LinkVisum consulting group _ty Culture Continuous Learning provement Services Differing Views Processing Benchmarking This document is con?dential, prepared solely for the ciient to whom it is addressed. it is not to be reproduced or distributed under any circumstances. Introduction and Back, round Data Gathering Method Slide 8 Findings Slide 12 Analysis Slide 135 Best Practices and Recommendations Slide 146 Appendix Slide 154 This document is confidential, prepared soieiy for the ciient to whom it is addressed. it is not to be reproduced or distributed under any circumstances. Our Benchmarking Methodology Define Activity Define the key activity under study (differing views programs) Prioritize aspects of the activity to benchmark Goal: Define detaiis 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 iogicai peer group for which benchmarking data be reievantfor the NRC Research 8: 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, in knowiedge gaps, and identify best practices This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any Deliver Results 0 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 Goai: Present resuits to stakehoiders and plan actions to address resuits Project Objectives: Differing Views Processing :33ny 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 This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any cirrumstances. Project Summary: Deliverables Deliverable Description Due Date Project Kick Off Summary of understanding of 3 weeks after task order benchmarking SEFVICES effective date Plan which includes research Project Plan methodology for consideration and approval from NRC PO 3 weeks after task order effective date Final version of the plan which includes Final Project Plan research methodology for consideration and approval from NRC PO One week after receiving comments from NRC COR This will be the format/template in 7 weeks before the end of the Draft Report which the final report will be delivered task order effective date Report will include the background, Final written report? methods, data references and results of the benchmarking performed 3 weeks before the end of the task order effective date This document serves as the final report deliverable This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced or distributed under any circamstances. Project Plan: Tasks 1 and 2 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 Summary, Plan and Template Review Previous Research Identify Organizational Contacts Establish NDAS as Required [Non-Disclosure Agreement) Develop Questionnaire Design of Key Question Focus Areas: a. DPD PoliciesfProcesses b. Implementation: Communication 8; Training c. Implementation: Evaluation Methods [usage tracking, assessment of effectiveness, impact) d. Implementation: Policies 8: Procedures for Retaliation e. Lessons Learned Contact Selected Organizations Conduct Secondary Research Second Round Data Gathering [Re-interview I Clarify Responses as Necessary} Collect Results Analyze Findings and Data Develop Draft Report Conduct Data Review Session Senior Advisory Review Develop Final Report Deliver Electronic and Hard Copy to NRC This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced or distributed under any circamstances. Peer Group Benchmark Target Selection Rationale I {Dafine - 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: Food and Drug Nt' IA t' Fd lA't' .. . a Iona eronau ms at era via Ion (FDA), and Space Administratlon (FAAPflzer Center for Drug Air Traffic Evaluation and (NASA) Organization (ATO) Research (CDER) This document is confidential, prepared soi'eiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any cimumstences. 1. Introduction and Background Slide 2 2. Data Gatherin Method 3. 4. 5. 6. Findings Slide 12 Analysis Slide 135 Best Practices and Recommendations Slide 146 Appendix Slide 154 This document is confidential, prepared saieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. Conduct Research to Benchmark Research Differing Views Processing - 8? . . Analysis Identify best Conduct research that is practices and applicable to current NRC ways to improve environment Focus on areas such as process, lessons learned in differing VIews the differing . processes policies or order to conSIder views process practices future implementation NASA FDA Pfizer Review current research related to Understand the most effective way of shaping a proactive and responsive differing views process that supports NRC mission and vision This document is confidential prepared solelyfor the client to whom it is addressed. It is not to be reproduced or distributed under any cI'rCIImstonce-s. We developed a research guide to direct secondary research as well as an interview questionnaire* for use during interviews with organizational representatives El Program Overview General Information DPO Review Process El Program Management Stakeholder Management Governance Communication Management Integrity and Quality Management CI Program Performance Program Statistics Program Effectiveness Questionnaire is ioccited within the Appendix section of this document This document is confidentidi, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or Estimated under any circamstances. 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: Cl NASA Safety Reporting System Program Manager CI FDA, Office of Ombudsman This document is confidentiai, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or fi'fstributed under any cirrumstances. Introduction and Background Slide 2 2 Data Gathering Method Slide 8 1. 4 Analysis Slide 135 5 Best Practices and Recommendations Slide 146 6 Appendix Slide 154 This document is confidentiai, prepared saieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. Each benchmarked organization includes a high-level organizational summary and subsequent sections covering the following four key topics: High-Level Organizational Summary Differing Views Program Policies/ Procedures Communication and Training Evaluation Methods Policies for Retaliation This document is confidential, prepared soiel'yfor the client to whom it is addressed. it is not to be reproduced Dr distributed under any Benchmarking Research for: National Aeronautics and Space I 1 A: This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any cirrumstances. ii 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 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 This document is confidential, prepared solely for the ciient to whom it is addressed. it is not to be reproduced or distributed under any NASA Differing Views Program Policies and/0r Processes, - This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any cimumstances. 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: . . . . Uniform, recognized process for resolving dissenting Dissenting Opinion . . . . . opinions that would prowde additional support to safety, Process and the success of both NASA and the mission An anonymous, voluntary, and responsive reporting channel to notify upper management of one?s concern about hazards NASA Safety Reporting System This document is cenfidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any NASA: Option One - Dissenting Opinion Process This document is confidentiai, prepared soieiyfor the tiient to whom it is addressed. it is not to be reproduced or distributed under any Within NASA, employees are able to raise a Dissenting Opinion, not to be confused with a Differing Professional Opinion Differing Professional Opinion Dissenting Opinion A Dissenting Opinion is not a Di?erence of Opinion that might be expressed in a manner such as: I would not do it that way if it were my decision The other alternative is better I would not do it that but I can live with it This document is canfidentiai, prepared soieiy for the client to whom it is addressed. it is not to be reproduced Or distributed under any circumstances. Office of Chief Engineer issued a requirement: every NASA project and program must follow the Dissenting Opinion Process* NPR 7120.5E replaced the policies and procedures within NPR 7120.5 D. The Dissenting Opinion Process refers to standard steps to be ta ken 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 should be read broadly to cover mission success, safety, the project, the program, etc. NASA Procedural Requirement (NPR) 7120.55- NASA Space Flight Program and Project Management Requirements This document is confidentiai, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any Team members have three choices when determining his/her position on a particular decision I Agree I I Disagree but be willing to fully support the decision I Initiate Dissenting I Disagree and raise a Dissenting Opinion . . OpInIon Process ?it 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.? This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced Or distributed under any circumstances. The dissenting opinion process can be broken into three parts Submit to Raise Next Higher Dissenting Level Opinion Management Review Resolve This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced Or distributed under any circumstances. The first part: raising a dissenting opinion involves three steps Sending to, and Documenting gaining concern in approval from representatives of each view memorandum form The Dissenting Opinion Memorandum must: CI Clearly define the issue El Identify the facts both parties agree upon CI Document the differing positions with rationale, impacts and individual recommendations for resolution This document is confidential, prepared soieiyfor the client to whom it is Sending memorandum to the Next Higher Levelof Management addressed. it is not to be reproduced Or distributed under any circumstances. Once a formal dissenting opinion is submitted, the process moves to the second part: Next Higher Level Management Review where the manager Renders and Prowdes copies of the Reviews the decision to the documents the . . . memorandum dissenter and notified decision managers The Next Higher Level Manager must fully support the Core Values of Teamwork. This includes conducting discussions, meetings, and boards in a professional mannerthat: El Promotes full and open discussion of issues with all their associated facts and considerations CI Fosters and respects diverse views El ls open to thoughtful presentations of alternative ideas and approaches CI Ensures the team understands the basis for the