GQMS Module 04 (CAPAs) - Workshop Activity 02 (Possible Answer)
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The University of Queensland *
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Industrial Engineering
Date
Dec 6, 2023
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GQMS Module 04 (CAPAs) – Workshop
Activity 2: CAPA-tain Marvel
Key Details:
Teams
4-5 People
Task Time
20 Minutes
Marking Time
N/A
Class Review Time
10 Minutes
Difficulty
Easy / Medium
Marking Method
N/A
Marking Criteria
N/A
Prize
N/A
Fun Level
Loud Guffawing
Hint
CAPA Template
Scenario:
Phase 3 of the Quality Cinematic Universe (QCU) saw the introduction of CAPA-tain Marvel, an otherworldly
superhero whose special powers include looking very, very serious whilst holding a clipboard and rapidly
analysing and assessing incidents prior to implementing a series of corrective and preventive actions (all of
which ensure the QCU continues to positively evolve and isn’t sucked into a wormhole containing hideous
documents where errors aren’t initialled and dated).
Earlier this morning, CAPA-tain Marvel was battling star baddie Thanos (Temperature, Humidity And Nachos
Out of Specification) at NuDrugs Toxicology. It was a particularly destructive encounter which involved two
separate, nasty incidents:
1) A space laser was utilised despite it being past its ‘Next Performance Due’ date.
2) An infinity organ underwent necropsy even though the operator was not trained in the procedure.
Unlike inferior movies, the stars of QCU always ensure that they complete their paperwork in an orderly
fashion following an incident, safe in the knowledge that they’ll come up squeaky clean when faced with
their 2-yearly NATA (National Association of Thespian Actors) OCD GLP Inspection.
Task:
Unfortunately, CAPA-tain Marvel has been called out on another emergency call at GenericDrugs
Bioanalytical (their movie-pirating software had been upgraded and released into the production
environment without undergoing change control). Given it is the CAPA-tain’s birthday you kindly offered to
complete the two CAPAs on their behalf. Draft the two CAPAs and include all relevant information.
The Twist:
Each CAPA is limited to one side of A4
The Fine Print:
Develop a template and then apply it to the two scenarios.
The Really Fine Print:
CAPAs are…. inevitable
Marking:
N/A
Page 1 of 1
Primary Learning Objective:
Confirmation of the CAPA process and
purpose
Secondary Learning Objective:
Documentation of ‘typical’ CAPAs from
a GxP environment
BIOT-7031-3009-FM001
Version 5
Corrective & Preventive Action (CAPA)
CAPA ID:
CAPA-2023-025
CAPA Source:
Internal Audit IA2023-17
Issue Description:
Space Laser MU-024 was utilised on 10 Mar 2023 as part of Study ABC-004. The previous performance
check was conducted on 18 Nov 2022. SOP-0159 requires that Space Lasers undergo a performance
check every 3 months. Space Laser MU-024 was therefore approximately 3 weeks overdue for its
performance check.
Completed By: Simon Lake
Date: 10 Mar 2023
Containment / Correction:
1) Space Laser MU-024 was immediately withdrawn from routine use on 10 Mar 2023.
2) All other Space Lasers were checked and found to be within their performance next due dates.
3) Space Laser MU-024 successfully underwent a performance check on 11 Mar 2023. Therefore, there is
not considered to be any impact on data integrity.
Completed By: Simon Lake
Date: 11 Mar 2023
Root Cause Analysis:
Why was Space Laser MU-024 used after its performance due date?
Because the operator did not check the label (the label was correct)
Why did the operator not check the label?
Because they weren’t aware they should (Primary Root Cause)
-----------------------------------------------------------------------------------------------------------
Why had Space Laser MU-024 not undergone its 3-monthly performance check?
Because the person assigned to conduct the check was away on holiday.
Why was a different operator not assigned to the task?
Because the monthly schedule of laboratory tasks was not visible to other staff.
Why was the monthly schedule of laboratory tasks not visible to other staff?
Because no other staff knew how to generate it (Secondary Root Cause)
Completed By: Simon Lake
Date: 11 Mar 2023
Corrective Action:
Primary Root Cause:
1) Operator has completed additional training and this has been documented in their training record.
2) A field has been added to the Assay Checklist requiring the operator to document the ‘Next Due’ date.
Secondary Root Cause:
1) All staff have been trained in generation of the monthly schedule of laboratory tasks.
2) A hard copy is to be attached to the primary laboratory noticeboard.
Completed By: Simon Lake
Date: 12 Mar 2023
Name
Position
Signature
Date
Reviewed By
Chris Banks
Analyst
Approved By
Rose Smith
Test Facility Management
Page 1 of 1
BIOT-7031-3009-FM001
Version 5
Corrective & Preventive Action (CAPA)
CAPA ID:
CAPA-2023-026
CAPA Source:
Study Audit S23-05
Issue Description:
An operator conducted a necropsy of Animal # 1234, under no supervision, as part of GLP Study DEG-
002. Although the operator had completed Level 1 & Level 2 competency training in SOP-687, they had
not been signed off as competent.
Completed By: Simon Lake
Date: 10 Mar 2023
Containment / Correction:
1) The operator was scheduled to conduct two further necropsies that day. An experienced trainer
observed these subsequent necropsies.
2) The operator was determined to be competent, and their training record was updated accordingly.
3) A comment was made against the record for Animal # 1234 explaining what had occurred and why
there was not considered to be an impact on data integrity.
Completed By: Simon Lake
Date: 11 Mar 2023
Root Cause Analysis:
Why did the operator commence the task when they knew they had not been signed off as competent?
Because they didn’t understand the importance of documenting competency.
Why didn’t the operator understand the importance of documenting competency?
Because they had not completed a Quality / GLP Induction
Why did they not complete a Quality / GLP Induction?
Because it had not been assigned to them in the electronic training module
Why had it not been assigned to them in the electronic training module.
Because the trainer’s supervisor had forgotten to assign this requirement (Primary Root Cause)
-----------------------------------------------------------------------------------------------------------
Why was the operator assigned to undertake the necropsy independently?
Because the operations manager did not review the training matrix prior to assigning tasks.
Why did the operations manager not review the training matrix prior to assigning tasks?
Because they were not aware of this requirement (Secondary Root Cause).
Completed By: Simon Lake
Date: 11 Mar 2023
Corrective Action:
Primary Root Cause:
1) Operator has undertaken a Quality / GLP Induction
2) Quality / GLP induction is now added automatically to staff training module (previously it was added
manually)
Secondary Root Cause:
1) Operations manager has had a documented training session on use of the training matrix.
Completed By: Simon Lake
Date: 12 Mar 2023
Name
Position
Signature
Date
Reviewed By
Chris Banks
Analyst
Approved By
Rose Smith
Test Facility Management
Page 1 of 1
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