Procedures for Implementation of the Fastener Quality Act

SUMMARY: The Director of the National Institute of Standards and

Technology (NIST), United States Department of Commerce, and the Under

Secretary of the Bureau of Export Administration, United States

Department of Commerce, request comments on proposed changes to the

regulations found at 15 CFR part 280 pertaining to implementation of

the Fastener Quality Act (the Act). The proposed changes allow

accreditation of in-process inspection activities of qualifying

statistical process control manufacturing facilities, address the issue

of passing laboratory inspection and testing reports along the supply

chain to the fastener manufacturer, address the issue of significant

alteration by removal of manufacturer or grade identification markings

for decorative purposes at the customer's request, address the issue of

grandfathering fasteners, and revise definitions and related sections

for clarity and to correct editorial error. The proposed changes will

facilitate the implementation of the Act and regulations and will

better accommodate modern industry practices by incorporating them into

the Fastener Quality Act certification process.

DATES: Comments must be received no later than November 7, 1997.

ADDRESSES: Comments on the proposed revisions must be submitted to: Dr.

Subhas G. Malghan, FQA Program Manager, Technology Services, National

Institute of Standards and Technology, Building 820, Room 306,

Gaithersburg, MD 20899, telephone number (301) 975-5120.

FOR FURTHER INFORMATION CONTACT: Dr. Subhas G. Malghan, FQA Program

Manager, Technology Services, National Institute of Standards and

Technology, Building 820, Room 306, Gaithersburg, MD 20899, telephone

number (301) 975-5120.

SUPPLEMENTARY INFORMATION:

Background

The Fastener Quality Act (the Act) protects the public safety by:

(1) Requiring that certain fasteners which are sold in commerce conform

to the specifications to which they are represented to be manufactured,

(2) providing for accreditation of laboratories engaged in fastener

testing; and (3) requiring inspection, testing and certification, in

accordance with standardized methods, of fasteners covered by the Act.

The Secretary of Commerce, acting through the Director of the

National Institute of Standards and Technology (NIST), published final

implementing regulations on September 26, 1996, establishing

procedures, under which: (1) Laboratories in compliance with the Act

may be listed; (2) laboratories may apply to NIST for accreditation;

(3) private laboratory accreditation entities (bodies) may apply to

NIST for approval to accredit laboratories; and (4) foreign

laboratories accredited by their governments or by organizations

recognized by the NIST Director under section 6(a)(1)(C) of the Act can

be deemed to satisfy the laboratory accreditation requirements of the

Act. The regulation also established, within the Patent and Trademark

Office (PTO), a recordation system to identify the manufacturers or

distributors of covered fasteners to ensure that the fasteners may be

traced to their manufacturers or private label distributors. In

addition, the regulations contained provisions on testing and

certification of fasteners, sale of fasteners subsequent to

manufacture, record keeping, applicability of the Act, enforcement,

civil penalties, and hearing and appeal procedures.

Those regulations became effective on November 25, 1996, and were

to apply to fasteners manufactured on or after May 27, 1997, the

``implementation date''. On April 18, 1997, pursuant to Section 15 of

the Fastener Quality Act, NIST announced a one year extension in the

implementation date of the regulations on grounds that there were an

insufficient number of accredited laboratories to conduct the volume of

inspection and testing required by the Act and regulations (62 Fed.

Reg. 19041 (1997)). NIST believes that it will have completed the

approval/accreditation of a sufficient number of accreditation bodies/

laboratories to implement the Act by May 26, 1998.

Following issuance of the final regulations on September 26, 1996,

the automobile industry approached the Department and expressed its

concerns that the Act and implementing regulations do not recognize the

use of modern manufacturing methods using prevention-based quality

assurance systems employing statistical process controls (SPC). During

the period of September 1996 to January 1997, the Department worked

with the automobile industry (domestic and foreign) to develop further

information about the extent of the problem. On February 4, 1997, a

Public Workshop was held at the National Institute of Standards and

Technology (NIST) to solicit information from the automobile,

aerospace, construction, and fastener industries on the use of

prevention-based quality assurance systems employing SPC in the

manufacture of fasteners. On the basis of this meeting and many

discussions with the concerned industries, the Department is proposing

amendments to the implementing regulations that will recognize the use

of prevention-based quality assurance systems under the Act and

regulations. These amendments are discussed in detail in Part 1 of this

proposed rule.

In addition to the above, the Department collaborated with industry

in conducting eleven Fastener Quality Act Workshops in various parts of

the United States, Europe, and Asia during the period from September

1996 to February 1997. The workshops attracted over 2,500 industry

participants who asked hundreds of questions of the Department on the

Act and regulations. As a result of those workshops and the great deal

of information provided by the industry participants on the impact of

the Act and regulations, the Department assembled evidence of need for

several possible amendments to the regulations. These amendments are

discussed in detail in Part 2 of this proposed rule.

Part 1: Summary of Proposed Amendments on Statistical Process Control

Background & Definition of the Issue

Ford, General Motors, and Chrysler Corporation established a

Supplier Quality Requirements Task Force in the 1980s to develop

quality system requirements (QS-9000) for their suppliers of materials

and parts. Initially, each company developed its own expectations for

supplier quality systems. In 1988, emphasis was placed on standardizing

the requirements, and in 1992 this was largely accomplished. The goal

of QS-9000 is the development of fundamental quality assurance systems

(QAS) that provide for continuous improvement, emphasizing

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defect prevention and the reduction in variation and waste in the

supply chain.

QS-9000 employs statistical process control (SPC) in ensuring the

quality of parts. Suppliers must demonstrate process capabilities which

will yield a given quantity of parts with a minimum specified number of

defects. Depending upon the fastener type and auto maker, the maximum

allowable defective Parts Per Million (PPM) ranges between 15 and 125

PPM.

The heart of the QS-9000 system is the Control Plan which each

company must develop and have approved by Ford, GM, or Chrysler as part

of their adherence to QS-9000. The Control Plan is a comprehensive

documentation of product/process characteristics, process controls,

tests, and measurement systems that will occur during mass production.

It will normally also specify how much in-process or final testing and

inspection will be carried out by the supplier company. This

determination is based upon demonstrated process capabilities,

experience with the supplier, etc. QS-9000 implies that, through

continuous improvement, a supplier company may ultimately be able to

demonstrate a capability of producing millions of parts with zero

defects by continuously monitoring and controlling the production

process rather than relying upon the inspection and testing of the

physical attributes of the manufactured product. Given the above, the

automotive industry asserts that the Fastener Quality Act's reliance on

lot control and final inspection of fasteners does not recognize the

reality of modern mass production using statistical process control.

As present, the FQA and implementing regulations, rely on the use

of accredited laboratories for inspection, testing, and certification

of fasteners to applicable standards and specifications. Sections 5 of

the Act and 280.5 of the regulations are very specific that a

manufacturer of a lot of fasteners shall cause a representative sample

of the fasteners in the lot to be inspected and tested by an accredited

laboratory, and a test report must be produced which indicates that the

fasteners tested are in conformance with all of the provisions of the

standards and specifications used by the manufacturer in the production

of the fasteners. The end result, and the cornerstone on which the Act

is based, is that every lot of fasteners is certified by the

manufacturer as conforming to a given standard and specification, and

the paperwork relating to such certification (e.g., certificates of

conformance and test reports) is maintained on file and available at

the purchaser's request.

In the case of fastener manufacturers supplying the automobile

industry, Ford, GM, and Chrysler, as major end users of the fasteners,

have established QS-9000 as a means of achieving the same end. Their

suppliers are required to: (1) Establish a control plan under which

they will produce fasteners to the auto industries standards and

specifications; (2) submit evidence in the form of production data that

they can produce fasteners under a specified defect rate; and (3)

perform continuous monitoring and tests to maintain control of the

production process and to assure that the final product will be in

conformance with fastener standards and specifications. The difference

between the previously published regulation and the QS-9000 approach is

that the regulation assures end users that fasteners meet standards and

specifications by relying upon the inspection and testing of fasteners

by accredited laboratories. Under QS-9000, the end users (Ford, GM, and

Chrysler) recognize the fastener manufacturer's entire production

process as a means of ensuring conformance to these end users standards

and specifications. Consequently, ensuring adherence to standards and

specifications, is equivalent under the QS-9000 approach to end product

testing. However, the automobile industry believes that reliance on QS-

9000, which is based upon continuous monitoring and improvement of the

manufacturing process, is more efficient and cost effective than

traditional manufacturing regimens of final inspection and testing of

the end product, and represents the direction in which manufacturing

technology is evolving in this country and abroad.

Parallels to QS-9000 are being used in other countries including

Japan, and in other industries. For example, the U.S. aerospace

industry employs statistical process control in much the same way that

the automobile industry does. That is, major end users of aerospace

fasteners are beginning to require their fastener suppliers to comply

with comparable quality assurance programs as a condition to supplying

them.

When the Fastener Quality Act was signed into law in 1990, QS-9000

was in the early stages of development, and its full implication for

the industry was not well known. There is some evidence in the history

of the Act that Congress was informed of the need to consider OEM based

quality assurance systems for procuring fasteners (e.g., Statement of

Donald Keil, Assistant Director of Quality, Caterpillar Inc., during

the Hearing on H.R. 3000 before the Committee on Commerce, Science, and

Transportation, United States Senate, S.Hrg. 101-509, November 20,

1989). However, the Act did not directly recognize major end user

quality system requirements for satisfying testing, inspecting and

certification provisions under section 5 of the Act. Similarly, in

August 1992, NIST published draft implementing regulations for public

comment. As a result of the public comment process, letters were

received from General Motors and Nissan Corporation calling attention

to quality assurance programs they had in place to qualify fastener

suppliers; they indicated that the Act would require some redundant

testing. However, no recommendations were made at that time to permit

recognition of QS-9000 type systems.

The discussions about the use of statistical process control within

the automobile industry, did not lead to specific recommendations for

treating SPC under the Act or regulations. However, the issue was

raised at a meeting of the Fastener Advisory Committee in May 1996. At

that meeting a member of the Advisory Committee raised the issue of

problems that fastener suppliers would face in meeting the inspection,

testing, and certification requirements of the Act and regulations.

Accordingly, a proposal was introduced to exempt from the regulations

the automotive fasteners produced to the standards of a major end user

such as GM, Ford, and Chrysler. Since May of 1996, the Department has

had many discussions of these issues with representatives of the

automobile industry (U.S. and foreign) and with fastener manufacturers

who supply such industries. On February 4, 1997, NIST held an open

meeting to solicit industry views on the use of SPC in the manufacture

of fasteners under the Act. The purpose of the meeting, attended by

some 150 industry representatives and Department officials, was to

determine the impact that inspection, testing, and certification

requirements of the Act and regulations would have on fastener

manufacturers who use SPC and to identify ways in which the

requirements of the Act and regulations might be met by prevention-

based QAS using SPC.

A report of the meeting was published in April 1997, NISTIR 6001--

``Summary of Public Meeting, Use of Quality Assurance Systems in the

Fastener Industry,'' and may be obtained from NIST. The report included

proposed regulatory language being considered at that time by the

Department for resolving the issues identified during the meeting. As

part of the report, the

[[Page 47242]]

Department invited industry to provide input on the suggested

regulatory approach. Some 30 letters were received by NIST, commenting

on the report and the proposed regulatory language. The vast majority

of these focused on the SPC issue, suggesting solutions ranging from

exempting the automobile industry from the Act and regulations to

incorporating SPC in the regulatory scheme. Many proposed specific

amendments to the regulations that would incorporate SPC. The

Department appreciates the spirit with which the automobile industry

has responded and had considered all comments received. It is believed

that the amendments proposed in this notice best achieve the

incorporation of SPC in the regulatory scheme.

The Proposed Solution to the QAS/SPC Issue

The Director of NIST is today proposing that a fastener

manufacturing facility employing a fastener quality assurance system

(QAS) as defined in the regulations may be deemed to be an accredited

laboratory for purposes of the Act and regulations if such facility has

been formally registered by a NIST-recognized quality systems

registrar.

NIST wishes to make it clear that recognition of facilities that

employ fastener QAS as accredited laboratories within the meaning of

the Act and regulations is an alternative to final inspection and

testing of fasteners that is still carried out by many fastener

manufacturers. Both approaches to meeting the requirements of the Act

and regulations are equally valid. Adoption of these proposed

amendments will enable the use of QAS in fastener manufacturing in a

manner consistent with the requirements of the Act by ensuring that

every lot of fasteners is sampled and examined to ensure conformance

with applicable standards and specifications. Manufacturers must follow

the requirements of the fastener standards and specifications, as

published by a consensus standards organization or a major end user.

For example, a fastener manufacturer cannot unilaterally decide to

replace final inspection and testing with a QAS unless the designated

standards or specifications provide for this as an alternative to final

inspection and testing.

A definition of ``Fastener Quality Assurance System (QAS)'' is

proposed as part of the amendments. In developing the QAS definition,

NIST feels it is important to provide guidance to the industry as to

the minimum elements a fastener manufacturer's QAS should contain to be

eligible for recognition as an accredited laboratory within the meaning

of the Act and regulations. These elements have been included in the

definition.

The Department believes that the proposed amendments resolve

industry's concerns that the Act and regulations should recognize the

use of modern manufacturing methods. Proposed procedures for applying

for NIST/ABEP recognition of registrar accreditation bodies that

accredit quality systems registrars, which are based upon international

standards, are included as subparts I through L.

Part 2: Summary of All Other Proposed Amendments

Since September 1996, eleven Fastener Quality Act Workshops have

been conducted in seven cities in the U.S. (Chicago [2], Cleveland,

Columbus, Houston, Newark, Atlanta, and Los Angeles), and in Taiwan and

the U.K. (two were held in London). Over 2,500 industry participants

attended the workshops. These included fastener manufacturers,

distributors, and importers, and representatives of industries such as

automotive, aerospace, construction, heavy machinery, etc., that

purchase and use high strength fasteners. At the workshops,

representatives of BXA, NIST, and the Patent and Trademark Office (PTO)

presented information on the Act and implementing regulations. In

addition, members of the Public Law Task Force (PLTF), a nine member

industry committee representing fastener manufacturers, distributors,

and importers, provided an industry perspective on the impact of the

Act and regulations. Over the course of the workshops some 450

questions from the participants were documented by the Department, with

the understanding that answers would be published as interpretive

opinions of the Department as soon as practicable.