decision made This document is confidentiaf, prepared sofeiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any cimumstances. Once the Next Higher Level Manager renders a decision, the process moves into the third part where the dissenter can either Support the joint resolution process, including the development and distribution of the joint decision memo When appealing 3 Appeal to the next decision, the first two higher level of parts of the process management (if not are repeated. The satisfied with process dissenter may take or outcome) the issue as high as to the Administrator This document is confidential, prepared soiel'yfor the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. NASA: Option Two NASA Safety Reporting System This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any The NASA Safety Reporting System (NSRS) is an anonymous, voluntary, and responsive reporting channel The NSRS is used to notify upper management of one?s concern about hazards that can affect: CI The Public CI The NASA Workforce CI NASA Assets This document is confidential, prepared sol'eiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any The NSRS is located within the NASA Headquarters? Office of Safety and Mission Assurance Office The NSRS Program Manager manages every facet of the . NASA Headquarters grogram Including: Washington DC "To assure the safety and enhance the success of all NASA activities" Investigation . . Performance Communlcatlon Process Management Investigation Information Exhibits This document is confidential, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any cimumstances. The NSRS is intended to supplement local hazard- reporting NASA SafetylHazard Reporting Hierarchy NSRS is open to any NASA Report to or contractor employee supervisor working in support of NASA. NASA uses the Safety/ Hazard Reporting youriuporvinoryou Hierarchy as a guide. mmxm? rmlvod. limb handiwork. clout. your concern. In general, submitters are encouraged to use the NSRS if they: El Reported a hazard locally and have seen no action taken El Are not satisfied with the response to a reported hazard El Fear reporting a hazard through local reporting channels will result in retaliatory actions This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. The NSRS reporting process starts with a hard copy safety concern submission to a Post Office Box 2 IRS mum human-9:1: Employees are instructed to provide as much information 3?33: ?8 as Including: Hard copy 532? n. n. CI The scope of the hazard "Tum? ?lm-?13 CI Manufacturing sources and/or part ensures: numbers . mum CI The submitter 1. A I LLit-Dll?la I, I Challiin The locatlon 0f hazard does not take the uomng ll :Ippc-?crf may In we NSRS Npo?ulwoolo: a: CI Whether or not the hazard W35 HDTE The NSRS wlnmu?llmponzw process reported elsewhere um are wuauredurn In in one u: m: um_or . . -?on rat a In Show!? Imp: clamWhether the hazard rEIates to a mxwrurwmuwamnamm pram! Risque-511mm?! . . 7.541535 protect event or process lulu"(luau SU bm Itte 5 El What Is behaved to have caused identity the a za rd 33.17.307.33? 1:333:33. nan mum. - Him Om! I Itlilhg pm?, - We DI 1mm, Cl What can be done to correct the hazard and prevent recurrence CI The consequences if issue is not resolved This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed un der any cirrumstances. A third party contractor checks the PO. 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. as? Office of Safety and Mission Assurance - - . I - .3 t; It mu ?mm ?Min?. rum-nu CI Name -.. ..- NASA Headquarters n- lay-r I. r-m'lwv also ?in: Ill'l atIlIIrm "'iaf: arias; ?at: CI Address DC Tile ?SI-glean cm lfml?tu: =f7llF?F-1fl 'F'vl?pmilli Jt?z NWFNIJ it I'll HUI Te I 0 be "To assure the safety and enhance the success of all NASA activities" Mmsejla ordcumumcfna'mah M134 ?Mn-2d" HT: 7" liming: r?l .. El Report Details NASA r" rem? NASA Safety Engineering Independent 3: 3,3, ,3 Center and Safety Verification E. 27.: Hm .. Center Validation llv'z'i him h! mull-talc" I?ll Im?i?'lu - . Safe 8. A NASA Centers Support 55'Ura?ce . . . Reqmrements ?acuivmland?i D'V s on Collection Transcription Dissemination This document is confidential, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced Or distributed under any circumstances. Upon receipt of the report, the Office of Safety and Mission Assurance Program Manager: Reviews the report and Assigns an investigator determines: while ensuring the: Monitors the progress of investigations CI The nature of the CI investigation is not issue and associated with the NSRS CI Daily for urgent issues CI whether the issue is urgent or non-urgent CI Investigator has no knowledge of submitter?s identity CI Weekly or for non-urgent issues m_m This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any The investigator has 30 days to investigate the hazard and report findings to the NSRS Program Manager Safety?: NSRS Assignment R?ssf'm?e Division NASA NASA Safety . ,2 Independent For investigations where a valid Center VeJifl'gZattiian 31 a non safety concern artists, the - - investigator makes a corrective NSRS . . NASA :1 . . action recommendation. The En ineerin . Missmn Program . 8 -. Support execution of the recommendation IS Safetv Center a Division Manager monitored by the NSRS Program Manager until completion. NASA Centers Report Findings This document is confidentiai, prepared sol'el'yfor the client to whom it is addressed. it is not to be reproduced Or distributed under any circumstances. NASA Policies and Procedures for Retaliation This document is confidentioi, prepared soieiyfor the eiient to whom it is addressed. it is not to be reproduced or distributed under any NASA ensures no retaliatory actions are taken against individuals who express dissenting opinions or report safety concerns Dissenting Opinion Explicit language and organizational policies requiring Process individuals refrain from retaliatory actions And, NASA Safety Program elements protecting the identification of the Reporting System individual submitting a safety report This document is cenfidentiai, prepared soieiyfor the tiient to whom it is addressed. it is not to be reproduced 0r distributed under any cimumstances. One of 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 protecting people who report things like illegal and/or wasteful activities)." Procedural Requirement (NPR) 7120.513: NASA Space Flight Program and Project Management Requirements This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced 0r distributed under any 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. CI Name CI Address CI Report Details CI Telephone Number CI Report Details Original Submission to NSRS Final Submission to Office of Contractor Safety and Mission Assurance This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced Or distributed under any cirrumstances. 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 Investigation Closed Corrective Action Pending Code Investigation Closed No Corrective Action Warra nted Code Investigation Closed Reported Concern Could Not Be Substantiated/Validated Code Investigation Closed Physical/Product Corrective Action Completed Code Investigation Closed Policy/Procedural Corrective Action Completed Code Investigation Closed Education/Awareness Corrective Action Completed Code 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 Investigation Closed Insufficient Information Provided to Perform an Investigation This document is confidentiai, prepared sol?el'yfor the tiient to whom it is addressed. it is not to be reproduced 0r distributed under any cimumstonces. 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. Clarifying Information Request NSRS Contractor Clarifying Information This document is confidentiai, prepared sofeiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. If employees sense retaliation, they are able to reach out to individuals within or external to their organization including: NASA Center Human Resource Points of Contact Internal Options Office of Inspector General] gxgtelrorll'lal m9 (from This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. NASA Communication and Training This document is confidentiai, prepared soieiyfor the eiient to whom it is addressed. it is not to be reproduced or distributed under any The Dissenting Opinion Process within NPR 7120.5D was accompanied by a suite of supporting documents including: Frequently Asked Dissenting Opinion FAQ's . Questions ent 1. What Is a Dissenting Opinion? Answer A "Dissenting Opinion" 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 speci?cain requests that the dissent be recorded and resolved by the dissenting opinion process. (See NPR paragraph @x A ?Dissenting Opinion" expresses a View that POWE ?t Sl'de 95k Dissenting Opinion Process explaining the process NPR 7120.50 This is one of a series of training presentations r12usLI. covering important topics in NPR 7120.50. This document is confidentiai, prepared soiel'yfor the client to whom it is addressed. it is not to be reproduced or distributed under any Each supporting document explains, in plain language: 2 Dissent Resolution Path - b' 4: I I I The Process and Roles and Responsibilities of Stakeholders a Responsibilities of individual Raising a Dissenting Opinion mien? . LizLx-? Responsibilities of individual WI Receiving the Dissenting Opinion gm; 3 ?i :t n35: Programmliic Programmatic - Technical Amharity Authority Technical Authority '5 Engineering Responsibilities of a Decision Maker a ?