Quality System - CAPA & Change Control
Quality System - CAPA & Change Control
Study online at https://quizlet.com/_jt8d9o
1. CAPA CAPA Plan - comprises of activities to eliminate the root cause of the non-confor-
mance and avoid recurrence and prevent occurrence.
Corrective Action - Action to eliminate root cause of an existing non-conformity or
other undesirable situation, and avoid recurrence.
Preventive Action - Actions to eliminate root cause of a potential non-conformity or
other undesirable situation. Usually detected or predicted through trends analysis
and data review. Prevent occurrence of the non-conformity.
Effectiveness Check - Measurable outcome to evaluate the success of CAPA, based
upon root cause.
Need to track both accountability of implementation and measurement of effective-
ness for each CAPA.
2. Develop CAPA -CAPA Plan Objectives
Plan -CAPA Deliverables
-Task Owners
-Target Completion Deadline
-Effectiveness Check of CAPA
3. Action Plan Im- Task owners complete task as per CAPA plan within the target timelines.
plementation
4. CAPA Effective- -Fixed period options (1,3,6,12 months), recommended to choose a time period
ness Check that matches the frequency of the process.
-Effectiveness Check Outcome:
>Fully Effective - Close CAPA
>Partially Effective - Extend CAPA to allow more time to evaluate or additional actions
required
>Ineffective - New CAPA additional actions required.
5. Closure After complete verification of full effectiveness of actions taken, CAPA is closed.
6. Change Control Purpose:
Management -Prevents unauthorized changes from being made to process, procedure, specifi-
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Quality System - CAPA & Change Control
Study online at https://quizlet.com/_jt8d9o
1. CAPA CAPA Plan - comprises of activities to eliminate the root cause of the non-confor-
mance and avoid recurrence and prevent occurrence.
Corrective Action - Action to eliminate root cause of an existing non-conformity or
other undesirable situation, and avoid recurrence.
Preventive Action - Actions to eliminate root cause of a potential non-conformity or
other undesirable situation. Usually detected or predicted through trends analysis
and data review. Prevent occurrence of the non-conformity.
Effectiveness Check - Measurable outcome to evaluate the success of CAPA, based
upon root cause.
Need to track both accountability of implementation and measurement of effective-
ness for each CAPA.
2. Develop CAPA -CAPA Plan Objectives
Plan -CAPA Deliverables
-Task Owners
-Target Completion Deadline
-Effectiveness Check of CAPA
3. Action Plan Im- Task owners complete task as per CAPA plan within the target timelines.
plementation
4. CAPA Effective- -Fixed period options (1,3,6,12 months), recommended to choose a time period
ness Check that matches the frequency of the process.
-Effectiveness Check Outcome:
>Fully Effective - Close CAPA
>Partially Effective - Extend CAPA to allow more time to evaluate or additional actions
required
>Ineffective - New CAPA additional actions required.
5. Closure After complete verification of full effectiveness of actions taken, CAPA is closed.
6. Change Control Purpose:
Management -Prevents unauthorized changes from being made to process, procedure, specifi-
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