During the course of the workshops a great deal of practical

information was exchanged among the participants on the impact of the

Act and regulations on daily commerce in fasteners. This information

has been analyzed by the Department and translated into proposed

amendments which are discussed below. Comments from the public are

requested on these proposed amendments.

1. Significant Alterations of Fasteners

Under section 280.2 of the regulations, ``significantly alter''

means to alter a fastener in a manner which could weaken or otherwise

materially affect the performance or capabilities of the fastener as it

was originally manufactured, grade or property class marked, tested or

represented. The term does not include the application of adhesives or

sealants, locking elements, provisions for lock wires, coatings and

platings of parts having a specified Rockwell C hardness of less than

32, or cutting off of fasteners. In the reference to Rockwell C

hardness, an editorial error was made in the September 26, 1996

issuance of the final regulations in that the word ``minimum'' was to

appear before the word ``specified'' so that it reads ``minimum

specified Rockwell C hardness of less than 32 * * * '' in section 280.2

and in section 280.11 (b) of the regulations. The Department proposes

amendments to these sections to correct this error.

2. Removal of Head Markings

Questions were raised during each of the workshops about specialty

fasteners and the practice of shaving or polishing of fastener heads to

remove all markings for decorative purposes. The cases mentioned were

of manufacturers of motorcycles and pianos which frequently special

order fasteners that will be subject to the Act and regulations without

any head markings on them because they do not want the markings to show

in the final product. However, the Department also recently received a

letter from the Association of International Automobile Manufacturers

(AIAM) indicating that some of its members produce company standards

which may reference consensus standards for certain requirements for

fasteners but which do not reference requirements for including the

manufacturer's insignia on the head of the fastener. AIAM asserts that

such practice is consistent with the Act and regulations and that the

manufacturer of the fastener may supply the fasteners to these

automobile manufacturers without any head markings. The issue is

whether a fastener manufacturer is in violation of the Act and

regulations if he/she fills such an order from a customer. Put another

way, how much flexibility does a customer have in requesting that

covered fasteners be supplied to them without the required headmarkings

if they are going to use the fasteners in their products and possibly

even sell them for repair and replacement parts?

The Department has studied this issue and is proposing to amend the

regulations by adding a new section 280.11(c) to allow a fastener user

or purchaser to special order fasteners covered under the Act and

regulations without the required manufacturer or grade identification

markings under certain conditions. The existing sections

[[Page 47243]]

280.11(c) and (d) are proposed to be redesignated as sections 280.11(d)

and (e). The new section 280.11(c) requires that: (1) The fasteners be

manufactured to an OEM or major end-user standard which does not

require such markings; or (2) the customer request in writing that

manufacturer or grade identification markings be removed for decorative

purposes and certifies that such fasteners will not be held out or sold

as meeting the requirements of a consensus standard which requires

manufacturer or grade identification markings.

3. Supplying Originals vs Copies of Test Reports

In all of the workshops, especially those held in Asia and in

Europe, concerns were expressed about the potential paperwork burden on

raw materials manufacturers in meeting the requirements of section

280.15 of the regulations. Raw materials manufacturers (domestic and

foreign) assert that the requirement for ``originally signed'' test

reports to accompany shipments of raw materials and finished fasteners

will be a significant burden to them.

In the case of raw material suppliers, the raw material purchased

by the fastener manufacturer typically goes through as many as four

processors, each performing a different operation that does not affect

the steel's chemical characteristics. In addition, distributors may be

involved in these transactions. Under one scenario, the following

successive processors/distributors transform the ingot/bloom to

fasteners:

Steel mill or melter or ingot producer irod produceri wire or rod

produceri distributori fastener producer

Current industry practice is that the steel mill is the primary

source at which the chemical characteristic certification is produced

and passed down to the first processor or distributor to whom it sells

the steel. All other subsequent processors, distributors and fastener

manufacturers in the above mentioned chain, produce their own

certification based on the results contained in the original chemical

certificate of the steel mill. This certificate consists of relevant

information such as the name of steel melter, steel mill

identification, heat number, and chemical analysis data. Therefore,

current industry practice is for everyone in the chain except the

original steel melter to reference the original chemical certification

data instead of passing on a certified copy of the chemical

characteristics certificate down the chain to the fastener

manufacturer. The primary reason for this practice is that from a

single heat number of steel, thousands of lots of fasteners can be

manufactured by an unknown number of fastener manufacturers. Moreover,

the steel mill would not know in advance the name of fastener

manufacturers who would purchase steel from a given heat number or the

number of certificates required from a heat number of the steel.

To comply with the Act and current regulations, either copies of

the laboratory report of chemical characteristics, certified by the

laboratory, must be passed down the supply chain ``through the metal

manufacturer'' or the fastener manufacturer must be responsible for

contacting the laboratory that performed the chemical tests to obtain a

certified copy directly. Since the metal manufacturers do not know how

many fastener manufacturers will acquire part of a particular heat or

coil, they do not know how many certified copies to request from the

laboratory at the time they obtain the original test report. The

fastener manufacturers feel it is burdensome for them to obtain

certified copies from the laboratories, and it is extremely burdensome

for the laboratories to have to retrieve reports and create certified

copies whenever requested by fastener manufacturers.

A solution that works for both fasteners of foreign origin and

domestically-produced fasteners is to allow copies of laboratory

testing reports of chemical characteristics only to be certified by

either the laboratory or the metal manufacturer. The definition of

``original laboratory testing report'' in section 280.2 is proposed to

be amended to allow metal manufacturers, as well as laboratories, to

certify copies of laboratory testing reports of chemical

characteristics.

4. Laboratory Test Reports

Several steel producers raised another issue with respect to the

chemistry certificate during the workshops. It deals with a discrepancy

in the language used in reporting of alternative chemical

characteristics, as follows:

1. Section 5(d)(3)of the Act requires reporting the, ``chemical

characteristics of such coil or heat number;''

2. Section 280.6(b)(5)(ii) of the regulations requires, ``test

results for each sample;'' and

3. Section 280.15(b) returns to the requirement for reporting,

``chemical characteristics of such coil or heat number.''

The chemical characteristics data required to be reported in

section 280.6(b)(5)(ii) is not the same as the other two sections

mentioned above. Currently, steel manufacturers use test reporting

methods that conform to section 5(d) of the Act, and section 280.15 of

the regulations. The reporting of the ``heat number analysis'' is well

defined in existing steel making practices and consensus standards. A

``heat number analysis'' consists of derived values for each element

from one or more samples taken from either molten metal or solid steel.

Overall, this method best describes the chemical characteristics of the

steel.

If section 280.6(b)(5)(ii) is not changed to make it in agreement

with other sections of the Act and regulations, several problems may

occur:

1. Steel suppliers will be forced to use their best judgement in

interpreting the Act, and proper methods of reporting of chemical

analysis;

2. Variations in interpretations will lead to serious disputes

between steel suppliers and their customers; and

3. Steel suppliers will be forced to change reporting methods to

those described in section 280.6(b)(5)(ii), which will result in

unnecessary costs to the industry.

Accordingly, the Department is proposing for public comment an

amendment to section 280.6(b), which is proposed to be redesignated as

section 280.6(c), which requires the reporting of test results for such

coil or heat number chemical analysis.

5. New Definition of ``Lot Number''

It was pointed out during the workshops that ``lot number'' as

defined in section 280.2 of the definitions means a number assigned to

the lot by a manufacturer, and that it is fairly common for

distributors and importers to assign their own unique lot number to

fasteners in addition to the number assigned by the manufacturer.

Further, section 280.11 of the regulations dealing with significant

alterations requires that significant alterors assign their lot numbers

to significantly altered fasteners. Accordingly, the Department is

proposing to amend the definition of lot number found in section 280.2

to include a number assigned by a manufacturer, importer, distributor,

or significant alterer to the lot. The amendment further stipulates

that a lot number assigned by an importer, distributor, or significant

alterer shall be traceable to a manufacturer's single, unique lot

number.

6. Grandfathered Fasteners Issue

Section 15 of the Act provides that the Act is applicable only to

fasteners manufactured after the implementation date of the Act.

Section 280.12(c) of the

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regulations further states that nothing in the Act or in the

regulations prohibits selling finished fasteners manufactured prior to

the implementation date of the Act, or representing that such fasteners

meet standards and specifications of a consensus standards organization

or a government agency. Additionally, this section of the regulations

states that fasteners manufactured prior to the implementation date of

the Act may not be represented as being in conformance with the Act or

the regulations.

It is clear that Congress, in enacting section 15 of the Act,

intended only to cover those fasteners produced after the

implementation date of the Act so as not to impose a hardship on the

industry by having existing product retested and certified. However,

representatives of the fastener industry met in January 1997 with

representatives of NIST and proposed that section 280.12(c) of the

regulations be amended by moving the last sentence of the section,

which states that fasteners manufactured prior to the implementation

date of the Act may not be represented as being in conformance with the

Act or the regulations, to section 280.602, Violations. This sentence

is moved to the violations section because as a prohibition on certain

specific conduct, it more appropriately belongs there.

Request for Public Comment: Persons interested in commenting on the

proposed regulations should submit their comments in writing to the

above address. All comments received in response to this notice will

become part of the public record and will be available for inspection

and copying at the Department of Commerce Central Reference and Records

Inspection facility, room 6228, Hoover Building, Washington, DC 20230.

Additional Information

Executive Order 12866

This rule has been determined not to be significant under section

3(f) of Executive Order 12866.

Executive Order 12612

This rule does not contain policies with Federalism implications

sufficient to warrant preparation of a Federalism assessment under

Executive Order 12612.

Regulatory Flexibility Act

Regulatory Flexibility Analysis of Procedures for Implementation of the

Fastener Quality Act

This proposed rule has been determined to be not significant for

the purposes of E.O. 12866.

The Assistant General Counsel for Legislation and Regulation of the

Department of Commerce certified to the Chief Counsel for Advocacy, the

Small Business Administration that this proposed rule, if adopted,

would not have a significant economic impact on a substantial number of

small entities as follows:

The proposed rule includes changes that allow accreditation of in-

process inspection activities of qualifying statistical process control

(SPC) manufacturing facilities, address the issue of passing laboratory

inspection and testing reports along the supply chain to the fastener

manufacturer, address the issue of significant alteration by removal of

manufacturer or grade identification markings for decorative purposes

at the customer's request, address the issue of grandfathering

fasteners, and revise definitions and related sections for clarity and

to correct editorial error. The proposed changes will facilitate the

implementation of the Fastener Quality Act (FQA) and regulations and

will better accommodate modern industry practices by incorporating them

into the FQA certification process. However, of all these proposed

changes, the major change covered here is that which allows

accreditation of in-process inspection activities of qualifying

statistical process control manufacturing facilities. The remaining

changes are relevant to the existing regulations that became effective

on November 25, 1996, and their impact on the fastener industry already

has been presented. Therefore, in this analysis, the issues relevant to

manufacturing of fasteners using only SPC or quality assurance systems

(QAS) are covered.

As presently constructed, the FQA and implementing regulations,

rely on the use of accredited laboratories for inspection, testing, and

certification of fasteners to applicable standards and specifications.

Sections 5 of the Act and 280.5 of the regulations are very specific

that a manufacturer of a lot of fasteners shall cause to be inspected

and tested a representative sample of the fasteners in the lot by an

accredited laboratory, and a test report must be produced which

indicates that the fasteners tested are in conformance with all of the

provisions of the standards and specifications used by the manufacturer

in the production of fasteners. The end result, and the cornerstone on

which the law is based, is that every lot of fasteners is certified by

the manufacturer as conforming to a given standard and specification,

and the paperwork relating to such certification (e.g., a certificate

of conformance and test reports) is maintained on file and available at

the purchaser's request.

In the case of fastener manufacturers supplying the automobile

industry, the industry has established QS-9000 as a means of achieving

the same end. That is, they qualify their suppliers by requiring them

to: (1) Establish a control plan under which they will produce

fasteners to their standards and specifications; (2) submit evidence in

the form of production data that they can produce fasteners under a

specified defect rate; and (3) perform continuous monitoring and tests

of the production process to maintain control of the process and to

assure that the final product will be in conformance with fastener

standards and specifications. The difference between the regulation as

it exists and the QS-9000 approach is that the regulation assures end

users that fasteners meet standards and specifications by relying upon

the inspection and testing of fasteners by accredited laboratories.

Under QS-9000, the end users (Ford, GM, and Chrysler) recognize the

fastener manufacturer's entire production process as a means of

assuring conformance to their standards and specifications. The end

result, that of assuring adherence to standards and specifications, is

the same under the QS-9000 approach as with end product testing.

However, the automobile industry believes that reliance on QS-9000,

which is based upon continuous monitoring and improvement of the

manufacturing process, is more efficient and cost effective than

traditional manufacturing regimens of final inspection and testing of

the end product, and represents the direction in which manufacturing

technology is evolving in this country and abroad.

To the extent the FQA permits flexibility in developing these draft

regulations, the Department has sought advice from the fastener and

end-user industries (automotive, aerospace, etc.) to maximize the cost-

effectiveness of the proposed rule. Those recommendations presented by

the industry at the February 4, 1997 meeting and at site visits to

industry have been incorporated in this proposed rule to assist

industry in implementing this rule, if accepted, in a cost-effective

manner.

It is difficult to estimate the total number of fastener

manufacturers in the U.S. because there are too many that do not belong

to any professional organization and operate very small shops. Some

estimate this number to be in excess of one thousand. However, based on

an estimate from the Industrial Fastener Institute, 80% of the U.S.

fastener production capacity is served

[[Page 47245]]

by approximately 120 major manufacturers. Of these, nearly 50%, or 60

manufacturers, supplying fasteners to the auto and aerospace industries

could be using the QAS included in this rule. A large majority of these

60 manufacturers could be classified as small businesses employing less

than 750 employees (as defined at 13 CFR 121.201).

