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Click to edit Master subtitle Action Corrective And Preventivestyle

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Quality is never an accident; it is always a result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives
William A. Foster

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A tool of Root cause analysis

Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems

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Corrective

Action (CA)

The process of reacting to an existing product problem, customer complaint or other nonconformity and fixing it

Preventive Action (PA)

It is the action to eliminate the cause of a potential nonconformity or other potential situation

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2 phases of corrective action

Short term immediate action

Action taken to contain a problem or non conformance. action taken should be swift and limited in scope.

The

Long term corrective action

Action

taken to prevent a problem or non conformance from re-occurrence. taken is methodical and deliberate. Deming PDCA cycle.

Action Uses

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WHY CAPA?
Regulatory

Requirements

ISO and other quality standards require an effective CAPA program as an essential component of quality system.
Customer

satisfaction

The ability to correct existing problems or implement controls to prevent potential problems is essential for continued customer satisfaction
Good

business practice significant

Quality problems can have a financial impact on a company

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CAPA Procedure (7 steps)

Identification

Clearly define the problem. It must include

The source of information. Detailed explanation of the problem. Documentation of the evidence that problem exists.

Evaluation

The situation must be evaluated to determine both the need for action and the level of action required.

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Capa Procedure (CONTD.)

Investigation

A written procedure for doing an investigation into the problem is created. It includes

Investigation Strategy. Assignment of responsibility.

Analysis

Each possible cause must be identified and data collected.

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Capa Procedure (CONTD.)

Action

Plan

Using the results from the analysis, best method for correcting or preventing the situation from future occurrence is determined.
Action

Implementation

The action plan that has been developed is executed and all identified tasks and activities completed.

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Capa Procedure (CONTD.)

Follow

up

One of the most fundamental steps in the CAPA process is completing an evaluation of the actions that were taken. Ask Key Questions Verification and validation of results

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Completion
When

the follow up gets finished the CAPA is complete. It should be dated and signed by appropriate, authorized personnel

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General Observation

Weak Weak

CA, Weak PA (Common) CA, Strong PA (Unusual) CA, Weak or unlinked PA (Common) PA linked to a strong CA (Ideal)

Strong Strong

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