United States Nuclear Regulatory Commission - Protecting People and the Environment

Information Notice No. 96-28: Suggested Guidance Relating to Development and Implementation of Corrective Action

                                 UNITED STATES
                         NUCLEAR REGULATORY COMMISSION
               OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                            WASHINGTON, D.C.  20555

                                  May 1, 1996


NRC INFORMATION NOTICE 96-28:  SUGGESTED GUIDANCE RELATING TO DEVELOPMENT AND  
                               IMPLEMENTATION OF CORRECTIVE ACTION


Addressees

All material and fuel cycle licensees. 

Purpose

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information
notice to provide addressees with guidance relating to development and
implementation of corrective actions that should be considered after
identification of violation(s) of NRC requirements.  It is expected that
recipients will review this information for applicability to their facilities
and consider actions, as appropriate, to avoid similar problems.  However,
suggestions contained in this information notice are not new NRC requirements;
therefore, no specific action nor written response is required.

Background

On June 30, 1995, NRC revised its Enforcement Policy (NUREG-1600) 60 FR
34381, to clarify the enforcement program's focus by, in part, emphasizing the
importance of identifying problems before events occur, and of taking prompt,
comprehensive corrective action when problems are identified.  Consistent with
the revised Enforcement Policy, NRC encourages and expects identification and
prompt, comprehensive correction of violations.  

In many cases, licensees who identify and promptly correct non-recurring
Severity Level IV violations, without NRC involvement, will not be subject to
formal enforcement action.  Such violations will be characterized as "non-
cited" violations as provided in Section VII.B.1 of the Enforcement Policy. 
Minor violations are not subject to formal enforcement action.  Nevertheless,
the root cause(s) of minor violations must be identified and appropriate
corrective action must be taken to prevent recurrence.

If violations of more than a minor concern are identified by the NRC during an
inspection, licensees will be subject to a Notice of Violation and may need to
provide a written response, as required by 10 CFR 2.201, addressing the causes
of the violations and corrective actions taken to prevent recurrence.  In some
cases, such violations are documented on Form 591 (for materials licensees) 


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which constitutes a notice of violation that requires corrective action but
does not require a written response.  If a significant violation is involved,
a predecisional enforcement conference may be held to discuss those actions.  
The quality of a licensee's root cause analysis and plans for corrective
actions may affect the NRC's decision regarding both the need to hold a
predecisional enforcement conference with the licensee and the level of
sanction proposed or imposed.

Discussion

Comprehensive corrective action is required for all violations.  In most
cases, NRC does not propose imposition of a civil penalty where the licensee
promptly identifies and comprehensively corrects violations.  However, a
Severity Level III violation will almost always result in a civil penalty if a
licensee does not take prompt and comprehensive corrective actions to address
the violation. 

It is important for licensees, upon identification of a violation, to take the
necessary corrective action to address the noncompliant condition and to
prevent recurrence of the violation and the occurrence of similar violations. 
Prompt comprehensive action to improve safety is not only in the public
interest, but is also in the interest of licensees and their employees.  In
addition, it will lessen the likelihood of receiving a civil penalty.  Compre-
hensive corrective action cannot be developed without a full understanding of
the root causes of the violation. 

Therefore, to assist licensees, the NRC staff has prepared the following
guidance, that may be used for developing and implementing corrective action. 
Corrective action should be appropriately comprehensive to not only prevent
recurrence of the violation at issue, but also to prevent occurrence of
similar violations.  The guidance should help in focusing corrective actions
broadly to the general area of concern rather than narrowly to the specific
violations.  The actions that need to be taken are dependent on the facts and
circumstances of the particular case. 

The corrective action process should involve the following three steps:

1.    Conduct a complete and thorough review of the circumstances that led to
      the violation.  Typically, such reviews include: 

      �   Interviews with individuals who are either directly or indirectly
          involved in the violation, including management personnel and those
          responsible for training or procedure development/guidance. 
          Particular attention should be paid to lines of communication
          between supervisors and workers.

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      �   Tours and observations of the area where the violation occurred,
          particularly when those reviewing the incident do not have day-to-
          day contact with the operation under review.  During the tour,
          individuals should look for items that may have contributed to the
          violation as well as those items that may result in future 
          violations.  Reenactments (without use of radiation sources, if they
          were involved in the original incident) may be warranted to better
          understand what actually occurred.

      �   Review of programs, procedures, audits, and records that relate
          directly or indirectly to the violation.  The program should be
          reviewed to ensure that its overall objectives and requirements are
          clearly stated and implemented.  Procedures should be reviewed to
          determine whether they are complete, logical, understandable, and
          meet their objectives (i.e., they should ensure compliance with the
          current requirements).  Records should be reviewed to determine
          whether there is sufficient documentation of necessary tasks to
          provide an auditable record and to determine whether similar
          violations have occurred previously.  Particular attention should be
          paid to training and qualification records of individuals involved
          with the violation.

