ML20097D375
| ML20097D375 | |
| Person / Time | |
|---|---|
| Site: | South Texas  |
| Issue date: | 02/02/1996 |
| From: | Rosen S HOUSTON LIGHTING & POWER CO. |
| To: | |
| Shared Package | |
| ML20097D352 | List: |
| References | |
| 0PGP02-ZA-003-DRAFT, PGP2-ZA-3-DRAFT, NUDOCS 9602120330 | |
| Download: ML20097D375 (22) | |
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l SOUTH TEXAS PROJECT ELECTRIC GENERATING STATION D0527
= - - - - Rev.O Page 1 of 22 OPGP02-ZA-0003 General Comprehensive Risk Management
. Quality Safety-Related Usage: Available Effective Date: 00/00/00 S. L Rosen C. R. Grantom R.1 Rehkugler Industry Relations PREPARER TECHNICAL llSER COGNIZANT ORGANIZATION Table of Contents Page 1.0 Pu rpo se a n d S c ope . . .. . .. . . .. . .. . . . . . . . . . . .. . . .. . . . . . . .. . . . . . . . . . . . ...... . .. .. . .. . . . ... . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . ..
2.0Defm'itions...................................................................................................................................2 3.0 Re spon s i bil i t i e s .. ... .. .. . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . ..... .. .. . . . . .. . . . . . . . . . ... . . . . . . . . . . . . . . . . . . . . .. . . .. . . . . . . . . ..
4.0 R e q u i re m e n t s . ... . . ... .. . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . .. .. .... ... . . ... . . . . . . . ... . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . .. . . . . . . . . . 4 5.0 Process.................................................................................................................................4 6.0 Records.....................................................................................................................................6 Addendu m i Grad ed Quality Assurance........ . .................. ........... ...................... ....... . ......................7 A d den d u m I , A t tach me n t 1 ... .. . ... .. .. .... . . . ... . ..... .... . ......... ... . .. ....... .. . .. .. .... .. ... . .. ... . . . .......... ..... ... . .. .. 12 A dde n d u m 1, A ttac h me n t 2 .......... ...... ... . . . . .. . .. ... . ........ .. . .... ... .... ......... .. . . . .... . . . .. .... ... . ..... ......... . ... ... . .. 16 A dden d u m 1, A ttach me nt 3 ... .. . ... ..... .... ..... . .. . ....... . . ..... . . ..... .. .. ... .. . .. ... . . . . .. . .... . ........... ...... . .... . 20 1
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,A Page 2 of 22 OPGP02-ZA-0003 Rev.O Comprehensive Risk Management
1.0 Purpose and Scope
1.1 To establish and provide guidance to the Expert Panel and associated Working Groups on the implementation of a risk informed, performance based comprehensive risk management program at STP.
2.0 Definitions 2.1 COMPREHENSIVE RISK MANAGEMENT (CRM)
The process by which the risk to station personnel, the public's health and safety and station economics of station requirements, commitments, processes, activities, human and equipment performance are identified, evaluated and dispositioned.
2.2 GRADED QUALITY ASSURANCE The process by which risk-based methodology [i.e., Probabilistic Safety Assessment (PSA)] and performance-based information analyses are combined to establish appropriate levels of. programmatic controls for systems, components or activities and appropriate levels of first line and independent oversight needed to provide necessary assurance that items will operate safely and activities are accomplished as prescribed.
2.3 EXPERT PANEL l
A multi-disciplinary group ofindividuals whose purpose is to guide the implementation of Comprehensive Risk Management activities at STP.
2.4 WORKING GROUPS Multi-disciplinary groups of individuals who provide risk-informed, performance-based recommendations to the Expert Panel.
2.5 INITIATING EVENT Any event that can cause a plant trip or otherwise initiate a sequence of events with a !
significant probability of core damage.
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.I OPGP02-ZA-0003 Rev.O Page 3 of 22 Comprehensive Risk Management 3.0 Responsibilities 3.1 EXPERT PANEL 3.1.1 Approve the criteria for categorization of systems, components, items and activities.
3.1.2 Validate the categorization of systems, components, items and activities.
3.1.3 Approve the criteria for assignment of Quality Assurance (QA) measures for systems, components, items and activities.
3.1.4 Validate the assignment of QA measures for systems, components, items and activities.
3.1.5 Maintain cognizance over the implementation of the CRM program and adjust program criteria, as appropriate.
3.1.6 Advance STP personnel, NRC staff and public understanding and support for the Comprehensive Risk Management program.