We believe the overall effect on the fastener industry of

adopting this proposed rule will be highly beneficial. No negative

effects are envisioned at this time. In fact, as we look into the

future, we believe market forces (improved quality and decreased

cost) will push the remaining manufacturers not currently using QAS

to adopt the QAS standards. This proposed rule, if adopted, would

allow these manufacturers to do so without incurring additional

costs to comply with the FQA. We believe this proposed rule, if

adopted, would benefit the industry in, at least, the following

ways:

1. Ability to use modern manufacturing technology to conform

with the law without a need to make any changes;

2. Ability to use just-in-time delivery and other advancements

to avoid production delays and reduce inventory costs; and

3. Overall improvement in the fastener quality at a lower

production cost.

Registration cost per facility will vary with scope (the number

of procedures and products, the number of sampling locations, etc.)

as in the case of laboratory accreditation. Based on the laboratory

accreditation carried out by NVLAP during the past nine months, we

estimate the annual cost of registration will run between $5,000 and

$15,000 per facility which is the same as the cost of laboratory

accreditation. Since most facilities are likely to adopt one of the

approaches, this will not be an additional cost. Moreover, most

facilities seeking registration have already obtained registration

under either ISO-9000 or QS-9000. Therefore, additional cost savings

may result because fastener manufacturers do not have to spend

resources solely for conforming with the FQA.

It is not expected that any manufacturing facility practicing

QAS will cease to operate; suffer a significant loss in gross

revenue; or have increased compliance costs because of this proposed

rule, if adopted.

We seek public comment providing data on impact for use in

determining the appropriateness of this certification for purposes

of a final rule. Moreover, within one to two years of the initial

implementation period, if adopted, we should have sufficient data to

assess impact for purposes of determining the necessity for review

under 5 U.S.C. Sec. 610(c).

The requirements for laboratory accreditation and registration

of manufacturing facilities under this rule are in accordance with

the established international standards, thus promoting uniformity

in the evaluation process. The rule allows the fastener manufacturer

and testing laboratories to decide which approach to choose for

seeking accreditation.

This rule contains a collection-of-information requirement

subject to the Paperwork Reduction Act. However, that requirement

involves paperwork already being produced by fastener manufacturers.

The only additional requirement is to prepare a synopsis of the

testing and inspection results in the form of a test report. This

requirement is proposed to facilitate enforcement actions of the

Bureau Of Export Administration (BXA), which has the enforcement

authority granted under the Fastener Quality Act.

As a result, no initial regulatory flexibility analysis has been

prepared.

Paperwork Reduction Act

Notwithstanding any other provision of the Act, no person is

required to respond to, nor shall any person be subject to a penalty

for failure to comply with a collection-of-information, subject to the

requirements of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.,

unless that collection of information displays a currently valid Office

of Management and Budget (OMB) control number.

This proposed rule revises an existing collection of information

subject to the requirements of the Paperwork Reduction Act that was

previously approved by the Office of Management and Budget under the

control number 0693-0015. The revision is applicable to persons

requiring approval of the Accreditation Body Evaluation Program (ABEP)

at NIST to register quality system registrars who would in turn

register fastener manufacturing facilities.

The collection of information requirement is applicable to persons

requiring approval of the Accreditation Body Evaluation Program (ABEP)

at NIST to accredit quality system registrars who would register

fastener manufacturing facilities. The public reporting burden per

respondent for the collection of information contained in this rule is

estimated to average 4 hours annually. This estimate includes the time

for reviewing instructions, searching existing information, gathering

and maintaining the information needed, and completing and reviewing

the collection of information.

Comments are requested concerning: (a) Whether the proposed

collection of information is necessary for the proper performance of

the functions of the agency, including whether the information will

have practical utility; (b) the accuracy of NIST's burden estimate; (c)

ways to enhance the quality, utility, and clarity of the information

collected; and (d) ways to minimize the burden of the collection of

information on the respondents, including the use of automated

collection techniques or other forms of information technology.

Comments should be addressed to the Office of Information and

Regulatory Affairs, Office of Management and Budget, Washington, D.C.

20503; and to NIST (Attn.: ABEP Program Manager, NIST, Building 820,

Room 306, National Institute of Standards and Technology, Gaithersburg,

MD 20899).

National Environmental Policy Act

This rule will not significantly affect the quality of the human

environment. Therefore, an environmental assessment or Environmental

Impact Statement is not required to be prepared under the National

Environmental Policy Act of 1969.

List of Subjects in 15 CFR Part 280

Business and industry, Fastener industry, Imports.

Dated: August 13, 1997.

Robert E. Hebner,

Acting Director, National Institute of Standards and Technology.

Dated: August 21, 1997.

William A. Reinsch,

Under Secretary for Export Adminstration.

For reasons set forth in the preamble, it is proposed that Title 15

of the Code of Federal Regulations be amended as follows:

PART 280--FASTENER QUALITY

1. The authority for part 280 continues to read as follows:

Authority: Section 13 of the Fastener Quality Act (Pub.L. 101-

592, as amended by Pub.L. 104-113).

2. Section 280.1 is amended by adding paragraph (d) to read as

follows:

Sec. 280.1 Purpose/description of rule.

* * * * *

(d) Delegations of authority. The Secretary of Commerce has

delegated authority to the Director, National Institute of Standards

and Technology to promulgate regulations in this part under sections 5

through 8 of the Fastener Quality Act (15 U.S.C. 5404-5407). In

addition, the Secretary of Commerce has delegated concurrent authority

to the Under Secretary for Export Administration to amend the

regulations issued under sections 5 through 7 of the Act, regarding

enforcement. The Secretary of Commerce had also delegated concurrent

authority to amend the regulations issued under section 8 of the Act,

regarding recordal of insignias, to the Assistant Secretary and

[[Page 47246]]

Commissioner of Patents and Trademarks.

3. Section 280.2 is amended by revising the definitions for

accreditation, lot number, original laboratory testing report, and

significantly alter and adding the remaining definitions as set forth

below:

Sec. 280.2 Definitions.

* * * * *

Accreditation for purposes of the Act and this part means

accreditation of a testing laboratory or the registration of a fastener

manufacturing facility employing a quality assurance system (a

Facility).

* * * * *

Accreditor means a registrar accreditation body that meets the

requirements of subpart K of this part, is recognized by NIST, and

appears on the Accreditors List described in Sec. 280.810(a).

* * * * *

Facility means a fastener manufacturing facility implementing a

quality assurance system as defined in this part, that has been

registered by a Registrar and appears on the Facilities List described

in Sec. 280.810(c).

* * * * *

Fastener Quality Assurance System (QAS). (1) Fastener Quality

Assurance System (QAS) means a fastener manufacturing system that has

as a stated goal the prevention of defects through continuous

improvement, and which seeks to attain that goal by incorporating:

(i) Advanced quality planning;

(ii) Monitoring and control of the manufacturing process;

(iii) Process inspection embodied in a comprehensive and written

control plan for product/process characteristics, process controls

(including statistical process control), tests, and measurement systems

that will occur during mass production; and

(iv) The creation, maintenance, and retention of electronic,

photographic, or paper records, available for inspection during the

periods required by section 10 of the Act and Sec. 280.7 of this part,

regarding the inspections, tests, and measurements required by or

performed pursuant to the control plan.

(2) A Fastener Quality Assurance System contains the following

elements at a minimum:

(i) A documented quality management system that satisfies the

requirements of ISO-9001 ``Quality Systems--Model for quality assurance

in design, development, production, installation and servicing,'' ISO-

9002 ``Quality Systems--Model for quality assurance in production,

installation and servicing,'' or other quality system standards that

incorporate ISO-9001 or ISO-9002 (e.g. QS-9000, ARD-9000, etc.);

(ii) A requirement that raw material certification supplied to the

fastener manufacturer shall be traceable to that of a mill heat of

material that has been tested by a laboratory on the Accredited

Laboratory List;

(iii) A requirement that subcontracted processes, including plating

and heat treating, are controlled by the manufacturer, and performed by

a Facility on the Facilities List described in Sec. 280.810 or tested

by a Laboratory on the Laboratories List described in Sec. 280.101, to

avoid product lot contamination, and that finished lots of fasteners

shall be traceable to subcontracted processes;

(iv) A QAS plan, requiring that the fastener manufacturer fully

document fastener sampling and inspection points and an in-process

control plan that emphasizes defect prevention, relates frequency of

inspection, corrective action for nonconforming characteristics, and

sampling frequency and sample size; a requirement that the control plan

be made available to the customer upon request and shall identify those

standards and specifications upon which the plan is based; and

(v) A requirement that the in-process control plan include those

characteristics specified by the QAS standard, characteristics

specifically indicated by applicable fastener standards or

specifications (consensus or major end-user standards as defined by the

Act and this part), or those characteristics appropriate for evaluating

product functionality.

* * * * *

Lot number means a number assigned by a manufacturer, importer,

distributor, or significant alterer to the lot. A lot number assigned

by an importer, distributor, or significant alterer shall be traceable

to a manufacturer's single, unique lot number.

* * * * *

Original laboratory testing report means:

(1) In general, a laboratory testing report which is originally

signed by an approved signatory or is a copy thereof, certified by the

laboratory that conducted the test; or

(2) For purposes of the alternative procedures for chemical

characteristics described in section 5(d) of the Act and Sec. 280.15 of

this part only, a laboratory testing report which is originally signed

by an approved signatory or is a copy thereof, certified by the

laboratory that conducted the test or by the metal manufacturer.

* * * * *

Registrar means a quality systems registrar that meets the

requirements of subpart L of this part, is accredited by an Accreditor

as defined in this part, and appears on the Registrars List described

in Sec. 280.810(b).

* * * * *

Registration means evaluation and certification of a manufacturing

facility as competent to carry out and conforming to the applicable

requirements of a Fastener Quality Assurance System when such

evaluation and certification is performed by a Registrar as defined in

this part.

* * * * *

Significantly alter means to alter or take any other action which

could weaken or otherwise materially affect the performance or

capabilities of the fastener as it was originally manufactured, grade

or property class marked, tested, or represented. The term does not

include the application of adhesives or sealants, locking elements,

provisions for lock wires, coatings and platings of parts having a

minimum specified Rockwell C hardness of less than 32, or cutting off

of fasteners. The cutting of finished threaded rods, bars or studs to

produce individual smaller length threaded studs for resale is not a

significant alteration. However, cut threaded studs, rods, and bars

offered for sale shall be individually marked with the grade or

property class identification marking appearing on or accompanying the

original threaded studs, rods, and bars from which the fasteners were

cut.

* * * * *

4. Section 280.6 is amended by redesignating paragraphs (b) and (c)

as paragraphs (c) and (d) respectively, adding new paragraphs (b) and

(e), and revising redesignated paragraph (c)(5)(ii) to read as follows:

Sec. 280.6 Laboratory Test Reports.

* * * * *

(b) When performing tests for which they are registered under this

part, each facility registered under Subpart I or J of these

regulations and currently listed in the Facilities List shall issue

test reports of its work which accurately, clearly, and unambiguously

present a synopsis of test results, and all information required by

this section. In addition, the facilities shall attach reports of

chemical characteristics and any report of the tests conducted in a

laboratory under the accredited laboratories list. All

[[Page 47247]]

reports must be in English or be translated into English, must be

signed by an approved signatory, must be protected by a tamper

resistant system, and contain the following information:

(1) Name and address of the facility;

(2) Unique identification of the test report including date of

issue and serial number, or other appropriate means;

(3) Name and address of client, if applicable;

(4) Fastener Description, including:

(i) Manufacturer (name and address);

(ii) Product family (screw, nut, bolt, washer, or stud), drive and/

or head configurations as applicable;

(iii)Date of manufacture;

(iv) Head markings (describe or draw manufacturer's recorded

insignia and grade identification or property class symbols);

(v) Nominal dimensions (diameter; length of bolt, screw or stud;

thickness of load bearing washer); thread form and class of fit;

(vi) Product standards and specifications, if any, related to the

facility in writing by the manufacturer, importer or distributor;

(vii) Lot number;

(viii) Specification and grade of material;

(ix) Coating material and standard and specification as applicable;

(5) Sampling information:

(i) Standards and specifications or reference for sampling scheme;

(ii) Production lot size and the number sampled;

(iii) Name(s) and affiliation of person performing the lot

sampling;

(6) Test Results:

(i) Actual tests required by the standard and specification;

(ii) Test results;

(iii) All deviations from the test method;

(iv) All other items required on test reports according to the test

method;

(v) Where the report contains results of tests performed by sub-

contractors, these results shall be clearly identified along with the

name of the laboratory/facility and accreditation/registration

information listed in paragraph (b)(10) of this section.

(vi) A statement that the samples tested either conform or do not

conform to the fastener standards and specifications or standards and

identification of any nonconformance;

(7) A statement that the report must not be reproduced except in

full;

(8) A statement to the effect that the test report relates only to

the item(s) tested;

(9) Name, title and signature of approved signatory accepting

technical responsibility for the tests and test report;

(10) The name of the registrar which registered the facility, and

code number assigned to the facility by the registrar, and the

expiration of registration.

(c) * * *

(5) * * *

(ii) Test results for such coil or heat number chemical

characteristics;

* * * * *

(e) For tests carried out by a Facility registered pursuant to

subpart I or J, the facility shall maintain laboratory test reports in

the forms of electronic, photographic, or paper records, available for

inspection during the periods required by section 10 of the Act and

Sec. 280.7, regarding the inspections, tests, and measurements required

or performed pursuant to the QAS control plan.

5. Section 280.7 is amended by revising paragraph (a)to read as

follows:

Sec. 280.7 Recordkeeping Requirements.

(a) Each laboratory accredited under subparts C, D, or E or

Sec. 280.104 of this part shall retain for 5 years after the

performance of a test all records pertaining to that test concerning

the inspection and testing, and certification, of fasteners under the

Act and this part. The final test report or the test records maintained

by the laboratory shall contain sufficient information to permit the

test to be repeated at a later time if a retest is necessary. The

laboratory shall maintain the test report and a record of all original

observations, calculations, and derived data. The records shall include

the identity of personnel involved in sample preparation and testing.

Procedures for storage and retrieval of records must be documented and

maintained in the laboratory's quality manual.

