ML20205F725
| ML20205F725 | |
| Person / Time | |
|---|---|
| Site: | Comanche Peak  |
| Issue date: | 06/10/1986 |
| From: | Tomlinson E NRC |
| To: | Trammel C NRC |
| Shared Package | |
| ML20205F644 | List: |
| References | |
| FOIA-87-89 NUDOCS 8703310270 | |
| Download: ML20205F725 (3) | |
Text
_-- ------- --
11~ , ~ s mrA-g1-g9 W-
&%LlN d 7 D #
cj,yg6 .
/A m f .'
hwn : E 574wsm W p
6 6g .- Aw as-f A.2 sy 4&/-s fwe AaA Aym A l r b,A Jn' rep /4 re<- y'yps h d h ar y 0777 lde /k b42 l herrahk i dre chsers;de/
b /~.
640n #- A, pose -
74 wdaje oyo A 2 a sharya'Am A/ 4 anseshard sn de essbi% cy' oise,yarves as oposea' 4 edsswfcar/m fyahadm fofseipmesas dres.a ea/ <a Av./.
7h end.,/fL 2 Jesa odu/g de sune- zGe sie a pfroma/s dyes.
6 don 8- dasst/lwhe? - 76e are .ssrae mois, ve,Jage charp as de kjemy- soyarde 8703310270 870325 6 M[ -
PDR hMA 89 6han a.4 wJA/ du/s anH y,pc
a,peaa J 4se de AspenAdyaey/eJoye..ro aos/sds/ar,Ja A /, a en/ne d.,4erssg ik AsenAed'is d,as fryoahy in ases<s'a.,ce au>K Awa so.s.de). In fev.e f & f,y=;dx i at/
te1fresse d / sea so.ssre) /2 dy'ac /vo ahy/h.s 6/rud d sva/ua4 rb e/ arya siwe if y/m.isJhve f A Jad,6
.a Zeeine,ir'sym 6/imd- EmA46 Oseess -
7hapadn f e r / i.h m b A f che/sadd'In v.2, s A m a.s,
'A4,se Ensi '<a aad ti ss/sys//smer'.sexe i Tha eas &q da -ah,s/a s/eyo G\ ih,9 av.a ,.J a n a. u .
AyV G isn4,is/ia .9e 4wdyser./ a'
(
R) j 'g O re /oik.4 a n d a d a 4 /a a d a s..r oy!/ea. 7bia aie a sAvec C clk p ,s p i n - i / s k ,= s .
Q d.* ,7&/vo 6
- -i- - -
. edmos synsef, reem @,
% /uI initials Dete
- Mk e ese ,
%/M f I
- s. w W L_S(YO (*'[W i<
g $ 7 y M e.t u n
/c e,W 4esrx::, rY/o S. ns,, r> t.er r w="" K M . W - hw f9 M of96t?" /h*C teW Wf 7'ON"/W g O. & mm o9 o v s f t +.rt;-
6 o* Ymoc ter A.so wg -g . f4*g r :.rso y r, v_ #
e, sn< 'bo/n Note end Return Action FB4 For Cleerence Per Conversation Approval Propees Reply As Roemosted For Correction For Your Information See Me e
[_ Ciseulate" investigste Signature F-
~
Jgetify r t Cr _: '-
M KS q E~ />v.l .
Per Ay* P&, -
by n~ -
/
concurrences, disposeis.
DO NOT use this form ency/Pos e Room No.--81dg.
FROIL Neme, non. ~-
-, /YJM
' seet-ter OPTgl FOltM 41 (Rev. 7-76) presa 64: cN-u.ses e ao : 1ser o - set-srs (22 )
CPRT-483 Log # TXX-4875 File # 10068 TEXAS UTILITIES GENERATING COMPAhT SKYW AY TOWrn = 400 NORTH OLIVE STREET. L.B. El
- DALLAS. TEX AB 75201 e ASTA?SEAD June 6, 1986 Mr. Vincent S. Noonan Director of Nuclea'r Reactor Regulation Comanche Peak Project Division of Licensing U. S. Nuclear Regulatory Commission j Washington, D.C. 20555
SUBJECT:
COMANCHE PEAK STEAM ELECTRIC STATION DOCKET NOS. 50-445 and 50-446 CPRT RESULTS REPORTS AND APPENDIX E, REVISION 2
Dear Mr. Noonan:
We transmit herewith the SRT approved Results Reports listed below. The files which contain supporting documentation for these Results Reports have been reproduced in their entirety and are available for public inspection in our Dallas office.
