14 replies to this topic

[Dharmadi Sadeli Putra]

Dear All,

I am a bit confused on the term of low risk supplier. My facility is classified as low risk zone (canned fish) but how about the fish suppliers? Do they also classified as low risk when histamin formation is concerned? As we know, histamin can't be reduced to safety level by thermal process

Please let me know your opinion  

Thanks 

[fcchoi]

Hi Avila,

 

Your fishes suppliers will be be high risk suppliers. Histamine is not readily reduced by thermal processing but sourcing of fishes from designated regions/niches is workable to enable supply of low histamine producing fishes.

[Madam A. D-tor]

Dear avila muncar,

 

Are you referring to requirement 3.5.1.2 of issue 7:

 

The company shall have a documented supplier approval and ongoing monitoring procedure to ensure that all suppliers of raw materials, including packaging, effectively manage risks to raw material quality and safety and are operating effective traceability processes. The approval and monitoring procedure shall be based on risk and include one or a combination of:

* certification (e.g. to BRC Global Standards or other GFSI-recognised scheme)

* supplier audits, with a scope to include product safety, traceability, HACCP review and good manufacturing practices, undertaken by an experienced and demonstrably competent product safety auditor

  

or, for suppliers assessed as low risk only, supplier questionnaires.

 

Where approval is based on questionnaires, these shall be reissued at least every 3 years and suppliers will be required to notify the site of any significant changes in the interim.

 

The site shall have an up-to-date list of approved suppliers.

 

In this requirement low risk suppliers does not refer to low risk production areas as in appendix 2.

You have to do a risk assessment on your suppliers and determine which for your product and your facility are high risk and which are low risk. Depending on the risks of the raw material/packaging material, the use of the raw material/packaging material and the supplier itself.

For example, I would consider any primary packaging material supplier as high risk.

 

In requirement 3.5.1.1 you need to perform a risk assessment annually on the raw materials/packaging materials itself, taking into account: allergens, foreign bodies, microbiological and chemical contaminations and sensibility for fraud. 

[Dharmadi Sadeli Putra]

Thanks fcchoi and Madam,

One more question, what if the occurence of over limit histamin content on received fish is low but we know the severity of Histamin Food poisoning is mid or high. Do we determine fish supplier  as low risk (based on the occurence) or high due to it's severity? :uhm:e

[Charles.C]

Thanks fcchoi and Madam,

One more question, what if the occurence of over limit histamin content on received fish is low but we know the severity of Histamin Food poisoning is mid or high. Do we determine fish supplier  as low risk (based on the occurence) or high due to it's severity? :uhm:e

 

Dear avila muncar,

 

there is some lengthy discussion on this topic elswhere in brc forum. From memory, examples are given in at least 2 threads.

The specific answer depends on the/your interpretation of brc's inter-related clauses and yr own, general, RA approach for suppliers, eg risk matrix+.

As usual, the result is likely to be subjective.

 

Rgds / Charles.C

[Madam A. D-tor]

Dear avila muncar,

 

For your last question I agree with Charles. It all depends on your own RA.

It is possible to have a high risk product supplied by a low risk supplier.

It is also possible to have a low risk product supplied by a high risk supplier.

[Charles.C]

Dear avila muncar,

 

I assume it was brc sec. 3.5.1.1 which mainly initiated yr OP. (also overlaps subsequent clauses).

 

Please see thread linked below, eg posts #7, 19 and the surrounding discussion. All of the thread is interesting IMO.

Note that this thread was oriented to ver.6 and some changes have occurred in ver.7, eg questionnaires, scope.

 

This whole categorization topic IMO is highly subjective regarding terminologies.Just like haccp. Pros and Cons of course.  

(BTW - This topic is also overviewed in the free (used to be anyway, now unsure) BRC enrollment guideline documents and the brief text there suggested (to me) that BRC are not anticipating masterpieces of risk analysis.)

 

Resuming, 2 previous threads (for BRC version 6 [which is very similar to ver.7 on this topic]) are useful, first one (2014)  is  -

 

http://www.ifsqn.com...isk-assessment/

 

A second informative thread (2012) also for ver.6,  is - 

 

http://www.ifsqn.com...-6-clause-3511/

 

#7 of 2nd thread directly addresses the scope of 3.5.1.1 (including "quality"). The detailed basis for the stated Risk results  and audit frequency are perhaps  detailed elsewhere.

 

@Madame A.D-tor - After some deconvolution/simplifying/combining of the BRC clauses  3.5.1.1 and 3.5.1.2, it seems one could state that   –

 

Both Supplier Approval and Monitoring  = f (RA[input[intrinsic-process-customer usage]] / [supplier cert.status / questionnaire / audit[procedure-frequency]])

I think this is In agreement with yr H-L-L-H philosophy.

 

Rgds / Charles.C

 

PS - as I understand, BRC does not explicitly require you to designate a supplier of raw material as intrinsically  L/H risk. No definition of a HR Supplier is mentioned in the standard. It is understandable to associate a HR Ingredient with a HR Supplier but the designation is liable to misinterpretation.

 

AFAIK, BRC is requiring, via compliance with its clauses, that the manufacturer demonstrate a methodology so as to ensure that an input from any Approved Supplier will, ultimately, not present a significant risk with respect to the end product’s agreed  characteristics, safety or non-safety.

[Dharmadi Sadeli Putra]

Dear Charles,

Your opinion and attached thread links give me more understanding on raw material's risk assesment, Thanks. 

