update at
regular intervals, and make available (through publications, electronic
media or other means), on request:
(i) Information about the authority under which the Accreditor
operates;
(ii) A documented statement of its accreditation system, including
its rules and procedures for granting, maintaining, extending,
reducing, suspending and withdrawing accreditation;
(iii) Information about the assessment and accreditation process;
(iv) A description of the means by which the Accreditor obtains
financial support, and general information on the fees charged to
applicants and accredited bodies;
(v) A description of the rights and duties of applicants and
accredited bodies, as specified, including requirements, restrictions
or limitations on the use of the Accreditor's logo and on the ways of
referring to the accreditation granted, in conformance with
Sec. 280.804(d); and
(vi) Information on procedures for handling complaints, describing
the scope of accreditation granted to each.
(2) The Accreditor shall establish and maintain procedures to
control all documents and data that relate to its accreditation
functions. These documents shall be reviewed and approved for adequacy
by appropriately authorized and competent personnel prior to issuing
any documents following initial development or any subsequent amendment
or change being made. A listing of all appropriate documents with the
respective issue and/or amendment status identified shall be
maintained. The distribution of all such documents shall be controlled
to ensure that the appropriate documentation is made available to
personnel of the Accreditor, or applicants and accredited bodies, when
required to perform any function relating to the activities of
applicants and accredited bodies.
(h) Records. (1) The Accreditor shall maintain a record system to
suit its particular circumstances and to comply with this part. The
records shall demonstrate that accreditation procedures have been
effectively fulfilled, particularly with respect to application forms,
assessment reports,
[[Page 47253]]
and other documents relating to granting, maintaining, extending,
reducing, suspending or withdrawing accreditation. The records shall be
identified, managed and disposed of in such a way as to ensure the
integrity of the process and confidentiality of the information. The
records shall be kept for a period of five years.
(2) The Accreditor shall have a policy and procedures for retaining
records for a period of five years. The Accreditor shall have a policy
and procedures concerning access to these records consistent with
paragraph (h)(1) of this section.
(i) Confidentiality. (1) The Accreditor shall have adequate
arrangements, consistent with applicable laws, to safeguard
confidentiality of the information obtained in the course of its
accreditation activities at all levels of its organization, including
committees and external bodies or individuals acting on its behalf.
(2) Except as required in this part, information about a particular
body shall not be disclosed to a third party without the written
consent of the body.
Sec. 280.1011 Accreditor personnel.
(a) General provisions. (1) The personnel of the Accreditor
involved in accreditation shall be competent for the functions they
perform.
(2) Information on the relevant qualifications, training and
experience of each member of the personnel involved in the
accreditation process shall be maintained by the Accreditor. Records of
training and experience shall be kept up to date.
(3) Clearly documented instructions shall be available to the
personnel describing their duties and responsibilities. These
instructions shall be maintained up to date.
(b) Qualification criteria for auditors and technical experts. (1)
In order to ensure that assessments are carried out effectively and
uniformly, the minimum relevant criteria for competence shall be
defined by the Accreditor.
(2) Auditors shall meet the requirements of the appropriate
international documentation.
(3) Technical experts are not required to comply with the
requirements for auditors, and guidance on their personal attributes
may be obtained from appropriate international documentation.
(c) Selection procedure. (1) The Accreditor shall have a procedure
for selecting auditors and, if applicable, technical experts on the
basis of their competence, training, qualifications and experience, and
for initially assessing the conduct of auditors and technical experts
during assessments, and subsequently monitoring the performance of
auditors and technical experts.
(2) When selecting the audit team to be appointed for a specific
assessment, the Accreditor shall ensure that the skills brought to each
assignment are appropriate. The team shall:
(i) Be familiar with the Fastener Quality Act and its implementing
regulations, accreditation procedures and accreditation requirements;
(ii) Have a thorough knowledge of the relevant assessment method
and assessment documents;
(iii) Have appropriate technical knowledge of the fastener
technology for which accreditation is sought and, where relevant with
associated procedures and their potential for failure (technical
experts who are not auditors may fulfil this function);
(iv) Have a degree of understanding sufficient to make a reliable
assessment of the competence of the accredited body to operate within
its scope;
(v) Be able to communicate effectively, both in writing and orally,
in the required languages;
(vi) Be free from any interest that might cause team members to act
in other than an impartial or non-discriminatory manner, for example,
(A) Audit team members or their organization shall not have
provided consulting services to the applicant or accredited body which
compromise the accreditation process and decision; and
(B) In accordance with the directives of the Accreditor, the audit
team members shall inform the Accreditor, prior to the assessment,
about any existing, former or envisaged link between themselves or
their organization and the body to be assessed.
(d) Contracting of assessment personnel. The Accreditor shall
require the personnel involved in the assessment to sign a contract or
other document by which they commit themselves to comply with the rules
defined by the Accreditor, including those relating to confidentiality
and those relating to independence from commercial and other interest,
and any prior and/or present link with the bodies to be assessed. The
Accreditor shall ensure that, and document how, any subcontracted
assessment personnel satisfy all the requirements for personnel
outlined in this subpart.
(e) Assessment personnel records. (1) The Accreditor shall possess
and maintain up-to-date records on personnel conducting assessments,
consisting of:
(i) Name and address;
(ii) Affiliation and position held in the organization;
(iii) Educational qualifications and professional status;
(iv) Experience and training in each field of competence of the
Accreditor;
(v) Date of most recent updating of record; and
(vi) Performance appraisal.