Anyone wishing to inspect these files should contact Ms. Susan Palmer (214/979-8242).
I.a.3 Butt Splice Qualification VII.a.4 Audit Program and Auditor Qualification We shall issue future Results Reports on a periodic basis as they are approved by the CPRT Senior Review Team.
Also enclosed with this submittal is Revision 2 of Appendix E of the CPRT Program Plan. This revision replaces the Appendix E, Revision 1 in its entirety.
Very truly yours,
,{ (Yi R.1 W. G. Counsil WGC:tj Enclosures A DIYiSION OF TEXA5 UTIL1 TEES ELECTRIC COMPANY N hff. - - - - - -
CPRT-482 Log # TUS-4872 File # 10068 TEXAS UTILITIES GENERATING COMPAhT SKYWAY TOWER
- 400 NORTH OIJVE STREET. L.B. SI e DALLAS. TEKAS 78204 1",",,y,5?," June 6, 1986 MEMORANDUM TO: Mr. W. G. Counsil
SUBJECT:
CPRT RESULTS REPORTS We transmit herewith the SRT approved Results Reports listed below. The files which contain supporting documentation for these Results Reports have been reproduced and are available in the Dallas file room for public inspection.
I.a.3 Butt Splice Qualification VII.a.4 Audit Program and Auditor Qualification
&. A r 'W.Beck John Chairman, CPRT Senior Review Team JWB:tj Enclosures I cc: CPRT File A nzvision or texas vrELxTIEs ELECTRIC COMPANY
R;visiens 2-Page 1 of 8 APPENDIX E CPRT Procedure For The Resolution Of Discrepancies Identified by tb4 CPRT A. PURPOSE The purpose of this procedure is to provide instructions for the resolution of discrepancies identified by the CPRT.
'The resolution processes described in this Appendix were primarily developed and designed to address discrepancies identified by the CPRT during the implementation of the ISAPs and DSAPs developed for the CPRT self-initiated investigatory efforts. In order to ensure consistency throughout the CPRT program,' these processes will also be applied in the reporting of the results of the CPRT investigatory efforts for ISAPs and portions of DSAPs that were developed to respond to concerns specifically identified by External Sources.
Additional information related to the development, approval and documentation of corrective actions for all deviations or deficiencies (both specific and programmatic) identified by the CPRT is provided in Appendix H to the CPRT Program Plan.
B. CLASSIFICATION Discrepancies identified by the CPRT are classified into categories of relative significance in order to determine the appropriate follow-up activities required to resolve and close them.
l The following definitions have been established for use in classifying identified discrepancies. The basis for classification -
of each discrepancy shall be documented.
- 1. Design Adequacy All design discrepancies are classified as observations, deviations or deficiencies, depending upon whether the design error resulted in a failure to meet design criteria and l depending on the safety significance of any failures to meet l design criteria. The definitions employed in this area by the CPRT are as follows:
(a) Design Discrepancy
{
Any identified error related to design inputs, implementing documents and outputs for safety-related structures, systems or components that could have an adverse impact on the adequacy of their design.
^
Rsvisient 2 Page 2 of 8 APPENDIX E (Cont'd)
B. CLASSIFICATION (Cont'd)
(b) Design Observation Any identified design discrepancy that has been determined to not constitute a design deviation.
(c) Design Deviation Any identified design discrepancy that has been determined to constitute a verified failure to meet a design commitment or specification. In this regard, design commitments include regulatory requirements, FSAR commitments, other licensing commitments, code commitments or other project-specific design criteria or commitments.
(d) Design Deficiency Any identified design deviation that has been determined to be safety-significant.
(e) Safety-Significant
" Safety 7significant", for purposes of the CPRT Program , is defined to mean that the identified discrepancy, if uncorrected, would result in the loss of capability of the affected system, structure or component to perform its intended safety function. For purposes of the CPRT Program, credit is not allowed for
, redundancy at the component, system, train or structure level.
(f) Programmatic Design Deficiency A set of related design discrepancies that have been determined to constitute an adverse trend that is programmatic in nature.
