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

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

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

� 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.

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