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

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?

Dear Miniaczka90

could you explain about OSS?

I don't know about this product?

Thanks

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

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

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.

.

Hello miniacka 90,

 

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

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

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.

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

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.