ML18191B244

NRC-2018-000296 - Resp 1 - Final

ML18191B244
Person / Time
Issue date:	03/13/2013
From:	NRC/OCIO
To:	Van Schooten D Project on Government Oversight
References
FOIA, NRC-2018-000296
Download: ML18191B244 (157)

Text

co su tng group fety Culture Continuous Learning Im rovement Services er 3: Differing Views Processing Benchmarking RIJJ d<<dntcnf 1, canflMn~!;,, **,,., ** 1e,v,.,,,-. IIM1111e "*"* It Ir lldd,-.netl. It t, not to he:,,,., edtl<<d er tA1Jft Cfu,te, *"*' ""' el, rwm.,..,.ee,.

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Introduction and Back round

2.

Data Gathering Method............................................ Slide 8

3.

Findings..................................................................... Slide 12

4.

Analysis.................................................................. Slide 135

5.

Best Practices and Recommendations............... Slide 146

6.

Appendix................................................................ Slide 154 r

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I Our Benchmarking Methodology Define Activity

• Define the key activity under study (differing views programs)

• Prioritize aspects of the activity to benchmark Goal: Define details and prioritized aspects of activity Define Peer Group

• Define criteria to identify peer group

• Evaluate relevant organizations against criteria

• Develop list of recommended benchmarks Goal: Identify logical peer group for which benchmarking data will be relevant for the NRC Analysis

• Review current research related to the research subject

• Identify gaps in the data

• Conduct additional research and fill gaps in data

• Analyze data for trends, similarities and differences Goal: Deepen understanding of topic, fill in knowledge gaps, and identify best practices I

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o Deliver Results

• Deliver results to the stakeholders

• Conduct action planning as a mechanism for institutionalizing the results throughout the safety organization

• Define feedback mechanism to determine follow up actions Goal: Present results to stakeholders and plan actions to address results

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Project Objectives: Differing Views Processing Define Activity The objective of this project is to provide benchmarking research in order to understand:

Differing views policies and processes Policies, processes and practices that are available for employees to raise differences of opinion Key elements and attributes of existing policies/processes Implementation of differing views processing Communication and training methods Evaluation methods (usage tracking and statics, assessment of effectiveness, impact)

Policies and procedures for retaliation Best practices Provide recommendations for effective policies, processes, or practices for employees to raise concerns This work leverages the previous benchmarking research completed on safety culture to gain greater insight into organizations' safety culture while providing detailed information about differing views programs. Differing views programs and safety culture are closely related; this information will help NRC in developing and enhancing their own safety culture and differing views program

Project Summary: Deliverables Deliverable Description Due Date Project Kick Off Project Plan Final Project Plan Draft Report Final written report*

Summary of understanding of benchmarking services Plan which includes research methodology for consideration and approval from NRC PO Final version of the plan which includes research methodology for consideration and approval from NRC PO This will be the format/template in which the final report will be delivered Report will include the background, methods, data references and results of the be,-':

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• This document serves as the final report deliverable TL._..J--**---* :_ ---1..J--*:-1 --------.J.--1-1 *. 1-- *'-.-,,.I,.--*+...,,.,L....,_ ;+,,.

3 weeks after task order effective date 3 weeks after task order effective date One week after receiving comments from NRC COR 7 weeks before the end of the task order effective date 3 weeks before the end of the task order effective date

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Project Plan: Tasks 1 and 2

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)j Project Kickoff/ Planning Session with NRC Confirm Scope, Objectives, Use Report Outline Review Criteria for Benchmark Organizations Confirm Benchmark Targets Define and Prioritize Benchmark Elements Develop Research Methodology Create Final Report Template NRC Review and Approval of Summarv, Plan and Template

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Review Previous Research Identify Organizational Contacts Establish NDAs as Required (Non-Disclosure Altreement)

Develop Questionnaire Design of Key Question Focus Areas:

a. DPO Policies/Processes

b. Implementation: Communication & Training

c. Implementation: Evaluation Methods (usage tracking, assessment of effectiveness, impact)

d. Implementation: Policies & Procedures for Retaliation

e. Lessons Learned Contact Selected Organizations Conduct Secondary Research Second Round Data Gathering {Re-interview / Oarify Responses as Necessary)

Collect Results Analyze Findings and Synthesize Data Develop Draft Report Conduct Data Review Session Senior Advisory Review Develop Final Report Deliver Electronic and Hard Copy to NRC I

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Benchmark Target Selection Rationale 1 Define Peer Group It was discussed during the project kick-off meeting that the previously studied federal sector organizations, NASA and FAA, would be considered as first targets.

These organizations have passed through selection criteria to determine fit for internal safety culture research. This will allow NRC to build on the body of research developed.

The private sector targets were reviewed for applicability and access.

The final organizations chosen for benchmarking include:

National Aeronautics and Space Administration (NASA)

Federal Aviation Administration (FAA),

Air Traffic Organization (ATO)

Pfizer Food and Drug Administration (FDA),

Center for Drug Evaluation and Research (CDER)

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1.

Introduction and Background.................................. Slide 2

2. Data Gatherin Method

3.

Findings..................................................................... Slide 12

4.

Analysis.................................................................. Slide 135

5.

Best Practices and Recommendations............... Slide 146

6.

Appendix................................................................ Slide 154 r

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Conduct Research to Benchmark Differing Views Processing Review current research related to differing views processes, policies or practices Identify best practices and ways to improve the differing Conduct research that is applicable to current NRC environment Research Analysis Focus on areas such as process, lessons learned in order to consider future implementation NASA FAA FDA Pfizer I

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Understand the most effective way of shaping a proactive and responsive differing views process that supports NRC mission and vision

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We developed a research guide to direct secondary research as well as an interview questionnaire* for use during interviews with organizational representatives D Program Overview

~ General Information

~ DPO Review Process D Program Management

~ Stakeholder Management/ Governance

~ Communication Management

~ Integrity and Quality Management D Program Performance

~ Program Statistics

~ Program Effectiveness

• Questionnaire is located within the Appendix section of this document

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Secondary research was conducted for all targets; sources included organizational websites, respective management directives and other information available via the internet Primary research was conducted via confidential interviews with organizational representatives. These included:

D NASA Safety Reporting System Program Manager D FDA, Office of Ombudsman r

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1.

Introduction and Background.................................. Slide 2

2.

Data Gathering Method............................................ Slide 8

3.

Findin s

4.

Analysis.................................................................. Slide 135

5.

Best Practices and Recommendations............... Slide 146

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Appendix................................................................ Slide 154 Th1<;. rlnr11mPnf,c rnnl"*~on*i,..I.,..........,....,....J,,.... 1,...1.. ~-- *'- - -'*--* *-

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Each benchmarked organization includes a high-level organizational summary and subsequent sections covering the following four key topics:

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Differing Views Program Policies/ Procedures

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I.__ c_o_m_m_u_n_ic_at_io_n_ a_nd_ Tr_a_in_i_ng _____________ ~-----J>

IL-E_v_a_lu_a_ti_o_n_M_e_t_h_o_ds ___________________ ---J)

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NASA 14

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Background information: National Aeronautics and Space Administration (NASA)

Size Overview Mission Stakeholders Safety Policy 18,000+ employees Industry Aviation and Aerospace NASA conducts its work in three principal organizations, called mission directorates:

• Aeronautics Research: pioneers and proves new flight technologies that improve our ability to explore and which have practical applications on Earth.

• Human Exploration and Operations: focuses on International Space Station operations and human exploration beyond low Earth orbit.

• Science: explores the Earth, solar system and universe beyond; charts the best route of discovery; and reaps the benefits of Earth and space exploration for society.

NASA is comprised of Headquarters in Washington, DC, nine Centers located around the country, and the Jet Propulsion Laboratory NASA's mission is to drive advances in science, technology, and exploration to enhance knowledge, education, innovation, economic vitality, and stewardship of Earth Aerospace scientists, engineers, researchers, astronauts, support staff, students Protect the public, NASA workforce, high-value equipment and property, and the environment from potential harm as a result of NASA activities and operations by factoring safety as an integral feature of programs, projects, technologies, operations, and facilities N A S4

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NASA Differing Views Program Policies and/or Pro£~sses:::~: ::>***

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With regard to supporting safety and mission success at NASA, one of their policies is to:

Establish and maintain independent lines of communications for unrestricted flow of information and adjudication of dissenting opinions concerning any matters affecting the ability to meet the safety and mission success requirements and criteria NASA offers the following two options:

Dissenting Opinion Process NASA Safety Reporting System Uniform, recognized process for resolving dissenting opinions that would provide additional support to safety, and the success of both NASA and the mission An anonymous, voluntary, and responsive reporting channel to notify NASA's upper management of one's concern about hazards f'

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NASA: Option One Process Dissenting Opinion NASA 18

Within NASA, employees are able to raise a Dissenting OpinionJ not to be confused with a Differing Professional Opinion Dissenting Opinion Differing Professional Opinion A Dissenting Opinion is not a Difference of Opinion that might be expressed in a manner such as:

NASA's Office of Chief Engineer issued a requirement: every NASA project and program must follow the Dissenting Opinion Process*

NPR 7120.SE replaced the policies and procedures within NPR 7120.5 D. The Dissenting Opinion Process refers to standard steps to be taken in the event:

There is a disagreement with a decision or action that an individual judges is of sufficient importance that it warrants a specific review and decision by higher level management and the individual specifically requests that the dissent be recorded and resolved by the dissenting opinion process.

Or, Someone expresses a view that a decision or action, in the dissenter's opinion, should be changed for the good of NASA and requests a review by higher level management. In this context, "for the good of NASA" should be read broadly to cover mission success, safety, the project, the program, etc.

