ML19322A242
| ML19322A242 | |
| Person / Time | |
|---|---|
| Site: | Crane  |
| Issue date: | 01/28/1977 |
| From: | Nolan F NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| References | |
| PROC-770128, NUDOCS 7902070045 | |
| Download: ML19322A242 (18) | |
Text
.g kh January 23, 1977 EVALUATI0tl 0F THE TRIAL ItiSPECTICt! PROGPJJi I?lVOL7ITIG
~ STATISTICAL SAMPLItiG INSPECTI0rt TECHNIQUES C0tiDUCTED AT METROPOLITAN EDISO:1 C0ftPANY'S THREE MILE ISLAND UNIT 1 BY THE OFFICE OF I;iSPECTIOil AND ENFORCEMEtiT 9
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Coordinated By:
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- M F. J. Nolan Reviewed By
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Approved By:
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1.
ABSTRACT A one-year trial inspection program involving statistical sampling inspection techniques was initiated on July 1, 1975 at an operating reactor facility.
The objective of the trial program was to evaluate the feasibility of utilizing statistical sampling inspection concepts which would reflect a numerical measure of confidence regarding the capability of the 11RC inspection program to detect a licensee who was in noncompliance with f1RC recuirements.
It has been concluded that the statistical sampling inspection concept is not a viable technicue for broad application to the flRC inspection process in that the costs asso-ciated with implementation of such a program would outweign significantly the benefits.
The concept does have application in specific areas of the inspection program.
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CONTENTS Pace S
1.
Abstract 1
2.
Introduction 3
3.
Trial Program Description S
4.
. Trial Program Results 6
4.1 Inspection Coverage 6
4.2 Noncompliance Identification 7
4.3 Inspection Effectiveness 10 4.4 Inspector Awareness 11 4.5 Management of Program 12 4.6 Support Functions 13 4.7 Impact on the Licensee 15 5.
Summary and Conclusions 16 5.1 Benefits 16 5.2 Costs 16 5.3 Conclusions 16 6.
Recomendations 18 i...
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2.
INTRODUCTION During the latter part of Calendar Year 1974, a review of the existing reactor inspection program was initiated by Sandia Labora cries at the request of the Directorate of Regulatory Goerations (new the Office of Inspectica and Enforcement).
The objective of this review was to determine the feasibility of utilizing statistical techniques to establish a numerical measure of confidence regarcing the capability of the existing inspection program to determine whether a licensee was operating his facility safely.
During the review process it was concluded that measurement of the safety of operations was not quantifiable because the discrete elements that ensure safety of operations are not universally agreed upen, nor is the individual impact of eacn on safety known.
It was furtner concluded that measurement of ccmoliance might be quantifiable, but no: under the existing program.
It was subsequently deciced to determine the feasibility of utilizing statistical sampling inspection technicues in an inspecticn arcgram which would reflect a numerical measure of confidence regarcing the acility of the program to detect licensees who are in noncomoliance with NRC recuire-ments.
The approach was to have application to inspection of construction, preoperational testing and operational phase activities at commercial nuclear power reactors licensed by the Atcmic Energy Commission (now Nuclea'r Regulatory Commission).
Early in development of an inspection program to tes: tne feasibility, it was concluded that the initial effort should be limited to the inspection of operating pcwer reactors.
This decision was based on the existence of more specific NRC recuirements acolicable to operating reactors than to reactors in the other phases of activity, therefore providing a broader base from which to develop the elements to be instected.
If the concept were found to be viable for applicaticn to operating reactors, it might then be expanded to the other pnases of the NRC inspection program.
The goal was to develop a trial inspection program which would provide a basis for a confidence level statement regarding the ability of the ins,cection program to detect a licensee who is in nonccmpliance witn NRC recuirements.
The resultant inspecticn program would also recognize tnat the NRC recuire-ments do not all have a censistent relationship to safdty.
The following type of statement resulted:
"The NRC inspection program is sucn that there is at least an X% probability of detecting any licensee who is less than Y% in compliance with NRC requirements over :ne period of a facility year."
In order to develop the basis for such a statement, the following.acticns were necessary:
a.
