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{{#Wiki_filter:Proposal to Modify Treatment of Greater than Green Performance IndicatorsROP Public MeetingApril 24, 2019  
{{#Wiki_filter:Proposal to Modify Treatment of Greater than Green Performance Indicators ROP Public Meeting April 24, 2019


===Background===
===Background===
*ROP enhancement recommendation 2B.5  
* ROP enhancement recommendation 2B.5 - prompt closure of White findings
-prompt closure of White findings
* Adopting the recommendation would:
*Adopting the recommendation would:
  - Encourage prompt evaluation, correction, and independent verification via inspection
-Encourage prompt evaluation, correction, and independent verification via inspection
  - Potentially impair aggregation of White findings - one of the ways ROP detects declining performance
-Potentially impair aggregation of White findings  
* Overall staff believes the recommendation benefits safety and recommends adoption
-one of the ways ROP detects declining performance
* Staff noted that this benefit did not extend to the manner in which GTG PIs are treated; explored whether GTG PI treatment should be modified 2
*Overall staff believes the recommendation benefits safety and recommends adoption
 
*Staff noted that this benefit did not extend to the manner in which GTG PIs are treated; explored whether GTG PI treatment should be modified 2
Current Treatment of GTG PIs White input Parallel Finding Column 2 Column 2 All Green When PI becomes White     PI might return to Green    Supplemental inspection
Current Treatment of GTG PIsWhite inputColumn 2Parallel FindingWhen PI becomes White
* White assessment input before supp. inspection
*White assessment input
* Close issue or keep open
*Action Matrix Column 2
* Action Matrix Column 2
*Supplemental inspection scheduledPI might return to Green before supp. inspection
* No longer a White
*No longer a White assessment input, even if no corrective actions taken or no supplemental inspection
* If PI has returned to Green
*Action Matrix Column 2Supplemental inspection
* Supplemental inspection    assessment input, even if  but issue not closed, scheduled                  no corrective actions      parallel White finding is taken or no supplemental    opened.
*Close issue or keep open
inspection
*If PI has returned to Green but issue not closed, parallel White finding is opened.*Parallel White finding backdated to when PI returned to GreenColumn 2All Green 3 Current Treatment of PIs Example
* Parallel White finding
*Unplanned scrams PI White in 3Q2016 and 4Q2016, returned to Green in 1Q2017
* Action Matrix Column 2      backdated to when PI returned to Green 3
*Plant moved to Column 2 and remains in Column 2 pending supplemental inspection, even with all Green inputs 4
 
Current Treatment of PIs Example
* Unplanned scrams PI White in 3Q2016 and 4Q2016, returned to Green in 1Q2017
* Plant moved to Column 2 and remains in Column 2 pending supplemental inspection, even with all Green inputs 4
 
Current Treatment of PIs Example
Current Treatment of PIs Example
*Notification of readiness for inspection received in June 2017*Inspection conducted in August 2017
* Notification of readiness for inspection received in June 2017
-Identified significant weaknesses in causal evaluations for scrams in March and June 2016
* Inspection conducted in August 2017
-Parallel White finding issued in 4Q2017 and backdated to 1Q2017 (when PI returned Green)
    - Identified significant weaknesses in causal evaluations for scrams in March and June 2016
*Parallel finding closed by inspection in 2Q20182Q20163Q20164Q20161Q20172Q20173Q20174Q20171Q20182Q2018Unplanned Scrams PIParallel White opened back to 1Q2017 95001 completed 6/28/18Scrams PI parallel white findingN/AN/AN/Aparallel WhiteAction Matrix ColumnColumn 1Column 2Column 2Column 2Column 2Column 2Column 2Column 2Column 2Assessment InputsAll Green1 White1 WhiteAll Green revised to 1 WhiteAll Green revised to 1 WhiteAll Green revised to 1 White1 White1 White1 White 5 Historical Data Review
    - Parallel White finding issued in 4Q2017 and backdated to 1Q2017 (when PI returned Green)
*Excluded Yellow and Red Findings and PIs
* Parallel finding closed by inspection in 2Q2018 2Q2016  3Q2016  4Q2016    1Q2017        2Q2017      3Q2017      4Q2017        1Q2018  2Q2018 Parallel White          95001 Unplanned Scrams PI                                                                                  opened back           completed to 1Q2017             6/28/18 Scrams PI parallel white finding    N/A    N/A      N/A  parallel White Action Matrix Column            Column 1 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 All Green    All Green    All Green Assessment Inputs                All Green 1 White  1 White  revised to 1 revised to 1 revised to 1 1 White      1 White 1 White White        White        White 5
*Excluded White inputs encompassed in 95002 or 95003 inspections
 
