Industry Comments on SafetyJanuary 24, 2011 11 Thank you for the opportunity to participate in this...

Industry Comments on SafetyCulture Policy Statement

January 24, 2011Thomas C. Houghton

Senior Director, Safety-Focused RegulationNuclear Energy Institute

Industry Supports the Policy Statement

* Definition was developed by practitioners- Plain English

- Calls for collective commitment by leaders andindividuals

- Emphasizes goal of protecting people and theenvironment

* Traits reflect appropriate behaviors andvalues inherent in a healthy safety culture

* Office of Enforcement commended

2

Industry Perspective

* Licensees have primary responsibility forensuring a positive safety culture

* NRC has an independent oversight role

° Statement of policy is the appropriate regulatoryaction to address safety culture

e Common language of safety culture is essential

* Care is needed in implementing the policy for- Individual industry segments

- Suppliers and vendors of safety-related equipment

3

Common Language of Safety Culture

* No sense to speak in two different languages* Two sets of terms confuse proper cause

identification and public communication

* Industry ready to work with NRC and otherstakeholders

* We request the Commission encourage swiftaction to complete this task

4

Industry is proactively taking steps toensure a strong nuclear'safety culture

" CNOs approved industry initiative tocomprehensively monitor and assess safetyculture at all stations- Four pilots were conducted with NRC observation

• Each operating company will implementprogram described in NEI 09-07, Fostering a,Strong Nuclear Safety Culture

• Key to success is placing responsibility onsite senior.leadership

i5

Industry Initiative

Uses corrective action program (CAP) tocollect and analyze a comprehensive set ofdata to provide insights into emerging safetyculture issues

*NRC inspection reports

.EmployeeConcerns/Allegations

mindustry Evaluations

*Oversight Findings

*CAP Trends

*Self Assessments

• Station Performance Trends

*Culture Assessments

mIn Field Observations

*Work Force Issues

*Operating Experience

mBenchmarking

6

Industry Initiative

" Multiple sources of data to identify trends thatmay be caused by nuclear safety cultureweaknesses

* Uses INPO Principles for a Strong NuclearSafety Culture

* Site leadership team directs actions to resolveweaknesses

" Outside organizations provide insights to thesite leadership team

- NRC oversight welcomed and expected

Regulatory Footprint

° Industry believes this initiative providessignificant advantages over the currentNRC SCCI approach

• We would welcome discussion onimproving the regulatory approach foroverseeing nuclear safety culture

8

Initiative Reflects Industry's Commitment toa Strong Nuclear Safety

* Standardized, robust, integrated approach" Nuclear operating company. leadership

responsible

" Constant reinforcement of nuclear safetyculture leadership and individual behaviors

" Safety culture requires frequent evaluation" Safety culture is a continuum - even the best

plants work at it every day

,• ii9

BACKUP

V,ý- 10

Site Nuclear Safety Culture Process

6o.

09i c)

Actions

I--

I CAII Evalua

Site ResponsePolicies

Program ModificationsTraining

AssessmentsBenchmarking

CommunicationInternal

RegulatorExternal

ON/SelfAssessmentl

Benchmarking

Prnrit Innsietc

SAFETY CULTURE DRAFTPOLICY COMMENTS

Fuel Cycle FacilitiesR.E. Link, Manager, EHS&L

AREVA, Richland, WAJanuary 24, 2011

Safety Culture Policy Comments - FuelCycle Facilities

° Strongly supports final draft definition-"Commensurate with safety

significance" during implementation

" Strongly supports including traits for clarity-Addition of "Questioning Attitude"

consistent with Safety Conscious WorkEnvironment

Safety Culture Policy Comments - FuelCycle Facilities - (cont.)