$95 All Board Members This document is confidentioi, prepared soiel'yfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any 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 The ?33 rs an anomnus. and responsrre report-rug channel to notify poste '5 e? "w 0 st re 7:31;; d, a a hm:- -:nn 1mm lhiui-ITI In: new}? been prOdUCEd In should Ema! :l'IL-ukl be 1-.I lhl: six different languages. HM: dc I :ur: mu Icport we Han-5? Her: my nr' mast-i Hc:-::qn::u1cr:? Her; um I HERE Roman-n? Once a month, there is a person who ensures that Individuals can access frequently displays are asked questions and the form itself restocked with through their website: forms. This document is confidential, prepared sol'eiyfor the then! to whom it is addressed. it is not to be reproduced or distributed under any 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 1% 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. This document is confidentioi, prepared soi'eiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any NASA Evaluation Methods This document is con?dential, prepared soreiyfor the client to whom it is addressed. It is not to be reproduced or distributed under any There are currently no direct or distinctive measurements of dissenting opinion processes; rather, related concepts are measured through annual safety culture surveys 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} . w-wwvw- . - NASA designed the survey to be: ?l W- . yaw-(wits . autumn Quick (easy to complete) MLFIYAQ - Accessible (not behind a firewall so that contractors could participate) I-IICM Not too specific (applicable to all) Screenshot ofsurvey portal: Participants rate each statement on a scale Sample survey questions are available through the portal Of "Very Satisfied? to "Very Dissatisfied? . - Comment boxes allow for additional open- fads ended feedback Anonymous participation - NASA uses third-party to support - ??20 universal questions; 2 - 4 Center-specific administration and analysis questions from Center Directors - Administered every two years This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced or distributed under any cimumstances. Survey results are shared with Center Directors who are able to use the data with minimal direction from HQ Survey Results Process Participation Results OSMA wanted to shift the perception of a - To be reportable, surveys must achieve a survey as an ?inspection? to a more 95% statistical confidence rate collaborative, Center-driven process . Highest participation rate: "55% In order to empower Centers, HQ did not want to give the sense of directing Centers with evaluations and corrective actions Centers began engaging in friendly Instead, HQwanted to act as a partner with competition to drive participation numbers Centers enabling Directors to be comfortable with sharing information and encouraging part?C?PatiO? in survey Efforts This approach enables Centers to take - Center Directors are-able tocommunicate ownership Of their safety culture and survey resmts to the? organ'zat'on and to tailor initiatives to their audience - respond to the information as they see fit 7' Centers can react in ways that considers the lFatll?lg .8 arger to local culture and climate institutionalize Agency-Wide - HQ receives an aggregated report of results assessments for the long'term from all Centers - Lowest participation rate: "19% This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced 0r distributed under any Benchmarking Research for: Federal Aviation Administration (FAA) Air Traffic Organization (ATO) i i! This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any cirrumstances Background information: Federal Aviation Administration Size 47,456 as of 6/30/10 Industry Aviation 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 Overview 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 mission is to provide the safest, most efficient aerospace system in the world vision is to strive to reach the next level of safety, efficiency, environmental responsibility and global leadership One of values: Safety is our passion Mission The American public, aircraft and aircraft part manufacturers, airlines, general and business Stakeholders aviation, airports, air traffic control, the flying public FAA works with the International Civil Aviation Organization the global forum for Safety Standards civil aviation, and other international partners to improve global aviation safety and environmental performance around the world. This document is confidential, prepared soieiyfor the tiient to whom it is addressed. it is not to be reproduced or distributed under any FAA Differing Views Program Policies and/or . This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any Safety is the foundation and driving force in everything FAA does FAA Safety Programs and Initiatives To reach the next level of safety, efficiency, Air Transportation Oversight System environmental responsibility and global leadership Vision Aviation Safety Action Program Aviation Safety Health Program International Aviation Safety Assessments To provide the safest, most Safer Skies Mission efficient aerospace system . in the world System Approach for Safety OverSIght Program Whistleblower Protection Program Safety is our passion Cabin SafF??tv Excellence is our promise Laser Safety Integrity is our touchstone People are our strength Innovation is our signature Unsatisfactory Condition Reporting Program Safety Management System This document is confidential, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. 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 Federal Aviation Administration Chief Offices Air Traffic Organization Administrative Offices En Route 8: Management . . Program - - . Commercial Management le Space - Transportation Technical Government 81 t' pera Ions Industry Affairs Management International Affairs and Environment Security Hazardous Materials Safety Support Finance and Management System . Terminal Operations Safety and Technical Training This document is confidentiai, prepared sol'eiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstance; In support of 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 Air Traffic Organization Aviation Safety Non-Concurrence Option Safety and Technical for Management Directives Unsatisfactory Condition Air Traffic Safety Action Reporting Program Program This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any circumstances. FAA: Option One Non?Concurrence Option for Management Directives This document is con?dentiat, prepared sotefyfor the client to whom it is addressed. It is not to be reproduced or distributed under any The ATO included a non-concurrence option as part of their FAA Order JO 1320.62, Air Traffic Organization Directives Management W. us. DEPARTMENT OF TRANSPORTATION ORDER 10 1320.62 is 3" e0 FEDERAL AVIATION ADMINISTRATION - Air Traf?c Orgamzatnon Policy - a! FAA Order 1320.1, . . Effective rm FAA DIrectIves - Management, SUBJ: Air Traffic Organization Directives Management out?nes the process for creating, i. We hm I: v. rillcn this Order In sIIm?IIL-Inunl Order [3201. FAA Directives .i-hmugI-mmr. - - The complexity nl?lhc Air Tmllic ()Tganimtinn 1) mandates that we develop detailed creation. ng? a production. and coordination precesscs our directix Further. in this order m: finalizing resPUnsihilit}.- for these pruccsses. Producers OW L. piecemFAA Orderi??l. 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. This document is confidentiai, prepared soielyfor the client to whom it is addressed. it is not to be reproduced or distributed under any cirrumstances. The non-concurrence option outlined within JO 1320.62 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: I A clear A . . . contact for non- citationls) Solution further concurrence . . dIscussmn Ineligible reasons for a non- concurrence include: In essence, all non-concurrences must Inability to make the coordination date deal with the facts and intent of the . . management directive Disagreement Wltl?l the document 5 external coordination scheme Disagreement with language, style, or format 7 This document is confidential, prepared soleiyfor the client to whom it is addressed. It is not to be reproduced 0r distributed under any cimumstances. All non-concurrences must be addressed. However, a non- resolution does not prevent the draft Management Directive from going forward in the approval process. If there is success Collect a new clearance record from the JO 1320.62 suggests the Office of Primary original office showing the concurrence Responsibility Elevate the need for and/0r writer- resolution to the . . lfthere IS no success . editor first engage in a discussion management chain with the technical point of contact Write an executive named on the summary explaining non-concurrence the non-concurrence, efforts to resolve It, and why it lacks merit FINAL NON-CONCURRENCE RESOLUTION SIGNATURE This document is confidential, prepared soiel'yfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any cirCumstance-s. FAA: Option Two Unsatisfactory Condition Report Program This document is confidentioi, prepared soieiyfor the eiient to whom it is addressed. it is not to be reproduced or distributed under any The FAA Unsatisfactory Condition Reporting Program provides all agency employees with direct means for advising management of an existing unsatisfactory condition. Situations that may cause or contribute to accidents, incidents, or present a hazard to personnel or equipment Employees are encouraged to report Systems or system components and software situations invo ving applications that exhibit chronic unsatisfactory maintenance characteristics safety or efficiency of prOCF??duresi equpment: Technical publications, aeronautical charts, working environment, engineering drawings or instructions that are operation or services incomplete, inaccurate, illegible, inconsistent, or . . unavailable Including Support equipment that is inadequate, incomplete, or unavailable and adversely affects performance of work This document is confidentiai, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. When completing an Unsatisfactory Condition Report, employees must: CI Write as much as necessary to explain the problem El Define one issue per report CI Provide objective, factual information and refrain from opinion CI Include documentation, if appropriate Unsatisfactory condition reports are entered into, tracked and closed using Safety Management Information System This document is confidential, prepared sol'eiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any cimumstances. Once an Unsatisfactory Condition Report (UCR) is entered into the Safety Management Information System (SMIS): Validated UCR gets sent to UCR Coordinator for action A The manager/ supervisor validates the reported condition exists The SMIS will notify the manager or supervisor 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. This document is confidential, prepared soiel?yfor the client to whom it is addressed. it is not to be rapmduced 0r distributed un der any cirrumstances. FAA: Option Three Air Traffic Safety Action Program This document is con?dentiaf, prepared sofei'yfor the client to whom it is addressed. It is not to be reproduced or distributed under any The Air Traffic Safety Action Program (ATSAP) is a Voluntary Safety Reporting Program (VSRP) specifically for ATO stakeholders and a key component to the Safety Management System. The information specified in employee reports is used to identify the root Provides a method to identify and causes and determine appropriate correct potential safety hazards remedial actions which are then Encourages voluntary submittals of monitored for effectiveness. safety reports from employees involved in the delivery of air traffic This process promotes collaboration services between employee work groups and management for the early identification of hazards and to maintain a proactive approach regarding safety concerns and T0 ensure the safe, expeditious corrective action recommendations. 