*Could not locate licensee readiness dates for some inspections, particularly early in ROP
-These inspections not included in timing data 6
Historical Data Review
Historical Data Review
*Focus on common part of process
* Excluded Yellow and Red Findings and PIs
-after GTG finding issued or PI submitted
* Excluded White inputs encompassed in 95002 or 95003 inspections
*White PI start time: first day of quarter in which White PI reported-Ex: By 1/21/15 a 4Q2014 White PI is submitted. Start date assumed to be 1/1/15.
* Could not locate licensee readiness dates for some inspections, particularly early in ROP
*White finding start time: date of issuance of final significance
  - These inspections not included in timing data 6
*This is the point in both processes when it is known that a supplemental inspection will occurWhite FindingsSignificance determinationWhite PIsVarious PI occurrencesPrepare for IP 95001 inspection and notify NRC of readinessNRC schedules and conducts IP 95001T=0 7 Historical Data ReviewWhite FindingsWhite PIsTimefor supplemental inspection readiness127 days average(2% greater than 1 year)(7% greater than 3 quarters)202 days average(9% greater than 1 year)(26% greater than 3 quarters)Time for agency to complete supplemental inspection66 days71 daysWhite FindingsSignificance determinationWhite PIsVarious PI occurrences127 days66 days202 days71 days 8 Historical Data Review
 
*Time until readiness for White PIs has been increasing while decreasing for White findings 9
Historical Data Review
Historical Data Review
*Similar trend observed in overall timelines from finding start date/PI submittal to completed supplemental inspection 10 Data Conclusions
* Focus on common part of process - after GTG finding issued or PI submitted
*Licensees taking more time to prepare for supplemental inspections for PIs than Findings
* White PI start time: first day of quarter in which White PI reported
*The "readiness gap" is widening 11 Data Conclusions
      - Ex: By 1/21/15 a 4Q2014 White PI is submitted. Start date assumed to be 1/1/15.
*Increase in time for readiness of inspection of White PIs despite White PIs shifting into IE cornerstone
* White finding start time: date of issuance of final significance
*IE cornerstone PIs involve discrete events that are individually evaluated when they occur, which would seem to streamline supplemental inspection preparation 12 Data Conclusions
* This is the point in both processes when it is known that a supplemental inspection will occur T=0 White Findings Significance determination  Prepare for IP 95001 inspection NRC schedules and White PIs      Various PI occurrences      and notify NRC of readiness    conducts IP 95001 7
*PIs are data driven so staff does not believe increased time is due to disagreement with characterization of the issue
 
*Does not appear to be due to IP 95001 scope concerns since the readiness trend (and overall timeline trend) for GTG findings is decreasing
Historical Data Review White Findings                    White PIs Time for supplemental          127 days average              202 days average inspection readiness (2% greater than 1 year)      (9% greater than 1 year)
*The four quarter requirement for GTG findings may be a reason for the trend toward quicker readiness for GTG finding supplemental inspections 13 Data Conclusions 14 Proposed Treatment of GTG PIsWhen PI becomes White
(7% greater than 3 quarters) (26% greater than 3 quarters)
*White parallel finding isopened and is the assessment input
Time for agency to            66 days                        71 days complete supplemental inspection White Findings Significance determination          127 days              66 days White PIs      Various PI occurrences                      202 days                      71 days 8
*Action Matrix Column 2
 
*Supplemental inspection scheduled when licensee is readyPI data reported as usual
Historical Data Review
*PIdata might return to Green or stay GTG
* Time until readiness for White PIs has been increasing while decreasing for White findings 9
*Either way the parallel finding is tracking the issue that must be inspectedSupplemental inspection
 
*Either closes the parallel finding or keeps it open
Historical Data Review
*If closed, plant moves to Column 1 even if PI hits haven't rolled off PI calculation yetParallel FindingColumn 2Column 1Parallel Finding closed by inspection 15 Proposed Treatment of GTG PIs
* Similar trend observed in overall timelines from finding start date/PI submittal to completed supplemental inspection 10
*Benefits of proposed approach:
 
