DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 280

Docket Number: 970724177-8057-02

RIN: 0693-AB43

PROCEDURES FOR IMPLEMENTATION OF THE FASTENER QUALITY ACT

AGENCY: National Institute of Standards and Technology, United States Department of Commerce

ACTION: Final Rule and Extension of implementation date

SUMMARY: The Director of the National Institute of Standards and Technology (NIST), United States Department of Commerce, and the Under Secretary of the Bureau of Export Administration (BXA), United States Department of Commerce (collectively referred to as the Department), are today issuing a final rule based on comments received in response to the notice of proposed rulemaking published in the Federal Register on September 8, 1997 (62 FR 47240-47260)(1997)) amending regulations found at 15 CFR Part 280 implementing the Fastener Quality Act (the Act). This final rule establishes the procedures for registration of in-process inspection activities of qualifying manufacturing facilities that use Quality Assurance Systems (QAS), revises definitions and related sections for clarity, and corrects editorial errors. These changes will facilitate the implementation of the Act and will better accommodate modern industry practices by incorporating these practices into the certification process of fasteners covered by the Act. This rule also extends the implementation date of the Fastener Quality Act by sixty days to July 26, 1998.

DATES: This rule is effective [insert 30 days after date of publication in the FEDERAL REGISTER]. The date of implementation of the Act is July 26, 1998.

FOR FURTHER INFORMATION CONTACT: Dr. Subhas G. Malghan, FQA Program Manager, Technology Services, National Institute of Standards and Technology, Building 820, Room 306, Gaithersburg, MD 20899, telephone number (301) 975-5120.

SUPPLEMENTARY INFORMATION

Extension of Implementation Date

The final rule implementing the Fastener Quality Act became effective on November 25, 1996, and was to apply to fasteners manufactured on or after May 27, 1997, the Aimplementation date@. On April 18, 1997, as permitted by Section 15 of the Act, NIST announced a one year delay of the implementation date of the regulations because there were an insufficient number of accredited laboratories to conduct the volume of inspection and testing required by the Act and regulations (62 Fed. Reg. 19041 (1997)). Currently, NVLAP and the NIST-recognized private accreditation bodies have received applications from approximately 430 testing laboratories, a sufficient number for implementation of the Act. Of these, approximately 130 testing laboratories have been accredited and are listed on the NIST Accredited Laboratory List. Although NVLAP and the private accreditation bodies have been working diligently to complete accreditation of these laboratories, it seems unlikely that the necessary 425 laboratories will be accredited by May 26, 1998. Therefore, to ensure that there are a sufficient number of accredited laboratories to conduct the inspection and testing required by the Act, pursuant to section 15 of the Act, NIST is extending the implementation date of the Act by sixty days to July 26, 1998.

Background - Final Rule

The Fastener Quality Act (the Act) protects the public safety by: (1) requiring that certain fasteners which are sold in commerce conform to the specifications to which they are represented to be manufactured; (2) providing for accreditation of laboratories and registration of manufacturing facilities engaged in fastener testing; and (3) requiring inspection, testing and certification, in accordance with standardized methods, of fasteners covered by the Act.

The Secretary of Commerce, acting through the Director of NIST, published final regulations implementing the Act on September 26, 1996. Those regulations established procedures under which: (1) laboratories in compliance with the Act may be listed; (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, recordkeeping, applicability of the Act, enforcement, civil penalties, and hearing and appeal procedures.

Those regulations became effective on November 25, 1996, and were to apply to fasteners manufactured on or after May 27, 1997, the Aimplementation date@. On April 18, 1997, as permitted by Section 15 of the Act, NIST announced a one year delay of the implementation date of the regulations because there were an insufficient number of accredited laboratories to conduct the volume of inspection and testing required by the Act and regulations (62 Fed. Reg. 19041 (1997)).