3.1.7 Appoint Expert Panel Working Groups 3.2 WORKING GROUPS 3.2.1 Analyze performance information.
3.2.2 Consider risk insights and risk ranking of systems and components.
3.2.3 Consider the application of processes / work activities / work organizations to systems, components and items relative to risk.
3.2.4 Inject deterministic knowledge / insight.
3.2.5 Develop recommendations, as prescribed in the addenda to this procedure, and provide them to the Expert Panel.
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OPGP02-ZA-0003 Rev.O Page 4 of 22 Comprehensive Risk Management l
3.3 STATION MANAGEMENT 3.3.1 Nominate and provide guidance to members of the Working Groups.
3.3.2 Implement the decisions of the Expert Panel.
3.4 CHANGE MANAGEMENT TEAM 3.4.1 Provide support and peer review for station management as Expert Panel decisions are implemented.
3.5 SENIOR MANAGEMENT TEAM 3.5.1 Maintain strategic level oversight of the CRM Program activities.
3.5.2 Provide resolution of any Expert Panel dissenting opinions.
4.0 Requirements 4.1 The Expert Panel is composed of the Managers of Design and Systems Engineering, Nuclear Licensing, Industry Relations, the Supervising Engineer-Risk and Reliability Analysis, the Director of Quality and the Unit #1 Plant Manager. The Manager ofIndustry Relations is chairman of the Expert Panel.
4.2 Working Groups shall be comprised ofindividuals as listed on the appropriate addenda to this procedure.
4.3 Expen Panel and Working Group personnel shall be trained to this procedure, associated PSA procedures and station performance reporting procedures. They shall additionally receive (or have received) training to the requirements of 10 CFR 50.59 and Root Cause Analysis.
4.4 The Expert Panel identifies activities, processes, commitments and requirements to be evaluated by the working groups.
5.0 Process DRAFT 5.1 Working Groups shall convene at frequencies as established in addenda to this procedure.
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OPGP02-ZA-0003 Rev.O Page 5 of 22 Comprehensive Risk Management i
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5.2 Minimum quorum requirements for Working Group meetings are the chairman and at least three regular members.
5.3 Recommendations shall be arrived at by consensus. Dissenting opinions shall be documented for Expen Panel resolution.
5.4 Using the criteria established in the addenda, the Working Groups shall analyze performance data, consider available risk information and their own deterministic insight, and shall develop recommendations.
5.4.1 Recommendations shall be documented, and shall include rationale and risk ranking / performance information that forms the bases for the recommendations.
i 5.4.2 Recommendations shall be forwarded to the Expert Panel. )
5.5 De Expert Panel shall convene, at a minimum, at the same frequencies as established for Working Groups in the addenda to this procedure.
1 5.6 Minimum quorum requirements for Expert Panel meetings are the chairman and at least l three regular members, one of whom must be the Supervising Engineer-Risk and l Reliability Analysis. There shall be no shon term designee representation.
5.7 Decisions shall be arrived at by consensus. Dissenting opinions shall be documented. Any l dissenting opinions shall be forwarded to the Senior Management Team (SMT) for resolution.
5.8 The Expert Panel shall use the same criteria as the Working Groups in reviewing recommendations and shall inject their own deterministic insight as appropriate.
Dusenting opinions from the Working Groups shall be resolved. )
5.9 De Expen Panel shall accomplish the tasks defined in 3.1 of this procedure and shall document its decisions. These shall be disseminated to the SMT and the Change Management Team (CMT).
5.10 The SMT shall resolve any dissenting opinions that require resolution.
5.11 The CMT shall provide support aEMFe@or station management as Expert Panel decisions are implemented.
OPGP02-ZA-0003 Rev.O Page 6 of 22 i
Comprehensive Risk Management 1
6.0 Records j i
6.1 Records of Expert Panel decisions shall be retained as Quality Assurance records in STP- l RMS, and shall consist of:
6.1.1 Expert Panel decisions.
l 6.1.2 Working Group recommendations / analyses.
l 6.1.3 PSA inputs.
l 6.1.4 Performance information/ analyses.