Concern with explicit application to"vendors and suppliers of safety relatedcomponents"-"Jurisdictional question --> oversight/

enforcement challenges


mplementation challenges

-Consistency yet diversity -- Broadscope of licensees

l Dual regulatory oversight due at sitessubject to NRC &Agreement State

e Research & data important & usefuIbut caution in extrapolation to diversetypes of licensees


e Greatest concern --> Reconciliation ofpriorities &resources

20-1! Final Safety CulturePolicy Statement

25 Years Is Long Enough ToBuild A Policy Sta temrn t!

Billie Pirner Garde,

Clifford & Garde, LLPJanuary 24, 2011

January 24, 2011 1

Chernobyl 1986

A QUESTIONING ATTITUDE

plus

A RIGOROUS AND PRUDENTAPPROACH

plus

COMMUNICATION

The result will be a major contributionto:

SAFETY

January 24, 2011 ;r-rI A; T K) IQIAL A.?TF P.; EWRG ArK'fA W, r-~ NqJaur.2,211 2 i H Ga S2

M illsto neý M. 1996

"The NRC ,expects that licenseeswill establish and maintain asafety ~onscious workenvironment in which employeesfeel free to raise concerns both totheir own management and theNRC without fear of retaliation."

May 1996 SCWE Policy StatementOctober 2004 SCWE Policy Update

anuarv 24. 2011 3J•. . . . . . , Im • . .

Davis-Besse 2,002 Incident

NRC Requirements: Safety Culture

"The Davis-Besse event re-emphasizedthe importance of safety culture anddemonstrated that significant problemscan occur as a direct result of safetyculture weaknesses that are notrecognized and addressed early."

May 24, 2006 SAFETY CULTURE INITIATIVE ACTIVITIES TOENHANCE THE REACTOR OVERSIGHT PROCESS ANDOUTCOMES OF THE INITIATIVES.

January 24, 2011 4

NRC Final Action Needed* Industry and Agency Need Final

Decision so that; work can begin toimplement new policy expectations;

" NRC Policy will become a benchmarkfor other industries, hopefullypreventing other disasters - Oil & Gas,Mining, Transportation, DOE complex,and others;

" Resources can be spent on addressingSafety Culture issues, not justifyingpolicy.

January 24, 2011 5

"In the aftermath of theDeepwater Horizon spill, could

the oil and gas industrysimilarly improve its safetyculture by creating a self-

policing entity like INPO as asupplement to government

oversight?..."

Deepwater Horizon Report,Chaeter 8, .R239

January 24, 2011 6

omments on Process ofDevelopment of

Safv Culture Policy* Policy Statement developed through

exhaustive collaboration and inclusionactivities, meeting the Commission'sdirection and expectations.

* Wide variety of activities to identifyand include all stakeholders- Meaningful participation opportunities- Significant interaction between

stakeholders

- Transparency and collaboration- Robust debates and discussions

January 24, 2011 7

Position of the Final SafetyCulture Policy Statement

* Agree and satisfied with final definitionas presented in the Final PolicyStatement;

" Agree with the exclusion of the word"security" from the definition, andinclusion of the explanation regardingthe importance of "security" in theFinaI Policy Statement;

• Agree with the Traits, as included anddefined:;

January 24, 2011 8

PON% ition of the Final SafetyCulture Policy Statem ent

(conrad)

• Agree that the trait "Environment for RaisingConcerns", as defined, addresses myconcerns about incorporating SafetyConscious Work Invironment issues;

* Agree with the addition of the "QuestioningAttitude" trait added by the Staff;

" Agree with the expansion of the Commissionexpectations to ALL those entities that formthe basis for nuclear safety, security andenvironmental protection.

January 24, 2011 9

Maintain Belief That Regulation

Policy StatementBelieye that regulation is necessaryand prudent in this area.- Adopt and restate my position from March, 2002

that regulation will provide consistent, reliable, andrepeatable expectations;

- Urge reconsideration of the position of theCommission that we can get there withoutregulation;

-Recommendation based o n philosophical view thatwe understand and work to what is measured, andfor which we are held accountable.