Following issuance of the final regulations on September 26, 1996, the automobile industry approached the Department and expressed its concern that the Act and the implementing regulations did not recognize the use of modern manufacturing methods using prevention-based quality assurance systems employing statistical process controls (SPC). On February 4, 1997, a Public Workshop was held at NIST to solicit information from all interested parties, including the automobile, aerospace, construction, and fastener industries on the use of prevention-based quality assurance systems employing SPC in the manufacture of fasteners. The Department published a notice of proposed rule making in the Federal Register on September 8, 1997, seeking public comments on proposed amendments to the regulations that recognize the use of prevention-based quality assurance systems under the Act.

To incorporate Quality Assurance Systems/Statistical Process Control (QAS/SPC) into the regulations, the Department proposed adding section 280.104, Accreditation of Certain Manufacturing Facilities as Laboratories; subpart I, Special Rule for the Accreditation of Certain Fastener Manufacturing Facilities, Whose Implemented Fastener Quality Assurance Systems Meet Defined Requirements, as Laboratories; subpart J, Recognition of Foreign Registrar Accreditation Bodies; subpart K, Requirements for Registrar Accreditation Bodies (Accreditors); and subpart L, Requirements for Registrars. In addition, the Department proposed adding a definition of Fastener Quality Assurance System (FQAS) and defining the terms Accreditor, Registrar, and Facility. The Department also proposed amendments to section 280.6, Laboratory Test Reports and section 280.10, Sampling, to specify requirements for facilities.

Summary of Public Comments Received by the Department in Response to the September 8, 1997 Request for Public Comments, and the Department=s Response to the Comments.

As noted above, on September 8, 1997, the Department published in the Federal Register (62 Fed. Reg. Pages 47240-47260) (1997)(Sept.8, 1997) a proposed rule to amend 15 CFR Part 280. The Department received 125 responses to the request for comments. Twenty-five comments were received from fastener manufacturers, twenty domestic and five foreign; twenty-five were from associations, twenty domestic and five foreign; thirteen were from consultants; ten were from fastener distributors; eight were from entities involved in laboratory accreditation/facility registration, three laboratory assessors, two fastener testing laboratories, one laboratory accreditor, one foreign QAS registrar, and one foreign registration accreditation body; eight were manufacturers of products that incorporate fasteners, five from the aerospace industry, two from the automobile industry (one domestic and one foreign), and one foreign equipment manufacturer; eight were from government agencies; six were from importers of fasteners; one was from a foreign exporter of fasteners; one was from a raw material manufacturer; and twenty were from other interested parties, fifteen domestic and five foreign. Of the some 125 commenters, 69 commented on the issue of incorporating SPC/QAS into the FQA regulations. A detailed analysis of the comments follow.

As explained in detail below, based on the comments received, the Department has included all the proposed changes, with some editorial corrections and clarifications, in the final rule. For further clarification, the Department also has included definitions for recognized accreditor, accredited registrar, registered facility, and authorized representative, and has amended the definition of consensus standards organization to clarify that it is NIST that will identify such organizations.

Comments on the Overall Effectiveness of the Proposed QAS Regulation

Of the 125 commenters, 69 commented on the issue of incorporating SPC/QAS into the FQA regulations; 44 favored the incorporation of SPC/QAS into the FQA regulations, and 25 were opposed.

Of the 44 commenters who favored the incorporation of SPC/QAS into the FQA regulations, thirteen were fastener manufacturers, ten domestic and three foreign; thirteen were trade associations, ten domestic and three foreign; six were manufacturers of products that incorporate fasteners, three aerospace manufacturers, two automobile manufacturers (one domestic and one foreign), and one foreign equipment manufacturer; three were fastener distributors; three were consultants; one was a government agency; one was a foreign QAS registrar; and four were other interested parties, two domestic and two foreign.

Of the 25 commenters opposed to the incorporation of SPC/QAS into the FQA regulations, four were consultants; four were laboratory accreditors/assessors; three were domestic fastener manufacturers; two were fastener distributors; three were government agencies; one was a raw material manufacturer; and seven were other interested parties.

