Post Certification Overview Kim C. Gavel Lead General Engineer

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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 Overview Kim C. Gavel Lead General Engineer

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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. - PowerPoint PPT Presentation

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Page 1: 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 HealthNational Personal Protective Technology Laboratory

Technical Evaluation Branch

Post Certification OverviewKim C. Gavel

Lead General Engineer

Page 2: Post Certification Overview Kim C. Gavel   Lead General Engineer

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)

Page 3: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 4: Post Certification Overview Kim C. Gavel   Lead General Engineer

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

Page 5: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 6: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 7: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 8: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 9: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 10: Post Certification Overview Kim C. Gavel   Lead General Engineer

Examples of Nonconformance Issues

Performance failure

Failure to maintain quality control requirements

Misleading advertising

Manufacturing under a private label without prior approval from NIOSH

Page 11: Post Certification Overview Kim C. Gavel   Lead General Engineer

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).

Page 12: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 13: Post Certification Overview Kim C. Gavel   Lead General Engineer

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

Page 14: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 15: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 16: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 17: Post Certification Overview Kim C. Gavel   Lead General Engineer

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

Page 18: Post Certification Overview Kim C. Gavel   Lead General Engineer

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

Page 19: Post Certification Overview Kim C. Gavel   Lead General Engineer

User-Reported Problems

Any Respirator User

Fire Departments

Law Enforcement

Chemical Industry

Mining

Healthcare

Field Problem Investigation

Firefighter SCBA Evaluation

Firefighter injury or fatality

with SCBA involved

Malfunction reported with any

respirator

Page 20: Post Certification Overview Kim C. Gavel   Lead General Engineer

Fire fighter Project Initiation

Fire Department

State/Local Fire Marshal’s Office

Law Enforcement Agency

Other

SCBA Performance Evaluation

NIOSH NPPTL

Technology Evaluation Branch

Pittsburgh

Cardiovascular Event

NIOSH Division of Surveillance, Hazard Evaluations, and Field

Studies

Cincinnati

Traumatic Injuries

NIOSH Division of Safety Research

Morgantown

Page 21: Post Certification Overview Kim C. Gavel   Lead General Engineer

FFFIP: Inspection

Condition of major components

Approved configuration

Identifying information

Suitability for testing

Page 22: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 23: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.

Page 24: Post Certification Overview Kim C. Gavel   Lead General Engineer

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

Page 25: Post Certification Overview Kim C. Gavel   Lead General Engineer

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)

Page 26: Post Certification Overview Kim C. Gavel   Lead General Engineer

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

Page 27: Post Certification Overview Kim C. Gavel   Lead General Engineer

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

Page 28: Post Certification Overview Kim C. Gavel   Lead General Engineer

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)

Page 29: Post Certification Overview Kim C. Gavel   Lead General Engineer

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.