[Federal Register Volume 63, Number 71 (Tuesday, April 14, 1998)]
[Rules and Regulations]
[Pages 18260-18287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9397]
[[Page 18259]]
_______________________________________________________________________
Part II
Department of Commerce
_______________________________________________________________________
National Institute of Standards and Technology
_______________________________________________________________________
15 CFR Part 280
Procedures for Implementation of the Fastener Quality Act; Final Rule
Federal Register / Vol. 63, No. 71 / Tuesday, April 14, 1998 / Rules
and Regulations
[[Page 18260]]
DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
15 CFR Part 280
[Docket Number: 970724177-8057-02]
RIN 0693-AB43
Procedures for Implementation of the Fastener Quality Act
AGENCY: National Institute of Standards and Technology, United States
Department of Commerce.
ACTION: Final rule and extension of implementation date.
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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 (BXA), United States
Department of Commerce (collectively referred to as the Department),
are today issuing a final rule based on comments received in response
to the notice of proposed rulemaking published in the Federal Register
on September 8, 1997 (62 FR 47240-47260) (1997)) amending regulations
found at 15 CFR part 280 implementing the Fastener Quality Act (the
Act). This final rule establishes the procedures for registration of
in-process inspection activities of qualifying manufacturing facilities
that use Quality Assurance Systems (QAS), revises definitions and
related sections for clarity, and corrects editorial errors. These
changes will facilitate the implementation of the Act and will better
accommodate modern industry practices by incorporating these practices
into the certification process of fasteners covered by the Act. This
rule also extends the implementation date of the Fastener Quality Act
by sixty days to July 26, 1998.
DATES: This rule is effective May 14, 1998. The date of implementation
of the Act is July 26, 1998.
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:
Extension of Implementation Date
The final rule implementing the Fastener Quality Act became
effective on November 25, 1996, and was to apply to fasteners
manufactured on or after May 27, 1997, the ``implementation date''. On
April 18, 1997, as permitted by section 15 of the Act, NIST announced a
one year delay of the implementation date of the regulations because
there were an insufficient number of accredited laboratories to conduct
the volume of inspection and testing required by the Act and
regulations (62 FR 19041 (1997)). Currently, NVLAP and the NIST-
recognized private accreditation bodies have received applications from
approximately 430 testing laboratories, a sufficient number for
implementation of the Act. Of these, approximately 130 testing
laboratories have been accredited and are listed on the NIST Accredited
Laboratory List. Although NVLAP and the private accreditation bodies
have been working diligently to complete accreditation of these
laboratories, it seems unlikely that the necessary 425 laboratories
will be accredited by May 26, 1998. Therefore, to ensure that there are
a sufficient number of accredited laboratories to conduct the
inspection and testing required by the Act, pursuant to section 15 of
the Act, NIST is extending the implementation date of the Act by sixty
days to July 26, 1998.
Background--Final Rule
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 and registration of
manufacturing facilities 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 NIST,
published final regulations implementing the Act on September 26, 1996.
Those regulations established procedures under which: (1) Laboratories
in compliance with the Act may be listed; (20 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, recordkeeping, 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, as permitted by section 15
of the Act, NIST announced a one year delay of the implementation date
of the regulations because there were an insufficient number of
accredited laboratories to conduct the volume of inspection and testing
required by the Act and regulations (62 FR 19041 (1997)).
Following issuance of the final regulations on September 26, 1996,
the automobile industry approached the Department and expressed its
concern that the Act and the implementing regulations did not recognize
the use of modern manufacturing methods using prevention-based quality
assurance systems employing statistical process controls (SPC). On
February 4, 1997, a Public Workshop was held at NIST to solicit
information from all interested parties, including the automobile,
aerospace, construction, and fastener industries on the use of
prevention-based quality assurance systems employing SPC in the
manufacture of fasteners. The Department published a notice of proposed
rule making in the Federal Register on September 8, 1997, seeking
public comments on proposed amendments to the regulations that
recognize the use of prevention-based quality assurance systems under
the Act.
To incorporate Quality Assurance Systems/Statistical Process
Control (QAS/SPC) into the regulations, the Department proposed adding
Sec. 280.104, Accreditation of Certain Manufacturing Facilities as
Laboratories; subpart I, Special Rule for the Accreditation of Certain
Fastener Manufacturing Facilities, Whose Implemented Fastener Quality
Assurance Systems Meet Defined Requirements, as Laboratories; subpart
J, Recognition of Foreign Registrar Accreditation Bodies; subpart K,
Requirements for Registrar Accreditation Bodies (Accreditors); and
subpart L, Requirements for Registrars. In addition, the Department
proposed adding a definition of Fastener Quality Assurance System
(FQAS) and defining the terms Accreditor, Registrar, and Facility. The
Department also proposed amendments to section 280.6, Laboratory Test
Reports and Sec. 280.10, Sampling, to specify requirements for
facilities.
[[Page 18261]]
Summary of Public Comments Received by the Department in Response
to the September 8, 1997 Request for Public Comments, and the
Department's Response to the Comments
As noted above, on September 8, 1997, the Department published in
the Federal Register (62 FR 47240-47260) (1997) (Sept. 8, 1997) a
proposed rule to amend 15 CFR part 280. The Department received 125
responses to the request for comments. Twenty-five comments were
received from fastener manufacturers, twenty domestic and five foreign;
twenty-five were from associations, twenty domestic and five foreign;
thirteen were from consultants; ten were from fastener distributors;
eight were from entities involved in laboratory accreditation/facility
registration, three laboratory assessors, two fastener testing
laboratories, one laboratory accreditor, one foreign QAS registrar, and
one foreign registration accreditation body; eight were manufacturers
of products that incorporate fasteners, five from the aerospace
industry, two from the automobile industry (one domestic and one
foreign), and one foreign equipment manufacturer; eight were from
government agencies; six were from importers of fasteners; one was from
a foreign exporter of fasteners; one was from a raw material
manufacturer; and twenty were from other interested parties, fifteen
domestic and five foreign. Of the some 125 commenters, 69 commented on
the issue of incorporating SPC/QAS into the FQA regulations. A detailed
analysis of the comments follow.
As explained in detail below, based on the comments received, the
Department has included all the proposed changes, with some editorial
corrections and clarifications, in the final rule. For further
clarification, the Department also has included definitions for
recognized accreditor, accredited registrar, registered facility, and
authorized representative, and has amended the definition of consensus
standards organization to clarify that it is NIST that will identify
such organizations.
Comments on the Overall Effectiveness of the Proposed QAS
Regulation
Of the 125 commenters, 69 commented on the issue of incorporating
SPC/QAS into the FQA regulations; 44 favored the incorporation of SPC/
QAS into the FQA regulations, and 25 were opposed.
Of the 44 commenters who favored the incorporation of SPC/QAS into
the FQA regulations, thirteen were fastener manufacturers, ten domestic
and three foreign; thirteen were trade associations, ten domestic and
three foreign; six were manufacturers of products that incorporate
fasteners, three aerospace manufacturers, two automobile manufacturers
(one domestic and one foreign), and one foreign equipment manufacturer;
three were fastener distributors; three were consultants; one was a
government agency; one was a foreign QAS registrar; and four were other
interested parties, two domestic and two foreign.
Of the 25 commenters opposed to the incorporation of SPC/QAS into
the FQA regulations, four were consultants; four were laboratory
accreditors/accessors; three were domestic fastener manufacturers; two
were fastener distributors; three were government agencies; one was a
raw material manufacturer; and seven were other interested parties.
Comment: Support for the proposed incorporation of QAS/SPC into the
regulation was widespread, although many raised questions on details of
the regulation, as is explained more fully elsewhere in this document.
However, a substantial minority of the commenters, twenty-five,
expressed the concern that without final testing, the QAS/SPC scheme
proposed by NIST would not ensure the quality of fasteners covered by
the regulations, and would fail to protect the public safety.
Response: The decision by the Department to include QAS/SPC into
the regulations as an alternative to end-of-line sampling and testing
is based upon strong evidence that QAS/SPC reduces the defect rate in
the fastener manufacturing process. A lower defect rate means that
fewer fasteners are manufactured that fail to comply with relevant
standards and specifications, and thus that fewer defective fasteners
will enter into commerce. Public safety is preserved and enhanced.
Furthermore, the Department has structured the regulation to provide
checks and balances to ensure that this is the case.
The administrative record for this rule-making contains strong
evidence that QAS/SPC systems utilizing continuous monitoring and
control in the manufacturing process yields a substantially lower
defect rate than do traditional manufacturing techniques that rely
solely upon end-of-line sampling and testing. Testimony at the Public
Workshop of February 7, 1997 indicates that the use of QAS/SPC may
reduce the defect rate from the range of thousands or tens of thousands
parts-per-million experienced by traditional manufacturing techniques
to approximately 100 parts-per-million. The improved manufacturing
techniques embedded in QAS/SPC thus improve the quality of fasteners by
reducing the portion of each lot that fails to meet standards and
specifications. The regulations being issued today offer the benefits
of QAS/SPC manufacturing to consumers in this country. But consistent
with the FQA, these regulations also mandate in-process inspection and
testing of fasteners manufactured under QAS/SPC systems, to verify that
the promise of QAS/SPC is the reality.
As a means of providing checks and balances to the process controls
that underlie the QAS/SPC methodology, the regulations mandate in-
process inspection and testing of fasteners to assure the quality of
fasteners, and thus the protection of public safety. Process controls
in QAS/SPC facilities are required by the regulation to be augmented by
all testing required by the standards and specifications that the
manufacturer holds out that a given lot meets. The general rule is set
out in Sec. 280.104(a), which states that registration of a fastener
manufacturing facility employing a fastener quality assurance system
(FQAS) shall be deemed to meet the requirements of accreditation of a
laboratory under the FQA. This general rule is amplified in Sec. 280.2,
which defines the term FQAS, and Sec. 280.10, which sets out
requirements for sampling methods to be followed by QAS/SPC facilities.