Comment: Support for the proposed incorporation of QAS/SPC into the regulation was widespread, although many raised questions on details of the regulation, as is explained more fully elsewhere in this document. However, a substantial minority of the commenters, twenty-five, expressed the concern that without final testing, the QAS/SPC scheme proposed by NIST would not ensure the quality of fasteners covered by the regulations, and would fail to protect the public safety.

Response: The decision by the Department to include QAS/SPC into the regulations as an alternative to end-of-line sampling and testing is based upon strong evidence that QAS/SPC reduces the defect rate in the fastener manufacturing process. A lower defect rate means that fewer fasteners are manufactured that fail to comply with relevant standards and specifications, and thus that fewer defective fasteners will enter into commerce. Public safety is preserved and enhanced. Furthermore, the Department has structured the regulation to provide checks and balances to ensure that this is the case.

The administrative record for this rule-making contains strong evidence that QAS/SPC systems utilizing continuous monitoring and control in the manufacturing process yields a substantially lower defect rate than do traditional manufacturing techniques that rely solely upon end-of-line sampling and testing. Testimony at the Public Workshop of February 7, 1997 indicates that the use of QAS/SPC may reduce the defect rate from the range of thousands or tens of thousands parts-per-million experienced by traditional manufacturing techniques to approximately 100 parts-per-million. The improved manufacturing techniques embedded in QAS/SPC thus improve the quality of fasteners by reducing the portion of each lot that fails to meet standards and specifications. The regulations being issued today offer the benefits of QAS/SPC manufacturing to consumers in this country. But consistent with the FQA, these regulations also mandate in-process inspection and testing of fasteners manufactured under QAS/SPC systems, to verify that the promise of QAS/SPC is the reality.

As a means of providing checks and balances to the process controls that underlie the QAS/SPC methodology, the regulations mandate in-process inspection and testing of fasteners to assure the quality of fasteners, and thus the protection of public safety. Process controls in QAS/SPC facilities are required by the regulation to be augmented by all testing required by the standards and specifications that the manufacturer holds out that a given lot meets. The general rule is set out in section 280.104(a), which states that registration of a fastener manufacturing facility employing a fastener quality assurance system (FQAS) shall be deemed to meet the requirements of accreditation of a laboratory under the FQA. This general rule is amplified in section 280.2, which defines the term FQAS, and section 280.10, which sets out requirements for sampling methods to be followed by QAS/SPC facilities.

These sections of the regulation address three issues in the regime required of QAS/SPC facilities:

What is the sampling methodology required of QAS/SPC facilities as part of their responsibility to conduct in-process testing and inspection?
What specific tests and testing techniques must QAS/SPC facilities apply to the samples that are to be tested?
Where must these tests be performed?

Sampling is a concept that will not always be relevant in the QAS/SPC environment. The definition of FQAS speaks about Aprocess inspection embodied in a comprehensive and written control plan for product/process characteristics, process controls (including statistical process control), tests, and measurement systems that will occur during mass production.@ The Department recognizes that under QAS/SPC, some tests and inspections will be conducted on every fastener in the lot. That is, the test sample will be one hundred percent of the fastener lot. Section 280.10(c), as it has been revised as a result of the public comment process, makes this point clear by stating, as one alternative, that Aa manufacturer operating a Registered Facility may elect to conduct inspections and tests upon all of the fasteners within a specified lot, provided that this election is documented in the control plan of its Fastener Quality Assurance System.@ Otherwise, the sample size is governed by the general rule in section 280.10(a), which states that A[f]or tests conducted either in a laboratory on the Accredited Laboratory List or in a Registered Facility, if a manufacturer represents that the fasteners in a particular sample have been manufactured to a standard or specification which provides for the size, selection or integrity of the sample to be inspected and tested, the sample shall be determined in accordance with that standard or specification@; or the first alternative in section 280.10(c) AFor tests conducted in a Registered Facility, and not in a laboratory on the Accredited Laboratory List, if a manufacturer represents that the fasteners in a particular sample have been manufactured to a standard or specification which does not provide for the size, selection or integrity of the sample to be inspected and tested, the sample for inspections and tests by the Facility shall be determined by the sampling plan provided by its Fastener Quality Assurance System or by standards and specifications intended for use with a Fastener Quality Assurance System, as appropriate.@

Tests are as required in the relevant standards and guidelines.

