Source: https://www.law.cornell.edu/cfr/text/42/84.41
Timestamp: 2018-10-20 00:58:37
Document Index: 229278717

Matched Legal Cases: ['art 84', '§ 84', 'art 51', '§ 577', '§ 651', '§ 652', '§ 653', '§ 654', '§ 655', '§ 656', '§ 658', '§ 659', '§ 660', '§ 661', '§ 662', '§ 663', '§ 664', '§ 665', '§ 666', '§ 667', '§ 668', '§ 669', '§ 669', '§ 670', '§ 671', '§ 671', '§ 672', '§ 673', '§ 674', '§ 675', '§ 676', '§ 677', '§ 678', '§ 3', '§ 5', '§ 7', '§ 811', '§ 842', '§ 844', 'art 84', 'art 84', 'art 84']

42 CFR 84.41 - Quality control plans; contents. | US Law | LII / Legal Information Institute
CFR › Title 42 › Chapter I › Subchapter G › Part 84 › Subpart E › Section 84.41
42 CFR 84.41 - Quality control plans; contents.
§ 84.41 Quality control plans; contents.
(a) Each quality control plan shall contain provisions for the management of quality, including:
(1) Requirements for the production of quality data and the use of quality control records;
(2) Control of engineering drawings, documentations, and changes;
(3) Control and calibration of measuring and test equipment;
(4) Control of purchased material to include incoming inspection;
(5) Lot identification, control of processes, manufacturing, fabrication, and assembly work conducted in the applicant's plant;
(6) Audit of final inspection of the completed product; and
(7) The organizational structure necessary to carry out these provisions.
(b) Each provision for incoming and final inspection in the quality control plan shall include a procedure for the selection of a sample of respirators and the components thereof for testing, in accordance with procedures set forth in Military Standard MIL-STD-414, 11 June 1957, including Change Notice No. 1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure, or an approved combination of sampling procedures. The procedure of Military Standard MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent sampling procedure. MIL-STD-414 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 1 CFR part 51. Copies may be obtained from DODSSP, Standardization Document Order Desk, 700 Robbins Avenue, Bldg. 4D, Philadelphia, PA 19111-5094. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the
(NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. Incoming bulk raw material inspection or verification of specification, and in-process inspection shall be sufficient to ensure control of product quality through the manufacturing cycle.
(c) The sampling procedure shall include a list of the characteristics to be tested by the applicant or his agent.
(d) The characteristics listed in accordance with paragraph (c) of this section shall be classified according to the potential effect of such defect and grouped into the following classes:
(1)Critical. A defect that judgment and experience indicate is likely to result in a condition immediately hazardous to life or health for individuals using or depending upon the respirator;
(2)Major A. A defect, other than critical, that is likely to result in failure to the degree that the respirator does not provide any respiratory protection, or a defect that reduces protection and is not detectable by the user;
(3)Major B. A defect, other than Major A or critical, that is likely to result in reduced respiratory protection, and is detectable by the user; and
(4)Minor. A defect that is not likely to materially reduce the usability of the respirator for its intended purpose, or a defect that is a departure from established standards and has little bearing on the effective use or operation of the respirator.
(e) The quality control inspection test method to be used by the applicant or his agent for each characteristic required to be tested shall be described in detail.
(f) Each item manufactured shall be 100 percent inspected for defects in all critical characteristics and all defective items shall be rejected.
(g) The Acceptable Quality Level (AQL) for each major or minor defect so classified by the applicant shall be:
(1)Major A. 1.0 percent;
(2)Major B. 2.5 percent; and
(3)Minor. 4.0 percent.
(h) Except as provided in paragraph (i) of this section, inspection level IV as described in MIL-STD-414, 11 June 1957, including Change Notice No.1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an equivalent procedure, shall be used for major and minor characteristics and 100 percent inspection for critical characteristics. Inspection level II as described in MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent procedure.
