ML20128N580

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Informs of Review of Draft Re Direct Rule Parts 2 & 51 & Requests Discussion on Couple of Issues
ML20128N580
Person / Time
Issue date: 04/22/1996
From: Cant G
NRC
To: Au M
NRC
Shared Package
ML20128N048 List:
References
FRN-61FR43406, FRN-61FR43409, RULE-PR-2, RULE-PR-51 AF43-2-019, AF43-2-19, NUDOCS 9610160438
Download: ML20128N580 (1)
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PDR. 2-1 From: .Geoffrey Cant To: MLA Date: 4/22/9611:10am

Subject:

Pts 2/51 direct rule I have reviewed the draft that you circulated and wish to discuss a couple of issues with you. I have also learned that JLieberman has signed off on it; nonetheless, I believe that it is important that we touch on these issues. Today and tomorrow are very busy for me; can we meet sometime on Wednesday?

Geoff -

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9610160439 961009 PDR PR 2 61FR43406 PDR .j

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UNITED STATES NUCLEAR REGULATORY COMMISSION fD/( 26 l 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.

J Purpose i 1

-The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to provide addressces 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.

Backaround-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 du ing an inspection, licensees will be subject to a Notice of Violation a ed to provide..a written response, as required by 10 CFR 2.201, addressing causes

'of the violations-and corrective' actions taken to prevent recurrence In some .

cases, such violations are documented on Form 591 (for materials licensees) 4604290193 if P-

' Copies of-NUREG-1600 can be obtained by calling the contacts listed at the end of the Information Notice.

l1 IN 96-28 l May 1, 1996 I Page 2 of 6 which constitutes a notice of violation that requires corrective action but does not require ; 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 tn 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 ^11 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 comolete and thorouah review of the circumstances that led to +

{ the violation. Typically, such reviews include:

Interviews with individuals who are either directly or indirectly e 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.

IN 96-28 May 1, 1996 Page 3 of 6

- 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 l 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 i paid to training and qualification records of individuals involved with the violation.

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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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i IN 96-28 May 1, 1996 Page 4 of 6

3. Take oromot and comorehensive 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 4 specific findings of the violation. For example, if the violation was J 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 pr. vent 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?

l 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?

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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?

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

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

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IN 96-28 May 1, 1996 Page 5 of 6

9. Is there a need for retaining an independent technical consultant to audit +Se area of concern or revise your procedures?
10. Are the procedures consistent with current NRC requ'rements, should they be clarified, or should new procedures be developedt
11. Is a system in place for keeping abreast of new or modified NRC requirements?
12. Does your staff appreciate the need to censider 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?

Attachment 1 IN 96 May 1, 1996

, Page 1 of 1 LIST OF RECENTLY ISSUED NMSS INFORMATION NOTICES J

4 Information Date of N.otice No. Subject Issuance Issued to 96-21 Safety Concerns Related 04/10/96 All NRC Medical Licensees i

to the Design of the Door authorized to use brachy-Interlock Circuit on therapy sources in high-Nucletron High-Dose Rate and pulsed-dose-rate remote and Pulsed Dose Rate 4

Remote Afterloading Brachy-therapy Devices 96-20 Demonstration of Associ- 04/04/96 All industrial radiography ated Equipment Compliance licensees and radiography with 10 CFR 34.20 equipment manufacturers i

96-18 Compliance With 10 CFR 03/25/96 All material licensees j Part 20 for Airborne authorized to possess and Thorium use thorium in unsealed form 96-04 Incident Reporting 01/10/96 All Radiography Licensees Requirements for and Manufacturers of Radiography Licensees Radiography Equipment 95-58 10 CFR 34.20; Final 12/18/95 Industrial Radiography Effective Date Licensees.

95-55 Handling Uncontained 12/6/95 All Uranium Recovery Yellowcake Outside of a Licensees.

Facility Processing Circuit 95-51 Recent Incidents Involving 10/27/95 All material and fuel cycle Potential Loss of Control licensees, of Licensed Material 95-50 Safety Defect in Gammamed 10/30/95 All High Dose Rate 12i Bronchial Catheter Afterloader (HDR) Licensees.

Clamping Adapters 95-44 Ensuring Combatible Use of 09/26/95 All Radiography Licensees.

Drive Cables Incorporating Industrial Nuclear Company Ball-type Male Connectors

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  • Attachment 2 IN 96-28 May 1, 1996 Page 1 of 1 L LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES 1

-Information Date of .

, Notice.No. Subject. Issuance Issued to L

1 .

Potential' Clogging of High 05/01/96 All holders of Ols or cps 4 96-27

Pressure Safety Injection for pressurized water Throttle Valves During reactors Recirculation Recent Problems with Over- All holders of Ols or. cps

! 96-26 04/30/96 head Cranes for nuclear power reactors j

Transversing In-Core Probe 04/30/96 All holders of OLs or cps j 96-25 Overwithdrawn at LaSalle for nuclear power reactors i County Station, Unit 1 Preconditioning of Molded- 04/25/96 All holders of OLs or cps 96-24.

Case Circuit Breakers for nuclear power reactors

' Before Surveillance Testing Fires in Emergency Diesel 04/22/96 All holders of OLs or cps

96-23 Generator Exciters During for nuclear power reactors l

Operation Following Unde-1 txted Fuse _ Blowing ,

'96-22 Improper Equipment Set- 04/11/96 All holders of OLs or cps i tings Due to the Use of for nuclear power reactors i Nontemperature-Compensated i ' Test Equipment i 96-21 Safety Concerns Related 04/10/96 All U.S. NRC Medical to the i to the Design of the Door Licensees authorized to use

Interlock Circuit on brachytherapy sources in i .Nucletron High-Dose Rate high- and pulsed-dose-rate i and Pulsed Dose Rate remote afterloaders t Remote Afterloading Brachytherapy Devices l

$ .96-20 Demonstration of Associ- 04/04/96 All industrial radiography i ated Equipment Compliance . licensees and radiography with 10 CFR 34.20 equipment manufacturers

l 1

l OL - Operating License CP = Construction Permit

IN 96-28 May 1, 1996 Page 6 of 6 This information notice requires no specific action nor written response. If you have any questions about the information in this notice, please contact i one of the technical contacts listed below.

, , h fg f: '/4t b<! h , _ . . . _

Eliz eth Q. n Eyck, Did ctor Donald A. Cool, Director Divn,a)ionoffuelCycleSafety 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:nlmenrc. gov Internet:djh0nrc. gov i Bruno Uryc, Jr., RII Bruce L. Burgess, RIII (404) 331-5505 (708) 829-9666 Internet:bxu0nrc. gov Internet:b1b0nrc. gov Gary F. Sanborn, RIV j (817) 860-8222 Internet:gfs0nrc. gov

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Attachments:

l. List of Recently Issued NMSS Information Notices
2. List of Recently Issued NRC Information Notices i

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