(2) The Accreditor shall ensure, and verify, that any subcontracted
body maintains records, which satisfy the requirements of this part, of
assessment personnel who are subcontracted to the Accreditor.
(f) Procedures for assessment teams. Assessment teams shall be
provided with up-to-date assessment instructions and all relevant
information on accreditation arrangements and procedures.
Sec. 280.1012 Decision on accreditation.
(a) The decision whether or not to accredit a body shall be made on
the basis of the information gathered during the accreditation process
and any other relevant information. Those who make the accreditation
decision shall not have participated in the audit.
(b) The Accreditor shall not delegate authority for granting,
maintaining, extending, reducing, suspending or withdrawing
accreditation to an outside person or body.
(c) The Accreditor shall provide to each of its accredited bodies
accreditation documents such as a letter outlining the scope of
accreditation and a certificate signed by an officer who has been
assigned such responsibility. These accreditation documents shall
identify, for the body and each of its sites covered by the
accreditation:
(1) The name and address;
(2) The scope of the accreditation granted, including as
appropriate:
(i) The type of registration scheme;
(ii) The standards and/or other normative documents and regulatory
requirements against which products, services or systems are
registered; and
(iii) Product categories.
(3) The effective date of accreditation and, as applicable, the
term for which the accreditation is valid.
(d) In response to an application for an amendment to the scope of
an accreditation already granted, the Accreditor shall decide what, if
any, assessment procedure is appropriate to determine whether or not
the amendment should be granted and shall act accordingly.
Sec. 280.1013 References to accredited status.
(a) An Accreditor which is proprietor or licensee of a symbol or
logo, intended
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for use under its accreditation program, shall have a policy governing
its use. It shall normally allow an accredited body to refer to its
accreditation in certificates, reports, and stationery and publicity
material relating to accredited activities.
(b) The Accreditor shall not allow use of its mark or logo in any
way which implies that the Accreditor itself approved a product,
service or system registered by an accredited body. Where a Facility is
registered only with respect to its quality assurance system, the
symbol or logo shall not be used on a product or in any other way that
may be interpreted as denoting product conformance, as required by
Sec. 280.804(d).
(c) The Accreditor shall take suitable action to deal with
incorrect reference to the accreditation system, or misleading use of
accreditation logos found in advertisements, catalogues, etc. Such
action could include corrective action, withdrawal of certificate,
publication of the transgression and, if necessary, other legal action.
Sec. 280.1014 Change in the accreditation.
The Accreditor shall give due notice of any changes it intends to
make in its requirements for accreditation. It shall take account of
views expressed by interested parties before deciding on the precise
form and effective date of the changes. Following a decision on, and
publication of, the changed requirements, it shall verify that each
accredited Registrar carries out any necessary adjustments to its
procedures within such time as, in the opinion of the Accreditor, is
reasonable.
Sec. 280.1015 Appeals, complaints and disputes.
The Accreditor shall keep a record of all appeals, complaints and
disputes, and remedial actions relative to accreditation; take
appropriate corrective and preventive action; and document the actions
taken and assess their effectiveness.
Sec. 280.1016 Access to records of appeals, complaints and disputes.
The Accreditor shall require each applicant and accredited
Registrar to make available to it, when requested, the records of all
complaints, appeals and disputes, and subsequent actions.
Requirements for Assessment
Sec. 280.1020 Application for accreditation.
(a)(1) The Accreditor shall maintain up-to-date as specified in
Sec. 280.1010(g)(1), detailed description of the assessment and
accreditation procedure, the documents containing the requirements for
accreditation, and documents describing the rights and duties of
accredited Registrars, and shall provide them to applicants and
accredited Registrars. The Accreditor shall require that an accredited
Registrar:
(i) Always complies with the relevant provisions of this part;
(ii) Makes all necessary arrangements for the conduct of the
assessment, including provision for examining documentation and the
access to all areas, records (including internal audit reports) and
personnel for the purposes of assessment, surveillance, reassessment
and resolution of complaints;
(iii) Only claims that it is accredited with respect to those
activities for which it has been granted accreditation;
(iv) Does not use its accreditation in such a manner as to bring
the Accreditor into disrepute, and does not make any statement
regarding its accreditation which the Accreditor may consider
misleading or unauthorized;
(v) Upon suspension or withdrawal of its accreditation,
discontinues use of all advertising matter that contains any reference
thereto and returns any accreditation documents as required by the
Accreditor;
(vi) Does not allow the fact of its accreditation to be used to
imply that a product, process, system, or person is approved by the
Accreditor, as required by Sec. 280.804(d);
(vii) Ensures that no accreditation document, mark or report, or
any part thereof, is used in a misleading manner; and
(viii) In making reference to its accreditation status in
communication media such as documents, brochures or advertising,
complies with the requirements of the Accreditor.
(2) When the desired scope of accreditation is related to a
specific program any necessary explanation shall be provided to the
applicant. If requested, additional application information shall be
provided to the body.
(b) The Accreditor shall require an official application form, duly
completed and signed by a duly authorized representative of the
applicant, in which or attached to which:
(1) The scope of the desired accreditation is defined; and
(2) The applicant agrees to comply with the requirements for
accreditation and to supply any information needed for its evaluation.