These sections of the regulation address three issues in the regime
required of QAS/SPC facilities:
What is the sampling methodology required of QAS/SPC
facilities as part of their responsibility to conduct in-process
testing and inspection?
What specific tests and testing techniques must QAS/SPC
facilities apply to the samples that are to be tested?
Where must these tests be performed?
Sampling is a concept that will not always be relevant in the QAS/
SPC environment. The definition of FQAS speaks about ``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.'' The Department recognizes that under
QAS/SPC, some tests and inspections will be conducted on every fastener
in the lot. That is, the test sample will be one hundred percent of the
fastener lot. Section 280.10(c), as it has been revised as a result of
the public comment
[[Page 18262]]
process, makes this point clear by stating, as one alternative, that
``a manufacturer operating a Registered Facility may elect to conduct
inspections and tests upon all of the fasteners within a specified lot,
provided that this election is documented in the control plan of its
Fastener Quality Assurance System.'' Otherwise, the sample size is
governed by the general rule in Sec. 280.10(a), which states that
``[f]or tests conducted either in a laboratory on the Accredited
Laboratory List or in a Registered Facility, if a manufacturer
represents that the fasteners in a particular sample have been
manufactured to a standard or specification which provides for the
size, selection or integrity of the sample to be inspected and tested,
the sample shall be determined in accordance with that standard or
specification''; or the first alternative in Sec. 280.10(c) ``For tests
conducted in a Registered Facility, and not in a laboratory on the
Accredited Laboratory List, if a manufacturer represents that the
fasteners in a particular sample have been manufactured to a standard
or specification which does not provide for the size, selection or
integrity of the sample to be inspected and tested, the sample for
inspections and tests by the Facility shall be determined by the
sampling plan provided by its Fastener Quality Assurance System or by
standards and specifications intended for use with a Fastener Quality
Assurance System, as appropriate.''
Tests are as required in the relevant standards and guidelines.
Where testing occurs in the QAS/SPC regime is governed by
Sec. 280.104(b) of the regulations, which requires that all in-process
laboratory inspection and testing must be performed in laboratories
accredited under the FQA; and Sec. 280.104(d), which requires that the
chemical composition of all fastener lots manufactured under QAS/SPC
must be conducted in laboratories accredited under the FQA. In-process
testing and inspection may occur within Registered Facilities.
In the view of the Department, these requirements meet the
statutory mandates of the FQA, and protect the public safety.
280.2 Definitions
Comment: Eight commenters addressed the issue of whether
subcontracted processes required final testing by an accredited
laboratory or whether they could be performed by another Facility.
Response: In Sec. 280.2, the definition of Facility has been
expanded to include a facility performing subcontracted processes such
as electroplating and heat treating, provided that they too are listed
on NIST's Facilities list. In addition, Sec. 280.807 allows
subcontracting to other Facilities listed on the Facilities list.
Comment: Eight commenters suggested that Quality Assurance Systems
are not equivalent, and that they do not define which characteristics
to measure and how to measure them.
Response: No changes have been made to the regulations based on
these comments because the QAS facilities must meet equally rigorous
standards to maintain their registration by an accredited Registrar.
Comment: Two commenters requested that the regulations be amended
to allow QAS in lieu of metal testing by a metal manufacturer.
Response: No changes were made to the regulations because to the
Department's knowledge, chemistry of metal is obtained by testing it in
a laboratory. Therefore, chemical analysis by QAS is not an acceptable
testing method.
Comment: Ten commenters suggested deleting references to ISO-9000
in the definition of Fastener Quality Assurance System because it lacks
quality details and does not contain the details of ISO-25. In
addition, three of these commenters stated that the proposed rule does
not satisfy the intent of the Congress and will have a serious effect
on the laboratory accreditation, and that a final inspection should be
still required.
Response: No changes were made to the regulations based on these
comments. The regulations are clear on laboratory accreditation and
registration of fastener manufacturing facilities. The laboratory
accreditation is performed in accordance with ISO Guides 58 and 25, and
specific requirements of the Act and the regulations. Registration of
fastener manufacturing facilities is carried out in accordance with the
ISO Guides 61, 62 and the specific requirements of the Act and the
regulations. The revised rule accommodating QAS facilities is fully
within the intent of the Act because under QAS, fasteners are produced
to stringent standards that yield fasteners of at least as good quality
as end-of-line laboratory testing can assure. Since the two programs,
accreditation and registration, are treated separately, the Department
does not believe that laboratory accreditation will be seriously
affected.
Comment: Two commenters suggested that the Department specify a
level of revision of ISO Guides referred to in the QAS regulations that
will assure the Department that the QAS approved today will remain
compliant in the future.
Response: No changes were made to the regulations based on these
comments. As they currently exist, the ISO Guides referenced in the QAS
regulations fulfill the needs of the Act and the regulations. The
regulations are sufficiently flexible to accommodate moderate change in
these standards.
Comment: One commenter remarked that the parameters of a control
plan are not discussed in the proposed rule.
Response: No changes were made to the regulations based on this
comment because the Department has decided that the broad parameters
described in Sec. 280.2 are sufficient.
Comment: One commenter suggested clarifying the meaning of
``documented criteria of a QAS.''
Response: No changes were made to the regulations based on this
comment because the definition of QAS describes specific criteria to be
met by the QAS facility.
Comment: One commenter suggested adding a requirement that
personnel who collect data pursuant to the operation of a QAS be held
to the same standards of training, experience and competency as
laboratory personnel.
Response: No changes were made to the regulations based on this
comment. The processes involved in laboratory testing differ from those
in a QAS facility. Requirements for personnel performing tasks involved
in these processes differ. The requirements for laboratory personnel
are described in ISO Guide 25. The requirements for QAS facility
personnel are described, in general, in the fastener QAS followed by
that QAS facility.
Comment: One commenter remarked that QAS plans should be required
to measure all characteristics called for in the standard and
specification, rather than just those that the manufacturer finds
appropriate for product functionality.
Response: The Department agrees. Changes were made to the
regulations in Sec. 280.2 under the definition of Fastener Quality
Assurance System in (2)(v). To improve clarity, this section is amended
to read as follows: ``a requirement that the in-process control plan
include those characteristics specified by the QAS standard,
characteristics specifically indicated by the applicable fastener
standards and specifications, and those characteristics as designated
by the end user for evaluating product functionality.''
Comment: One commenter asked if a fastener standard does not accept
SPC as an alternative to the final testing, then can the SPC be used.
[[Page 18263]]
Response: No changes were made to the regulations based on this
comment. If a fastener standard does not accept SPC, SPC may not be
used to meet the requirements of that standard.
Comment: One commenter requested amending Sec. 280.5 to confer upon
the major end user the responsibility of specifying how a lot of
fasteners is to be tested, including in accordance with major end users
in-house publication or in accordance with QAS, rather than in
accordance with the embedded standards and specifications.
Response: No changes were made to the rule based on this comment
because section 5(b)(1) of the Act requires that a manufacturer have
lot samples tested to determine whether the lot conforms to the
standards and specifications to which the manufacturer represents it
has been manufactured. The Act does not offer the flexibility of
delegating this responsibility to the end user.
Comment: One commenter suggested adding a definition of major end
user to the rule.
Response: The Department has not made any changes to the
regulations based on this comment. A definition of major end user is
not necessary because the term major end user does not appear in the
regulations.
Comment: One commenter remarked that NIST overlooked the basis of
its Malcolm Baldrige award, and NIST should practice its quality
outreach program by reissuing regulations to encompass ISO-9002 and QS-
9000 and state of the art quality programs.
Response: No changes were made to the regulations based on this
comment. ISO-9002 and QS-9000 are used worldwide while the Malcolm
Baldrige criteria are familiar only to United States firms. Since
fasteners to which the Act and the regulations apply are produced
worldwide, international standards are more appropriate.
280.5 Certification of Fasteners
Comment: One commenter proposed an amendment to Sec. 280.5 of the
rule to clarify that a manufacturer that follows QAS is in compliance
with the Act.
Response: No changes were made based on this comment because
Sec. 280.5(a) states the rule for inspecting, testing, and
certification of covered fasteners, and Sec. 280.104(a) brings
registered QAS facilities under this general rule, and therefore, in
compliance with the Act.
280.6 Laboratory Test Reports
Comment: Nine commenters stated that manufacturers registered to
QAS should not have to prepare test reports as proposed in Sec. 280.6
(b) and that requirement would make the QAS program unworkable. These
commenters stated that amendments to proposed Sec. 280.6(b) would be
necessary. In addition, two additional commenters requested that the
Department reduce the contents of the test reports for QAS facilities
since it is unnecessary and burdensome, limit requirements to those of
the Act and require just a statement that fasteners conform to the QAS
plan on the report.
Response: The requirement for a test report is mandated by sections
5 and 7 of the Act. However, based on these comments, amendments have
been made to Sec. 280.6(b) of the regulations by deleting certain
reporting requirements. Also, similar amendments were made in
Sec. 280.6(a) to simplify laboratory test report requirements for both
laboratories and Facilities. Further, Sec. 280.7 was amended to
accommodate amendments made to Sec. 280.6.
Comment: Two commenters asked whether imported fasteners produced
under QAS must be accompanied by a certificate and laboratory testing
report.
Response: No changes were made to the regulations because there is
no exception that states that imported fasteners produced under QAS
need not be accompanied by a certificate and laboratory test report.
Section 280.13 describes the requirements for imported fasteners, which
include a manufacturer's certificate of conformance and an original
laboratory test report.
