Corrective and Preventive Actions
GPTKB entity
Statements (28)
Predicate | Object |
---|---|
gptkbp:instanceOf |
Quality management process
|
gptkbp:abbreviation |
gptkb:CAPA
|
gptkbp:component |
Corrective Action
Preventive Action |
https://www.w3.org/2000/01/rdf-schema#label |
Corrective and Preventive Actions
|
gptkbp:purpose |
prevent recurrence
improve processes eliminate causes of non-conformities prevent occurrence |
gptkbp:regulates |
gptkb:ISO_13485
gptkb:FDA gptkb:ISO_9001 |
gptkbp:relatedTo |
quality assurance
risk management continuous improvement |
gptkbp:requiredDocuments |
yes
|
gptkbp:requires |
gptkb:Good_Manufacturing_Practice
21 CFR Part 820 |
gptkbp:step |
gptkb:investigation
root cause analysis effectiveness check identification of problem implementation of action |
gptkbp:usedIn |
manufacturing
medical device industry pharmaceutical industry |
gptkbp:bfsParent |
gptkb:CAPA_(Corrective_and_Preventive_Actions)
|
gptkbp:bfsLayer |
8
|