I This definition, which is employed in the CPRT Program for purposes -
of sample expansion, is more restrictive than that usually applied to the term " safety-significant" for regulatory purposes or in common parlance, in that it ignores redundancies that do exist in real life. [ Compare 10CFR50, Appendix A (Introduction, " Single Failure"); 10CFR50.55(e)(1) . ] Identification of a deficiency as
" safety-significant" for purposes of the CPRT Program, therefore, is not necessarily equivalent to a statement that, in fact, the deficiency, if uncorrected, would have resulted in unsafe operation.
.I R2 vision: 2 Page 3 of 8 APPENDIX E (Cont'd)
B. CLASSIFICATION (Cont'd)
- 2. Construction Adequacy All construction discrepancies are classified either as deviations or deficiencies, depending upon the safety significance of the discrepancy. The definitions employed by the CPRT in this area are as follows:
(a) Construction Deviation Any identified discrepancy related to construction or installation of safety-related hardware that has been ,
determined to constitute a verified failure to construct or install a safety-related structure, system or component in accordance with safety-significant-attributes and criteria contained in design drawings and specifications or installation procedures /
requirements.
(b) Construction Deficiency Any identified construction deviation that has been determined to be safety-significant.
(c) Safety-Significant See B.I.(e) and associated footnote for definition.
(d) Programniatic Construction Deff eiency A set of related construction deviations that has been determined to constitute an adverse trend that is programmatic in nature.
- 3. Testing Program Adequacy All testing discrepancies are classified either as deviations or deficiencies, depending upon the significance of the discrepancy. The definitions employed by the CPRT in this area are as follows:
(a) Testing Deviation Any verified failure to meet a testing program commitment, regulatory requirement or a project specific testing commitment. In this regard, commitments include FSAR commitments and other licensing commitments.
Rivicient 2 Page 4 of 8 APPENDIX E (Cont'd)
B. CLASSIFICATION (Cont'd)
(b) Testing Deficiency Any identified testing deviation that is determined to have resulted in a failure to meet a testing program objective such that retesting is required to demonstrate that the affected structure, system or component is capable of performing its intended safety function.
(c) Programmatic Testing Deficiency A set of related testing deviations that has been determined to constitute an adverse trend that is programmatic in nature.
- 4. QA/QC Program Adequacy All QA/QC program discrepancies are classified either as deviations or deficiencies, depending upon the significance of the discrepancy. The definitions employed by the CPRT in this aree. are as follows:
(a) QA/QC Program Deviation Any verified failure of the QA/QC program to meet regulatory requirements (i.e., 10CFR50 Appendix B),
FSAR commitments or other licensing commitments.
(b) QA/QC Program Deficiency Any identified QA/QC program deviation meeting one or more of the following criteria:
Inadequacy of a QA/QC program element such that substantive revision of the program or other corrective action is required to bring it into compliance with the regulatory requirements, FSAR commitments or other licensing commitments; or Extensive evaluation would be required to determine the effect on the quality of construction.
i
~
,1 Rsvisien: 2 Page 5 of 8 a
-APPENDIX E (Cont'd)
B. CLASSIFICATION (Cont'd)
(c) Programmatic QA/QC Program Deficiency A set of related QA/QC deviations that has been determined to constitute an adverse trend that is programmatic in nature.
- 5. Adverse Trends
( S' k' f. ip CdS5 dd [S74 c .
A trend is a set of related observations and/or deviations having attributes that reflect a discernible commonality.
Examples of possible commonalities include:
The individual, group of individuals or organization performing the safety-related activity; and The program requirements, procedures or controls governing the performance of the safety-related activity.
A trend is considered to be adverse if it is determined that the identifi,ed pattern or commonality is likely to have resulted in the occurrence of an undetected deficiency in the affected area, population or stratum. Adverse trends are also i
referred to as programmatic deficiencies.
Each trend identified by the CPRT will be evaluated to determine whether it is adverse (unless it is processed as an
' unclassified trend). CPRT Review Team Leaders are responsible for performing such evaluations and for making such determinations within their areas of responsibility.
The nature and extent of these evaluations will vary depending upon the nature of the identified trend and the information already available regarding the implications of the trend.
Considerations in this regard include the extent to which:
The boundaries of the trend have been identified; The underlying cause and/or contributing causes of the trend have been identified; The area, population or stratum affected by the trend has been investigated; The potential safety significance of the trend has been identified; and i
--.~ . _ _ . , - -- . - . , , , - . _ - . - - . . . . , - . . ._. , . . - . - . . - _ _ - . , - , - . .
O R2visien: 2 Page 6 of 8 4
APPENDIX E (Cont'd) l B. CLASSIFICATION (Cont'd)
Corrective action has already been taken to address the trend.