Comment: One commenter suggested that a ``synopsis'' of the test
report would not provide assurances for end user.
Response: In response to this comment, the word, ``synopsis'' has
been deleted from Sec. 280.6(b) to clarify that registered facilities
must include test results in their reports rather than a synopsis of
their test results. The reporting of actual test results will provide
assurances for the end user.
Comment: Two commenters asked that QAS reports include basic and
unique identification information to tie a particular fastener lot with
the report and control plan.
Response: In response to this comment, the Department has amended
Sec. 280.6(b)(2) to require that test reports include: ``Unique
identification of the test report, including date of issue and serial
number, or other appropriate means, including reference to the control
plan identification.''
Comment: Three commenters suggested allowing facilities to make a
certified statement that fasteners with a specific lot number are
fulfilling the requirements of stated standards and specifications, in
place of a detailed test report as required by Sec. 280.6(b).
Response: No changes were made to the regulations based on this
comment because a certified statement will not satisfy the requirements
of sections 5 and 7 of the Act. An original laboratory testing report
and a manufacturer's conformance certificate are required.
Comment: One commenter asked how he should report QAS test results
in accordance with the regulations.
Response: No changes were made to the regulations based on this
comment because Sec. 280.6 describes procedures for reporting QAS test
results.
280.10 Sampling
Comment: Two commenters addressed a conflict between Sec. 280.10,
which pertains to sampling, and one of the goals of QAS. According to
these commenters, Sec. 280.10 appears to permit a plan provided by a
Fastener QAS only when the standards and specifications do not provide
for size, selection and integrity of the sample. However, one of the
goals of QAS is to have a control plan which describes a sampling plan.
Therefore, these commenters requested guidance on which sampling plan
should they follow. Another commenter requested allowing sampling plans
specified by the customer in a QAS control plan.
Response: Section 280.10 has been rewritten in response to these
concerns to clarify sampling requirements under the FQA and these
regulations. Section 5(b)(2) of the Act restricts the authority of the
Department to prescribe sampling procedures for fastener testing to
those instances where the standards and specifications relevant to a
fastener lot are silent on sampling. This is why revised Sec. 280.10(a)
states ``For tests conducted either in a laboratory on the Accredited
Laboratory List or in a Registered Facility, if a manufacturer
represents that the fasteners in a particular sample have been
manufactured to a standard or specification which provides for the
size, selection or integrity of the sample to be inspected and tested,
the sample shall be determined in accordance with that standard or
specification''.
However, in response to these comments, the Department has included
Sec. 280.10(c) to clarify sampling procedures in the QAS/SPC setting.
Section 280.10(c) sets out procedures to be followed when
Sec. 280.10(a) does not apply: ``For tests conducted in a Registered
Facility, and not in a laboratory on the Accredited Laboratory List, if
a manufacturer represents that the fasteners in a particular sample
have been manufactured to a standard or
[[Page 18264]]
specification which does not provide for the size, selection or
integrity of the sample to be inspected and tested, the sample for
inspections and tests by the Facility shall be determined by the
sampling plan provided by its Fastener Quality Assurance System or by
standards and specifications intended for use with a Fastener Quality
Assurance system, as appropriate. Or, a manufacturer operating a
Registered Facility may elect to conduct inspections and tests upon all
of the fasteners within a specified lot, provided that this election is
documented in the control plan of its Fastener Quality Assurance
System.''
The last sentence in Sec. 280.10(c) has been added because sampling
is a concept that will not always be relevant in the QAS/SPC
environment. The definition of FQAS speaks about ``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.'' The Department recognizes that under QAS/SPC, some
tests and inspections will be conducted upon every fastener in the lot.
That is, the test sample will be one hundred percent of the fastener
lot. The last sentence in Sec. 280.10(c), as it has been revised as a
result of the public comment process, makes this point clear by stating
that ``[A] manufacturer operating a Registered Facility may elect to
conduct inspections and tests upon all of the fasteners within a
specified lot, provided that this election is documented in the control
plan of its Fastener Quality Assurance System''.
Comment: Three commenters remarked that the default sampling plans
prescribed in the regulations are overly restrictive. One commenter
cited the example of sampling plans restricting lot size to 250,000
pieces while manufacturing lots may be larger.
Response: No changes were made to the regulations based on this
comment. Section 5(b)(2)(B) of the Act provides that default sampling
plans prescribed by the Secretary must, to the extent practicable, use
consensus testing standards and related materials. Sampling plans are
prescribed by these standards and specifications. NIST does not have
the authority to change those standards.
280.12 Applicability
Comment: Eighteen commenters stated that the planned implementation
date of May 26, 1998 will not allow enough time for NIST to approve
Accreditors, for Accreditors to accredit Registrars, and for the
Registrars to register fastener manufacturing facilities. Suggested
approaches were: (1) To delay implementation date of the Act until a
sufficient number of facilities are registered, (2) to grant
provisional approval of current QAS-registered facilities and begin
audit in six months, (3) to convene a meeting of all interested parties
to establish a reasonable time line for industry compliance.
Response: The Department has studied these comments and assessed
the registration requirements of the fastener industry. To accommodate
the industry needs, the Department has developed the following plan,
codified in Sec. 280.810(c)(3), to provisionally approve current QAS-
registered facilities so that commerce in fasteners is unaffected as a
result of the July 26, 1998 implementation date.
If a Facility intends to be listed in accordance with
Sec. 280.810(c)(1) but the registration process will not be completed
by July 26, 1998, the Facility may be provisionally listed on the
Facilities List by providing the following to NIST on or before
September 30, 1998:
1. Certification that: (a) The Facility is registered to QS-9000 or
an equivalent by a quality systems registrar; (b) the Facility conforms
to all other requirements of the Act and the regulations at the time of
certification; (c) if the Facility ceases to be registered to QS-9000
or an equivalent by an accredited Registrar and/or ceases to conform to
any other requirement of the Act and the regulations at any time during
the provisional listing period, it will notify NIST of that fact within
three working days; and (d) if the Facility fails to apply to an
accredited Registrar for registration under the FQA within 30 days of
the time the Registrar is accredited by a NIST-approved Accreditor, an
authorized representative of the Facility will immediately notify NIST.
(If the Facility's current Registrar decides not to seek accreditation
under the FQA, it is the Facility's responsibility to apply to another
Registrar that has been approved by NIST-ABEP.);
2. A list of fasteners produced or processed by the Facility,
identified by either a part number or a specification number;
3. A list of standards included in the Facility's registration;
4. A copy of the Facility's registration certificate; and
5. The listing fee established by NIST.
The Facility must meet all the requirements of the Act and the
regulations by May 25, 1999. If the Facility fails to receive FQA
registration by May 25, 1999, it will be removed from the Facilities
List.
Comment: Six commenters requested delaying the implementation date
(for example, one more year) so that outstanding questions can be
interpreted and lead time provided to get ready for implementation of
the Act.
Response: Changes were made to the regulations based on these
comments. As described earlier, the Department has developed a
procedure, based on industry input, by which manufacturing Facilities
in the QS-9000 system may ``self-certify'' for one year. The Department
is also delaying the implementation date from May 26, 1998 to July 26,
1998, following the Department's determination that there will be an
insufficient number of accredited laboratories to perform the volume of
inspections and testing required on May 26, 1998.
Comment: Three commenters, including a U.S. government agency,
requested delaying the implementation date until a detailed regulatory
flexibility analysis is conducted and published for public comment.
They claim the proposed regulations will have a significant negative
impact on fastener distributors and manufacturers because of the cost
of inventory scrapped, the cost of accrediting laboratories, the loss
of potential market share because of exemption of fasteners in free
trade zones, the disruption in supply and resulting loss of business to
OEM customers, the disproportionate cost of laboratory accreditation on
QAS registered facilities, and the disproportionate cost to certify raw
materials.
Response: A detailed regulatory flexibility analysis was conducted
and published as part of the final regulations on September 26, 1996,
which considered almost all issues raised by these commenters. The
remaining issues related to QAS regulations were addressed as part of
the proposed rule on September 8, 1997. As noted above, the Department
has delayed the implementation date until July 26, 1998.
Comment: An agency of the U.S. Government commented that the
proposed rule does not provide a meaningful regulatory alternative to
small businesses because of the short deadline of May 26, 1998, and
does not address economic impact on affected sectors.
Response: The Department has addressed the issue of the short
deadline for registering a sufficient number of facilities before the
July 26, 1998 implementation date by adding Sec. 280.810(c)(3), which
allows
[[Page 18265]]
provisional approval of current QAS-registered facilities if they meet
certain requirements.
The Department certified, under 5 U.S.C. 605(b), that the proposed
rule would not have a significant economic impact on a substantial
number of small entities. The factual basis for this certification was
published with the proposed rule. The Department does not agree with
the commenter's conclusion that the proposed rule does not afford a
meaningful alternative to small businesses as no preference is given to
large manufacturers and registrars over small industry participants.
This methodology would be available to any business, large or small,
that employs QAS of manufacturing. Moreover, whether small or large,
businesses are not forced to adopt QAS. The amended rule would
establish a second option for those manufacturers interested and
qualified to use the QAS of manufacturing.
On the issue of cost of inventory produced before the
implementation date, the industry has long recognized this problem and
has had adequate time to react appropriately. This issue has been
discussed several times since the 1992 comment process. In its January
10, 1995, report and recommendations for amending the Act, the Public
Law Task Force, the fastener industry coalition, recommended that
fasteners manufactured before the implementation date not be allowed to
be certified as conforming fasteners under the Act. This recommendation
was endorsed by the Fastener Advisory Committee in letters to Congress
dated February 9, 1995. Other cost elements were addressed in the
September 26, 1996 notice of final rulemaking.