NASA Procedural Requirement (NPR) 7120.5£:

NASA Space Flight Program and Project Management Requirements

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Team members have three choices when determining his/her position on a particular decision Agree Disagree but be willing to fully support the decision Disagree and raise a Dissenting Opinion I

Initiate Dissenting Opinion Process ult was decided that [the] establishment of a uniform, recognized process for resolving dissenting opinions would provide additional support to safety, and the success of both NASA and the mission."

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The dissenting opinion process can be broken into three parts

.""4 Raise DisseU.ting Oeiriion Submit to

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The first part: raising a dissenting opinion involves three steps 0

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Documenting concern 1n memorandum form Sending to, and gaining approval from representatives of each view The Dissenting Opinion Memorandum must:

D Clearly define the issue D Identify the facts both parties agree upon D Document the differing positions with rationale, impacts and individual recommendations for resolution I

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Sending memorandum to the Next Higher Level of Management NASA 23

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Once a formal dissenting opinion is submitted, the process moves to the second part: Next Higher Level Management Review where the manager Provides copies of the decision to the dissenter and notified managers The Next Higher Level Manager must fully support the Core Values of Teamwork.

This includes conducting discussions, meetings, and boards in a professional manner that:

D Promotes full and open discussion of issues with all their associated facts and considerations D Fosters and respects diverse views D

Is open to thoughtful presentations of alternative ideas and approaches D Ensures the team understands the basis for the decision made ftl A SA

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Once the Next Higher Level Manager renders a decision, the process moves into the third part where the dissenter can either OR 0

Support the joint resolution process, including the development and distribution of the joint decision memo Appeal to the next higher level of management (if not satisfied with process or outcome)

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I When appealing a decision, the first two parts of the process are repeated. The dissenter may take the issue as high as to the Administrator NAS4

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NASA: Option Two - NASA Safety Reporting System r* I I

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The NASA Safety Reporting System {NSRS) is an anonymous, voluntary, and responsive reporting channel The NSRS is used to notify NASA's upper management of one's concern about hazards that can affect:

D The Public D The NASA Workforce D NASA Assets N AS~

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The NSRS is located within the NASA Headquarters' Office of Safety and Mission Assurance Office Office of Safety and Mission Assurance The NSRS Program Manager manages every facet of the program including:

"To assure the safety and enhance the success of all NASA activities" Investigation Process Investigation Resolution Information Exhibits Marketing

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The NSRS is intended to supplement NASA's local hazard-reporting channels NASA Safety/Hazard Reporting Hierarchy

. NSRS is open to any NASA or contractor employee working in support of NASA. NASA uses the Safety/Hazard Reporting Hierarchy as a guide.

In general, submitters are encouraged to use the NSRS if they:

D Reported a hazard locally and have seen no action taken D Are not satisfied with the response to a reported hazard D Fear reporting a hazard through local reporting channels will result in retaliatory actions Report to Supervisor R port your concern and ttl lac of r olu on

• Then. to your Cen Of Component F ac:il Safety/H Otfia a).

irt to your C nt Dir or Of anager

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If your cone m.. not resolved Cent In elnate your concern to NASAHeadqu

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The NSRS reporting process starts with a hard copy safety concern submission to a Post Office Box Employees are instructed to provide as much information as possible including:

D The scope of the hazard D

Manufacturing sources and/or part numbers D The physical location of hazard D Whether or not the hazard was reported elsewhere D Whether the hazard relates to a single event or recurring process D What is believed to have caused the hazard D What can be done to correct the hazard and prevent recurrence D The consequences if issue is not resolved HIii POtlOl UH 8tl'NfJOA U0l"tl 2H1,u Submission NASA SAftTf IOClfl* STSll)I POI01 S12' am.cw Ill ZCIIU-ttU

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D The submitter does not take the process lightly D The ability to protect the submitter's identity N A SA

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A third party contractor checks the P.O. box for submissions six days a week The contractor is responsible for collecting, transcribing, and forwarding safety concern reports to the NASA Headquarters Office of Safety and Mission Assurance Program Manager.

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llTilllOA*tw_**"U D Name D Address D Telephone Number D Report Details "To assure the safety and enhance the success of all NASA activities*

Collection Transcription NASA Safety Center NASA Centers NASA

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NASA Engineering and Safety Center Mission Support Division NASA Independent Verification &

Validation Safety &

Assurance Requirements Division Dissemination

I Upon receipt of the report, the Office of Safety and Mission Assurance Program Manager:

Review Assigns an investigator while ensuring the:

D investigation is not associated with the NSRS D Investigator has no knowledge of submitter's identity Assignment I

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The investigator has 30 days to investigate the hazard and report findings to the NSRS Program Manager For investigations where a valid safety concern exists, the investigator makes a corrective action recommendation. The execution of the recommendation is monitored by the NSRS Program Manager until completion.

NASA Safety Center NASA Engineering &

Safety Center Safety &

Assurance Requirements Division NASA Centers NASA lndt!p@ndent V@rification &

Validation Mission Support Division NASA

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NASA ensures no retaliatory actions are taken against individuals who express dissenting opinions or report safety concerns Dissenting Opinion Process NASA Safety Reporting System Explicit language and organizational policies requiring individuals refrain from retaliatory actions

And, Program elements protecting the identification of the individual submitting a safety report NA SA

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One of NASA's Procedural Requirements* requires the Dissenting Opinion Process allow:

"Diverse views [are] to be fostered and respected in an environment of integrity and trust with no suppression or retribution."

This requirement captures the overarching idea within the policies and principles outlined in the Civil Rights Act of 1978 including to:

"Protect employees against reprisal for the lawful disclosure of information in 'whistleblower' situations (i.e., protecting people who report things like illegal and/or wasteful activities)."

• NASA's Procedural Requirement (NPR) 7120.SE:

NASA Space Flight Program and Project Management Requirements NASA

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Within NSRS, anonymity is a key factor and primary means for ensuring retaliatory actions are not taken against a reporter To protect reporter identity, the NSRS does not accept reports by telephone or email.

Instead, reporters are instructed to send hard copy forms to the NSRS Contractor where their data will be reviewed and any identifying information will be removed.

D Name D Address D Telephone Number D Report Details D Report Details I

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Reporters receive a receipt letter with instructions on how to check the status of their report They are able to access feedback through a coded, blind public website with the following codes:

Code A - Investigation Open Code B - Investigation Closed - Corrective Action Pending Code C - Investigation Closed - No Corrective Action Warranted Code D - Investigation Closed - Reported Concern Could Not Be Substantiated/Validated Code E - Investigation Closed - Physical/Product Corrective Action Completed Code F - Investigation Closed - Policy/Procedural Corrective Action Completed Code G - Investigation Closed - Education/Awareness Corrective Action Completed Code H - Out of Scope - Referred to Another Functional Area for Investigation/Analysis Code I - Out of Scope, Involves Waste/Fraud/Abuse. Referred to the NASA Inspector General Code J - Investigation Closed - Insufficient Information Provided to Perform an Investigation r

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To protect the reporter's identification during the course of the investigation, all clarifying information is coordinated through the NSRS Contractor The contractor will contact the reporter directly and relay the information back to the inquiring stakeholder.

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If employees sense retaliation, they are able to reach out to individuals within or external to their organization including:

Internal Options External Option NASA Center Human Resource Points of Contact (NASA Office of Inspector General J NASA

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NASA Communication and Training

The Dissenting Opinion Process within NPR 7120.SD was accompanied by a suite of supporting documents including:

Dissenting Opinion FAQ's

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Answer A "Dissenting Opinion* 1s a disagreement with a decision or action that an individual judges is of sufficient importance that it warrants a specific review and decision by higher level management and the individual &pecifically reque&ts that the dissent be recorded and resolved by the dissenting opinion process. (See NPR 7120.SD paragraph 3.3.

PowerPoint slide deck explaining the process This is one of a series of training presentations covering important topics in NPR 7120.SD.

Frequently Asked Questions document Dissenting Opinion Process NPR 7120.50 s

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Each supporting document explains, in plain language:

The Process and Roles and Responsibilities of Stakeholders Responsibilities of Individual Ral Ing a Dissenting Opinion Responsibilities of Individual R

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The NSRS option is heavily communicated throughout all NASA centers and facilities Displays, including the yellow submission forms, must be available in every building in every NASA center.

A black display poster is the most frequently used, and has been produced in six different languages.

Once a month, there is a person who ensures that displays are restocked with yellow forms.

Individuals can access frequently asked questions and the form itself through their website:

http:ljwww.hg.nasa.gov/nsrs NASA

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Every NASA center holds an annual safety event where the NSRS Program Manager attends to promote and inform attendees about the NSRS During these events, the Program Manager issues a survey to gauge level of knowledge about safety reporting.

As an incentive, the Program Manager offers giveaways to those willing to participate in the survey Per an interview with the NSRS Program Manager, due to the heavy marketing of the NSRS throughout all NASA facilities, the majority of NASA employees are well aware of the reporting option.