January 24, 2011 110

Concerns About Barriers toSuccessful Imple entation

* Applicability to Agreement States Needs toBe Clearly Established - licensees must beaccountable to follow policy;

* Industry (NEI and INPO) needs to adopt thePolicy Statement and Traits, refresh itsprogram materials, and implement with rigor;

" Agency needs to demonstrate a bias foraction in integrating Policy Statement intoAgency program materials.

January 24, 2011 11

Thank you for theopportunity to participate

in this important topic.

Billie Pirner GardeClifford & Garde, LLP

1707 L Street, NW Ste 500Washington, D.C. 20036

,(202) 280m6116

January 24, 2011 12

Comments on Proposed FinalSafety Culture Policy

Statement

January 24, 2011

Edward FE Maher, Sc . D ., CHP

President, Health Physics Society

Overall

The Health Physics Societyis very supportive of theCommission's efforts to

develop and involvestakeholders in the Radiation

Safety Culture initiative

~2

Issue #1 with Draft Policy

' "One Size Fits Al1" Approach- Not all licensees are the same

-Severity of Consequences differwidely across licensees.

Suggest: Culture should becommensurate with the safetyand security significance of theirorganizations and functions

Issue #2 with Draft Policy

* Internally Driven

-Licensees should be allowed toself-pace development of aRadiation Safety Culture

HPS supports the issuance of aPolicy Statement, rather than anactual or implied regulatoryapproach.

4

Question #1 in Draft Policy

* Emphasis of Safety overCompeting Goals is Bothersome

Taking a drastic action in theinterest of safety may haveconsequences greater than thesafety issue itself

-Add: Safety over competing goalscommensurate with all risksinvolved


* Do Safety Culture Traits RequireClarification?

-No, but examples that demonstrateeach of these traits would behelpful

-How do you know these traits exist

in an organization?

-Possible Proofs of Presence are.......

Proof of Presence

" Organization Structure

" How Competing BudgetaryPriorities are Resolved

" Employee Empowerment

" Ombudsmen Office

• Corrective Action ReportingSystem

" Root Cause Analysis Training

7


• Are NRC's Expectations on theBalance between Safety andSecurity Clear in the draft SOP?

- Yes, but how that is accomplished isless clear. Examples would help.

- The Balance between Security andSafety is not the same with differentRadionuclides and Applications.

• 8


* Should a Discussion RegardingComplacency be Added to SOP?

- Not a detailed discussion, but itsimportance in Safety ProgramManagement should be mentioned

- Complacency is a crosscuttingmanagement problem that is notunique to Radiation Safety Culture


Are Some or All of the FiveAdditional Traits Necessary?

Yes, two. of the five, "QuestioningAttitude" and "Training Quality" aresufficiently different

"Training Quality" should be replacedby "Technical Competency," a morecomprehensive trait for developing aSafety Culture Environment

Briefing to the NRC Commissionre: NRC Safety Culture Policy

Statement

Kevin Buckley

Children's Hospital Boston

Harvard Medical School

On Behalf of AAPM.

January 24, 2011

TV7

AAPM

° Is the the premier organization in medicalphysics; a broadly-based scientific andprofessional discipline encompassing physicsprinciples and applications in biology andmedicine whose mission is to advance thescience, education and professional practiceof medical physics.

* Represents over 7,500 medical physicists.4ht

General Comments.,

The NRC is to be commended for gatheringtogether a wide cross section of licensees todiscuss this topic.

• NRC solicited input from andý responded toconcerns of this group.

4hI3

Safety Culture Policy

* It is the responsibility of the licensees andcertificate holders for developing andmaintaining a strong safety program.

* It is critical that a common language of safetyculture traits and behaviors exist betweenNRC and each category of licensee.

General Comments* AAPM concurs with the revised definition

however:

- It is extremely important to emphasize thatthe term "protection of people" in the'abovedefinition includes "patients".

* AAPM concurs with excluding the term"security" from the definition.- Including security in the definition denigrates

other equally important processes thatprotect the patient, the public, and theenvironment.

