NIOSH Conformity Assessment Notice

Subject: Summarized Information about NIOSH Respirator Approval Program (i) Basic Application Procedures (ii) Quality Assurance Requirements and (iii) Supplier or Subcontractor Agreements

Supersedes: March 2021 version

Supersedes: April 7, 2005 Letter to All Manufacturers, Clarification of Supplier and Subcontractor Relationships

Supersedes: September 24, 2012 Letter to All Manufacturers, Respirator Sampling Procedures

NIOSH CA 2021-1034R1
June 2021

1 – Summary

NIOSH requires approval holders to meet performance requirements and the respirators must be manufactured under a quality management system (QMS) that is reviewed and accepted as part of the approval process. To keep NIOSH’s applicants informed about the respirator approval program, NIOSH is providing this document to clarify expectations related to (1) the basic application procedures; (2) the quality assurance (QA) requirements in the NIOSH regulation, 42 CFR Part 84, Subpart E; and (3) requirements for supplier and subcontractor agreements.

Throughout this document, applicant refers to an individual, partnership, company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval for such respirator. NIOSH considers domestic applicants to be those whose design/development activities, quality assurance activities, and manufacturing sites are located inside the United States. NIOSH considers applicants whose headquarters are located within the United States but whose design/development activities, quality assurance activities, and/or manufacturing sites are not within the United States to be non-domestic applicants.

This guidance can assist applicants in navigating the NIOSH review process by better outlining the QA requirements in one document, because guidance is currently located in multiple documents. This document does not create any new requirements, although it does provide a new example of acceptable ways to present information to NIOSH for use in the QA review. This guidance is not a substitute for reviewing and understanding 42 CFR Part 84 or the NIOSH Standard Application Procedure (SAP) relevant to the respiratory protective device that an applicant will submit to NIOSH for approval. The example provided is tailored for filtering facepiece respirators (FFRs), but this guidance can be used as a starting point for all applicants. Please consider all parts of this document.

Note: If an applicant has already submitted an application and determines, based on this guidance, that the application is not adequate, the applicant should submit a request to withdraw the application. This can be accomplished by emailing theRecords Room (RecordsRoom@cdc.gov) or the Reviewer actively working the application. An approval request can be resubmitted after all guidance is considered and the requirements are met.

Note: It is not appropriate to refer to any product as NIOSH-approved, pending NIOSH approval, compliant to NIOSH standards, or similar claims prior to receiving the NIOSH approval. NIOSH approval encompasses NIOSH evaluation and acceptance of the respirator and the QMS. This cannot be achieved until the approval process is complete, including an engineering review, testing, and the assessment of the QMS by NIOSH. Similarly, if a product was once NIOSH-approved, but that approval was subsequently revoked or rescinded, the product may not be represented as NIOSH-approved.

Note: NIOSH expects the applicant to complete a full or limited production run (if all respirators are produced using the QMS presented to NIOSH) prior to submitting an application. The number of respirators produced prior to achieving NIOSH approval should be carefully considered because respirators not produced under the quality control system evaluated and accepted by NIOSH cannot be labeled as NIOSH-approved.

3 – Topics Explained

(i) Basic Application Procedure

(ii) NIOSH Quality Requirements:

NIOSH approval goes beyond assuring the device meets the appropriate minimum performance requirements defined by 42 CFR Part 84 for the intended protection. The approval extends to the entire QMS utilized to produce the respirators, which ensures that products produced continue to meet the NIOSH performance requirements. NIOSH requires respirator approval holders to inspect and/or test samples of respirators and components as part of their quality control plans. This requirement is stated in 42 CFR Part 84, specifically in § 84.41(b)-(i). Because of the stringent quality assurance requirements, this is often the part of the review process that applicants struggle with the most. The following sections reiterate the necessities of a comprehensive QMS.

(iii) Supplier and Subcontractor Relationships

If a company wishes to seek approval but does not manufacture the respirators in-house, it is possible to still apply for NIOSH approval, but only if the company who is applying as the approval holder controls the quality and design of the product. In order to correctly present this information to NIOSH, the prospective approval holder should carefully review the definitions of a supplier and a subcontractor (below). If subcontractors are used, the Quality Manual for the subcontractor should be supplied with the application, along with a subcontractor agreement that covers the elements required by the Subcontractor Relationship Responsibilities, outlined below. If multiple manufacturing sites are used for production or quality assurance, the Quality Manual for all applicable sites should be provided with the application.

Note: Roles and responsibilities within the QMS should not be confused with roles and responsibilities for NIOSH approved product private packaging and private labeling agreements. Please see NIOSH Conformity Assessment Notice 2020-1030 for information about private packaging and private labeling NIOSH approved respirators. It is expected that NIOSH-approved respirators are made following the QMS described to and accepted by NIOSH.

