Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19: Appendix A, quality control plans

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The quality control plan must include:

  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 manufacturer’s plant
  6. audit of final inspection of the completed product
  7. the organizational structure necessary to carry out these provisions
  8. each provision for incoming and final inspection in the quality control plan, including a procedure for the selection of a sample of respirators and the components thereof for testing, in accordance with procedures set forth in recognized standards for sampling by variables or sampling by attributes

Incoming bulk raw material inspection or verification of specification and in-process inspection should be sufficient to ensure control of product quality through the manufacturing cycle:

  1. the sampling procedure shall include a list of the characteristics to be tested by the manufacturer
  2. the characteristics listed in accordance with paragraph (a) of this section shall be classified according to the potential effect of such defect and grouped into the following classes:
    • 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
    • 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
    • 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
    • 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
  3. the quality control inspection test method to be used by the manufacturer for each characteristic required to be tested shall be described in detail
  4. each item manufactured shall be 100% inspected for defects in all critical characteristics and all defective items shall be rejected
  5. the acceptable quality level (AQL) for each major or minor defect so classified by the manufacturer shall be:
    • Major A: 1.0%
    • Major B: 2.5%
    • Minor: 4.0%
  6. except as provided in paragraph (g) of this section, normal inspection as described in the sampling standards (ISO 2859-1, ANSI/ASQC Z1.4, ASTM E2234, ASTM E2762) or an equivalent procedure shall be used for major and minor characteristics and 100% inspection for critical characteristics.
  7. subject to the approval of Health Canada, 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 (f) of this section.

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