0f air traffic throughout the National Airspace System This document is confidential, prepared soiel'yfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any ATSAP is available to all Air Traffic Organization personnel within: Where they are collected and Reports can be filled onllne tracked through the ATSAP via Terminal Services Reporting System Employees are encouraged The ATSAP is a confidential to report: reporting system. However, it En Route and CI Air traffic safet events is not an anonymous Oceanic Services program. CI Air traffic safety problems Confidentiality means dealing w'th: individually identifiable Policies information is disclosed only Systems 0 Procedures on a need-to-know basis and Operations 0 Equipment only to those with Event Services 0 Automation Review Committee 0 Publications authorization This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. FAA Policies and Procedures for Retaliation This document is confidentioi, prepared soieiyfor the eiient to whom it is addressed. it is not to be reproduced or distributed under any 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. Although the subject of anti? pmm. 5?,me mg? 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. A mums IRA roe 's NON-DISCRIMINATION Tllt: FctlorLII lnl'mn is RI :Il discriminatzon laws. ant: policies in ?It: on Ihl: tux]: gender ic'cnlin . . Sysi 1&9 No employee shall be subject to retaliation for making a charge of discrimination, giving testimony, assisting. or otherwi a complaint of discrimination; nor shall an employee be retaliated against for ?ling a grievance or participating in the grievanc: addressing hislher concerns through others available means Administrator's Hotline, Inspector General complaint, Acool This document is confidentiai, prepared solely for the client to whom it is addressed. It is not to be reproduced 0r distributed under any FAA Communication and Training This document is confidentiai, prepared soieiyfor the eiient to whom it is addressed. it is not to be reproduced or distributed under any The safety reporting and non?concurrence options are communicated through FAA Management Directives and web pages 4? x1? to: rei?. 1' pm . ATSAP Hal?; nova-u BDWIorasC-hanL Call Sign Confusi 1" . '5 u. e-utlee nor": 3? U.S. DEPARTMENT OF TRANSPORTATION ORDER FEDERAL AVIATION ADMINISTRATION NUNIBER National Policy 1800.68 Effective Date: QIEEIDS SUBJ: Unsatist'amory Condition - Au, US. DEPARTMENT OF TRANSPORTATION or? FEDERAL AVIATION ADMINISTRATION ORDER Air Traf?c Organization Policy JO 132052 1. Purpose ofthis Order. This. On] Unsatisfactory Condition Report (UC F??eclite Date (lh't?ii'l?l I SUBJ: Air Traf?c Organization Directives Management We luau: Iillh order In supplement FAA Older 132". 1. F.4d Dim-inn .IitiricigI-int-wii. I 11:: colliplemy of the m: I'rel'i'u: i A I nun-Jane; that II- I: detailed creation, production, and cunniination mixesscs for our dlrectixts. Further. ill this order ulcer]; assign responsibility for these [mucous Producers of ATO directives must use this order as :Icnmpanion- FAA Unit-.1" This document is confidential, prepared soi?ei'yfor the client to whom it is addressed. it is not to be reproduced or ?stributed under any FAA Evaluation Methods This document is con?dential, prepared soreiyfor the client to whom it is addressed. It is not to be reproduced or distributed under any 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. Leadership Survey Questionnaire a l? FM-eeadership Summit~2006 Safety Culture Survey all CH- D-.- PM D-- 5 DH 0. 1. cur?an.- . DI- 91.; H.47- ?m and 'ulttf ma: ill lm Iulrry with? Iu uth HM. var-M II I. nut-hut bill'V- nun. lli harm-mumbl- In. in: "ha-urn". II-mq th- I. Ihl?l? I. AM Im I'u l- shiny, bung" MIL-mali- Auto.rlulsararr-lru'lt anFAAIATO SAFETY CLIMATE-CULTURE SURVEY INSTRUCTIONS: Before completing this survey. please be sure tltat you have read the attached cover letter. which git-es details regarding the purpose of the survey. and the sponsoring. agency. You will also he asked to review and sign :1 "Participants Consent Form? prior to answering survey questions. The Consent Form. and all Survey data. will be collected and kept at the Naval Postgraduate School. Monterey California. We very much appreciate your candid answers to the following survey items. Please be assured that this survey is completely anonymous and no attempt will be made to identify particular participants and their questionnaire survey answers. Respond to the rating items by marl-ting the block that best represents your level of agreement with a given statement. using the rating scale shew-n below: l: Strongly Disagree 3: Neutral 4. Agree 5. Strongly Not Don't Disagree Agree Applicable Know (Dirt) 1. helieve that has a Very effective process for 2 3 4 5 WA reporting safety concerns. This document is confidentiai, prepared soieiyfor the dim! to whom it is addressed. it is not to be reproduced 0r distributed under any Reponses to safety culture survey show some growth toward a cohesive safety culture In general, people in my facility beHeve: Safety Culture relaxed standards 47% 53% We focus on errors rather than non-eventful risky behavior. 76%: 24/" Actionable feedback from safety reporting processes is I: made available to the workforce on a regular basis. 22/6 78/6 ?Raise the bar? ?Lower the boom? 38% 62% At?risk behaviors are clearly defined and commonly understood by management and the workforce. 19/6 81/6 Front line managers are adept at recognizing and . . . 27% 73% correcting drift, I.e.non-compllance. Front line managers should act as a filter or buffer . 629/ 389/ between thE'll' employees and upper management. 0 a Minor or occasional deviations from standards are 71% 2 ?a acceptable for the sake of efficiency/capacity. 9/ Our reactions to safety events are frequently driven by 0 0 political interest and the 24 7 media environment. 88/6 12?6 This document is confidentioi, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any cirrumstonces. Results around their safety reporting indicated a rather large opportunity for improvement. However, this singular metric does not give a dearenough picture. Benchmarking Research for: Food and Drug Administration nil".- This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any cimumstances. 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 This document is confidential, prepared solely for the ciient to whom it is addressed. it is not to be reproduced or distributed under any FDA, Center for Drug Evaluation and Research (CDER) Differing Views Program Policies /o Precesses This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any cimumstances. The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency Office of the Office Of the . Commissioner ?Fh'el Core Functions I Office of Global . Office of Of?ce of Foods . . Regulatory . Medical Of?ce of . and Veterlnary . Operations and . . Products and Operatlons . Medlcme Pollcy Tobacco Center for Biologics Office of Center for Evaluation and Research Safety and Regulatory . Affairs App.ll.Ed Center for Devices and NUtr't'On Radiological Health (CDRH) Office of Center for Center for Drug Evaluation National Center International Veterinary and Research for Toxicological Programs Medicine Research Center for Tobacco Products Office of Special Medical Programs This document is cenfidentiai, prepared soiel'yfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any 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 This document is confidentioi, prepared sol'eiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any 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 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 SDR 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 eachlevel Actively interact with initiators of the SDR 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 SDR process Consider alternative avenues for SDR other than chain?of?command This document is confidentiai, prepared soi'ei'yfor the client to whom it is addressed. it is not to be reproduced or distributed under any The FDA research in this document focuses on the Center for Drug Evaluation and Research (CDER) CDER is one of nine main Centers and Offices at FDA Prior to SMG 9010.1, CDER already had in place the most solidified and formal DPO process 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 Center for Drug Evaluation and Research This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced 0r distributed under any policies and procedures foster quality and timely decision-making CDER works to create a collaborative working environment for decision-making which includes: Increases engagement and transparency Open communication and exchange of ideas in a mutually The full and open participation of all relevant disciplines and organizational components in the decision-making process Allows for early identification of concerns that could disrupt a respectful, professional, and successful decision? ma king process respectful professional environment These values help conduct business and make high-quality decisions using the 1. Communication Collaboration Community Conflict management Consumer focus This document is confidentiai, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. 