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21 Cards in this Set
- Front
- Back
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CAPA |
CORRECTIVE ACTION PREVENTATIVE ACTJON |
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CAPA objectives 1-3 |
1. Define and document CAPA system 2. See if product and QUALITY PROBLEMS IDENTIFIED 3. Determine Trends - unfavorable trends have been identified |
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CAPA objectives 4-6 |
4. Challenge Quality Data information system 5. Verify statistical meter to detect problems 6. Determine if failure investigation procedures followed |
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CAPA OBJECTIVES 7- 8 |
7. Determine appropriate action 8. Determine if corrective and preventative action were effective and verified |
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CAPA objectives 9- 10 |
9. CAPA Implementation and documented 10. Problems in quality properly dissemination |
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Manufacture review |
- Done 2X per year - if something out of specification (OOS) then must do investigation |
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Manufacture review - internal |
1x - non conformance report -Routine issue and OPEN CAPA |
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Deviation |
Departure from approved instructions or established standard - May or may not result in batch rejection |
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Deviation concern |
Primary concern is the deviation degree to which it has effected product quality |
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Product quality |
Each deviation must be evaluated for impact on product quality |
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Product quality |
Did deviation effect the strength or quality |
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Deviation in product quality |
- Some are minor = lab or factory - others = potential quality risk and escalate to investigation such as a CAPA |
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Deviation system |
- documented -system used to track= deviation events, investigation status , CAPA |
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Deviation investigation |
Failures = investigates to determine what is not the cause |
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Deviation investigation |
Failures = investigates to determine what is not the cause |
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Corrective action and preventative action |
Should be looked at by quality control group to check product quality |
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Deviation investigation |
Non- product quality deviation then it’s done quickly aka minor |
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Deviation investigation |
Non- product quality deviation then it’s done quickly aka minor |
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Minor incident discrepancies |
Can turn into more significant = CAPA - should be resolved by QA |
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Failures/Non-conformance |
Does not meet its specification (OOS) |
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Failures/ non-conformance (OOS) |
-Out of specification - failure of any specific component and raw material used in main product = product failure |