Selection of the trial facility.
b.
Development of the population of inspectable elements based on regulatory requirements established in NRC regulatiens and the facility technical specifications.
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Stratification of the population in accordance with safety importance.
(1) Stratum A -- Significant Safety Requirements -- Those inspectable regulatory requirements having a major impact on safe reactor operations ; e.g., limiting conditions for operation havino the stated purpose of ensuring safe reactor operation; recuirements which identify and prohibit certain modes of cperation; recuirements designed to ensure the safe snutdown margin establisned in the technical specifications; requirements pertaining to off-site radiological releases.
(2) Stratum B -- Safety Requirements -- Those inspectable regulatory requirements which have an imoact on safe reactor operations; 4
e.g., surveillance requirements directly related to safety limits and limiting conditions for coeration, other than those certaining to nonradiological environmental matters; surveil'ance recuirements designed to ensure the functional integrity of engineereo safety feature mechanical and c
trical comoonents; retuirements establishing the design ares delineated in the tecnnical specifications; requiremei cs pertaining to radiological environ-mental monitoring; requirements that establisn the crite' ia for r
physical protection of the facility and attendant nuclear materials.
(3) Stratum C -- Safety-Related Requirements -- Those inspectable regulatory requirements that could imoact on safe reactor operations; e.g., requirements pertaining to record keeping; recorting and organizational procedures; recuirements pertaining to nonradiological environmental monitoring; all other license and technical soecifi-cations not included as a significant safety requirement or safety requirement.
d.
Independent verification of the stratified population by tiRC personnel.
e.
Selection of the confidence level to be associated.with each safety stratum.
f.
Generation of the random samole of inspection elements to be examined from the stratified inspection population.
g.
Development of irspection procedures for the inspection elements selected in the sample.
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TRIAL PROGRAM DESCRIPTION Metropolitaa Edison Company's Three Mile Island Unit No. I facility, near Harrisburg, Pennsylvania, was selected as the accropriate site for the trial inspection program becadse it was a recently licensed facility representative of the new generation of nuclear power plants.
S tra ti fi-cation of the identified population was accomplished in accordance with the criteria delineated in Section 2.c.
s For the trial reogram, the population of inspection elements, sample size and result nt confidence level statement for each safety strata were established as follows:
Population of Inspection Inspection Confidence Strata Elements Samole Level 1
A 854 266 95/99 B
. 966 58 95/95 C
724 22 90/90 Overall 2544 74 95/96 Consistent with estimated manpower resource recuirements and the gradation of the inspection effort to safety importance, the confidence leveis for strata A, B and C were estaolished as. delineated above.
It should be noted that the overall confidence level statement was limited to the 95/95 level by the occurrence of the 22nd inspection samole for Stratum C during the randcm sample selection process. Selection of an overall confidence level statement was not predetermined.
Inspection procedures were develoced for each of the inspacticn elements identified in the inspection samaie.
Since the statistical sampline Ms::ctic--
program (SSIP) was essentially limited to a review of facility records associated with licensee activities, it was augmented with portions of the normal inspection program (MC 2515).
This augmentation included facility tours and witnessing of on-going activities.
It should be noted that wnereas the MC 2515 inspection program is based cn examiaation of compliance witn numemus regulatory requirements associated with a specific functicnal activity, it was necessary from the statistical. validity standpoint to develop.the statistical sampling inspection program such that each inspectable element was independent of the other inspectable elements from a compliance standpoint.
Following a meeting with Metropolitan Edison Comoany to inforn them that
-Three Mile Island Unit No. I had been selected for a trial ins:ection program involving statistical samoling inspection technicues, the trial inspection program covering the reactor operating period July 1,1975 to June 30, 1976 was initiated.
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4.
TRIAL INSPECTION RESULTS
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'4.1 Inspection Coverace and Effectiveness The Statistical Sampling Inspectidn Program (SSIP) is a highly defined inspection program which is limited to inspection of the legal regulatory t
requirements established in the Rules and Regulations, Facility License, Technical Specifications, Emergency Plan, Security Plan, and the Licensee's
_ uality A;surance Program for Operation.