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 Scientific] Regulatory Dispute Resolution for Individuals within a Management Chain Outlined in Manual of Policies and Procedures 4151.8 Outlined in MAPP 4151.1R 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 This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. Equal Voice ensures decisions are made only after all appropriate expertise is heard Equal Voice: Discipline and Organizational Component Discipline Regulatory Decisions Maker Collaboration in Scientific and/or CDER staff are involved in making a wide variety of decisions 0 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. Each individual who contributes to the decision?making process 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. is responsible for representing the views Depending on the magnitude of the decision being made, of his/her discipline opinions should be documented and supported by data, giving rationale and for his or her position. This document is confidentiai, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any CircumstancEs. 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 This document is confidentioi, prepared sol'eivfor the client to whom it is addressed. it is not to be reproduced or distributed under any Another option to manage individual differences of opinion: escalate the issue to the next highest management official Scientific/ Regulatory Dispute Resolution for Individuals within a Management Chain Outiined in MAPP 41511:? Next highest If the disputant does Disputant can submit a detailed written statement of dispute the next highest management official management official makes a decision, rites a memorandu with the decision and rationale not align with the decision, can present the disagreement to the next highest management o?iciai for consideration and resolution Initiate the DPO process A copy of the memorandum is sent to individuals involved and addedtothe administrative file 1 The appeals process can be repeated until it reaches the CDER Director Dispute statement includes: - Detailed description of issue which the disputant disagrees - Nature of and reasons for the difference in opinion - Proposed changes and rationale if the disputant heiieves his or her opinion was not adequateiy considered, and a significantiy negative pabiic heaith impact resuit Statement is distributed to peopie who are invoived, sent to next highest management o?iciai, and inciuded in the administrative fiie This document is canfidentiai, prepared soieiy for the ciient to whom it is addressed. it is not to be reproduced or distributed under any circumstances. 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 as discipline and neither one is the final decision-maker, the dispute should still be documented in the administrative file This document is confidential, prepared sol'eiyfor the dim! to whom it is addressed. it is not to be reproduced or distributed under any 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 This document is confidentiai, prepared solelyfor the client to whom it is addressed. it is not to be reproduced or distributed under any cirrumstances. 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 Once complete, the package should be sent to the CDER Ombudsman VI. Summary statement ofthe position with WhiCh I disagree (is it a prevailing staff view; existing decision, proposed regulatory action, etc.) . Description of my views and how they differ from above . Description of the nature of the disagreement (is it a di?erence in opinion, interpretation, methodoiogy, judgment) . An assessment ofthe potential negative and consequential impact to the public?s health my position is not adopted Three suggested FDA employees with appropriate technical expertise to serve on the Ad Hoc Review Panel ifthe DPO is filed If applicable, reason for not utilizing other avenues for dispute resolution This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any The CDER Director, Ombudsman, and an Ad Hoc Review Panel, including a chairperson, are involved in the UPC process The DPO process includes the CDER Director, the CDER Ombudsman FOOD AND DRUG and an Ad Hoc Review pane OFFICE OF MEDICAL AND TOBACCO PRODUCTS FOR DRUG EVALUATION AND RESEARCH Mam Tole 305-796-5100 Fa 301-347 8352 The Center Director appoInts a m, . . 10903 New IIarIIoshIre Ave chairperson for the Ad Hoc Rewew DPO Ad . . CENIER DIRECTOR panel, and the chalrperson appolnts Janetk?Jocdcock,MD Hoc Review the panel members Panel OFFICE OF REGULATORY POLICY OFFICE OF MANAGEMENT OFFICE OF COMMUNICITIONS DIRECTOR DIRECTOR DIRECTOR . Jane A Axalrad ?vIelane ?we! Jul-e A Zamsz: Il-sa Bernstein Pm Dg} IUHNMI EDBNBI :oaNcI mam, I I I 1 OFFICE OF OFFICE OF MEDICAL POLICY TRANSLATIONIL SCIENCES OFFICE OF EXECU TNE PROGRAMS TOR OIRLC DIRECTOR DIRFCTOR Rachel Sherman. Shamhrce B;c;r;a; 0 Ph Mary 8th (.3. 1: Memo: Rosemary ?nbctis mam: CDER Ombudsman?s menu. mam, IDBNGI . Of?ce: located In the _,of Executive Programs I I I OFFICE OF SURVEILLANCE OFFICE OF NEW DRUGS OFFICE OF PHARMACEUTICAL OFFICE OF PLANNING AND EPIDEMIOLOGY DIRECTOR SCIENCE AND INFORMATICS DIRECTOR John Jerk as DIRECTOR DIRECTOR Gerad Dal Pan, 5 Helen Wm'uue Theresa Mulun. Pn This document is confidentiai, prepared sol'el'yfor the client to whom it is addressed. It is not to be reproduced or distributed un der any cirrumstances. The CDER Ombudsman?s general mission is to quickly and impartially investigate complaints and resolve disputes The U5. 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: Confidentiality Neutrality Upon request, Communication With receives and reviews each complaint Informality informally receives and listens to the Ombudsman Will be considered in an objective and fair manner, free confidential although it may SIOW from bias, and treats all parties progress of the dispute resolution. without favor or prejudice. complainants, provides advice and feedback, and informally investigates complaints. 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. This document is confidentioi, prepared soiel'yfor the ciient to whom it is addressed. it is not to be reproduced Or distributed under any circumstances. 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 The CDER Ombudsman uses several complaints, not only from internal different techniques to work toward employees but also from: solutions: Regulated industry - Investigation Health associations Mediation The public Conciliation - Negotiation 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?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 publishing aggregate data annually This document is confidentiai, prepared sol'el'yfor the client to whom it is addressed. it is not to be reproduced or distributed under any The CDER Ombudsman is the focal point for receiving, managing, and facilitating the DPO process End CDER CDER Ombudsman CDER Is the Ombudsman maintains record of Ombudsman DPO works with UFO-submission and Sta rt receives written package submitter to rm" to ?le DPO package omplet ensure package 4? is complete 0 Within five business Within five days of receipt of business days of the Yes DPO package, CDER DPO filing, DPO Ad onsequence_ Ombudsman. Hoc review panel thHave all of the decision responds chairperson Is 0 erddVentUES in question to appointed, he or she or 9 potentiallv all appoints Ad Hoc serious enough No the Review panel members been to warrant supervisoryr chain, 4\ explored? filing the team lead, Super- . DPO Office Directors w'th'" two decision not to file business days Of the and reasons the UPC) filing, as to why CDER Director appoints a chairperson for the DPO Ad Hoc review panel CDER Ombudsman Within five business days of receipt of DPO works with CDER package, CDER Ombudsman responds in writing Director to :1 to the submitter and all individuals within the file a UFO submitter?s surmrvisorvr chain, team lead, Super-Of?ce Directors decision to file the DPO This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced 0r distributed under any 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 DPO Ad HOC Review list of proposed panel members Panel receives DPO package from the 3. If available, and time allows, one CDER Ombudsman with relevant technical expertise from outside the FDA, chosen by the panel chairperson? The Ombudsman works with the Ad Hoc ponei members to ensure they have an unbiased view of the issue 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 M?l?v?lust 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 This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any cimumstonces. 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 All records surrounding the one process was not adequate opportunity to must be maintained in administrative present their views, or if he/she files and uniess the DPO pertained to a processes were not regulatory be followed maintained by the CDER Ombudsman This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any cirrumstances. 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 This document is confidentioi, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any FDA Policies and Procedures for Retaliation This document is confidentioi, prepared soieiyfor the eiient to whom it is addressed. it is not to be reproduced or distributed under any 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 This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any cirrumstances. 