A true example of CAPA - Accident that show its cause and the corrective action

D

Dr.mohamedezeldin

#1
hi , i am new in this forum and i am looking to a true accident that show it cause and the corrective action , and the protective action.
and finally thank you.:agree:
 
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CarolX

Super Moderator
Super Moderator
#2
hi , i am new in this forum and i am looking to a true accident that show it cause and the corrective action , and the protective action.
and finally thank you.:agree:
Hi Dr.mohamedezeldin and Welcome to the Cove! :bigwave:

I am not sure what you are looking for - are you looking for any example of a CAPA for defective product, or something else? You refer to an "accident" - could you clarify a little more.
 

Ajit Basrur

Staff member
Admin
#4
hi , i am new in this forum and i am looking to a true accident that show it cause and the corrective action , and the protective action.
and finally thank you.:agree:
Welcome to the cove :bigwave:

Do you mean a "nonconformance" when you refer as accident ? If you are looking for examples of CA and PA (Preventive Action) and not Protective action, we have lot of examples in the forum. Use the SEARCH to get information.
 
D

Dr.mohamedezeldin

#5
Thanks for your replies,
what i mean is a nonconformance specialy in pharmaceutical industries.
 
J

Jimmy the Brit

#6
Thanks for your replies,
what i mean is a nonconformance specialy in pharmaceutical industries.
Pharmaceutical nonconformances don't come much bigger than this:
Clothier Report
Department of Health and Social Security
Report of the Committee appointed to inquire into the circumstances, including the production, which led to the use of contaminated infusion fluids in the Devonport section of Plymouth General Hospital. (Cmnd. 5035)
London: HMSO, 1972
ISBN: 0101503504
Five people died as a result - a salutory lesson to those who think that drugs are "overcontrolled".

Regards,

Jimmy
 
S

Sandra Gauvin

#7
Here's a few real world examples....

Example 1: A Quality Assurance person responsible for reviewing and approving Change Controls let his yearly GMP refresher training lapse while continuing to review and approve Change Controls.

Example 2: An operator documented incorrect information (i.e. wrong date) on a controlled record and did not use good documentation practices when they fixed the error.

Example 3: A nonconformance investigation was not completed within the specified amount of time prescribed in the SOP and did not have any approved extension justifications.

Example 4: Procedure required a 'Performer' and a 'Verifier' to complete and document task....only the Performer signed off on the documentation.
 
A

achorste

#8
What about Centerpulse's major problems that ultimately led to the company being sold off to Zimmer?

If I remember correctly (this is second hand info - someone else may be able to clarify), they changed their machining / cleaning processes without going through the normal change control / testing requirements that mean the cups did not fixate properly (pain for the patient & another operation to replace).
 
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