6 replies to this topic

[petratsitlak2]

Hi quality team,

 

I need your experience and guidance for probably a stupid question...

Up to now, we were minimally processing dry food ingredients to other food manufacturers and there was no reason of providing other than CofCs to the customers. Now, we have launched a new process line in which the finished product is micro-tested per batch and a CofA is provided with each delivery to our customer. The fact that we supply a CofA, does this imply that there should be a positive release procedure described in our quality manual? and if yes, is there something that i should really pay attention? or could I avoid having a positive release by saying something like "there is no positive release since all the procedures, PSOP have been followed"?  

 

Many thanks.

 

Best regards,

Petra

[Charles.C]

Hi Petra,

 

What is CofA ?

What is PSOP ?

 

Thanks.

[Yentso]

From my perspective...

 

CofC - Certificate of Conformance
CofA - Certificate of Analysis

PSOP - *something* Standard Operating Procedure?

 

Considering that your product to the customer is a food ingredient, they require specifications and certificate of analysis in order for them continue processing/manufacturing/packaging in compliance with regulations. Manufacturer's must qualify your product based on your certificate of analysis. Your operating procedures should describe how you came about those specifications. Internally you would have test methods and validation if necessary to accompany each specification. Your quality manual will require how you approve and release products, which is related to your certificate of analysis. I'm not sure what you mean by "positive release", but assuming you have written procedures for the creation of specifications, and the release of products for distribution then it should be fine. Providing a CofA to customers is better than a CofC for any food ingredient. 

[Charles.C]

Hi Yentso Kuo,

 

Thanks for the Clarification. I should have spotted the variety. Just some more US innovations i guess. (added to Forum Acronym List).

 

COC = CofC

COA = CofA

PSOP looks to be a made-up acronym.

 

@ Petra - I assume yr Quality Manual is intended to be part of an overall Manufacturing System required to conform to a (FS)Standard.

 

Afaik (my experience is for BRC) such Standards typically require a documented "Release Procedure" to exist.

The usual expectation is that it will be of a Positive variety, eg results of specification-related testing procedures documented as in compliance.

 

COC IMEX is a commercially oriented document whose actual meaning/interpretation is often case-by-case and can be a minefield.

COA IMEX has a more definitive intention from an analytical POV.

eg -

http://www.labhut.co...f-analysis.html

[petratsitlak2]

Thank you very much for your replies.

 

Apologies for my abbreviations, just to clarify:

 

CofC: Certificate of Conformance

CofA: Certificate of Analysis

PSOP: Product Standard Operating Procedure

 

We are recently accredited to BRC Food safety Standard; This new product line, as I mentioned earlier, requires of micro-testing results in every production batch. Thinking of it, I went back to one of the clauses of the standard which states " the site shall ensure that finished product is not released unless all agreed procedures have been followed. Where products require positive release, procedures shall be in place to ensure that release does not occur until all release criteria have been completed and release authorised." 

 

Taking into account our processing, I am trying to interpret the aforementioned clause. Roughly, we minimally process the product, pack and sample, then we micro-test to ensure that micro-organisms are within the specified limits as stated in the specification sheet and then we dispatch product accompanied with a CofA to the customer. 

 

Therefore I was thinking that I should mention somewhere into our quality manual that "Positive release is followed when a CofA is completed prior to product release to customers". However, what I don't know is in what extent there should be special checks or requirements, responsibilities, etc. which need to be introduced and described in our procedures. 

 

Is someone having experience in positive release which could share it in the forum??

 

Any thoughts will be greatly appreciated!

 

Many thanks.

Petra 

[Charles.C]

Hi Petra,

 

IMEX the (BRC) response is to issue a Procedure with a Form (or Excel Sheet), both titled Positive Release.

The PR Procedure is referencable within the top level Procedures listed in the Quality Manual.

"Shipped" product lots are then date-listed on the Form together with a xreference(s) to the data which supported the positive release and a ticked box in the column for positive release.

 

What you mention in yr Quality Manual depends on the format style of the manual.

[* Steve]

Hi,

 

You can provide a CofA without the need for positive release.

 

If you are awaiting micro results for instance, the CofA can be sent after all results are collated.

 

If the customer requires the CofA with, or on the day of delivery then you can add 'awaiting results' in that field and then send the completed CofA later.