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NASA Evaluation Methods

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There are currently no direct or distinctive measurements of dissenting opinion processes; rather, related concepts are measured through annual safety culture surveys Screenshot of survey portal: https://www.nasascs.org/mainpage.aspx Sample survey questions are available through the portal Quick facts

• Anonymous participation

• "'20 universal questions; 2 - 4 Center-specific questions from Center Directors

• Administered every two years

• Questions are designed to measure employee perceptions of the five safety culture factors Centers have all completed the first cycle and HQ is the last to participate (as of March 2012)

• NASA designed the survey to be:

Quick (easy to complete)

Accessible (not behind a firewall so that contractors could participate)

Not too specific (applicable to all)

• Participants rate each statement on a scale of "Very Satisfied" to "Very Dissatisfied" Comment boxes allow for additional open-ended feedback

• NASA uses third-party to support administration and analysis t

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• Survey results are shared with Center Directors who are able to use the data with minimal direction from HQ Survey Results Process

• OSMA wanted to shift the perception of a survey as an "inspection" to a more collaborative, Center-driven process In order to empower Centers, HQ did not want to give the sense of directing Centers w ith evaluations and corrective actions Instead, HQ wanted to act as a partner with Centers - enabling Directors to be comfortable with sharing information and encouraging participation in survey efforts

• Center Directors are able to communicate survey results to their organization and respond to the information as they see fit Centers can react in ways that considers t he local culture and climate

• HQ receives an aggregated report of results from all Centers Participation Results

• To be reportable, surveys must achieve a 95% statistical confidence rate

• Highest participation rate: ""55%

• Lowest participation rate: -19%

• Centers began engaging in friendly competition to drive participation numbers This approach enables Centers to take ownership of their safety culture and to tailor initiatives to their audience -

facilitating the larger effort to institutionalize Agency-wide assessments for the long-term t'

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Federal Aviation Administration (FAA)

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Background information: Federal Aviation Administration a -

Size Overview Mission Stakeholders Safety Standards 47,456 as of 6/30/10 Industry Aviation FAA's main roles and responsibilities are to:

Regulate civil aviation to promote safety Encourage and develop civil aeronautics, including new aviation technology Develop and operate a system of air traffic control and navigation for both civil and military aircraft Research and develop the National Airspace System and civil aeronautics Develop and carry out programs to control aircraft noise and other environmental effects of civil aviation Regulate U.S. commercial space transportation FAA's mission is to provide the safest, most efficient aerospace system in the world FAA's vision is to strive to reach the next level of safety, efficiency, environmental responsibility and global leadership One of FAA's values: Safety is our passion The American public, aircraft and aircraft part manufacturers, airlines, general and business aviation, airports, air traffic control, the flying public FAA works with the International Civil Aviation Organization (ICAO), the global forum for civil aviation, and other international partners to improve global aviation safety and environmental performance around the world.

FAA Differing Views Program Policies and/or Pro_~~$.Ses:::::: :::.---*

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Safety is the foundation and driving force in everything FAA does To reach the next level of safety, efficiency, environmental responsibility and global leadership To provide the safest, most efficient aerospace system in the world Safety is our passion Excellence is our promise Integrity is our touchstone People are our strength Innovation is our signature FAA Safety Programs and Initiatives Air Transportation Oversight System Aviation Safety Action Program Aviation Safety & Health Program International Aviation Safety Assessments Safer Skies System Approach for Safety Oversight Program Whistleblower Protection Program Cabin Safety Laser Safety Safety Management System Unsatisfactory Condition Reporting Program CW c *****

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It is especially important for the Air Traffic Organization (ATO) and the Administrative Office of Aviation Safety whose primary service is to move air traffic safely and efficiently Chief Offices Staff Counsel Federal Aviation Administration Air Traffic Organization En Route &

Oceanic Mission Support System Operations Safety and Technical Training I

Management Services Program Management Terminal Technical Operations Administrative Offices Airports Civil Rights Communication Government &

Industry Affairs International Affairs and Environment Aviation Safety Commercial Space Transportation Finance and Management Human Resources Management NextGen Security & Hazardous Materials Safety

In support of FAA's vision, mission, and values the ATO and Administrative Aviation Safety Office offers the following three options for employees to express non concurrence or report safety

. issues Federal Aviation Administration Administrative Offices Aviation Safety

FAA: Option One - Non-Concurrence Option for Management Directives

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The ATO included a non-concurrence option as part of their FAA Order JO 1320.62, Air Traffic Organization Directives Management U.S. DEPARTMENT OF TRANSPORTATION FEDERAL AVIATION ADMINISTRATION Air Traffic Organization Policy SUBJ: Air Traffic Organization Directives Management ORDER JO 1320.62 Effective Oat'

~30 _01 l JO 1320.62 is supplementary to FAA Order 1320.1, FAA Directives Management, which outlines the process for creating, reviewing, and finalizing management directives within ATO and FAA respectively The policies and procedures outlined in JO 1320.62 are similar to, and follow those outlined in FAA Order 1320.1. Per FAA Order 1320.1, only those directly involved in the creation, review and finalization of the management directive are allowed to raise a non-concurrence.

The non-concurrence option outlined within JO 1320.62 can only be used when there are serious operational or legal concerns, or if the applicable stakeholder finds substantive flaws in a process A non-concurrence must include the following four written elements:

Ineligible reasons for a non-concurrence include:

Inability to make the coordination date Disagreement with the document's external coordination scheme Disagreement with language, style, or format In essence, all non-concurrences must deal with the facts and intent of the management directive

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All non-concurrences must be addressed. However, a non-resolution does not prevent the draft Management Directive from going forward in the approval process.

JO 1320.62 suggests the Office of Primary Responsibility and/or writer-editor first engage in a discussion with the technical point of contact named on the non-concurrence If there is success If there is no success If still no success NON-CONCURRENCE RESOLUTION Collect a new clearance record from the original office showing the concurrence Elevate the need for resolution to the appropriate management chain Write an executive summary explaining the non-concurrence, efforts to resolve it, and why it lacks merit FINAL SIGNATURE

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FAA: Option Two Program Unsatisfactory Condition Report

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The FAA Unsatisfactory Condition Reporting Program provides all agency employees with direct means for advising management of an existing unsatisfactory condition.

When completing an Unsatisfactory Condition Report, employees must:

D Write as much as necessary to explain the problem D Define one issue per report D Provide objective, factual information and refrain from opinion D Include documentation, if appropriate Unsatisfactory condition reports are entered into, tracked and closed using FAA's Safety Management Information System

Once an Unsatisfactory Condition Report (UCR) is entered into the Safety Management Information System (SMIS):

The SMIS will notify the manager or supervisor The manager/

supervisor validates the reported condition exists Validated UCR gets sent to UCR Coordinator for action Each level of management shall evaluate the UCR and ensure action has been taken to resolve or initiate resolution The complete UCR review cycle is 30 calendar days beginning with the date the UCR is entered into the SMIS and ending with the report being closed by the appropriate manager/supervisor, also within SMIS. The applicable manager/supervisor is responsible for ensuring the issue is resolved.

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FAA: Option Three - Air Traffic Safety Action Program

The Air Traffic Safety Action Program (ATSAP) is a Voluntary Safety Reporting Program (VSRP) specifically for ATO stakeholders and a key component to the ATO's Safety Management System.

The information specified in employee reports is used to identify the root causes and determine appropriate remedial actions which are then monitored for effectiveness.

Th is process promotes collaboration between employee work groups and management for the early identification of hazards and to maintain a proactive approach regarding safety concerns and corrective action recommendations.

Purpose Provides a method to identify and correct potential safety hazards Encourages voluntary submittals of safety reports from employees involved in the delivery of air traffic services Goal

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ATSAP is available to all Air Traffic Organization personnel within:

Reports can be filled online via www.atsapsafety.com Employees are encouraged to report:

D Air traffic safety events D Air traffic safety problems dealing with:

o Policies o Procedures o Equipment o Automation o Publications Where they are collected and tracked through the ATSAP Reporting System The ATSAP is a confidential reporting system. However, it is not an anonymous program.

Confidentiality means individually identifiable information is disclosed only on a need-to-know basis and only to those with Event Review Committee authorization

FAA Policies and Procedures for Retaliation

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I FAA fully supports the rules and regulations outlined in anti-discrimination and retaliation policies This support is formally housed within their Human Resources and Equal Employment Opportunity offices.

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NON-DISCRIMINATION Although the subject of anti-retaliation is not explicitly addressed within the respective reporting options, it is written in their policies. With this, it is strongly implied that FAA does not and will not tolerate retaliation of any kind.

b. Coercion or Retaliation: It is a violation of FM policy to coerce threaten, retaliate against, or interfere with any person n the,

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The safety reporting and non-concurrence options are communicated through FAA Management Directives and web pages SUBJ:

U.S. DEPARTMENT OF TRANSPORTATION FEDERAL AVIATION ADMINISTRATION National Policy ORDER Nl.\\IBER 1800.hB Effective Date:

9/26/0 U.S. DEPARTMENT OF TRANSPORTATION FEDERAL AVIATION ADMINISTRATION Air Traffic Orga lzation Policy SUBJ: N, TralflC Organization D rectlves Management

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There is no direct or distinctive measurement of the non-concurrence process; rather, related concepts are measured through safety culture surveys The FAA, in its continual pursuit to improve their safety culture, conducts agency wide safety culture surveys. The ATO additionally has their own unique safety culture and senior leadership surveys. The senior leadership surveys were issued to establish a baseline on the state of their safety culture and risks.

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You will also be a ked 10 review and. ign a "Panicipants onsen1 Form** prior to a cring survey question. The Consent Fonn. and all urvey dam, will be collcc1cd and kepi at the Naval P I raduate I. M nt re alifi m1a. We very mu h apprcc1atc our ndid an wcr t th following *urvcy 11cms. Please be a

• urcd that this survey is completely anon mou and n allcmpl, ill be made lo identify panicular participants and their 4ue tionnaire urvc anM er~.

Respond to the rating item by marking 1he block that best reprcsenL~ your level of agreement with n given statement, usin the rating sc.,le shown below:

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Reponses to ATO's safety culture survey show some growth toward a cohesive safety culture Results around Safety Culture = relaxed standards 47%

53%

We focus on errors rather than non-eventful risky 76%

24%

their safety behavior.

reporting Actionable feedback from safety reporting processes is 22%

78%

indicated a rather made available to the workforce on a regular basis.