The results of these evaluations will be documented and .
retained in the CPRT working files.
l
- 6. Unclassified Deviations Or Trends ,
As noted in the Program Plan (e.g., Program Plan, Section s l IV(A), p.14), it may be determined that it is more practical or expeditious, with respect to a given deviation or set of d',)
f, ,
i deviations or trend, to proceed directly to analysis of root cause and generic implications and to specification of Q7 corrective actions. Where such a determination has been made, performing a safety significance evaluation in respect of the /n h-.
unclassified deviation (s) or an adverse trend analysis in respect of the unclassified trend would serve no purpose and
\4e e
\
will not be done. Such unclassified deviations or trends will l be tracked as deficiencies or adverse trends for purposes of /
root cause and generic implications analysis and for the v purpose of corrective actions.
C. FOLLOW-UP ACTIVITIES CPRT follow-up activities for each classification of discrepancies are listed below. In addition, activities relevant ta corrective action shall be accomplished in accordance with Appendix H of the Program Plan. -
m b-In special cases, actions beyond those listed for any given classification may be warranted. For example, it may be considered appropriate to assess root cause and generic implications for a
[V9f I
\
particular deviation or (non-adverse) trend. Review Team Leaders
,are responsible for identifying any such potential special cases to (g ,
the Senior Review Team. The Senior Review Team in conjunction 7 e with the Review Team Leader will determine what additional action ~ kt is required in such cases.
- 1. (Design) Observations Design observations will be collectively evaluated for the purpose of identifying adverse trend.
.si
- j R;visien: 2 Page 7 of 8 s !
APPENDIX E (Cont'd)
C. FOLLOW-UP ACTIVITIES (Cont'd)
- 2. Deviations l
All deviations will be transmitted to the CPSES Project for ,
evaluation and disposition in accordance with CPSES Project '
. procedures for processing nonconformances.
- The CPRT will determine (to the extent required by Appendix H) that appropriate corrective action has been defined and ;
accomplished for the non-conformance associated with the deviation.
1 All deviations within each area of CPRT activities (i.e.,
design, construction, testing, and QA/QC program) will be collectively evaluated for the purpose of identifying adverse trends.
- 3. Deficiencies (Including Unclassified Deviations) -
All deficiencies will be transmitted to the CPSES Project for evaluation and disposition in accordance with CPSES Project procedures for processing nonconformances.
An investigation of the root cause and/or contributing causes for the deficiency will be conducted.
The generic implications of the deficiency will be evaluated.
This evaluation must be of sufficient scope to provide reasonable assurance that there are no remaining undetected deficiencies within the affected area, population or stratum.
Any additional discrepancies that may be identified as a result of the generic implications evaluation will each be classified and dispositioned in accordance with this Appendix.
In addition, the associated set of such discrepancies will be further evaluated for commonalities that may be indicative of i
an adverse trend.
The CPRT will determine (to the extent required by Appendix H)
, that appropriate corrective action has been accomplished for the non-conformance associated with the deficiency.
The bases for the above-mentioned determinations will be documented.
- 4. Trends
, No specific follow-up activities are required for a trend which has not been classified as an adverse trend.
4 l-
. . a.W "I'
- Ravisien: 2 Page 8 of 8 1
APPENDIX E (Cont'd)
C.. FOLLOW-UP ACTIVITIES (Cont'd)
- 5. Adverse Trends (Including Unclassified Trends) and Programmatic Deficiencies An investigation of the root cause and/or contributing causes of the trend will be conducted.
The generic implications of the trend will be evaluated. This evaluation must be of sufficient scope to provide reasonable assurance that there are no undetected deficiencies within the affected area, population or stratum.
Appropriate corrective actions for any additional deviations or deficiencies identified during the evaluation of generic implications must be defined.
Appropriate corrective action to preclude recurrence in the future must be defintd.
The results of these activities will be documented and ,
retained in the CPRT working files.
- D. CLOSURE For the purpose of the third-party effort, each CPRT-identified discrepancy shall be considered closed when the applicable actions of this procedure have been completed and documented.
+
i.