Where testing occurs in the QAS/SPC regime is governed by section 280.104(b) of the regulations, which requires that all in-process laboratory inspection and testing must be performed in laboratories accredited under the FQA; and section 280.104(d), which requires that the chemical composition of all fastener lots manufactured under QAS/SPC must be conducted in laboratories accredited under the FQA. In-process testing and inspection may occur within Registered Facilities.

In the view of the Department, these requirements meet the statutory mandates of the FQA, and protect the public safety.

280.2 Definitions.

Comment: Eight commenters addressed the issue of whether subcontracted processes required final testing by an accredited laboratory or whether they could be performed by another Facility.

Response: In section 280.2, the definition of Facility has been expanded to include a facility performing subcontracted processes such as electroplating and heat treating, provided that they too are listed on NIST=s Facilities list. In addition, section 280.807 allows subcontracting to other Facilities listed on the Facilities list.

Comment: Eight commenters suggested that Quality Assurance Systems are not equivalent, and that they do not define which characteristics to measure and how to measure them.

Response: No changes have been made to the regulations based on these comments because the QAS facilities must meet equally rigorous standards to maintain their registration by an accredited Registrar.

Comment: Two commenters requested that the regulations be amended to allow QAS in lieu of metal testing by a metal manufacturer.

Response: No changes were made to the regulations because to the Department=s knowledge, chemistry of metal is obtained by testing it in a laboratory. Therefore, chemical analysis by QAS is not an acceptable testing method.

Comment: Ten commenters suggested deleting references to ISO-9000 in the definition of Fastener Quality Assurance System because it lacks quality details and does not contain the details of ISO-25. In addition, three of these commenters stated that the proposed rule does not satisfy the intent of the Congress and will have a serious effect on the laboratory accreditation, and that a final inspection should be still required.

Response: No changes were made to the regulations based on these comments. The regulations are clear on laboratory accreditation and registration of fastener manufacturing facilities. The laboratory accreditation is performed in accordance with ISO Guides 58 and 25, and specific requirements of the Act and the regulations. Registration of fastener manufacturing facilities is carried out in accordance with the ISO Guides 61, 62 and the specific requirements of the Act and the regulations. The revised rule accommodating QAS facilities is fully within the intent of the Act because under QAS, fasteners are produced to stringent standards that yield fasteners of at least as good quality as end-of-line laboratory testing can assure. Since the two programs, accreditation and registration, are treated separately, the Department does not believe that laboratory accreditation will be seriously affected.

Comment: Two commenters suggested that the Department specify a level of revision of ISO Guides referred to in the QAS regulations that will assure the Department that the QAS approved today will remain compliant in the future.

Response: No changes were made to the regulations based on these comments. As they currently exist, the ISO Guides referenced in the QAS regulations fulfill the needs of the Act and the regulations. The regulations are sufficiently flexible to accommodate moderate change in these standards.

Comment: One commenter remarked that the parameters of a control plan are not discussed in the proposed rule.

Response: No changes were made to the regulations based on this comment because the Department has decided that the broad parameters described in section 280.2 are sufficient.

Comment: One commenter suggested clarifying the meaning of Adocumented criteria of a QAS.@

Response: No changes were made to the regulations based on this comment because the definition of QAS describes specific criteria to be met by the QAS facility.

Comment: One commenter suggested adding a requirement that personnel who collect data pursuant to the operation of a QAS be held to the same standards of training, experience and competency as laboratory personnel.

