respirator approval program: action planning overview roles, develop succession and retention plans...

Respirator Approval Program:

Action Planning Overview Action Plan Facilitator: Susan M. Moore, Ph.D.

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NIOSH values drive transparent continual improvements tothe Approval Program, done in partnership with industry.

Relevance Transparency

Responsive to problems

Quality

Highest level of data quality

Partnership

Partner with industry

Openly share information

Impact

Results-oriented

Diversity

Diverse interventions, solutions, and staff

A 2017 NIOSH Director’s goal was to develop an Approval ProgramAction Plan to further emphasize a focus on continuous improvement.

Scope of Effort

Includes the approval and the post-market aspects of the Program’s design, manner of execution, and

measurements of performance.

• Approach to developing requirements • Application review process and procedures

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• Management of the NIOSH mark and listing • Post-market product and site audits

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In March 2017, NPPTL Director established an Action Plan Team with individuals having diverse perspectives and experience.

Strategic planning for technology-centeredPrograms Executive strategy for Approval Program Oversee Approval Program Operations Execute daily Approval Program activities Support design or implementation of

conformity assessment (CA) programs – International community – National Institute of Standards and

Technology (NIST)

The Action Plan Team considered numerous sources of inputfrom outside the Team. National Academies of Sciences

(NAS) – 2009 NIOSH Personal Protective

Equipment (PPE) Program review

Manufacturer input – Monthly meetings w/ International

Safety Equipment Association (ISEA) – December 7 Manufacturer’s Meeting

Independent reviewer (PhD student) – Limiting process variance

NIOSH strategic goals – Reduce cancer, cardiovascular disease,

adverse reproductive outcomes and other chronic diseases.

– Reduce immune, infectious and dermal disease

– Reduce respiratory disease

National Academies of Sciences

• Expedite revision of regulations and fees • Provide post-marketing

notifications/recalls expeditiously and effectively

• Ensure soundness of product audit methodological/statistical approach

• Ensure consistent and effective site audits

• Disseminate test results data

Manufacturer Input

• Make turnaround times shorter and predictable

• Improve communication with applicants • Improve Program staff consistency • Consider risk-based approach to process • Clarify how number of applications is

determined • Remove process redundancy • Perform high-risk chemical, biological,

radiation, or nuclear tests immediately

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Independent Reviewer • Improve upon existing process

documentation • Explore developing new electronic data

system • Develop operational plan for new org.

structure • Improve organizational health—e.g., carefully

assess appropriateness of employees in multiple roles, develop succession and retention plans

• Establish Program staff accountable process • Develop and implement an Approval Program

quality assurance program

NIOSH Strategic Planning • Ensure integrity of national resp. supply by

implementing efficient, high quality approval process

• Perform post-market surveillance activities to establish corrective measures and inform selection

• Develop new/improved test systems/methods to advance respiratory protection

• Develop and disseminate guidance, recs., outreach products and methods for resp. selection, use and maintenance

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In addition to this input, the Team conducted its own analysis to inform the Action Plan. Program Workflow & Decision Logic

– Detailed and reviewed existing process

Application Turnaround Analysis– Review turnaround times from 2004

to Sept 2017

CA Workshop Series– Conformity Assessment Approaches,

Process Management, and Process Tools

Ongoing Program Improvement Activities

– Review active continuous improvement efforts

Policy and Procedural Changes– Review potential impact of policy or

procedural changes on turnaround times

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CA Workshop Series Objective: Identify features of CA programs w/ potential to provide greater efficiency if integrated into Approval Program

12:15-12:45 Conformity Assessment Workshop Overview Lisa Carnahan

Application Turnaround Analysis Objective: Characterize turnaround times as a function of the existing process design and workflow.

1:15-1:45 Respirator Approval Program Process Analysis Robert Stein

Workflow and Decision Logic Objective: Document and vet Approval Program workflow and decision logic with consideration of 42 CFR 84 requirements.

12:45-1:15 Respirator Approval Program Workflows Heidi Sewchok

Ongoing Program Improvements Objective: Document ongoing Program improvement activities and explore value of continued investment.

Policy and Procedural Changes Objective: Review policy and procedural changes to determine potential impact on turnaround times.

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Ongoing Program improvement activities address select comments from NAS, independent reviewer, and mfr. input.