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, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the 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 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 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 This document is confidentiai, prepared soiel'yfor the ciieht to whom it is addressed. it is not to be reproduced or distributed under any The FDA Equal Employment Office (EEO) has a defined process to investigate discrimination, including retaliation Office of Global Regulatory Operations and Policy Commissioner Office of the Office of Regulatory Affairs Office of International Programs Office of Foods and Veterinary Medicine Center for Food Safety and Applied utrition Center for Veterinary Medicine Office of Medical Products and Tobacco Office of the Chief Scientist Office of Operations Center for Biologics Evaluation and Research Center for Dewces and Radiological Health Center for Drug Evaluation and Research Center for Tobacco Products Office of Special Medical Programs National Center for Toxicological Research This document is confidential, prepared sol?el'yfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any The EEO is located under the Office of Operations The EEO process to investigate discrimination, including retaliation, is a two-step process two-step process investigates any allegation of discrimination based on: Race Sex (including Sexual Orientation) Disability (Physical 0r Mental) Color National Origin Retaliation/Reprisal REIIBIOH Age Genetic Information Step 1: Informal Complaint 1. Within 45 days of the occurrence, contact an EEO Step 2; Formal Complaint counselor 2. The counselor will inform you of your rights and conduct an informal inquiry 3. Counseling should be completed within 30 days 4. After completing the informal complaint process, the individual may file a formal complaint This document is confidentiai, prepared soieiyfor the tiient to whom it is addressed. it is not to be reproduced 0r distributed under any 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 Completes the "Complaint of Alleged Discrimination form" (notice of the intent to file a final counseling, the formal complaint} found in the counseling report and send form to the Director of the Division of Compliance 2) If complaint is accepted, within 180 days Must acknowledge receipt, conduct and complete a fair investigation, make attempts at of receiving Complaint of Alleged settlement, provide the individual with a copy of the investigative file and notice of rights Discrimination form, 3) Within 30 days of the receipt of the May request: investigative file and notice of rights, a} an immediate and final agency decision, or the b) a hearing in front of an EEO Commission administrative judge 3a) If the individual fails to respond, OR The agency will make a decision based on the their review of the investigative report and requests an immediate and final agency complaint file decision, within 60 days 3b) If the individual requests a hearing, Must oversee discovery, conduct a hearing, issue findings of facts and conclusions of the within 180 days the appointed EEO law. The judge will issues an immediate remedy if a discrimination finding was made administrative 4) Within 60 days of the judge?s conclusion, Must issue a final decision, can accept, reject, or modify the judge?s decision the This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced 0r distributed under any cirrumstances. CDER includes in its policies wording about its commitment to protecting employees from retaliation for expressing differing viewpoints MAPP 4151.1R: Scientific/Regulatory Dispute Resolution for individuals within a Management Chain ?ca Includes policy MAPP 4151.2R: Resolution of Differing Professional ?If about retaliation Opinions: Review by Ad Hoc Panel and CDER Director Both MAPPs include information about: - 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 This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any 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 and inserting the following: - designate a Whistleblower Protection Ombudsman who shall educate agency employees? 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 This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced or distributed under any cimumstonces. FDA Communication and Training This document is confidentiai, prepared soieiyfor the eiient to whom it is addressed. it is not to be reproduced or distributed under any cimumstances. Office of the Ombudsman uses an informational flyer to promote and inform employee about its services Office of the Ombudsman?s informational flyer Of?ce of the Ombudsman Dispute Resolunon and Problem Solving U?:e c? the e? 5: e'tss' This document is confidentiai, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any CircumstancEs. The content in the FDA Office of the Ombudsman?s informational flyer Who We Are, What We Do in ombudsman is We who tools into and addresses complaints and disputes ins-others] :1 organization. But andDruq Administration involves Iiuch more. FDA's ombudsman function is handled at two levets: I a separate of?ce within the Office at the Commissioner (FDA Office of the Ombudsman} I designated ?nudism-n i-I'tnin specific product centers (drugs. devices. biologics. tobacco, and veterinary medicine) Comoan'ies can turn to the FDA Office of the Ombudsman for, I dispute resolution I mediation I breaking up 'lug jam? with the agency I guidance and assistance In solving problems the agency or with FDALreoulated moducts I general regulatory questions or concerns Cases We Handle The following types of cases are rounnely handed by the FDA Office of the Ombudsman; I Disputesjcornptaints from regulated industry regarding agency product center actions. or lact 01 action. and those issues that cut across center Jurisdiction I Disputes/complaints from regulated industry related to Interactions with agency ?eld of?ces including impaction and compliance issues I Disputesicornptaints abciut import detention: o' enemy-regulated products I (molalnts from small buslnessu. illduqu those referred try the U.S. Small Eusmess anistration I [nqmnes about the agency?s handling of both consumer complaints and Freedom of Information Act reQuests I Requests for information and assistance from regulated industry regarding agency policy and regulations, and on how to work nith the agency How We Handle Disputes and Complaints The various methods used by the FDA D'Ihce at the Ombudsman for handing disputes and complaints Induce (mutation. dispute resolution. Ind medlanon. typical actions include I Determining relevant issues and obtaining comptete and accurate information about a case I learning and acting on cases In a timety manner I Initiating meetings inth affected names I more transparent reasons for agency actionldecrtion. when warranted I Recommending atternatnre courses of action Confidentiality. I May be ream-sled regard to identin and nature of cornolaints I 'lil be honored. but may restrict complaint/dispute resolution actions FDA has a strict non-retaliation policy that molecu- atyone rho files a complaint against the agency. Other Functions The FDJI Dl?ce of the Ombudsman has responsibility for the following additional functions: liaison to the Small ?rmness Administration I Serves as FDA liaison to the National Cinbudsrnan?s Office at the Small Emmett. Administration (SBA) I Handles issues that fall under the Small Business Regulatory Enforcement Fairness Act I Responds to all complaints referred to FDA under SBREFA, invoking any agency regulatory area (wit-nation of: I (ertain appeals rude under 21 10.75 I Complaints received under the Information Quality Act I (ertain adrmnistratiire hearings that fall under 21 (Fit Part to I lleqrrests for reinstatement by disqualified clinical investigators I Disputes arising under the humanity Dualny Standards Act This document is confidential, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any circumstancES. FDA OFFICE OF THE DMIUDSHAH tune leniel. Elli. 10.. Director Ross. Deputy Ombudsman ?In Of?ce of the Mods-an ions new Wile Mei-ire ID 32. loom cm sever no am; Home {301} 116-3530 Fur: (301} ear-am t-Ila'll: Madman-u ?ab: mfdepe?rlhicmpuyw FDA ream CENTEI OHBUDSMEN hill male: (301} {-aait Devices Phone {301} ?6-59? E-nail; W?epr ?eludes {Hutu-031'! Eonail; Indict- l'hone: raw) 2764'"! t-nait Widow.? Tet-ea Phone {301} 196-9239 {-lai: General FDA Information Hione ton-rm: Isa-worm {us-4534312} The CDER Ombudsman makes new employees aware of the processes available to raise differences of opinion 1- During the new employee orientation, the CDER Ombudsman presents information about their options Ombudsman is Defined processes exist there to support for employees to address Employees have all employees differences of opinion the right to have their voice heard; a dijj?erence of opinion will be Ombudsman wants to increase employees? awareness of options available to support them to resent differences of Stronger Wt is I opinion documented, there We care about An online training* is ?5 data to support available to learn about Rather than offer the opinion, and the employees uses what you think processes to address differences of opinion information about the chain of processes in detail, command to Employees shouid'take the Ombudsman express this personal responsibility as 0 presents information difference of Wm? $9??an is to 501/ opinion some thing if they do ?or abOUt: 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 This document is confidential, prepared solelyr for the client to whom it is addressed. it is not to be reproduced or distributed under any cimumstances. 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 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 opinions these processes and how the topic should CDER has M'ddle management be brought up with employees a top-down - Upper management impresses upon middle management: there should be approach to make employees aware of disagreements to encourage healthy debate the processes a k and policy Employees Managers must wa -t e-wa an a good example for employees - Equal voice should be always be used This document is confidential, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. FDA Evaluation Methods This document is con?dential, prepared soreiyfor the client to whom it is addressed. It is not to be reproduced or distributed under any 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 4151.1R Resolution of Ddfering Professional Opinions: Review by Ad Hoc Panel and CDER Director, MAPP 4151.2R This document is confidential, prepared solelyr for the client to whom it is addressed. it is not to be reproduced or distributed under any cirrumstances. One way CDER has been able to review the effectiveness of their differing views processes is through survey results A All the CDER notedanincrmeinthese CDER noted an increase in employees? . measures, however the . . Tlme quantitative data is not availabie; fEEImg comfortable 3 Misc notionafgraph 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 Never . ?0 the enVIronment has changed for the web? ??ow posmve and IS movung In the right . no . . we? Cogkge?? 0? o9 woi??t direction 00 do? 4&3 \5 ?lo $53 349?". 