"Raise the bar" = "Lower the boom" 38%

62%

large opportunity In general, At-risk behaviors are clearly defined and commonly 19%

81%

for improvement.

understood by management and the workforce.

people However, this in my Front line managers are adept at recognizing and facility correcting "drift," i.e. non-compliance.

27%

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singular metric believe:

Front line managers should act as a filter or buffer 62%

38%

does not give a between their employees and upper management.

Minor or occasional deviations from standards are 71%

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clear enough acceptable for the sake of efficiency/capacity.

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Our reactions to safety events are frequently driven by 88%

12%

political interest and the 24 x 7 media environment.

Benchmarking Research for:

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Food and Drug Administration

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Background information: Food and Drug Administration (FDA)

Size Overview Mission Stakeholders 11,516 as of 10/1/2009 Industry Government, Regulatory The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.

FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines, and to reduce tobacco use to improve health.

The American public; food, drug, tobacco, and medical suppliers, manufacturers, retailers, and consumers, international food and drug regulatory authorities

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FDA, Center for Drug Evaluation and Research (CDER)

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The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the a enc Core Functions Office of Global Regulatory Operations and Policy Office of Regulatory Affairs Office of International Programs Office of Foods and Veterinary Medicine I

Center for Food Safety and Applied Nutrition Center for Veterinary Medicine Office of the Commissioner Office of Medical Products and Tobacco Center for Biologics Evaluation and Research Center for Devices and Radiological Health (CDRH)

Center for Drug Evaluation and Research (CDER)

Center for Tobacco Products Office of Special Medical Programs Office of Operations Office of the Chief Scientist National Center for Toxicological Research

Since 2007 there has been a continual effort at FDA to improve the process of internal dispute resolution In September 2007 the Values and Vision all-hands broadcast communicated important organizational values and outlined a three-part plan to develop:

1) leadership, 2) improve processes and enhance resources, and 3) empower employees through effective communication The Commissioner highlighted the importance of discussion of differences of opinion; the agency strengthened its focus on addressing internal differing scientific opinions As part of this continual improvement effort, the Staff Manual Guide 9010.1 describes how issues of scientific dispute are managed throughout FDA The manual includes:

Mandatory elements to be included in all scientific dispute resolution processes Best practices in relation to scientific dispute resolution An agency-wide appeals process for internal scientific disputes FDA Staff Manual Guides (SMG), Volume IV, Agency Program Directives General or Multidiscipline Dispute Resolution Scientific Dispute Resolution at the FDA SMG 9010.1, effective 1/13/09

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SMG 9010.1 requires Centers to maintain standard operating procedures (SOP) for scientific dispute resolution (SDR)

SMG 9010.1 also required each of the Centers to develop and distribute required communication about the SDR process SMG 9010.1 presents best practices for formal SDR at the Centers Communication Ombudsman Training and Mentorship Monitoring the SOR Process Alternative Avenues Recommended communication could utilize various communication vehicles, or reinforce concepts via training or retreats Formal dispute resolution could only happen when the issue is documented in written format Encourages transparent review and written documentation of decisions at each level Actively interact with initiators of the SOR process to help them feel at ease Train supervisors and scientists on good management practices, including dispute resolution techniques Encourage open communication Consider using an annual survey to gauge awareness of and satisfaction with SOR process Consider alternative avenues for SOR other than chain-of-command

The FDA research in this document focuses on the Center for Drug Evaluation and Research (CDER)

Prior to SMG 9010.1, CDER already had in place the most solidified and formal DPO process CDER's DPO process was developed during a multi-disciplinary review team summit during which all the CDER supervisors discussed SOPs and created a draft of the DPO process CDER is one of nine main Centers and Offices at FDA Office of Global Regulatory Opera tons and Pohcy Office of Regulatory

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lnternationa Programs Office of Foods and Veterinary Medicine eri t o

Food Safety and Applied L

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-enter for Jetenna Medicine Of,ce o the Comm,ss,oner Office of MedtC.al Products and Tobacco Center for 81olog1cs 11aluat1on and Researc 1..enter for Devices anc d olog1cal Health (CDP!-,

Center for Drug Evaluation and Research (CDER)

Center for Tobacco Products Office of Special Medic Programs Office of Operations Office of the Chief Scientist ii 10 Center for Tox1colog1cal Research

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CDER's policies and procedures foster quality and timely decision-making CDER works to create a collaborative working environment for decision-making which includes:

Open communication and exchange of ideas in a mutually respectful professional environment The full and open participation of all relevant disciplines and organizational components in the decision-making process These values help conduct business and make high-quality decisions using the "SCs"

1. Communication

2. Collaboration

3. Community

4. Conflict management

5. Consumer focus

i CDER has standard operating procedures in place to resolve internal disputes before reaching the DPO process CDER maintains a working environment that encourages employees to express their best professional judgments and have a healthy debate about topics to reach the best decision When there is a debate about a topic, the goal is to reach alignment: A state of general support for a position to be taken or a decision to be made; this does not necessarily mean full agreement, but a reasonable action even it differs from an individual's recommendation(s).

If individuals have internal disputes, or can not reach alignment in decision-making, CDER has documented processes in place to help employees resolve these issues:

Equal Voice: Discipline and Organizational Component Collaboration in Scientific and/or Regulatory Decisions Outlined in Manual of Policies and Procedures (MAPP) 4151.8 Scientific/Regulatory Dispute Resolution for Individuals within a Management Chain Outlined in MAPP 4151.lR These processes used to resolve internal disputes prior to using the DPO process do not have anonymous reporting options. The vast majority of disputes or disagreements are resolved through one of these two options~ before the DPO process is used

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81

Equal Voice ensures decisions are made only after all appropriate expertise is heard Equal Voice: Discipline and Organizational Component Collaboration in Scientific and/or Regulatory Decisions Outlined in MAPP 4151.8 CDER staff are involved in making a wide variety of decisions every day: scientific, regulatory, administrative, etc. For each of the regulatory decisions that CDER has to make, a decision maker is designated from group of individuals handling this topic: the decision-maker is the person who holds the authority and responsibility of making the final decision.

A decision can only be made after expertise from all relevant disciplines is heard. Depending on the context of the decision being made, the weight of each of the discipline's perspectives may not carry equal importance.

Depending on the magnitude of the decision being made, opinions should be documented and supported by data, giving rationale and for his or her position.

Each individual who contributes to the decision-making process is responsible for representing the views of his/her discipline

Equal Voice policies and procedures have many benefits to employees The Equal Voice policy expects employees will respect each other's viewpoints during the decision-making process and not apply pressure for employees with differing viewpoints to change their viewpoints The Equal Voice policies and procedures:

Encourage full and open participation in decision-making Engage the professional input of all parties Allow the opportunity to voice concerns Increase transparency Allow for early identification of concerns that could disrupt the decision-making process Increase the collaborative and team-based environment If alignment cannot be reached, critical to Equal Voice working is: 1) exercising good judgment in assessing which issues must be elevated to the next highest level of management and 2) assuming accountability and responsibility for raising concerns in a timely manner

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Another option to manage individual differences of opinion:

escalate the issue to the next highest management official Dispute statement includes:

• Detailed description of issue which the disputant disagrees

• Nature of and reasons for the difference in opinion

• Proposed changes and rationale 2

A copy of the memorandum is sent to individuals involved and added to the administrative file Statement is distributed to people who ore involved, sent co next highest manageme t official, and included in the administrative file 3

If the disputant does not align with the decision, can present the disagreement to the next highest management official The appeals process can be repeated until it reaches the CDER Director Initiate the DPO process If the disputant believes his or her opinion still was not adequately considered, and a significantly negative public health impact will result

Written documentation is an important part of the decision-making process and helps with transparency If a decision-maker reaches a decision that is inconsistent with the conclusions or recommendations made by any individual on his or her staff, the decision-maker must write a memorandum documenting his or her rationale for the decision, including a discussion of how differing opinions were taken into consideration The memorandum is entered into the administrative file, and provided to staff relevant to the issue. This will apply even if an individual has not initiated the dispute resolution process If a dispute arises between two individuals within a discipline and neither one is the final decision-maker, the dispute should still be documented in the administrative file Administrative File

If CDER employees can not reach alignment through normal processes, they may use the DPO process Individuals should normally use the Scientific/Regulatory Dispute Resolution for Individuals within a Management Chain and Equal Voice to reach alignment.

The DPO process, FDA CDER MAPP 4151.2R Resolution of Differing Professional Opinions: Review by Ad Hoc Panel and CDER Director, is reserved for the most serious differences of opinion. An individual can choose to file a DPO process if:

1)

The initial processes to reach alignment have already been used to the fullest extent

2)

The individual feels that using these initial processes to reach alignment may not result in a timely resolution

3)

Agency action or inaction will lead to a significant impact on public health The DPO process is a formal process to ensure individuals' opinions are heard and carefully considered by CDER management

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To initiate the DPO process, a CDER employee must prepare and submit a written package The written package will contain at least the topics included to the right The package MUST include items one through five in order to be considered and processed through the DPO process The written submission does not need to be lengthy Once complete, the package should be sent to the CDER Ombudsman I.

Summary statement of the position with which I disagree (is it a prevailing staff view, existing decision, proposed regulatory action, etc.)