(c) At least the following shall be provided by the applicant prior
to the on-site assessment:
(1) The general features of the applicant body, such as corporate
entity, name, address, legal status and, where relevant, human and
technical resources;
(2) General information concerning the body covered by the
application, such as its functions, and its relationship in a larger
corporate entity, and its physical locations;
(3) A description of the systems or products it registers and the
standards or other normative documents applicable to each; and
(4) A copy of its quality manual and, where required, the
associated documentation.
Sec. 280.1021 Preparation for assessment.
(a) Before proceeding with the assessment, the Accreditor shall
conduct, and maintain records of, a review of the request for
accreditation to ensure that:
(1) The requirements for accreditation are clearly defined and
documented;
(2) Any difference in understanding between the Accreditor and the
applicant is resolved; and
(3) The Accreditor has the capability to perform the accreditation
service with respect to the scope of the accreditation sought, the
location of the applicant's operations, and any special requirements
such as the language used by the applicant.
(b) The Accreditor shall prepare a plan for its assessment
activities to allow for the necessary arrangements to be made.
(c) The Accreditor shall nominate a qualified audit team to
evaluate all material collected from the applicant and to conduct the
audit on its behalf. Experts in the areas to be assessed may be
attached to the Accreditor's team as advisers.
(d) The applicant shall be informed of the names of the members of
the audit team who will carry out the assessment, with sufficient
notice to appeal against the appointment of any particular auditors or
experts.
(e) The audit team shall be formally appointed and provided with
the appropriate working documents. The plan for and the date of the
audit shall be agreed upon with the applicant. The mandate given to the
audit team shall be clearly defined and made known to the applicant,
and shall require the audit team to examine the structure, policies and
procedures of the applicant, and confirm that these meet all the
requirements relevant to the scope of accreditation, and that the
procedures are implemented and are such as to give confidence in the
registrations of the applicant.
[[Page 47255]]
Sec. 280.1022 Assessment.
(a) The audit team shall assess all services of the applicant
covered by the defined scope against all applicable accreditation
requirements.
(b) The Accreditor shall witness fully the on-site activities of
one or more assessments or audits conducted by an applicant before an
initial accreditation is granted for any function requiring on-site
activity by the applicant.
Sec. 280.1023 Assessment report.
(a) The Accreditor may adopt reporting procedures that suit its
needs but, as a minimum, these procedures shall ensure that:
(1) A meeting takes place between the audit team and the
applicant's management prior to leaving the premises, at which the
audit team provides a written or oral indication on the conformity of
the applicant with the particular accreditation requirements and
provides an opportunity for the applicant to ask questions about the
findings and their basis;
(2) The audit team provides the Accreditor with a report of its
findings as to the applicant's conformity to all of the accreditation
requirements;
(3) A report on the outcome of the assessment is promptly brought
to the applicant's attention by the Accreditor, identifying any
nonconformity to be discharged in order to comply with all of the
accreditation requirements;
(4) The Accreditor shall invite the applicant to comment on the
report and to describe the specific actions taken, or planned to be
taken within a defined time, to remedy any nonconformity with the
accreditation requirements identified during the assessment, and shall
inform the applicant of the need for full or partial reassessment or
whether a written declaration to be confirmed during surveillance will
be considered adequate;
(5) The report shall contain as a minimum:
(i) The date(s) of the audit(s);
(ii) The name(s) of the person(s) responsible for the report;
(iii) The names and addresses of all sites audited;
(iv) The assessed scope of accreditation or reference thereto;
(v) Comments on the conformity of the applicant with the
accreditation requirements and, where applicable, any useful
comparisons with the results of previous assessment of the applicant;
and
(vi) An explanation of any differences from the information
presented to the applicant at the closing meeting.
(b) If the final report authorized by the Accreditor differs from
the report referred to in paragraphs (b) (3) and (5) of this section,
it shall be submitted to the applicant with an explanation of any
differences from the previous report. The report shall take into
consideration:
(1) The qualification, experience and authority of the staff
encountered;
(2) The adequacy of the internal organization and procedures
adopted by the applicant to give confidence in the quality of its
services; and
(3) The actions taken to correct identified nonconformities
including, where applicable, those identified at previous assessments.
Sec. 280.1024 Surveillance and reassessment procedures.
(a) The Accreditor shall have an established documented program,
consistent with the accreditation granted, for carrying out periodic
surveillance and reassessment at sufficiently close intervals to verify
that its accredited Registrar continues to comply with the
accreditation requirements.
(b) Surveillance and reassessment procedures shall be consistent
with those concerning the assessment of the applicant as described in
this part.
(c)(1) The Accreditor shall have arrangements to ensure that an
accredited Registrar informs it without delay of changes in any aspects
of its status or operation that affect its:
(i) Legal, commercial or organizational status;
(ii) Organization and management, for example key managerial staff;
(iii) Policies or procedures, where appropriate;
(iv) Premises; and
(v) Personnel, equipment, facilities, working environment or other
resources, where significant.
(2) The accredited Registrar shall also inform the Accreditor of
other such matters that may affect activities, or conformance with the
requirements, or any other relevant criteria of competence specified by
the Accreditor.
Subpart L--Requirements for Registrars
Sec.
