Basis for Verifying Corrective Actions and Effectiveness

Q

QP029

#1
Our auditor issued a non-conformance for failure to " NC against ISO 8.5.2, 8.5.3. Can anyone please clarify what is needed to 'define the basis'? In my report for verifying effectiveness is included a reference to the action, the method of verification and the actual results. Thanks,
 
Elsmar Forum Sponsor
#2
First, and formost... welcome to the cove... :bigwave:

Your post doesn't have a lot of detail, but I will try to answer it. 13485 requires two things in both corrective action and preventive actions.

First that you review the corrective (or prevetive) action taken. Did you complete a good investigation, and did you carry out the plan outlined in the action? I see a lot of corrective actions that address only the symptoms, not the root cause.

Secondly, you must review the effectiveness of the action taken. Did you make sure that action taken did in fact either stop the problem from happening, or recurring? Determining the effectiveness of actions is a bit harder. In order to truly determine they are effective, you must have had the opportunity for the problem to occur(or recurr). However, there are things you can do such as maintaining data showing the problem is not occuring (recurring)
 
G

gholland

#4
db has it right. Determine the root cause for pursuing either the corrective action (taken for Non Conformances) or preventative action (reducing the chance of a Non Conformance) and then proving that you have reduced the failure rate to an acceptable level.

If you are taking SPC data you should be able to do a statisitcal analysis on the failure rates before and after your CA/PA and prove the effectiveness. If you are not taking SPC data you will have to rely on other means such as scrap rate or complaint data to show improvement. This is where the investment into SPC can really pay off.

:2cents:
 
Q

QP029

#5
Thank you all for your input. The auditor sited 2 completed CAPAs in the non-conformance not the procedure so I believe my procedure adequately covered verifying the actions were completed and effective; nor did she site the investigation or actions being inadequate. These CAPAs were basically for simple documentation; statistical analysis was not possible. The audit report contained no further information other than: " Two CAPAs reviewed did not clearly define the basis used to “verify effectiveness” (CAPA 107, 112)."

I was wondering if there was some industry best practice or guidance document that referred to "basis" for verification that I have not seen or heard of before.
 

sagai

Quite Involved in Discussions
#6
There is one :)

http: // ghtf. org /documents/sg3/sg3_n18.pdf - DEAD 404LINK UNLINKED

It is a brilliant one.

Reflecting to your problem regardless fully know it.
The verification of the Effectiveness shall be predefined and shall be based on the root cause(s). but everything in the document. Required 4-6 times re-reading to really understand what are the objectives behind its wording.

br
Sz.
 
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C

christine22

#7
:thanks: I am this looks as if it will be quite informative! Not to mention exactly what I need right now... THANKS!
 
#8
QP029 - actually, the basis for verifying the corrective action is the reported non-conformity itself! As you can tell, from the 2 you were written by your CB auditor, if it's not clear what the issue is, then the verification can be open to such foolish findings or worse!

As you will find, scanning posts here, rarely - if ever - do auditors report the 'effectiveness' of the process which is affected by the NC. Your auditor has fallen into this trap. They prey on the fact that you don't know enough about what they've written to push back - force them - into reporting what the real problem is!

So, yes, you may well have some improving to do, with the way your internal audits are done/reported, but your CB could well do with leading by example!

I'd ask them for clarification, before doing anything...
 
K

kgott

#10
Sorry people but I don't understand that about the report of the noncofnrmity being the evidence of corrective action? it went over my head. What was that??
thanks
 
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