Start Date Completion
Resume:
Tasks :
Task No: ****
Task Code: CP-**** **** CAPA plan objective
Task short text: Improve LSOP/training for vessel swabbin
Task Status:
TSCO Task Completed APPR CAPA approved
NORE No date extension request
Task Responsible: KF786389 Kayla Fettro Functional Location: /
Planned Start Date: 12/23/2019 Planned Finish Date: 12/23/2019 Init Plan Fin Date: 01/05/2020 Task completion date: 01/03/2020
Task completed by: MED96208
Long Text:
In response to UE 200751996, improve the LSOP and training process for vessel swabbing including the following actions:
Update LSOP 900******* “Equipment Return to Service and Routine Cleaning
Monitoring” to provide adequate pictures/diagrams of the vessel swabbing locations. A new OJT/PA will also be created specifically for vessel swabbing so that the training is completed with an actual tank, instead of the QC labs. Also, update LSOP 900******* "QCM - Swabbing Procedures for Viral and TOC
Tasks :
Task No: 0002
Task Code: CP-0010 0010 Internal Corrective Action Task short text: Update LSOP 9*28822
Task Status:
TSOS Task Outstanding RESU result encoded
REAP Approved date extension
Task Responsible: JMH56352 Functional Location: /
Planned Start Date: 12/23/2019 Planned Finish Date: 07/31/2020 Init Plan Fin Date: 06/30/2020 Task completion date: /
Task completed by: /
Long Text:
Task Completion: LSOP 900******* was updated to include instructions on where to take tank TOC samples. Pictures of swab locations were added.
The revision also includes instructions to ensure a cycle is run for equipment that is processed through the autoclave and visually checked before introducing the equipment into service. Directions are in section 8. Reference Task 2 Annex 01 for effective copy of LSOP 900*******.
Update LSOP 900******* "Equipment Return to Service and Routine Cleaning" to include adequate instruction on where to take tank TOC samples. Revision is to include diagrams and/or pictures of vessel swabbing locations.
The revision will also include instructions to ensure a cycle is run for equipment that is processed through the autoclave and visually checked before introducing the equipment into service. This task is being transferred from CAPA 200745740 which was generated as a result of UE 200727269 as identified in Addendum 1 to this CAPA.
Create OJT/PA for vessel swabbing to be performed in B46 or B32 loading dock where vessels are swabbed. Include instruction on swabbing locations and techniques used using the swab extender.
*What Action:
*Who did it:
*Where did it happen:
*When did it occur:
*How was it performed:
Delay Extension Request:
*Progression Status: LSOP is being revised currently.
*Reason for date extension request: LSOP also covers activities associated with AS03 activities, and later due date will allow alignment with the completion of these activities.
*Risk associated with a date extension: There is minimal risk associated with extending this CAPA task. Extending the task could increase the chance of a repeat deviation, however the risk is low because the task is only performed on an annual basis.
*Impact on other tasks: N/A
*Request done by / on: 08Jun2020
*Current Due Date: 30Jun2020
*Requested new due date: 31Jul2020
*Approved by / on:
*Approval Justification: The risk is low and it makes sense to align the revision to other activities (AS03)
*Refused by / on: N/A
*Refusal Justification: N/A
Tasks :
Task No: 0005
Task Code: CP-0010 0010 Internal Corrective Action Task short text: Update LSOP 900*******
Task Status:
TSCO Task Completed APPR CAPA approved
NORE No date extension request
Task Responsible: KDB87113 Functional Location: /
Planned Start Date: 01/03/2020 Planned Finish Date: 09/30/2020 Init Plan Fin Date: 09/30/2020 Task completion date: 06/16/2020
Task completed by: RR386988
Long Text:
Update LSOP 900******* "QCM - Swabbing Procedures for Viral and TOC Swabbing". Add a statement in section 6.11 to reference LSOP 900******* "Equipment Return to Service and Routine Cleaning Monitoring" for swabbing locations. 9*28822 is also being revised to include these locations, so 9*10454 will need to travel with it.
LSOP 900******* was updated to reference LSOP 900******* "Equipment Return to Service and Routine Cleaning Monitoring" for swabbing locations. Effective date was 29APR2020. Refer to Attachment #1 (for Task 5). KDB 16JUN2020.
List of Annexes :
Annex Number
Annex Type
Version
Annex Description
Annex Status
ACP
00
CAPA 20755392 Task 5 Attachement #1
Completed
ACP
00
Task 2 Annex 01
Completed
ACP
00
Task 3 Annex 01
Completed
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