280.104 Accreditation of Certain Manufacturing Facilities as
Laboratories
Comment: Four commenters stated that the requirement that in-
process testing be done by a laboratory on the Accredited Laboratory
List would require a costly additional evaluation of the laboratory by
an accreditation body. In addition, one suggested that the QS-9000
registration process should include accreditation of the Facility's
laboratory.
Response; No changes were made to the regulations based on this
comment. The requirement that in-process testing be performed by a
laboratory on the Accredited Laboratory List is included in the
regulations because registration of a QAS facility under ISO Guide 9001
or 9002 or QS-9000 does not include evaluation of technical credibility
and validity of test results from an accredited laboratory.
Comment: One commenter stated that having to be assessed by a body
approved by NIST is just as onerous a burden as getting laboratory
accreditation.
Response: No changes were made to the regulations because section 6
of the Act mandates that laboratory accreditation be performed by
accreditation bodies recognized by NIST. Facilities are brought into
the FQA regime under Sec. 280.104(a) of the regulations, which deems
registration of Facilities to meet the requirements of laboratory
accreditation. Therefore, the Act's requirements for laboratory
accreditation apply to the registration of Facilities, as well.
Comment: One commenter suggested clarifying the phrase ``any in-
process inspection and testing,'' because it does not include all in-
process testing at a QAS facility.
Response: Based on this comment, the Department revised
Sec. 280.104(d) of the regulations to clarify which tests must be
performed by a laboratory on the Accredited Laboratory List.
Comment: Three commenters suggested making laboratories used by QAS
registered facilities meet ISO Guide 25 and proficiency testing
requirements so that QAS registered facilities provide consistency in
accreditation of laboratories.
Response: Since these requirements are already present in the
revised regulations, no changes were made.
Comment: One commenter suggested that since laboratories must
comply with stricter standards (ISO-25, EN-45001, etc) than
manufacturers, the Department should allow laboratories owned by
distributors to use the same standards as manufacturers.
Response: No changes have been made to the regulations because
manufacturers follow QAS standards defined under Sec. 280.2 of the
regulations to qualify as a QAS facility. Distributors are not
manufacturers manufacturing, hence they cannot follow the same
standards as the manufacturers. However, irrespective of the ownership
of the laboratory, the laboratory has to meet the same requirements.
Comment: One commenter stated that recognizing SPC as an
alternative to final testing inspection is unlikely to benefit the
aerospace industry because aerospace industry specifications
specifically do not allow SPC.
Response: No changes were made to the regulations based on this
comment because the incorporation of fastener specific QAS standards is
an essential element of the QAS requirements. If the aerospace industry
requires final testing and inspection, it will not be affected by the
addition of the QAS option.
Comment: One commenter suggested that if a chemical laboratory is
included in the registration of a QAS registered facility, there is no
need to go to an accredited laboratory for testing.
Response: No changes were made based on this comment. Section
280.104(d) requires that chemical testing be performed by a laboratory
on the Accredited Laboratory List. Section 280.104(b) allows that 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 the regulations other than Sec. 280.104(a).
Therefore, a chemical laboratory cannot be accredited through
registration process.
Comment: One commenter requested providing clarification as to when
a QAS Facility does testing and when an accredited laboratory does
testing.
Response: In response to this comment, Sec. 280.104(d) has been
amended to clarify the requirements for laboratory tests.
Subparts I-L: Accreditation of Manufacturing Facilities; Foreign
Accreditors; Accreditors; Registrars
Comment: Two commenters requested amending Sec. 280.800 to allow
the use of QAS facilities registration by another agency, in addition
to NIST.
Response: No changes were made to the regulations based on this
comment. NIST is the only government agency allowed to carry out
laboratory accreditation under section 6 of the Act.
Comment: Three commenters suggested recognizing accreditation
bodies that have been recognized by organizations other than NIST. Two
commenters mentioned recognizing accreditation bodies accessed under
the International Accreditation Forum. One commenter suggested that if
one accreditation body is recognized in Europe under the Act and the
regulations, NIST should recognize all other bodies that are part of
multilateral agreements to which the recognized accreditation body is a
party.
Response: No changes were made to the rule based on this comment.
Section 6 of the Act allows FQA accreditation only by bodies recognized
by NIST. Under this regulatory program, each accreditation body must
apply to NIST directly and be individually evaluated to obtain
recognition. Blanket accreditation under a multilateral agreement or
under an international forum would not allow NIST to ensure that each
accreditation body meets all
[[Page 18266]]
requirements of the Act and the regulations.
Comment: One commenter asked if the Registrars will be required to
evaluate the substantive content of control plan.
Response: Under the definition of a Fastener QAS in Sec. 280.2, one
of the elements of a QAS is a requirement that a fastener manufacturer
fully document a detailed control plan. Therefore, it is the
responsibility of the manufacturer to develop and maintain a detailed
control plan. However, as part of the registration process, a Registrar
is required to evaluate the contents of the control plan.
Comment: One commenter stated that in Japan, a government body
approves QAS registered fastener manufacturing facilities as JIS
Marking factories. In this situation, the commenter asked, how will the
proposed system of registration work.
Response: No changes were made to the regulations based on this
comment because the system of registration in the current regulations
is based on internationally accepted procedures. The system proposed by
the commenter is different from the internationally accepted standards
procedures. The commenter has two options to comply with the
regulations: 1. Separation of registration and accreditation
activities; or 2. Use of a private registrar to register facilities.
Comment: One commenter asked if the United Kingdom Accreditation
Service (UKAS) can accredit Registrars for QAS assessments.
Response: No changes were made to the regulations based on this
comment because the procedures for seeking recognition by NIST-ABEP are
described in the ABEP handbook. If interested in engaging in the
acceditation of Registrars, UKAS must apply to NIST-ABEP for
recognition.
Comment: One commenter inquired whether approving Registrars will
require additional resources for NIST. According to the commenter, if
NIST approves registrars, it will be perceived as expansion of
government into a role previously performed by the private sector. If
that is the case, the commenter asked, why not rely on the private
sector.
Response: No changes were made to the regulations based on this
comment because the revised regulations clarify that NIST will not
directly accredit Registrars. NIST will rely on NIST-approved private
sector Registrar Accreditation Bodies to perform Registrar
accreditation. There will be no additional resources required for NIST
because section 6(d)(2) of the Act specifies that accreditation
activities performed by NIST will be on a reimbursable basis.
Comment: One commenter asked how NIST-ABEP will assure that a
manufacturer is competent to conduct fastener testing if the criteria
is based on ISO-9000 series.
Response: No changes were made to the regulations based on this
comment. Registering a fastener manufacturing facility to ISO-9000 does
not indicate that the facility is competent to perform laboratory
tests. Any laboratory tests performed during in-process inspection and
testing must be performed by a laboratory on the Accredited Laboratory
List.
Comment: One commenter commented that elements (ii), (iv), and (v)
in proposed Sec. 280.1010(d)(5) are not related to quality elements.
Response: No changes have been made to the regulations as a result
of this comment. Section 280.1010(d)(5) details the requirements for a
quality manual, which necessarily must contain administrative
information as well as quality elements. The same information is
required by ISO Guide 61, so these requirements are familiar to the
industry.
Comment: One commenter asked for clarification of terms used in
Secs. 280.1010 and 280.1011: ``appropriate international
documentation'' in Sec. 280.1010(d)(5)(xiv); ``informed'', ``corrective
action'', and ``timely and appropriate'' in Sec. 280.1010(f);
``appropriate international documentation'', ``technical experts'',
``assessment of familiarity'' and others in Sec. 280.1011. Similarly,
this commenter suggested that subparts K and L need to be reworked to
eliminate vague terms.
Response: No change was made to the regulations. The ABEP handbook
will provide guidance for interpreting these terms.
Comment: One commenter mentioned that Sec. 280.1010(i)(2), the
prohibition on disclosure of information about an accreditation body
without its written consent, could interfere with the responsibilities
of end-users to control the quality of their suppliers in quality
management.
Response: No changes were made to the regulations based on this
comment. Section 280.1010(i)(2) refers to confidentiality of
information obtained by the Accreditor concerning the applicant
Registrars. The Department feels that this provision is required to
safeguard confidentiality of the information provided by the Registrar
to its Accreditor. The regulations do not prevent the end user from
getting the quality management-related information of its Registrar
from the Registrar itself or from the Accreditor with the Registrar's
written permission.
Comment: One commenter stated that there is a high probability of
inconsistent requirements under various registration systems. This
commenter specifically asked how NIST will assure that NIST and
Registrar Accreditation Body recognition requirements are equivalent.
Response: No changes have been made to the regulations in response
to this comment. Subparts I through L describe the criteria by which
Registrar Accreditation Bodies will be approved and by which Registrars
will be accredited by the approved bodies. NIST plans to closely adhere
to these requirements to maintain uniformity among the Registrars
accredited by various bodies.
Comment: One commenter asked if auditors will be approved for
appropriate standard industrial codes. The commenter also asked if
auditors will be required to be experts in both QAS and fastener
technology.
Response: No changes were made to the regulations based on this
comment. Approval of auditors will be the responsibility of accredited
Registrars under subpart L, which is based on ISO Guide 62. Auditors
will be required to be competent in both QAS and fastener technology.
Additional requirements specific to the fastener technology will be
described in the ABEP Handbook.
Comment: One commenter requested that NIST function as a Registrar
Accreditation Body if no accreditation body seeks NIST's approval.
Response: No changes were made to regulations based on this comment
because NIST does not foresee such a problem. The industry has
indicated that accreditation bodies are ready to apply once the
regulations take effect.
Comment: One commenter suggested that all Registrars currently
approved by Registrar Accreditation Bodies should be automatically
approved by NIST and all companies with QAS systems accredited by those
Registrars should be deemed to have approved QAS.