.-J Log 4 TXX-4875 CPRT-483 File # 10068 i
TEXAS UTILITIES GENERATING COMPANY y3j SKYW AY TOWE R = 400 NORTH OLIVE STREET. L.B. 8 8
- DAILAS. TEX AS ? Stol
- June 6, 1986 UWJ Ai 0f.YS Mr. Vincent S. Noonan Director of Nuclea'r Reactor Regulation Comanche Peak Project Division of Licensing U. S. Nuclear Regulatory Commission Washington, D.C. 20555
SUBJECT:
COMANCHE PEAK STEAM ELECTRIC STATION DOCKET NOS. 50-445 and 50-446 CPRT RESULTS REPORTS AND APPENDIX E, REVISION 2
Dear Mr. Noonan:
We transmit herewith the SRT approved Results Reports listed below. The files which contain supporting documentation for these Results Reports have been reproduced in their entirety and are available for public inspection in our Dallas office.
Anyone wishing to inspect these files should contact Ms. Susan Palmer (214/979-8242).
I.a.3 Butt Splice Qualification VII.a.4 Audit Program and Auditor Qualification he shall issue future Results Reports on a periodic basis as they are approved by the CPRT Senior Review Team.
Also enclosed with this submittal is Revision 2 of Appendixthe E of the CPRT Program Plan. This revision replaces Appendix E, Revision 1 in its entirety.
Very truly yours,
,l (T: ?.JA W. G. Counsil E ures S/5 A DIVESiON OF TEXAS UTTLETIES ELECTRIC COAtPANY
[f -- _ _---
CPRT-482 Log # TUS-4872 File # 10068 TEXAS UTILITIES GENERATING COMPANY SKYWAY TOWEB
- 400 NORTH OUVE STREET. L.B. El e DALLAB.'I'EXAS 78201 Gy,1,y,5c," June 6, 1986 7
MEMORANDUM TO: Mr. W. G. Counsil I
SUBJECT:
CPRT RESULTS REPORTS We transmit herewith the SRT approved Results Reports listed ,
below. The files which contain supporting documentation for these Results Reports have been reproduced and are available in the Dallas file room for public inspection.
I.a.3 Butt Splice Qualification VII.a.4 Audit Program and Auditor Qualification
~
John W. Beck Chairman, CPRT Senior Review Team JWB:tj Enclosures cc: CPRT File g l
A DIY1510N OF TEXAS L71LETIES ELECTRIC COMPANY
Rsvision: 2 Page 1 of 8 APPENDIX E CPRT Procedure For The Resolution Of Discrepancies Identified by the CPRT A. PURPOSE The purpose of this procedure is to provide instructions for the resolution of discrepancies identified by the CPRT.
The resolution processes described in this Appendix were primarily developed and designed to address discrepancies identified by the CPRT during the implementation of the ISAPs and DSAPs developed for the CPRT self-initiated investigatory efforts. In order to ensure-
. consistency throughout the CPRT program, these processes will also be applied in the reporting of the results of the CPRT investigatory efforts for ISAPs and portions'of DSAPs that were
' developed to respond to concerns specifically identified by External Sources.
,. Additional information related to the development, approval and documentation of corrective actions for all deviations or deficiencies (both specific and programmatic) identified by the CPRT is provided in Appendix H to the CPRT Program Plan.
s B. CLASSIFICATION Discrepancies identified by the CPRT are classified into categories of relative significance in order to determine the appropriate
~
follow-up activities required to resolve and close them.
The following definitions have been established for use in classifying identified discrepancies. The basis for classification of each discrepancy shall be documented.
- 1. Design Adequacy -
All design discrepancies are classified as observations, deviations or deficiencies, depending upon whether the design error resulted in a failure to meet design criteria and depending on the safety significance of any failures to meet design criteria. The definitions employed in this area by the CPRT are as follows:
(a) Design Discrepancy Any identified error related to design inputs, implementing documents and outputs for safety-related structures, systems or components that could have an adverse impact on the adequacy of their design.
, Rsvisient 2 Page 2 of 8 APPENDIX E (Cont'd)
B. CLASSIFICATION (Cont'd)
(b) Design Observation Any: identified design discrepancy that has been determined to not constitute a design deviation.
(c) Design Deviation I
Any identified design discrepancy that has been determined to constitute a verified failure to meet a design commitment or specification. In this regard, design commitments include regulatory requirements, FSAR commitments, other licensing commitments, code commitments or other project-specific design criteria or commitments.
1 (d) Design Deficiency Any identified decign deviation that has been determined to be safety-significant.