(i) Subject to the approval of the Institute, where the quality control plan provisions for raw material, processes, manufacturing, and fabrication, inspections are adequate to ensure control of finished article quality, destructive testing of finished articles may be conducted at a lower level of inspection than that specified in paragraph (h) of this section.
(The information collections contained in this section are approved under OMB control number 0920-0109)
[ 60 FR 30355, June 8, 1995, as amended at 80 FR 3907, Jan. 26, 2015]
§ 577a
§ 651 - Congressional statement of findings and declaration of purpose and policy
§ 652 - Definitions
§ 653 - Geographic applicability; judicial enforcement; applicability to existing standards; report to Congress on duplication and coordination of Federal laws;...rights, duties, or liabilities of employers and employees unaffected
§ 654 - Duties of employers and employees
§ 655 - Standards
§ 656 - Administration
§ 658 - Citations
§ 659 - Enforcement procedures
§ 660 - Judicial review
§ 661 - Occupational Safety and Health Review Commission
§ 662 - Injunction proceedings
§ 663 - Representation in civil litigation
§ 664 - Disclosure of trade secrets; protective orders
§ 665 - Variations, tolerances, and exemptions from required provisions; procedure; duration
§ 666 - Civil and criminal penalties
§ 667 - State jurisdiction and plans
§ 668 - Programs of Federal agencies
§ 669 - Research and related activities
§ 669a - Expanded research on worker health and safety
§ 670 - Training and employee education
§ 671 - National Institute for Occupational Safety and Health
§ 671a - Workers’ family protection
§ 672 - Grants to States
§ 673 - Statistics
§ 674 - Audit of grant recipient; maintenance of rec­ords; contents of records; access to books, etc.
§ 675 - Annual reports by Secretary of Labor and Secretary of Health and Human Services; contents
§ 676 - Omitted
§ 677 - Separability
§ 678 - Authorization of appropriations
§ 3 - Duties of United States Bureau of Mines
§ 5 - Reports of investigations
§ 7 - Fees for tests or investigations
§ 811 - Mandatory safety and health standards
§ 842 - Dust concentration and respiratory equipment
§ 844 - Rock dust and gas hazards; controls
Title 42 published on 03-Aug-2018 03:34
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 84 after this date.
2018-03-22; vol. 83 # 56 - Thursday, March 22, 2018
83 FR 12527 - Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators; Technical Amendments
FR Doc. 2018-05775
RIN 0920-AA66
Docket No. CDC-2018-0003
NIOSH-309
Comments must be received by May 21, 2018.
42 CFR Part 84
The Department of Health and Human Services (HHS) proposes to modify current language found in Title 42 of the Code of Federal Regulations which addresses post-approval testing of closed-circuit escape respirators (CCERs). The revised language should clarify that post-approval testing of CCERs may exclude human subject testing and environmental conditioning, at the discretion of the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention, HHS. The revision to the text in this paragraph will clarify the scope of post-approval testing conducted by NIOSH.
2017-11-17; vol. 82 # 221 - Friday, November 17, 2017
82 FR 54315 - Total Inward Leakage Requirements for Respirators
FR Doc. 2017-24950
RIN 0920-AA33
Docket No. HHS-OS-2009-0019
NIOSH-0137
As of November 17, 2017, the proposed rule published on October 30, 2009, at 74 FR 56141, is withdrawn.
The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2009 notice of proposed rulemaking (NPRM). The 2009 NPRM proposed to establish total inward leakage requirements for half-mask, air-purifying particulate respirators approved by NIOSH.
2015-08-12; vol. 80 # 155 - Wednesday, August 12, 2015
80 FR 48268 - Closed-Circuit Escape Respirators; Extension of Transition Period
FR Doc. 2015-19750
RIN 0920-AA60
Docket No. CDC-2015-0004
NIOSH-280
This rule is effective on August 12, 2015.