Response: No changes were made to the regulations based on this
comment. Recognition of Accreditation Bodies, accreditation of
Registrars, and registration of Facilities under the Act and the
regulations include meeting requirements specific to the Act and
regulations. Therefore, prior recognition, accreditation, or
registration, based on different requirements, are insufficient to meet
the requirements of the Act and the regulations.
[[Page 18267]]
Comment: One commenter suggested appointing the major users of QS-
9000 as registrars.
Response: The requirements for an organization to qualify as a
registrar are outlined in subpart L. If a major user wants to become a
registrar, it must meet those requirements and must apply to a
recognized registrar accreditation body to become an accredited
registrar.
Comment: One commenter requested that the Act should merely require
that certification (recognition of accreditation bodies and
accreditation of registrars) be made in accordance with applicable
standards because existing certification practices are sufficient to
meet the purposes of the Act.
Response: No changes were made to the regulations based on this
comment because existing practices do not require that accreditation
bodies and registrars meet the specific requirements of the Act and its
implementing regulations and, therefore, are insufficient for these
purposes.
Comment: One commenter suggested modifying Sec. 280.1010(e)(1) by
replacing ``partially or in total, for all or part of the accreditation
body's scope of accreditation'' with ``for FQA.''
Response: No changes were made to the regulations based on this
comment. The regulations apply only to FQA accreditations, not all
accreditations. Therefore, the current language of Sec. 280.1010(e)
refers only to partial or total suspension or withdrawal of
accreditation under the FQA.
Comment: One commenter suggested modifying Sec. 280.1012(c)(2)(iii)
by replacing ``product categories'' with ``Fasteners.''
Response: The Department has accepted the suggestion and modified
Sec. 280.1012(c)(2)(iii) by replacing ``product categories'' with
``fasteners covered by the Act.''
Comment: One commenter requested deleting the requirement for
accreditors in Sec. 280.1010(b)(17) that they must have a structure
where members are chosen to provide a balance of interest, where no
single interest predominates.
Response: The Department has not made any changes to
Sec. 280.1010(b)(17) based on this comment because a balance of
interest is required to maintain objectivity in making decisions
related to accreditation.
Comment: One commenter requested deleting Sec. 280.1010(b)(18),
which is a requirement for accreditors that offer other products,
processes or services not to compromise confidentiality or the
objectivity or impartiality of its accreditation process and decisions.
Response: No changes were made to the regulations based on this
comment because, according to ISO Guide 61, this is a necessary
condition that assures a fair decision making process in granting
accreditations.
Comment: One commenter suggested the following changes to the
proposed regulations: replace ``international documentation'' in
Sec. 280.1010(d)(5)(xiv), Sec. 280.1010(b)(2), and Sec. 280.1010(b)(3)
with ``ISO Guide 10011-1.''
Response: No changes were made to the proposed regulations based on
this comment. The Department deliberately used the term ``international
documentation'' rather than referring to an existing document so as not
to restrict the interpretation of that term. The Department notes that
Secs. 280.1010(b)(2), and 280.1010(b)(3) do not include the words
``international documentation.''
Comment: Two commenters requested changing the reassessment period
for accreditors, registrars, and QAS manufacturing facilities from two
years to three years to be consistent with the policies of the
International Accreditation Forum.
Response: No changes were made to the regulations based on this
comment. The Department has decided to retain the two year reassessment
period in order to be consistent with the laboratory accreditation
reassessment period under the Act and the regulations.
Comment: Three commenters requested that NIST should have an
oversight role on the Registrar activities to assure uniformity.
Response: No changes were made to the regulations based on this
comment. Detailed descriptions of oversight roles will appear in the
ABEP Handbook.
Part 2: Summary of Comments Received on Six Proposed Amendments
Six issues were addressed in the proposed amendments with a request
for public comment. A discussion of the comments received, and the
actions taken by the Department as a result of these comments follows:
1. Significant Alterations of Fasteners
Of the 125 commenters, 15 commented on the issue of significant
alteration of fasteners; eight favored the proposed changes to the FQA
regulations, and seven others offered different issues in the area of
significant alteration. Of the eight commenters who favored the
proposed changes regarding the significant alteration of fasteners,
four were trade associations, three domestic and one foreign; two were
fastener manufacturers, one domestic and one foreign; one was a
fastener distributor; and one was an other interested party. Of the
seven commenters who proposed changes regarding the significant
alteration of fasteners, three were government agencies; two were
aerospace manufacturers; and two were consultants.
In the notice of proposed rulemaking, the Department proposed
changes to the definition of ``significantly alter'' in Sec. 280.2 and
to Sec. 280.11(b) to correct editorial errors in the reference to
Rockwell C hardness in these sections. These changes have been adopted
into the final rule.
Comment: One aerospace manufacturer, one professional organization
and one consulting organization commented that other alterations such
as application of adhesives, locking elements and cutting off of
finished fasteners should be considered significant alterations.
Response: Based upon advice from the Fastener Advisory Committee,
the Department has determined that application of adhesives, locking
elements, and cutting off of finished fasteners are not significant
alterations because they do not weaken or otherwise materially affect
the performance or capabilities of fasteners as they were originally
manufactured, grade or property class marked, tested, or represented.
This language appears in the current definition of ``significantly
alter.'' Therefore, no changes were made based on these comments.
Comment: One distributor commented that clarification is needed as
to whether ``coating'' a fastener with a Rockwell hardness of C32 or
above is a significant alteration.
Response: The definition of ``alter'' as contained in the Act lists
only through-hardening, electroplating, and machining as forms of
alteration. The regulations do not expand upon this definition.
Therefore, ``coating'' other than electroplating is not a significant
alteration under the Act and the regulations.
Comment: The Department received three comments, two from
distributors and one from an equipment manufacturer, requesting that
the regulations be revised to allow alterers who electroplate the
option of either testing or warning rather than requiring them to test
to the plating specifications.
Response: Based upon advice from the Fastener Advisory Committee,
which deliberated this issue at great length during the initial review
of the regulations implementing the Act and recommended the requested
option not
[[Page 18268]]
be offered for electroplating due to concerns about hydrogen
embrittlement as a result of electroplating, the Department has made no
changes to the rule.
Comment: One distributor suggested deleting all references to
adhesives and sealants from the regulations and workshop materials and
requested that the Department issue a clarifying statement that these
issues are not covered by the Act.
Response: No changes have been made to the rule based on this
comment. The definition of ``significantly alter'', as it appears in
the regulations, specifically states that ``[t]he term does not include
the application of adhesives or sealants * * *.'' The Department feels
that retaining this definition clarifies what processes are not
considered significant alterations for purposes of the Act and the
regulations.
2. Removal of Head Markings
Of the 125 commenters, 18 commented on the proposed amendment to
allow the removal of head markings for decorative purposes and to meet
customer needs; eight favored the proposed changes, and 10 were
opposed. Of the eight commenters who favored the proposed changes
regarding the removal of head markings, five were trade associations;
three domestic and two foreign; one was a foreign equipment
manufacturer; one was a foreign fastener manufacturer; and one was a
foreign other interested party. Of the 10 commenters who opposed the
proposed changes regarding the removal of head markings, four were
government agencies; two were fastener distributors; two were fastener
manufacturers, one domestic and one foreign; one was a trade
association; and one was an aerospace manufacturer. In all of these
comments, it was noted that the proposed amendments did not contain the
statement, ``fasteners are to be manufactured according to the OEM or
major end user standard which does not require head marking'' though
the same was found in the preamble. This statement was included in the
preamble in error. Some of these commenters noted that removal of head
markings would not have adverse implications.
The proposed rule included a proposed new Sec. 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. Based on comments
received, the Department has excluded this section from the final rule.
Comment: Two commenters suggested that the head marking exclusion
be moved to Sec. 280.700(b).
Response: No changes have been made based on this proposal. Since
the Department has decided not to adopt the proposed change, it will
not appear in either section.
Comment: Several commenters stated that the proposal to remove head
markings is contrary to the intent of the Act, and that markings are
vital for informing the user of strength levels and traceability. These
commenters emphasized that the removal of head markings does not
conform with the purpose of the Act that fasteners conform with
standards to which they were represented to have been manufactured. One
commenter from a trade association stated that removal of markings
promotes unsafe alteration of fasteners. Three commenters (a
manufacturer and two trade associations) noted that allowing the
removal of markings could lead to misapplication, misrepresented
fasteners, entry of substandard fasteners into commerce, and
significant equipment failures. These commenters stated that if the end
users want fasteners without markings, they can contract to have them
made that way. One manufacturer stated that no sales should be allowed
without the markings. Two commenters from U.S. Government agencies
stated that the removal of head markings would hinder investigations
and reduce accountability; therefore, it should not be allowed.
Response: Based on comments, the Department has decided not to
adopt the proposed change but to retain the existing rule.
3. Supplying Originals vs Copies of Test Reports
Of the 125 commenters, 18 commented on the issue of originals vs.
copies of test reports; 13 favored the proposed changes, and five were
opposed. Of the 13 commenters who favored the proposed changes
regarding originals vs. copies of test reports, five were trade
associations, two domestic and three foreign; four were fastener
manufacturers, three domestic and one foreign; three were consultants;
and one was a government agency. Of the five commenters opposed to the
proposed changes, two were government agencies; two were fastener
manufacturers, one domestic and one foreign; and one was a raw material
manufacturer.
The proposed rule included a proposed amendment to the definition
of ``original laboratory testing report'' in Sec. 280.2 to allow metal
manufacturers, as well as laboratories, to certify copies of laboratory
testing reports of chemical characteristics. Based on comments
received, the new definition has been included in the final rule. In
addition, the Department has added a definition of ``certified copy''
to further clarify the issue.
