CAPA CERTIFICATION EVALUATION TEST
2026 QUESTIONS AND ANSWERS GRADED
A+
●● Definitions.
Answer: -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
●● 21 CFR 829 Reg Req.
Answer: Establish and maintain procedure for implementing CAPA
(define, doc, implement)
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
●● CAPA Planning.
Answer: 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 implemented in design controls
Improvement plans- how to use info once you have data/met threshold
Input management-how/when to provide data to management
●● Establishing data sources for CAPA.
2026 QUESTIONS AND ANSWERS GRADED
A+
●● Definitions.
Answer: -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
●● 21 CFR 829 Reg Req.
Answer: Establish and maintain procedure for implementing CAPA
(define, doc, implement)
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
●● CAPA Planning.
Answer: 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 implemented in design controls
Improvement plans- how to use info once you have data/met threshold
Input management-how/when to provide data to management
●● Establishing data sources for CAPA.
