This document outlines procedures for handling deviations from quality standards in pharmaceutical manufacturing. It discusses the deviation investigation process, which involves describing what occurred, analyzing potential causes, conducting a root cause analysis using the "5 Whys" technique, and developing corrective and preventive actions (CAPA). An example CAPA is presented as a case study. Additional quality control topics covered include Pareto analysis and further reading suggestions. The overall goal is to identify and address the root causes of deviations in order to improve quality and prevent future issues.

1. Quality Control
Handling Deviations
Dimitris Papamatthaiakis
Pharma Life-cycle Consultancy

2. Outline
 OOS process in general
 Deviation Investigation
 RCA - 5 WHY’s approach
 CAPA - Case study
 Pareto Analysis
 Further reading

3. OOSprocessingeneral

4. Deviation Investigation: page 1/2
Date: …………………… Leader : …………………… Participants:
…………………………………………
1 Description 2 Cause analysis
Cause Selection
Immediate action:
Initial impact assessment:
Comments, list of attachments:
Cause Rejected/Selected Rationale
Shopfloor visit, interview of witnesses:
Pictures available:
IS IS NOT SPECIFICS
What What is the problem?
Which product/batch?
What is the defect?
Who Who is involved?
Which team?
Which supplier/customer?
Where Which process step?
Which area?
Which method?
When Date and time?
Since when?
How How was it detected?
By which method?
What are the symptoms?
How much Defects, rejects?
Cost?
Time?
Why Is it a deviation?
What are the risks?
Mother Nature Material Manpower
Measure Method Machine

5. Date: …………………… Leader : …………………… Participants:
…………………………………………
3 Root Cause Analysis 4 CAPA
Root cause found : yes / no
Root cause description :
Final impact assessment :
Goal of the CAPA:
Cause:
Because:Why
Because:Why
Because:Why
Because:Why
Because:Why
Corrective Actions Deliverable Date Resp
Preventive Action Deliverable Date Resp
Effectiveness check Deliverable Date Resp
Human error root cause analysis:
Deviation Investigation: page 2/2

6. Control: Assess impact of actions and implement control measures to prevent reoccurrence. Did actions resolve the problem? If not, what further needs to be done?
Define the problem
(as simply as you can)
Analyse: Is the first why clear (see refined problem statement), then one can start immediately with a profound analysis (5why or Causal factor tree analysis). When not,
then first start with an exploring analysis (fishbone analysis).
Data & flow: Current Conditions; Gemba the problem. Gather facts & data (pictures, trend data, sketches) on the problem. Map process.
Informed:
 Department leader
SHE  QA
Quick Fix Action:
Is there a quick fix to put in place until root
cause can be determined?
Improve:
Chosen solution to address root cause:
Responsible + due date:
Problem Solving ProcessTeam: Start Date:Process:
List up the facts:
WHO
WHEN
WHERE
WHAT
WHICH
HOW
Root Cause:
4a. Refined Problem Statement:
Who do I need to finish the
RCA?
 SHE  QA  MAINT
 Other(s):
1a
1b
1c
2
3
4a
4b
5
6
7
5 WHY’s approach

7. This is a free preview copy of the original training “Quality Control Handling Deviations”
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