General Comments

* NRC needs to acknowledge for medicalinstitutions that patient safety is first andforemost and that the use of radioactivematerials in the practice of medicine is toenhance diagnosis or treatment of diseasewhile ensuring that the patient receivesthe best medical care.

?YI7

One Size Does Not Fit All!

* Although it is laudable to try and have asingle definition that can apply to allcategories of licensees, it is equallyimportant to note that implementation ofthe traits and behaviors as they apply tothe specific licensee categories may differ...

Differences toSpecific Application of. UJse

I In medical uses, nuclear safety does not pre-empt or override patient safety especially inemergency situations. For example, lifesaving measures should always pre-empt theneed to decontaminate a patient in theemergency room.

:h

Path Forward

• NRC must define:

the characteristics that, in the agency'sview, define a positive safety culture, and

-the metrics for assessing a licensee'sprogram against those characteristics.

* Without specific definition, the interpretationof a positive safety culture remainssubjective.

4h~

Next Steps

* AAPM believes the next critical step is to-develop specific actionable characteristicsand behaviors specific to each licensecategory.

° This next level or "third tier," once developedwill provide more meaning in the individuallicensee category and relate the generalcharacteristics to specific behaviors andindications of a strong safety culture in that 4h,particular field.

AAPM Recommendations

* NRC must work closely with the AgreementStates to prioritize this effort relative to otherregulatory issues.

. In the absence of adequate Agreement Statesupport for this initiative, the safety cultureconcept would potentially only be, applied toapproximately twenty percent of thebyproduct materials users nationwide.


* NRC should conduct workshops, incoordination with the Agreement States,specific to each category of licensee to clarifyNRC's approach to safety culture and ensurethat its expectations are clearly understood.

* These should be specific roundtablediscussions and not simply presentations atprofessional society conferences. Ali~


° Guidelines explaining NRC expectationsregarding adoption of Safety Culture valuesmust be promulgated.

* If stakeholders do not understand how toimplement Safety Culture, and have metricsto use internally to determine theeffectiveness of their efforts, attention will beminimal.


• That the NRC's Safety Culture implementationbe clarified so that if medical licensees candemonstrate they are meeting the "intent ofthe NRC Safety Culture policy", the licenseesshould not have to use methods andterminology developed by the NRC staff.

TV~

Questions?

ILt

INA, Commission Meeting

Safety Culture PolicyStatement

January 24, 2011

George MarshaPGDirector-= APNGA

I

Safety Culture Definition +Traits

* Evolved into Universal Version* 9 Traits in Layman's Terms (INPO

Pamphlet)

* Use Industry Specific Examples &Analogies

• Include-Aspects of SCWE &Human Factors

le SC Version Commensurate withthe Risk

2

Portable Gauge Industry

• Low Risk but High Visibility(Gauge Thefts)

" Training - Room for Improvement

* Lack of Management Support" Hidden Benefits of SC Training

Improved Compliance

-Lessens the Workload toAgencies

3

Going Forward

* 5,000+ LicenseeslCompanies* Lacking Structure, Org., Mgmt.,

Radiological Expertise• ResourcelStaffing & Budget

Challenged

e WorkIPartner with Industry(Associations, Manufacturers,Tralinig Providers)

* Training, Websites, Newsletters

Training

SIndustry Driven (Similar to ReactorSC Implementation)

* Already Provides Training - Add SC-Two Focal Points

* Ongoing Training: AnnualEmployee/RSO RefresherTra inin g

SLeadershi Involvement:Management Refresher Training(engages Mgmt, Leaders)

