This document outlines the corrective and preventive action (CAPA) procedure for addressing non-conformances and quality problems. It defines when a CAPA should be initiated, such as for systemic or repetitive issues. It describes assigning a CAPA owner to investigate the root cause and identify corrective actions. Effectiveness of these actions must be verified through follow-up audits. Preventive actions may also be initiated through trend analysis to address potential problems. All CAPAs require management review and sign-off for implementation and closure within 4 months. The CAPA coordinator communicates results and actions to management.

1. Corrective and Preventive Action Procedure SOP-820.100
Rev 0
Contents
1 Purpose..............................................................................................................................2
2 Scope/Application.............................................................................................................2
3 Reference Documents/Definitions/Acronyms..................................................................2
4 Corrective and Preventive Action Procedure....................................................................3
5 Roles and Responsibilities................................................................................................5
6 Revision History...............................................................................................................5
Page 1 of 5 Confidential

2. 1 Purpose
To define the process for control of non-conformance/deficiencies or quality
problems that is determined by management to be corrective action and
preventive action (CAPA) and has to be documented using this procedure and the
CAPA form to assure thorough investigation and management review of
investigations, corrective and preventive actions and that quality systems are in
conformance with 21 CFR Part 820.100 standard.
2 Scope/Application
The requirements of this procedure apply to all CAPAs that affect the quality of
products or services at and its contract manufacturers.
3 Reference Documents/Definitions/Acronyms
References
Quality Manual
FRM 820.100 CAPA Form
FRM 820.90 CAR Form
Definition/Standards
CAR: Corrective Action Request
Concessions: Allowance to use otherwise nonconforming product, often
done through a Material Review Board. Review all records for the proper
disposition of nonconforming products for assurance that use of
nonconforming product has not resulted in the distribution of defective
devices. The distribution and justification for concessions must be
documented and based on scientific evidence. Concessions should be
closely monitored and not become normal practice. Deficiencies would
include a lack of scientific evidence for justification of the concession. If a
concession resulted in a change of product specifications (form, fit or
function), the change should be evaluated for possible 510(k) submission.
At a minimum, a risk analysis should always be considered for any changes.
Reference: Nonconformity Review and Disposition - 21 CFR 820.90(b)(1)
Corrective Action: An action taken to eliminate the causes of an existing
nonconformity, defect or other undesirable situation in order to prevent
recurrence. It is resolving an actual cause that exists in direct relation to the
problem. The cause is known and addressed directly.
Preventive Action: An action taken to eliminate the causes of a potential
nonconformity, defect or other undesirable situation in order to prevent
occurrence. It is resolving potential causes that exist as a symptom of the
problem. Only the potential is known, so you address something that could
occur rather than that which is occurring.
NC: Non-conformance

3. 4 Corrective and Preventive Action Procedure
Corrective Action
Management review determines that a non-conformance or complaint should be
issued as a CAPA:
• based on the non-conformance being systemic, repetitive and has a greater impact
on quality and
• through a meeting or monthly quality management review: analyzing processes,
work operations, concessions, quality audit reports, quality records, service
records, complaints, returned product, and other sources of quality data to identify
existing and potential causes of nonconforming product, or other quality
problems. Appropriate statistical methodology shall be employed where necessary
to detect recurring quality problems.
CAPA will be issued:
a. by Quality Management Review (QMR) or Internal Auditors
as a result of Internal Audits
b. or chronic or major customer complaints/vendor issues
c. for chronic non-conformance/deficiencies/corrective actions/NCR’s or
problems (can be product, process or quality system problems)
d. and other sources that may reveal “opportunities for improvement,”
and most often include:
Internal Quality Audit Observations (An
observation is an opportunity for improvement.)
Potential Failure Mode and Effects Analysis
(FMEA)
Trends observed in Statistical Process
Control (SPC) Charts
Employee Suggestion Programs

4. QA issues CAPA number and assigns a CAPA owner.
QA shall assign the CAPA to the department (manufacturing site and/or ) or
functional group who shall investigate the cause of nonconformities relating to:
• product
• processes or
• quality system
The assigned role together with management shall identify the action(s) needed
to correct and prevent recurrence of nonconforming product and other quality
problems.
The CAPA owner completes the CAPA Form FRM-820.100.
Corrective Action Review and Implementation
4..1 Once a Corrective Action has been written and reviewed by the CAPA
coordinator at , a copy will be given to the Department/Area Supervisor (assigned
role) and it will be their responsibility to correct the problem.
4..2 Each item in the action plan should be verified or validated to ensure that the
corrective and preventive action is effective and does not adversely affect the
finished device. See signatories in the CAPA form.
4..3 All implementation and actions shall be recorded whether they are changes in
methods and procedures needed to correct and prevent identified quality
problems.
4..4 and contract manufacturing site Quality Management shall ensure that
information related to quality problems or nonconforming product is disseminated
to those directly responsible for assuring the quality of such product or the
prevention of such problems.
4..5 The CAPA owner and CAPA coordinator shall submit relevant information on
identified quality problems, as well as corrective and preventive actions, for
management review (by both Quality Management in the manufacturing site
and ).
4..6 Following implementation of Corrective Action, a Follow-up Audit will be done
to verify that the Corrective Action is effective. If it is not effective, then another
method of correcting the problem must be tried and verified.

5. Preventive Action
A Preventive Action is documented on the CAPA Form
and should be issued as a result of:
a) Trend analysis
b) Potential problems with product or process
c) Any problem that the Quality Board or Management Review
may anticipate
Determination of Preventive Action
Cause-and-effect diagrams (Fish-bone or Ishikawa diagrams) may also be used to
determine what preventive action should be taken to eliminate the potential cause of
a nonconformance.
Initiation of Preventive Action
Initiation of preventive action must be followed up with the application of controls
to ensure that the preventive action is effective. The effectiveness of preventive
actions can be verified through follow up internal audits of the affected area,
through monitoring of the area concerned (Field Reports, R&D metrics and results),
etc. The application of controls and responsibility for preventive action should be
clearly defined wherever such action is taken.
Preventive Action Management Review and Follow-up
As a minimum, a summary of the preventive actions taken must be submitted for
management review. This summary can include an item-by-item review of each
completed action.
The CAPA coordinator at shall communicate to management and the
manufacturing site the result of the management review and preventive actions
taken on each action. He/She reviews and signs off the CAPA form before
implementation and for closure (preferably all CAPAs should be closed within four
months from their creation date).
Once the Preventive Action has been implemented, a follow-up must be done to
verify that it is effective as indicated in the Effectiveness section of the CAPA form.
5 Roles and Responsibilities
The CAPA coordinator at shall communicate to management and the
manufacturing site the result of the management review and preventive actions
taken on each action to avoid re-inventing the wheel. He/she will initiate
management meeting for CAPA determination of a non-conformance/corrective
action/quality problem and monitor CAPA, update the CAPA log and create trends
analysis.
6 Revision History
Rev Date Name Change
00 6/2/2010 Connie Dello Buono Initial release