Transcript Post Certification Overview Kim 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.

Post Certification
Overview
Kim 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
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)
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.
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
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.
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.
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.
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.
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.
Examples of Nonconformance Issues
 Performance failure
 Failure to maintain quality control requirements
 Misleading advertising
 Manufacturing under a private label without prior
approval from NIOSH
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).
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.
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
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.
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.
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.
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
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
User-Reported Problems
Firefighter
injury or
fatality
with SCBA
involved
Firefighter SCBA
Evaluation
Any Respirator User
Fire Departments
Law Enforcement
Chemical Industry
Mining
Healthcare
Malfunction
reported
with any
respirator
Field Problem
Investigation
Fire fighter Project Initiation
Fire Department
State/Local Fire Marshal’s Office
Law Enforcement Agency
Other
Traumatic Injuries
NIOSH Division of Safety
Research
Morgantown
Cardiovascular Event
NIOSH Division of Surveillance,
Hazard Evaluations, and Field
Studies
Cincinnati
SCBA Performance Evaluation
NIOSH NPPTL
Technology Evaluation Branch
Pittsburgh
FFFIP: Inspection
 Condition of major components
 Approved configuration
 Identifying information
 Suitability for testing
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.
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.
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
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)
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
FFFIP: Outputs
 Report of inspection and
testing results
 Report provided to entity
that submitted unit and
SCBA manufacturer
 Results provided to NIOSH -
DSR or DSHEFS (if involved)
 Field problem investigation
initiated if warranted
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)
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.