In March 2012, the Department of Health and Human Services (HHS) published a final rule establishing a new standard for the certification of closed-circuit escape respirators (CCERs) by the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC). The new standard was originally designed to take effect over a 3-year transition period. HHS has determined that extending the concluding date for the transition is necessary to allow sufficient time for respirator manufacturers to meet the demands of the mining, maritime, railroad and other industries. Pursuant to this final action, NIOSH extends the phase-in period until 1 year after the date that the first approval is granted to certain CCER models.
2015-01-29; vol. 80 # 19 - Thursday, January 29, 2015
80 FR - Respirator Certification Fees
FR Doc. C1-2015-01046
RIN 0920-AA42
Docket No. CDC-2013-0004
NIOSH-216
80 FR 4801 - Closed-Circuit Escape Respirators; Extension of Transition Period
FR Doc. 2015-01057
This rule is effective on January 29, 2015. Comments must be received by March 30, 2015.
In March 2012, the Department of Health and Human Services (HHS) published a final rule establishing new standards for the certification of closed-circuit escape respirators (CCERs) by the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC). The new standards were designed to take effect over a 3-year transition period. HHS has determined that extending the concluding date for the transition is necessary to allow sufficient time for respirator manufacturers to meet the demands of the mining, maritime, railroad, and other industries. Pursuant to this interim final rule, NIOSH will extend the phase-in period until 6 months after the date that the first approval is granted to certain CCER models.
2015-01-26; vol. 80 # 16 - Monday, January 26, 2015
80 FR 3891 - Respirator Certification Fees
FR Doc. 2015-01046
This final rule is effective on May 26, 2015.
The Department of Health and Human Services (HHS) is revising the fee structure currently used by the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), to charge respirator manufacturers for the examination, inspection, and testing of respirators which are submitted to NIOSH for the purpose of creating or modifying a certificate of approval. Existing regulations reflect prices for respirator testing and approval that were promulgated in 1972, and have not kept pace with the actual costs of providing these services that benefit respirator manufacturers. This final rule is designed to update the regulations.
2013-11-19; vol. 78 # 223 - Tuesday, November 19, 2013
78 FR 69361 - Development of Inward Leakage Standards for Half-Mask Air-Purifying Particulate Respirators
FR Doc. 2013-27445
Docket No. CDC-2013-0017
NIOSH-250
Reopening of comment period.
Stakeholder comments to the questions included in the notice of September 4, 2013 (78 FR 54432) must be received by 11:59 p.m. ET on December 31, 2013.
On September 17, 2013, the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) held a public meeting concerning inward leakage performance requirements for the class of NIOSH-certified non-powered air-purifying particulate respirators approved as half-facepiece respirators for protection from particulate-only hazards. The purpose of this meeting was to share information and to seek stakeholder feedback, in identified topic areas, concerning the development of inward leakage performance standards. Questions concerning the identified topics of specific interest were included in the meeting notice published in the Federal Register on September 4, 2013. Written comments were to be received by October 18, 2013. HHS/CDC received a request from a stakeholder for additional time to comment on this notice. In consideration of this request HHS/CDC is reopening the public comment period through December 31, 2013.
2013-09-04; vol. 78 # 171 - Wednesday, September 4, 2013
78 FR 54432 - Development of Inward Leakage Standards for Half-Mask Air-Purifying Particulate Respirators
FR Doc. 2013-21430
Request for comment and notice of public meeting.
The public meeting will be held September 17, 2013, 1:00 p.m.-5:00 p.m. ET, or after the last public commenter has spoken. Stakeholder comments to the questions included in this document must be received by 11:59 p.m. ET on October 18, 2013.
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting concerning inward leakage performance requirements for the class of NIOSH-certified non-powered air-purifying particulate respirators approved as half-facepiece respirators for protection from particulate-only hazards. The purpose of this meeting is to share information and to seek stakeholder feedback, in identified topic areas, concerning the development of inward leakage performance standards. Questions concerning the identified topics of specific interest are included in this document. Attendance at the public meeting is not required to submit written responses to the questions in this notice.
