Deviation,
Investigation and CAPA
CAPA
Investigation Deviations
Dr. Ahmed Badran
QA Section Head.
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OVERVIEW
• Definition
• Deviation Handling &Reporting
• Deviation, OOS and reporting
• Classification
• Root Cause Analysis
• Investigation
– Investigative tools: Why –Why , Cause & Effect and FTA
– Investigation Steps
– Investigation report
• CAPA
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DEFINITION
• Deviation: Departure from an approved
instruction or established standard
• Incident: Operational event which is not part of
standard operation (GAMP
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DEFINITION
Correction: An action to eliminate a detected nonconformity.
Remedial action : Repair, rework, or adjustment
Corrective Action: The action taken to eliminate the causes of an
existing nonconformity, defect or other undesirable situation
in order to prevent recurrence.
Preventive Action: The action taken to eliminate the cause of a
potential nonconformity, defect, or other undesirable situation
in order to prevent occurrence.
Nonconformity: non-fulfillment of a specified requirement.
Any material or process that does not meet its required
specifications or documented procedure.
Note: There is no definition for CAPA in the drug cGMP regulation
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How does a Quality System Fit Together ?
• Training
Change Incidents &
Deviations
Quality
Control Control
Document
Validation Failure Investigat’n Lab OOS
Control
Production Management
CAPA Review
Control
Supplier
Assurance Annual Product
Monitoring & Review
External Trend Analysis
Complaints &
Internal Audits Recall
Regulatory Pharmacovigilance
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WHO Guidance Deviation Handling
An efficient deviation handling system, should implement a mechanism to
discriminate events based on their relevance and to objectively categorize them,
concentrating resources and efforts in good quality investigations of the root causes of
.relevant deviations
A sequence of steps may be identified when handling events and possible
:deviations
Event Detection-
Decision Making Process / DeviationCategorization-
Deviation Treatment-
Root cause investigation-
CAPA-
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How to Report Deviation
1. Description – Describe clearly the Problem/Failure.
2. Determine: What, Why, Where, When, Who, How?
3. Immediate Actions taken : Contain/ stop continue
4. Immediate ( known ) Product Quality Impact
5. Complete the above within 24 hours from time of an incident
identified
6. Initial ( preliminary ) QA Review
– Above section must be completed within 2 days of receipt
– Complete the investigation as per SOP (preferably 3-5 days)
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Deviation/Incident Reporting
“If An Incident /problem is well defined , a problem half
solved”
– Keep in mind it is to Correct, Prevent & Improve
– No shortcut to conclude as human error
5W:
• What is affected
• Where does the problem takes place
• When is the problem indentified
• Who is indentified
• What is the consequence
2H:
• How much is affected
• How often has the problem occurred
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ROOT CAUSE
Root Cause identification is the most important
step
Root Cause Analysis (RCA) is a systematic
approach to identify the actual root causes of a
problem.
CAPA will be effective to eliminate the
reoccurrence if root cause is identified correctly
and accurately
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Root Cause Analysis(RCA)
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Root Cause Analysis (RCA)
Root cause and the “weed”:
Weeds can be difficult to remove
once they start to grow and spread.
To eradicate the weed you have to
get below the surface, identify the
root, and pluck it out.
Thus, you have to go beyond the
obvious, ascertain an accurate
route cause, so the appropriate
corrective action can be pursued to
prevent recurrence.
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Root Cause Analysis (RCA)
A root cause is a system or a process that caused the
problem you observed.
• Root Cause : That condition, action, or lack of action
that led to the problem occurring.
• Root Cause Analysis: The process of identifying all
the causes (root causes and contributing causes) that
have or may have led to an deviation.
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Investigation
Objective: Prevent the similar failure by effective CAPA.
Seven steps of CAPA
1. Identification –Clearly define the problem
2. Evaluation – Appraise the magnitude and impact
3. Investigation – Make a plan to research the problem
4. Analysis /RCA– Perform a thorough assessment
5. Action Plan – CAPA -Create a list of required tasks
6. Implementation – Execute the action plan
7. Follow Up – Verify the effectiveness
Do not “release the deviation /OOS batch.” until establish the
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conclusion
Investigation Tools
RCA Technique/ Methodology
1. Why- Why analysis
2. Brain storming
3. Cause and Effect / Ishikawa / Fishbone
Diagram:
4. Fault Tree Analysis (FTA)
5. FEMA etc
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Investigation Tools
5 whys
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Root cause – Fishbone
diagram
People Methods Machines
Batch record does In process checks No changes in plant
Manufacturing staff not include all may not be good
performed an preparation enough or
additional step instructions completed correctly No maintenance
without approval performed
Plastic
contaminant
New freeze drying No changes in
trays used environment
Materials Environment
Want to solve the problem !
Think Differently
We can not Solve
our problems with
the same thinking
we used when we
created them
-Einstein
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Investigation Process
• Review past history /similar issue
• Review records and documents
• Review process/operations
• Review the situation/ environment
• Interview people closest to the problem
• Inspect and test the product/ material
• Gemba-Inspect equipment & facilities at site
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Investigation Steps
• Information must be captured from the
people who were involved
• Gather the facts quickly to avoid the loos
of information/ evidence
• Determine what historical data is available
• Determine what is known rather than
what is “from memory”
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Investigation Report
• Record the details
– Location
– Date and time of occurrence, discovery
– Personnel ( titles / names ) involved
• Explain why the event is different from what
is expected
– Initial scope:
– Product / materials
– Lot/batch / campaign
– Equipment / train 24
Investigation Report
• Record the details
– Location
– Date and time of occurrence, discovery
– Personnel ( titles / names ) involved
• Explain why the event is different from what
is expected
– Initial scope:
– Product / materials
– Lot/batch / campaign
– Equipment / train 25
CAPA
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Important “CAPA” Definitions
• Correction: Correction refers to repair, rework or adjustment and relates to the disposition of
an existing non-conformity, defect, or other undesirable situation
• Corrective Action: Action to eliminate the causes of an existing non- conformity, defect or
other undesirable situation in order to prevent recurrence.
• Preventive Action: Action taken to eliminate the cause of a potential non-conformity, defect,
or other undesirable situation in order to prevent occurrence
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Ahmed Badran
QA Section Head
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