-Encourages prompt correction and inspection of issues*PI hits can be removed once inspection closes the parallel finding
Data Conclusions
*Action Matrix movement upon inspection completion
* Licensees taking more time to prepare for supplemental inspections for PIs than Findings
-Elimination of backdated parallel findings
* The readiness gap is widening 11
*Enhances regulatory certainty
 
*More timely and stable assessment results 16 Proposed Treatment of GTG PIs Example 1
Data Conclusions
*Revisiting the unplanned scrams GTG PI example2Q20163Q20164Q20161Q20172Q20173Q20174Q20171Q20182Q2018Unplanned Scrams PIParallel White opened back to 1Q2017 95001 completed 6/28/18Scrams PI parallel white findingN/AN/AN/Aparallel WhiteAction Matrix ColumnColumn 1Column 2Column 2Column 2Column 2Column 2Column 2Column 2Column 2Assessment InputsAll Green1 White1 WhiteAll Green revised to 1 WhiteAll Green revised to 1 WhiteAll Green revised to 1 White1 White1 White1 White2Q20163Q20164Q20161Q20172Q20173Q20174Q20171Q20182Q2018Unplanned Scrams PIParallel finding opened 95001 completed 6/28/18Action Matrix ColumnColumn 1Column 2Column 2Column 2Column 2Column 2Column 2Column 2Column 2Assessment InputsAll Green1 White1 White1 White1 White1 White1 White1 White1 White 17 Proposed Treatment of GTG PIs Example 2
* Increase in time for readiness of inspection of White PIs despite White PIs shifting into IE cornerstone
*Assume PI went White in 4Q2017 due to scrams in 1Q2017 and 4Q2017
* IE cornerstone PIs involve discrete events that are individually evaluated when they occur, which would seem to streamline supplemental inspection preparation 12
*2 additional scrams in 2Q2018 18 Proposed Treatment of GTG PIs Example 2
 
*After going White in 4Q2017 the PI returned to Green in 1Q2018
Data Conclusions
*Two additional scrams in 2Q2018 drove the PI White again
* PIs are data driven so staff does not believe increased time is due to disagreement with characterization of the issue
-Supplemental inspection had not been scheduled yet*Supplemental inspection completed in December 2018 and plant moved to Column 1 19 Proposed Treatment of GTG PIs Example 2
* Does not appear to be due to IP 95001 scope concerns since the readiness trend (and overall timeline trend) for GTG findings is decreasing
*Existing process provided little incentive for prompt evaluation and readiness for supplemental inspection, until the two additional scrams drove the PI White again
* The four quarter requirement for GTG findings may be a reason for the trend toward quicker readiness for GTG finding supplemental inspections 13
*Under the proposal, had a supplemental inspection closed the White PI issue before the end of 2Q2018, the new PI hits would not have resulted in a White PI in 3Q2018 20 Proposed Treatment of GTG PIs 21 Conclusion
 
*Staff believes current treatment of GTG PIs should be enhanced
Data Conclusions 14
-Process does not encourage prompt evaluation, correction, and inspection
 
-Regulatory uncertainty due to backdating of parallel findings-Delayed performance assessment
Proposed Treatment of GTG PIs Parallel Finding Parallel Finding closed by inspection Column 2                                                  Column 1 When PI becomes White           PI data reported as usual  Supplemental inspection
-Data review shows that readiness for PI supplemental inspections lags supplemental inspections for findings 22 ConclusionGTG FindingGTG PIWhitefinding issued, plant moves to Column 2White PI reported, parallel finding opened and plant moves to Column 2White finding remains open assessment inputuntil supplemental inspection completedParallel finding remains open assessment inputuntil supplemental inspection completedCorrective actions completedCorrective actions completed, PI might return to GreenSupplemental inspection completed
* White parallel finding is
*Findingis closed and removed from assessment process
* PI data might return to
*Finding cannot be closed and remains open until future inspectionSupplemental inspection completed
* Either closes the parallel opened and is the                 Green or stay GTG          finding or keeps it open assessment input
*Finding is closed and removed from assessment process, PI hits removed
* Either way the parallel
*Finding cannot be closed andremains open until future inspection 23 Next Steps
* If closed, plant moves to
*Commission paper votes:
* Action Matrix Column 2            finding is tracking the    Column 1 even if PI hits
-Proposal to modify closure of GTG findings to supplemental inspection completion
* Supplemental inspection          issue that must be        havent rolled off PI scheduled when licensee          inspected                  calculation yet is ready 15
-Proposal to modify treatment of GTG PIs
 