89 0" $19" ?3 C0 \09 om?. $605 0 The questions listed get at the gist of questions asked in an Employee Viewpoint Survey, however the exact wording is not listed here This document is canfidentiai, prepared soieiyfor the eiient to whom it is addressed. it is not to be reproduced Or distributed under any circamstances. Results from other surveys show positive growth at CDER Comparing results from the U.S. Office of Personnel Management (0PM) Employee Viewpoint Survey between 2008 and 2010 showed an increased number of positive responses Between 2008 and 2010, there Only one area showed a was an increase in the positive decrease in positive responses: responses to the following areas: . Work ?fe: our only - My work experience decrease (satisfaction with My agency childcare programs, elder care programs, employee My work ?mt assistance program) Supervisory/Team Leader Leadership My satisfaction This document is confidentiai, prepared soi'el'yfor the client to whom it is addressed. it is not to be reproduced or distributed under any In 2011, the Ombudsman received 282 communications, most of which, 94%, were received via email or phone The table below outlines the groups who contacted the CDER Ombudsman in 2011 II The 66 communications to the Ombudsman from CDER employees included the following topics: Industry: commercial sponsors, pharmaceutical industry - General enquiries about the Ombudsman?s role Media/Press Requests for help with external constituents Whistleblowers Law firms - Help with workplace conflict (these . Research 5 onsors cases were referred to the Conflict Prevention and Resolution Staff in Consumers FDAIS Office Of Equal Employment Health care professionals Opportunity and Diversity Group 22% Consultants Management or the Employee 28% Assistance Program) Advocacy groups Other Group FDA employees 24% (mostly CDER employees) This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. Benchmarking Research for: Pfizer This document is con?dentiat, prepared safetyfor the client to whom it is addressed. It is not to be reproduced or distributed under any Background information: Pfizer, Inc. Size Overview Mission Stakeholders Safety Standards ?120,000 employees 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 health 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 This document is confidentiai, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any cirrumstonces. Pfizer D?ffEring Views Program Policies and/0r Processes- This document is confidentiai, prepared soieiyfor the client to whom it is addressed. It is not to be reproduced or distributed under any 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 23> 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 This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any 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 Boa rd of Directors A A Audit Regulatory Committee Compliance Committee Assists the Board with Oversees and reviews overseeing the company's health care law compliance financial statements, internal programs and the status of controls, compliance with legal compliance with laws, regulatory requirements, regulations and internal independent auditor's procedures applicable to qualifications, independence pharmaceutical sales 8: performance, internal audit marketing function and performance A Pfizer CEO Compliance Division; Chief Compliance and Risk Officer 9 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 This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced or distributed under any cimumstances. 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. This document is confidentioi, prepared sol'eiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any 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 hours 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 This document is confidentioi, prepared soieiyfor the tiient to whom it is addressed. it is not to be reproduced or distributed under any 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 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 This document is confidential, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any Pfizer?s Compliance Helpline was established to facilitate reporting violations of law, policy, or workplace misconduct The some 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 This document is confidentioi, prepared sol'eiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any cirrumstonces. A CONCERN FOLLOW UP 0" A REPORYED HUME On-Line Compliance I pl i New Responses from P?zer Inc Date Response Prowded: 2013 01 1 Response: When yo report a concern Thank you for the Corporate Cornstance P?zer VJ cok rtto vcur rounr or cancer-1 to ensure that 5 approp'ntery' adcressed and resulted ca?ststen: (ompan?r potty. [Jeoencng :n the nature dimer 1: th tl report, the have plotted mar.- nr- ?Jen-?r: to an department for you have 0 I Ip la ce 0 Ine? provider] your name and 1:0":st 3.0.1 may hr;- (JJH'Iditr?l by :he rti'aritinal rr?r: has been assigned It: your matter. If y'ntl (lulu-re to re'ndn please .mrielslar'ri thol ilw rulwlludl In you a re give a report westgate your report may need to recuest nfar'naton. ThE'e?J'e, you wl? be p'owtled I?d or her name so that you may contact him or her drectl?r for a :or?derta! conversation corn; Whit" yoo would have the opportune; to pounds ac dtronal n?ormaton as recessed: In other case, you may contnue to con~munrcate ber a pi to Ch eCk for add't onal to Comprance by using the reps?: member and on numaer you "ave been assigned. any responses to YOU report Do you have any additional information? - - Current text. length: 0 5000 characters maxmum To the right IS a screen shot . pp mg th . Do you have any files to attach? page 0 Vlew any Attachments are submitted the report as a permanent record. follow up actions from your report or add additional Report Historyr Informatlon Dale Activity Details 2013-01-11 Innal Report Suhmtted Juie Vranelo requested the company provrde her with ntonhamn about the corporate compiance program are the emai address prowded. Juie was thanked for calng and was Issued .3 report rdenn?catron number. m- r, a? GVJU {asp-rte a- - is #35 i'fs-PU ed This document is confidential, prepared soi?ei'yfor the client to whom it is addressed. it is not to be reproduced 0r distributed under any cr'mumstonces. 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 This document is confidential, prepared soiel'yfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any 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 This document is confidential, prepared sol'eiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any 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 This document is confidentioi, prepared soieiyfor the ciient to whom it is addressed. It is not to be reproduced or distributed under any cirrumstonces. Pfizer Policies and Procedures for Retaliation This document is confidentioi, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any cimumstonces. 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: - Denialof 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. This document is confidential, prepared soielyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any 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 This document is canfidentiai, prepared soielyfor the client to whom it is addressed. it is not to be reproduced or distributed under any Pfizer makes confidentiality a priority in order to protect those who raise concerns Pfizer wants to create an environment that is open and secure for those who participate in the compliance program and report a concern. - 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 This document is confidentioi, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any Pfizer Communication and Training This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any Pfizer?s Blue Book thoroughly summarizes business conduct policies and expectations The third page of the blue book is a letter to employees from the ..- CEO, in which he: Deur Coltrhiguhos. - Reiterates the importance of . . working the core value of m?gmr?j?1?17 gym? I integrity ue BOO - Directs employees to hehe cal-m mP?zu?sPokmoanmEu-pm rl' refer to The Blue Book . and companion WebSIte - leadership support mutt-um comm,atrponngmacm mmwdeII-mbu - Encourages employees to use ??m?gmd??~3mewmm the many available options to discuss concerns or report -- misconduct News? 9 ?c - Reassures employees of mewsmma policies in place to protect those who raise concerns This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced or distributed under any clrcumstancea 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 ofJustice (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 and SEC. As part of the 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 This document is confidentioi, prepared sol'eiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any Pfizer Evaluation Methods This document is con?dential, prepared soreiyfor the client to whom it is addressed. It is not to be reproduced or distributed under any cirrumstances. 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 Internal Audit Group Chief Financial Officer (CFO) The internoi audit group has or direct reporting reiotionship 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 This document is confidentioi, prepared soieiyfor the ciient to whom it is addressed. it is not to be reproduced or distributed under any cirrumstonces. 1. 2. 3. Introduction and Background Slide 2 Data Gathering Method Siide 8 Findings Slide 12 5. 6. Best Practices and Recommendations Slide 146 Appendix Slide 154 This document is confidentiai, prepared saieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. Each organization champions a strong safety culture by offering a variety of programs and channels to raise differing views 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 This document is confidentiai, prepared soiel?yfor the client to whom it is addressed. it is not to be reproduced origigtributed under any cirrumstances. Safety reporting options among the organizations are structured and managed relatively differently, yet they share common elements Policy/ Procedures Retaliation . Reporters are protected by anti-retaliation laws Reporting safety concerns Is relatively easy and policies Onllne reporting optlons 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 This document is confidential, prepared solely for the client to whom it is addressed. it is not to be reproduced orlcligtributed under any cirrumstances. Despite strong support from the organization through the various reporting channels, and protection from retaliation through Federal and organizational laws and it Organizational Support 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 This document is confidentiai, prepared soiel?yfor the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. This fear of retaliation in turn negatively affects the overall organizational safety culture Consequences of which reach far beyond the office of the individual I noticing the safety issue Job LOSS If employees are Demotion too afraid to Harassment raise or report a Discrimination safety I concern/Issue Until it causes physical damage or harm This document is confidentiai, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstancea. 