(e) Safety-Significant
" Safety 7significant", for purposes of the CPRT Program , is defined to mean that the identified discrepancy, if uncorrected, would result in the loss of capability of the affected systes, structure or component to perform its intended safety function. For purposes of the CPRT Program, credit is not allowed for redundancy at the component, system, train or structure level.
! (f) Programmatic Design Deficiency A set of related design discrepancies that have been determined to constitute an adverse trend that is programmatic in nature.
' This definition, which is employed in the CPRT Program for purposes of sample expansion, is more restrictive than that usually applied .
to the term " safety-significant" for regulatory purposes or in common parlance, in that it ignores redundancies that do exist in real life. [ Compare 10CFR50, Appendix A (Introduction, " Single Failure"); 10CFR50.55(e)(1) . ] Identification of a deficiency as
" safety-significant" for purposes of the CPRT Program, therefore, is not necessarily equivalent to a statement that, in fact, the deficiency, if uncorrected, would have resulted in unsafe operation.
l
R2 vision: 2 Page 3 of 8 APPENDIX E (Cont'd)
B. CLASSIFICATION (Cont'd)
- 2. Construction Adequacy All construction discrepancies are classified either as deviations or deficiencies, depending upon the safety significance of the discrepancy. The definitions employed by the CPRT in this area are as follows:
(a) Construction Deviation
. Any identified discrepancy related to construction or installation of safety-related hardware that has been determined to constitute a verified failure to construct or install a safety-related structure, system or component in accordance with safety-significant attributes and criteria contained in design drawings and specifications or installation procedures /
requirements.
(b) Construction Deficiency Any identified construction deviation that has been determined to be safety-significant.
(c) Safety-Significant See B.1.(e) and associated footnote for definition.
(d) Programmatic Construction Deficiency A set of related construction deviations that has been determined to constitute an adverse trend that is programmatic in nature.
- 3. Testing Program Adequacy All testing discrepancies are classified either as deviations or deficiencies, depending upon the significance of the discrepancy. The definitions employed by the CPRT in this area are as follows:
(a) Testing Deviation Any verified failure to meet a testing program commitment, regulatory requirement or a project specific testing commitment. In this regard, commitments include FSAR commitments and other licensing commitments.
Rsvision: 2 Page 4 of 8 APPENDIX E (Cont'd)
B. CLASSIFICATION (Cont'd)
(b) Testing Deficiency Any identified testing deviation that is determined to have resulted in a failure to meet a testing program objective such that retesting is required to demonstrate that the affected structure, system or component is capable of performing its intended safety function.
(c) Programmatic Testing Deficiency A set of related testing deviations that has been determined to constitute an adverse trend that is programmatic in nature.
- 4. QA/QC Program Adequacy All QA/QC program discrepancies are classified either as 4 deviations or deficiencies, depending upon the significance of the discrepancy. The definitions employed by the CPRT in this area are as follows:
(a) QA/QC Program Deviation Any verified failure of the QA/QC program to meet regulatory requirements (i.e., 10CFR50 Appendix B),
FSAR commitments or other licensing commitments.
(b) QA/QC Program Deficiency Any identified QA/QC program deviation meeting one or more of the following criteria:
Inadequacy of a QA/QC program element such that substantive revision of the program or other corrective action is required to bring it into compliance with the regulatory requirements, FSAR commitments or other licensing commitments; or Extensive evaluation would be required to determine the effect on the quality of construction.
- . , . - - -y- , . - - - - . , - . _ . . . . . -. .-. - . - - . - - - - . - . - - , , , - . . _ _ - -
~~
Rsviaicn: 2 Page 5 of 8 APPENDIX E (Cont'd) l B. CLASSIFICATION (Cont'd)
(c) Programmatic QA/QC Program Deficiency A set of related QA/QC deviations that has been determined to constitute an adverse trend that is programmatic in nature.
- 5. Adverse Trends A trend is a set of related observations and/or deviations having attributes that reflect a discernible commonality.
Examples of possible commonalities include:
The individual, group of individuals or organization performing the safety-related activity; and The program requirements, procedures or controls governing the performance of the safety-related activity.
A trend is considered to be adverse if it is determined that the identified pattern or commonality is likely to have resulted in the occurrence of an undetected deficiency in the affected area, population or stratum. Adverse trends are also referred to as programmatic deficiencies.
Each trend identified by the CPRT will be evaluated to determine whether it is adverse (unless it is processed as an unclassified trend). CPRT Review Team Leaders are responsible for performing such evaluations and for making such determinations within their areas of responsibility.