6.1.5 Other deterministic insight / rationale not covered by 6.1.3 or 6.1.4.
6.1.6 Dissenting opinions and resolutions.
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OPGP02-ZA-0003 Rev.O Page 7 of 22 Comprehensive Risk Management Addendum 1 GRADED QUALITY ASSURANCE Page1of5 This addendum describes the Graded Quality Assurance (GQA) process, prescribes the performance reporting of the Operating Experience Group (OEG), and prescribes the activities of the GQA Working Group. It also prescribes the thought processes / criteria to be applied in formulating recommendations to the Expert Panel. The Expert Panel shall use these same processes / criteria in considering Working Group recommendations when arriving at decisions.
Figure 1 for this Addendum depicts a high level process flow chart for GQA.
~ PSA RISK RANIONG : : : :
. High GQA WORKING GROUP
- Medium ; ; -
- % e Analyzes performarco data e Low e Considers risk ranlong d'
---e= e Ingects determnstic knowledge / insight 1i e Develops recommendations regarding
- , levels of programmate control and activity oversight STATION & INDUSTRY PERFORM ANCE
4s 1'
Document recommendations
& rationale to Expert Panel Ji 3
- Program controls are estatAshed or modfied EXPERT PANEL e Reviews W. G. performance data analyses e Considers rtsk ranking - DOCUMENTED EXPERT _ 1' e inlects determnstic knowdpinsight PANEL DE*
- ISIONS g j 2
- Levels of overview are estabkshed or modifed
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= = = = = =
loNooiNo rEEDSAcxl= =
FIGURE 1 DRAFT
OPGP02-ZA-0003 Rev.O Page 8 of 22 Comprehensive Risk Management Addendum 1 GRADED QUALITY ASSURANCE Page 2 of 5 GRADED QUALITY ASSURANCE:
Attachment I to this addendum describes the two different programs that shall be applied as appropriate for plant items and activities.
Attachment 2 and 3 to this addendum prescribe the thought processes and criteria the Working Group and Expert Panel shall use in determining the appropriate level of program controls to be applied to plant equipment and activities. There are two different programs to be applied in three different manners --
" Full", " Targeted", and " Basic" levels of program control.
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- Full" program controls shall be applied to plant equipment determined to be high safety / risk significance, l plus activities determined to be safety significant or those performed on high risk components. These ,
1 controls represent the highest levels of program controls and line/ independent oversight to be afforded to items or activities and are designed to provide a high degree of assurance that items perform safely and activities are accomplished as expected.
" Targeted" program controls shall be applied to plant equipment and activities which, while not being l
- high risk," are nevertheless significant or important for other reasons (Attachments 2 and 3 delineate those criteria). These controls are actually elements of " full" program controls and are applied to those attributes ofitems or activities which render them significant or important. These controls are designed to provide a high degree of assurance that the items will perform their specific significant function and I activities
- important elements are accomplished, as expected.
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- Basic" program controls shall be applied to plant equipment and activities which, while not being "high risk" or significant/impoitant for other reasons, are nevertheless subject to the controls of 10CFR50 Appendix B. These controls represent fundamental good business practices which comply with applicable Appendix B requirements, and are designed to provide assurance that items perform, and activities are accomplished, as expected.
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OPGP02-ZA-0003 Rev.O Page 9 of 22 Comprehensive Risk Management Addendum I GRADED QUALITY ASSURANCE Page 3 of 5 OPERATING EXPERIENCE GROUP REPORTING:
The OEG compiles and analyzes performance of plant equipment and activities in accordance with OPGP03-XX-XXXX. On a biannual basis,in coordination with Working Group schedules, the OEG shall provide performance reports to the Working Group. These reports shall provide performance information for the current and two prior six months periods, by organization and attributes.
These reports include both positive and negative indicators that are graded on a scale of one to five using the following criteria-
- 1) Sustained excellence
- 2) Good with an improving trend
- 3) Good performance
- 4) Good with a declining trend
- 5) Poor performance For any performance attribute with a rating of four or five, the OEG shall provide accompanying backup information along with the report, for Working Group and Expert Panel analysis purposes.
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Page 10of 22 l OPGP02-ZA-0003 Rev.O Comprehensive Risk Management Addendum 1 GRADED QUALITY ASSURANCE Page 4 of 5 GQA WORKING GROUP:
The GQA Working Group shall be chaired by the representative from Systems Engineering and have members from Design Engineering, Quality, Risk and Reliability Analysis, Operating Experience and Generation. This membership will be augmented as needed, depending on the topics under consideration.
The GQA Working Group members shall be senior level personnel with backgrounds that enable them to render logical recommendations. GQA Working Group membership shall be endorsed by the Expert Panel.
The GQA Working Group shall meet, as a minimum, biannually, to establish and/or adjust levels of programmatic control and oversight.
