Understanding The Corrective and Preventive Actions
Understanding The Corrective and Preventive Actions
Understanding The Corrective and Preventive Actions
Corrective and
Preventive Actions
(CAPA)
Objective
1. To understand the importance of CAPA
2. To be able to know how to create CAPA
Plan
3. To be able to identify the root cause and
its corrective action
4. To be able to identify the different forms
of CAPA
DEFINITION OF TERMS
Correction Actions
Immediate actions taken to
address the cause of a
detected non-conformity.
Also termed as containment
action.
Corrective Actions
A reactive process used to
address an existing product
problem, customer complaint
or other nonconformity and
fixing it to prevent recurrence.
Preventive Actions
A proactive process
intended to prevent
occurrences of potential
problems or to prevent to
become more severe.
Why CAPA?
Regulatory Requirements
Both FDA and ISO require an active CAPA program as
an essential element of a quality system.
Customer Satisfaction
The ability to correct existing problems or implement
controls to prevent potential problems is essential for
continued customer satisfaction
Good Business Practice
Quality problems can have a significant financial
impact on a company.
CAPA Procedures
Implementing an effective and fully
compliant Corrective / Preventive action
program is a seven step process.
Each step must be thoroughly documented!
Properly documented actions provide
important historical data for a continuous
quality improvement plan and are
essential for any product that must meet
the regulatory requirements demanded by
FDA and ISO.
CAPA Procedures
Seven Steps
1. Identification – clearly define the problem
2. Evaluation – appraise the magnitude and impact
3. Investigation – make a plan to research the
problem
4. Analysis – perform a thorough assessment
5. Action Plan – create a list of required tasks
6. Implementation – execute the action plan
7. Follow Up – verify and assess the effectiveness
1. Identification
The initial step in the process is to clearly
define the problem or potential problem.
This should include:
the source of the information,
a detailed explanation of the problem,
Documentation of the available
evidence that a problem exists.
1. Identification
Source of the Information
The specific source of the information is documented.
There are many possible sources:
Service requests Recalls
Risk analysis Management Reviews
Staff observations Warning Letters
Out of Trend Regulatory Audits
Process monitoring Out of Specs
Customer Complaints Supplier/customer Audit
Internal Audits Yield data
EXAMPLES
EXAMPLE 1 Nobody accomplished
Nobody thought that
cleaning it is
a cleaning procedure
necessary
No cleaning
procedure Nobody thought
that it is necessary
to document
METHOD
Nobody thought Nobody thought
that it is necessary that cleaning it is
to include in SSOP necessary
Not included in
SSOP
Neglected to
Brush include in SSOP
holders
at Bldg.6
are dirty Personnel did not
thought
and slimy that cleaning it is
necessary
Sanitation Personnel
unable to clean Nobody thought that
Nobody instructed
cleaning it is
to clean
necessary
MANPOWER
Nobody thought that
Nobody instructed / cleaning it is
reminded to clean necessary
Sanitation Personnel
unaware that it Personnel did not
should be cleaned thought
that cleaning it is
necessary
Non-Conformity Brush holders at Bldg.6 are dirty and slimy based on IQA last June 10,
2016
Root Cause Nobody thought that cleaning it is necessary.
Actual
frying
temperature Supervisors verify the Insufficient system
(OOR) monitoring records but on review of
is different do not relay the data records
from standard Insufficient system
as stated in the on review
product SOP Frequency of of records
MATERIAL Product SOP is outdated document review is
deviated
Lack of manpower
Lack of manpower
Frequency of document
METHOD review is deviated
Insufficient system
on review
of records
Non- Actual frying temperature is different from standard as stated in the
Conformity product SOP
Root Insufficient system on review of records.
Cause
Correction Not applicable
Action
Review and revise the Control of Records Procedure according to
Corrective the need of the system
Action Revise the product SOP for frying section (OOR)
Issue updated product SOP and Control of Records Procedure to
concerned department
Re-orientation of the updated system
Review Supervisor’s responsibilities and allocation
Timeline June 2016
Person QA Officer/ R&D/ QC Supervisor/ Production Supervisor
Responsible
Preventive Review the product SOP for all products
Action Conduct internal quality audit quarterly
Orientation of newly hired or transferred employees (Supervisor)
IQA CAPA
SAMPLE FILLED UP CAPA
EXAMINATION
TIME!!!
(30 minutes)
INSTRUCTIONS:
Fill up the CCAF form issued by
QA department (except the
verification section)
Accomplish a Root Cause
Analysis at the back of the Form.