General
280.1100 Introduction.
280.1101 Scope.
Requirements for Registrars
280.1110 Registrars.
280.1111 Registrar personnel.
280.1112 Changes in the registration requirements.
280.1113 Appeals, complaints and disputes.
Requirements for Registration
280.1120 Application for registration.
280.1121 Preparation for assessment.
280.1122 Assessment.
280.1123 Assessment report.
280.1124 Decision on registration.
280.1125 Surveillance and reassessment procedures.
280.1126 Use of certificates and logos.
280.1127 Access to records of complaints to fastener manufacturers.
General
Sec. 280.1100 Introduction.
This subpart sets out organizational, operational and other
requirements that must be met by all Registrars accredited under
subparts I or J of this part.
Sec. 280.1101 Scope.
These are general requirements that must be met by a third-party
body registering Facilities.
Note: In some countries, the bodies which verify conformity of
quality systems to specified standards are called ``certification
bodies,'' in others ``registration bodies,'' in others ``assessment
and registration bodies'' or ``certification/registration bodies,''
and in still others ``registrars.'' Reference to such bodies as
``Registrars'' should not be understood to be limiting.
Requirements for Registrars
Sec. 280.1110 Registrars.
(a) General provisions. (1) The policies and procedures under which
the Registrar operates shall be non- discriminatory, and they shall be
administered in a non-discriminatory manner. Procedures shall not be
used to impede or inhibit access by applicants other than as specified
in this part.
(2) The Registrar shall make its services accessible to all
applicants. There shall not be undue financial or other conditions.
Access shall not be conditional upon the size of the applicant body or
membership of any association or group, nor shall registration be
conditional upon the number of Facilities already registered.
(3) The criteria against which the quality assurance system of an
applicant is assessed shall be those outlined in the quality system
standards or other normative documents relevant to the function
performed. If an explanation is required as to the application of these
documents to a specific registration program, it shall be formulated by
relevant and impartial committees or persons possessing the necessary
technical competence, and published by the Registrar.
(4) The Registrar shall confine its requirements, assessment, and
decision on registration to those matters specifically related to the
scope of the registration being considered.
(b) Organization of a Registrar. The structure of the Registrar
shall be such
[[Page 47256]]
as to give confidence in its registrations. In particular, the
Registrar shall:
(1) Be impartial;
(2) Be responsible for its decisions relating to the granting,
maintaining, extending, reducing, suspending and withdrawing of
registration;
(3) Identify the management (committee, group, or person) which
will have overall responsibility for each of the following:
(i) Performance of assessment and registration as defined in this
part;
(ii) Formulation of policy matters relating to the operation of the
Registrar;
(iii) Decisions on registration;
(iv) Supervision of the implementation of its policies;
(v) Supervision of the finances of the Registrar; and
(vi) Delegation of authority to committees or individuals, as
required, to undertake defined activities on its behalf.
(4) Have documents which demonstrate that it is a legal entity;
(5) Have a documented structure which safeguards impartiality,
including provisions to assure the impartiality of the operations of
the Registrar. This structure shall enable the participation of all
parties significantly concerned in the development of policies and
principles regarding the content and functioning of the registration
system;
(6) Ensure that each decision on registration is taken by a person
or persons different from those who carried out the assessment;
(7) Have rights and responsibilities relevant to its registration
activities;
(8) Have adequate arrangements to cover liabilities arising from
its operations and/or activities;
(9) Have the financial stability and resources required for the
operation of a registration system;
(10) Employ a sufficient number of personnel having the necessary
education, training, technical knowledge, and experience for performing
registration functions relating to the type, range, and volume of work
performed, under a responsible senior executive;
(11) Have a quality system, as outlined in Sec. 280.1110(d), giving
confidence in its ability to operate a registration system for
Facilities;
(12) Have policies and procedures that distinguish between
registration and any other activities in which the Registrar is
engaged;
(13) Together with its senior executive and staff, be free from any
commercial, financial, and other pressures which might influence the
results of the registration process;
(14) Have formal rules and structures for the appointment and
operation of any committees which are involved in the registration
process; such committees shall be free from any commercial, financial,
and other pressure that might influence decisions;
(15) Ensure that activities of related bodies do not affect the
confidentiality, objectivity, or impartiality of its registrations and
shall not offer or provide, directly or indirectly, those services that
it registers others to perform, consulting services to obtain or
maintain registration, or services to design, implement, or maintain
quality systems;
(16) Have policies and procedures for the resolution of complaints,
appeals, and disputes received from fastener manufacturers or other
parties about the handling of registration or any other related
matters;
(17) Have a structure where members are chosen to provide a balance
of interests, where no single interest predominates; and
(18) Assure that other products, processes, or services that may be
offered, directly or indirectly, do not compromise confidentiality or
the objectivity or impartiality of its registration process and
decisions.
(c) Subcontracting. (1) When a Registrar decides to subcontract
work related to registration (e.g. audits) to an external body or
person, a properly documented agreement covering the arrangements,
including confidentiality and conflicts of interest, shall be drawn up.
The Registrar shall:
(i) Take full responsibility for such subcontracted work and
maintain its responsibility for granting, maintaining, extending,
reducing, suspending, or withdrawing registration;
(ii) Ensure that the subcontracted body or person is competent and
complies with the applicable provisions of this part, including section
280.7, and is not involved, either directly or through its employer,
with the design, implementation, or maintenance of a quality system in
such a way that impartiality could be compromised; and
(iii) Obtain the consent of the applicant or fastener manufacturer
whose Facility is registered.
