Post Certification Overview Kim C. Gavel Lead General Engineer

1. Post Certification OverviewKim C. Gavel Lead General Engineer Fire Fighter Fatality/Injury SCBA Evaluation Overview Thomas Pouchot General Engineer National Institute for Occupational Safety and Health National Personal Protective Technology Laboratory Technical Evaluation Branch

2. Post Certification • Steps that continue after respirator is granted NIOSH Approval. • Ensure that respirator continues to be produced according to NIOSH criteria. • Post Certification activities include: • Product Audits • Site Audits • Certified Product Investigation Process (CPIP) • Long Term Field Evaluation (LTFE) • Fire Fighter Fatality/Injury SCPA Evaluation Program (FFFIP)

3. Product Audits • Purchase units commercially to test and ensure performance to applicable criteria. • Typically filtering facepiece units. • Verify performance of all units through default to test program. • Shelf life testing: • Verify performance up through expiration date.

4. Product Audit Testing • Tests conducted on filtering facepiece respirators: • Respirator Performance • Filter efficiency and leakage (for valve) • Quality assurance evaluation • Check labeling, user instructions, visual inspection • NIOSH submits report to Approval Holder • Pass or Fail

5. Product Audit Outcome • If unit passes testing • No action required by Approval Holder. • Approval Holder can continue to manufacture and control quality of product to NIOSH approval criteria. • If unit fails testing • Certified Product Investigation Process (CPIP) is initiated and NIOSH sends letter to open investigation. • Approval Holder must identify cause of failure and provide resolution.

6. Site Audits • WHERE: • All manufacturing site locations, including approval holder subcontractors. • WHEN: • Typically every 2 years (every year in some cases). • WHO: • NIOSH or Contract representative. • HOW: • Evaluate against Title 42, Code of Federal Regulations, Part 84 (42 CFR 84) & NIOSH Approved Quality Control Plan at facility.

7. Site Audit Report Outcome • Following the Site Audit, NIOSH sends a report documenting to the Approval Holder. • Overall result of Site Audit: • Acceptable – No corrective actions required. • Provisionally Acceptable – Production of respirators may continue while the required corrective actions are implemented. • Not Acceptable – Failure to promptly complete corrective actions may result in Stop Sale and/or Revocation of NIOSH approvals.

8. Site Audit Process – Follow-up • Approval Holder provides NIOSH with documentation to show corrective actions have been completed. • At next site audit visit, NIOSH will verify that corrective actions were put into place.

9. Certified Product Investigation Program (CPIP) • PURPOSE: • To ensure the quality of NIOSH approved respiratory units by promptly investigating and resolving reports of product nonconformance issues.

10. Examples of Nonconformance Issues • Performance failure • Failure to maintain quality control requirements • Misleading advertising • Manufacturing under a private label without prior approval from NIOSH

11. When is a CPIP Needed? • When an approved NIOSH respirator is in nonconformance with the specified requirements in Title 42, Code of Federal Regulations, Part 84 (42 CFR 84).

12. CPIP Goals • Maintain quality of NIOSH approved units. • Investigate Internal, External and Self-Reported issues. • Document findings of the approval holder’s investigation and their corrective actions. • Address inventory units, field units and future production.

13. Possible Follow-Up Actions • User Notices • Stop Sales • Recalls • NIOSH Applications to make changes to: • QA Manual • Production Process • Engineering Design • Request to voluntarily rescind Approval Numbers

14. CPIP Closing • Has approval holder properly identified the cause of the nonconformance? • Has approval holder developed effective corrective actions to resolve nonconformance? • Has approval holder successfully addressed inventory units, field units and future production? • When NIOSH determines investigation can be closed, Approval Holder receives closing letter.

15. Long Term Field Evaluations (LTFE) • Purpose: • To evaluate long term field performance of self-contained self-rescuers (SCSR) units certified by NIOSH. • Method • Randomly selected units are collected from mines and are tested on the Automated Breathing and Metabolic Simulator.