* * * * *

6. Section 280.10 is revised to read as follows:

Sec. 280.10 Sampling.

In the event that the standard or specification to which a

manufacturer represents the fasteners in a particular sample to have

been manufactured does not provide for the size, selection or integrity

of the sample to be inspected and tested, inspections and tests under

section 5 of the Act shall be carried out using ASME/ANSI B18.18.2M,

Inspection and Quality Assurance For High-Volume Machine Assembly

Fasteners; ASME/ANSI B18.18.3M, Inspection and Quality Assurance for

Special Purpose Fasteners; or ASME/ANSI B18.18.4M, Inspection and

Quality Assurance for Highly Specialized Engineering Applications--

Fasteners, or a sampling plan provided by a Fastener Quality Assurance

System or by standards and specifications intended for use with a

Fastener Quality Assurance System, as appropriate.

7. Section 280.11 is amended by redesignating paragraphs (c) and

(d) as paragraphs (d) and (e) respectively, adding new paragraph (c),

and revising paragraph (b) and redesignated paragraph (d) to read as

follows:

Sec. 280.11 Significant Alterations of Fasteners.

* * * * *

(b) If the significant alteration is only electroplating of

fasteners having a minimum specified Rockwell C hardness of 32 or

above, the requirements set forth in paragraphs (a)(2) and (a)(3) of

this section shall not apply, but the alterer shall assign a new lot

number as set forth in paragraph (a)(1) of this section and shall test

the electroplated fasteners as required by the plating standards and

specifications.

(c) If the significant alteration is only the removal of

manufacturer or grade identification markings for decorative purposes

at the customer's request, the requirements set forth in paragraph

(a)(2) of this section shall not apply, but the alterer shall assign a

new lot number as set forth in paragraph (a)(1) of this section and

shall either test the fasteners or provide a written statement

disclosing the alteration as set forth in paragraph (a)(3) of this

section. Along with such an order the fastener manufacturer must

require a written certification from the customer stating that

fasteners from the altered lot will not be held or sold as meeting the

requirements of a consensus standard which requires manufacturer or

grade identification markings.

(d) Any person who knowingly sells a significantly altered fastener

as described in paragraph (a) of this section, and who did not alter

such fastener, shall provide to the purchaser a copy of the statement

required by paragraph (a)(3) of this section; unless the significant

alteration is only electroplating of the fastener, as described in

paragraph (b) of this section or removal of manufacturer or grade

identification markings, as described in paragraph (c) of this section.

* * * * *

8. Section 280.12 is revised to read as follows:

Sec. 280.12 Applicability.

(a) The requirements of the Fastener Quality Act and this part

shall be applicable only to fasteners manufactured on or after May 26,

1998.

(b) Metal manufactured prior to May 26, 1998 may not be used to

[[Page 47248]]

manufacture fasteners subject to the Act and this part unless the metal

has been tested for chemistry pursuant to Sec. 280.15 of this part by a

laboratory accredited under the Act and this part and the chemical

characteristics of the metal conform to those required by the standards

and specifications.

(c) Nothing in the Act and this part prohibits selling finished

fasteners manufactured prior to May 26, 1998 or representing that such

fasteners meet standards and specifications of a consensus standards

organization or a government agency.

9. Section 280.104 is added to subpart B to read as follows:

Sec. 280.104 Accreditation of Certain Manufacturing Facilities as

Laboratories

(a) Subject to the limitations contained in paragraphs (b), (c),

and (d) of this section, registration of a fastener manufacturing

facility employing a fastener quality assurance system shall be deemed

to meet the requirements of accreditation of a laboratory for purposes

of the Act and this part. The independent third-party registrar

registering such facility under this section shall comply with all

procedures set forth in subparts I through L of this part. Records

documenting the inspection and testing of a lot of fasteners performed

by such an accredited laboratory shall be maintained by the facility in

accordance with the requirements of Secs. 280.6 and 280.7.

(b) In any instance where a Facility accomplishes any in-process

inspection and testing by performing laboratory tests on a sample of

fasteners at any stage in the manufacturing process, those tests must

be conducted by a laboratory on the Accredited Laboratory List. Such a

laboratory may be located on the same premises as a fastener

manufacturing facility if the laboratory is separately accredited

pursuant to a provision of this part other than Sec. 280.104(a).

(c) Any laboratory tests performed outside the Facility's in-

process inspection and testing must be conducted by a laboratory on the

Accredited Laboratory List.

(d) Chemical testing and raw material testing must be performed by

a laboratory on the Accredited Laboratory List.

10. Section 280.602 is amended by revising paragraphs (e)(2), (h),

and (j) and adding paragraphs (k), (l), (m), and (n) to read as

follows:

Sec. 280.602 Violations.

* * * * *

(e) Misrepresentation and concealment of facts * * *

(2) In connection with the preparation, submission, use,

maintenance of a laboratory test report, certificate of conformance as

described in Secs. 280.5 and 280.6 of this part or any quality

assurance system document required by this part or;

* * * * *

(h) Falsification of Documents Relating to Accreditation of

Laboratories or Registrars or Approval or Recognition of Accreditors or

Accreditation Bodies. No person shall falsify or make any false or

misleading statement on or in connection with any document relating to

laboratory accreditation or approval or recognition of accreditation

bodies, Accreditors or Registrars as required by section 6(a) or 6(b)

of the Act or this part.

* * * * *

(j) Falsification of Laboratory Accreditation, Accreditation Body

or Accreditor. No person shall falsely claim to be an accredited

laboratory or approved or recognized accreditation body or Accreditor

as described in section 6 of the Act or subparts B, C, D, E, I and J of

this part.

(k) Sale of fasteners manufactured prior to the implementation date

as compliant with the Act. No person shall represent, sell, or offer

for sale fasteners manufactured prior to May 26, 1998 as being in

conformance with the Act or this part.

(l) Failure to Assign lot number traceable to Manufacturer's

single, unique lot number: No importer, distributor, or significant

alterer shall assign a lot number unless the assigned lot number is

traceable to a manufacturer's single, unique lot number.

(m) Falsification of Documents relating to the registration of

Fastener Manufacturing Facilities as accredited laboratories,

accreditation of Registrars or recognition of Accreditors. No person

shall falsify or make any false or misleading statement on or in

connection with any document relating to the registration of Fastener

Manufacturing Facilities as accredited laboratories, accreditation of

Registrars or recognition of Accreditors as required by Subparts I, J,

K, and L of this part.

(n) False claim of registration of Fastener Manufacturing

Facilities as accredited laboratories, accreditation of Registrars, and

recognition of Accreditors. No person shall falsely claim to be a

registered Fastener Manufacturing Facility, an accredited Registrar, or

a recognized Accreditor as described by Subparts I, J, K, and L of this

part.

11. Subparts I through L are added to read as follows:

Subpart I--Special Rule for the Accreditation of Certain Fastener

Manufacturing Facilities, Whose Implemented Fastener Quality

Assurance Systems Meet Defined Requirements, as Laboratories

Sec.

280.800 Introduction.

280.801 Application.

280.802 Review and decision process.

280.803 Criteria for recognition.

280.804 Maintaining recognized status.

280.805 Voluntary termination of recognition.

280.806 Involuntary termination of recognition by NIST.

280.807 Subcontracting.

280.808 Reports.

280.809 Recordkeeping.

280.810 Listing of recognized accreditors, accredited registrars,

and registered facilities.

280.811 Removal from a list.

280.812 Appeal.

Sec. 280.800 Introduction.

(a) This special rule applies to those fastener manufacturers,

employing a fastener quality assurance system (QAS) as defined in this

part, who wish to seek accreditation of the particular manufacturing

facility employing the QAS as a laboratory within the meaning of the

Act. This rule consists of this subpart, and subparts J, K, and L. The

rule adopts the view that a fastener manufacturing facility is deemed

to be an accredited laboratory for purposes of the Act and this part if

such facility employs a fastener quality assurance system (QAS) that

has been formally registered by a NIST-recognized quality systems

registrar. The rule applies only to facilities manufacturing fasteners;

raw materials for fastener manufacture must be tested and certified by

a laboratory listed on the Accredited Laboratory List. This subpart

sets out the full process that NIST requires for the accreditation of a

fastener manufacturing facility employing a QAS in the United States: a

fastener manufacturing facility employing a QAS (a ``Facility'') will

be deemed to be an accredited laboratory if it is registered by a

Quality Systems Registrar (a ``Registrar'') that in turn has been

accredited by a Registrar Accreditation Body (an ``Accreditor'') that

has been recognized by NIST. Subpart J provides for foreign Accreditors

to be recognized and to recognize Registrars under the same procedures.

(b) A chain is thus established to assure the proper regulation of

[[Page 47249]]

Facilities: NIST recognizes Accreditors that meet the requirements of

subpart K, which is based upon ISO Guide 61; the NIST-recognized

Accreditors may, in turn, accredit Registrars that meet the

requirements of Subpart L, which is based upon ISO Guide 62. The

Registrars, in turn, may register Facilities that satisfy the elements

of a fastener quality assurance system (QAS), as defined in this part.

(c) Within this subpart, Secs. 280.801 through 280.809 contain the

procedures that NIST uses to process requests from Accreditors for

recognition by NIST. Section 280.810 establishes three lists that NIST

will maintain: Sec. 280.810(a) provides for a list of Accreditors that

have been recognized by NIST; Sec. 280.810(b) provides for a list of

Registrars that have been accredited by Accreditors listed according to

Sec. 280.810(a); and Sec. 280.810(c) provides for a list of Facilities

that have been registered by Registrars listed according to

Sec. 280.810(b). The remainder of this subpart, Secs. 280.811 and

280.812, contain procedural provisions related to the lists established

by Sec. 280.810.

Sec. 280.801 Application.

(a) Application must be made by Accreditors to NIST for recognition

to accredit Registrars under the Act. Upon request, NIST will provide

application forms and instructions. The applicant shall complete the

application in English and may provide whatever additional enclosures,

attachments or exhibits the applicant deems appropriate.

(b) Application packages may be obtained from: Manager, FQA

Accreditation Body Evaluation Program, NIST, Bldg. 820, Room 282,

Gaithersburg, Maryland, 20899. Requests may be made by mail or by FAX

to: (301) 963-2871.

(c) The applicant shall reimburse NIST for all costs incurred in

the evaluation of its accreditation program and subsequent costs

incurred in ensuring the continued compliance of its program.

Reimbursement shall be in accordance with the fee schedule established

by NIST for this purpose.

(d) An application may be revised by an applicant at any time prior

to the final decision by NIST. An application may be withdrawn by an

applicant, without prejudice, at any time prior to the final decision

by NIST.

Sec. 280.802 Review and decision process.

(a) Applications submitted by Accreditors will be accepted by NIST

and their receipt acknowledged in writing. The applications will be

reviewed by NIST against the criteria specified in this subpart and in

subpart K of this part. NIST may request additional information as

needed from the applicant.

(b) NIST shall conduct on-site assessments of the facilities of the

applicant including all of the applicant's organizational units and

locations covered by the application.

(c) If the applicant's program is deemed by NIST to have met the

requirements for recognition, the applicant shall be notified by NIST

in writing. The recognition notice shall include the date when the

recognition begins and the scope of the recognition. The recognition

period shall be for as long as the Accreditor continues to satisfy the

requirements of Sec. 280.803. As part of maintaining its approved

status, each Accreditor shall agree to be reassessed by NIST every two

years following its initial notice of recognition. NIST will maintain

and make available to the public a list of recognized Accreditors.

(d) If the applicant does not meet the requirements for

recognition, the applicant shall be notified in writing, listing the

specific requirements from this subpart and subpart K of this part

which the applicant's program has not met. After receipt of such a

notification, and within the response period provided by NIST, the

applicant may:

(1) Submit additional information for further review. Reviewing the

new submission may involve additional on-site visits by NIST personnel.

Additional fees may be required. Or,

(2) Submit a request that the original application be reconsidered,

including a statement of reasons why the applicant should have been

recognized.

Sec. 280.803 Criteria for recognition.

An applicant for NIST recognition must demonstrate the ability to

operate a registrar accreditation program consistent with the

requirements of this subpart and subparts A and K of this part, and

accredit registrars of Facilities to requirements set out in subpart L

of this part.

Sec. 280.804 Maintaining recognized status.

(a) Accreditors shall continue to satisfy all the requirements of

recognition during the recognition period.

(b) Upon request, recognized Accreditors shall make available to

NIST and/or BXA all records and materials pertaining to the program.

(c) NIST has the right to participate as an observer during any on-

site visit to a Registrar being audited by a NIST-recognized

Accreditor, or a Facility being audited by an accredited Registrar, or

it may perform its own surveillance visit of such bodies at its

discretion.

(d) Neither the Accreditor, nor any Registrar it accredits, nor any

Facility registered under the Act and this part shall take any action

which states or implies the approval, or endorsement by NIST or any

other agency of the U.S. Federal Government of any product or report

pertaining to a product associated with any activities carried out

under the recognition. None of these entities may take any action which

states or implies that they are recognized or authorized by NIST to act

or perform in any area(s) beyond that which was specified in their

recognition under this part.

Sec. 280.805 Voluntary termination of recognition.

An Accreditor may voluntarily terminate its recognition by giving

written notice to NIST and to all Registrars accredited by that body

under its accreditation program. The written notice shall state the

date on which the termination will take effect.

Sec. 280.806 Involuntary termination of recognition by NIST.

(a) NIST may terminate or suspend its recognition of an Accreditor

if such an action is deemed to be in the public interest.

(b) Before terminating the recognition of an Accreditor, NIST will

notify the Accreditor in writing, giving it the opportunity to rebut or

correct the stated reasons for the proposed termination. If the

problems are not corrected or reconciled within 30 days, or such longer

time as NIST in its sole discretion may grant, the termination shall

become effective.

(c) An Accreditor may appeal a termination to the Director by

submitting a statement of reasons why the recognition should not be

terminated. NIST may, at its discretion, hold in abeyance the

termination action pending a final decision by the Director. Within 60

days following receipt of the appeal, the Director shall inform the

Accreditor in writing of his or her decision.

