St. Peter’s College
Sabayle Street, Iligan City
Identification of
Corrective and
Preventative
Actions
Submitted by:
VINCE LOUIE C. EBLAMO
ALREY JUNE T. PANGATUNGAN
NORHAN A. ALOYODAN
DRANREB C. PALABON
Students
Submitted to:
MR. ABDUL HALIL S. ABDULLAH II
Instructor
Cover Page
Introduction
Purpose/Importance
CAPA Organization
Concept of CAPA
Examples of corrective actions
Corrective and Preventive Action Processes
General requirements
Sources of data
Corrective and Preventive Actions Procedures
Problem Solving Tools
Alternate Investigation flow
References
Introduction
Corrective and Preventive Action (CAPA, also called corrective action / preventive action, or
simply corrective action) are improvements to an organization's processes taken to eliminate causes
of non-conformities or other undesirable situations.[1] CAPA is a concept within Good Manufacturing
Practice (GMP), 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, or 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).
Purpose/Importance
The purpose of the corrective and preventive action subsystem is to collect information, analyze
information, identify and investigate product and quality problems, and take appropriate and effective
corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and
preventive actions, communicating corrective and preventive action activities to responsible people,
providing relevant information for management review, and documenting these activities are essential
in dealing effectively with product and quality problems, preventing their recurrence, and preventing or
minimizing device failures.
One of the most important quality system elements is the corrective and preventive action subsystem.
CAPA OrganizationUnder the CAPA umbrella, the organization should include all activities and
processes taken to eliminate the causes of potential nonconforming products, processes and conditions
within its documented quality system. For most manufacturers of medical devices, these activities
include their methods for:
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Complaint handing (21 CFR 820.198).
Medical device reporting (21 CFR 803).
Reports of corrections and removals (21 CFR 806).
Product recalls (21 CFR 810).
Postmarket surveillance (for companies assessed under the Medical Device Directive 93/42/EEC
from the European Economic Community).
Quality audits (21 CFR 820.22).
Nonconforming products, processes and conditions (21 CFR 820.90 for nonconforming
products).
Device tracking, as appropriate (21 CFR 821).
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Concept of CAPA
• Clearly identified sources of data which identify problems that will be investigated.
• Root cause analysis to identify the cause of a discrepancy or deviation and suggest corrective
actions of a problem which is identified.
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.
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 both
include investigation, action, review, and further action if so 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 is nothing but the action/s based on
the problem identification. The problem or a non-conformance can be identified internally through staff
suggestions, management reviews, document reviews or internal audits. Customer complaints /
suggestions, customer rejections, non-conformities raised in customer / third party audits and
recommendations by the auditors are the external sources which lead to find the root cause of the
problem.
Corrective action is a reaction to any of the cause/non-conformance mentioned above and can be
divided in two phases of action: 1) Identification of root cause: Total Quality Management tools such as
fish-bone or cause and effects analysis can be practiced. CAPA is appropriate and effective if and only if
the root cause of problem(s) has been identified. 2) Taking necessary actions: The effectiveness of the
corrective action taken has to be verified periodically through a systematic approach of PDCA (plan-docheck-act) cycle.
Preventive action is prediction of problem and trying to avoid the occurrence (fail safe) through self
initiated actions and analysis related with processes/products. This can be initiated with the help of
active participation of staff members/workers through improvement teams, improvement meetings,
management review, customer feedback and deciding own goals quantized in terms of business growth,
reducing rejections, utilizing the equipment effectively, etc.
Examples of corrective actions
Error Proofing (Poka yoke)
Visible or Audible Alarms
Process Redesign
Product Redesign
Training or enhancement/ modification of existing training programmes
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.
Corrective andPreventive Action Processes
Corrective Action Process
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Locate and document the root cause of the nonconformity.
Scan the entire system to ensure no other similar nonconformity could occur.
Analyze the effect such a nonconformity may have had on a product or service produced before the
nonconformity was discovered, and take action appropriate to the severity of the situation by either
recalling the product, notifying the customer, downgrading or scrapping product.
 Establish thorough follow-up to ensure the correction is effective and recurrence has been
prevented.
Preventive Action Process
 Take proactive steps to ensure a potential nonconformity does not occur.
 Employ process and system analysis to determine how to build in safeguards and process changes to
prevent nonconformance. For example, use a failure mode and effects analysis to identify risks and
potential deficiencies and to set priorities for improvement.
Developmental Action Process (Treated as Preventive Actions)
 Initiate an improvement project, with project plans, justification for planned expenditures, resource
controls and evaluation.