Seems i missed some interesting threads last time

[Charles.C]

Dear avila muncar,

 

Unfortunately, useful search words like matrix now exist on the forum in such quantity that both search engines have user limitations. I  remembered reading  other useful threads but could no longer find them. I suppose tags are one option, but no-one has time to use them.

 

This topic has IMO never been simple but used to be reasonably intelligibly presented within the Standard. It is now a shambles and I place the blame squarely on the “diligent” shoulders of BRC. The standard is being obliged to become a Jack-of-All-Trades but …..And especially with regard to Food Safety.

 

Rgds / Charles.C

[Tony-C]

To add to the useful info posted by Madam A. D-tor and Charles:

 

BRC Interpretation Guideline

 

Raw material risk assessment

All proposed ingredients and packaging must be subjected to a documented assessment of their inherent risk. This may form part of the HACCP plan; however, as this is an important starting point for the production of safe food, it needs to be detailed and will be assessed specifically by the auditor.

 

The risk assessment must consider the potential for:

•             allergen contamination

•             foreign-body risks

•             microbiological contamination

•             chemical contamination

•             substitution or fraud.

 

For example, it should consider:

•             Known hazards associated with the ingredient provided or components of it (examples of hazards include …….. histamine in fish

•             Use of the ingredient

•             Spread of ingredient in the company/final products.

•             Nature of the supplier.

•             Historical evidence of the supplier and raw material.

•             Geographic origins (products from particular origins may carry a greater risk due to environmental conditions, because of more relaxed local legal requirements or a less developed food safety culture).

•             Methods of manufacture (e.g. if a site is using pineapple as an ingredient, the risk will depend on whether fresh or canned pineapple is used).

•             Significance of the ingredient to the final product

•             Customer or legislative requirements (e.g. suppliers may be specified by customers, but this does not negate the need for risk assessment).

•             The potential for fraudulent activity in the supply chain

 

Your ingredient is a major part of your product and you have identified that it may contain a hazard that is not removed by your process. In theory therefore it is high risk. It may be that historical evidence and the controls in place mean that you categorise the risk lower.

 

Regards,

 

Tony

[Charles.C]

Hi Tony,

 

Thks for the titbit.

 

I suggest an extrapolation of yr closing paragraph -

Presumably, in a HACCP sense, if control of the raw material/histamine is categorizable (ie Va-Ve achievable) as a  Prerequisite Activity the histamine hazard  will be of Low Risk at process input, by definition. and similarly the relevant fish (for this specific hazard anyway).

The final risk status will then depend on the process T/t.

 

There are maybe some analogies to fresh produce and molluscs respectively.

 

Do BRC allow this activity to be regarded a PRP ? "Operational Conditions" ? (Yr quoted extract would, to me, imply YES but BRC ....?)

Do BRC in fact allow the use of iso22002-1 to define one's Prerequisites ? (ISO seem very Pro- QA functions as Prerequisites)

 

Rgds / Charles

 

@avila muncar, IMEX regarding yr post #4, for many RA/risk matrices, but not 100%, a low (especially a negligible) frequency of occurrence will take priority over a high severity so as to yield  Low Risk. But some matrices prioritize on severity giving an opposite opinion. Such is HACCP.

[Tony-C]

Hi Tony,

 

Thks for the titbit.

 

I suggest an extrapolation of yr closing paragraph -

 

Do BRC allow this activity to be regarded a PRP ? "Operational Conditions" ? (Yr quoted extract would, to me, imply YES but BRC ....?)

Do BRC in fact allow the use of iso22002-1 to define one's Prerequisites ? (ISO seem very Pro- QA functions as Prerequisites)

 

Rgds / Charles

 

Hi Charles,

 

Please clarify what you require an extrapolation of....

 

BRC will accept that based on risk you have implemented appropriate measures......regardless what you wish to call them.

 

BR,

 

Tony

[Charles.C]

Hi Tony,

 

Sorry my poor grammar.

 

I meant that i was proposing an extrapolation. (lines 4-5 to be precise)

 

Rgds / Charles

[trubertq]

Having worked with fish for some years, histamine levels are a function of freshness, so therefore the quality of your fish is a pre requisite and is controlled by Supplier Assessment control and monitoring.

The Shellfish company I have worked with for 15 years  has all shellfish suppliers as High risk as the quality of the product they send is directly relatable to the product produced ( i.e. bad fish can't be improved by processing),especially for scallops as you have the biotoxin to worry about.

 

The same situation applies to the pelagic smoker I work with also and the organic salmon processor.

 

Having a CCP at intake doesn't make sense as there is nothing you can do to influence the freshness or otherwise of the product before it gets to you other than have strict acceptance criteria which is part of Supplier approval and monitoring. The way the fishermen treat the fish after they catch it is out of your control.This doesnt mean you can't control the quality of the fish being processed though, your acceptance criteria are the  control. I have never seen Intake as a CCP but that doesn;t mean it shouldn't be, this is just my opinion for what it's worth.

 

I hope what I'm saying makes sense... it's been a long day....

[Charles.C]

I agree with you, it's been a painfully long day.

 

I agree the conclusion is all about control. It's also about  terminologies/definitions. And HACCP flavour.

Standardized interpretations of High Risk etc simply, afaik, don't exist. And probably never will. One might also say the same thing about (all?) aspects of HACCP.

 

USFDA imply that control is feasible over there (reality??) so they have CCPs at receiving as an option (within their HACCP methodology)(in 2011 anyway). The Fishery Guide has the details. It is quite possible that the USA are unique. Other than perhaps on-board processors (if there are any).

 

And geographically onwards for all the variables mentioned above.

 

Charles.C