CAPA Management – Process Flow

2a) Log CAPA on 2b) Is CAPA

tracker, issue related to a 2b) Relates to a
customer/regulatory 5) Actions &
reference complaint, NO 7b) CAPA 8) CLOSE
authority audit approval
number & CAPA deviation or accepted, Notify relevant
form other? finding? approve form parties of
and update successful CAPA
Quality Assurance YES tracker closure
/ Senior Management
2c) Make decision on whether risk is
considered critical, major or minor FINISH
following the decision tree guide YES

2d) Assign owner and RFI

to answer who, what,
when, where, how, why
questions in the CAPA 4) Action plan defined, Minor
form (Only applicable to justified, classified, due Actions
complaints and date(s) assigned &
deviations) approved by owner

3b) Discussion YES

CAPA Owner / with other
3c) Classify the CAPA.
Subject Matter SMEs, QA/SM,
Priorities CAPA plan
Expert external parties
1) Identify the need accordingly. Execute 7a) Effectiveness,
3a) Obtain and complete 6) Action owner's Critical &
for CAPA through urgent actions monitor the
information the root cause complete actions Major
various sources immediately if need be completed actions.
from SMEs, analysis on & confirm by Actions
(Internal/External). Was it successful?
START QA/SM, CAPA email
Share requested
information to external parties
QA/SM NO

Quality Assurance
/ Senior Management
2) Is CAPA derived from any of
following:
• Deviation from approved process?
• Service deviation by 3rd party
vendor?
• Customer complaint?
• Reported EHS incident?
NO
1) CAPA has been
identified / notified to
QA/SM and logged
onto spreadsheet
CAPA Management – Risk Assessment Decision Tree Guide
Carefully consider the following statements bearing in mind that inappropriate downgrading may result in
unacceptable residual risks and failure to address the real issues
The problem has had or is
The problem has had or is The problem is very
likely to have a direct
3a) … and likely to have an indirect unlikely to have adverse
adverse impact on
information has adverse impact on impact on product quality
product quality / patient
been obtained, product quality / patient / patient safety or result
YES safety or result in death or
including any NO safety or result in lost NO in lost time injury or any
serious and/or permanent
immediate actions time injury or repairable environmental impact or
injury or irreparable
taken environmental impact or any financial loss . Could
environmental impact or
minor financial loss. be an agreed
major financial loss or
Problem is recurring improvement action
adverse publicity
YES
YES YES
CAPA is CRITICAL
Immediate and urgent CAPA is MAJOR
action(s) must be taken Actions must be taken to CAPA is MINOR
3b) Process CAPA as
to mitigate critical risks mitigate identified risks Actions are not urgent
per the
to product / patient / to product / patient / but must be planned,
customer/regulatory
personnel or personnel or achievable and
authority audit
environment and environment or completed at a time to
finding classification
controls must be put in business. be agreed with CAPA
place to prevent Actions must be timely owner / stakeholders
recurrence to prevent recurrence
4) Outputs of above process must be recorded on CAPA form and used to progress CAPA
planning, execution and evaluation