WorksheetsQuality Day 2023 (2nd Game)
Total questions: 10
Worksheet time: 3mins
Unplanned discrepancies are called ____, planned modifications are called ____
Events, Changes
Changes, Events
None of the choices
A Global electronic Quality Management System (TrackWise) to manage Event Handling, Change Control and Actions.
Kabi Reg Track
KabiSafe
Kabi Track
None of the choices
Change of National Safety Officer (NSO) is a Regulatory - relevant change
Yes
No
I don't know
This defines all Change Actions including definition of deliverables, and effectiveness checks required for the execution of the change control.
Root Cause Analysis
Change Plan
Investigation
Effectiveness Check
This evaluates whether the defined actions have sustainably eliminated the root cause of the Event.
Corrective Action
Effectiveness Check
Preventive Action
Which of the following are commonly used RCA tools and methods:
5 Whys Technique
Cause and Effect Analysis
Fault Tree diagram
All of the above
Inform the Quality Management Team within ____ upon notice of the incident.
2 days
7 days
1 day
5 days
For MedTech-related events, temporary injury or impairment not requiring professional medical intervention falls under which category?
Minor
Negligible
Serious
Major
All events records created by KabiTrack are set by the system to be completed within ____?
45 days
30 days
60 days
90 days
What is considered a GxP supplier?
Packaging materials supplier
Warehousing/ Logistics service provider
PV service provider
All of the above