2013-03-27; vol. 78 # 59 - Wednesday, March 27, 2013
78 FR 18535 - Respirator Certification Fees
FR Doc. 2013-06914
HHS invites comments on this proposed rule from interested parties. Comments must be received by May 28, 2013.
The Department of Health and Human Services (HHS) proposes to revise the fee structure currently used by the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC) to charge respirator manufacturers for the examination, inspection, and testing of respirators which are submitted to NIOSH for the purpose of creating or modifying a certificate of approval. Existing regulations reflect prices for respirator testing and approval that were promulgated in 1972, and have not kept pace with the actual costs of providing these services that benefit respirator manufacturers. This proposed rule is designed to update the regulations.
2013-01-14; vol. 78 # 9 - Monday, January 14, 2013
78 FR 2618 - Self-Contained Breathing Apparatus Remaining Service-Life Indicator Performance Requirements
FR Doc. 2013-00371
RIN 0920-AA38
Docket No. CDC-2012-0009
NIOSH-258
This final rule is effective February 13, 2013.
On June 25, 2012, the Department of Health and Human Services (HHS) published a notice of proposed rulemaking proposing to update respirator approval standards in response to a petition to amend our regulations, current requirements for self-contained breathing apparatus (SCBA) remaining service-life indicators or warning devices. These indicators are built into a respirator to alert the user that the breathing air provided by the respirator is close to depletion. In this final rule, HHS responds to public comment on the proposed rule and revises the current standard, employed by the National Institute for Occupational Safety and Health (NIOSH) located within the Centers for Disease Control and Prevention (CDC), to allow greater flexibility in the setting of the indicator alarm to ensure that the alarm more effectively meets the different worker protection needs of different work operations. This final rule sets a minimum alarm point at 25 percent of the rated service time and allows the manufacturer to offer remaining service life set point at a higher value or values appropriate to the purchaser&apos;s use scenario.
2012-06-25; vol. 77 # 122 - Monday, June 25, 2012
77 FR 37862 - Open-Circuit Self-Contained Breathing Apparatus Remaining Service-Life Indicator Performance Requirements
FR Doc. 2012-14764
Comments must be received by August 24, 2012.
As a component of its ongoing update of respirator certification standards under Part 84 and in response to a petition to amend 42 CFR 84.83(F), HHS proposes a revision to the current requirement for open-circuit self-contained breathing apparatus (OC-SCBA) remaining service-life indicators (indicators), which are devices built into a respirator to alert the user that the breathing air provided by the respirator is close to depletion. HHS intends to revise the current standard, employed by the National Institute for Occupational Safety and Health (NIOSH) located within the Centers for Disease Control and Prevention (CDC), to allow greater latitude in the setting of the indicator alarm to ensure that the alarm more effectively meets the different worker protection needs of different work operations. This revision sets a default service life at 25 percent of the rated service time and allows the indicator to be adjusted higher by the manufacturer, at the request of the purchaser.
2012-03-08; vol. 77 # 46 - Thursday, March 8, 2012
77 FR 14168 - Approval Tests and Standards for Closed-Circuit Escape Respirators
FR Doc. 2012-4691
RIN 0920-AA10
Docket No. NIOSH-005
This final rule is effective April 9, 2012. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of April 9, 2012.
This final rule announces updated requirements that the National Institute for Occupational Safety and Health (NIOSH or Agency), located within the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS or Department), will employ to test and approve closed-circuit respirators used for escaping atmospheres considered to be immediately dangerous to life and health, including such respirators required by the Mine Safety and Health Administration (MSHA) for use in underground coal mines. NIOSH and MSHA jointly review and approve this type of respirator used for mine emergencies under regulations concerning approval of respiratory protective devices. NIOSH also approves these respirators for use in other work environments where escape equipment may be provided to workers, such as on vessels operated by U.S. Navy and Coast Guard personnel. The purpose of these updated requirements is to enable NIOSH and MSHA to more effectively ensure the performance, reliability, and safety of CCERs.
42 CFR 84.20 — Establishment of Fees.