Could you tell me about the difference between the Deviation and the CAPA?
I’d like to rebuild the quality system on that area.
Do I have to make two regulation(Deviation and CAPA)?
Or CAPA can be a part of the Deviation?
Or they are same thing?
I’m confusing.
Is there any possibilty to go through CAPA without deviation?
Please tell me the difference and reference.
thank you for reading.
Our approach is that CAPAs are for systemic issues and deviations are for “1-off” instances. Deviation analysis/trending might indicate systemic issues which would trigger a CAPA.
you mean I might make two different SOP.
anyway they are not same meaning. All right.
very thank you for your help.
Dear Yadon
Could you throw some light on systemic issues?
I am not still clear about diff between CAPA and deviation.
Warm Regards
Ravindra Upare.
Maybe an example would help.
Let’s say that we validate equipment. In one test event, one of our testers doesn’t follow GDP in a couple of instances. In this case, we would consider these deviations, correct the issues (using appropriate controls), and move on. If, however, that same tester exhibited repeated occurrences of GDP violations or all our testers were violating GDP practices, we would have to consider this a systemic issue. In this case, we would write a CAPA, determine root cause, and correct the issue. Note that in this case, we would have both corrections (correct the GDP violations) AND corrective actions (address the root cause).
I chose testing to show that the concept can be applied across all disciplines. Maybe you assemble 50 widgets and 1 is not built correctly - you’d probably consider this a deviation. If 1 in every lot is not built correctly (with the same issue), you may have a systemic issue and need to assess root cause / corrective actions. Maybe you write software and testing indicates one of the programming teams consistently introduces memory management errors - enough so that it is considered systemic. Probably a CAPA is warranted to understand why and to correct the root cause.
Hope that helps.
I would consider following description of CAPA and Deviations in the same Quality Policy.
Some times it is a good practice (my belief) to proceed with identifying the root cause and propose both corrective and preventive actions for eliminating re-currence.
Best regards,
Dear Yadon
Thanks a lot for wonderful example and explanation.
Warm Regards
Ravindra Upare.
CAPA : Corrective Action and Preventive Action.
Corrective action is " Action taken to prevent Re-Occurance"
Preventive Action is " Action taken to prevent Occurance"
Normally corrective action happens when any failure occured.
Preventive action happens when any “out of trend” value found, So that failure can be prevented.
Deviation is “anything fall out side of the defined procedures”.
Hence whenever any deviation is happen CAPA should he triggered.
Also, CAPA can be triggered from Out of trend, Market complaints, Audit reports etc.
[quote=ssnmd]CAPA : Corrective Action and Preventive Action.
Hence whenever any deviation is happen CAPA should he triggered.
etc.[/quote]
From what I’ve witnessed, this is impractical. The CAPA system would be utterly overloaded and staff would be over-burdened with CAPA processing.
To me, a company should be judicious in dropping things in the CAPA system - it shouldn’t be used as a dumping ground for every deviation that pops up. There should be a real need to identify a root cause and correct a systemic issue. I’ve seen numerous companies create their own worst nightmares (often resulting in 483s) when the CAPA system gets stressed as a result of overloading. A favorite finding of the FDA is CAPAs not handled in a timely manner. Another favorite is failure to identify root cause.
In an ideal world, it would be great to do a detailed investigation of every deviation and fine-tune the system to prevent future recurrence. Just realize that if you attempt to do so, you could be setting yourself up for failure.
I agree with Yodon. Normally, it is very good options to handle every deviation with a CAPA system. But before doing that we shoul think twice that are not we giving us overload that can not be carried out.
Normally, the nature of the deviations should be analyzed. It is not good approach to rank and take actions to every deviation in same manner. The deviations should be ranked and the criticality of the deviations should be determined and the most critical deviations should be handled through CAPA system. This will help you to identify which deviations are having reoccurence and which deviations need immediate action and rectify them through CAPA system.
Prawan Dahal