Purpose
To lay down the
procedure for assigning, tracking, closure and effectiveness monitoring of CAPA to ensure appropriate
actions are taken in order to avoid recurrence of issues and to minimize the
risks associated with it
Approval of CAPA.
To review implemented CAPA for its
effectiveness.
Tracking and closure of CAPA.
Trending of CAPA.
Implementation and Compliance with
SOP.
Approval of SOP.
To revised the SOP as when required.
Procedure:
Definition
Correction: Action to eliminate a detected
nonconformity. A correction can be made in conjunction with a corrective
action.
Corrective Action: Action taken to
eliminate the cause of a non conformance that has occurred, and prevent
re occurrence of the
non conformance. (In this
case a non conformance has
already occurred).
Preventive Action: Action taken to
eliminate the cause of a potential non conformance and prevent the
non conformance from occurring. (In this
case a non conformance has not yet occurred).
CAPA is a
fundamental tool that shall be used in every quality system. CAPA consist of
seven steps as follows:
Identification- The initial step begins with clearly
defining the potential or actual problem, nonconformity or incident, and
describing the situation as it currently exists, and shall be reported and
documented accurately.
Evaluation- The identified problem should be
evaluated to determine the need for action. The potential impact of the problem
and the actual risks to the product quality, safety, process, and equipment
and/or customers must be determined and documented.
Investigation- Investigation shall depend on the
circumstances, must incorporate a comprehensive review and analysis of all of
the circumstances related to the identified problem.
Analysis- Analysis is to determine the root
cause of the problem described, investigating all possible causes to determine
the root cause of the identified problem. Appropriate tools shall be used to identify
the root cause such as FMEA, Ishikawa diagram, Brain storming, 5 Why
and FMECA.
Action Plan- The plan should include,
the items to be completed, document changes, any process, procedure, or system
changes required, employee training, and any monitors or controls necessary to
prevent the problem or a recurrence of the problem. The action plan shall also
identify the person or persons responsible for completing each task.
Implementation- All of the required tasks listed and
described in the action plan shall be initiated, completed and documented.
Effectiveness check / Follow Up-
The implementation and completion of the listed action plan must be verified
and recorded. Appropriate information shall be documented that all actions have
been completed successfully.
Corrective
Action and Preventive Action shall be documented and implemented for
non-conformities discovered from following sources but not limited to;
Product complaints
Deviations
Lab incidents
Process validation, performance and
variations
Customer Query Response
Annual Product Quality Review / Trend
Data
External Audits and Internal Audits
Out of specification
Out of trend
Stability Failures (Significant
changes)
Failure Investigation Reports
Utility / Equipment failures
All the above
listed sources of CAPA shall be appropriately evaluated & investigated to
determine the root cause.
Based on the
root cause identified the concerned department Head/Designee shall initiate for
CAPA and send request for CAPA Form to QA.
QA shall record
the details in the “CAPA Logbook”.
Concerned
department Head/Designee shall list all the actions required for correction /
prevention (if applicable) of the identified problem “CAPA Form” & forward
it to QA for their review.
QA Head/Designee
shall review the CAPA form for correctness & completeness and approve /
reject the proposed CAPA.
Responsible
persons and target completion date shall be assigned based on the agreement of
the department which are involved in the implementation of CAPA.
All the action
plan listed in the CAPA form shall be implemented within due date and with
appropriate documentation.
If any document
/ equipment / facility has to be modified / change as per action plan shall be
routed through the SOP for “Change Control”,
Concerned
department Head/Designee involved in implementation of CAPA shall record the
implementation details of the implemented CAPA.
QA Head or
Designee shall verify implemented CAPA for its correctness and completeness.
Effectiveness check
QA Head or
Designee shall review the need of effectiveness check & provide the details.
In case
effectiveness check is not required than the CAPA shall be closed by QA Head or
Designee after verifying the implemented CAPA.
QA Head or designee
shall assign owner to perform the effectiveness check of the implemented action along with duration
to perform the Effectiveness Check.
Effectiveness
check owner shall verify the effectiveness of implemented CAPA for following
(but not limited to);
Expected results are obtained.
Effect on the other system / product /
equipment.
Occurrence of the similar problem
after implementation of CAPA.
After completion
of the effectiveness check of implemented action Effectiveness check owner
shall enter the details of effectiveness check and forward to QA Head.
QA Head/Designee
shall review the effectiveness of the implemented CAPA.
Based on the review
Head QA or Designee shall decide whether the implemented CAPA is effective or
not.
CAPA closure
In case
implemented CAPA is not effective then CAPA shall be closed as not effective
and new CAPA shall be initiated.
Previous CAPA shall be consider as closed and reference of previous CAPA
shall be given in the new CAPA.
In case
implemented CAPA is effective then CAPA shall be closed as CAPA effective.
In case CAPA is
not implemented within the proposed due date, concerned department
Head/Designee shall give the justification for delay and propose the tentative
date for closure as per Format “Justification Form for
Delay in Closure of CAPA”,
QA Head or
Designee shall review the justification and extend the due date up to 2 months,
and maximum 3 extensions shall be allowed.
Concern
Department shall implement the CAPA with in extended completion date and record
the details in CAPA.
Trending of CAPA:
CAPA shall be
reviewed on quarterly basis for indication of specific or recurring issue
requiring attention short term or long term additional Corrective and
Preventive action.
CAPA trend and graphical representation shall be used
to present the data.
CAPA trend &
re occurrence issues are to be discussed in the management review meeting.
All the product
specific CAPA recommendation shall be reviewed during the annual product
quality review.
Based on the
review, if required further corrective action / preventive action shall be
taken for specific or reoccurring problems.
