Answer to Question #76722 in Accounting for Brodie
When a company seeks to implement their CAPA process, they must identify and define the problem. The definition phase requires clear reporting (i.e. documentation). Document how you gathered or deduced the problem information. Provide proof that the problem exists.
2) The Appraisal
Procedure #2 of the preventive corrective action focuses on appraisal. Here you determine the impact that the problem is likely to have on the company's overall business. Study the possible impacts related to costs, function, product quality, safety, reliability, and/or customer satisfaction issues. Include possible risk to customers, employees and any form of necessary remedial actions.
If a remedial action has not resolved the issue at hand during phase #2 then undertake the discovery phase of the CAPA process.
The examination stage of the preventive corrective action isolates the root cause of the problem.
5) Action And Implementation
During the action and implementation stage you start to make progress to fixing the problem. Here you develop a methodology that prevents the problem from reoccuring. Like the other CAPA stages, this plan must be documented. Assign responsibility and due dates for the various actions.
The closure of the CAPA investigation occurs only after evaluating the concluded CAPA actions. The evaluation, must not only verify the successful completion of the identified tasks, but also assess the appropriateness and effectiveness of the actions taken. Accomplish this by answering a series of questions.
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