Is this a Nonconformance - Incubation Period exceeding that in our Procedure.

P

paito

#1
Hi!
I would show this situation:

We have one microbiological test accredited by one accreditation organism in my country. This test says 2 days for incubation samples.
The customer is according with made the incubation for 72 hours ( because of there is a weak end), (this time not modified the final result ) so my questions is:

a) is this a non conforming work ?
b) In the report I write a legend for no conforming work and the report have the logo of accreditation organism? or
c) the report wil be without legend and without logo?

I have a lot of auditories and the auditors no are in accord sometimes .One person say OK an other say no!!!!!! He say: it is no noconforming work and without logo!!!

I hope that you can understand me!!!!
Thank you for your opinion!!!!!
 
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pkost

Trusted Information Resource
#2
Re: non conforming work

You really need to speak to a microbiologist and I am not one!

You do not say what the test is, I'm going to work on the assumption that it is bioburden testing, in which case, in my limited experience I would say that 3 days is a more rigourous test and therefore better.

Is it a non conformance? If the test procedure allows for only 2 days, not more, not less then yes it is technically a non conformance. If appropriate though, the procedure should be written to say "at least 2 days", then it wouldn't be a non conformance
 
P

paito

#3
Re: non conforming work

Thank you for your answer but my problem is not microbiological! my problem is:

a) if a client agree other condition different of accredited condition is it non conforming work?

b) the report have or not the accreditation logo and a legend like this: "this test have a deviation with the agree of client "

c) the report is without legend but with logo

d)the report is without legend and without logo

Two auditors said me differents things and the last audit I have a non conformity because I have this agree with client and my report was whit logo and with legend!

Sorry for my bad english! but I speak spanish!
I hope that you can understand me!
Paito
 
J

Jaxsters

#4
If you are deviating from a written procedure, then yes. It is a non conformity or a deviation. In the bio/pharmaceutical industry there has been a divergence of the term non comformity and deviation. A non conformity is when materials or results are not performing as expected. A deviation is when a person deviates from a written procedure. The CAPA is generally a tool to capture larger more system emcompassing issues and which require greater tracking and may involve multiple departments and should be an item to bring to management review.
 
J

Jason PCSwitches

#5
I can't really understand what your saying, not being rude but the way it reads is somewhat hard to follow.

A procedure is a guideline that should be followed unless there is a reason to deviate from it. If your customer has specified that the deviation is required, warranted or requested it is not a non-conformance, you are adhering to the customer requirements. Evidence of that should be keep for records in the event you run into a situation such as the one you are presently involved with.

If this is off base from your intended post please let us know and within the best of your abilities try and provide it in context that is more clear.
 
P

paito

#6
Sorry for my english but I speak spanish!!!
your words:
Aprocedure is a guideline that should be followed unless there is a reason to deviate from it. If your customer has specified that the deviation is required, warranted or requested it is not a non-conformance, you are adhering to the customer requirements. this is OK! I agree
But my problem is in the way to write the final test report

a-the report have or not the accreditation logo and a legend like this: "this test have a deviation with the agree of client "

b-the report is without legend but with logo of accreditation body

c- the report is without legend and without logo of accreditation body

auditors said me differents things and the last audit I have a non conformity because I have this agree with client and my report was whit logo and with legend!

Best regards!!!!
 
J

Jason PCSwitches

#7
Sorry for my english but I speak spanish!!!
your words:
Aprocedure is a guideline that should be followed unless there is a reason to deviate from it. If your customer has specified that the deviation is required, warranted or requested it is not a non-conformance, you are adhering to the customer requirements. this is OK! I agree
But my problem is in the way to write the final test report

a-the report have or not the accreditation logo and a legend like this: "this test have a deviation with the agree of client "

b-the report is without legend but with logo of accreditation body

c- the report is without legend and without logo of accreditation body

auditors said me differents things and the last audit I have a non conformity because I have this agree with client and my report was whit logo and with legend!

Best regards!!!!
What exactly are you referring to when you state "logo"?
 
P

paito

#8
logotype of accreditation organism like UKAS (UK), ENAC (Spain)
This logotipe visually show that in a test report there is an accredited test.
 
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