The normal NRC Inspection Program Q
1 (MC 2515) is more extensive in that it also requires that NRC inspectors review 3afety-related matters which may.not be fully covered by specific regulatory requirements, thereby enhancing the feedback of information necessary for optimi:ation of the overall regulatory process.
As a result of the difference in inspection coverage, NRC inspectors have expressed a higher degree of confidence regarding their evaluation of the safety of l
the licensee's operation utilizing MC 2515 as ccmpared to the SSIP.
Because the SSIP. samples were selected randcoly, scme areas were not adequately covered by the sample.
The following table denotes examples of the disparity in inspection coverage during.the trial program:
Procram Manhours MC 2515
$51P - Samole Security 40 Hrs.
3 Hrs.
I Emergency Planning 22 Hrs.
O Hrs.
Environmental 32 Hrs.
6 Hrs.
. Refueling 50 Hrs.
3 Hrs.
The MC 2S15 hours indicate the average time scent per facility per year in the respective area.
The SSIP hours reflect the time recuired to com-plete the inspection procedures selected in the random sample for the i
trial inspection program.
On the other hand, the sample size of the SSIP elements were 'ound to be excessively large in some areas.
As an example, the inspector was required to inspect all design. changes initiatec in a sample period of two months to ensure that licensee evaluaticns required by 10 CFR 50.59 had been completed. Although this would normally be an acceptable sample size, there happened to be aporoximately 100 design changes during the two month period.
The resulting effort was much lass efficient and less productive than reviewing several significant des 1gn i
changes to ascertain whether all regulatory requirements had been satisified in the.' sample selected.
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4.2 floncomoliance Identification A comparison of the total number of items of noncomoliance identified within the SSIP program at Three f4ile Island *with those identified during MC 2515 inspection efforts at the same facility and at other facilities
. ith B&W reactors over the same time period is as follows:
w Table A
- Onsite Man-Days Items of Noncomol tance Insoect.
Per Item Facility Infractions Deficiencies Total Man-Cays of Noncocaliance Arkansas 1 14 9
23 74.0 3.21 Oconee 1 17 7
24 49.9 2.08 Oconee 2 16 6
22 49.8 2.26 Oconee 3 16 4
20 32.3 1.61 Rancho Seco 6
5 11 60.6 5.51 Average of B&W Facilities (above) 12.4 6.2 18.6 53.3 2.86 Three Mile Island SSIP 7
3 10 75.2 7.52 2515 12 10 22 112.5 5.11
- It is noted tnat tnese cata are dependent in part on the quality of the licensee's management control systems for operaticn of the respective facil'ities.
Therefore, care should be exercised in the review, evaluation and further use of these data.
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r The following represents com arison of the time required to ccmplete the trial inspection program at Three Mile Island Unit No. I with the averag' inspection effort at other operating facilities:
Table B Preparation Onsite Time Inspection Time Facility Man-Days Pan-Days / Yea r Three Mile Island SSIP 14.0 75.2 2515 17.5 112.5 SSIP & 2525 31.5 187.7
- NP.C 1-2515 Unknown 120.1 As indicated in Table A, a total of ten items of noncomaliance were identi-fied within the SSIP while an additional twenty-two itens were detected during the MC 2515 inspection effort at Three Mile Island Unit No.1.
The ten iteas of nonccmpliance detectad under the SSIP consisted of seven infractions (70%) and three deficiencies (30%) while the twenty-two items of nonccmpliance detected under MC 2515 consisted of twelve infractions (55%) and ten deficiencies (45%).
The results indicate that the higher yield of infractions as compared to deficiencies detected during the SSIP resulted from the fact that the SSIP inspection sample was weighted with elements involving more significant safety requirements, i.e., made up of 256 Stratum A elements (76.95),
59 Stratum B elements (16.8%), and 22 Stratum C elements (6.3%).
It should be noted that results are in good agreement with the noncompliance history at other S&W facilities inspected against MC 2515 recuirements wnere infrac-tions ranged from 61% to 80% with an average of 68% and the deficiencies ranged from 20% to 45% with an average of 325.
Items of noncomoliance involving violations were not detected 6t any of the facilities discussed above.
