Quality Day 2023 (2nd Game)

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