Sampling Procedures

Letter to All Respirator Manufacturers

Issue Date: September 24, 2012

From: Heinz Ahlers, Chief, Technology Evaluation Branch, National Personal Protective Technology Laboratory

Subject: Sampling Procedures

The National Institute for Occupational Safety and Health (NIOSH) requires that respirator approval holders inspect and/or test samples of respirators and components as part of their quality control plans. This requirement is stated in Title 42, Code of Federal Regulations, Part 84 (42 CFR 84), specifically in §§ 84.41(b) through 84.41(i).

Some applicants or approval holders have had difficulty understanding how to select and use a sampling procedure which meets the requirements. This letter is intended to explain the practical use of common standard procedures acceptable to NIOSH.

This letter will not discuss statistical theory underlying acceptance sampling. If applicants or approval holders intend to use alternatives to the procedures described here, they must understand the concepts of acceptance sampling and process control. The use of more modern methods such as calculating process capability values (C_pk) or employing statistical process control (SPC) is encouraged where this is compatible with the approval holder’s operations and provides equivalent assurance of respirator performance. Justification to demonstrate the equivalence of these procedures must be provided in the application seeking approval.

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