The nature and extent of these evaluations will vary depending upon the nature of the identified trend and the information already available regarding the implications of the trend.
Considerations in this regard include the extent to which:
The boundaries of the trend have been identified; The underlying cause and/or contributing causes of the trend have been identified; The area, population or stratum affected by the trend has been investigated; The potential safety significance of the trend has been identified; and
R;visien: 2 Page 6 of 8 e
APPENDIX E (Cont'd)
B. CLASSIFICATION (Cont'd)
Corrective action has already been taken to address the trend.
The results of these evaluations will be documented and retained in the CPRT working files.
- 6. Unclassified Deviations Or Trends As noted in the Program Plan (e.g., Program Plan,Section IV(A), p.14), it may be determined that it is more practical or expeditious, with respect to a given deviation or set of deviations or trend, to proceed directly to analysis of root cause and generic implications and to specification of corrective actions. Where such a determination has been made, performing a safety significance evalua' tion in respect of the unclassified deviation (s) or an adverse trend analysis in respect of the unclassified trend would serve no purpose and will not be done. Such unclassified deviations or trends will be tracked as deficiencies or adverse trends for purposes of root cause and generic implications analysis and for the purpose of corrective actions.
l C. FOLLOW-UP ACTIVITIES CPRT follow-up activities for each classification of discrepancies
- are listed below. In addition, activities relevant to corrective
- action shall be accomplished in accordance with Appendix H of the
} Program Plan.
In special cases, actions beyond those listed for any given classification may be warranted. For example, it may be considered appropriate to assess root cause and generic implications for a particular deviation or (non-adverse) trend. Review Team Leaders are responsible for identifying any such potential special cases to the Senior Review Team. The Senior Review Team in conjunction with the Review Team Leader will determine what additional action is required in such cases.
- 1. (Design) Observations Design observations will be collectively evaluated for the purpose of identifying adverse trend.
Rsvisient. 2 Page 7 of 8 o
APPENDIX E (Cont'd)
C. FOLLOW-UP ACTIVITIES (Cont'd)
- 2. Deviations All deviations will be transmitted to the CPSES Project for evaluation and disposition in accordance with CPSES Project procedures for processing nonconformances.
The CPRT will determine (to the extent required by Appendix H) that appropriate corrective action has been defined and accomplished for the non-conformance associated with the deviation.
All deviations within each area of CPRT activities (i.e.,
design, construction, testing, and QA/QC program) will be collectively evaluated for the purposa of identifying adverse trends. '
- 3. Deficiencies (Including Unclassified Deviations)
All deficiencies will be transeitted to the CPSES Project for
- evaluation and disposition in accordance with CPSES Project procedures for processing nonconformances.
An investigation of the root cause and/or contributing causes
- . for the deficiency will be conducted.
The generic implications of the deficiency will be evaluated.
This evaluation must be of sufficient scope to provide reasonable assurance that there are no remaining undetected deficiencies within the affected area, population or stratum.
Any additional discrepancies that may be identified as a result of the generic implications evaluation will each be classified and dispositioned in accordance with this Appendix.
' In addition, the associated set of such discrepancies will be further evaluated for commonalities that may be indicative of an adverse trend.
The CPRT will determine (to the extent required by Appendix H) that appropriate corrective action has been accomplished for the non-conformance associated with the deficiency.
4 The bases for the above-mentioned determinations will be
, documented.
- 4. Trends 1
No specific follow-up activities are required for a trend which has not been classified as an adverse trend.
l l
i-
y-r.
Rivision: 2 Page 8 of 8 o
APPENDIX E (Cont'd)
C. FOLLOW-UP ACTIVITIES (Cont'd)
- 5. Adverse Trends (Including Unclassified Trends) and Programmatic Deficiencies An investigation of the root cause and/or contributing causes of the trend will be conducted.
The generic implications of the trend will be evaluated. This evaluation must be of sufficient scope to provide reasonable assurance that there are no undetected deficiencies within the affected area, population or stratum.
Appropriate corrective actions for any additional deviations or deficiencies identified during the evaluation of generic implications must be defined.
Appropriate corrective action to preclude recurrence in the future must be defined.
The results of these activities will be documented and ,
retained in the CPRT working files.
D. CLOSURE For the purpose of the third-party effort, each CPRT-identified discrepancy shall be considered closed when the applicable actions of this procedure have been completed and documented.
m = -" -- ~- m m - , - -