The GQA Working Group shall consider plant systems / components / items in accordance with Attachment 2 of this addendum. They shall consider plant activities in accordance with Attachment 3 to this addendum. They shall consider plant and activities performance provided by the OEG, as applicable, per those attachments. Specific attention shall be afforded to areas of poor or declining performance, with special attention to activities which have or can have direct effect on plant systems and components. l These considerations, as they may be augmented by group members' deterministic insights, form the bases for recommendations regarding the levels of programmatic controls to be imposed on systems, components, items and activities. They also form the basis for recommending the levels of oversight (both line and independent) that should be afforded to station activities.
I Recommendations developed by the GQA Working Group shall be documented and shall be forwarded to the Expert Panel for their consideration and concurrence. Documentation shall include, as a minimum, I I
the following:
- Detailed recommendations for systems / component / item categorization (i.e., full, targeted or basic levels of control).
- Detailed recommendations for activities categorization (i.e., full, targeted or basic levels of control).
- The bases for making those mcommendations (i.e., including PS A inputs, performance analysis results, details regarding any other deterministic inputs).
Deterministic inputs to be considered by the GQA Working Group shall include areas not within the scope of the PS A including balance of plant performance, instrumentation, mode transition and shutdown operations and proper tregghy reliable components and stmetures.
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l OPGP02-ZA-0003 Rev. O Page 1I of 22 l Comprehensive Risk Management l Addendum 1 GRADED QUALITY ASSURANCE Page 5 of 5 The GQA Working Group shall specifically consider, as a minimum, uncertainties caused by :
- 1. PSA model assumptions
- 2. Common cause or common mode failure rates
- 3. Treatment of support systems
- 4. Level of definition of cut sets and cut set tmncation
- 5. Model assumptions relative to repair and restoration of failed equipment
- 6. Human error rates used in the PSA
- 7. Limitations in the meaning ofimportance measures Any dissenting opinions.
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OPGP02-ZA-0003 Rev.O Page 12 of 22 Comprehensive Risk Management Attachment 1 QUALITY ASSURANCE PROGRAM LEVELS AND Page 1 of 4 DESCRIPTIONS Two separate and distinct programs exist in the GQA Program " Full" and " Basic." For items and activities with high risk ranking, " Full" program controls are applied. For items and activities with ;
medium risk rankings, or determined to be NOT risk significant, yet determined to be significant for other ;
reasons, " Full" program controls will be applied in a selected manner, specifically targeted at those I attributes of the item or activity which render it significant. For items and activities determined to be NOT significant, yet subject to the controls of 10 CFR 50, Appendix B, " Basic" program controls are applied. ;
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OPGP02-ZA-0003 Rev.O Page 13 of 22 Comprehensive Risk Management ;
Attachment 1 QUALITY ASSURANCE PROGRAM LEVELS AND Page 2 of 4 DESCRIPTIONS GRADED QA PROGRAM CONTROLS:
FULL:
Full Program Controls are defined as the highest levels of program controls and oversight that are to be afforded to items and activities. These are in full compliance with the requirements of 10CFR50 Appendix B, and additionally represent compliance with the applicable STP UFSAR commitments relative to USNRC Regulatory Guides and ANSI Standards which they endorse. Other recognized industry standards are applied, as appropriate. These controls shall be prescribed in implementing procedures specific to the item or activity.
Items and activities categorized to receive across-the-board full Program Controls are afforded multi- i tiered levels of oversight consisting of independent / dual line verification as appropriate plus focused independent oversight in the form of audits, perfomiance monitoring, assessment, evaluation, inspection, and/or testing, as appropriate to the item or activity. These items and activities shall remain in this category, regardless of performance, due to their high level of risk significance /importance.
In the event that OEG performance reports indicate a declining trend in performance of these items or activities for two consecutive reporting periods, a "CAQ-S" Condition Report shall be initiated in accordance with OPGP03-ZX-0002, to determine the apparent cause and initiate appropriate corrective actions. If poor performance is indicated, a "S-CAQ" Condition Report shall be initiated (if one has not already been) to effect a root cause investigation and appropriate corrective actions.
