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Is validation required to release out-of-specification (OOS) product?


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#1 miniaczka90

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Posted 17 April 2019 - 01:06 AM

Hello All

I have a question what about releasing OOS finished product ?
Any validation studies should be done ?
What about HACCP ? To do you have any recommendations?
If the product with OOS coliform will be released?



#2 tamdongnai

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Posted 17 April 2019 - 02:06 AM

Dear Miniaczka90

could you explain about OSS?

I don't know about this product?

Thanks



#3 miniaczka90

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Posted 17 April 2019 - 02:30 AM

Hey, there is not a product . OOS - out of specification on coliform



#4 tamdongnai

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Posted 17 April 2019 - 03:27 AM

Dear Miniaczka90

With HACCP and depend on Standard of your country, if target of out specification: this product must be hold.

Sometimes: if Coliforms (+) but E.coli (-) can be released



#5 Charles.C

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Posted 17 April 2019 - 03:53 AM

Hello All

I have a question what about releasing OOS finished product ?
Any validation studies should be done ?
What about HACCP ? To do you have any recommendations?
If the product with OOS coliform will be released?

 

coliform is a possible hygiene indicator. Not specifically related to safety.

 

the significance of any result relates to context, for example to -

 

product

spec. (legal/internal/customer)

sampling/analytical methodology

number of results

history

 

For example, the result of one isolated random sample from a batch may be totally meaningless.

 

The results of five random samples from a batch all  being 100x yr customer's specification could be a major problem.

 

So  please clarify.

.


Kind Regards,

 

Charles.C


#6 EagleEye

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Posted 17 April 2019 - 05:38 AM

Hello miniacka 90,

 

Are you testing for Coliforms only or for E.coli too?



#7 miniaczka90

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Posted 17 April 2019 - 10:52 AM

Hey guys, thank you for all replies. We are testing for Coli and Ecoli .
Coliform are high, and Ecoli in spec <10



#8 Charles.C

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Posted 17 April 2019 - 11:00 AM

Hey guys, thank you for all replies. We are testing for Coli and Ecoli .
Coliform are high, and Ecoli in spec <10

 

See my Post 5.

Need some data/context.

 

eg spec. coliform = ?

result coliform = ?

 

A logical initial follow-up would be to -

 

(1) validate the sampling/analytical procedures

(2) Assuming (1) is satisfactory, resample the related lot at an increased density to validate 1st result.


Edited by Charles.C, 17 April 2019 - 02:32 PM.
expanded

Kind Regards,

 

Charles.C


#9 miniaczka90

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Posted 18 April 2019 - 09:58 PM

Hello , thank you for reply.
Spec less than 1000
Different batches over 2000 Cfu/g
But now, what action needs to be taken ? Haccp validation?
Ecoli less than 10



#10 Charles.C

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Posted 19 April 2019 - 02:25 AM

Hello , thank you for reply.
Spec less than 1000
Different batches over 2000 Cfu/g
But now, what action needs to be taken ? Haccp validation?
Ecoli less than 10

 

coliform is a possible hygiene indicator. Not specifically related to safety.

 

the significance of any result relates to context, for example to -

 

(a) product

(b)spec. (legal/internal/customer)

(c) sampling/analytical methodology

(d) number of results

(e) history

 

(f) For example, the result of one isolated random sample from a batch may be totally meaningless.

 

The results of five random samples from a batch all  being 100x yr customer's specification could be a major problem.

 

So  please clarify.

.

 

See my Post 5.

Need some data/context.

 

eg spec. coliform = ?

result coliform = ?

 

A logical initial follow-up would be to -

 

(1) validate the sampling/analytical procedures

(2) Assuming (1) is satisfactory, resample the related lot at an increased density to validate 1st result.

 

Suggested Action - See ^^^

 

Sorry but IMO impossible to be more specific without further details on Product/Process etc. A few micro. comments  -

 

(a) yr spec/data is high for some products, not so much for others.

(b) Some methods may give inaccurate/high results for some products.

(c) One sample/lot is not advisable for basing major decisions.


Kind Regards,

 

Charles.C





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