Information Notice 1996-28, Suggested Guidance Relating to Development and Implementation of Corrective Action

Suggested Guidance Relating to Development and Implementation of Corrective Action

ML031060071
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	05/01/1996
From:	Cool D, Teneyck E NRC/NMSS/FCSS, NRC/NMSS/IMNS
To:
References
IN-96-028, NUDOCS 9604290193
Download: ML031060071 (8)

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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'Copies of NUREG-1600 can be obtained by calling the contacts listed at

the end of the Information Notice.

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IN 96-28 May 1, 1996 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.

Attachment 1 IN 96-28 May 1, 1996 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

96-21 Safety Concerns Related 04/10/96 All NRC Medical Licensees

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

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

96-18 Compliance With 10 CFR 03/25/96 All material licensees

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

Attachment 2 IN 96-28 May 1, 1996 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

96-27 Potential Clogging of High 05/01/96 All holders of OLs or CPs

Pressure Safety Injection for pressurized water

Throttle Valves During reactors

Recirculation

96-26 Recent Problems with Over- 04/30/96 All holders of OLs or CPs

head Cranes for nuclear power reactors

96-25 Transversing In-Core Probe 04/30/96 All holders of OLs or CPs

Overwithdrawn at LaSalle for nuclear power reactors

County Station, Unit 1

96-24 Preconditioning of Molded- 04/25/96 All holders of OLs or CPs

Case Circuit Breakers for nuclear power reactors

Before Surveillance Testing

96-23 Fires in Emergency Diesel 04/22/96 All holders of OLs or CPs

Generator Exciters During for nuclear power reactors

Operation Following Unde- tected Fuse Blowing

96-22 Improper Equipment Set- 04/11/96 All holders of OLs or CPs

tings Due to the Use of for nuclear power reactors

Nontemperature-Compensated

Test Equipment

96-21 Safety Concerns Related 04/10/96 All U.S. NRC Medical to the

to the Design of the Door Licensees authorized to use

Interlock Circuit on brachytherapy sources in

Nucletron High-Dose Rate high- and pulsed-dose-rate

and Pulsed Dose Rate remote afterloaders

Remote Afterloading

Brachytherapy 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

OL - Operating License

CP = Construction Permit

IN 96-28 May 1, 1996 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.

IN 96-28 May 1, 1996 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?

IN 96-28 May 1, 1996 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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IN 96-28 May 1, 1996 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.

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I-I-/ 7/ (>

A _

Eli zaeth Q. Eyck, Di ctor Doriald A. Cool, Director

Div ion of Fuel Cycle Safety Di%vision of Industrial

and Safeguards atnd Medical Safety

Office of Nuclear Material Safety Off'ice of Nuclear Material Safety

and Safeguards aand 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

-Attachments:

Stb do

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

1.