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OPGP02-ZA-0003 Rev.O Page 14 of 22 Comprehensive Risk Manags ment Attachment 1 QUALITY ASSURANCE PROGRAM LEVELS AND Page 3 of 4 DESCRIPTIONS GRADED QA PROGRAM CONTROLS (Continued)
TARGETED:
Activities categorized to receive Targeted Full Program Controls are subjected to the same levels of program controls applied to those attributes of the item or activity which placed it into that category. This requires a detailed analysis by the Working Group of the item or activity to determine its attributes. This analysis shall be documented, along with the basis for selection of the full program attributes determined to be appropriate to that item or activity. Until such time as this analysis is completed, across-the-board program controls shall be maintained. These items and activities shall also be afforded multi-tiered levels of line and independent oversight targeted to those attributes which placed them into this category.
Targeted items and activities shall have the same level of Corrective Action Program thresholds as those items and activities categorized for across-the-board Full Program applicability. Any time performance reports indicate declining or poor performance, the Working Group shall additionally revisit the program attributes and oversight applied to those items or activities to confirm that the decisions made were appropriate. Adjustments shall be made, as necessary. These considerations shall be documented and included in the recommendations to the Expert Panel.
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OPGP02-ZA-0003 Rev.O Page 15 of 22 Comprehensive Risk Management Attachment 1 QUALITY ASSURANCE PROGRAM LEVELS AND Page 4 of 4 DESCRIIYTIONS GRADED QA PROGRAM CGNTROLS(Continued):
BASIC:
Basic Program Controls are defined as good business practices which reflect the most economical and efficient means of conducting business while maintaining compliance with the basic requirements of 10CFR50 Appendix B. They do not reflect the strict controls as depicted in USNRC Regulatory Guides and the ANSI standards they endorse. Other industry standards are applied, as appropriate. These controls shall be prescribed in implementing procedures specific to the item or activity.
Items and activities categorized to receive basic levels of program controls shall be afforded minimal levels of oversight. The primary means of verification shall be by the line organization, with periodic selected independent oversight in the form of audits, performance monitoring, assessments, evaluations, inspection, and/or testing as appropriate to the item or activity.
In the event that OEG performance reports indicate declining or poor performance of these items or activities, the Working Group shall revisit the categorization to confirm that it was appropriate. If not (e.g., it should have been categorized as Targeted or higher), the item or activity shall be recategorized and a "CAQ-S" Condition Report shall be initiated to determine the apparent cause of the mis-categorization and effect appropriate corrective actions.
If the Working Group concludes that the categorization is appropriate, the declining or poor performance of the item or activity, by def'mition, cannot constitute a Significant Condition Adverse to Quality; however, remediation of declining or poor performance is desirable. If performance declines for two consecutive reporting periods or is poor, a "CAQ-S" Condition Report shall be initiated to determine the apparent cause and effect the appropriate corrective actions.
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1 OPGP02-ZA-0003 Rev.O Page 16 of 22 Comprehensive Risk Management Attachment 2 CATEGORIZATION OF PLANT Page1of4 SYSTEMS / COMPONENTS Systems / components shall be evaluated / categorized using the following:
- 1) What is the item's PSA risk ranking?
H-M-
L-NM (Not Modeled)-
- 2) Is the item Maintenance Rule significant?
Yes No Specify: l l
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- 3) Has the item directly caused an initiating event? !
Yes No Specify:
- 4) Is the item deterministically important?
Yes No Specify:
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OPGP02-ZA-0003 Rev.O Page 17 of 22 Compreh6nsive Risk Management Attachment 2 CATEGORIZATION OFPIANT Page 2 of 4 SYSTEMS / COMPONENTS
- 5) Is the item imponant related to ALARA, environmental, industrial safety, etc.?
Yes No Specify:
- 6) What are the requirements / commitments applicable to this item?
Specify:
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- 7) Is the item " safety-related"?
Yes No In answering these questions, use the following logic (See Figure 2 for depiction):
If the answer to No.1 is "H", Full Program Control shall be applied. No further consideration is needed. !
If the answer to No. I is not "H", proceed and answer remaining questions.
(NOTE: If any answer to No. 2 through 6 is in the affirmative, no funher consideration is needed. Targeted program controis will be applied to those characteristics / elements of the item which cause the affirmative answer).
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4 OPGP02-ZA-0003 Rev.O Page 18 of 22 Comprehensive Risk Management Attachment 2 CATEGORIZATION OF PLANT Page 3 of 4 SYSTEMS / COMPONENTS
- If the answer to No.1 is not "H" and the answers to No. 2 through 6 are in the negative, answer No. 7.
- If the answer to No. 7 is yes, Basic Program Control will be applied.
- If the answer to No. 7 is no, no further consideration is needed.