Comment: Two foreign equipment manufacturers commented that the
proposed rule does not allow a fastener manufacturer to test his own
fasteners rather than rely on the metal manufacturer's chemical
analysis of the metal.
Response: The Department has determined that the proposed rule does
not prevent fastener manufacturers who choose to adopt QAS from
obtaining chemical analysis, provided that the fastener manufacturers
obtain such analysis from an accredited laboratory.
Comment: A manufacturer proposed an approach in which the fastener
manufacturer keeps the actual test report of material chemistry and
transfers only the data from the raw material test report.
Response: The Department has determined that this approach is not
consistent with section 5 of the Act, according to which the entire
chemical test report is necessary for traceability purposes.
Comment: One commenter recommended that the term ``certified copy
of test report'' be explained or defined.
Response: The Department concludes that it would be useful to
provide guidance as to what constitutes a certified copy. Therefore,
this final rule amends Sec. 280.2 to add a definition to read as
follows: ``Certified Copy (of a laboratory testing report) means a
complete and accurate copy of the original laboratory testing report,
which contains a statement describing it as an accurate and complete
copy of the original and which is signed by an authorized
representative of the accredited laboratory issuing the report or, in
the case of metal chemistry testing reports, an authorized
representative of the metal manufacturer.''
Comment: One consulting firm recommended that the Department repeal
Sec. 280.15(d) of the regulations because it allows the fastener
manufacturer to use tests performed on the raw materials by the metal
manufacturer; however, the fastener manufacturer cannot prove that
fasteners came from the same coil or heat as required by
Sec. 280.15(d).
Response: The Department has determined that repeal of this section
is not appropriate at this time. Allowing chemical testing of raw
material by the
[[Page 18269]]
metal manufacturer to be sufficient for meeting the requirements of
chemical certification of fasteners was one of several options
recommended by a large segment to the industry as part of the 1996
amendments to the Act. The Fastener Advisory Committee supported this
amendment.
4. Laboratory Test Reports
Of the 125 commenters, seven commented on the issue of laboratory
test reports; all favored the proposed changes. Of the seven
commenters, three were trade associations, two domestic and one
foreign; two were foreign fastener manufacturers; and one was a
consultant.
Based on these comments, the Department has adopted the proposed
amendments dealing with a discrepancy in the language used in reporting
of alternative chemical characteristics. Following the amendments,
Sec. 280.6(b)(5)(ii), which is redesignated as Sec. 280.6(c)(5)(ii),
reads as follows:
Test results for such coil or heat number chemical
characteristics.
5. New Definition of Lot Number
Of the 125 commenters, 18 commented on the new definition of lot
number; four were in favor of the proposed changes, and 14 were
opposed. Of the four commenters who favored the proposed changes, two
were trade associations, one domestic and one foreign; one was a
fastener distributor; and one was a consultant. Of the 14 commenters
who opposed the proposed changes, five were fastener manufacturers,
four domestic and one foreign; three were domestic trade associations;
three were government agencies; one was a fastener distributor; one was
a fastener testing laboratory; and one was an other interested party.
The proposed rule included a proposed amendment to the definition
of ``lot number'' in Sec. 280.2 to include a number assigned by a
manufacturer, importer, distributor, or significant alterer to the lot.
Based on comments received, the Department has excluded the proposed
definition of lot number and retained the original definition of lot
number in the final rule. Based on the comments, for purposes of the
Act and the regulations, there is only one lot number that is assigned
by the manufacturer of fasteners or significant alterers, i.e., the lot
number is unique to the manufacturer or significant alterer.
Distributors and importers may use ``tracking numbers''; however, if
the tracking number is used for lot identification, both lot number and
tracking number must be used. Therefore, the Department has decided not
to adopt the proposed change but to retain the existing rule, under
which the ``Lot number means a number assigned by a manufacturer to the
lot.''
The following issues were highlighted by those that opposed the
adoption of the new definition of lot number:
--Allowing distributors and importers to designate lot numbers will
make it impossible for users to verify that the test report relates to
the fasteners they receive, possibly requiring them to engage in costly
retesting,
--The proposed rule would thwart enforcement efforts by creating gaps
in the paper trail,
--The proposed rule would conflict with published consensus standards,
--The proposed rule would conflict with numerous Federal and State
codes,
--The proposed rule would prevent product recalls,
--The proposed rule would make counterfeiting easier.
These commenters suggested that the original manufacturer's lot
number and any number assigned by an importer or distributor should be
sent to the end user. Otherwise, merely requiring that a subsequent lot
number be traceable to a manufacturer's lot number creates too great a
possibility that traceability will be lost. These comments suggested
that the lot number should be reserved for the number assigned to a lot
by the manufacturer; distributors and importers may assign their own
inventory number or tracking number or traceability number.
Comment: One commenter suggested allowing alterers to deliver only
the new lot number assigned by the alterer so long as it is traceable
to the manufacturer's lot number.
Response: The Department does not consider this to be an
appropriate change because traceability would be questionable.
Comment: A common theme among those who supported this proposed
change in the definition of lot number is that distributors and
importers that use their own lot numbers should be able to prove that
those lot numbers link to manufacturer's lot numbers all the way back
to ladle analysis, and there should be no provision allowing the
fasteners to be sold without the manufacturer's original lot number.
Response: No changes were made to the regulations based on these
comments because importers and distributors can use a trace number to
avoid confusion with the lot number that is assigned by manufacturers.
Comment: One commenter asked how the two numbers should be
identified.
Response: The Department recommends that both numbers, the lot
number assigned by the manufacturer and the trace number assigned by
the distributor or importer, appear on the package and wherever the
trace number appears.
6. Grandfathered Fasteners Issue
In response to the notice of proposed rulemaking, NIST received 28
comments on the issue of grandfathering, i.e., representing that
fasteners produced prior to the implementation date of May 26, 1998 are
in compliance with the Act and the regulations. Of the seven commenters
that opposed any form of grandfathering, three were agencies of the
U.S. Government, two were domestic fastener manufacturers, and one was
a domestic trade association. Of the 21 commenters who suggested that
grandfathering of different degrees should be allowed, 10 were fastener
manufacturers, nine domestic and one foreign; five were domestic trade
associations; three were fastener distributors; one was a foreign
automobile manufacturer; and one was an other interested party.
In the notice of proposed rulemaking, the Department proposed
amending section 280.12(c) of the regulations by moving the last
sentence of that 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 Sec. 280.602,
Violations. Based on the comments and because as a prohibition on
certain specific conduct, the language more appropriately belongs in
the Violations section, the Department has included this change in the
final rule, with appropriate modification to reflect the changes made
to Sec. 280.12 that are described below.
Although the commenters supported the proposed change, the comments
NIST received offered a wide variety of alternative grandfathering
solutions. The Department considered each of these, as well as other
regulatory alternatives.
The first and most crucial ``regulatory'' alternative for the
disposition of pre-existing inventory is found in section 15 of the Act
itself, which provides that the requirements of the Act apply only to
fasteners manufactured after the implementation date of the regulation,
now set at July 26, 1998. Thus, the sale of pre-existing inventory
after the regulation becomes effective is legal, and the fasteners may
properly be held out as complying with relevant standards and
specifications.
[[Page 18270]]
Five other regulatory alternatives have been considered by the
Department during the current rulemaking. The genesis of the
Department's consideration of the pre-existing inventory or
``grandfathering'' issue, however, predates the promulgation of the
final rule implementing the FQA on September 26, 1996. (See 61 FR
50538.) During that rulemaking, NIST sought the advice of the Fastener
Advisory Committee on the grandfathering issue, noting that the Act
prohibited all parties from holding out fasteners in the pre-existing
inventory as being compliant without the various lots of fasteners
being retested. The Fastener Advisory Committee responded that
fasteners in the pre-existing inventory, if not held out as FQA
compliant, could still be sold after the implementation of the Act,
meaning that the companies would suffer no economic loss on these
fasteners. The Committee, also, however, recommended to NIST that
finished fasteners manufactured prior to the implementation date be
permitted to be retested to be in compliance with the FQA provided that
all the associated requirements of law could be met for the lot of
fasteners in question, such as the presence of the original set of
certifications. The Committee also recommended a one year moratorium on
the retesting of these fasteners to avoid shortages in the pipeline
that could occur if pre-implementation material was put up for
retesting at the same time as new complying material was put up for
initial testing. There also was discussion of placing a time limit,
i.e., three years or five years, on retesting of pre-implementation
fasteners, but no conclusion was reached on this issue. The Fastener
Advisory Committee reemphasized that if the holders of pre-existing
inventory did not wish to incur the cost of the retesting after the
proposed moratorium, the product would still be saleable in commerce
under section 15 of the Act.
Due to concerns about lot integrity and falsification of
certification documents for pre-implementation fasteners, and the
``bottle-necking'' concerns raised by the Fastener Advisory Committee,
in the final regulations of September 26, 1996, NIST made no provision
for the retesting of the pre-existing inventory. This effectively meant
that the fasteners in the pre-existing inventory, when sold after the
effective date of the regulations, could not be held out as FQA
compliant.
Following the September 8, 1997 notice of proposed rulemaking, the
Department has considered the following alternative solutions to the
grandfathering issue, each of which was supported by one or more
comments:
(1) Seven of the comments opposed any regulatory change that would
permit fasteners manufactured before the effective date of the
regulation to be held out as complying with the FQA. The Department
views this as essentially a reaffirmation of the proposed change. Among
the reasons stated for this position were: The inability of a procurer
of fasteners to determine whether the fasteners were manufactured pre-
or post-FQA; possible hindrance of the Government's ability to
prosecute defective or counterfeit fastener cases currently being
investigated; enforcement problems; the additional cost and demand on
laboratories that retesting would cause; and the inability to
``upgrade'' lots of fasteners produced to previous revisions of
consensus standards to certify that they conform to the requirements of
the current revisions.