16. LTFE • Outcomes: • Comparisons are made between deployed units and new units. • If a nonconformance to 42 CFR Part 84 is identified, a CPIP is opened. • Results of the LTFE testing are reported to mine operators, MSHA, and Manufacturers.

17. Fire Fighter Fatality/Injury SCBA Evaluation Program Overview (FFFIP) • Purpose: • To determine the conformance of SCBA involved in fire fighter injuries or fatalities to the NIOSH approval requirements found in Title 42, Code of Federal Regulations, Part 84 • Inspection • Testing • To provide information resulting in the reduction of firefighter injuries and fatalities

18. FFFIP • History: • Evaluations have been conducted as part of respirator certification program since 1972 • Congress included language in FY1998 budget directing NIOSH to investigate firefighter fatalities • Average of 7 SCBA investigations annually since FY1998

19. User-Reported Problems Any Respirator User Fire Departments Law Enforcement Chemical Industry Mining Healthcare Firefighter injury or fatality with SCBA involved Malfunction reported with any respirator Firefighter SCBA Evaluation Field Problem Investigation

20. Fire fighter Project Initiation Fire Department State/Local Fire Marshal’s Office Law Enforcement Agency Other Cardiovascular Event NIOSH Division of Surveillance, Hazard Evaluations, and Field Studies Cincinnati Traumatic Injuries NIOSH Division of Safety Research Morgantown SCBA Performance Evaluation NIOSH NPPTL Technology Evaluation Branch Pittsburgh

21. FFFIP: Inspection • Condition of major components • Approved configuration • Identifying information • Suitability for testing

22. FFFIP: Air Sampling and Testing • Air Sampling • Sample taken if air remaining in cylinder • Tested against CGA G-7.1 • Dewpoint: OSHA 29 CFR 1910.134(i)(4)(iii) requires ≤ -50°F,NFPA 1500 standard requires ≤ -65°F • Testing • 7 tests are performed if SCBA unit is suitable. • 6 NIOSH, 1 NFPA • May replace cylinder and/or facepiece for testing depending on damage.

23. NIOSH Tests Performed • Rated Service Time Test/ Positive Pressure Test • How long can SCBA provide air? • Does SCBA maintain positive pressure in facepiece? • Gas Flow Test • Continuous airflow provided by SCBA while still keeping positive facepiece pressure. • Requirement is 200 lpm at full rated pressure and at 500 psig.

24. NIOSH Tests Performed • Remaining Service Life Indicator Test(Low-Air Alarm) • RSLI provides user with warning of air exhaustion • Must alarm at 20-25% or 23-27% of service life (pressure) • Six runs performed, average determines pass or fail

25. NIOSH Test Performed • Static Pressure Test / Exhalation Resistance Test • Static pressure is facepiece pressure at zero flow condition (≤ 1.5”H2O) • Exhalation resistance is facepiece pressure at 85 lpm continuous flow (≤ 2”H2O above static)

26. NFPA Air Flow Performance Test • NFPA 1981 breathing machine • Test parameters 103 lpm, 30 breaths/minute • Facepiece Pressure must remain between 0 and 3.5”H2O

27. FFFIP: Outputs • Report of inspection and testing results • Report provided to entitythat submitted unit andSCBA manufacturer • Results provided to NIOSH -DSR or DSHEFS (if involved) • Field problem investigationinitiated if warranted

28. FFFIP: Key Findings • Few evaluations result in a Field Problem Investigation • < 5%, based on sample from last five years • Maintenance, maintenance, maintenance • Most common test failure is remaining service life indicator (usually set high)

29. Quality Partnerships Enhance Worker Safety & Health Visit Us at: http://www.cdc.gov/niosh/npptl/ http://www.cdc.gov/niosh/programs/ppt/ Disclaimer:The findings and conclusions in this presentation have not been formally disseminated by the National Institute for Occupational Safety and Health and should not be construed to represent any agency determination or policy.