In determining the extent of program controls to be applied to items which were categorized by any means other than a high risk ranking, performance of the item and associated work activities shall be considered.
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OPGP02-ZA-0003 Rev.O Page 19 of 22 Comprehensive Risk Management Attachment 2 CATEGORIZATION OF PLANT Page 4 of 4 SYSTEMS / COMPONENTS Figure 2 Categorization of Plant Systems and Components
- LOW RISK SIGNIFICANCE COMPONENTS
& COMPONENTS NOT MODELED IN M '
PROBABILISTIC SAFETY ANALYSIS QUESTIONS e NO NO NO NO NO YES l
COMPONENT *1 ->" 2 5 3 + 4 + 5 + 6 + 7 BASIC QA PROGRAM g
65 IE
) )f lf lf lf lf FULt. TARGETED i QA QA NO QA l PROGRAM PROGRAM QUESTIONS:
- 1. WHAT IS THE RISK RANKING OF THIS COMPONENT 7 HIGH_ MEDIUM LOW NOT MODELED i
- 2. IS IT MAINTENANCE RULE SIGNIFICANT?
3, HAS IT DIRECTLY CAUSED AN INITIATING EVENT 7
- 4. IS IT DETERMINISTICALLY IMPORTANT7
- 6. ARE WE COMMITTED / REQUIRED TO APPLY OA TO THIS COMPONENT?
- 7. IS IT
- SAFETY-RELATED*?
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OPGP02-ZA-0003 Rev.O Page 20 of 22 Comprehensive Risk Management Attachment 3 CATEGORIZATION OF PLANT ACTIVITIES Page 1 of 3 Plant activities shall be evaluated / categorized using the following:
- 1) Is this a PSA modeled, or otherwise, safety significant activity?
Yes No ,
Specify:
1
- 2) Is this activity perfonned on high risk components?
Yes i No I l
l Specify: !
- 3) Has this activity directly caused an initiating event?
Yes No Specify:
- 4) Is this activity important for an ALARA, environmental or industrial safety reason?
Yes No Specify:
. l Na OPGP02-ZA-0003 Rev.O Page 21 of 22 Comprehensive Risk Management Attachment 3 CATEGORIZATION OF PLANT ACTIVITIES Page 2 of 3
- 5) Are we required / committed to apply some type of QA to this activity (e.g., Security, Fire Protection, Emergency Preparedness, etc.)?
Yes No Specify:
- 6) Is this a 10 CFR 50 Appendix B activity?
Yes No Specify:
In answering these questions use the following logic (See Figure 3 for depiction):
If answer to questions No. I or 2 is yes, Full Program Control shall be applied. No further consideration is needed.
If answers to questions No.1 and 2 are no, proceed and answer remaining questions.
(NOTE: If any answer to questions No. 3 through 5 is in the affirmative, no further consideration is needed. Targeted Program Controls will be applied to those attributes of the activity which caused the affirmative answer).
If the answers to No. I and 2 are no, and the answers to 3 through 5 are in the negative, answer No. 6.
If the answer to No. 6 is yes, Basic Program Controls will be applied.
- If the answer to No. 6 is no, no funher consideration is needed.
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s Rev.O Page 22 of 22 OPGP02-ZA-0003 Comprehensive Risk Management CATEGORIZATION OFPLANT ACTIVITIES Page 3 of 3 Attachment 3 In determining the extent of program controls to be applied to activities which were categorized by any means other than Yes" answers to No. I and No. 2, performance of the activity shall be considered.
FIGURE 3 Categorization of Plant Activities m e e m e g3 ACTIVITY > 1 + 2 + 3 + 4 + 5 + 6 >
BASIC OA
-- -~
PROGRAM NO YES YES YES YES YES lf lf lf lf II TARGETED CA NO OA PROGRAM PROGRAM OUESTIONS:
- 2. IS THIS ACTMTY PERFORMED ON HIGH RISK
- 3. HAS THIS ACTMTY DIRECTLY CAUSED AN INITIATING
- 5. ARE WE REQUIRED / COMMITTED TO APPLY OA TO THIS AC1MTY (e g. SECURITY, FIRE PROTECTION, PREPAREDNESS,
- 6. IS THIS A 10 CFR 50 APPENDIX B DRAFT
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t PROCEDURE TITLE: DEVELOPMENT OF GQA BASIC PROGRAM ATTRIBUTES 1.0 PURPOSE AND SCOPE 1.1 This procedure prescribes the process used to evaluate STP program / procedural controls against STP commitments and regulatory requirements, and to identify those program attributes necessary to reflect good business practices and comply t**?
applicable 10CFR50 Appendix B requirements. This procedure applies to those items and activities categorized to receive " basic" program controls as prescribed in OPGPO3-XX-XXXX, Comprehensive Risk Management.