(d) Registrars and registered organizations which have been listed

by NIST in accordance with this subpart, based on their accreditation

by an Accreditor whose recognition has been terminated, shall be

removed from the list, unless an exception is granted by NIST.

Sec. 280.807 Subcontracting.

If a recognized Accreditor, an accredited Registrar, or a

registered Facility subcontracts any of its functions

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to another entity it must place the work with another recognized

Accreditor, accredited Registrar, or registered Facility; inform the

client, before the fact, that subcontracting will be necessary, and

clearly indicate in all appropriate records, and reports to the client,

specifically what functions were subcontracted.

Sec. 280.808 Reports.

Reports and records shall be maintained in such a manner to

preserve original data, and be collected as required into a final form,

sufficient to satisfy customer and legal requirements. Such reports

shall be provided upon request to the Bureau of Export Administration,

to the National Institute of Standards and Technology, or to any other

agency of the federal government authorized to obtain such records

under this part.

Sec. 280.809 Recordkeeping.

Each recognized Accreditor, accredited Registrar, or fastener

manufacturer whose Facility has been registered shall retain all

applicable records required under the Act and this part for 5 years.

All records are subject to the requirements in Sec. 280.7 of this part.

Sec. 280.810 Listing of recognized accreditors, accredited registrars,

and registered facilities.

(a) List of Accreditors. NIST shall prepare and maintain a list of

Accreditors recognized under this subpart and subpart J.

(b) List of Registrars. NIST shall prepare and maintain a list of

Registrars accredited by Accreditors listed in accordance with

Sec. 280.810(a).

(1) Names and information regarding accredited Registrars may only

be included on the list from information submitted to NIST by an

Accreditor listed in accordance with Sec. 280.810(a) that submits the

listing fee established by NIST and the following information, in

English:

(i) The name of the Accreditor which granted the accreditation ;

(ii) The name and address of the Registrar affected by the

accreditation action;

(iii) The nature of the accreditation action (e.g., initial

accreditation, renewal of accreditation, etc.);

(iv) A copy of the Registrar's accreditation certificate and a

scope of accreditation which states the quality system standard(s) for

which the Registrar has been accredited for purposes of assessing and

registering a fastener manufacturer's Facility; and

(v) The name and telephone number of the accredited Registrar's

authorized representative(s), and information concerning the physical

locations of all organizational units involved in the accreditation

activities.

(2) All Accreditors listed by NIST in accordance with

Sec. 280.810(a) shall promptly notify NIST of each accreditation action

taken. Accreditation actions include initial accreditations, denials of

accreditation, renewals, suspensions, terminations, and changes in

scope. Notifications shall be filed with: Fastener Quality Act Program

Manager, Office of Standards Services, National Institute of Standards

and Technology, Gaithersburg, Maryland 20899.

(c) List of facilities. NIST shall prepare and maintain a list of

Facilities registered by Registrars listed in accordance with

Sec. 280.810(b).

(1) Names and information regarding registered Facilities may only

be included on the list from information submitted to NIST by

accredited Registrars listed in accordance with Sec. 280.810(b) that

submit the listing fee established by NIST, through their Accreditors,

and the following information:

(i) The name of the fastener manufacturer and the address of the

registered Facility;

(ii) The name of the authorized representative of the fastener

manufacturer whose Facility is registered;

(iii) The scope of registration, stating the quality system

standard(s) to which the Facility has been registered; and

(iv) The effective dates of the registration.

(2) All Registrars listed by NIST in accordance with

Sec. 280.810(b) shall promptly notify NIST of each registration action.

Registration actions include initial registrations, denials of

registration, renewals, suspensions, terminations, and changes in

scope. Notifications shall be filed with: Fastener Quality Act Program

Manager, Office of Standards Services, National Institute of Standards

and Technology, Gaithersburg, Maryland 20899.

(d) These lists will be readily accessible to the public. Only

entities listed by NIST are authorized to offer services which comply

with the Act and this part. NIST shall revise as appropriate all

listings when notified of applicable actions and shall take appropriate

steps to make changes promptly available to the public.

Sec. 280.811 Removal from a list.

NIST may remove from a list any listed entity if NIST deems such

action to be in the public interest. An entity may appeal the removal

or proposed removal from a list to the Director by submitting a

statement of reasons why it should remain on the list. NIST may, at its

discretion, hold in abeyance a removal action pending a final decision

by the Director. The Director shall inform the entity in writing of the

decision within sixty days following receipt of the appeal.

Sec. 280.812 Appeal.

An applicant Accreditor, Registrar, or fastener manufacturer whose

Facility has been registered may appeal the removal or proposed removal

from the Accreditors list, the Registrars list, or the Facilities list,

to the Director.

Subpart J--Recognition of Foreign Registrar Accreditation Bodies

Sec.

280.900 Introduction.

280.901 Recognition of foreign entities.

Sec. 280.900 Introduction.

In accordance with section 6(a)(1)(C) of the Act, this subpart sets

forth the conditions under which the recognition of foreign entities by

their governments, by organizations acting on behalf of their

governments, or by organizations recognized by the Director shall be

deemed to meet the requirements of the Act.

Sec. 280.901 Recognition of foreign entities.

Foreign Accreditors wishing to be recognized to accredit Registrars

must submit an application for evaluation to NIST according to subpart

I. NIST recognition is limited to bodies that accredit Registrars which

register Facilities producing fasteners covered by the Act. To be

recognized by NIST, Accreditors must meet conditions set out in

subparts I and K and accredit Registrars of Facilities to conditions

set out in subpart L.

Subpart K--Requirements for Registrar Accreditation Bodies

(Accreditors)

Sec.

General

280.1000 Introduction.

280.1001 Scope.

Requirements for Accreditors

280.1010 Accreditors.

280.1011 Accreditor personnel.

280.1012 Decision on accreditation.

280.1013 References to accredited status.

280.1014 Change in the accreditation.

280.1015 Appeals, complaints and disputes.

280.1016 Access to records of appeals, complaints and disputes.

Requirements for Assessment

280.1020 Application for accreditation.

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280.1021 Preparation for assessment.

280.1022 Assessment.

280.1023 Assessment report.

280.1024 Surveillance and reassessment procedures.

General

Sec. 280.1000 Introduction.

This subpart sets out organizational, operational and other

requirements that must be met by all Accreditors recognized by NIST

under subpart I or J of this part. This subpart also sets out the

requirements against which an Accreditor assesses the competence of an

applicant Registrar.

Sec. 280.1001 Scope.

These are general requirements for an Accreditor to follow if it is

to be recognized as competent and reliable in assessing and

subsequently accrediting Registrars.

Requirements for Accreditors

Sec. 280.1010 Accreditors.

(a) General provisions. (1) The policies and procedures under which

the Accreditor operates shall be non-discriminatory, and they shall be

administered in a non-discriminatory manner. Procedures shall not be

used to impede or inhibit access by applicant bodies other than as

specified in this part.

(2) The Accreditor shall make its services accessible to all

applicants whose activities fall within its declared field of

operation. There shall not be undue financial or other conditions.

Access shall not be conditional upon the size of the applicant body or

membership of any association or group, nor shall accreditation be

conditional upon the number of bodies already accredited.

(3) The accreditation criteria against which the competence of a

registrar is assessed shall be those outlined in subpart L of this

part. If an explanation is required as to the application of these

documents to a specific accreditation program, it shall be formulated

by relevant and impartial committees or persons possessing the

necessary technical competence, and published by the Accreditor.

(4) The Accreditor shall confine its requirements, assessment and

decisions on accreditation to those matters specifically related to the

scope of the accreditation being considered.

(b) Organization of a recognized Accreditor. The structure of the

Accreditor shall be such as to give confidence in its accreditations.

In particular, the Accreditor shall:

(1) Be impartial;

(2) Be responsible for its decisions relating to the granting,

maintaining, extending, reducing, suspending and withdrawing of

accreditation;

(3) Identify the management (committee, group or person) which will

have overall responsibility for all of the following:

(i) Performance of assessment and accreditation as defined in this

part;

(ii) Formulation of policy matters relating to the operation of the

Accreditor;

(iii) Decisions on accreditation;

(iv) Supervision of the implementation of its policies;

(v) Supervision of the finance of the Accreditor; and

(vi) Delegation of authority to committees or individuals, as

required, to undertake defined activities on its behalf.

(4) Have documents which demonstrate that it is a legal entity;

(5) Have a documented structure which safeguards impartiality,

including provisions to assure the impartiality of the operations of

the Accreditor; this structure shall enable the participation of all

parties significantly concerned in the development of policies and

principles regarding the content and functioning of the accreditation

system;

(6) Ensure that each decision on accreditation is taken by a person

or persons different from those who carried out the assessment;

(7) Have rights and responsibilities relevant to its accreditation

activities;

(8) Have adequate arrangements to cover liabilities arising from

its operations and/or activities;

(9) Have financial stability and resources required for the

operation of an accreditation system;

(10) Employ a sufficient number of personnel having the necessary

education, training, technical knowledge and experience for performing

accreditation functions relating to the type, range and volume of work

performed, under a responsible senior executive;

(11) Have a quality system, as outlined in Sec. 280.1010(d), giving

confidence in its ability to operate an accreditation system for

registration bodies;

(12) Have policies and procedures that distinguish between

accreditation and any other activities in which the Accreditor is

engaged;

(13) Together with its senior executive and staff, be free from any

commercial, financial and other pressures which might influence the

results of the accreditation process;

(14) Have formal rules and structure for the appointment and

operation of any committees which are involved in the accreditation

process; such committees shall be free from any commercial, financial

and other pressures that might influence decisions;

(15) Ensure that activities of related bodies do not affect the

confidentiality, objectivity or impartiality of its accreditations and

shall not offer or provide, directly or indirectly, those services that

accredit others to perform, consulting services to obtain or maintain

accreditation, or services to design, implement or maintain a

certification scheme;

(16) Have policies and procedures for the resolution of complaints,

appeals and disputes received from bodies or other parties about the

handling of accreditation of any related matters;

(17) Have a structure where members are chosen to provide a balance

of interest, where no single interest predominates; and

(18) Assure that other products, processes or services that may be

offered, directly or indirectly, do not compromise confidentiality or

the objectivity or impartiality of its accreditation process and

decisions.

(c) Subcontracting. (1) When an Accreditor decides to subcontract

work related to accreditation (e.g. audits) to an external body or

person, a properly documented agreement covering the arrangements,

including confidentiality and conflict of interest, shall be drawn up.

The Accreditor shall:

(i) Take full responsibility for such subcontracted work and

maintain its responsibility for granting, maintaining, extending,

reducing, suspending or withdrawing accreditation

(ii) Ensure that the subcontracted body or person is competent and

complies with the applicable provisions of this part, including

Sec. 280.807, and is not involved, either directly or through its

employer, with the design, implementation or maintenance of a

registration scheme in such a way that impartiality could be

compromised; and

(iii) obtain the consent of the applicant or accredited body.

(2) Requirements in paragraphs (c)(1) (i) and (ii) of this section

are also relevant, by extension, when an Accreditor uses, for granting

its own accreditation, work provided by another Accreditor with which

it has signed an agreement.

(d) Quality system. (1) The management of the Accreditor with

executive responsibility for quality shall define and document its

policy for quality, including objectives for quality and its commitment

to quality. The management shall ensure that this

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policy is understood, implemented and maintained at all levels of the

organization.

(2) The Accreditor shall operate a quality system in accordance

with the relevant elements of this part and appropriate to the type,

range and volume of work performed. This quality system shall be

documented, and the documentation shall be available for use by the

staff of the Accreditor.

(3) The Accreditor shall ensure effective implementation of the

documented quality system procedures and instructions.

(4) The Accreditor shall designate a person with direct access to

its highest executive level who, irrespective of other

responsibilities, shall have defined authority to ensure that a quality

system is established, implemented and maintained in accordance with

this part, and report on the performance of the quality system to the

management of the Accreditor for review and as a basis for improvement

of the quality system.

(5) The quality system shall be documented in a quality manual and

associated quality procedures, and the quality manual shall contain or

refer to at least the following: :

(i) A quality policy statement;

(ii) A brief description of the legal status of the Accreditor,

including the names of its owners, if applicable, and, if different,

the names of the persons who control it;

(iii) The names, qualifications, experience and terms of reference

of the senior executive and other accreditation personnel influencing

the quality of the accreditation function;

(iv) An organization chart showing lines of authority,

responsibility and allocation of functions stemming from the senior

executive and, in particular, the relationship between those

responsible for the assessment and those making decisions regarding

accreditation;

(v) A description of the organization of the Accreditor, including

details of the management (committee, group or person), its

constitution, terms of reference and rules of procedure;

(vi) The policy and procedures for conducting management reviews;

(vii) Administrative procedures including document control;

(viii) The operational and functional duties and service pertaining

to quality, so that the extent and limits of each person's

responsibility are known to all concerned;

(ix) The policy and procedures for the recruitment and training of

Accreditor personnel (including auditors) and monitoring their

performance;

(x) A list of its subcontractors and details of the procedures for

assessing, recording and monitoring their competence;

(xi) Its procedures for handling nonconformities and for assuring

the effectiveness of any corrective actions taken;

(xii) The policy and procedures for implementing the accreditation

process, including:

(A) The conditions for issue, retention and withdrawal of

accreditation documents

(B) Checks of the use and application of documents used in the

accreditation

(C) The procedures for assessing and accrediting applicants; and

(D) The procedures for surveillance and reassessment of accredited

bodies.

(xiii) The policy and procedures for dealing with appeals,

complaints and disputes; and

(xiv) The procedures for conducting internal audits based on

appropriate international documentation.

(e) Conditions for granting, maintaining, extending, reducing,

suspending and withdrawing accreditation. (1) The Accreditor shall

specify the conditions for granting, maintaining, extending and

reducing accreditation, and the conditions under which accreditation

may be suspended or withdrawn, partially or in total, for all or part

of the accredited body's scope of accreditation. In particular, the

Accreditor shall require the accredited body to notify it promptly of

any intended changes to the quality system or other changes which may

affect conformity.