(2) Requirements in paragrphs (c) (1) and (2) of this section are
also relevant, by extension, when a Registrar uses, for granting its
own registration, work provided by another Registrar with which it has
signed an agreement.
(d) Quality system. (1) The management of the Registrar with
executive responsibility for quality shall define and document its
policy for quality, including objectives for quality and its commitment
to quality. The management shall ensure that this policy is understood,
implemented, and maintained at all levels of the organization.
(2) The Registrar shall operate a quality system in accordance with
the relevant elements of this part and appropriate to the type, range,
and volume of work performed. This quality system shall be documented
and the documentation shall be available for use by the staff of the
Registrar.
(3) The Registrar shall ensure effective implementation of the
documented quality system procedures and instructions.
(4) The Registrar shall designate a person with direct access to
its highest executive level who, irrespective of other
responsibilities, shall have defined authority to ensure that a quality
system is established, im plemented, and maintained in accordance with
this part, and report on the performance of the quality system to the
management of the Registrar for review and as a basis for improvement
of the quality system.
(5) The quality system shall be documented in a quality manual and
associated quality procedures and the quality manual shall contain or
refer to at least the following:
(i) A quality policy statement;
(ii) A brief description of the legal status of the Registrar,
including the names of its owners, if applicable, and, if different,
the names of the persons who control it;
(iii) The names and qualifications, experience, and terms of
reference of the senior executive and other certification/registration
personnel, affecting the quality of the certification/registration
function;
(iv) An organization chart showing lines of authority,
responsibility, and allocation of functions stemming from the senior
executive and, in particular, the relationship between those
responsible for the assessment and those taking decisions regarding
registration;
(v) A description of the organization of the registration body,
including details of the management (committee, group, or person), its
constitution, terms of reference and rules of procedure;
(vi) The policy and procedures for conducting management reviews;
(vii) Administrative procedures including document control;
(viii) The operational and functional duties and services
pertaining to quality, so that the extent and limits of each person's
responsibility are known to all concerned;
(ix) The policy and procedures for the recruitment and training of
registration
[[Page 47257]]
body personnel (including auditors) and monitoring their performance;
(x) A list of its subcontractors and details of the procedure for
assessing, recording, and monitoring their competence;
(xi) Its procedures for handling nonconformities and for assuring
the effectiveness of any corrective actions taken;
(xii) The policy and procedures for implementing the registration
process, including:
(A) The conditions for issue, retention, and withdrawal of
registration documents;
(B) Checks of the use and application of documents used in the
registration of quality systems;
(C) The procedures for assessing and registering fastener
manufacturers' quality systems as employed in particular Facilities;
and
(D) The procedures for surveillance and reassessment of registered
Facilities.
(xiii) The policy and procedures for dealing with appeals,
complaints, and disputes; and
(xiv) The procedures for conducting internal audits based on the
provisions described in appropriate international documentation.
(e) Conditions for granting, maintaining, extending, reducing,
suspending, and withdrawing registration. (1) The Registrar shall
specify the conditions for granting, maintaining, reducing, and
extending registration and the conditions under which registration may
be suspended or withdrawn, partially or in total, for all or part of
the Facility's scope of registration. In particular, the Registrar
shall require the fastener manufacturer to notify it promptly of any
intended changes to the quality assurance system or other changes which
may affect conformity.
(2) The Registrar shall require the fastener manufacturer to have a
documented quality system which conforms to applicable quality system
standards or other normative documents.
(3) The Registrar shall have procedures to grant, maintain,
withdraw and, if applicable, suspend registration; to extend or reduce
the scope of registration; and to conduct reassessment in the event of
changes significantly affecting the activity and operation of the
Facility (such as change of ownership, changes in personnel or
equipment), or if analysis of a complaint or any other information
indicates that the registered fastener Facility no longer complies with
the requirements of the Registrar.
(4) The Registrar shall have documented procedures which shall be
made available on request for:
(i) Initial assessment and for the surveillance and reassessment of
a fastener manufacturer's quality assurance system as employed in a
particular Facility
(ii) Continuing conformity with relevant requirements; and for
verifying and recording that a fastener manufacturer takes corrective
action on a timely basis to correct all nonconformities; and
(iii) Identifying and recording nonconformities and the need for
corrective action by fastener manufacturers on a timely basis for such
items as incorrect references to the registration or misleading use of
registration information.
(f) Internal audits and management reviews. (1) The Registrar shall
conduct periodic internal audits covering all procedures in a planned
and systematic manner, to verify that the quality assurance system is
implemented and is effective. The Registrar shall ensure that personnel
responsible for the area audited are informed of the outcome of the
audit; corrective action is taken in a timely and appropriate manner;
and the results of the audit are recorded.
(2) The top management of the Registrar shall review its quality
system at defined intervals sufficient to ensure its continuing
suitability and effectiveness in satisfying the requirements of this
part and the stated quality policy and objectives. Records of such
reviews shall be maintained.