2.0 DEFINITIONS None - applicable definitions are as found in OPGPO3-XX-XXXX.
3.0 RESPONSIBILITIES 3.1 The STP Graded Quality Assurance (GQA) Working Group, with input from associated station organizations, is responsible for coordinating station efforts associated with identification of commitments and evaluation of work processes in accordance with guidance provided in this procedure. It is, additionally, responsible for consideration / analysis of station organization input, formulation or recommendations and submittal to the STP Comprehensive Risk Management (CRM) Expert Panel.
3.2 The STP Quality Department is responsible for support of other station organizations in accomplishing their identification and analysis activities as prescribed in this procedure.
3.3 STP organizations are responsible for compiling needed information, performing GQA Working Group-requested analyses, and providing this information to the Working Group for consideration. They are, additionally, responsible for effecting procedural changes in accor-dance with CRM Expert Panel decisions.
3.4 The STP Senior Management Team (SMT) is responsible for maintaining strategic level oversight of all CRM activities, and for resolving Expert Panel dissenting opinions.
3.5 The STP Change Management Team (CMT) is responsible for ensuring that Expert Panel decisions are effec-tively implemented, in a timely manner.
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b PROCEDURE TITLE: DEVELOPMENT OF GQA BASIC PROGRAM ATTRIBUTES
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4.0 REQUIREMENTS 4.1 As requested by the Working Group, station organi-zations, with support from the STP Quality Depart-ment, shall develop and document listings of station commitments relative to identified work processes, plus a corresponding listing of basic program requirements as found in 10CFR50 Appendix B (see Attachment 1 for an example related to design control activities).
4.2 Responsible station organizations, with support from the Quality Department, shall identify and document the programmatic / procedural attributes in place to satisfy applicable commitments.
4.3 Responsible station organizations, with support from the Quality Department, shall then identify those process attributes which are, required to comply with basic 10CFR50 Appendix B requirements. These represent the minimum mandatory attributes which must be retained in the basic process.
4.4 The results of these actions shall be provided to the GQA Working Group for consideration.
4.5 The Working Group, with support from the Quality Department and responsible station organization, shall confirm the input for accuracy, and shall evaluate remaining (non-mandatory) process attri-butes and determine those which, while not being necessary for Appendix B compliance, represent good business practices and should be retained.
4.6 The Working Group shall develop a set of process change recommendations and submit them to the CRM Expert Panel.
4.7 Minimum quorum requirements for the Working Group, !
consensus methodology and documentation requirements !
for dissenting opinions shall be applied as prescribed l in OPGPO3-XX-XXXX. 1 4.8 The Expert Panel shall confirm the Working Group input for accuracy, and shall render decisions as l to process changes that should occur. Any Working Group dissenting opinions shall be resolved and documented.
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PROCEDURE TITLE: DEVELOPMENT OF GQA BASIC PROGRAM ATTRIBUTES 4.9 Minimum quorum requirements for the Expert Panel, consensus methodology and documentation requirements for dissenting opinions shall be applied as prescribed in OPGPO3-XX-XXXX.
4.10 Expert Panel decisions shall be disseminated to the SMT, CMT and responsible station organizations.
4.11 The SMT shall resolve any dissenting Expert Panel opinions.
4.12 The CMT shall ensure that responsible stations organizations effectively implement Expert Panel decisions, in a timely manner.
5.0 RECORDS 5.1 Expert Panel decisions shall be retained in STP-RMS as Quality records, and shall include, as a minimum:
5.1.1 Expert Panel decisions 5.1.2 Working Group recommendations I l
5.1.3 Results of commitments and requirements i identification 5.1.4 Identification of process attributes related I to commitment satisfaction and regulatory compliance 5.1.5 Resolution of any dissenting opinions l
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. . _ . . . - - - _ . _ . . . . _ = _ _ . _ . _ _ _ . . _ _ _ . . _ _ _ . . _ . _ . _ . _ _ . - - - , _ . . . . . . _ . _ _ _ _ . . . . ~ ..