- Nine operating facili tics in NRC-1 that had the same basic operating cycie, including a refueling outage.
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While items of noncompliance and man-days of inspection effort per item of noncompliance are interesting parameters, they are not considered to be reliable indicators of the overall effectivenss of a licensee's operation as related to safety.
This is based in part on the variation in fiRC requirements from facility' to facility, variability in insoectors, and lack of direct correlation of NRC requirements to a measurement of safe operations.
In order to verify that items of noncompliance were not overlooked or misinterpreted, an independent review by experienced inspectors was completed using the same procedures employed by the trial program inspectors.
The audit involved 27 of the inspection procedures, and reflected no disagreement with the trial inspector's., findings.
It should be noted that documentation of preparation time identifiet.
n Table B is unique to the trial inspection program and is not recuireo to be recorded for the MC 2515 inspection at all operating facilities.
The as-found confidence level data associated with the SSIP are as follows:
Table C Items of Noncomoliance Detected Ccmpliance Strata Violations inf rac 1ons Deficiencies Total Factor A
0 6
2 8
95/96 B
0 1
1 2
95/90 C
0 0
3 0
90/90 If it is assumed that the inspection elements were randcmly select d frca the total population rather than frcm each stratum, these data translate into the following overall ccnfidence level statement:
"The NRC is 95'.'
confident that Three Mile Island Unit No. I was operated in compliance with at least 95% of the NRC requirements during the trial inspection program."
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. 4.3 Inspection Effectiveness A review of the actual time required for completion of both portions (SSIP and MC 2515) of the trial inspy. tion program as described in Section 4.2 Table B, indicate that the SSIP recuired 40% of the combined inspection effort while MC 2515 required 60%. A review of related inspection reports and inspector comments relating to the trial inspection program indicate'that tne inspectors are less effective under the SSIP than under MC 2515.
This reduction in inspection effectiveness is con-sidered to be caused by the following:
a.
By requiring review of all data associated with a single regt atory requirement during a specific time interval, less effort can Je expended in determining tne tecnnical adequacy of the most important aspects associated with the functional activity addressed by the regulatory requirement.
b.
The SSIP elements selected as the sample did not require the death of inspection normally conducted under the MC 2515 program.
This difference resulted from the fact that it was necessary to limit each SSIP element to a single regulatory recuirement in order to facili-tate the random sampling process.
The MC 2515 inspection procedures are generally based on the aggregate of regulatory requirements associated with a specific licensee activity.
The SSIP elements in looking at only one 'egal recuirement per c.
inspection procedure, e.g., 50.59 evaluation ccmoleted, or procedure exists, or change reviewed by the on-site review cormittee, recuce the inspectors' ability to determine the overall adequacy of the licensee's program in t'ie area being inspected.
d.
Due to the requisite historical nature of the SSIP, the majority of the inspection effort was expended in paper review and little in inspection of on-going activities.
e.
The SSIP sample is independent of current events.
In selecting the randem sample at the beginning of each annual inspection period, the enmputer has no input to allow the selection to be tailored to changes in plant conditions, unexpected problems, or significant schecule changes.
This approach allows known significant events to pass l
uninspected.
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r 4.4 Insoector Awareness The collective evaluation by the inspectors involved and Region I supervisory personnel was that under the SSI? the inspector was less familiar with activities at the fa'ctlity.
This reduction in familiarity was caused by the SSIP technique of :nspection to verify one specific requirement as compared to a programmatic approach as utilized under MC 2515.
Even with the inspection narrowed to a specific requirement, (e.g.,-50.59 evaluation performed), the depth of the inspection effort was not sufficient -(e.g., no adequacy of evaluation), to provide the inspector with the desired overview of_ the effectiveness of the licensee's management control systems in the area insoected.
Another example of this is associated with review of operating procedures wherein technical r:
adequacy of a specific procedure was not acdressed within the samole that is designed to verify that a procedure has been reviewed and aoproved by the licensee.
It should be noted, however, that other inspection elements required the inspector to ascertain whether the content of the related procedure was adequate for its intended function.
These elements were not necessarily part of the selected sample due to the randemness of the selection process.