(g) Documentation. (1) The Registrar shall document, update at
regular intervals, and make available through publications, electronic
media, or other means, on request
(i) Information about the authority under which the Registrar
operates;
(ii) A documented statement of its registration system including
its rules and procedures for granting, maintaining, extending,
reducing, suspending, and withdrawing registration;
(iii) Information about the assessment and registration process;
(iv) A description of the means by which the Registrar obtains
financial support, and general information on the fees charged to
applicants and fastener manufacturers whose Facilities have been
registered;
(v) A description of the rights and duties of applicants and
fastener manufacturers whose Facilities have been registered, including
requirements, restrictions, or limitations on the use of the
Registrar's logo and on the ways of referring to the registration
granted;
(vi) Information on procedures for handling complaints, appeals and
disputes; and
(vii) A directory of registered Facilities, including their
locations, describing the scope of registration granted to each.
(2) The Registrar shall establish and maintain procedures to
control all documents and data that relate to its registration
functions. These documents shall be reviewed and approved for adequacy
by appropriately authorized and competent personnel prior to issuing
any documents following initial development or any subsequent amendment
or change being made. A listing of all appropriate documents with the
respective issue and/or amendment status identified shall be
maintained. The distribution of all such documents shall be controlled
to ensure that the appropriate documentation is made available to
personnel of the Registrar or of the fastener manufacturer whose
Facility is registered, when required to perform any function relating
to the activities of an applicant or registered Facility.
(h) Records. (1) The Registrar shall maintain a record system to
suit its particular circumstances and to comply with this part. The
records shall demonstrate that the registration procedures have been
effectively fulfilled, particularly with respect to application forms,
assessment reports, and other documents relating to granting,
maintaining, extending, reducing, suspending, or withdrawing
registration. The records shall be identified, managed and disposed of
in such a way as to ensure the integrity of the process and
confidentiality of the information. The records shall be kept for a
period of five years.
(2) The Registrar shall have a policy and procedures for retaining
records for a period of five years. The Registrar shall have a policy
and procedures concerning access to these records consistent with
paragraph (h)(1) of this section.
(i) Confidentiality. (1) The Registrar shall have adequate
arrangements, consistent with applicable laws to safeguard
confidentiality of the information obtained in the course of its
registration activities at all levels of its organization, including
committees and external bodies or individuals, acting on its behalf.
(2) Except as required in this part, information about a particular
product, quality assurance system, Facility, or fastener manufacturer
shall not be dis closed to a third party without the written consent of
the fastener manufacturer.
[[Page 47258]]
Sec. 280.1111 Registrar personnel.
(a) General provisions. (1) The personnel of the Registrar involved
in registration shall be competent for the functions they perform.
(2) Information on the relevant qualifications, training and
experience of each member of the personnel involved in the registration
process shall be maintained by the Registrar. Records of training and
experience shall be kept up to date.
(3) Clearly documented instructions shall be available to the
personnel describing their duties and responsibilities. These
instructions shall be maintained up to date.
(b) Qualification criteria for auditors and technical experts. (1)
In order to ensure that assessments are carried out effectively and
uniformly, the minimum relevant criteria for competence shall be
defined by the Registrar.
(2) Auditors shall meet the requirements of the appropriate
international documentation. For the assessment of a quality system,
the relevant guidelines for auditing and the criteria for auditors are
those defined in the appropriate international documentation.
(3) Technical experts are not required to comply with the
requirements for auditors, and guidance on their personal attributes
may be obtained the appropriate international documentation.
(c) Selection procedure. (1) The Registrar shall have a procedure
for selecting auditors and, if applicable, technical experts on the
basis of their competence, training, qualifications, and experience,
and for initially assessing the conduct of auditors and technical
experts during assessment and subsequently monitoring the performance
of auditors and technical experts.
(2) When selecting the audit team to be appointed for a specific
assessment, the Registrar shall ensure that the skills brought to each
assignment are appropriate. The team shall:
(i) Be familiar with the Fastener Quality Act and its implementing
regulations, registration procedures and registration requirements;
(ii) Have a thorough knowledge of the relevant assessment method
and assessment documents;
(iii) Have appropriate technical knowledge of the fastener
technology for which registration is sought and where relevant with
associated procedures and their potential for failure (technical
experts who are not auditors may fulfill this function);
(iv) Have a degree of understanding sufficient to make a reliable
assessment of the competence of the Facility to provide products,
processes or services in its registered scope;
(v) Be able to communicate effectively, both in writing and orally,
in the required languages;
(vi) Be free from any interest that might cause team members to act
in other than an impartial or non-discriminatory manner, for example:
(A) Audit team members or their organization shall not have
provided consulting services to the applicant or fastener manufacturer
whose Facility is registered which compromise the registration process
and decision; and
(B) In accordance with the directives of the Registrar, the audit
team members shall inform the Registrar, prior to the assessment, about
any existing, former or envisaged link between themselves or their
organization and the fastener manufacturer whose Facility is to be
assessed.
(d) Contracting of assessment personnel. The Registrar shall
require the personnel involved in the assessment to sign a contract or
other document by which they commit themselves to comply with the rules
defined by the Registrar, including those relating to confidentiality
and those relating to independence from commercial and other interests,
and any prior and/or present link with the fastener manufacturers whose
Facilities are to be assessed. The Registrar shall ensure that, and
document how, any subcontracted assessment personnel satisfy all the
requirements for assessment personnel outlined in this subpart.