(2) The Accreditor shall have procedures to grant, maintain,

withdraw and suspend accreditation; to extend or reduce the scope of

accreditation; and to conduct reassessment in the event of changes

significantly affecting the activity and operation of the accredited

body (such as change of ownership, changes in personnel or equipment),

or if analysis of a complaint or any other information indicates that

the accredited body no longer complies with the requirements of the

Accreditor.

(f) Internal audits and management reviews. (1) The Accreditor

shall conduct periodic internal audits covering all procedures in a

planned and systematic manner, to verify that the quality system is

being implemented and is effective. The Accreditor shall ensure that

personnel responsible for the area audited are informed of the outcome

of the audit; corrective action is taken in a timely and appropriate

manner; and the results of the audit are documented.

(2) The top management of the Accreditor shall review its quality

system at defined intervals sufficient to ensure its continuing

suitability and effectiveness in satisfying the requirements of this

part and the stated quality policy and objectives. Records of such

reviews shall be maintained.

(g) Documentation. (1) The Accreditor shall document, update at

regular intervals, and make available (through publications, electronic

media or other means), on request:

(i) Information about the authority under which the Accreditor

operates;

(ii) A documented statement of its accreditation system, including

its rules and procedures for granting, maintaining, extending,

reducing, suspending and withdrawing accreditation;

(iii) Information about the assessment and accreditation process;

(iv) A description of the means by which the Accreditor obtains

financial support, and general information on the fees charged to

applicants and accredited bodies;

(v) A description of the rights and duties of applicants and

accredited bodies, as specified, including requirements, restrictions

or limitations on the use of the Accreditor's logo and on the ways of

referring to the accreditation granted, in conformance with

Sec. 280.804(d); and

(vi) Information on procedures for handling complaints, describing

the scope of accreditation granted to each.

(2) The Accreditor shall establish and maintain procedures to

control all documents and data that relate to its accreditation

functions. These documents shall be reviewed and approved for adequacy

by appropriately authorized and competent personnel prior to issuing

any documents following initial development or any subsequent amendment

or change being made. A listing of all appropriate documents with the

respective issue and/or amendment status identified shall be

maintained. The distribution of all such documents shall be controlled

to ensure that the appropriate documentation is made available to

personnel of the Accreditor, or applicants and accredited bodies, when

required to perform any function relating to the activities of

applicants and accredited bodies.

(h) Records. (1) The Accreditor shall maintain a record system to

suit its particular circumstances and to comply with this part. The

records shall demonstrate that accreditation procedures have been

effectively fulfilled, particularly with respect to application forms,

assessment reports,

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and other documents relating to granting, maintaining, extending,

reducing, suspending or withdrawing accreditation. The records shall be

identified, managed and disposed of in such a way as to ensure the

integrity of the process and confidentiality of the information. The

records shall be kept for a period of five years.

(2) The Accreditor shall have a policy and procedures for retaining

records for a period of five years. The Accreditor shall have a policy

and procedures concerning access to these records consistent with

paragraph (h)(1) of this section.

(i) Confidentiality. (1) The Accreditor shall have adequate

arrangements, consistent with applicable laws, to safeguard

confidentiality of the information obtained in the course of its

accreditation activities at all levels of its organization, including

committees and external bodies or individuals acting on its behalf.

(2) Except as required in this part, information about a particular

body shall not be disclosed to a third party without the written

consent of the body.

Sec. 280.1011 Accreditor personnel.

(a) General provisions. (1) The personnel of the Accreditor

involved in accreditation shall be competent for the functions they

perform.

(2) Information on the relevant qualifications, training and

experience of each member of the personnel involved in the

accreditation process shall be maintained by the Accreditor. Records of

training and experience shall be kept up to date.

(3) Clearly documented instructions shall be available to the

personnel describing their duties and responsibilities. These

instructions shall be maintained up to date.

(b) Qualification criteria for auditors and technical experts. (1)

In order to ensure that assessments are carried out effectively and

uniformly, the minimum relevant criteria for competence shall be

defined by the Accreditor.

(2) Auditors shall meet the requirements of the appropriate

international documentation.

(3) Technical experts are not required to comply with the

requirements for auditors, and guidance on their personal attributes

may be obtained from appropriate international documentation.

(c) Selection procedure. (1) The Accreditor shall have a procedure

for selecting auditors and, if applicable, technical experts on the

basis of their competence, training, qualifications and experience, and

for initially assessing the conduct of auditors and technical experts

during assessments, and subsequently monitoring the performance of

auditors and technical experts.

(2) When selecting the audit team to be appointed for a specific

assessment, the Accreditor shall ensure that the skills brought to each

assignment are appropriate. The team shall:

(i) Be familiar with the Fastener Quality Act and its implementing

regulations, accreditation procedures and accreditation requirements;

(ii) Have a thorough knowledge of the relevant assessment method

and assessment documents;

(iii) Have appropriate technical knowledge of the fastener

technology for which accreditation is sought and, where relevant with

associated procedures and their potential for failure (technical

experts who are not auditors may fulfil this function);

(iv) Have a degree of understanding sufficient to make a reliable

assessment of the competence of the accredited body to operate within

its scope;

(v) Be able to communicate effectively, both in writing and orally,

in the required languages;

(vi) Be free from any interest that might cause team members to act

in other than an impartial or non-discriminatory manner, for example,

(A) Audit team members or their organization shall not have

provided consulting services to the applicant or accredited body which

compromise the accreditation process and decision; and

(B) In accordance with the directives of the Accreditor, the audit

team members shall inform the Accreditor, prior to the assessment,

about any existing, former or envisaged link between themselves or

their organization and the body to be assessed.

(d) Contracting of assessment personnel. The Accreditor shall

require the personnel involved in the assessment to sign a contract or

other document by which they commit themselves to comply with the rules

defined by the Accreditor, including those relating to confidentiality

and those relating to independence from commercial and other interest,

and any prior and/or present link with the bodies to be assessed. The

Accreditor shall ensure that, and document how, any subcontracted

assessment personnel satisfy all the requirements for personnel

outlined in this subpart.

(e) Assessment personnel records. (1) The Accreditor shall possess

and maintain up-to-date records on personnel conducting assessments,

consisting of:

(i) Name and address;

(ii) Affiliation and position held in the organization;

(iii) Educational qualifications and professional status;

(iv) Experience and training in each field of competence of the

Accreditor;

(v) Date of most recent updating of record; and

(vi) Performance appraisal.

(2) The Accreditor shall ensure, and verify, that any subcontracted

body maintains records, which satisfy the requirements of this part, of

assessment personnel who are subcontracted to the Accreditor.

(f) Procedures for assessment teams. Assessment teams shall be

provided with up-to-date assessment instructions and all relevant

information on accreditation arrangements and procedures.

Sec. 280.1012 Decision on accreditation.

(a) The decision whether or not to accredit a body shall be made on

the basis of the information gathered during the accreditation process

and any other relevant information. Those who make the accreditation

decision shall not have participated in the audit.

(b) The Accreditor shall not delegate authority for granting,

maintaining, extending, reducing, suspending or withdrawing

accreditation to an outside person or body.

(c) The Accreditor shall provide to each of its accredited bodies

accreditation documents such as a letter outlining the scope of

accreditation and a certificate signed by an officer who has been

assigned such responsibility. These accreditation documents shall

identify, for the body and each of its sites covered by the

accreditation:

(1) The name and address;

(2) The scope of the accreditation granted, including as

appropriate:

(i) The type of registration scheme;

(ii) The standards and/or other normative documents and regulatory

requirements against which products, services or systems are

registered; and

(iii) Product categories.

(3) The effective date of accreditation and, as applicable, the

term for which the accreditation is valid.

(d) In response to an application for an amendment to the scope of

an accreditation already granted, the Accreditor shall decide what, if

any, assessment procedure is appropriate to determine whether or not

the amendment should be granted and shall act accordingly.

Sec. 280.1013 References to accredited status.

(a) An Accreditor which is proprietor or licensee of a symbol or

logo, intended

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for use under its accreditation program, shall have a policy governing

its use. It shall normally allow an accredited body to refer to its

accreditation in certificates, reports, and stationery and publicity

material relating to accredited activities.

(b) The Accreditor shall not allow use of its mark or logo in any

way which implies that the Accreditor itself approved a product,

service or system registered by an accredited body. Where a Facility is

registered only with respect to its quality assurance system, the

symbol or logo shall not be used on a product or in any other way that

may be interpreted as denoting product conformance, as required by

Sec. 280.804(d).

(c) The Accreditor shall take suitable action to deal with

incorrect reference to the accreditation system, or misleading use of

accreditation logos found in advertisements, catalogues, etc. Such

action could include corrective action, withdrawal of certificate,

publication of the transgression and, if necessary, other legal action.

Sec. 280.1014 Change in the accreditation.

The Accreditor shall give due notice of any changes it intends to

make in its requirements for accreditation. It shall take account of

views expressed by interested parties before deciding on the precise

form and effective date of the changes. Following a decision on, and

publication of, the changed requirements, it shall verify that each

accredited Registrar carries out any necessary adjustments to its

procedures within such time as, in the opinion of the Accreditor, is

reasonable.

Sec. 280.1015 Appeals, complaints and disputes.

The Accreditor shall keep a record of all appeals, complaints and

disputes, and remedial actions relative to accreditation; take

appropriate corrective and preventive action; and document the actions

taken and assess their effectiveness.

Sec. 280.1016 Access to records of appeals, complaints and disputes.

The Accreditor shall require each applicant and accredited

Registrar to make available to it, when requested, the records of all

complaints, appeals and disputes, and subsequent actions.

Requirements for Assessment

Sec. 280.1020 Application for accreditation.

(a)(1) The Accreditor shall maintain up-to-date as specified in

Sec. 280.1010(g)(1), detailed description of the assessment and

accreditation procedure, the documents containing the requirements for

accreditation, and documents describing the rights and duties of

accredited Registrars, and shall provide them to applicants and

accredited Registrars. The Accreditor shall require that an accredited

Registrar:

(i) Always complies with the relevant provisions of this part;

(ii) Makes all necessary arrangements for the conduct of the

assessment, including provision for examining documentation and the

access to all areas, records (including internal audit reports) and

personnel for the purposes of assessment, surveillance, reassessment

and resolution of complaints;

(iii) Only claims that it is accredited with respect to those

activities for which it has been granted accreditation;

(iv) Does not use its accreditation in such a manner as to bring

the Accreditor into disrepute, and does not make any statement

regarding its accreditation which the Accreditor may consider

misleading or unauthorized;

(v) Upon suspension or withdrawal of its accreditation,

discontinues use of all advertising matter that contains any reference

thereto and returns any accreditation documents as required by the

Accreditor;

(vi) Does not allow the fact of its accreditation to be used to

imply that a product, process, system, or person is approved by the

Accreditor, as required by Sec. 280.804(d);

(vii) Ensures that no accreditation document, mark or report, or

any part thereof, is used in a misleading manner; and

(viii) In making reference to its accreditation status in

communication media such as documents, brochures or advertising,

complies with the requirements of the Accreditor.

(2) When the desired scope of accreditation is related to a

specific program any necessary explanation shall be provided to the

applicant. If requested, additional application information shall be

provided to the body.

(b) The Accreditor shall require an official application form, duly

completed and signed by a duly authorized representative of the

applicant, in which or attached to which:

(1) The scope of the desired accreditation is defined; and

(2) The applicant agrees to comply with the requirements for

accreditation and to supply any information needed for its evaluation.

(c) At least the following shall be provided by the applicant prior

to the on-site assessment:

(1) The general features of the applicant body, such as corporate

entity, name, address, legal status and, where relevant, human and

technical resources;

(2) General information concerning the body covered by the

application, such as its functions, and its relationship in a larger

corporate entity, and its physical locations;

(3) A description of the systems or products it registers and the

standards or other normative documents applicable to each; and

(4) A copy of its quality manual and, where required, the

associated documentation.

Sec. 280.1021 Preparation for assessment.

(a) Before proceeding with the assessment, the Accreditor shall

conduct, and maintain records of, a review of the request for

accreditation to ensure that:

(1) The requirements for accreditation are clearly defined and

documented;

(2) Any difference in understanding between the Accreditor and the

applicant is resolved; and

(3) The Accreditor has the capability to perform the accreditation

service with respect to the scope of the accreditation sought, the

location of the applicant's operations, and any special requirements

such as the language used by the applicant.

(b) The Accreditor shall prepare a plan for its assessment

activities to allow for the necessary arrangements to be made.

(c) The Accreditor shall nominate a qualified audit team to

evaluate all material collected from the applicant and to conduct the

audit on its behalf. Experts in the areas to be assessed may be

attached to the Accreditor's team as advisers.

(d) The applicant shall be informed of the names of the members of

the audit team who will carry out the assessment, with sufficient

notice to appeal against the appointment of any particular auditors or

experts.

(e) The audit team shall be formally appointed and provided with

the appropriate working documents. The plan for and the date of the

audit shall be agreed upon with the applicant. The mandate given to the

audit team shall be clearly defined and made known to the applicant,

and shall require the audit team to examine the structure, policies and

procedures of the applicant, and confirm that these meet all the

requirements relevant to the scope of accreditation, and that the

procedures are implemented and are such as to give confidence in the

registrations of the applicant.

[[Page 47255]]

Sec. 280.1022 Assessment.

(a) The audit team shall assess all services of the applicant

covered by the defined scope against all applicable accreditation

requirements.

(b) The Accreditor shall witness fully the on-site activities of

one or more assessments or audits conducted by an applicant before an

initial accreditation is granted for any function requiring on-site

activity by the applicant.

Sec. 280.1023 Assessment report.