II. Description of my views and how they differ from above Ill. Description of the nature of the disagreement (is it a difference in opinion, interpretation, methodology, judgment)

IV. An assessment of the potential negative and consequential impact to the public's health my position is not adopted V. Three suggested FDA employees with appropriate technical expertise to serve on the Ad Hoc Review Panel if the DPO is filed VI. If applicable, reason for not utilizing other avenues for dispute resolution

The CDER Director, Ombudsman, and an Ad Hoc Review Panel, including a chairperson, are involved in the DPO process The DPO process includes the CDER Director, the CDER Ombudsman and an Ad Hoc Review Panel The Center Director appoints a chairperson for the Ad Hoc Review panel, and the chairperson appoints the review panel members OFFICE OF REGULA TORY POLICY RECTOR

~A""anclJD (OIINMl OFFICE OF. EOICAL POllCY CTOR Rachele SIie/man 1,10 PH tD I

FOOD AND DRUG ADMINISTRATION OFFICE OF MEDICAL AND TOBACCO PRODUCTS

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The CDER Ombudsman 1s general mission is to quickly and impartially investigate complaints and resolve disputes The U.S. Ombudsman's Association defines a governmental ombudsman as "an independent, impartial public official with authority and responsibility to receive, investigate or informally address complaints about governmental actions, and, when appropriate, make findings and recommendations, and publish reports."

The CDER Ombudsman position was created in 1995; his/her role is to work to improve the functionality and transparency of CDER by providing efficient resolution of disputes and by fostering communications with stakeholders.

The CDER Ombudsman, reports directly to the Center Director, and follows the same operating principles as the FDA Agency Ombudsman:

Utilizing the CDER Ombudsman provides a way for anyone with a complaint or dispute involving CDER entities or programs to work through their problem at a level closer to the source.

I

The CDER Ombudsman plays an active role in investigating issues that are raised Additionally, the CDER Ombudsman also has the authority to take initiative to investigate any problem he/she observes and work toward a solution The CDER Ombudsman receives complaints, not only from internal employees but also from:

Regulated industry Health associations The public In working to resolve issues or disputes between external stakeholders and CDER staff or among CDER staff, the CDER Ombudsman does not work alone but coordinates activities with the FDA Chief Mediator and Ombudsman's office The CDER Ombudsman uses several different techniques to work toward solutions:

Investigation Mediation Conciliation Negotiation The CDER Ombudsman's role extends to include advising the Center Director or other CDER managers on current issues and problems and suggesting solutions or reporting observed trends in CDER problems and issues, through informal discussions with CDER managers and L_ ______________ publishing aggregate data annually v~

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The CDER Ombudsman is the focal point for receiving, managing, and facilitating the DPO process End Start CDER Ombudsman +--t<

receives written DPO p cka e Within five business days of the DPO filing, DPO Ad Hoc review panel chairperson is appointed, he or she appoints Ad Hoc Review panel members 1'

Within two business days of the DPO filing, CDER Director appoints a chairperson for the DPO Ad Hoc review panel CDER Ombudsman works with CDER Director to file a OPO CDER Ombudsman No works with submitter to ensure package is complete No Yes in question potentially serious enou h Within five business days of receipt of DPO package, CDER Ombudsman r sponds In writing R"----t to the submitter and all individuals within the submitter's supervisory chain, team lead, Super-Office Directors decision to file the DPO es CDER Ombudsman maintains record of OPO submission and decision not to file Within five business days of receipt of DPO package, CDER Ombudsman responds in writing to the submitter and all individuals within the submitter's supervisory chain, team lead, Super-Office Directors decision not to file t he DPO and reasons as to why

Once the DPO Ad Hoc review panel is in place, the submitter can expect to hear a response within 35 business days Prior to filing the DPO, the Center Director may decide, in the interest of public health, the DPO process must be expedited or the review plan must be changed; if this is the case, the CDER Ombudsman notifies the submitter, Ad Hoc review panel, and other parties involved DPO Ad Hoc Review Panel Includes the following members*:

1. One with relevant technical expertise

2. One chosen from the submitter's list of proposed panel members

3. If available, and time allows, one with relevant technical expertise from outside the FDA, chosen by the panel chairperson**

The Ombudsman works with the Ad Hoc panel members to ensure they have an unbiased view of the issue DPO Ad Hoc Review Panel receives DPO package from the CDER Ombudsman

• To the extent possible, panel members should not be individuals who have been involved in the decision-making process through the time the DPO file was submitted

• • Must be a special government employee, screened for conflict of interest DPO Ad Hoc Review Panel will:

• Determine if they have sufficient documentation, if not request what is needed

• As needed, request technical assistance from either within or outside the CDER

• Review materials

• Make written recommendation as to the appropriate course of action

The CDER Director will review the Ad Hoc review panel's recommendations Once the CDER Director receives the panel's recommendations, within five business days, the CDER Director must provide the submitter and other staff initially notified of the DPO a written decision and rationale for the decision.

The individual who submits a DPO file is able to appeal a decision within 10 calendar days twice during the DPO process:

1) If the initial, completed file was not considered sufficient to warrant the filing of a DPO

2) After he/she receives the final decision made from the DPO process, and he/she believes there was not adequate opportunity to present their views, or if he/she believes processes were not followed All records surrounding the DPO process must be maintained in administrative files and unless the DPO pertained to a specific regulatory submission, will be maintained by the CDER Ombudsman VA\\

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At the Center level, the DPO process serves as a full review of the issue at hand If a disputant does not agree with the decision made at the Center level, he or she can appeal at the agency level.

Initially there was debate, when DPO processes were being developed, about whether an appeal at the agency level would be another level of scientific review of the issue or not The decision made: when a disputant appeals the DPO decision at the agency level, the review is only about whether or not the Center followed the correct process and not about the issue itself

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FDA Policies and Procedures for Retaliation

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The FDA Non-Retaliation Policy directs employees to immediately report any allegation of retaliation to the Ombudsman Issues in regards to retaliation or any related issues-will be treated in confidence and the Ombudsman will work with other agency offices to address all relevant items The most commonly stated reason for seeking confidentiality when working with the Ombudsman is the fear of retaliation CDER Ombudsman principles and code of ethics Despite these policies at the Center and Agency level, several articles present information about instances when former FDA employees' were ordered, coerced and intimidated to recommend approval of certain drugs, then experienced retaliation when they expressed differing opinions and called out this behavior to management, and present the FDA as having an "unfriendly" environment for whistleblowers

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In January 2012, six FDA whistleblowers who were fired from their positions, filed a lawsuit against the FDA November 2008: The plaintiffs alerted the US House and Energy Committee that the FDA Center for Devices and Radiological Health (CDRH} had "ordered I intimidated, and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the I

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January 2009: A letter sent to the Obama transition team which "raised issues of public concern, including, but not limited to, corruption within the FDA device review process, managerial misconduct, dangers to public health, welfare and safety, and retaliation against whistleblowers... "

The scientists' claim their constitutional right to privacy was violated when FDA began monitoring their personal emails and communications on their work computers despite having permission to use work computers for personal purposes.

The FDA did release a statement saying their monitoring program was "limited and intended to determine whether confidential commercial information had been inappropriately released to the bl.

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The situation sparked a Congressional Investigation; many news articles indicate what a "chilling" effect this type of monitoring and situation has on future whistleblowers and its negative impact on being able to identify misconduct and corruption in the government

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I The FDA Equal Employment Office {EEO) has a defined process to investigate discrimination, including retaliation Office of Global Regulatory Operations and Policy Office of Regulatory Affairs Office of International Programs Office of Foods and Veterinary Medicine Center for Food Safety and Applied Nutrition Center for Veterinary Medicine Office of the Commissioner Office of Medical Products and Tobacco Center for Biologics Evaluation and Research Center for Tobacco Products Office of Special Medical Programs Office of Operations Office of the Chief Scientist National Center for Toxicological Research The EEO is located under the Office of Operations

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The EEO process to investigate discrimination, including retaliation, is a two-step process EEO's two-step process investigates any allegation of discrimination based on:

~ Race

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~ Religion

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1. Within 45 days of the occurrence, contact an EEO counselor

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An individual may file a formal complaint and request a hearing in from of an EEO Commission administrative judge From the time an individual submits a formal complaint, if he/she requests a hearing, it could be 450 days before the individual receives a final decision on the matter Step 2: Formal Complaint

1) Within 15 calendar days of the notice of final counseling, the individual...

2) If complaint is accepted, within 180 days of receiving Complaint of Alleged Discrimination form, EEO...

3) Within 30 days of the receipt of the '

investigative file and notice of rights, the individual...

3a) If the individual fails to respond, OR requests an immediate and final agency decision, within 60 days EEO...

3b) If the individual requests a hearing, within 180 days the appointed EEO administrative judge...

Completes the "Complaint of Alleged Discrimination form" (notice of the intent to file a formal complaint) found in the counseling report and send form to the Director of the Division of Compliance Must acknowledge receipt, conduct and complete a fair investigation, make attempts at settlement, provide the individual with a copy of the investigative file and notice of rights May request:

a) an immediate and final agency decision, or b) a hearing in front of an EEO Commission administrative judge The agency will make a decision based on the their review of the investigative report and complaint file Must oversee discovery, conduct a hearing, issue findings of facts and conclusions of the law. The judge will issues an immediate remedy if a discrimination finding was made

4) Within 60 days of the judge's conclusion, Must issue a final decision, can accept, reject, or modify the judge's decision the agency...