(e) Assessment personnel records. (1) The Registrar shall possess
and maintain up-to-date records on assessment personnel, consisting of:
(i) Name and address;
(ii) Affiliation and position held in the organization,
(iii) Educational qualifications and professional status;
(iv) Experience and training in each field of competence of the
Registrar;
(v) Date of most recent updating of records; and
(vi) Performance appraisal.
(2) The Registrar shall ensure and verify that any subcontracted
body maintains records which satisfy the requirements of this part, of
assessment personnel who are subcontracted to the Registrar.
(f) Procedures for audit teams. Audit teams shall be provided with
up-to-date assessment instructions and all relevant information on
registration arrangements and procedures.
Sec. 280.1112 Changes in the registration requirements.
The Registrar shall give due notice of any changes it intends to
make in its requirements for registration. It shall take account of
views expressed by the interested parties before deciding on the
precise form and effective date of the changes. Following a decision
on, and publication of, the changed requirements, it shall verify that
each fastener manufacturer whose Facility is registered carries out any
necessary adjustments to its procedures within such time as, in the
opinion of the Registrar, is reasonable.
Sec. 280.1113 Appeals, complaints and disputes.
Appeals, complaints and disputes brought before the Registrar by
fastener manufacturers or other parties shall be subject to the
procedures of the Registrar. The Registrar shall keep a record of all
appeals, complaints and disputes, and remedial actions relative to
registration; take appropriate corrective and preventive action; and
document the actions taken and assess their effectiveness.
Requirements for Registration
Sec. 280.1120 Application for registration.
(a)(1) The Registrar shall maintain up-to-date as specified in
Sec. 280.1110(g)(1), a detailed description of the assessment and
registration procedure, the documents containing the requirements for
registration and documents describing the rights and duties of fastener
manufacturers whose Facilities are registered, and shall provide them
to applicants and those fastener manufacturers. The Registrar shall
require that a fastener manufacturer whose Facility is registered:
(i) Always complies with the relevant provisions of this part;
(ii) Makes all necessary arrangements for the conduct of the
assessment, including provision for examining documentation and the
access to all areas, records (including internal audit reports) and
personnel for the purposes of assessment, surveillance, reassessment,
and resolution of complaints;
(iii) Only claims that its Facility is registered with respect to
those activities for which it has been granted registration;
(iv) Does not use the registration in such a manner as to bring the
Registrar into disrepute, and does not make any statement regarding its
registration which the Registrar may consider misleading or
unauthorized;
(v) Upon suspension or withdrawal of the registration (however
determined),
[[Page 47259]]
discontinues use of all advertising matter that contains any reference
thereto and returns any registration documents as required by the
Registrar;
(vi) Uses registration only to indicate that the quality assurance
system as employed in its Facility is in conformity with specified
standards or other normative documents, and does not use the
registration to imply that a product or service is approved by the
Registrar, as required by section 280.804;
(vii) Ensures that no registration document, mark or report, or any
part thereof, is used in a misleading manner; and
(viii) In making reference to the registration in communication
media such as documents, brochures, or advertising, complies with the
requirements of the Registrar.
(2) When the desired scope of registration is related to a specific
program, any necessary explanation shall be provided to the fastener
manufacturer. If requested, additional application information shall be
provided to the fastener manufacturer.
(b) The Registrar shall require an official application form, duly
completed and signed by a duly authorized representative of the
applicant fastener manufacturer in which or attached to which:
(1) The scope of the desired registration is defined; and
(2) The applicant agrees to comply with the requirements for
registration and to supply any information needed for its evaluation.
(c)(1) At least the following information shall be provided by the
applicant prior to the on-site assessment:
(i) The general features of the applicant, such as corporate
entity, name, addresses, legal status and, where relevant, human and
technical resources;
(ii) General information concerning the quality system and the
activities it covers;
(iii) A description of the systems to be registered and the
standards or other normative documents applicable to each; and
(iv) A copy of its quality manual and, where required, the
associated documentation.
(2) The information gathered from the application documentation and
the quality manual review may be used for the preparation of the on-
site assessment and shall be treated with appropriate confidentiality.
Sec. 280.1121 Preparation for assessment.
(a) Before proceeding with the assessment the Registrar shall
conduct, and maintain records of, a review of the request for
registration to ensure that:
(1) The requirements for registration are clearly defined,
documented, and understood;
(2) Any difference in understanding between the Registrar and the
applicant is resolved; and
(3) The Registrar has the capability to perform the registration
service with respect to the scope of the registration sought, the
location of the applicant's operations, and any special requirements
such as the language used by the applicant.
(b) The Registrar shall prepare a plan for its assessment
activities to allow for the necessary arrangements to be made.
(c) The Registrar shall nominate a qualified audit team to evaluate
all material collected from the applicant and to conduct the audit on
its behalf. Experts in the areas to be assessed may be attached to the
Registrar's team as advisers.
(d) The fastener manufacturer shall be informed of the names of the
members of the audit team who will carry out the assessment, with
sufficient notice to appeal against the appointment of any particular
auditors or experts.
(e) The audit team shall be formally appointed and provided with
the appropriate working documents. The plan for and the date of the
audit shall be agreed to by the fastener manufacturer. The mandate
given to the audit team shall be clearly defined and made known to the
fastener manufacturer, and shall require the audit team to examine the
structure, policies, and procedures of the Facility and the quality
assurance system it employs, and confirm that these meet all the
requirements relevant to the scope of registration, and that the
procedures are implemented and are such as to give confidence in the
products, processes, or services of the Facility being evaluated.