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r 4.5 Manacement of Procram The effort required to schedule and maintain status of the SSIP during the trial program was accroximately 300 man-bours per year.
This is the time expended by the principal inscector in inspection scheduling, data verification and orientation of specialist inspectors regarding the SSIP.
It is noted that the average principal inspector requires about 200 man-hours per year per facility for this effort in connection with the MC 2515 inspection program.-
The SSIP as currently structured would be administratively imoractical if implemented at all operating facilities.
This is caused, in part, by inspection elements being tied to the specific recuirements delineated in the technical specifications, 10 CFR, security plan and QA program for operations.
Since many of these requirements are not standardized, the inspection program at each facility would continue to be unique.
It is recognized that inscection elements associated with certain 10 CFR require-ments, Regulatory Guides, and industry standards referenced in technical specifications would be ccmmon to some facilities.
These uniform require-ments are ccunterbalanced by the other facility-unique recuirements to an extent that only a r:odest reduction in mancower/ reactor to manage the SSIP could be achieved in expanding the SSIP to many facilities.
It is noted that a total of 96 changes to requirements in the Three tiile Island Technical Specifications were acproved by the Office of tiuclear Reactor Regulation (i;RR), during. the trial ins::ection program.
Based on current practices, these revisions are effective on the date of issuance.
Under the SSIP, associated inspection procedures wculd have to be revised to reflect the technical specificaticn changes.
This action would necessiate a new inspection sacole and result in a perturbatior, in the overall management of the program for the facility.
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. 4.6 Support Functions The effort required to develop and support an on-going SSIP at all operating facilities may be quantified as follows:
a.
Develocing and maintaining insoection cooulation A part of the cost invc.ved in implementing a SSIP for the inspection of nuclear reactors would be that required to develoo and maintain a population of inspectable elements for each reactor facility.
It is from these populations that samples would be drawn to provide the basis for NRC inspections.
The population develocment for the trial inspection program included a three-ste.n process which resulted in expenditure of the following effort:
Population generation:
Generation of the trial program population recuired four man-weeks of effort.
It is estimated that a reduction to three man-weeks could be effected after the fifth poculation.
If standard techni-cal specifications (STS) become available, a further reduction.is considered possible.
This premise is based on the fact that once elements based on documents other than technical specifications (CFR, Regulatory Guides, etc.) have been defined, they can be used for all populations.
Population verification:
Verification of the population requires a thorough examination of the population to assure that all recuirements are covered ar.d that population elements are properly defined and stratified.
This effort required four man-weeks for the trial program.
It is estimated that this effort can be reduced to three man-weeks af ter the first five populations and tFat further reducticn can be expected if STS are available.
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' Preparation of procedures:
Preparation of procedures selected for the trial inspection program sample required thirty-eight man-weeks of effort.
It should be noted that the sample selected was equivalent to one-sixth of the total population.
Therefore, approximately two hundred man-weeks would be recuired to develop procedures for the comolete population.
It is estimated that approximately 25% of the inspection requirements presently are facility-unique. Therefore, acproximately 50 man-weeks would be required to develop the inspection procedures applicable to each facility.
With regard to TS modifications, a total of five TS changes involving 96 inspection elements were approved during the trial program.
Because actual procedure preparation was approximately 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> per procedure, it can be assumed that forty-eight man-days or ten man-weeks would have been required.to prepare revised procedures.
Over the forty year operating life, this number can most likely be reduced to an average of one man-week per facility / year.
b.
Computerized Succort A computerized program was not utilized for management of the trial inspection program.
It appears that such a program would be com:atible with the. Module Tracking System (MTS) program wnicn was developed for the current Light Water Reactor Inspection program.
It is estimated that two man-years of effort / year would be required to manage the computerized aspects of the program for all operating facilities, c.
Other Mancower Considerations Headquarters effort:
Or.e Headquarters individual was assigned responsibility for review and evaluation of on-going trial program activities.
The manpower recuired for this affort was equivalent to eight man-weeks of effort. A similar functM would be required for any future program.
However, the man-power required could be iedeced to approximately two man-weeks / reactor facility / year.