 Contain a related series of actions, often separated by long periods so you can wait and see progress
and results.
 Use a variety of appropriate disciplines at different times during the project.
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Establish a means for communicating what has been done and what has to be done to facilitate
communication about changes to project team members.
Include a clear trail of actions taken and decisions made to substantiate the decision to proceed,
document lessons learned and avoid needless reinvention on future similar projects.
Documenting and controlling corrective and preventive actions ensure appropriate action is taken
within a reasonable timeframe and the resulting changes work.
General Requirements
The CAPA system should be designed to include actions needed to correct nonconforming product and
other quality problems (correction), prevent recurrence of nonconforming product and other quality
problems (corrective action), and eliminate the cause of potential nonconforming product and other
quality problems (preventive action).
In most cases, a process approach can be followed to ensure the system captures the required
information using appropriate sources of data and is effective. The concepts utilized in this approach
are:
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The CAPA system procedures address the regulatory requirements and quality system standards.
Management has provided definitions and interpretation of words or terms.
Existing and potential problems are identified (quality data sources are identified and data from
those sources are analyzed). Data are complete, accurate and analyzed in a timely manner.
Statistical and nonstatistical techniques are used to detect recurring quality problems. Results of
analyses are compared across different data sources and used to identify and develop the extent of
problems.
Failure investigation is adequate (procedures are followed and the investigation is commensurate
with the significance and risk of the nonconformity). Where possible, the root cause has been
identified.
Product is controlled to prevent distribution of nonconforming product.
After root causes are identified, appropriate corrective and preventive actions are taken. Actions are
verified and validated, are effective and do not adversely affect the finished device. Corrective and
preventive actions are documented.
CAPA information is disseminated to individuals directly responsible for assuring product quality and
preventing quality problems.
Sources of Data
Data to be included in a CAPA system come from a variety of sources, both internal and external. Some
sources of internal data include:
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In-process and final inspection and test data.
Scrap and yield data.
Process control data.
Incoming component testing and inspection test data.
Equipment data (preventive maintenance, calibration).
Internal audits.
Device history records.
Training records.
Change control records.
Rework and reprocessing.
Nonconforming materials reports.
Some sources of external data include:
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Complaints--customers, employees, MedWatch (the FDA's medical products reporting program),
field service reports, journal articles, information from the FDA and other regulatory bodies.
Warranty reports.
Legal claims.
Study reports.
Third-party audits.
Corrective and Preventive Actions Procedures
Corrective action procedures
Documentation of the identified nonconforming product, process or condition should be performed
according to the organization's documented procedures. After being informed of the identified
nonconformance, responsible personnel then assign appropriate personnel to investigate the
nonconformance and identify its root causes. Representatives from other functions may be used.
Once the investigation is completed, appropriate meetings, discussions and training sessions are held
with department personnel and other groups whose activities may be impacted by the investigation and
corrective action implementation.
The identification of the root causes (established, in part, by failure analysis, when appropriate) is
indicated on the company's appropriate documents. The documents are completed, returned to the
individuals who identified the nonconformance and then reviewed according to the process described in
documented procedures.
Once the corrective action has been verified as implemented, the documents are forwarded to quality
department personnel, who enter the corrective action information into the database for future
statistical analysis.
Preventive action procedures
As a result of identified nonconformances (for example, identified through trending) and effective
corrective actions, an individual may decide to implement a similar action to prevent the occurrence of a
nonconforming condition.
If department management identifies and approves a preventive action plan, it should also initiate
documentation. The preventive action plan and associated documentation are described on the report
form. Once the preventive action plan is accepted, the initiator verifies implementation and
effectiveness.
Documentation of preventive action is forwarded to quality department personnel for entry into the
database and possible subsequent statistical analysis.
Finally, records of corrective and preventive actions are maintained in accordance with the company's
defined process for control of quality records.
Alternate Investigation flow
References
http://asq.org/quality-progress/2005/03/problem-solving/corrective-vs-preventive-action.html
http://en.wikipedia.org/wiki/Corrective_and_preventive_action
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm
http://asq.org/quality-progress/2001/11/standards-outlook/corrective-and-preventive-action-inmedical-device-manufacturing.html
http://www.feinsteininstitute.org/wp-content/uploads/2013/02/PREP-29-CAPA-Template.pdf
http://fmdic.org/wp-content/uploads/2012/05/Lewandowski-CAPA.pdf
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/UCM334579.pdf
http://www.rmbimedical.com/RegulatoryAffairs/capa%20guidelines.pdf