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CDER includes in its policies wording about its commitment to protecting employees from retaliation for expressing differing viewpoints MAPP 4151.lR: Scientific/Regulatory Dispute Resolution for Individuals within a Management Chain MAPP 4151.2R: Resolution of Differing Professional Opinions: Review by Ad Hoc Panel and CDER Director Both MAPPs include information about:

Includes policy

===- about retaliation CDER being committed to protecting employees who express differing viewpoints or opinions from retaliation Supervisors and management being expected to:

support and respect the dispute resolution or DPO processes protect employees from real or perceived/appearance of a retaliatory threat for expressing a differing viewpoint or opinion, or for using the DPO process Specific processes on how to address any allegations of retaliation are not included in these MAPPs

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I Whistleblower protection conversations continue as an important topic of conversation, even beyond the FDA On a December 2012 Coalition of Federal Ombudsman teleconference, a discussion topic was Inspector General Whistleblower Protection; FDA CDER Ombudsman, Virginia Behr, was in attendance The Whistleblower Protection Enhancement Act of 2012 (Appendix A) amended the Inspector General Act of 1978 (5 U.S.C. App.), replacing subsection (d) and inserting the following:

"{C) designate a Whistleblower Protection Ombudsman who shall educate agency employees-(i) about prohibitions on retaliation for protected disclosures; and (ii) who have made or are contemplating making a protected disclosure about the rights and remedies against retaliation for protected disclosures.

(2) The Whistleblower Protection Ombudsman shall not act as a legal representative, agent, or advocate of the employee or former employee."

Meeting participants discussed the topic is important and agreed they needed to have further discussions on it is warranted, in particular how the Inspector General Ombudsman role would be implemented, especially within this context, and where in the organization this role would reside

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The CDER Ombudsman makes new employees aware of the processes available to raise differences of opinion During the new employee orientation, the CDER Ombudsman presents information about their options to present differences of opinion Rather than offer information about processes in detail, the Ombudsman presents information conceptually about:

Employees have the right to have their voice heard; a difference of opinion will be stronger if it is documented, there is data to support the opinion, and the employees uses the chain of command to express this difference of opinion Ombudsman is there to support all employees Defined processes exist for employees to address differences of opinion Ombudsman wants to increase employees' awareness of options available to support them We care about what you think An on line training* is available to learn about processes to address differences of opinion Employees should take personal responsibility as a public servant is to say something if they do not align with a decision

• Feedback on the online training:

the training was long and burdensome so many people did not take it; it is a one-time training and is always available

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More recently, the processes to resolve differing opinions have become much more visible Recently there has been a push from the Commissioner down for a focus on and awareness of processes to resolve differing opinions CDER has used a top-down approach to make employees aware of the processes and policy Management often talks about processes and policies at town hall meetings Processes and policies to resolve differing opinions are always on the agenda Upper management impresses upon middle management the importance of these processes and how the topic should be brought up with employees Upper management impresses upon middle management: there should be disagreements to encourage healthy debate Managers must "walk-the-walk" and be a good example for employees Equal voice should be always be used

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CDER does not have a formal process to evaluate the effectiveness of their processes to resolve differing opinions Most individual differences are resolved by using the process to escalate issues through the management chain; employees are encouraged to use this process to resolve issues Although differences of opinions resolved through the management chain are documented and become part of the formal record, they are not tracked The DPO process has not been used in the past year; the last time it was used was approximately two and a half years ago and the Ombudsman decided not to move the issue through the DPO process CDER does formally track the resolution of differences of opinion resolved with the formal DPO process, however the DPO process has not been used enough times to be able to look at any effectiveness measures

• Scientific/Regulatory Dispute Resolution for Individuals within a Management Chain, MAPP 4151.lR

• • Resolution of Differing Professional Opinions: Review by Ad Hoc Panel and CDER Director, MAPP 4151.2R

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One way CDER has been able to review the effectiveness of their differing views processes is through survey results All the Time CDER noted an increase in these measures, however the quantitative data is not available; this is a notional graph CDER noted an increase in employees' feeling comfortable expressing a differing opinion and having their scientific opinion considered during decision-making Results have shown improvement with people feeling their opinion matters These increases leads CDER to believe the environment has changed for the positive and is moving in the right direction II Past II Present

• The questions listed get at the gist of questions asked in an Employee Viewpoint Survey, however t he exact wording is not listed here

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Results from other surveys show positive growth at CDER Comparing results from the U.S. Office of Personnel Management (OPM)

Employee Viewpoint Survey between 2008 and 2010 showed an increased number of positive responses Between 2008 and 2010, there was an increase in the positive responses to the following areas:

My work experience My agency My work unit Supervisory/Team Leader Leadership My satisfaction Only one area showed a decrease in positive responses:

Work life: our only decrease (satisfaction with childcare programs, elder care programs, employee assistance program)

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In 2011, the Ombudsman received 282 communications, most of which, 94%, were received via email or phone The 66 communications to the Ombudsman from CDER employees included the following topics:

General enquiries about the Ombudsman's role Requests for help with external constituents Help with workplace conflict (these cases were referred to the Conflict Prevention and Resolution Staff in FDA's Office of Equal Employment Opportunity and Diversity Management or the Employee Assistance Program}

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Industry: commercial sponsors, pharmaceutical industry Consultants Media/Press Whistleblowers Law firms Research sponsors Consumers Health care professionals Consultants Advocacy groups Other FDA employees (mostly CDER employees)

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Background information: Pfizer, Inc.

Size Overview Mission Stakeholders Safety Standards

"'120,000 employees Industry Pharmaceuticals Founded in 1849, Pfizer is the world's largest research-based pharmaceutical company.

Based in New York City, Pfizer has operations in more than 90 countries. The company manages a portfolio of products and medicines for both humans and animals. Global operations include research and development, manufacturing, and supply chain.

Mission: To become the world's most valued company to patients, customers, colleagues, business partners, investors and communities

Purpose:

To improve healt~ and quality of humans' lives by providing high quality human and animal health products Global consumers, health care professionals, scientists and researchers, manufacturing plants, supply chain and transportation professionals Pfizer's global Environment, Health, and Safety (EHS) Policy aligns closely with elements prescribed in both ISO 14001 and OSHAS 18001, international standards that specify requirements for an environmental, health and safety management system

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Pfizer's Compliance Program is a proactive effort to ensure employees work with integrity and take ownership of compliance Pfizer's Compliance Program is designed to support legal and ethical conduct throughout the company. It incorporates elements such as training, access to information, and an organizational structure that lend themselves to encouraging employees to think beyond compliance.

Pfizer's Compliance Program incorporates many different elements :

>-" Written policies and procedures, providing easily accessible guidance on conduct surrounding day-to-day operations

>-" Compliance Officer and Compliance Committees, having corporate structures in place to monitor compliance

>-" Effective training and education, offering employees easily accessible online and in-person education about compliance

>-" Effective lines of communication, offering multiple channels through which to report compliance concerns, and anti-retaliation and confidentiality policies to protect employees who use these channels

>-" Internal Monitoring and Auditing, setting policies and procedures that help the organization detect and prevent compliance issues

>-" Enforcement through Discipline, clearing defining consequences if there is a failure to adhere to compliance standards

>-" Prompt Response and Correction Action for Detected Problems, requiring a prompt response when compliance violations are detected 1

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Pfizer's has a Compliance Division, along with Audit and Compliance Committees under the Board of Directors The Compliance Division, is responsible for administering all aspects of the Compliance Program, including training programs and monitoring systems, developing informational resources, and investigating potential violations of law or Company policy

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performance, & internal audit function and performance Oversees and reviews health care law compliance programs and the status of compliance with laws, regulations and internal procedures applicable to pharmaceutical sales &

marketing Compliance Division; Chief Compliance and Risk Officer Chief Compliance and Risk Officer: provides oversight of Pfizer's compliance programs and guidance to help colleagues stay fully compliant with applicable laws, regulations and company policies Pfizer CEO

In addition to the Compliance Division, Pfizer has executive-level committees to oversee compliance with regulations Corporate Compliance Committee, Chaired by the Chief Compliance and Risk Officer, includes:

Senior leaders (such as the CFO)

General Counsel Senior leaders from compliance, finance, audit, HR and Pfizer's business units Executive Compliance Committee, oversees and supports Pfizer to ensure business is conducted appropriately in every country in which it operates, includes:

Senior leaders from across the country The Executive Compliance Committee and Corporate Compliance Committee promote leadership oversight. Leadership oversight also comes from various business units and divisional committees, creating a structure that complements the embedded divisional and business unit compliance organizations and increases the proactive approach to maintaining compliance and an open environment in which to voice concerns.

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Pfizer offers several avenues for employees who want to identify potential compliance violations or concerns Compliance helpline: Phone and web-reporting tools, in most countries available 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> a day, 7 days a week, which allow employees to report a concern or to get information or advice anonymously; information is reported to Pfizer's Compliance Division Compliance Direct: Employees may contact the Compliance Division directly via email, phone, or FAX Open door policy: Encourages colleagues to discuss all issues, concerns, problems and suggestions with their immediate supervisors, Human Resources, the Compliance Division, managers, or the team attorney without fear of retaliation and with the assurance that the matter will be kept as confidential as possible Office of the Ombudsman: provides an informal place where employees can talk confidentially and off-the-record

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The Compliance Division has exclusive responsibility to investigate significant potential, suspected or actual violations of law or policy The Chief Compliance and Risk Officer gives this exclusive responsibility for investigation to the Compliance Division The Compliance Division may enlist others individuals or groups to investigate matters The Compliance Division investigates concerns and compliance issues reported through the various available avenues. The goal is to respond promptly to all questions and reported concerns. Where possible and appropriate, the Compliance Division will provide periodic status updates but will share information with select individuals who "need to know" to maintain an individual's confidentiality J

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Pfizer's Compliance Helpline was established to facilitate reporting violations of law, policy, or workplace misconduct The same process can be used to report a concern online Call the Compliance Helpline to report a concern; the Helpline is answered by Global Compliance, a third party company contracted by Pfizer to document concerns about Violations of law, policy, or other workplace misconduct; calls are not recorded or traced A communication Specialist will answer, the phone, ask some basic information, document statements, and ask follow up questions as needed; if one chooses to report anonymously, the communication specialist will not ask for your name or refer to gender in the report Communication specialist will prepare a written report of the concern; can document a request for information or advice from a Pfizer representative; can not offer opinions on ethics, policy, or course of action At the end of the call, the employee will be given a report number and pin; can use this information to check back at a later time for a response to the report or to provide additional facts pertaining to the report

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On-Line Compliance Helpline When you report a concern to the Compliance Hotline, you are give a report number and pin to check for any responses to your report To the right is a screen shot of the page to view any follow up actions from your report or add additional information REPORT A COlfC(Rll FOllO Ill' ON A REPORTFD CONCER Z 1-15 New Responses from pflzer lnc Date Respon5e Provded:

2013 01 II Do you have any additional information?