(a) The Accreditor may adopt reporting procedures that suit its

needs but, as a minimum, these procedures shall ensure that:

(1) A meeting takes place between the audit team and the

applicant's management prior to leaving the premises, at which the

audit team provides a written or oral indication on the conformity of

the applicant with the particular accreditation requirements and

provides an opportunity for the applicant to ask questions about the

findings and their basis;

(2) The audit team provides the Accreditor with a report of its

findings as to the applicant's conformity to all of the accreditation

requirements;

(3) A report on the outcome of the assessment is promptly brought

to the applicant's attention by the Accreditor, identifying any

nonconformity to be discharged in order to comply with all of the

accreditation requirements;

(4) The Accreditor shall invite the applicant to comment on the

report and to describe the specific actions taken, or planned to be

taken within a defined time, to remedy any nonconformity with the

accreditation requirements identified during the assessment, and shall

inform the applicant of the need for full or partial reassessment or

whether a written declaration to be confirmed during surveillance will

be considered adequate;

(5) The report shall contain as a minimum:

(i) The date(s) of the audit(s);

(ii) The name(s) of the person(s) responsible for the report;

(iii) The names and addresses of all sites audited;

(iv) The assessed scope of accreditation or reference thereto;

(v) Comments on the conformity of the applicant with the

accreditation requirements and, where applicable, any useful

comparisons with the results of previous assessment of the applicant;

and

(vi) An explanation of any differences from the information

presented to the applicant at the closing meeting.

(b) If the final report authorized by the Accreditor differs from

the report referred to in paragraphs (b) (3) and (5) of this section,

it shall be submitted to the applicant with an explanation of any

differences from the previous report. The report shall take into

consideration:

(1) The qualification, experience and authority of the staff

encountered;

(2) The adequacy of the internal organization and procedures

adopted by the applicant to give confidence in the quality of its

services; and

(3) The actions taken to correct identified nonconformities

including, where applicable, those identified at previous assessments.

Sec. 280.1024 Surveillance and reassessment procedures.

(a) The Accreditor shall have an established documented program,

consistent with the accreditation granted, for carrying out periodic

surveillance and reassessment at sufficiently close intervals to verify

that its accredited Registrar continues to comply with the

accreditation requirements.

(b) Surveillance and reassessment procedures shall be consistent

with those concerning the assessment of the applicant as described in

this part.

(c)(1) The Accreditor shall have arrangements to ensure that an

accredited Registrar informs it without delay of changes in any aspects

of its status or operation that affect its:

(i) Legal, commercial or organizational status;

(ii) Organization and management, for example key managerial staff;

(iii) Policies or procedures, where appropriate;

(iv) Premises; and

(v) Personnel, equipment, facilities, working environment or other

resources, where significant.

(2) The accredited Registrar shall also inform the Accreditor of

other such matters that may affect activities, or conformance with the

requirements, or any other relevant criteria of competence specified by

the Accreditor.

Subpart L--Requirements for Registrars

Sec.

General

280.1100 Introduction.

280.1101 Scope.

Requirements for Registrars

280.1110 Registrars.

280.1111 Registrar personnel.

280.1112 Changes in the registration requirements.

280.1113 Appeals, complaints and disputes.

Requirements for Registration

280.1120 Application for registration.

280.1121 Preparation for assessment.

280.1122 Assessment.

280.1123 Assessment report.

280.1124 Decision on registration.

280.1125 Surveillance and reassessment procedures.

280.1126 Use of certificates and logos.

280.1127 Access to records of complaints to fastener manufacturers.

General

Sec. 280.1100 Introduction.

This subpart sets out organizational, operational and other

requirements that must be met by all Registrars accredited under

subparts I or J of this part.

Sec. 280.1101 Scope.

These are general requirements that must be met by a third-party

body registering Facilities.

Note: In some countries, the bodies which verify conformity of

quality systems to specified standards are called ``certification

bodies,'' in others ``registration bodies,'' in others ``assessment

and registration bodies'' or ``certification/registration bodies,''

and in still others ``registrars.'' Reference to such bodies as

``Registrars'' should not be understood to be limiting.

Requirements for Registrars

Sec. 280.1110 Registrars.

(a) General provisions. (1) The policies and procedures under which

the Registrar operates shall be non- discriminatory, and they shall be

administered in a non-discriminatory manner. Procedures shall not be

used to impede or inhibit access by applicants other than as specified

in this part.

(2) The Registrar shall make its services accessible to all

applicants. There shall not be undue financial or other conditions.

Access shall not be conditional upon the size of the applicant body or

membership of any association or group, nor shall registration be

conditional upon the number of Facilities already registered.

(3) The criteria against which the quality assurance system of an

applicant is assessed shall be those outlined in the quality system

standards or other normative documents relevant to the function

performed. If an explanation is required as to the application of these

documents to a specific registration program, it shall be formulated by

relevant and impartial committees or persons possessing the necessary

technical competence, and published by the Registrar.

(4) The Registrar shall confine its requirements, assessment, and

decision on registration to those matters specifically related to the

scope of the registration being considered.

(b) Organization of a Registrar. The structure of the Registrar

shall be such

[[Page 47256]]

as to give confidence in its registrations. In particular, the

Registrar shall:

(1) Be impartial;

(2) Be responsible for its decisions relating to the granting,

maintaining, extending, reducing, suspending and withdrawing of

registration;

(3) Identify the management (committee, group, or person) which

will have overall responsibility for each of the following:

(i) Performance of assessment and registration as defined in this

part;

(ii) Formulation of policy matters relating to the operation of the

Registrar;

(iii) Decisions on registration;

(iv) Supervision of the implementation of its policies;

(v) Supervision of the finances of the Registrar; and

(vi) Delegation of authority to committees or individuals, as

required, to undertake defined activities on its behalf.

(4) Have documents which demonstrate that it is a legal entity;

(5) Have a documented structure which safeguards impartiality,

including provisions to assure the impartiality of the operations of

the Registrar. This structure shall enable the participation of all

parties significantly concerned in the development of policies and

principles regarding the content and functioning of the registration

system;

(6) Ensure that each decision on registration is taken by a person

or persons different from those who carried out the assessment;

(7) Have rights and responsibilities relevant to its registration

activities;

(8) Have adequate arrangements to cover liabilities arising from

its operations and/or activities;

(9) Have the financial stability and resources required for the

operation of a registration system;

(10) Employ a sufficient number of personnel having the necessary

education, training, technical knowledge, and experience for performing

registration functions relating to the type, range, and volume of work

performed, under a responsible senior executive;

(11) Have a quality system, as outlined in Sec. 280.1110(d), giving

confidence in its ability to operate a registration system for

Facilities;

(12) Have policies and procedures that distinguish between

registration and any other activities in which the Registrar is

engaged;

(13) Together with its senior executive and staff, be free from any

commercial, financial, and other pressures which might influence the

results of the registration process;

(14) Have formal rules and structures for the appointment and

operation of any committees which are involved in the registration

process; such committees shall be free from any commercial, financial,

and other pressure that might influence decisions;

(15) Ensure that activities of related bodies do not affect the

confidentiality, objectivity, or impartiality of its registrations and

shall not offer or provide, directly or indirectly, those services that

it registers others to perform, consulting services to obtain or

maintain registration, or services to design, implement, or maintain

quality systems;

(16) Have policies and procedures for the resolution of complaints,

appeals, and disputes received from fastener manufacturers or other

parties about the handling of registration or any other related

matters;

(17) Have a structure where members are chosen to provide a balance

of interests, where no single interest predominates; and

(18) Assure that other products, processes, or services that may be

offered, directly or indirectly, do not compromise confidentiality or

the objectivity or impartiality of its registration process and

decisions.

(c) Subcontracting. (1) When a Registrar decides to subcontract

work related to registration (e.g. audits) to an external body or

person, a properly documented agreement covering the arrangements,

including confidentiality and conflicts of interest, shall be drawn up.

The Registrar shall:

(i) Take full responsibility for such subcontracted work and

maintain its responsibility for granting, maintaining, extending,

reducing, suspending, or withdrawing registration;

(ii) Ensure that the subcontracted body or person is competent and

complies with the applicable provisions of this part, including section

280.7, and is not involved, either directly or through its employer,

with the design, implementation, or maintenance of a quality system in

such a way that impartiality could be compromised; and

(iii) Obtain the consent of the applicant or fastener manufacturer

whose Facility is registered.

(2) Requirements in paragrphs (c) (1) and (2) of this section are

also relevant, by extension, when a Registrar uses, for granting its

own registration, work provided by another Registrar with which it has

signed an agreement.

(d) Quality system. (1) The management of the Registrar with

executive responsibility for quality shall define and document its

policy for quality, including objectives for quality and its commitment

to quality. The management shall ensure that this policy is understood,

implemented, and maintained at all levels of the organization.

(2) The Registrar shall operate a quality system in accordance with

the relevant elements of this part and appropriate to the type, range,

and volume of work performed. This quality system shall be documented

and the documentation shall be available for use by the staff of the

Registrar.

(3) The Registrar shall ensure effective implementation of the

documented quality system procedures and instructions.

(4) The Registrar shall designate a person with direct access to

its highest executive level who, irrespective of other

responsibilities, shall have defined authority to ensure that a quality

system is established, im plemented, and maintained in accordance with

this part, and report on the performance of the quality system to the

management of the Registrar for review and as a basis for improvement

of the quality system.

(5) The quality system shall be documented in a quality manual and

associated quality procedures and the quality manual shall contain or

refer to at least the following:

(i) A quality policy statement;

(ii) A brief description of the legal status of the Registrar,

including the names of its owners, if applicable, and, if different,

the names of the persons who control it;

(iii) The names and qualifications, experience, and terms of

reference of the senior executive and other certification/registration

personnel, affecting the quality of the certification/registration

function;

(iv) An organization chart showing lines of authority,

responsibility, and allocation of functions stemming from the senior

executive and, in particular, the relationship between those

responsible for the assessment and those taking decisions regarding

registration;

(v) A description of the organization of the registration body,

including details of the management (committee, group, or person), its

constitution, terms of reference and rules of procedure;

(vi) The policy and procedures for conducting management reviews;

(vii) Administrative procedures including document control;

(viii) The operational and functional duties and services

pertaining to quality, so that the extent and limits of each person's

responsibility are known to all concerned;

(ix) The policy and procedures for the recruitment and training of

registration

[[Page 47257]]

body personnel (including auditors) and monitoring their performance;

(x) A list of its subcontractors and details of the procedure for

assessing, recording, and monitoring their competence;

(xi) Its procedures for handling nonconformities and for assuring

the effectiveness of any corrective actions taken;

(xii) The policy and procedures for implementing the registration

process, including:

(A) The conditions for issue, retention, and withdrawal of

registration documents;

(B) Checks of the use and application of documents used in the

registration of quality systems;

(C) The procedures for assessing and registering fastener

manufacturers' quality systems as employed in particular Facilities;

and

(D) The procedures for surveillance and reassessment of registered

Facilities.

(xiii) The policy and procedures for dealing with appeals,

complaints, and disputes; and

(xiv) The procedures for conducting internal audits based on the

provisions described in appropriate international documentation.

(e) Conditions for granting, maintaining, extending, reducing,

suspending, and withdrawing registration. (1) The Registrar shall

specify the conditions for granting, maintaining, reducing, and

extending registration and the conditions under which registration may

be suspended or withdrawn, partially or in total, for all or part of

the Facility's scope of registration. In particular, the Registrar

shall require the fastener manufacturer to notify it promptly of any

intended changes to the quality assurance system or other changes which

may affect conformity.

(2) The Registrar shall require the fastener manufacturer to have a

documented quality system which conforms to applicable quality system

standards or other normative documents.

(3) The Registrar shall have procedures to grant, maintain,

withdraw and, if applicable, suspend registration; to extend or reduce

the scope of registration; and to conduct reassessment in the event of

changes significantly affecting the activity and operation of the

Facility (such as change of ownership, changes in personnel or

equipment), or if analysis of a complaint or any other information

indicates that the registered fastener Facility no longer complies with

the requirements of the Registrar.

(4) The Registrar shall have documented procedures which shall be

made available on request for:

(i) Initial assessment and for the surveillance and reassessment of

a fastener manufacturer's quality assurance system as employed in a

particular Facility

(ii) Continuing conformity with relevant requirements; and for

verifying and recording that a fastener manufacturer takes corrective

action on a timely basis to correct all nonconformities; and

(iii) Identifying and recording nonconformities and the need for

corrective action by fastener manufacturers on a timely basis for such

items as incorrect references to the registration or misleading use of

registration information.

(f) Internal audits and management reviews. (1) The Registrar shall

conduct periodic internal audits covering all procedures in a planned

and systematic manner, to verify that the quality assurance system is

implemented and is effective. The Registrar shall ensure that personnel

responsible for the area audited are informed of the outcome of the

audit; corrective action is taken in a timely and appropriate manner;

and the results of the audit are recorded.

(2) The top management of the Registrar shall review its quality

system at defined intervals sufficient to ensure its continuing

suitability and effectiveness in satisfying the requirements of this

part and the stated quality policy and objectives. Records of such

reviews shall be maintained.

(g) Documentation. (1) The Registrar shall document, update at

regular intervals, and make available through publications, electronic

media, or other means, on request

(i) Information about the authority under which the Registrar

operates;

(ii) A documented statement of its registration system including

its rules and procedures for granting, maintaining, extending,

reducing, suspending, and withdrawing registration;

(iii) Information about the assessment and registration process;

(iv) A description of the means by which the Registrar obtains

financial support, and general information on the fees charged to

applicants and fastener manufacturers whose Facilities have been

registered;

(v) A description of the rights and duties of applicants and

fastener manufacturers whose Facilities have been registered, including

requirements, restrictions, or limitations on the use of the

Registrar's logo and on the ways of referring to the registration

granted;

(vi) Information on procedures for handling complaints, appeals and

disputes; and

(vii) A directory of registered Facilities, including their

locations, describing the scope of registration granted to each.

(2) The Registrar shall establish and maintain procedures to

control all documents and data that relate to its registration

functions. These documents shall be reviewed and approved for adequacy

by appropriately authorized and competent personnel prior to issuing

any documents following initial development or any subsequent amendment

or change being made. A listing of all appropriate documents with the

respective issue and/or amendment status identified shall be

maintained. The distribution of all such documents shall be controlled

to ensure that the appropriate documentation is made available to

personnel of the Registrar or of the fastener manufacturer whose

Facility is registered, when required to perform any function relating

to the activities of an applicant or registered Facility.

(h) Records. (1) The Registrar shall maintain a record system to

suit its particular circumstances and to comply with this part. The

records shall demonstrate that the registration procedures have been

effectively fulfilled, particularly with respect to application forms,

assessment reports, and other documents relating to granting,

maintaining, extending, reducing, suspending, or withdrawing

registration. The records shall be identified, managed and disposed of

in such a way as to ensure the integrity of the process and

confidentiality of the information. The records shall be kept for a

period of five years.