Regional office effort:
The extra mnagerial effnrt for the trial program is discussed in section 4.5. Manage. ment of program.
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4.7 Imoact on the Licensee A total of 61 and 49 licensee events were reported to the NRC by the trial facility licensee during theiyears ending July 1,1975 and July 1, 1976, respectively. The effect, if any, of the SSIP on the number of Licensee Event Reports (LER) is not obvious.
The number of LER were impacted by facility technical specifications and by the changes in reporting requirements put into effect in 1975.
The nutter is also affected by such things as the quality of the licensee's training program, preventive maintenance programs, procedure quality, time since licensing and management attention.
The licensee's evaluation of the effect of the SSIP as compared to the MC 2515 inspection program was requested during a speci.a1 meeting with onsite licensee management at the conclusion of the trial inspection program.
The lice.1see's evaluation was as follows:
a.
The statistical approach appears to provide a distorted view which would have an adverse impact on the industry.
This distortion results from:
- The positive and negative nature of. the findings, i.e., if 99% of data were satisfactory, but 1% not satisfactory, it would be a negative finding.
- The necessary paper orientation of. SSIP slights two important aspects of an inspection program, personnel performance and hardware perforTance.
This paper orientation is caused by the statistical approach of looking at historical data.
- The narrow focus of the program could cause areas significant to safety to be completely missed.
b.. The regional inspection staff has observed indications that under the SSIP, key licensee supervisory personnel tend to be less involved in systematic prcblem review.
The tender.cy caused by the historical approach of the SSIP is for the licersee supervisory personnel to scend more time in their offices reviewing data to ensure the blanks are filled in and less time in the plant looking for programmatic problems. -Like-wise, the NRC inspectors are less involved with supervisory personnel due, to the increased time spent on specific data review and less time on programmatic adequacy and quality of operations.
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SUWARY AND CONCLUSIONS 5.1 Benefits a.
The SSIP provides a means to quantify the effect of changes in inspection intensity upon the ability to detect r.oncompliance.
b.
If NRC requirements were applied uniformly to all facilities, the SSIP concept would provide a basis for comparative evaluation of licensee performance as related to compliance with NRC requirements.
c.
The SSIP'provides a means to adjust' inspection emphasis by changing strata or confidence levels.
5.2 Costs a.
The cost of identifying noncompliance in tenns of man-days per item was approximately 1.5 times the routine program at the same facility.
b.
The SSIP relies almost exclusively upon record review at the expense of direct observations.
c.
The resources recuired for establishing a SSIP for current operating facilities would be 70 man-years.
d.
The resources required for implementing a SSIP at current operating facilities would be 1.3S man-years / reactor / year.
5.3 Conclusions
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a.
The SSIP does not appear to be a viable inspection concept by itself.
However, the SSIP could be used in concert with a more ccmprehensive inspection program such as the current inspection program.
The value of the SSIP portion of the program would be the provisien of a statis-tical statement.
The value of the SSIP in terms of significant pre-ventive enforcement and facility improvement is limited.
b.
For the SSIP to be a viable management concept, it would require adoption of standard technical specif'utions for all operating facilities.
This action appears necessary to inimize the manpower recuired for develop-ment and management of the Psogram by IE.. Based on hardware differences and site considerations, it is questionable whether standard technical specifications can ever be developed.
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The SSIP limits significantly the inspector's ability to determine the overall adequacy of the licensee's operation.
d.
The SSIP relies primarily on record review; therefore, areas signi-ficant to safety are ~issed.
e.
A broad range of confidence level statements can be developed for use with inspection populations which are most likely to be encountered during inspections of construction and operations chase activities
-at all nuclear power clants, for example, preparation of a simple table whi.ch relates the number of weld radiographs which must be examined with a wide range of confidence level values.
f.
The SSIP concept is not compatible with cbservation of on-going licensee activities because of the random nature of the inspection sample.
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RECO o:E::DATIGilS.
It is reco. mended that:
a.
Expenditure of. further develcpmental effort for the SSIP be terminated.
. b.
Confidence level statements associated with a wide range of populations and sample sizes t:e developed for possible ' application to discrete portions of the inspection and investigation programs.
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