Response: No changes were made to the regulations based on this comment. The processes involved in laboratory testing differ from those in a QAS facility. Requirements for personnel performing tasks involved in these processes differ. The requirements for laboratory personnel are described in ISO Guide 25. The requirements for QAS facility personnel are described, in general, in the fastener QAS followed by that QAS facility.

Comment: One commenter remarked that QAS plans should be required to measure all characteristics called for in the standard and specification, rather than just those that the manufacturer finds appropriate for product functionality.

Response: The Department agrees. Changes were made to the regulations in section 280.2 under the definition of Fastener Quality Assurance System in (2)(v). To improve clarity, this section is amended to read as follows: Aa requirement that the in-process control plan include those characteristics specified by the QAS standard, characteristics specifically indicated by the applicable fastener standards and specifications, and those characteristics as designated by the end user for evaluating product functionality.@

Comment: One commenter asked if a fastener standard does not accept SPC as an alternative to the final testing, then can the SPC be used.

Response: No changes were made to the regulations based on this comment. If a fastener standard does not accept SPC, SPC may not be used to meet the requirements of that standard.

Comment: One commenter requested amending section 280.5 to confer upon the major end user the responsibility of specifying how a lot of fasteners is to be tested, including in accordance with major end users in-house publication or in accordance with QAS, rather than in accordance with the embedded standards and specifications.

Response: No changes were made to the rule based on this comment because section 5(b)(1) of the Act requires that a manufacturer have lot samples tested to determine whether the lot conforms to the standards and specifications to which the manufacturer represents it has been manufactured. The Act does not offer the flexibility of delegating this responsibility to the end user.

Comment: One commenter suggested adding a definition of major end user to the rule.

Response: The Department has not made any changes to the regulations based on this comment. A definition of major end user is not necessary because the term major end user does not appear in the regulations.

Comment: One commenter remarked that NIST overlooked the basis of its Malcolm Baldrige award, and NIST should practice its quality outreach program by reissuing regulations to encompass ISO-9002 and QS-9000 and state of the art quality programs.

Response: No changes were made to the regulations based on this comment. ISO-9002 and QS-9000 are used worldwide while the Malcolm Baldrige criteria are familiar only to United States firms. Since fasteners to which the Act and the regulations apply are produced worldwide, international standards are more appropriate.

280.5 Certification of Fasteners

Comment: One commenter proposed an amendment to section 280.5 of the rule to clarify that a manufacturer that follows QAS is in compliance with the Act.

Response: No changes were made based on this comment because section 280.5(a) states the rule for inspecting, testing, and certification of covered fasteners, and section 280.104(a) brings registered QAS facilities under this general rule, and therefore, in compliance with the Act.

280.6 Laboratory Test Reports

Comment: Nine commenters stated that manufacturers registered to QAS should not have to prepare test reports as proposed in section 280.6(b) and that requirement would make the QAS program unworkable. These commenters stated that amendments to proposed section 280.6(b) would be necessary. In addition, two additional commenters requested that the Department reduce the contents of the test reports for QAS facilities since it is unnecessary and burdensome, limit requirements to those of the Act and require just a statement that fasteners conform to the QAS plan on the report.

Response: The requirement for a test report is mandated by sections 5 and 7 of the Act. However, based on these comments, amendments have been made to section 280.6(b) of the regulations by deleting certain reporting requirements. Also, similar amendments were made in section 280.6(a) to simplify laboratory test report requirements for both laboratories and Facilities. Further, section 280.7 was amended to accommodate amendments made to section 280.6.

Comment: Two commenters asked whether imported fasteners produced under QAS must be accompanied by a certificate and laboratory testing report.

Response: No changes were made to the regulations because there is no exception that states that imported fasteners produced under QAS need not be accompanied by a certificate and laboratory test report. Section 280.13 describes the requirements for imported fasteners, which include a manufacturer<