47240 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

DEPARTMENT OF COMMERCE

National Institute of Standards and

Technology

15 CFR Part 280

[Docket No: 970724177–7177–01]

Procedures for Implementation of the

Fastener Quality Act

AGENCY: National Institute of Standards

and Technology, United States

Department of Commerce.

ACTION: Notice of proposed rulemaking;

request for comments.

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 preventionbased 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
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules 47241

defect prevention and the reduction in

variation and waste in the supply chain.

QS–9000 employs statistical process

control (SPC) in ensuring the quality of

parts. Suppliers must demonstrate

process capabilities which will yield a

given quantity of parts with a minimum

specified number of defects. Depending

upon the fastener type and auto maker,

the maximum allowable defective Parts

Per Million (PPM) ranges between 15

and 125 PPM.

The heart of the QS–9000 system is

the Control Plan which each company

must develop and have approved by

Ford, GM, or Chrysler as part of their

adherence to QS–9000. The Control

Plan is a comprehensive documentation

of product/process characteristics,

process controls, tests, and

measurement systems that will occur

during mass production. It will

normally also specify how much inprocess 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
47242 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

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 NISTrecognized 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
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules 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 ➩rod

producer➩ wire or rod producer➩

distributor➩ 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
47244 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

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
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules 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. § 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-ofinformation 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:

§ 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
47246 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

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:

§ 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

§ 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 § 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 § 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 § 280.810 or tested by a Laboratory on

the Laboratories List described in

§ 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

§ 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 § 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:

§ 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
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules 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 § 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:

§ 280.7 Recordkeeping Requirements.

(a) Each laboratory accredited under

subparts C, D, or E or § 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:

§ 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:

§ 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:

§ 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
47248 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

manufacture fasteners subject to the Act

and this part unless the metal has been

tested for chemistry pursuant to

§ 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:

§ 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 §§ 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

§ 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:

§ 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 §§ 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.

§ 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
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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, §§ 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: § 280.810(a)

provides for a list of Accreditors that

have been recognized by NIST;

§ 280.810(b) provides for a list of

Registrars that have been accredited by

Accreditors listed according to

§ 280.810(a); and § 280.810(c) provides

for a list of Facilities that have been

registered by Registrars listed according

to § 280.810(b). The remainder of this

subpart, §§ 280.811 and 280.812,

contain procedural provisions related to

the lists established by § 280.810.

§ 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.

§ 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 § 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 onsite 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.

§ 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.

§ 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 NISTrecognized 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.

§ 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.

§ 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.

§ 280.807 Subcontracting.

If a recognized Accreditor, an

accredited Registrar, or a registered

Facility subcontracts any of its functions
47250 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

to another entity it must place the work

with another recognized Accreditor,

accredited Registrar, or registered

Facility; inform the client, before the

fact, that subcontracting will be

necessary, and clearly indicate in all

appropriate records, and reports to the

client, specifically what functions were

subcontracted.

§ 280.808 Reports.

Reports and records shall be

maintained in such a manner to

preserve original data, and be collected

as required into a final form, sufficient

to satisfy customer and legal

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.

§ 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 § 280.7 of this

part.

§ 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 § 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 § 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 § 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 § 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

§ 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 § 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.

§ 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.

§ 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.

§ 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.

§ 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

§ 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.

§ 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

§ 280.1010 Accreditors.

(a) General provisions. (1) The

policies and procedures under which

the Accreditor operates shall be nondiscriminatory, 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 § 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 § 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
47252 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

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 § 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,
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules 47253

and other documents relating to

granting, maintaining, extending,

reducing, suspending or withdrawing

accreditation. The records shall be

identified, managed and disposed of in

such a way as to ensure the integrity of

the process and confidentiality of the

information. The records shall be kept

for a period of five years.

(2) The Accreditor shall have a policy

and procedures for retaining records for

a period of five years. The Accreditor

shall have a policy and procedures

concerning access to these records

consistent with paragraph (h)(1) of this

section.

(i) Confidentiality. (1) The Accreditor

shall have adequate arrangements,

consistent with applicable laws, to

safeguard confidentiality of the

information obtained in the course of its

accreditation activities at all levels of its

organization, including committees and

external bodies or individuals acting on

its behalf.

(2) Except as required in this part,

information about a particular body

shall not be disclosed to a third party

without the written consent of the body.

§ 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 nondiscriminatory 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.

§ 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.

§ 280.1013 References to accredited

status.

(a) An Accreditor which is proprietor

or licensee of a symbol or logo, intended
47254 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

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

§ 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.

§ 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.

§ 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.

§ 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

§ 280.1020 Application for accreditation.

(a)(1) The Accreditor shall maintain

up-to-date as specified in

§ 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 § 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.

§ 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.
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules 47255

§ 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 onsite activity by the applicant.

§ 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.

§ 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

§ 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.

§ 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

§ 280.1110 Registrars.

(a) General provisions. (1) The

policies and procedures under which

the Registrar operates shall be nondiscriminatory, 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
47256 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

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 § 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
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules 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.
47258 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

§ 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 nondiscriminatory 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.

§ 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.

§ 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

§ 280.1120 Application for registration.

(a)(1) The Registrar shall maintain upto-date as specified in § 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),
Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules 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.

§ 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.

§ 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.

§ 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;
47260 Federal Register / Vol. 62, No. 173 / Monday, September 8, 1997 / Proposed Rules

(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.

§ 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.

§ 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.

§ 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.

§ 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