STANDARD OPERATING PROCEDURE SOP ON CORRECTIVE ACTION & PREVENTIVE ACTION (CAPA)
STANDARD
OPERATING PROCEDURE
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SUBJECT :
SOP
ON CORRECTIVE ACTION & PREVENTIVE ACTION
(CAPA)
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DEPARTMENT : QA
SOP
NO. :
\
Page
No :
Effective
Date :
Next
Review :
SOP
REVISION :
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1.0 OBJECTIVE:
To
provide a system and instructions, and assign responsibilities for initiating,
requesting,
implementing
and verifying the effectiveness of corrective and preventative actions (CAPA)
2.0 POLICY:
2.1 To lay down a procedure
for applies to prevent and correct non-conformities related to resources,
components, subassemblies, completed services, operational process and quality
system.
2.2 CAPA focuses on the systematic investigation of discrepancies
(failures and / or deviations) in an attempt to prevent their recurrence (for
corrective action) or to prevent occurrence
(For preventive action)
2.3 Resolution of identified quality issues
2.4 Prevention of issue recurrence
2.5 The system shall be applied for addressing nonconformance,
incidents and implement quality systems. The same shall be applicable to all
GMP operations and areas
2.6 Documentation of all correction and preventive action
activities.
3.0 PROCEDURE:
Definitions:
3.1 Corrective Actions: A corrective action is a term that encompasses the process
of reacting to product problems, customer complaints or other nonconformities
and fixing them. The process includes:
•
Reviewing and defining the problem or nonconformity.
• Finding
the cause of the problem.
• Developing an action plan
to correct the problem and prevent a recurrence.
•
Implementing the plan.
•
Evaluating the effectiveness of the correction.
A corrective action is a reaction to a problem that has
already occurred. It assumes that a nonconformance or problem exists and has
been reported by either internal or external sources.
The actions initiated are intended to: a) fix the problem
and b) modify the quality system so that the process that caused it is
monitored to prevent a reoccurrence. The documentation for a corrective action
provides evidence that the problem was recognized, corrected, and proper
controls installed to make sure that it is does and not happen again.
3.2 Preventive
Actions: A preventive action
is a process for detecting potential problems or nonconformance’s and
eliminating them. The process includes:
• Identify
the potential problem or nonconformance.
• Find the
cause of the potential problem.
• Develop
a plan to prevent the occurrence.
•
Implement the plan.
• Review
the actions taken and the effectiveness in preventing the problem.
A preventive action is initiated to stop a potential
problem from occurring.
3.3 CAPA PROCESS:
To effectively manage the CAPA
system and the associated documentation, the following
process exists:
3.3.1 Identification:
The initial step
in the CAPA process is to clearly identify the potential problem(s).
1.1.1.1
This should include the source of information, detailed explanation
of the problem, documentation of the available evidence that a problem exists.
3.3.1.2
Identification of recurring / critical /
major problems from internal or external sources shall be carried out by
Quality Assurance and forwarded to core team members.
3.3.1.3
Core team shall review the complete list of
Market Complaints, Deviations and OOS on yearly basis and accordingly will take decision for
initiation of CAP
3.3.1.4
ch
Market Compliant, OOS and Deviation has Corrective and
Preventive action mentioned in its format, however to take it in CAPA format of this SOP, Core Team will take
decision for waiver in initiation of CAPA.
3.3.2
Evaluation:
3.3.2.1
Based on the decision
by core team CAPA will be initiated site QA. The details shall be
captured.
3.3.2.2
The situation shall be
evaluated along with concerned person related to the problem to determine the
need and level of action required.
3.3.3
Investigation:
3.3.3.1
Core team to arrive at
the root cause and will carry out failure investigation.
3.3.3.2
Thorough investigation
shall be carried out to arrive at the root cause. Comprehensive review of all
circumstances related to the problem shall be considered. E.g. Equipment,
Personnel, Design, Software, Materials, Procedures, Training, External factor
and so on.
3.3.3.3
The necessary data and
other information collected shall be used to determine the primary cause of the
problem.
3.3.3.4
It is
very important to distinguish between the observed symptoms of a problem and
the fundamental (root) cause of the problem.
3.3.3.5
Approval of concerned authority shall be
sought on the proposed actions. Impact evaluation shall be done through change
control system.
3.3.4
Implementation:
3.3.4.1
Core team shall ensure that the action plan
that has been developed is executed and all identified tasks and activities are
completed. When implementation is over, the CAPA shall be considered as
complete.
3.3.4.2
Approval of concerned authority shall be
sought on CAPA report and the CAPA shall be closed.
3.3.5
Effectiveness (Follow up)
:
3.3.5.1
Core team shall verify
effectiveness of the CAPA. Duration of verification shall vary case to case and
depend upon the situation. To verify effectiveness of CAPA, core team shall
ensure that.
3.3.5.2
Root cause of the problem has been solved. The actions
taken had no other adverse effects. Adequate monitoring of the situation is in
place.
3.3.5.3
CAPA tracking and effectiveness shall be evaluated periodically CAPA
database bank with different colour index/codes like Green represents Closed,
Yellow represents Ongoing, Orange represents Open and Red represents Overdue.
It will be maintained in soft copy of excel file.
4.0
FREQUENCY:
As and when
required.
5.0
RESPONSIBILITY:
G.M
(Q.A)./Production Manager / Dept. Supervisors/Departmental Heads.
6.0
REVIEW GUIDE:
........
7.0 ANNEXURE:
Corrective and Preventive Action Tracking Log
8.0 SOPs
DISTRIBUTION:
This
SOP shall be distributed to following Departments:
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Name
of the Department
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Master Copy
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Circulatory Copy
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QA/QC
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√
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√
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Production
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x
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√
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Warehouse
|
x
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√
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General
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x
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√
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Maintenance
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x
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√
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