Quality Issue
Alexia
Created on October 9, 2024
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Transcript
Start
Escape room
Quality Issue
INTRODUCTION
Sometimes errors happen in our work that may affect its quality. It is our responsibility to find out what went wrong and why, so we can avoid these errors from happening again. You will be presented with information, practice activities. Please use your critical thinking to choose the correct answer. We intentionally did not provide the information beforehand so you can test your own judgement.
Next
2
1
Next
The Quality Issue process provides a structured and logical approach to investigating and resolving non-compliance problems and has five distinct phases.Try to arrange the workflow steps in the right order by putting the numbers (steps) into the box.
Quality Issue Creation
A
3
CAPA Completion
C
CAPA Plan Approval
D
4
5
Investigation & Root Cause Analysis
E
Back
B
CAPA Planning
c
RCA
CAPA planning
CAPA creation
Determine relevant _________ and Subject Matter Experts to continue RCA.
Owners
Scientists
Understand the _________ Issue
Subject
Quality
Root Cause
RCA
Quality
Next
Back
Stakeholders
Stakeholders
Critical and/or Major Quality Events require in-depth understanding of why they happened to ensure effective Corrective Actions, Preventive Actions are identified & implemented. Root Cause Analysis (RCA) is a method that facilitates such understanding which can be achieved by 6 steps. Fill in the gaps to find out more
Agree immediate steps necessary to stop problem from getting worse
Analyze the facts to determine the root cause of the problem - why did it go wrong? Develop robust and effective ____________________ (CAPA)
Quality Issue
Root Cause Analysis
Corrective And Preventative Action
Gather _______: What happened vs. What should've happened & asses Impact, Scope, and Scale of the QI.
Answers
Information
Reports
Corrective and Preventative Action
information
FILL IN THE BLANKS
Next
Back
Preventative Action
Corrective Action
Solution
Continue
Reactive Actions
Proactive Actions
Actions that correct/fix the problem
Prevent the problem from happening again
Drag concepts to the corresponding group
The AZ CAPA Process includes the investigation of a Quality Event to determine root causes, identify and implement solutions. which categories do the below statements belong? Try to match the correct definitions.
Exit
Back
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Top employee
AWESOME CERTIFICATE
Actions that correct/fix the problem
Proactive Actions
Prevent the problem from happening again
Reactive Actions