*Staff recommending that both changes be adopted*If approved, would engage with industry on guidance revisions to accommodate removal of PI hits once inspected and closed 24 Questions}}
Proposed Treatment of GTG PIs
* Benefits of proposed approach:
  - Encourages prompt correction and inspection of issues
* PI hits can be removed once inspection closes the parallel finding
* Action Matrix movement upon inspection completion
  - Elimination of backdated parallel findings
* Enhances regulatory certainty
* More timely and stable assessment results 16
 
Proposed Treatment of GTG PIs Example 1
* Revisiting the unplanned scrams GTG PI example 2Q2016    3Q2016    4Q2016    1Q2017        2Q2017      3Q2017      4Q2017        1Q2018  2Q2018 Parallel White          95001 Unplanned Scrams PI                                                                                  opened back           completed to 1Q2017             6/28/18 Scrams PI parallel white finding    N/A      N/A      N/A  parallel White Action Matrix Column            Column 1 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 All Green     All Green    All Green Assessment Inputs                All Green 1 White  1 White  revised to 1 revised to 1 revised to 1 1 White      1 White 1 White White        White        White 2Q2016    3Q2016    4Q2016    1Q2017        2Q2017      3Q2017      4Q2017        1Q2018  2Q2018 Parallel                                                                          95001 Unplanned Scrams PI                        finding                                                                         completed opened                                                                           6/28/18 Action Matrix Column            Column 1 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Assessment Inputs                All Green 1 White  1 White  1 White      1 White      1 White      1 White      1 White 1 White 17
 
Proposed Treatment of GTG PIs Example 2
* Assume PI went White in 4Q2017 due to scrams in 1Q2017 and 4Q2017
* 2 additional scrams in 2Q2018 18
 
Proposed Treatment of GTG PIs Example 2
* After going White in 4Q2017 the PI returned to Green in 1Q2018
* Two additional scrams in 2Q2018 drove the PI White again
    - Supplemental inspection had not been scheduled yet
* Supplemental inspection completed in December 2018 and plant moved to Column 1 19
 
Proposed Treatment of GTG PIs Example 2
* Existing process provided little incentive for prompt evaluation and readiness for supplemental inspection, until the two additional scrams drove the PI White again
* Under the proposal, had a supplemental inspection closed the White PI issue before the end of 2Q2018, the new PI hits would not have resulted in a White PI in 3Q2018 20
 
Proposed Treatment of GTG PIs 21
 
Conclusion
* Staff believes current treatment of GTG PIs should be enhanced
  - Process does not encourage prompt evaluation, correction, and inspection
  - Regulatory uncertainty due to backdating of parallel findings
  - Delayed performance assessment
  - Data review shows that readiness for PI supplemental inspections lags supplemental inspections for findings 22
 
Conclusion GTG Finding                                      GTG PI White finding issued, plant moves to Column 2 White PI reported, parallel finding opened and plant moves to Column 2 White finding remains open assessment input  Parallel finding remains open assessment input until supplemental inspection completed      until supplemental inspection completed Corrective actions completed                  Corrective actions completed, PI might return to Green Supplemental inspection completed            Supplemental inspection completed
* Finding is closed and removed from
* Finding is closed and removed from assessment process                            assessment process, PI hits removed
* Finding cannot be closed and remains open
* Finding cannot be closed and remains open until future inspection                        until future inspection 23
 
Next Steps
* Commission paper votes:
  - Proposal to modify closure of GTG findings to supplemental inspection completion
  - Proposal to modify treatment of GTG PIs
* Staff recommending that both changes be adopted
* If approved, would engage with industry on guidance revisions to accommodate removal of PI hits once inspected and closed 24
 
