Revision as of 19:35, 21 February 2021

Abstract

Corrective and Preventive Actions (CAPA) are procedures designed to handle nonconformity and other undesirable situations. In this context is corrective actions is defined as actions set in motion to eliminate an occurred nonconformities or unwanted situations, and preventive actions as actions set in motion to eliminate potential nonconformities or unwanted situations ^[1]]]

The 7 steps of CAPA

Step 1: Identification

Step 2: Evaluation

Step 3: Investigation

Step 4: Analysis

Step 5: Action plan

Step 6: Implementation

Step 7: Follow-up

CAPA Report and documentation

Limitations

Critically reflect on the tool/concept/theory and its application context. What can it do, what can it not do? Under what circumstances should it be used, and when not? How does it compare to the “status quo” of the standards – is it part of it, or does it extent them? Discuss your article in the context of key readings / resources provided in class. Substantiate your claims with literature

Other relevant Wiki articles

How to create a working CAPA team: Roles and responsibilities in project team.

How to control the scope of the CAPA project: Project Scope Management.

How to ensure control of the CAPA proces: Project Control.

How to improve your CAPA processes: Lessons learned.

Annotated Bibliography

Provide key references (3-10), where a reader can find additional information on the subject. The article MUST make appropriate references to the and reference material provided in class – either incorporating it as a source, or critically discussing aspects that are missing from it but covered by this article. Summarize and outline the relevance of each reference to the topic (around 100 words per reference). The bibliography is not counted in the suggested 3000 word target length of the article.

Bibliography

Rodríguez-Pérez, José, CAPA for the FDA Regulated Industry - American Society for Quality 2011