Approval Holder. The party of record to whom certificates of approval will be or have been issued. The approval holder maintains responsibility for, and control of, product design, performance, configuration management, manufacture, quality, and support.

Supplier. A supplier produces components or subassemblies under their own quality system for delivery to the approval holder. The approval holder confirms the acceptability of incoming goods by accepting a Certificate of Compliance and inspecting incoming goods to ensure compliance with all product design, performance, and quality assurance criteria (drawings and engineering control). The approval holder releases the final product for distribution and sale.

Subcontractor. The approval holder may authorize a subcontractor to release NIOSH-approved respirators directly from the subcontractor’s facility for distribution and sale, or to release components and subassemblies directly to an authorized repair center. This role and responsibility should be made clear in the documentation included in the application to NIOSH. The approval holder maintains responsibility for, and control of, product design, performance, configuration management, manufacture, quality, and support by maintaining influence over, and active involvement in, the subcontractor’s quality system. As such, the subcontractor’s facility is considered to be a manufacturing site for the approval holder.

Subcontractor Relationship Responsibilities. The approval documentation on file at NIOSH must demonstrate that the following criteria have been met for NIOSH recognition of a subcontractor.

  • As with all other NIOSH approvals, the approval holder maintains responsibility for all aspects of the approval: control over product design, performance, configuration management, manufacture, quality, and support. This includes product drawings, material specifications, parts lists, and manufacturing processes; control over the requirements for final inspection and testing; and approval of any changes to the above.
  • The approval holder must ensure that a subcontractor has demonstrated the ability to produce product that consistently meets the established release criteria and has adequate quality systems and procedures in place to assure product quality on an ongoing basis.
  • The approval holder must establish and maintain active involvement and influence over subcontractor quality systems. This can be demonstrated in many ways. One example of this involvement and influence can be exhibited by participating in the subcontractor’s management reviews (as defined by ISO 9001 sec. 5.6, 2000) required by the subcontractor’s Quality System. A second example is participation in the subcontractor’s Material Review Board.
  • The approval holder’s methods for maintaining active involvement and influence over their subcontractor’s quality system needs to be documented in a plan or procedure that suits the individual situation and manufacturing complexity of the secured goods. The approval holder must formally submit this plan or procedure to NIOSH.
  • The approval holder will maintain copies of subcontractor quality records that demonstrate compliance with NIOSH performance requirements. It is important to ensure that, in the event of a broken relationship, both the approval holder and NIOSH have continued access to those records.
  • All submissions related to the approval must be made by an authorized representative of the approval holder. The subcontractor’s Quality Manual and related quality system documents must represent how the approval holder establishes and maintains active involvement and influence over the subcontractor’s quality system. This information must be specifically indicated and documented as part of a Quality Assurance application if the subcontractor is added after an initial approval application.
  • As with all Quality Manuals, a process must be established and followed for ongoing resubmission of the Quality Manual and related quality system documents in the event of significant changes, and on a periodic basis, per NIOSH requirements.
  • All subcontractor relationships must be listed as an approval holder’s manufacturing site, with a designated point of contact, on the NIOSH Standard Application Form (SAF) for direct shipment from the subcontractor to be acceptable under the NIOSH approval.
  • NIOSH will audit all manufacturing sites for NIOSH-approved products, including subcontractor facilities, every two years. NIOSH will not contact the subcontractor directly but will always work through the approval holder’s designated representative for the specific manufacturing site.

4 – Supplemental Information – Example Only

The following table is provided merely as an example. The numbers and plans in Table 3 are not a representation of a quality plan used for a currently approved respirator but were included to show that a combination of various sampling plans may be utilized. Information and values, presented as “#” below, are for illustrative purposes only.

Table 3. Example of how the sampling method, classifications of defects, and acceptable quality limits could be presented to NIOSH (provided for illustrative purposes only).

Inspection Procedure Classification
of Defect
AQL Sampling
Standard
Sampling
Level
Inspection
Description
Inspection
Method/
Equipment
Inspection
Criteria
Table 3. Example of how the sampling method, classifications of defects, and acceptable quality limits could be presented to NIOSH (provided for illustrative purposes only).
Incoming IN1 Major A 1.0 C=0 Filter Media basis weight Balance ## gsm* +/-## gsm
IN2 Major A 1.0 MIL-STD-105D S-2 Filter Media filtration efficiency TSI 8130 Particle filtration ≥ 95%
IN3 Major A 1.0 MIL-STD-105D S-2 Strap elasticity Tensile tester ###%, # N
IN4 Minor 4.0 MIL-STD-105D General Level II Media Appearance Visual No stains, defects visible
IN5 Major A 1.0 C=0 Outer layer basis weight Balance ## gsm +/-## gsm
IN6 Major A 1.0 C=0 Inner layer basis weight Balance ## gsm +/-## gsm
In-Process IP1 Major B 2.5 MIL-STD-105D General Level II Head strap length verification Steel ruler ### ± # mm
IP2 Major B 2.5 MIL-STD-105D General Level II Dimension verification Caliper Length ### ± ## mm
Width ### ± ## mm
IP3 Major A 1.0 MIL-STD-105D General Level II Strap attachment strength Weight Breakage point
Final FI1 Major A 1.0 MIL-STD-105D S-2 Filtration efficiency TSI 8130 Particle filtration ≥ 95%
FI2 Major A 1.0 MIL-STD-105D S-2 Inhalation resistance Manometer ≤ 35 mmH20
FI3 Major A 1.0 MIL-STD-105D S-2 Exhalation resistance Manometer ≤ 25 mmH20
FI4 Major A 1.0 MIL-STD-105D S-2 Exhalation valve leakage Gilibrator ≥ 30 mL/min
FI5 Minor 4.0 MIL-STD-105D General Level II Appearance Visual No stains, printing legible, no frayed edges