Add SC to NUREG 1556, Volume 1

STA New NUREG?•Training Requirements

6

SUmmary

" Benefits Licensees & Agencies" Let Industry Carry the Load" Focus on:a

-ngoinglRefresher Training- ManagementiLeadership

In vo lvem entlTraining

-Keeping SC from beingDOA/Fiash in the Pan

Acronyms

" APNGA - American PortableNuclear Ga uge Association

" INPO - Institute of Nuclear PowerOperations

" NRC- Nuclear Regu atoryCommission

" NUREG 1556 - ConsolidatedGuidance for Materials Licensees

00

Acronyms (continued)

* RSO - Radiation Safety Officer" SC - Safety Culture

" SCW - Safety Conscious WorkEnvironment

9

USNRCI UNITED STATES NUCLEAR REGULATORY COMMISSIONProtecting People and the Environment

A MUI Comments on the.Proposed Safety Culture

Policy

Bruce Thomadsen, Ph.D.

Advisory Committee on the Medical. Uses of Isotopes

January 24, 2011

ACMUI's Overall Evaluation - I" The Advisory Committee has reviewed

the NRC staff's draft Safety CulturePolicy Statement and would like tocommend the staff for its efforts.

" The Committee agrees that nuclear andradioactive material safety and securityare important issues influenced by thetraits that define a positive safetyculture in the work places

2

ACMUI's Overail Evaluation - 2* Safety culture policy can be a nebulous

concept with many possibleinterpretationsfS

* However, the draft Policy Statement iswell written, highly thoughtful,appropriately balanced againstcompeting priorities in the workplacewithin a complex regulatory framework,and considerate of public comments.

" The ACMUI has some concerns about thepolicy statement.

3

Completeness of the Trait List

SWhile good, the list of traits is notexhaustivefir

" There are many other traits oforganizations with safety culturesnot included.

* The policy statement recognizesthis.

4

Necessity of the Traits

* Also, while the traits are good, anorganization need not exhibit the traits tobe safe.

* For example, an organization without trustor respect can, and likely would, establishprocedures with layers of redundancy,possibly automatic, to prevent errors sincethe leaders would have no trust that theworkers would execute their jobscorrectly.

5

Value of the Traits

* Safety is easiest and most natural inorganizations that exhibit and inherentlyvalue such traits.

* That is why publicizing them would be agood educational enterprise.

6

Forcing e Traitsh" A positive safety culture is: in the

nature of an organization and cannotbe forced on an organization.

" While practices can be imposed,forcing practices that appear as goodtraits likely will not have the same.effect as if the organizationdeveloped then naturally.

7

Forcing the Traits-m 2

o Forcing practices that appear asgood traits can becounterproductive if it usesresources that could be devoted toactual safety practices.

8

Forcing the Traits m 3

* Forcing goov behavior can beproductive and may change practicesor eventually culture.

* For example, Time-out beforeprocedures, forced by JC, has led tothe practice becoming almost routine,without thought. This may not haveworked as quickly by trying to changethe culture first.

9

Implementation of the Policy

Given the last points, the statementin the policy,' "these traits are notnecessarily inspectable and werenot developed for that purpose,"should be remembered into thefuture.

10

~ U.S.NRCUnited. States Nuclear Regulatory Commission

Protecting People and the Environment

Proposed Safety CulturePolicy Statement

January 24, 2011

Office of EnforcementOffice of Federal and State

Materials and EnvironmentalManagement Programs

Agenda

* Opening: Bill Borchardt, OEDO• Introduction: Andy Campbell, OE

* Overview: Dave Solorio, OE* Safety Culture Policy Statement:

Diane Sieracki, OE

* Safety Culture in the MaterialsArea: James Firth, FSME

2

Proposed Safety Culture PolicyStatement (SCPS)

Diane SierackiSr. Safety Culture

Program Manager, OE

Background and OutreachActivities

* Commission Direction

* November 2009 FRN

* February 2010 3-day workshop* NRC staff presentations

• September 2010 FRN

* September 2010 public meeting

4.

Discussion Items

* 2010 workshop definition andtraits

* Treatment of security

* Inclusion of the traits in theStatement of Policy

* Policy vs. regulation

Discussion Items (cont.)