(2) One comment suggested that NIST permit new fasteners tested in
a duly accredited FQA laboratory prior to the effective date of the
regulation be permitted to be held out as FQA compliant. NIST deemed
this alternative to be permissible under the FQA since the requirement
of testing in a FQA accredited laboratory has been met.
(3) Two comments suggested that the regulation be amended to permit
fasteners to be held out as FQA compliant if they are included in lots
of fasteners manufactured before the effective date of the regulation
but subsequently tested or retested after the effective date of the
regulation in FQA accredited laboratories. NIST deemed this alternative
to be permissible under the FQA since the FQA requirement of testing in
an FQA accredited laboratory has been met.
(4) Eight comments suggested that since fasteners are manufactured
to high standards, NIST should permit all fasteners manufactured prior
to the effective date of the regulation to be held out as FQA
compliant, regardless of whether the fasteners were ever tested in a
laboratory, accredited or otherwise. NIST has rejected this alternative
because the FQA requires that fasteners must be tested by an accredited
laboratory to be deemed FQA compliant. Hence, this alternative is not
permissible by law, since it does not require testing.
(5) Six comments suggested that fasteners manufactured prior to the
effective date be deemed to be FQA compliant after a ``paperwork''
review of laboratory records. NIST has rejected this alternative
because the FQA requires that fasteners must be tested by an FQA
accredited laboratory to be deemed FQA compliant. Hence, this
alternative is not permissible by law, since the tests being reviewed
were not conducted by FQA accredited laboratories.
(6) The recommendation of the Fastener Advisory Committee received
no comment, but is the sixth alternative considered by NIST.
Thus, NIST was left with four lawful alternatives, options (1),
(2), (3), and (6) above. Based upon the public comments, NIST believes
that the weight of the evidence supports the view that some form of
grandfathering beyond option (1) is appropriate. Accordingly, NIST has
decided to proceed immediately with option (2) and has included this
option in the final rule in Secs. 280.12 (d) and (e). Section 280.12(d)
allows that ``fasteners manufactured on or after May 14, 1998 may be
represented, sold, or offered for sale as complying with the Act and
these regulations if they are tested and certified by a laboratory
appearing on the Accredited Laboratory List * * * and meet all other
requirements of the Act and this part.'' Section 280.12(e) allows that
``fasteners manufactured on or after May 14, 1998 by a Facility listed
on the Facilities List may be represented, sold, or offered for sale as
complying with the Act and regulations'' if the Facility meets the
requirements of Sec. 280.810(c)(3).
NIST does not believe that the existing record permits it to
endorse either option (3) or (6).
7. Paperwork Reduction Act and Regulatory Flexibility Act
Various commenters questioned the statements made in the preamble
to the proposed rule regarding the Paperwork Reduction Act or the
Regulatory Flexibility Act or both. In general, these commenters stated
that the Department understated the cost to industry to comply with the
Act and regulations and the impact that those costs would have on small
businesses. The costs cited in these comments included the costs of
scrapping inventories and disruptions to supply because customers would
not accept preimplementation fasteners on or after the implementation
date, the costs of obtaining laboratory accreditation or using an
accredited laboratory, the costs of testing small lots, the costs of
added paperwork and storage of records. Two specific proposals were
made in regard to this issue. One proposal was to form a joint
government-industry task force to measure the costs of compliance. The
other proposal was to conduct an in-
[[Page 18271]]
depth analysis of the negative impact on distributors and manufacturers
under the Regulatory Flexibility Act and publish it for public comment.
Several commenters recommended delaying implementation of regulations
because of the costs to industry. The Department notes that all of the
concerns cited above relate to the cost of complying with the existing
rule. The final rule creates an option for fastener manufacturers to
use, in certain instances, instead of the existing rule. Any costs
associated with developing a registered fastener QAS would not be
affected by the costs of complying with the existing rule. Therefore,
the Department is not delaying the implementation of the regulations
due to this issue.
Comment: Two trade organizations commented that the cost of raw
material analysis obtained by coil analysis is disproportionately high
for small producers.
Response: No change is made based on this comment. The requirements
for raw material analysis and reports under the Act are the same for
large producers and small producers. Under the revised regulations,
small firms may obtain raw material analysis reports from either the
laboratory that conducted the tests or from the metal manufacturer.
Part 3: Comments Received Regarding Issues Not Presented for Public
Comment in the Notice of Proposed Rulemaking
The Department received many comments on issues that were not
presented for public comment in the notice of proposed rulemaking.
These issues included: Repeal the Fastener Quality Act, amend the
Fastener Quality Act, deem compliance with other regulations to be
compliance with the Fastener Quality Act, create exemptions to the
coverage of the Act and regulations, and define more terms. The
Department will not respond to these comments at this time because they
were not presented for public comment in the notice of proposed
rulemaking but will retain these comments for possible action at a
later date.
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
The Assistant General Counsel for Legislation and Regulation of the
Department of Commerce certified to the Chief Counsel for Advocacy of
the Small Business Administration that this rule will not have a
significant economic impact on a substantial number of small entities.
NIST received one comment, addressed above, regarding this
certification. This comment did not cause a change in the determination
regarding the certification. As a result, no final regulatory
flexibility analysis was 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 rule contains collections of information subject to the
requirements of the Paperwork Reduction Act that have been cleared
under OMB Control Nos. 0693-0015 and 0693-0026. The public reporting
burden for the self-certification of QAS fastener manufacturing
facilities is approximately four hours: The provisional registration is
estimated at three hours, and one hour for the associated recordkeeping
requirements. Send comments regarding these burden estimates or any
other aspect of the data requirements, including suggestions for
reducing the burden to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Washington, DC 20230
(Attention: NIST Desk Officer) and to NIST (Attention: FQA 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: April 3, 1998.
Robert E. Hebner,
Acting Deputy Director, National Institute of Standards and Technology.
Dated: April 3, 1998.
William A. Reinsch,
Under Secretary for Export Administration.
For reasons set forth in the preamble, Title 15 of the Code of
Federal Regulations part 280 is amended as follows:
PART 280--FASTENER QUALITY
1. The authority for part 280 continues to read as follows:
Authority: Sec. 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 has also delegated concurrent
authority to amend the regulations issued under section 8 of the Act,
regarding recordal of insignias, to the Assistant Secretary and
Commissioner of Patents and Trademarks.
3. Section 280.2 is amended by revising the definitions for
accreditation, consensus standards organization, and original
laboratory testing report, 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).
* * * * *
Accredited registrar means a registrar, as defined in this part,
that is accredited by a recognized accreditor and appears on the
Registrars List described in section 280.810(b).
* * * * *
[[Page 18272]]
Accreditor means a Registrar accreditation body that meets the
requirements of subpart K of this part.
* * * * *
Authorized representative means an employee of an organization who
is authorized by that organization to speak on its behalf for purposes
of the Act and this part.
* * * * *
Certified Copy (of a laboratory testing report) means a complete
and accurate copy of the original laboratory testing report, which
contains a statement describing it as an accurate and complete copy of
the original and which is signed by an authorized representative of the
accredited laboratory issuing the report or, in the case of metal
chemistry testing reports, an authorized representative of the metal
manufacturer.
* * * * *
Consensus standards organization means the American Society for
Testing and Materials (ASTM), American National Standards Institute
(ANSI), American Society of Mechanical Engineers (ASME), Society of
Automotive Engineers (SAE), or any other consensus standards setting
organization (domestic or foreign) publicly identified by NIST as
having comparable knowledge, expertise, and concern for the health and
safety in the field for which such organization purports to set
standards.
* * * * *
Facility means a fastener manufacturing facility, or a facility
performing subcontracted processes for a fastener manufacturing
facility, implementing a fastener quality assurance system as defined
in this part.
* * * * *
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, AS-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, to avoid product
lot contamination, and that finished lots of fasteners shall be
traceable to subcontracted processes performed by a registered Facility
on the Facilities List described in Sec. 280.810 of tested by a
Laboratory on the Laboratories List described in Sec. 280.101;
(iv) A requirement 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 and
specifications, and those characteristics as designated by the end user
for evaluating product functionality.
* * * * *
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.
* * * * *
Recognized accreditor means an accreditor, as defined in this part,
that is recognized by NIST and appears on the Accreditors List
described in Sec. 280.810(a).
* * * * *
Registered facility means a facility, as defined in this part, that
is registered by an accredited registrar and appears on the Facilities
List described in Sec. 280.810(c).
* * * * *
Registrar means a quality systems Registrar that meets the
requirements of subpart L of this part.
* * * * *
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 revised to read as follows:
Sec. 280.6 Laboratory test reports.
(a) When performing tests for which they are accredited under this
part, each laboratory accredited under subparts C, D, or E of this part
and currently listed in the Accredited Laboratory List shall issue test
reports of its work which accurately, clearly, and unambiguously
present the test conditions, test set-up,
[[Page 18273]]
test results, and all information required by this section. All 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 laboratory;
(2) Unique identification of the test report including date of
issue and serial number, or other appropriate means;
(3) Name and address of client;
(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 indicating washer); thread form and class of fit;
(vi) Product standards and specifications related to the laboratory
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) Final manufacturing lot size;
(6) Test Results:
(i) Test results for each sample;
(ii) All deviations from the test method;
(iii) All other items required on test reports according to the
test method;
(iv) Where the report contains results of tests performed by sub-
contractors, these results shall be clearly identified along with the
name of the laboratory and accreditation information listed in
paragraph (a)(10) of this section.
(v) A statement that the samples tested either conform or do not
conform to the fastener standards and specifications and identification
of any nonconformance, except as provided for in Secs. 280.13 and
280.14;
(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 body which accredited the laboratory for the
specific tests performed which are the subject of the report, and code
number assigned to the laboratory by the accreditation body, and the
expiration of accreditation.
