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Corrective and
preventive action

Corrective and preventive action (CAPA,

also called corrective action/preventive
action or simply corrective action)
consists of improvements to an
organization's processes taken to
eliminate causes of non-conformities or
other undesirable situations. It is usually a
set of actions that laws or regulations
require an organization to take in
manufacturing, documentation,
procedures, or systems to rectify and
eliminate recurring nonperformance. Non-
conformance is identified after systematic
evaluation and analysis of the root cause
of the non-conformance. Non-
conformance may be a market complaint
or customer complaint or failure of
machinery or a quality management
system, or misinterpretation of written
instructions to carry out work. The
corrective and preventive action is
designed by a team that includes quality
assurance personnel and personnel
involved in the actual observation point of
nonconformance. It must be
systematically implemented and observed
for its ability to eliminate further
recurrence of such non-conformation. The
8D framework can be used as an effective
method of structuring a CAPA.[1]

Corrective action: Action taken to eliminate

the causes of non-conformities or other
undesirable situations. Preventive action:
Action taken to prevent further
reoccurrence of such non-conformities.

In certain markets and industries, CAPA

may be required as part of the quality
management system, such as the Medical
Devices and Pharmaceutical industries in
the United States. In this case, failure to
adhere to proper CAPA handling is
considered a violation of US Federal
regulations on good manufacturing
practices. As a consequence, a medicine
or medical device can be termed as
adulterated or substandard if the company
has failed to investigate, record and
analyze the root cause of a non-
conformance, and failed to design and
implement an effective CAPA.[2]

CAPA is used to bring about improvements

to an organization's processes, and is
often undertaken to eliminate causes of
non-conformities or other undesirable
situations.[3] CAPA is a concept within
good manufacturing practice (GMP),
Hazard Analysis and Critical Control
Points/Hazard Analysis and Risk-based
Preventive Controls (HACCP/HARPC) and
numerous ISO business standards. It
focuses on the systematic investigation of
the root causes of identified problems or
identified risks in an attempt to prevent
their recurrence (for corrective action) or
to prevent occurrence (for preventive
action).

Corrective actions are implemented in

response to customer complaints,
unacceptable levels of product non-
conformance, issues identified during an
internal audit, as well as adverse or
unstable trends in product and process
monitoring such as would be identified by
statistical process control (SPC).
Preventive actions are implemented in
response to the identification of potential
sources of non-conformity.

To ensure that corrective and preventive

actions are effective, the systematic
investigation of the root causes of failure
is pivotal. CAPA is part of the overall
quality management system (QMS).

Concepts
 Clearly identified sources of data that
identify problems to investigate
Root cause analysis that identifies the
cause of a discrepancy or deviation, and
suggest corrective actions

A common misconception is that the

purpose of preventive action is to avert the
occurrence of a similar potential problem.
This process is all part of corrective action
because it is a process of determining
such similarities that should take place in
the event of a discrepancy.
The PDCA cycle[4]

Preventive action is any proactive

methodology used to determine potential
discrepancies before they occur and to
ensure that they do not happen (thereby
including, for example, preventive
maintenance, management review or other
common forms of risk avoidance).
Corrective and preventive actions include
stages for investigation, action, review, and
further action is required. It can be seen
that both fit into the PDCA (plan-do-check-
act) philosophy as determined by the
Deming-Shewhart cycle.

Investigations to root cause may conclude

that no corrective or preventive actions are
required, and additionally may suggest
simple corrections to a problem with no
identified systemic root cause. When
multiple investigations end in no corrective
action, a new problem statement with
expanded scope may be generated, and a
more thorough investigation to root cause
performed.

Implementation of corrective and

preventive actions is the path towards
improvement and effectiveness of Quality
Management Systems. Corrective actions
are nothing but action/actions based on
problem identification. The problem or a
non-conformance can be identified
internally through staff suggestions,
management reviews, document reviews
or internal audits. External leads to finding
the root cause of the problem can include
Customer complaints/suggestions;
customer rejections; non-conformities
raised in customer/third-party audits;
recommendations by auditors.

A root cause is the identification of the

source of the problem where the
person(s), system, process, or external
factor is identified as the cause of the
nonconformity. The root cause analysis
can be done via 5 Whys or other methods,
e.g. an Ishikawa diagram.
Corrective action is the re-
work/rectification activity of the non-
conforming products as per ISO 9001:2008
(8.5.2).

Preventive action includes the prediction of

problems and attempts to avoid such
occurrences (fail-safe) through self-
initiated actions and analysis related to
the processes/products. This can be
initiated with the help of active
participation by staff members/workers
through improvement teams, improvement
meetings, opportunities for improvement
during internal audits, management review,
customer feedback and deciding own
goals quantized in terms of business
growth, reducing rejections, utilizing the
equipment effectively, etc.

Medical devices and FDA

compliance
To comply with the United States Food
and Drug Administration's code FDA 21
CFR 820.100[5] medical device companies
need to establish a CAPA process within
their QMS. This part of the system may be
paper or digital, but it is something that is
looked for during an FDA visit.[6] In 2015
there were over 450 issues found with the
CAPA systems for medical device
companies. To have an FDA-compliant
QMS system required the ability to capture,
review, approve, control, and retrieve
closed-loop processes.[7]

Examples of corrective
actions
Error Proofing
Visible or Audible Alarms
 Process Redesign
Product Redesign
Training or enhancement/ modification
of existing training programs
Improvements to maintenance
schedules
Improvements to material handling or
storage

In some cases, a combination of such

actions may be necessary to fully correct
the problem.

See also
 Eight Disciplines Problem Solving
Good documentation practice
Good manufacturing practice
Good Automated Manufacturing
Practice (GAMP)

References
1. Pruitt, W. Frazier (May 2019). "A
Disciplined Approach" . asq.org.
Retrieved 31 October 2019.
2. "Corrective and Preventive action
Guidelines for Pharma Industry" .
Retrieved 2016-12-30.
3. ISO 9000 Quality management system
- Fundamentals and vocabulary. ISO.
2005.
4. "Taking the First Step with PDCA" . 2
February 2009. Retrieved 17 March
2011.
5. "CFR - Code of Federal Regulations
Title 21" . www.accessdata.fda.gov.
Retrieved 2016-05-20.
6. "Does Your CAPA Process Need a
CAPA?" . SOLABS. Retrieved
2016-08-29.
 7. "Guidance for Industry- Q10
Pharmaceutical Quality System"
(PDF). www.fda.gov. Retrieved
2016-08-29.

External links
Quality Systems Approach to
Pharmaceutical CGMP Regulations
(FDA)

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