" Vendors and suppliers

" Diversity of regulated entities

" Results of INPO Validation Study

" Questioning Attitude trait

" Concerns with Next Steps

Proposed Final Draft PolicyStatement

* Definition and traits.- Included in the Statement of Policy

" Safety and security

" Preamble addresses "security"* "Questioning Attitude" trait

addresses complacency

7

Proposed Final Draft PolicyStatement (cont.)

* Recognizes diversity of regulatedentities

* Vendors and suppliers included

• Cautions stakeholders to considernegative factors (i.e., incentivegoals, etc.)

8

Proposed Safety CultureDefinition

Nuclear Safety Culture is the corevalues and behaviors resulting

from a collective commitment byleaders and individuals to

emphasize safety over competinggoals to ensure protection ofpeople and the environment.

9

Proposed Safety Culture Traits

" Leadership Safety Values andActions

" Personal Accountability

" Work Processes

• Continuous Learning

10

Proposed Safety Culture Traits(cont.)

* Problem Identification andResolution

• Environment for Raising Concerns

* Effective Safety Communication

• Respectful Work Environment

• Questioning Attitude

11

Tiers for Development andImplementation of SCPS

Tier I

Tier 2

Tier 3

- Definition

- Descriptions/Traits

- Application/Industry-Specific

12

"Leadership" TraitExample of Tier 3

* Management in the field ensuringstandards are met

• Commitment to maintainingequipment

* Resolves conflict

* Actions match words

"Leadership" TraitExample of Tier 3 (cont.)

• Positive reinforcement used toreinforce desired positive nuclearsafety behaviors

" Respects differing opinions

* Schedules are realistic and do notchallenge safety standards

14

SCPS Rollout (Projected)

* SCPS will provide a commonlanguage

e Outreach will continue

" Staff will continue working withlicensees and.Agreement States

* Staff will consider education andworkshops

.15

Increasing Attention to SafetyCulture in the Materials Area

James FirthProject Manager, FSME

Response to CommissionTracking

* Strategy and efforts toincrease attention to SC(materials)

* Progress of materialslicensees to address SC

17

Use of Stakeholder.Involvement and Outreach

*Development of policystatement

*Common terminology

18

Efforts to IncreaseAttention

• Use of current approaches

* Guidance development

* Other opportunities

19

Progress of MaterialsLicensees

* Contributions of AgreementStates

* Measures of progress

- Engagement

- Awareness

20

Closing Remarks

Dave SolorioBranch Chief, OE

Key Messages

" Two year effort - extensivestakeholder outreach

" Workshop definition and traits arethe first step in our ongoingefforts to develop/harmonizecommon language

• Stakeholders request involvementduring rollout of the policy

22

Next Steps

* Commission Direction-Request approval to publish SCPS

* Implementation Phase- Stakeholder involvement with

program offices for "Tier 3"

- OE will support program officesduring SCPS rollout

23

List of Acronyms

" ACMUI -,Advisory Committee onthe Medical Use of Isotopes

• ACRS - Advisory Committee onReactor Safeguards

" FC - Fuel Cycle* FRN - Federal Register Notice

24

List of Acronyms (cont.)

* IMC 0613 - Documenting IOCFR52Construction and Test Inspections

* IMC 1246 - Formal QualificationPrograms in NMSS Area

* IMC 2505-- Periodic Assessmentof Construction InspectionProgram Results

25


* INPO- Institute of Nuclear PowerOperations

" ISFSI - Independent Spent FuelStorage Installation

" NUREG-1556 - ConsolidatedGuidance about MaterialsLicensees

* ROP - Reactor Oversight Process

26


• RTR- Research and Test Reactor

* SC - Safety Culture* SCPS - Safety Culture Policy

Statement

" SECY - Synonymous withCommission Paper

* SRM - Staff RequirementsMemorandum

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Industry Comments on SafetyJanuary 24, 2011 11 Thank you for the opportunity to participate in this...

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