Questions}}

Latest revision as of 20:24, 19 October 2019

Proposal to Modify Treatment of Greater than Green Performance Indicators Presentation 04/24/2019
ML19107A491
Person / Time
Issue date: 04/24/2019
From: Alex Garmoe
NRC/NRR/DIRS/IRAB
To:
Garmoe A
References
Download: ML19107A491 (25)


Text

Proposal to Modify Treatment of Greater than Green Performance Indicators ROP Public Meeting April 24, 2019

Background

  • ROP enhancement recommendation 2B.5 - prompt closure of White findings
  • Adopting the recommendation would:

- Encourage prompt evaluation, correction, and independent verification via inspection

- Potentially impair aggregation of White findings - one of the ways ROP detects declining performance

  • Overall staff believes the recommendation benefits safety and recommends adoption
  • Staff noted that this benefit did not extend to the manner in which GTG PIs are treated; explored whether GTG PI treatment should be modified 2

Current Treatment of GTG PIs White input Parallel Finding Column 2 Column 2 All Green When PI becomes White PI might return to Green Supplemental inspection

  • White assessment input before supp. inspection
  • Close issue or keep open
  • Action Matrix Column 2
  • No longer a White
  • If PI has returned to Green
  • Supplemental inspection assessment input, even if but issue not closed, scheduled no corrective actions parallel White finding is taken or no supplemental opened.

inspection

  • Parallel White finding
  • Action Matrix Column 2 backdated to when PI returned to Green 3

Current Treatment of PIs Example

  • Unplanned scrams PI White in 3Q2016 and 4Q2016, returned to Green in 1Q2017
  • Plant moved to Column 2 and remains in Column 2 pending supplemental inspection, even with all Green inputs 4

Current Treatment of PIs Example

  • Notification of readiness for inspection received in June 2017
  • Inspection conducted in August 2017

- Identified significant weaknesses in causal evaluations for scrams in March and June 2016

- Parallel White finding issued in 4Q2017 and backdated to 1Q2017 (when PI returned Green)

  • Parallel finding closed by inspection in 2Q2018 2Q2016 3Q2016 4Q2016 1Q2017 2Q2017 3Q2017 4Q2017 1Q2018 2Q2018 Parallel White 95001 Unplanned Scrams PI opened back completed to 1Q2017 6/28/18 Scrams PI parallel white finding N/A N/A N/A parallel White Action Matrix Column Column 1 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 All Green All Green All Green Assessment Inputs All Green 1 White 1 White revised to 1 revised to 1 revised to 1 1 White 1 White 1 White White White White 5

Historical Data Review

  • Excluded Yellow and Red Findings and PIs
  • Excluded White inputs encompassed in 95002 or 95003 inspections
  • Could not locate licensee readiness dates for some inspections, particularly early in ROP

- These inspections not included in timing data 6

Historical Data Review

  • Focus on common part of process - after GTG finding issued or PI submitted
  • White PI start time: first day of quarter in which White PI reported

- Ex: By 1/21/15 a 4Q2014 White PI is submitted. Start date assumed to be 1/1/15.

  • White finding start time: date of issuance of final significance
  • This is the point in both processes when it is known that a supplemental inspection will occur T=0 White Findings Significance determination Prepare for IP 95001 inspection NRC schedules and White PIs Various PI occurrences and notify NRC of readiness conducts IP 95001 7

Historical Data Review White Findings White PIs Time for supplemental 127 days average 202 days average inspection readiness (2% greater than 1 year) (9% greater than 1 year)

(7% greater than 3 quarters) (26% greater than 3 quarters)

Time for agency to 66 days 71 days complete supplemental inspection White Findings Significance determination 127 days 66 days White PIs Various PI occurrences 202 days 71 days 8

Historical Data Review

  • Time until readiness for White PIs has been increasing while decreasing for White findings 9

Historical Data Review

  • Similar trend observed in overall timelines from finding start date/PI submittal to completed supplemental inspection 10

Data Conclusions

  • Licensees taking more time to prepare for supplemental inspections for PIs than Findings
  • The readiness gap is widening 11

Data Conclusions

  • Increase in time for readiness of inspection of White PIs despite White PIs shifting into IE cornerstone
  • IE cornerstone PIs involve discrete events that are individually evaluated when they occur, which would seem to streamline supplemental inspection preparation 12

