Corrective and Preventive Actions (CAPA)
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''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'' | ''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'' | ||
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| + | =Other relevant Wiki articles= | ||
| + | '''How to create a working CAPA team:''' [http://wiki.doing-projects.org/index.php/Roles_and_responsibilities_in_project_team Roles and responsibilities in project team.] | ||
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| + | '''How to control the scope of the CAPA project:''' [http://wiki.doing-projects.org/index.php/Project_Scope_Management Project Scope Management.] | ||
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| + | '''How to ensure control of the CAPA:''' [http://wiki.doing-projects.org/index.php/Project_Control Project Control.] | ||
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| + | '''How to improve your CAPA processes:''' [http://wiki.doing-projects.org/index.php/Lessons_learned Lessons learned.] | ||
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=Annotated Bibliography= | =Annotated Bibliography= | ||
Revision as of 23:13, 18 February 2021
Contents |
Abstract
Corrective and Preventive Actions (CAPA) are procedures designed to handle nonconformity and other undesirable situations. Corrective actions can be defined as actions set in motion to eliminate an occurred nonconformities or unwanted situations, where preventive actions are defined as actions set in motion to eliminate potential nonconformities or unwanted situations [2].
The context of CAPA
Project management
Regulatory authorities
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: 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.