*gsm is defined as grams per square meter

5 – Contacting the Respirator Approval Program

If you have any questions regarding the information provided in this document or elsewhere, please feel free to reach out to the Respirator Approval Program. You will be put in contact with the appropriate party to answer your question(s). Respirator Approval Program employees cannot act as consultants, but they will be able to answer specific questions about the approval process and requirements.

All emails to the Respirator Approval Program should include your company name in the subject line. If you have a 3-letter manufacturer’s code, this should also be included.

6 – References

Approval of Respiratory Protective Devices, 42 CFR Part 84external icon

Standard Application Procedure for the Approval of Air-Purifying Filtering Facepiece Respirators Under 42 CFR Part 84, revised March 12, 2018, Sections 3.1 and 3.2

Standard Application Procedure for the Approval of Closed-Circuit Escape Respirators Under 42 CFR Part 84, revised October 16, 2018, Sections 3.1 and 3.2

Standard Application Procedure for the Approval of Supplied-Air Respirators, Industrial Self- Contained Breathing Apparatus, and Combination Supplied-Air Respirators/Industrial Self- Contained Breathing Apparatus Under 42 CFR Part 84, revised March 12, 2018, Sections 3.1 and 3.2

Standard Application Procedure for the Approval of Powered Air-Purifying Respirators and Chemical, Biological, Radiological and Nuclear Powered Air-Purifying Respirators Under 42 CFR Part 84, revised March 12, 2018, Sections 3.1 and 3.2

Standard Application Procedure for the Approval of Air-Purifying Respirators and Chemical, Biological, Radiological and Nuclear Air-Purifying Respirators Under 42 CFR Part 84, revised March 12, 2018, Sections 3.1 and 3.2

Standard Application Procedure for the Approval of Self-Contained Breathing Apparatus, and Chemical, Biological, Radiological and Nuclear Self-Contained Breathing Apparatus Under 42 CFR Part 84, revised March 12, 2018, Sections 3.1 and 3.2

NIOSH Conformity Assessment Notice (CA 2019-1012) | NPPTL | NIOSH | CDC

NIOSH CA 2019-1019 – NIOSH Quality Control Plan Requirements

NIOSH CA 2020-1030 – Requirements and Responsibilities of Approval Holders and Assignees in NIOSH Approved Respirator Private Labeling and Private Packaging Arrangements

American National Standards Institute [2003a]. Sampling procedures and tables for inspection by attributes. Milwaukee, WI: American Society for Quality, American National Standard ANSI/ASQ Z1.4-2003.

American National Standards Institute [2003b]. Sampling procedures and tables for inspection by variables for percent nonconforming. Milwaukee, WI: American Society for Quality, American National Standard ANSI/ASQ Z1.9-2003.

Squeglia NL [2008]. Zero acceptance number sampling plans. 5th ed. Milwaukee, WI: American Society for Quality.

U.S. Department of Defense [1957]. Sampling procedures and tables for inspection by variables for percent defective. Washington, DC: Office of the Assistant Secretary of Defense (Supply and Logistics), Military Standard MIL-STD-414 (including Notice 1, 8 May 1968).

U.S. Department of Defense [1963]. Sampling procedures and tables for inspection by attributes. Washington, DC: U.S. Government Printing Office, Military Standard MIL-STD-105D (including Change Notice 2, 20 March 1964).

U.S. Department of Defense [1989]. Sampling procedures and tables for inspection by attributes. Washington, DC: Department of Defense, Military Standard MIL-STD-105E.

International Organization for Standardization [2000]. Quality management systems — Requirements (ISO Standard No. 9001). Retrieved from https://www.iso.org/standard/21823.htmlexternal icon.

 

Revision (R) Date Reason for Revision
Revision table
1.0 12 May 2021 NIOSH revised this notice based on HHS review and comments.
Page last reviewed: June 9, 2021