Sec. 280.1122 Assessment.
The audit team shall assess the quality assurance system, employed
in the Facility being evaluated, covered by the defined scope against
all applicable registration requirements.
Sec. 280.1123 Assessment report.
(a) The Registrar may adopt reporting procedures that suit its
needs but, as a minimum, these procedures shall ensure that:
(1) A meeting takes place between the audit team and the fastener
manufacturer's management prior to leaving the premises, at which the
audit team provides a written or oral indication regarding the
conformity of the quality assurance system, as employed in particular
Facility, with the particular registration requirements and provides an
opportunity for the fastener manufacturer to ask questions about the
findings and their basis;
(2) The audit team provides the Registrar with a report of its
findings as to the conformity of the quality assurance system, as
employed in the particular Facility, with all of the registration
requirements;
(3) A report on the outcome of the assessment is promptly brought
to the fastener manufacturer's attention by the Registrar, identifying
any nonconformity to be discharged in order to comply with all of the
registration requirements;
(4) The Registrar shall invite the fastener manufacturer to comment
on the report and to describe the specific actions taken, or planned to
be taken within a defined time, to remedy any nonconformity with the
registration requirements identified during the assessment of its
quality assurance system, as employed in the particular Facility, and
shall inform the fastener manufacturer of the need for full or partial
reassessment of its quality assurance system or whether a written
declaration to be confirmed during surveillance will be considered
adequate;
(5) The report shall contain as a minimum:
(i) The date(s) of the audit(s);
(ii) The name(s) of the person(s) responsible for the report;
(iii) The names and addresses of the Facility audited;
(iv) The assessed scope of registration or reference thereto,
including reference to the standard(s) applied;
(v) Comments on the conformity of the quality assurance system, as
employed in the particular Facility, with the registration
requirements, with a clear statement of nonconformity and, where
applicable, any useful comparison with the results of previous
assessments of the quality assurance system, as employed in that
particular Facility; and
(vi) An explanation of any differences from the information
presented to the body at the closing meeting.
(b) If the final report authorized by the Registrar differs from
the report referred to in paragraphs (a) (3) and (5) of this section,
it shall be submitted to the fastener manufacturer with an explanation
of any differences from the previous report. The report shall take into
consideration:
(1) The qualification, experience, and authority of the staff
encountered;
[[Page 47260]]
(2) The adequacy of the internal organization and procedures
adopted by the applicant body to give confidence in the quality
assurance system, as employed in the particular Facility; and
(3) The actions taken to correct identified nonconformities
including, where applicable, those identified at previous assessments.
Sec. 280.1124 Decision on registration.
(a) The decision whether or not to register a fastener Facility
shall be taken by the Registrar on the basis of the information
gathered during the registration process and any other relevant
information. Those who make the registration decision shall not have
participated in the audit.
(b) The Registrar shall not delegate authority for granting,
maintaining, extending, reducing, suspending, or withdrawing
registration to an outside person or body.
(c) The Registrar shall provide to each fastener manufacturer whose
Facility is registered, registration documents such as a letter or a
certificate signed by an officer who has been assigned such
responsibility. These documents shall identify, for the fastener
manufacturer and the particular Facility covered by the registration:
(1) The name and addresses;
(2) The scope of registration granted, including as appropriate:
(i) The quality system standards and/or other normative documents
to which quality systems are registered;
(ii) The product, process, or service categories; and, if
appropriate,
(iii) Regulatory requirements, product standards, or other
normative documents against which products are supplied.
(3) The effective date of registration and the term for which the
registration is valid.
(d) Any application for amendment to the scope of a previously
granted registration shall be processed by the Registrar. The Registrar
shall decide what, if any, assessment procedure is appropriate to
determine whether or not the amendment should be granted and shall act
accordingly.
Sec. 280.1125 Surveillance and reassessment procedures.
(a) The Registrar shall carry out periodic surveillance and
reassessment at sufficiently close intervals to verify that its
registered Facilities continue to comply with the registration
requirements. The period involved cannot be greater than one year.
(b) Surveillance and reassessment procedures shall be consistent
with those concerning the assessment of the Facility as described in
this part.
Sec. 280.1126 Use of certificates and logos.
(a) The Registrar shall exercise proper control over ownership, use
and display of its quality system registration mark and logos.
(b) If the Registrar confers the right to use a symbol or logo to
indicate registration of a Facility, the fastener manufacturer may use
the specified symbol or logo only as authorized in writing by the
Registrar. This symbol or logo shall not be used on a product or in a
way that may be interpreted as denoting product conformity.
(c) The Registrar shall take suitable action to deal with incorrect
references to the registration system or misleading use of certificates
and logos found in advertisements, catalogs, etc. Such action could
include corrective action, withdrawal of certificate, publication of
the transgression and, if necessary, other legal action.
Sec. 280.1127 Access to records of complaints to fastener
manufacturers.
The Registrar shall require each fastener manufacturer whose
Facility is registered to make available to the Registrar, when
requested, the records of all complaints and corrective action taken in
accordance with the requirements of the quality system standards or
other normative documents.
[FR Doc. 97-23613 Filed 9-5-97; 8:45 am]
BILLING CODE 3510-13-P