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,. HIGH SIGNIFICANT COMPONENT LOW SIGNIFICANT COMPONENT l i
! Design Control Design Control l
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- 1) Document selection of 1) Applicable regulatory.
i design inputs. requirements and design bases
- are accurately translated into
- 2) Identify-and document' specifications, drawings, L j changes to design inputs. procedures, and instructions. l l
l 3) During design process, 2) Appropriate quality ;
! perform 50.59 evaluations. standards are specified and j included in design documents ,
i 4) Assure design inputs and any deviations'are accurately translated into J
.! controlled. ;
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specifications, drawings, !
procedures, or instuctions. 3) Materials, parts, !
equipment, and processes ;
- 5) Design activities performed essential to the safety- '
i to approved procedures by related functions shall be l qualified personnel. selected and' reviewed. ,
- 6) Analyses results verified I i.
- 4) Design interface among i and documented. participating organizations j 1 (internal and external) will J
- 7) . Design documents include quality standards. Deviations be identified and controlled. j i
from quality standards shall 5) Procedures shall control i be identified and controlled. the review, approval, release, I
. distribution, and revisions of )
- 8) Alternate quality standards documents involving design documented and approved. interfaces.
- 9) Desing analyses detailed so 6) Design adequacy shall be technically qualified verified by either design personnel can review and review, alternate calculation, verify without recourse to qualification testing, or originator. combination.
- 10) Review for suitability of 7) Verification shall be materials, parts, equipment, performed by individuals or and processes essential to groups other than those who
-function is part of design performed the original design, document preparation and but may be from the same review process. organization.
- 11) Procedures for preparation 8) Verification by testing and review of design documents program shall include suitable require industry standards and qualifications testing of a specifications be used for the prototype unit under the most review in number 10 above. adverse design conditions.
, m n c g]gy, l
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i HIGH SAFETY SIGNIFICANT COMPONENT
- 12) Review of off-the-shelf 9) Design changes, including commercial materials, parts, field changes, shall be and equipment for application subject to design control ;
with quality related commensurate with those structures, systems, and applied to the original design components will be conducted 5-d be approved by the same before selection. organization that performed the original design. (ka
- 13) Design interface among alternate organization may be participating organizations designated)
(internal and external) will be identified and controlled.
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- 14) Adequacy of design and design changes will be j verified. i 14a) Design verification will ,
be performed by qualified personnel to assure adequacy and conformance to specified design input.
14b) Design control procedures specify requirements for selection and performance of design verification.
14c) Design shal1 be verified i
by either design review, alternate calculation, qualification testing, or combination. l 14d) Depth of verification commensurate with importance ;
l to plant safety, complexity of i design, and similarity of design to previous designs.
I 14e) Verification by qualification testing requires:
Procedures shall provide criteria specifying verification by test
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- - Prototype, component, or feature testing shall be performed as early as possible before installation of plant equipment or before the installation becomes irreversible.
Testing shall be performed under conditions that simulate most adverse design conditions determined by analysis.
14f) Design verification shall be performed by competent individuals or groups other than those who performed the original design.
14g) Design verification should not be performed by individuals that have immediate supervisory responsibility for individual performing the design; have specified a singular design approach; have ruled out certain design considerations; i or have established the design inputs for the design. The i supervisor may perform the verification if the supervisor-is the only technically qualified individual and the need is approved and documented by the supervisor's ;
management. !
14h) Design verification will normally be performed prior to release for procurement, manufacture, installation, or use by another design organization. Exceptions
, shall be' justified and documented.
a o-Procedures shall control the i justification of exceptions !
and verification completion of all affected design outputs I prior to relying on the structure, system, or l component to perform its function.
- 15) The approval, issuance, and changes to design documents shall be controlled to prevent inadvertent use of superseded design information.
- 16) Changes to design documents are reviewed and approved by the same groups or organizations which reviewed and approved the original design. If unavailable, another organization may be designated is competent in the specific design area, has access to pertinent background information, and has an adequate understanding of the requirements and intent of the i
original design.
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- 17) Errors and deficiencies found in approved design documents, including methods, shall be documented and action taken to correct and prevent '
recurrence. l
- 18) Maintenance and I modification activities shall be performed to ensure quality at least equivalent to that specified in the UFSAR or other design bases and requirements.
- 19) A list of quality related structures, systems, and components shall be maintained.
- 20) only verified, qualified and controlled computer codes may be authorized for use.
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- 21) Modifications will be l' checked against the design :
change documentation for satisfactory implementation prior to closing out the design change process. '
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