(2) The Registrar shall have a policy and procedures for retaining

records for a period of five years. The Registrar shall have a policy

and procedures concerning access to these records consistent with

paragraph (h)(1) of this section.

(i) Confidentiality. (1) The Registrar shall have adequate

arrangements, consistent with applicable laws to safeguard

confidentiality of the information obtained in the course of its

registration activities at all levels of its organization, including

committees and external bodies or individuals, acting on its behalf.

(2) Except as required in this part, information about a particular

product, quality assurance system, Facility, or fastener manufacturer

shall not be dis closed to a third party without the written consent of

the fastener manufacturer.

[[Page 47258]]

Sec. 280.1111 Registrar personnel.

(a) General provisions. (1) The personnel of the Registrar involved

in registration shall be competent for the functions they perform.

(2) Information on the relevant qualifications, training and

experience of each member of the personnel involved in the registration

process shall be maintained by the Registrar. Records of training and

experience shall be kept up to date.

(3) Clearly documented instructions shall be available to the

personnel describing their duties and responsibilities. These

instructions shall be maintained up to date.

(b) Qualification criteria for auditors and technical experts. (1)

In order to ensure that assessments are carried out effectively and

uniformly, the minimum relevant criteria for competence shall be

defined by the Registrar.

(2) Auditors shall meet the requirements of the appropriate

international documentation. For the assessment of a quality system,

the relevant guidelines for auditing and the criteria for auditors are

those defined in the appropriate international documentation.

(3) Technical experts are not required to comply with the

requirements for auditors, and guidance on their personal attributes

may be obtained the appropriate international documentation.

(c) Selection procedure. (1) The Registrar shall have a procedure

for selecting auditors and, if applicable, technical experts on the

basis of their competence, training, qualifications, and experience,

and for initially assessing the conduct of auditors and technical

experts during assessment and subsequently monitoring the performance

of auditors and technical experts.

(2) When selecting the audit team to be appointed for a specific

assessment, the Registrar shall ensure that the skills brought to each

assignment are appropriate. The team shall:

(i) Be familiar with the Fastener Quality Act and its implementing

regulations, registration procedures and registration requirements;

(ii) Have a thorough knowledge of the relevant assessment method

and assessment documents;

(iii) Have appropriate technical knowledge of the fastener

technology for which registration is sought and where relevant with

associated procedures and their potential for failure (technical

experts who are not auditors may fulfill this function);

(iv) Have a degree of understanding sufficient to make a reliable

assessment of the competence of the Facility to provide products,

processes or services in its registered scope;

(v) Be able to communicate effectively, both in writing and orally,

in the required languages;

(vi) Be free from any interest that might cause team members to act

in other than an impartial or non-discriminatory manner, for example:

(A) Audit team members or their organization shall not have

provided consulting services to the applicant or fastener manufacturer

whose Facility is registered which compromise the registration process

and decision; and

(B) In accordance with the directives of the Registrar, the audit

team members shall inform the Registrar, prior to the assessment, about

any existing, former or envisaged link between themselves or their

organization and the fastener manufacturer whose Facility is to be

assessed.

(d) Contracting of assessment personnel. The Registrar shall

require the personnel involved in the assessment to sign a contract or

other document by which they commit themselves to comply with the rules

defined by the Registrar, including those relating to confidentiality

and those relating to independence from commercial and other interests,

and any prior and/or present link with the fastener manufacturers whose

Facilities are to be assessed. The Registrar shall ensure that, and

document how, any subcontracted assessment personnel satisfy all the

requirements for assessment personnel outlined in this subpart.

(e) Assessment personnel records. (1) The Registrar shall possess

and maintain up-to-date records on assessment personnel, consisting of:

(i) Name and address;

(ii) Affiliation and position held in the organization,

(iii) Educational qualifications and professional status;

(iv) Experience and training in each field of competence of the

Registrar;

(v) Date of most recent updating of records; and

(vi) Performance appraisal.

(2) The Registrar shall ensure and verify that any subcontracted

body maintains records which satisfy the requirements of this part, of

assessment personnel who are subcontracted to the Registrar.

(f) Procedures for audit teams. Audit teams shall be provided with

up-to-date assessment instructions and all relevant information on

registration arrangements and procedures.

Sec. 280.1112 Changes in the registration requirements.

The Registrar shall give due notice of any changes it intends to

make in its requirements for registration. It shall take account of

views expressed by the interested parties before deciding on the

precise form and effective date of the changes. Following a decision

on, and publication of, the changed requirements, it shall verify that

each fastener manufacturer whose Facility is registered carries out any

necessary adjustments to its procedures within such time as, in the

opinion of the Registrar, is reasonable.

Sec. 280.1113 Appeals, complaints and disputes.

Appeals, complaints and disputes brought before the Registrar by

fastener manufacturers or other parties shall be subject to the

procedures of the Registrar. The Registrar shall keep a record of all

appeals, complaints and disputes, and remedial actions relative to

registration; take appropriate corrective and preventive action; and

document the actions taken and assess their effectiveness.

Requirements for Registration

Sec. 280.1120 Application for registration.

(a)(1) The Registrar shall maintain up-to-date as specified in

Sec. 280.1110(g)(1), a detailed description of the assessment and

registration procedure, the documents containing the requirements for

registration and documents describing the rights and duties of fastener

manufacturers whose Facilities are registered, and shall provide them

to applicants and those fastener manufacturers. The Registrar shall

require that a fastener manufacturer whose Facility is registered:

(i) Always complies with the relevant provisions of this part;

(ii) Makes all necessary arrangements for the conduct of the

assessment, including provision for examining documentation and the

access to all areas, records (including internal audit reports) and

personnel for the purposes of assessment, surveillance, reassessment,

and resolution of complaints;

(iii) Only claims that its Facility is registered with respect to

those activities for which it has been granted registration;

(iv) Does not use the registration in such a manner as to bring the

Registrar into disrepute, and does not make any statement regarding its

registration which the Registrar may consider misleading or

unauthorized;

(v) Upon suspension or withdrawal of the registration (however

determined),

[[Page 47259]]

discontinues use of all advertising matter that contains any reference

thereto and returns any registration documents as required by the

Registrar;

(vi) Uses registration only to indicate that the quality assurance

system as employed in its Facility is in conformity with specified

standards or other normative documents, and does not use the

registration to imply that a product or service is approved by the

Registrar, as required by section 280.804;

(vii) Ensures that no registration document, mark or report, or any

part thereof, is used in a misleading manner; and

(viii) In making reference to the registration in communication

media such as documents, brochures, or advertising, complies with the

requirements of the Registrar.

(2) When the desired scope of registration is related to a specific

program, any necessary explanation shall be provided to the fastener

manufacturer. If requested, additional application information shall be

provided to the fastener manufacturer.

(b) The Registrar shall require an official application form, duly

completed and signed by a duly authorized representative of the

applicant fastener manufacturer in which or attached to which:

(1) The scope of the desired registration is defined; and

(2) The applicant agrees to comply with the requirements for

registration and to supply any information needed for its evaluation.

(c)(1) At least the following information shall be provided by the

applicant prior to the on-site assessment:

(i) The general features of the applicant, such as corporate

entity, name, addresses, legal status and, where relevant, human and

technical resources;

(ii) General information concerning the quality system and the

activities it covers;

(iii) A description of the systems to be registered and the

standards or other normative documents applicable to each; and

(iv) A copy of its quality manual and, where required, the

associated documentation.

(2) The information gathered from the application documentation and

the quality manual review may be used for the preparation of the on-

site assessment and shall be treated with appropriate confidentiality.

Sec. 280.1121 Preparation for assessment.

(a) Before proceeding with the assessment the Registrar shall

conduct, and maintain records of, a review of the request for

registration to ensure that:

(1) The requirements for registration are clearly defined,

documented, and understood;

(2) Any difference in understanding between the Registrar and the

applicant is resolved; and

(3) The Registrar has the capability to perform the registration

service with respect to the scope of the registration sought, the

location of the applicant's operations, and any special requirements

such as the language used by the applicant.

(b) The Registrar shall prepare a plan for its assessment

activities to allow for the necessary arrangements to be made.

(c) The Registrar shall nominate a qualified audit team to evaluate

all material collected from the applicant and to conduct the audit on

its behalf. Experts in the areas to be assessed may be attached to the

Registrar's team as advisers.

(d) The fastener manufacturer shall be informed of the names of the

members of the audit team who will carry out the assessment, with

sufficient notice to appeal against the appointment of any particular

auditors or experts.

(e) The audit team shall be formally appointed and provided with

the appropriate working documents. The plan for and the date of the

audit shall be agreed to by the fastener manufacturer. The mandate

given to the audit team shall be clearly defined and made known to the

fastener manufacturer, and shall require the audit team to examine the

structure, policies, and procedures of the Facility and the quality

assurance system it employs, and confirm that these meet all the

requirements relevant to the scope of registration, and that the

procedures are implemented and are such as to give confidence in the

products, processes, or services of the Facility being evaluated.

Sec. 280.1122 Assessment.

The audit team shall assess the quality assurance system, employed

in the Facility being evaluated, covered by the defined scope against

all applicable registration requirements.

Sec. 280.1123 Assessment report.

(a) The Registrar may adopt reporting procedures that suit its

needs but, as a minimum, these procedures shall ensure that:

(1) A meeting takes place between the audit team and the fastener

manufacturer's management prior to leaving the premises, at which the

audit team provides a written or oral indication regarding the

conformity of the quality assurance system, as employed in particular

Facility, with the particular registration requirements and provides an

opportunity for the fastener manufacturer to ask questions about the

findings and their basis;

(2) The audit team provides the Registrar with a report of its

findings as to the conformity of the quality assurance system, as

employed in the particular Facility, with all of the registration

requirements;

(3) A report on the outcome of the assessment is promptly brought

to the fastener manufacturer's attention by the Registrar, identifying

any nonconformity to be discharged in order to comply with all of the

registration requirements;

(4) The Registrar shall invite the fastener manufacturer to comment

on the report and to describe the specific actions taken, or planned to

be taken within a defined time, to remedy any nonconformity with the

registration requirements identified during the assessment of its

quality assurance system, as employed in the particular Facility, and

shall inform the fastener manufacturer of the need for full or partial

reassessment of its quality assurance system or whether a written

declaration to be confirmed during surveillance will be considered

adequate;

(5) The report shall contain as a minimum:

(i) The date(s) of the audit(s);

(ii) The name(s) of the person(s) responsible for the report;

(iii) The names and addresses of the Facility audited;

(iv) The assessed scope of registration or reference thereto,

including reference to the standard(s) applied;

(v) Comments on the conformity of the quality assurance system, as

employed in the particular Facility, with the registration

requirements, with a clear statement of nonconformity and, where

applicable, any useful comparison with the results of previous

assessments of the quality assurance system, as employed in that

particular Facility; and

(vi) An explanation of any differences from the information

presented to the body at the closing meeting.

(b) If the final report authorized by the Registrar differs from

the report referred to in paragraphs (a) (3) and (5) of this section,

it shall be submitted to the fastener manufacturer with an explanation

of any differences from the previous report. The report shall take into

consideration:

(1) The qualification, experience, and authority of the staff

encountered;

[[Page 47260]]

(2) The adequacy of the internal organization and procedures

adopted by the applicant body to give confidence in the quality

assurance system, as employed in the particular Facility; and

(3) The actions taken to correct identified nonconformities

including, where applicable, those identified at previous assessments.

Sec. 280.1124 Decision on registration.

(a) The decision whether or not to register a fastener Facility

shall be taken by the Registrar on the basis of the information

gathered during the registration process and any other relevant

information. Those who make the registration decision shall not have

participated in the audit.

(b) The Registrar shall not delegate authority for granting,

maintaining, extending, reducing, suspending, or withdrawing

registration to an outside person or body.

(c) The Registrar shall provide to each fastener manufacturer whose

Facility is registered, registration documents such as a letter or a

certificate signed by an officer who has been assigned such

responsibility. These documents shall identify, for the fastener

manufacturer and the particular Facility covered by the registration:

(1) The name and addresses;

(2) The scope of registration granted, including as appropriate:

(i) The quality system standards and/or other normative documents

to which quality systems are registered;

(ii) The product, process, or service categories; and, if

appropriate,

(iii) Regulatory requirements, product standards, or other

normative documents against which products are supplied.

(3) The effective date of registration and the term for which the

registration is valid.

(d) Any application for amendment to the scope of a previously

granted registration shall be processed by the Registrar. The Registrar

shall decide what, if any, assessment procedure is appropriate to

determine whether or not the amendment should be granted and shall act

accordingly.

Sec. 280.1125 Surveillance and reassessment procedures.

(a) The Registrar shall carry out periodic surveillance and

reassessment at sufficiently close intervals to verify that its

registered Facilities continue to comply with the registration

requirements. The period involved cannot be greater than one year.

(b) Surveillance and reassessment procedures shall be consistent

with those concerning the assessment of the Facility as described in

this part.

Sec. 280.1126 Use of certificates and logos.

(a) The Registrar shall exercise proper control over ownership, use

and display of its quality system registration mark and logos.

(b) If the Registrar confers the right to use a symbol or logo to

indicate registration of a Facility, the fastener manufacturer may use

the specified symbol or logo only as authorized in writing by the

Registrar. This symbol or logo shall not be used on a product or in a

way that may be interpreted as denoting product conformity.

(c) The Registrar shall take suitable action to deal with incorrect

references to the registration system or misleading use of certificates

and logos found in advertisements, catalogs, etc. Such action could

include corrective action, withdrawal of certificate, publication of

the transgression and, if necessary, other legal action.

Sec. 280.1127 Access to records of complaints to fastener

manufacturers.

The Registrar shall require each fastener manufacturer whose

Facility is registered to make available to the Registrar, when

requested, the records of all complaints and corrective action taken in

accordance with the requirements of the quality system standards or

other normative documents.

[FR Doc. 97-23613 Filed 9-5-97; 8:45 am]

BILLING CODE 3510-13-P