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 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 This document is confidentiai, prepared soieiyfor the tiient to whom it is addressed. it is not to be raproduced or distributed under any circumstancEs. 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 "Confidentiality means individually identifiable information is disclosed only on a need-to-know basis and only to those with Event Review Committee authorization" "May be requested with regard to identity and nature of complaints? "Will be honored, buy may restrict complaint/dispute 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 confidentiality" However, in cases where confidentiality i_s an option, the issue remains what happens 0 er the report and resolution process? This document is confidential, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced orlt?tributed under any cimumstonces. 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 result, affected stakeholders eventually learned the reporter?s identity and took retaliatory actions against the reporter. Job Loss Demotion Harassment Discrimination This document is confidentiai, prepared soieiyfor the tiient to whom it is addressed. it is not to be reproduced 0r distributed under any cirrumstances. This is perhaps due to the absence of a formal follow up with the regorter and applicable stakeholders to ensure no retaliatory actions were taken after the report and resolution processes Discrimination This document is confidentiai, prepared soieiyfor the client to whom it is Job Loss Demotion Harassment addressed. it is not to be reproduced 0r distributed un der any cirrumstances. This is evidenced in numerous accounts of individuals coming forward with their differences and suffering retaliatory actions Disciosing FAA Failures, Corruption, Misconduct and Intimidation, The Good, The Bad, and The Ugiy. Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety Appeals court hacks scientist in Pfizer retaliation case By Lee. Howard Publication: theday.com The Perilous Path of FAA Whistle?Blowers This document is confidentioi, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any cimumstonces. 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 Organizational Should the focus shift to Safety CUIture specific elements of safety cultures, organizations may uncover and properly address I I Safet some of the issues surrounding Knowlezl Safety Options discomfort in reporting safety 3 concerns and expressing non- CONCUFFEHCE Saflety Reporting _eta iation R-eporting discomfort This document is confidentiai, prepared saieiy for the client to whom it is addressed. it is not to be reproduced er distributed under any 1. 2. 3. 4. 5 6. Introduction and Background Slide 2 Data Gathering Method Slide 8 Findings Slide 12 Analysis Slide 135 Best Practices and Recommendations Appendix Slide 154 This document is confidential, prepared soieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any There are five key factors in developing an open organizational culture with effective non?concurrence processes 1. Leadership commitment . 7 Policiesand procedures 2. Clear policies and procedures 3. Communication 4. Training and education 5. Evaluation methods These factors create a top-down and a culture 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 I, 2 environment where employees take personal Training and I responsibility and act accordingly whether I Education) management is present or not This document is confidentiai, prepared soieiyfor the tiient to whom it is addressed. it is not to be reproduced 0r distributed under any cirrumstances. Leadership Commitment is a driver in creating any change within an organization Leadership In order to have successful non?concurrence processes in an organization, ommitment leadership commitment to the issue must be demonstrated; this focuses employees? priorities and channels resources to the initiative Best Practices I Rationale 0 Communicate the vision for organization Contributes the necessary authority and 't5 culture Adds credibility to the initiative - Talk about ethical behavior, non? Recognized as a priority concurrence processes, and personal accountability, at any given opportunity, via varied communication vehicles Normalizes use of the non?concurrence processes by encouraging it Dedicates resources to the initiative Encourage employees to use the non? concurrence processes Encourages a dialogue about the topic - Publicly acknowledge and reward employees who pinpoint ethical issues This document is confidential, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. Clear policies and procedures for non-concurrence processes are essential to their success 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 Best Practices Rationale Include independent or neutral parties to facilitate the non-concurrence process Process should be transparent, with findings and documentation shared with the employee and relevant parties Timeframe in which the process takes place should be timely and resolved within a short period of time Process includes ways to hold employees accountable for their actions; consequences, decisions and results are clear and enforceable Process includes option to remain anonymous; complaints and allegations must be professionally, independently, objectively and confidentially investigated and reviewed Policies and procedures Neutral parties investigating the matter ensure an independent review Transparent process gives employees more confidence in the process Timely investigation and a short timeframe to investigate the issue increases employees? confidence in the process and demonstrates respect for employee(s) and the issue at hand Clear, enforceable consequences encourage employees to act in accordance with policies and reduces impetus to retaliate against those who utilize non-concurrence processes Being able to use non-concurrence processes anonymously increases the likelihood of employees using the resource This document is confidentiai, prepared soiel'y for the client to whom it is addressed. it is not to be reproduced or distributed under any CircumstancEs. 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 Rationale I 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 This document is confidential, prepared sol'ei'yfor the client to whom it is addressed. it is not to be reproduced Or distributed under any circumstances. Employees are provided training to understand and use the process In order for employers to expect employees to complete their job Trainingand functions properly, as well as feel comfortable using non-concurrence education) processes, training should be accessible Best Practices I Rationale - Offer frequently scheduled training on Developing employees? current skills and enhancing skills needed for current job role providing opportunities to learn new ones enhances employees? self?esteem and Develop a learning plan with employees to of value In the workplace map out employee development goals in areas that will complement current skills 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 - Offer varied trainings, in different formats, on aspects of non?concurrence processes This document is confidentiai, prepared soieiyfor the client to whom it is addressed. it is not to be reproduced Or distributed under any circumstances. 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 - Employees will have a different perspective from non-concurrence processes management who may be involved in developing non-concurrence processes; gathering input from employees about non- . concurrence processes will enhance the final - Share performance data with employees product - Gather both quantitative and qualitative data when evaluating the processes - Set performance goals to match aspects ofthe . non-concurrence 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 This document is confidential, prepared sol'el'yfor the client to whom it is addressed. it is not to be reproduced 0r distributed un der any cirrumstances. Best practices for handling retaliation in non- COHCU rrence 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 This document is confidentioi, prepared sol'eiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circamstances. Introduction and Background Slide 2 Data Gathering Method Slide 8 Findings Slide 12 Analysis Slide 135 oendix Best Practices and Recommendations Slide 146 This document is confidential, prepared saieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any circumstances. 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 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 UPC) review process from initial submission to final decision? How long does the DPD 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 UFO meet in order to go forward in the process? Does this criteria change? If so, how are they determined? How do you determine the 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 consensus, unanimous, majority vote)? How does the program hold stakeholders accountable for their actions? This document is confidentidi, prepared sol'eiy for the client to whom it is addressed. it is not to be reproduced or distributed under any 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 Governance - Which stakeholders (and their respective levels) are involved in the UPC 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 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 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? How does the ram maintain accountabilit and incor-orate stakeholder feedback? This document is confidential, prepared solely for the client to whom it is addressed. It is not to be reproduced or distributed under any cirrumstances. 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 Proararn 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 . 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? This document is confidentiai, prepared seieiy for the client to whom it is addressed. it is not to be reproduced or distributed under any