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How to validate a final product sampling program?


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#1 nkonstas

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Posted 26 September 2016 - 08:43 AM

Good morning everyone,

could you please inform me how can I validate a sampling programm in our final products.

We are producing dry mixtures from powdered raw materials. Our product categories are 1)dairy blends. (rm are milk powder,whey powders,milk proteins powder) 2)instant sauces-bechamels (rm are modified starches, stabilizers like xanthan sodium alginate etc milk proteins and flavours) 3)additive blends (phosphates, nitrates etc).

The acceptance of raw materials is being made only with Certif. of Analysis and from our procedure for the Suppliers acceptance (according to BRCv7). Twice a year we send to external lab 1 sample from each category for micro and chemical analysis.

In the ISO 22000 audit the auditor told us that the only NC is that the sampling programm is not validated and insist to read the Regulation (EC) No 882/2004 (and implement a validated programm...

 

Please help me if you have some previous experience

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#2 Charles.C

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Posted 26 September 2016 - 10:19 AM

Hi nkonstas,

 

I am a litttle confused regarding yr text/requirements.

 

I deduce you have no sampling plan/ do no testing for the incoming raw materials ?

 

Are the samples you refer being sent to external lab from the incoming raw material or the finished product ?

 

Is a specific clause of the iso22000 standard related to yr query ? Normally data on the finished product is only required to verify a haccp plan (eg clause 7.8) ?

 

Pls clarify.


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Charles.C


#3 nkonstas

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Posted 26 September 2016 - 10:46 AM

Explain:

We take no samples of our RM. we have for over 10 years the same suppliers.

The samples are from the finished product.

We are certified with BRC for 7 years and none of the auditor ever made NC that our testing/sampling programm is not valifated.

In this ISO22000 audit there were an external auditor from the state authorities in order to inspect the audit of the certification body. And this auditor told us how can you validate the sampling programm by taking samples twice a year and no fewer or more times and how many samples and from how many batches etc. 

Maybe the historical data can approve/validate the frequency of samplin. eg we never have found micro above the limits of the technical specs.


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#4 Charles.C

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Posted 26 September 2016 - 11:32 AM

Hi nkonstas,

 

I deduce you have done no sampling on yr RM for 10 years. That IMEX is amazing even for a seemingly blending-only operation. Category Low Risk ?

 

My (textbook) understanding of the implementation of a FS (haccp) based system is that  finished product analysis can/should be minimal unless specifically required by customers. Yr external auditor should agree with this philosophy but his/her official practice may well be different hence the comment.

 

Regardless it is undeniable that yr sampling plan for final goods seems sort of arbitrary. It's difficult to advise too much without familiarity yr production output.

 

As per yr attachment in the OP, sampling plans are usually risk based and relate to product specification. If you look at the product specs in EC documents they typically (micro) use 5 samples/batch and set limits. How often one needs to sample different batches/different products depends on factors like (finished product/item being sampled for/item specification/existing results). And the COST. IMEX external labs are not cheap.

 

My experience (BRC) is with an in-house lab which cannot really compare with yr situation since micro/physical/basic chemical analysis available on demand so the frequency is less restricted.

 

i would guess that yr auditor might have expected to see some occasional 5-sample micro. analyses of random lots of > 1 type of product as a "validation". But I'm only speculating depending on the details of yr conversation.


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Charles.C


#5 Markcra

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Posted 26 September 2016 - 09:04 PM

Hi Nkonstas,

 

I am an ISO 22000 Food Safety auditor and I would question the auditor under what element of the standard has the NC been raised? Your final product sampling seems to be a validation of your food safety plan control measures under section 8 of the standard and not a control measure that requires validation. Many of my clients only do micro tests once per year as a final validation determined by the food safety team. The exception is when regular micro batch testing is required by the food regulators.

 

Regards

 

Mark


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#6 Charles.C

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Posted 26 September 2016 - 11:37 PM

Hi Nkonstas,

 

I am an ISO 22000 Food Safety auditor and I would question the auditor under what element of the standard has the NC been raised? Your final product sampling seems to be a validation of your food safety plan control measures under section 8 of the standard and not a control measure that requires validation. Many of my clients only do micro tests once per year as a final validation determined by the food safety team. The exception is when regular micro batch testing is required by the food regulators.

 

Regards

 

Mark

 

Hi Mark,

 

I agree yr ISO comment and did ask similarly in Post 2 but no response. (TBH, micro tests once per year looks equally dodgy IMO).

 

I get the impression that many auditees believe that an auditor's viewpoint is gospel and cannot be challenged. I suspect auditors are just as prone to human error as the rest of us.


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Charles.C


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#7 Markcra

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Posted 27 September 2016 - 01:13 AM

Agree. I guess the level of micro testing is based on a risk analysis, including past performance, They don't appear to have had any issues in the last 10 years and all of their raw materials are accepted with a CoA and the process appears to be blending and packing of dry powders. I guess at some point you need to trust the HACCP plan and validation of the CCPs to provide a sound product. Of-course for high risk products that are ready to eat, then finished product sampling and testing is prudent. However I see a difference between a sampling program for finished product testing verses a validation of the HACCP plan. 


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#8 jayakrish

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Posted 27 September 2016 - 07:16 AM

Good morning. 

 

I feel that your Quality Plan should cover the Raw materials also. A suitable sampling method can be employed and can be validated with the Raw material / Finished Product performance over a period of time - it could be specific to your product range.

 

Normally Quality Plan covers all the stages of processing: Raw material, Packing material, In Process stock and Finished Product. A good Food Safety Management System can not ignore any of these stages.

 

Welcome your comments.

 

Krishnan, R

India.

Food Safety Auditor

 


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#9 Charles.C

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Posted 27 September 2016 - 07:55 AM

Hi jayakrish,

 

This stage is usually handled as a PRP for iso/fssc22000, ie section 7.2.3 or iso22002-1


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Charles.C


#10 nkonstas

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Posted 27 September 2016 - 08:33 AM

Thanks a lot for your responces.

First of all we didnt want an ISO 22000 cert. we do the audit only to pay a favour in a friend. As far as I know ISO22000 is not a GFSI recognised scheme so for us is a little bit useless, but you can learn a lot of thing from every process/audit.

From our RM risk assessment (BRC) all of them are categorized as low risk and below (ph, aw, trusted suppliers, past evidence etc) so it saves as money and time from micro-chem tests. Secondly our final products are low risk. Due to exports in balcan countries we are obliged to make aflatoxin test in our final product in every batch that is exported and never had we any issue.

But its always good to fortify your safety plan. So I am here to ask if anyone knows to forward me any guidance/guidlines/databases/bibliography for the sampling plan (eg how many samples regarding the quantity of batches etc).

 

Thanks again for your time


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#11 Charles.C

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Posted 27 September 2016 - 09:39 AM

Hi nkonstas,

 

Regarding sampling plans, see the thread below, the sub-link in Post 6, and onward sub-sub links.

 

http://www.ifsqn.com...-qa-monitoring/

 

I daresay you know this already but "Sampling" is a huge subject and any particular Plan choice depends very much on the specific objective/resources.

 

Hopefully of some use.


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Charles.C





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