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Corrective and

Preventive Actions

A Five Step Approach

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Topics to Be Covered

What is CAPA? Governing authority

Five steps to a good CAPA

process Where companies have

difficulty Example citations

Recap

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What Is CAPA?

Corrective Action Preventive Action

Eliminate Preventdetected nonconformity

nonconformity occurrence

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CAPA Process Map

Deviations/OOS/Failure Problem

Occurs

Determine Root Cause

Determine Corrective Action

Initiate CAR

CAR Respondent(s) and

Approver(s) Determined

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CAPA Process Map

Respondent(s) Provides Corrective Responses, Root Cause

Verification, and Implement Due Dates

Response(s) Summarized

Corrective Action

Implementation begins

Respondent(s) review similar systems for Preventive Action

Opportunities

Effectiveness review date set

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CAPA Process Map

Respondent(s) sign-off when

implementation is complete

Effectiveness is reviewed

and signed-off

CAR Closed

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Records and Reports

Anyunexplained discrepancyshall be thoroughly investigated.

The investigation shall extend to other batches that may have

been associatedwith the specific failure or discrepancy.

A written record of the investigation shall be made and shallinclude conclusions and follow up

Written procedures should be established for investigating

critical deviations or failures of intermediate or final batches tomeet specifications.

Investigationsshould extend to other batches.

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Corrective and Preventive ActionManufacturer shall establish procedures for implementing

corrective and preventive action.

The procedures shall include requirements for:

1) Analyzing processes, work operations, concessions,

quality audit reports, quality records, service records,complaints, returned product.

2) identify existing and potential causes of

nonconforming product, or other quality problems

Statistical methodologyshall be employed to detectrecurring quality problems

3) Investigatingthe causeof nonconformities relating to

product, processes, and the quality system.

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Corrective and Preventive Action4) Identify action(s) needed to correct and prevent

recurrence of nonconforming product and other qualityproblems;

5) Verifying or validatingthe corrective and preventive

action to ensure actions are effective;

6) Implement and recordchanges in methods and

proceduresneeded to correct and prevent identified

quality problems;

7) Submitting relevant information on corrective and

preventive actions, for management review.

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1. Failure to implement corrective/preventiveaction or conduct a thorough investigation

a) Repeated test failures not investigated

b) Inadequate investigation of failed

particulate inspection

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Failure to document corrective action

regarding instrument calibration check

which did not meet specification

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Failure to establish and maintain adequate proceduresfor implementing corrective and preventive action, as

required.

For-example: (a) The procedure titled corrective Action Handling

[redacted] was not approved and implemented to

address corrective and preventive action and no

established procedure was found to have been inplace.

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Failure to adequately establish and maintain

procedures for implementing corrective and preventive

actions as required

Example : a. Corrective Action Request # & # were not

closed out by the QC Supervisor as required by (SOP)

Corrective and Preventive Action, Rev 1.

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Failure to adequately establish and maintain procedures for

implementing corrective and preventive actions as required

Example :(b) (SOP) Corrective and Preventive Action, identifiesrepair reports as a source for identification of potential CAPA

activities; however, repair reports are not being trended or

reviewed for CAPA

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RECAP

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