GQMS Module 04 (CAPAs) - Workshop Activity 01 (Task)
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Dec 6, 2023
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GQMS Module 04 (CAPAs) – Workshop
Activity 1: Wondering Why
Key Details:
Teams
4-5 People
Task Time
20 Minutes (Max)
Marking Time
1 Minute
Class Review Time
4 Minutes
Difficulty
Medium / Hard
Marking Method
First Correct Answer
Marking Criteria
Correct or Incorrect
Prize
Lindt Lindor
Fun Level
Side-Splitting
Hint
Separate Stories
Scenario:
Four significant incidents recently occurred in a GxP facility. They were:
1)
Validated parameters for a GxP study have been exceeded
2)
Raw electronic data, relating to a completed GxP study, is unavailable
3)
Audit trail settings on a GxP system were found to be modifiable by general staf
4)
GxP Sample analysis activities have been delayed (meaning data will not be available within the
agreed timeline)
Each of them underwent root cause analysis (utilising the 5 Whys) in order to ensure that appropriate
corrective action was taken. Five questions were asked (in relation to each of the four incidents), resulting in
twenty answers. Unfortunately, one cofee too many resulted in the twenty answers becoming all muddled
up!
Task:
Match the root cause analysis questions with the respective scenarios, ensuring that they are in the correct
order (i.e. there is a logical and sensible question flow).
The Twist:
Some answers could potentially fit into more than one place – but if it’s not in its intended place, that will
mean there is something ‘left-over’ in another sequence.
The Fine Print:
The winning team is the first team to provide me with the correct answer code. However, if you have even
one answer incorrect, you are out of the competition.
The Really Fine Print:
A sensible first step is to try and ‘roughly group’ the answers under a incident. Then try and establish the order of the answers. Tutors will be
roaming the room and are able to discuss / confirm answers as you go.
Marking:
Request an answer check if you think you have cracked it!
BIOT 7031 / 3009 (Quality Systems in Biotechnology)
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1
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Primary Learning Objective:
Review of key terms and concepts
related to root cause analysis
Secondary Learning Objective:
Familiarisation with typical ‘real-life’
examples of root cause analysis
Answer Sheet:
Item
Why?
1
Because the freezer door seal was in poor condition
2
Because the process was not conducted under formal change control
3
Because a non-archiving staf member had access and inadvertently deleted it
4
Because testing of the new QC samples showed they were prepared incorrectly
5
Because the organisation had not fully assessed the risks to data integrity
6
Because management deemed the risk of not performing preventative maintenance acceptable
7
Because the operator was following a superseded method
8
Because they had not been provided sufficient training
9
Because raw electronic data files had been deleted from the electronic archive
10
Because document control procedures had not been followed
11
Because the freezer did not maintain the correct temperature
12
Because the new QC samples were prepared incorrectly
13
Because the software vendor had updated it automatically without notifying the system owner
14
Because it had not undergone preventative maintenance
15
Because general users had been assigned administrator permissions
16
Because the electronic archive had not been properly validated
17
Because the analytical samples were thawed for 10 hours
18
Because the system owner was unaware of the system update
19
Because the hardcopy in the laboratory had not been replaced when the method was revised.
20
Because user roles were not checked against permissions after a recent software update
Incident
Question
One
Two
Three
Four
1
2
3
4
5
BIOT 7031 / 3009 (Quality Systems in Biotechnology)
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