FDA CAPA
FDA CAPA
Study online at https://quizlet.com/_fecne0
1. Purpose of CAPA -Aid in assessment of overall effectiveness of QMS
reviewed in all FDA inspections, level 1 and 2
-Collect and analyze info to identify actual and potential product/QA problems
-Investigate product/QA prob and take appropriate and effective corrective or
preventative action
-Once you ID something is wrong, do something about it
-Verify or validate effectiveness of corrective/preventative actions
-Comm corrective and preventative action to appropriate ppl responsible
-Provide info for management for review
Doc activities
2. Definitions -Correction: action to eliminate detected nonconformity
>Correction can be made in conjunction with with a corrective action
>Can be rework/regrade
-corrective action: action to eliminate the cause of a detected non-conformity or
other undesirable situation.
>can be more than one cause for NC
>corrective action taken to prevent recurrence
>difference between correction and corrective action
>EX: if mispelt word in slide, correction could be to update word, corrective action
would be to eliminate cause: EX add spell check to presentation dev process
-Preventive action: action to eliminate cause of a potential nonconformity or other
undesirable situation
>There can be more than one cause for a potential nonconformity
>Preventive action is taken to prevent occurrence
>EX: implement spell check prior to all power point creation in processes
3. 21 CFR 829 Reg Establish and maintain procedure for implementing CAPA (define, doc, imple-
Req ment)
1/5
1
, FDA CAPA
FDA CAPA
Study online at https://quizlet.com/_fecne0
Depends on complexity of device, process, org for how you dev procedures
CAPA applies to DC and non distributed product that are suspected of having
potential nonconformities
4. CAPA Planning Plan should include:
Data source and criteria- what to measure and when, what is threshold for CAPA,
not every NC will be a CAPA
Measuring and analysis of data sources- define how and what way to do this,
quantitative when possible, limit subjectivity in qualitative, should be already im-
plemented in design controls
Improvement plans- how to use info once you have data/met threshold
Input management-how/when to provide data to management
5. Establishing data Product quality issues can be internal and external
sources for CAPA
Examples- Internal Data
>Process control data
>Test/inspection data
>DHR- trend over time to see how things work based on specs
>Internal audits
>NC material report
>Rework/scrap yield data
>Training record
Examples - External Data
>Supplier controls- MFG is responsible for purchasing control
>Customers- customer feedback or complaints, complaints could trigger a CAPA
>Complaints
>Servicing repairs- issues not ID during design
>Adverse event reporting MDR- your own and competitor from MAUDE
>FDA
>Similar device from competitors
2/5
2
FDA CAPA
Study online at https://quizlet.com/_fecne0
1. Purpose of CAPA -Aid in assessment of overall effectiveness of QMS
reviewed in all FDA inspections, level 1 and 2
-Collect and analyze info to identify actual and potential product/QA problems
-Investigate product/QA prob and take appropriate and effective corrective or
preventative action
-Once you ID something is wrong, do something about it
-Verify or validate effectiveness of corrective/preventative actions
-Comm corrective and preventative action to appropriate ppl responsible
-Provide info for management for review
Doc activities
2. Definitions -Correction: action to eliminate detected nonconformity
>Correction can be made in conjunction with with a corrective action
>Can be rework/regrade
-corrective action: action to eliminate the cause of a detected non-conformity or
other undesirable situation.
>can be more than one cause for NC
>corrective action taken to prevent recurrence
>difference between correction and corrective action
>EX: if mispelt word in slide, correction could be to update word, corrective action
would be to eliminate cause: EX add spell check to presentation dev process
-Preventive action: action to eliminate cause of a potential nonconformity or other
undesirable situation
>There can be more than one cause for a potential nonconformity
>Preventive action is taken to prevent occurrence
>EX: implement spell check prior to all power point creation in processes
3. 21 CFR 829 Reg Establish and maintain procedure for implementing CAPA (define, doc, imple-
Req ment)
1/5
1
, FDA CAPA
FDA CAPA
Study online at https://quizlet.com/_fecne0
Depends on complexity of device, process, org for how you dev procedures
CAPA applies to DC and non distributed product that are suspected of having
potential nonconformities
4. CAPA Planning Plan should include:
Data source and criteria- what to measure and when, what is threshold for CAPA,
not every NC will be a CAPA
Measuring and analysis of data sources- define how and what way to do this,
quantitative when possible, limit subjectivity in qualitative, should be already im-
plemented in design controls
Improvement plans- how to use info once you have data/met threshold
Input management-how/when to provide data to management
5. Establishing data Product quality issues can be internal and external
sources for CAPA
Examples- Internal Data
>Process control data
>Test/inspection data
>DHR- trend over time to see how things work based on specs
>Internal audits
>NC material report
>Rework/scrap yield data
>Training record
Examples - External Data
>Supplier controls- MFG is responsible for purchasing control
>Customers- customer feedback or complaints, complaints could trigger a CAPA
>Complaints
>Servicing repairs- issues not ID during design
>Adverse event reporting MDR- your own and competitor from MAUDE
>FDA
>Similar device from competitors
2/5
2