2.    Identify the root cause of the violation.

      Corrective action is not comprehensive unless it addresses the root
      cause(s) of the violation.  It is essential, therefore, that the root
      cause(s) of a violation be identified so that appropriate action can be
      taken to prevent further noncompliance in this area, as well as other
      potentially affected areas.  Violations typically have direct and
      indirect cause(s).  As each cause is identified, ask what other factors
      could have contributed to the cause.  When it is no longer possible to
      identify other contributing factors, the root causes probably have been
      identified.  For example, the direct cause of a violation may be a
      failure to follow procedures; the indirect causes may be inadequate
      training, lack of attention to detail, and inadequate time to carry out
      an activity.  These factors may have been caused by a lack of staff
      resources that, in turn, are indicative of lack of management support. 
      Each of these factors must be addressed before corrective action is
      considered to be comprehensive.


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3.    Take prompt and comprehensive corrective action that will address the
      immediate concerns and prevent recurrence of the violation.

      It is important to take immediate corrective action to address the
      specific findings of the violation.  For example, if the violation was
      issued because radioactive material was found in an unrestricted area,
      immediate corrective action must be taken to place the material under
      licensee control in authorized locations.  After the immediate safety
      concerns have been addressed, timely action must be taken to prevent
      future recurrence of the violation.  Corrective action is sufficiently 
      comprehensive when corrective action is broad enough to reasonably
      prevent recurrence of the specific violation as well as prevent similar
      violations.

In evaluating the root causes of a violation and developing effective
corrective action, consider the following:

1.    Has management been informed of the violation(s)?

2.    Have the programmatic implications of the cited violation(s) and the
      potential presence of similar weaknesses in other program areas been
      considered in formulating corrective actions so that both areas are
      adequately addressed?

3.    Have precursor events been considered and factored into the corrective
      actions?

4.    In the event of loss of radioactive material, should security of
      radioactive material be enhanced?

5.    Has your staff been adequately trained on the applicable requirements?

6.    Should personnel be re-tested to determine whether re-training should be
      emphasized for a given area?  Is testing adequate to ensure
      understanding of requirements and procedures? 

7.    Has your staff been notified of the violation and of the applicable
      corrective action?

8.    Are audits sufficiently detailed and frequently performed?  Should the
      frequency of periodic audits be increased?


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9.    Is there a need for retaining an independent technical consultant to
      audit the area of concern or revise your procedures? 

10.   Are the procedures consistent with current NRC requirements, should they
      be clarified, or should new procedures be developed?

11.   Is a system in place for keeping abreast of new or modified NRC
      requirements?

12.   Does your staff appreciate the need to consider safety in approaching
      daily assignments?

13.   Are resources adequate to perform, and maintain control over, the
      licensed activities?  Has the radiation safety officer been provided
      sufficient time and resources to perform his or her oversight duties?

14.   Have work hours affected the employees' ability to safely perform the
      job?

15.   Should organizational changes be made (e.g., changing the reporting
      relationship of the radiation safety officer to provide increased
      independence)?

16.   Are management and the radiation safety officer adequately involved in
      oversight and implementation of the licensed activities?  Do supervisors
      adequately observe new employees and difficult, unique, or new
      operations?

17.   Has management established a work environment that encourages employees 
      to raise safety and compliance concerns? 

18.   Has management placed a premium on production over compliance and
      safety?  Does management demonstrate a commitment to compliance and
      safety?

19.   Has management communicated its expectations for safety and compliance? 

20.   Is there a published discipline policy for safety violations, and are
      employees aware of it?  Is it being followed?

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This information notice requires no specific action nor written response.  If
you have any questions about the information in this notice, please contact
one of the technical contacts listed below.


      signed by                                 signed by

Elizabeth Q. Ten Eyck, Director           Donald A. Cool, Director
Division of Fuel Cycle Safety             Division of Industrial
  and Safeguards                            and Medical Safety                
Office of Nuclear Material Safety         Office of Nuclear Material Safety 
  and Safeguards                            and Safeguards

Technical contacts:  Nader L. Mamish, OE        Daniel J. Holody, RI
                     (301) 415-2740             (610) 337-5312
                     Internet:nlm@nrc.gov       Internet:djh@nrc.gov

                     Bruno Uryc, Jr., RII       Bruce L. Burgess, RIII
                     (404) 331-5505             (708) 829-9666
                     Internet:bxu@nrc.gov       Internet:blb@nrc.gov
           
                     Gary F. Sanborn, RIV
                     (817) 860-8222
                     Internet:gfs@nrc.gov
Page Last Reviewed/Updated Thursday, November 21, 2013