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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.

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Top employee

AWESOME CERTIFICATE

Actions that correct/fix the problem

Proactive Actions

Prevent the problem from happening again

Reactive Actions