(b) When performing tests for which they are registered under this
part, each facility registered under subpart I or J of this part and
currently listed in the Facilities List shall issue test reports of its
work which accurately, clearly, and unambiguously present 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 reports must be in English or be translated into
English, must be signed by an approved signatory, must be protected by
a temper 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 including
references to control plan identification;
(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 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) Final manufacturing lot size;
(iii) Identification of control plan governing production of the
lot to which the test report is applicable;
(6) Test Results:
(i) Test results of actual tests required by applicable fastener
standards and specifications, and characteristics designated by the end
user;
(ii) All deviations from the test method;
(iii) All other items required on test reports according to the
applicable fastener standards and specifications, and characteristics
designated by the end user;
(iv) 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)(9) of this section.
(v) Where all processes under the applicable QAS were found to be
in accordance with the inspections, tests and measurements required by
the standards and specifications and the QAS and characteristics
designated by the end user, a statement that the samples tested conform
to the applicable fastener standards and specifications;
(vi) Where any process under the applicable QAS was found not to be
in accordance with the inspections, tests, or measurements required by
such QAS, a statement that the samples tested do not conform to the
applicable fastener standards and specifications and identification of
any nonconformance;
(7) A statement that the report must not be reproduced except in
full;
(8) Name, title and signature of approved signatory accepting
technical responsibility for the tests and test report;
(9) 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) For alternative chemical tests carried out under Sec. 280.15 of
this part, each laboratory accredited under subparts C, D, or E of this
part and currently listed in the Accredited Laboratory List shall
provide to the fastener manufacturer, either directly or through the
metal manufacturer, a written inspection and testing report containing
all required information. All 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 laboratory;
(2) Unique identification of the test report including date of
issue and serial number or other appropriate means;
(3) Name and address of client;
(4) Coil or heat number of metal being tested;
(5) Test Results:
(i) Actual tests required by the standards and specifications;
(ii) Test results for such coil or heat number chemical
characteristics;
(iii) All deviations from the test method;
(iv) All other items required on test reports according to the test
method;
[[Page 18274]]
(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 and accreditation information listed in
paragraph (c)(9) of this section.
(vi) A statement that the samples tested either conform or do not
conform to the metal standards and specifications and identification of
any nonconformance;
(6) A statement that the report must not be reproduced except in
full;
(7) A statement to the effect that the test report relates only to
the item(s) tested;
(8) Name, title and signature of approved signatory accepting
technical responsibility for the tests and test report;
(9) The name of the body which accredited the laboratory for the
specific tests performed which are the subject of the report, and code
number assigned to the laboratory by the accreditation body, and the
expiration of accreditation.
(d) The laboratory shall issue corrections or additions to a test
report only by a further document suitably marked, e.g., ``Supplement
to test report serial number * * *.'' This document must specify which
test result is in question, the content of the result, the explanation
of the result, and the reason for acceptance of the result.
(e) For tests carried out by a Facility registered pursuant to
subpart I or J of this part, 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 of this part, 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 performing the 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.
(a) For tests conducted either in a laboratory on the Accredited
Laboratory List or in a Registered Facility, if a manufacturer
represents that the fasteners in a particular sample have been
manufactured to a standard or specification which provides for the
size, selection or integrity of the sample to be inspected and tested,
the sample shall be determined in accordance with that standard or
specification.
(b) For tests conducted in a laboratory on the Accredited
Laboratory List, if a manufacturer represents that the fasteners in a
particular sample have been manufactured to a standard or specification
which does not provide for the size, selection or integrity of the
sample to be inspected and tested, the sample shall be determined in
accordance with the sampling plan provided by 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.
(c) For tests conducted in a Registered Facility, and not in a
laboratory on the Accredited Laboratory List, if a manufacturer
represents that the fasteners in a particular sample have been
manufactured to a standard or specification which does not provide for
the size, selection or integrity of the sample to be inspected and
tested, the sample for inspections and tests by the Facility shall be
determined by the sampling plan provided by its Fastener Quality
Assurance System or by standards and specifications intended for use
with a Fastener Quality Assurance System, as appropriate. Or, a
manufacturer operating a Registered Facility may elect to conduct
inspections and tests upon all of the fasteners within a specified lot,
provided that this election is documented in the control plan of its
Fastener Quality Assurance System.
7. Section 280.11 is amended by revising paragraph (b) 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.
* * * * *
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 July 26,
1998.
(b) Metal manufactured prior to July 26, 1998 may not be used to
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 July 26, 1998 or representing that such
fasteners meet standards and specifications of a consensus standards
organization or a government agency.
(d) Fasteners manufactured on or after May 14, 1998, may be
represented, sold, or offered for sale as complying with the Act and
these regulations if they are tested and certified by a laboratory
appearing on the Accredited Laboratory List described in Sec. 280.101,
and meet all other requirements of the Act and this part.
(e) Fasteners manufactured on or after May 14, 1998, by a Facility
listed on the Facilities List may be represented, sold, or offered for
sale as complying with the Act and these regulations upon NIST's
acknowledgment of receipt of the items required in Sec. 280.810(c)(3).
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
[[Page 18275]]
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, 280.808, and 280.809
of this part.
(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 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), (n), and (o) to read as
follows:
Sec. 280.602 Violations.
* * * * *
(e) Misrepresentation and concealment of facts. * * *
(2) In connection with the preparation, submission, use, or
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 July 26, 1998 as being in
conformance with the Act or this part except as provided for in
Sec. 280.12(d) or (e) of 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.
(o) Falsification of documents relating to the certification of FOA
compliance required for provisional listing on the Facilities List. No
person shall falsify or make any false or misleading statement on or in
connection with any document relating to the certification of FQA
compliance required for provisional listing on the Facilities List
pursuant to Sec. 280.810(c)(3).
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 Record keeping.
280.810 Listing of recognized accreditors, accredited Registrars,
and registered facilities.
280.811 Removal from a list.
280.812 Appeal.
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.
(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 of
this part. 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
Facilities: NIST recognizes Accreditors that meet the requirements of
subpart K of this part, which is based upon ISO Guide 61; the NIST-
recognized Accreditors may in turn accredit Registrars that meet the
requirements of subpart L of this part, 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.
[[Page 18276]]
Section 280.810 establishes three lists that NIST will maintain:
Section 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 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.
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
[[Page 18277]]
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 of this part.
(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 the 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.
(3)(i) If a Facility intends to be listed in accordance with
Sec. 280.810(c)(1) but the registration process will not be completed
by July 26, 1998, the Facility may be provisionally listed on the
Facilities List by providing the following to NIST on or before
September 30, 1998:
(A) Certification that:
(1) The Facility is registered to QS-9000 or an equivalent by a
quality systems registrar;
(2) The Facility conforms to all other requirements of the Act and
these regulations at the time of certification;
(3) If the Facility ceases to be registered to QS-9000 or an
equivalent by an accredited Registrar and/or ceases to conform to any
other requirement of the Act and these regulations at any time during
the provisional listing period, it will notify NIST of that fact within
three working days; and
(4) If the Facility fails to apply to an accredited Registrar for
registration under the FQA within 30 days of the time the Registrar is
accredited by a NIST-approved Accreditor, an authorized representative
of the Facility will immediately notify NIST. (If the Facility's
current Registrar decides not to seek accreditation under the FQA, it
is the Facility's responsibility to apply to another Registrar that has
been approved by NIST-ABEP.);
(B) A list of fasteners produced or processed by the Facility,
identified by either a part number or a specification number;
(C) A list of standards included in the Facility's registration;
(D) A copy of the Facility's registration certificate; and
(E) The listing fee established by NIST.
(ii) The Facility must meet all the requirements of the Act and
these regulations by May 25, 1999. If the Facility fails to receive FQA
registration by May 25, 1999, it will be removed from the Facilities
List.
(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.
Subpart J--Recognition of Foreign Registrar Accreditation Bodies
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,
[[Page 18278]]
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 of this part. 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 of this part and accredit Registrars of Facilities
to conditions set out in subpart L of this part.
Subpart K--Requirements for Registrar Accreditation Bodies
(Accreditors)
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.
280.1021 Preparation for assessment.
280.1022 Assessment.
280.1023 Assessment report.
280.1024 Surveillance and reassessment procedures.
Subpart K--Requirements for Registrar Accreditation Bodies
(Accreditors)
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 of 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 paragraph (d) of this
section, 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
[[Page 18279]]
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 section
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 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 functions;
(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;
[[Page 18280]]
(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, 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 Act and this part, 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 fulfill 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;
(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
[[Page 18281]]
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) Fasteners covered by the Act.
(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 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) As specified in Sec. 280.1010(g)(1) of this part, the
Accreditor shall maintain up-to-date detailed descriptions 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
[[Page 18282]]
(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.
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--Requirement for Registrars
General
Sec.
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.
Subpart L--Requirements for Registrars
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''
[[Page 18283]]
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 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 paragraph (d) of this
section, 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 the 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
Sec. 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 paragraphs (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, implemented, and maintained in accordance with
this part, and report on
[[Page 18284]]
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 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
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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 disclosed to a third party without the written consent of
the fastener manufacturer.
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 by 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 Act and this part, 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
[[Page 18286]]
corrective and preventive action; and document the actions taken and
assess their effectiveness.
Requirements for Registration
Sec. 280.1120 Application for registration.
(a)(1) As specified in Sec. 280.1110(g)(1) of this part, the
Registrar shall maintain up-to-date 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), 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 Sec. 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 asses 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
[[Page 18287]]
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.
(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. 98-9397 Filed 4-13-98; 8:45 am]
BILLING CODE 3510-13-M