Data Conclusions

  • PIs are data driven so staff does not believe increased time is due to disagreement with characterization of the issue
  • Does not appear to be due to IP 95001 scope concerns since the readiness trend (and overall timeline trend) for GTG findings is decreasing
  • The four quarter requirement for GTG findings may be a reason for the trend toward quicker readiness for GTG finding supplemental inspections 13

Data Conclusions 14

Proposed Treatment of GTG PIs Parallel Finding Parallel Finding closed by inspection Column 2 Column 1 When PI becomes White PI data reported as usual Supplemental inspection

  • White parallel finding is
  • PI data might return to
  • Either closes the parallel opened and is the Green or stay GTG finding or keeps it open assessment input
  • Either way the parallel
  • If closed, plant moves to
  • Action Matrix Column 2 finding is tracking the Column 1 even if PI hits
  • Supplemental inspection issue that must be havent rolled off PI scheduled when licensee inspected calculation yet is ready 15

Proposed Treatment of GTG PIs

  • Benefits of proposed approach:

- Encourages prompt correction and inspection of issues

  • PI hits can be removed once inspection closes the parallel finding
  • Action Matrix movement upon inspection completion

- Elimination of backdated parallel findings

  • Enhances regulatory certainty
  • More timely and stable assessment results 16

Proposed Treatment of GTG PIs Example 1

  • Revisiting the unplanned scrams GTG PI example 2Q2016 3Q2016 4Q2016 1Q2017 2Q2017 3Q2017 4Q2017 1Q2018 2Q2018 Parallel White 95001 Unplanned Scrams PI opened back completed to 1Q2017 6/28/18 Scrams PI parallel white finding N/A N/A N/A parallel White Action Matrix Column Column 1 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 All Green All Green All Green Assessment Inputs All Green 1 White 1 White revised to 1 revised to 1 revised to 1 1 White 1 White 1 White White White White 2Q2016 3Q2016 4Q2016 1Q2017 2Q2017 3Q2017 4Q2017 1Q2018 2Q2018 Parallel 95001 Unplanned Scrams PI finding completed opened 6/28/18 Action Matrix Column Column 1 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Column 2 Assessment Inputs All Green 1 White 1 White 1 White 1 White 1 White 1 White 1 White 1 White 17

Proposed Treatment of GTG PIs Example 2

  • Assume PI went White in 4Q2017 due to scrams in 1Q2017 and 4Q2017
  • 2 additional scrams in 2Q2018 18

Proposed Treatment of GTG PIs Example 2

  • After going White in 4Q2017 the PI returned to Green in 1Q2018
  • Two additional scrams in 2Q2018 drove the PI White again

- Supplemental inspection had not been scheduled yet

  • Supplemental inspection completed in December 2018 and plant moved to Column 1 19

Proposed Treatment of GTG PIs Example 2

  • Existing process provided little incentive for prompt evaluation and readiness for supplemental inspection, until the two additional scrams drove the PI White again
  • Under the proposal, had a supplemental inspection closed the White PI issue before the end of 2Q2018, the new PI hits would not have resulted in a White PI in 3Q2018 20

Proposed Treatment of GTG PIs 21

Conclusion

  • Staff believes current treatment of GTG PIs should be enhanced

- Process does not encourage prompt evaluation, correction, and inspection

- Regulatory uncertainty due to backdating of parallel findings

- Delayed performance assessment

- Data review shows that readiness for PI supplemental inspections lags supplemental inspections for findings 22

Conclusion GTG Finding GTG PI White finding issued, plant moves to Column 2 White PI reported, parallel finding opened and plant moves to Column 2 White finding remains open assessment input Parallel finding remains open assessment input until supplemental inspection completed until supplemental inspection completed Corrective actions completed Corrective actions completed, PI might return to Green Supplemental inspection completed Supplemental inspection completed

  • Finding is closed and removed from
  • Finding is closed and removed from assessment process assessment process, PI hits removed
  • Finding cannot be closed and remains open
  • Finding cannot be closed and remains open until future inspection until future inspection 23

Next Steps

  • Commission paper votes:

- Proposal to modify closure of GTG findings to supplemental inspection completion

- Proposal to modify treatment of GTG PIs

  • Staff recommending that both changes be adopted
  • If approved, would engage with industry on guidance revisions to accommodate removal of PI hits once inspected and closed 24

Questions