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Pfizer's Open Door Policy The Open Door Policy encourages colleagues to present ideas, raise concerns and ask questions-especially those of a legal or ethical nature, but also those relating to quality of work and the working environment The foundation of Pfizer's Compliance Program, and included in it, its Open Door policy, is:

Openness Accessibility Discussion within the Pfizer community The idea with the Open Door Policy is employees will feel comfortable discussing any matter with their managers, or if preferred, their next level supervisor, operating unit head, another manager or supervisor, Human Resources, or the Compliance Division and problems will be resolved at the local level prior to the issue escalating Managers are all expected to maintain an open door policy

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Pfizer's Office of the Ombudsman supplements ways for employees to report concerns When an employee wants to report a concern and make note of it officially, they must use the open door policy, the Compliance Helpline, or contact the Compliance Division directly. The Office of the Ombudsman provides assistance and guidance on how to address and resolve work-related issues objectively and fairly.

The Office of the Ombudsman is a neutral place to discuss ideas or concerns when the individual is:

Unclear where to present an issue Deciding how to raise an issue Question whether something they witnessed was unethical or a violation of a law or policy Needing assistance in identifying options for addressing conflicts in the workplace; Looking to talk off-the-record to a subject matter expert who has extensive knowledge of Pfizer's policies and practices before taking a formal step to.voice a concern

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Pfizer encourages a culture where working with integrity is the norm and tolerating anything less is unacceptable Pfizer makes known the following guidelines which help employees understand it is their responsibility to know and understand standards, policies, laws, and to raise concerns when they are not followed.

Know the standards, and live by them. Will help each employee serve as a role model Know the law and ask questions. Employees are expected to be familiar with the laws and policies that apply to their role and are encouraged to ask questions of a manager or the Legal or Compliance Division if any arise Raise concerns. Employees are encouraged to raise a concern if they believe someone may be violating a law or policy; Pfizer wants to uphold standards and address any concerns that are raised.

Always act with integrity. Employees are made aware that they should never feel encouraged or pressured to violate a law or policy, even if it means improving the bottom line or helping to meet a performance goal

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Pfizer has anti-retaliation policies to protect those who raise concerns Retaliation against any colleague who seeks advice, raises a concern or reports misconduct is strictly prohibited. The anti-retaliation policy states that raising a concern may not be the basis of:

• Denial of benefits

• Threats

• Termination

• Harassment

• Demotion

• Discrimination

• Suspension Action will be taken against anyone who displays any type of retaliation toward someone for honestly, and in good faith, reported a concern, even if the reported concern turned out to be false. This does not hold true if the concern was intentionally submitted a false report.

The disciplinary action taken against someone who retaliates varies from case to case and can range from monitoring the situation to termination.

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Pfizer's Chief Compliance and Risk Officer and the Compliance Division are responsible for enforcing standards Pfizer's Blue Book of Policies and Business Conduct clearly state that any violation of a law or company policy can result in disciplinary action, including termination of employment.

Retaliation is among the behaviors that are included in the list which would result in disciplinary action:

Knowingly and intentionally violate the law or policy Direct others to violate the law or policy Fail to cooperate in a Company investigation of possible violations Retaliate against another colleague for reporting a concern or a violation Fail to effectively monitor the actions of subordinates The Blue Book cautions employees that non-compliance with Company standards may result in the following consequences:

Prosecution, fines, imprisonment and other penalties for improper conduct Disciplinary action up to and including termination of employment Damage to personal reputation Serious injury or illness

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Pfizer will maintain an employee's confidentiality when any aspect of the Compliance Program is accessed However, depending on the nature of the investigation, possible legal issues, needing additional information, it may not be possible to maintain confidentiality

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• Reiterates the importance of working with the core value of integrity

• Directs employees to refer to The Blue Book and companion Website

• Reinforces leadership support

• Encourages employees to use the many available options to discuss concerns or report misconduct

• Reassures employees of policies in place to protect those who raise concerns Dear Colleagues.

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Pfizer is committed to providing effective training on their Compliance Program Pfizer has accessible online training for employees to learn about their Compliance Program including how to report concerns or compliance infractions.

In 2012, Pfizer had a settlement with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) due to Pfizer employees making improper payments to doctors and healthcare professionals employed by government-controlled or owned healthcare providers in foreign countries. This was in violation of the Foreign Corrupt Practices Act (FCPA).

Pfizer modeled what they expect of their employees in terms of reporting concerns, and self-reported these violations to the DOJ and SEC. As part of the DOJ's Deferred Prosecution Agreement it required Pfizer to improve upon existing compliance procedures. In part of this agreement, Pfizer will conduct training on anti-corruption policies:

Twice a year, for employees and executives Three times a year, for third parties whose activities may bring them under the reach of the FCPA 132

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Pfizer is committed to continuous improvement and regularly evaluates its programs Pfizer regularly uses surveys to measure employee inclusion, engagement, and understanding of opportunities and challenges Pfizer regularly reviews its compliance program to ensure it remains "best in class" The Corporate Audit Committee and the Chief Compliance and Risk Officer have wide authority to investigate any complaints or compliance issues Audit Committee of the Board of Directors Chief Financial Officer (CFO}

Internal Audit Group The internal audit group has a direct reporting relationship to the Audit Committee of the Board of Directors and the CFO More specific information about Pfizer's evaluation processes were said to be proprietary and not able to be shared with the public r* '

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1.

Introduction and Background.................................. SI ide 2

2.

Data Gathering Method............................................ Slide 8

3.

Findings..................................................................... Slide 12

4.

Anal sis

5.

Best Practices and Recommendations............... Slide 146

6.

Appendix................................................................ Slide 154 r

135

Each organization champions a strong safety culture by offering a variety of programs and channels to raise differing views Organization Reporting Option Dissenting Opinion Process NASA Safety Reporting System Air Traffic Safety Action Program Non-Concurrence Option Unsatisfactory Condition Reporting Program Scientific/Regulatory Dispute Resolution for Individuals within a Management Chain Equal Voice Resolution of Differing Professional Opinions: Review by Ad Hoc Panel and CDER Director Compliance Helpline Compliance Direct Open Door Policy Office of the Ombudsman l'

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Safety reporting options among the organizations are structured and managed relatively differently, yet they share common elements Polic~LProcedures Retaliation Reporters are protected by anti-retaliation laws Reporting safety concerns is relatively easy and policies:

Online reporting options 0

Whistleblower Enhanced Protection Act Use of third party contractors to manage (WEPA) process 0

Notification and Federal Employee The review process is quick and efficient Antidiscrimination and Retaliation (No FEAR) Act Each review ends with a resolution Communication and Training Evaluation High visibility Covered within the respective agency or Heavily communicated throughout organization organizational safety culture surveys Communication involves both official directives as well as leadership Explanations are clear and easy to follow Training on policies is a key part of onboarding 117 137 J

Despite strong support from the organization through the various reporting channels, and protection from retaliation through Federal and organizational laws and policies...

... Research found in some cases, reluctance to report safety concerns due to fear of retaliation Job Loss Demotion Harassment Discrimination This is perhaps fueled by ongoing and even recent instances where employees have come forward with their differences or concerns, only to have retaliatory actions taken against them I

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This fear of retaliation in turn negatively affects the overall organizational safety culture Job Loss Demotion Harassment If employees are too afraid to raise or report a safety concern/issue Consequences of which reach far beyond the office of the individual noticing the safety issue 139

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It appears the options that offer anonymity have greater acceptance by employees Where anonymity was an option, such as through the NASA Safety Reporting System, great lengths were taken to ensure the reporter's identity was protected for the sole reason of preventing retaliation Hardcopy submissions to prevent email and keystroke monitoring Investigator recusal if he or she learns of the reporter's identity

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I Where confidentiality was an option such as those options discussed for FAA, FDA, and Pfizer, measures were put in place to ensure individuals aware of the reporters identity were not in a position to exact any retaliatory actions against the reporter...

"Confidentiality means individually identifiable information is disclosed only on a need-to-know basis and only to those with Event Review Committee

,~.c;..---, authorization" "May be requested with regard to identity and nature of complaints" "Will be honored, buy may restrict complaint/dispute

,...,,1i'-.w..., ---- resolution actions" "Where possible and appropriate, the Compliance Division will provide periodic status updates but will share the information with select individuals who

'need to know' to maintain an individual's

... However, in cases where confidentiality is an option, the issue remains what happens after the report and resolution process?

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Research showed numerous cases where although confidentiality was an option, the nature of the cases could not fully protect the reporter's identity As a resu It, affected stakeholders eventually learned the reporter's identity and took retaliatory actions against the reporter.

Job Loss Demotion Harassment Discrimination

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This is perhaps due to the absence of a formal follow up with the reporter and applicable stakeholders to ensure no retaliatory actions were taken after the report and resolution processes Job Loss Demotion Harassment Discrimination Follow Up

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This is evidenced in numerous accounts of individuals coming forward with their differences and suffering retaliatory actions Disclosing FAA Failures, Corruption, Misconduct and Intimidation, The Good, The Bad, and The Ugly.