New management approach – Directed-Management

Improved process documentation

– Work instructions (WIs) – Standard operating procedures

(SOPs) Staff Training

– Cross-training – Technical training

Shifting of staff duties – Increase FTEs associated with

approval component of Program

Develop new requirements or procedures

– Research to inform requirements and test methods

– Partnering with other agencies

In early 2017, Program implemented a Directed-Management approach to manage applications.

For each aspect of process order based on when applications submitted Mgmt. assigns applications based on

complexity, expertise, and Program priorities Mgmt. reviews, assigns due dates, and

tracks application progress weekly

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Program resources were allocated to improve processdocumentation and support new requirements & procedures.

WIs and SOPs Formal process for developed

– Draft, peer-review, and approve WIand SOPs

– Review and updates occur as needed or every 5 years

Completed documentation (to date) – Records and Receiving WI – Initial Review WI – SOP for overall application

process

New Requirements & Procedures Powered-air purifying respirators

(PAPRs) Respirator fit capability Implementation of NIOSH Panel Test procedures to support

coordination with Food and DrugAdministration

NIOSH added and is training staff to create an agile workforce that can redirect resources to respond to process demands.

Initial Review –Two new hires (June 2016)

Initial and Final Reviewers –Trained to perform both aspects of process –Training to perform QA pending

QA Reviewers –Trained on new statistical sampling

techniques Upcoming training will be on overall SOP (Feb 2018)

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Time associated with approval component of Program increased for QA staff.

Previous QA Staff Priorities New and modified applications Site qualifications and audits Certified Product Investigation Process Continuous improvement activities Current QA Staff Priorities New and modified applications Continuous improvement activities









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Team evaluated Program policy and procedure changes to determine if they result in greater burden to applicant or turnaround times.

Standard Application Procedures (SAPs)

– Reviewed changes to SAP since2005

Letters to All Manufacturers and Interested Parties

– Reviewed all letters since 2012

Changes to the standard application procedures (SAPs) were… Included new fee tables and payment instructions

Removed Private Label Notification form and providedinstructions to document private label requests onAssembly Matrix.

Replaced form, fit, and function terminology withperformance and design throughout SAP.

Included definition for performance and design.

Updated Cautions and Limitations list for all currentlyapproved respirator types.

Updated approval schedule listing to include 13Gapprovals for closed-circuit escape respirators (CCERs).

Included NIOSH Application Checklist for reference/useby the approval holder.

Updated Branch Name and mailing address.

Added Private Label checklists.

Updated Respirator Test Selection Guide to includerequired tests for filtering facepiece respirators (FFRs), CBRN respirators, and CCERs.

Added additional sample documentation samples.

Added appendix of relevant Letters to All Manufacturers.

Clarify that QA submission can only include thesubmission of QA manual.

Documents that Product Quality Plan (PQP) changes mustbe submitted as a modification to existing approval ratherthan QA submission.

Require new NIOSH approval numbers (instead ofmodifications to existing approvals) be issued for eachnew revision of NFPA 1981 compliant respirators.

Require that PQP-affected approvals be identified on allassociated Assembly Matrices.

Changes noted through Letters to All Manufacturers or Letters to Interested Parties were… October 2, 2017

– Recognizes NFPA 1986 devices for CBRN approval and Emergency Breathing Support Systems use

June 18, 2015 – Default To Test program is discontinued – Replacement Rate metric has been discontinued – Approval decision letters will be transmitted via

email

August 22, 2014 – Current costs for testing completed at the Army’s

Edgewood Chemical Biological Center still relevant as they were not incorporated into Fee Rule

June 10, 2014 – Program recognized use of buddy breathers on

NFPA 1981 (2013 edition)

May 15, 2015* – Indicated relationship between the Approval Label,

User Instruction and replacement parts

September 30, 2014* – Identified questions and answers relevant to the

Site Audit Program

September 24, 2014* – Indicated acceptable sampling plans and

documented how to establish equivalency to an acceptable sampling plan

*Responded to issues/concerns raised by stakeholders or approval holders

Summary

Sources of Input

Action Plan Team Members Susan M. Moore, Ph.D. Facilitator

Jeff Peterson, B.S.Acting Chief for Conformity Verification andStandards Development Branch

Robert Stein, M.S.Acting Deputy Chief for Conformity Verificationand Standards Development Branch

Colleen Miller, B.S.

Heidi Sewchok, M.S.

Jeremy Brannen

Lisa Carnahan, M.S.Co-facilitator, NIST

Disclaimer: The findings and conclusions in this report/presentation are those of the author(s) and do not necessarily represent the views of the National Institute for Occupational Safety and Health.

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