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Although each organization conducts safety culture surveys, there is no specific data speaking to whether the respective options promote the safety culture or prevent retaliation Although the data may be available, the current focus is on the broader safety culture and not specific differing views processes Safety Reporting Retaliation Reporting discomfort Safety Knowledge Safety Options

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Should the focus shift to specific elements of safety cultures, organizations may uncover and properly address some of the issues surrounding discomfort in reporting safety concerns and expressing non-concurrence

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1.

Introduction and Background.................................. Slide 2

2.

Data Gathering Method............................................ Slide 8

3.

Findings..................................................................... Slide 12

4.

Analysis.................................................................. Slide 135

5.

Best Practices and Recommendations

6.

Appendix................................................................ Slide 154

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There are five key factors in developing an open organizational culture with effective non-concurrence process-=--e=-s ____

1. Leadership commitment

2. Clear policies and procedures

3. Communication

4. Training and education

5. Evaluation methods These factors create a top-down and a bottom-up approach to developing an open organizational culture that supports successful non-concurrence processes Developing these five key factors is a proactive approach to creating an environment where employees take personal responsibility and act accordingly whether management is present or not Open culture

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Leadership Commitment is a driver in creating any change within an organization In order to have successful non-concurrence processes in an organization, leadership commitment to the issue must be demonstrated; this focuses employees' priorities and channels resources to the initiative

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I Best Practices I f Rationale I

Communicate the vision for organization Contributes the necessary authority and its culture Adds credibility to the initiative Talk about ethical behavior, non-Recognized as a priority concurrence processes, and personal Dedicates resources to the initiative accountability, at any given opportunity, via varied communication vehicles Normalizes use of the non-concurrence Encourage employees to use the non-processes by encouraging it concurrence processes Encourages a dialogue about the topic Publicly acknowledge and reward employees who pinpoint ethical issues r

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Clear policies and procedures for non-concurrence processes are essential to their success 7-'.~licies and l Polices and procedures for non-concurrence processes must be clear and accessible for employees to understand, know what resources are available, and where to go for support

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Rationale Include independent or neutral parties to Neutral parties investigating the matter ensure facilitate the non-concurrence process an independent review Process should be transparent, with findings and Transparent process gives employees more documentation shared with the employee and confidence in the process relevant parties Timely investigation and a short timeframe to Timeframe in which the process takes place investigate the issue increases employees' should be timely and resolved within a short confidence in the process and demonstrates period of time respect for employee(s) and the issue at hand Process includes ways to hold employees Clear, enforceable consequences encourage accountable for their actions; consequences, employees to act in accordance with policies decisions and results are clear and enforceable and reduces impetus to retaliate against those Process includes option to remain anonymous; who utilize non-concurrence processes complaints and allegations must be Being able to use non-concurrence processes professionally, independently, objectively and anonymously increases the likelihood of confidentially investigated and reviewed employees using the resource

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Open, honest, and clear communication among all levels promotes an open and positive organizational culture An open and positive organizational safety culture is one in which employees feel empowered and safe to use non-concurrence processes. Communication represents both a top-down and bottom-up approach to developing an open and positive organizational safety culture I

Best Practices I

Rationale Communication about non-concurrence processes are frequent and delivered via varied communication vehicles Communication is two-way; employees have the opportunity to provide feedback and have their opinions heard Communications are clear and offer information the employees need and want to know There is a well-established open-door policy There are feedback mechanisms to determine whether the intended message was received Frequent communications via varied communications vehicles better ensures the employee receives the information, and receives it in a format that relates to how the employee best receives and retains information Two-way communication opportunities, including an open-door policy, give the employee a sense of belonging in the organization and increases his/her personal accountability for a positive, open environment, and makes the employee feel respected when he/she can offer his/her opinion and be heard Clear communications keeps the employees informed, consequently developing better attitudes among the employees Receiving feedback on communications provides the opportunity to revise future communications as needed

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Employees are provided training to understand and use the process In order for employers to expect employees to complete their job functions properly, as well as feel comfortable using non-concurrence f Training_ and\\

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Best Practices I I Rationale I

Offer frequently scheduled training on enhancing skills needed for current job role Develop a learning plan with employees to map out employee development goals in areas that will complement current skills Offer varied trainings, in different formats, on aspects of non-concurrence processes Developing employees' current skills and providing opportunities to learn new ones enhances employees' self-esteem and feelings of value in the workplace Training on non-concurrence processes ensure employees understand processes, know how to use them; normalizes the use of the processes and makes them less unfamiliar, increasing the chance employees will use non-concurrence processes if need be

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Systemic, regular methods to assess non-concurrence processes should be in place In order to know whether non-concurrence processes are working, and what revisions to the processes must be made, a set process must be in place to evaluate the processes' effectiveness and promote continuous improvement Gather input from the field when developing non-concurrence processes Gather both quantitative and qualitative data when evaluating the processes Share performance data with employees Set performance goals to match aspects of the non-concurrence Employees will have a different perspective from management who may be involved in developing non-concurrence processes; gathering input from employees about non-concurrence processes will enhance the final product Gathering both quantitative and qualitative data will produce a more comprehensive picture of the program and will better identify areas for improvement Sharing performance data with employees will highlight the value of the non-concurrence processes and increase employees' confidence in the processes Setting performance goals helps focus and prioritize employees' work 1

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Best practices for handling retaliation in non-concurrence processes...

... mirror those best practices for developing an open organizational culture that supports successful non-concurrence processes Ensure employees are aware of the complaint process, understand it and can easily follow it Consider having an employee hotline where employees can submit complaints Ensure supervisors are trained on the anti-retaliation policy and understand expectations of upholding the policy Dedicate an impartial individual/department to periodically review and implement anti-retaliation policies and procedures, conduct investigations, and provide training Implement disciplinary action consistently and fairly Document all performance appraisals and disciplinary actions to retain proof that your practices are fair and lawful Regularly check in with the employee during and after the investigation Despite maintaining these best practices for anti-retaliation policies, retaliation is difficult to prove and employees may be hesitant to use non-concurrence processes for fear of retaliation. The best remedy for this is to work proactively to develop an open organizational safety culture, where employees take personal responsibility for their actions, there is a communal feel to the environment, and everyone is working toward the same goals

1.

Introduction and Background.................................. Slide 2

2.

Data Gather i n g Method............................................ SI id e 8

3.

Findings..................................................................... Slide 12

4.

Analysis.................................................................. Slide 135

5.

Best Practices and Recommendations............... Slide 146 I

6.

A endix

We Used the Following Questions as Part of the Data Gathering Process. The Questions were Designed to Align with the Information NRC Requested about DPO Programs Program Overview General Information

• What options (policies, processes, practices) are available for your employees to raise concerns or express differences of opinions that relate to the mission of the organization?

• Can you give a high-level description of these options?

• What is the purpose of this program/[document]?

• What are the overall goals of the program/[document]?

• Where does the program reside organizationally?

• In terms of use and participation, who are the target stakeholders?

DPO Review Process

• How would a stakeholder formally raise a concern or express their difference of opinion?

• Walk us through a typical case where an employee raises a concern that relates to the mission of the organization.

• What options are available for stakeholders to submit their concerns or differences anonymously?

• What type of situations would warrant a formal concern or difference of opinion?

• How are DPOs collected and tracked throughout the review process?

• What is the DPO review process from initial submission to final decision?

• How long does the DPO process typically take from initial submission to final decision?

• What is the primary method of communication during the review process (email, phone, in-person)?

• What criteria must a DPO meet in order to go forward in the process?

Does this criteria change? If so, how are they determined?

• How do you determine the DPO's priority and/or severity level?

What are the criteria for a "stand down" or "stop work" decision?

What are some examples?

• How is the final decision determined (i.e. consensus, unanimous, majority vote)?

• How does the program hold stakeholders accountable for their actions?

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We Used the Following Questions as Part of the Data Gathering Process. The Questions were Designed to Align with the Information NRC Requested about DPO Programs Program Management Stakeholder Management I Governance

• Which stakeholders (and their respective levels) are involved in the DPO review process?

Who do they (board/committee) report to?

How are they selected?

How often are they selected (standard panel for each review, as needed, or based on the content of the issue)?

On average, how many stakeholders are involved in the review process?

• How does the program prevent conflicts of interest?

• How does the program protect submitters from retaliation?

Communication Management

• How is the program publicized and promoted to the target stakeholders (i.e. methods, frequency, tone and nature)?

• How does the program maintain stakeholder awareness and understanding of program policies, procedures, and documents?

• How does the program gain stakeholder confidence in review process?

• How does the program incorporate training (i.e. standalone or as part of general employee onboarding)?

What type of training is used?

How often is training leveraged?

Integrity and Quality Management

• How does the program ensure the review process is completed in a timely manner and according to program policies and procedures?

• How does the program ensure decisions are fair and unbiased?

• What mechanisms are in place to allow for review process transparency?

• How often is the program evaluated for effectiveness?

How is the program evaluated?

If surveys are employed, what types of questions are included?

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We Used the Following Questions as Part of the Data Gathering Process. The Questions were Designed to Align with the Information NRC Requested about DPO Programs Program Performance Program Statistics

• What metrics do you use to track performance?

• How do you track metrics or performance?

• On average, how many DPOs did the program process within the past calendar year?

• Which stakeholder group uses the Program the most or submits the most DPOs?

• Was there an increase or decrease in submissions?

• What additional data speaks to the program's effectiveness and success?

• Have you tracked how the program has impacted the organization's safety culture, and if yes, how?

Program Effectiveness

• What impact has the program had on the organization's safety culture?

What are some examples?

• What are some common themes in terms of program improvement?

Additional Questions

• What organizations come to mind in terms of having a good difference of opinion program or safety culture?

Why?

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