We just completed our stage 2 audits for ISO 22000 and one of the findings was in relation to a biological hazard that we know exists on an incoming ingredient but we have a kill step and keep it segregated in its raw form.

The finding is written as (with some changes to protect the innocent):
Hazard assessment includes the use of "ingredient", and recognized the fact of the likelihood of contamination with "biological hazard", but there is not any action to control this hazard.

The auditor feels we should test the incoming ingedient to show that it is contaminated but than we would never be able to use the ingredient because there is a high chance we will find the hazard. The industry the ingredient comes from will not even test it or provide a COA becuase they know that they will find the hazard.

So my question is this:
If we address the hazard as if it always exists and take the precautions necessary to prevent contamination through segregation of the ingredient from all other ingredients or processes, as well as verification and validation after the kill step, why would we need to test it to prove it is there before the kill step?

You've got a good point and a better one than the auditor (and it doesn't matter how he feels)

If you segregate all of it, perform the kill step and then test afterwards with negative evidence of contamination you have resolution.........

Looking at the "finding" (I hate that term in its use) you in fact do have control as evidenced by your actions and test results.

Is your method validated to kill any level of the hazard? In the device sterilization field determining the level of bioburden on the product is a requirement of the validation process.

Randy:
My point exactly as this did come down to a, "I feel" versus, "the standard says". We made the evaluation and can show that we are under control which is what is required.

Doug:
Yes, our method is validated to reduce any level of the hazard coming in to an acceptable level going out.

Thanks for the input guys,

Tim Smith

Hey go for it. And while you're at it, it may be worthwhile to remind your supplier of services (auditing organization) that you aren't paying for feelings, warm fuzzies and a bunch of "I thinks", you're paying for a good hard look, solid evidence and fact.

Is your auditor a microbiologist? They usually don't leave things to chances and logic. They go for the absolute. Using an ingredient that have a high chance of contamination (and you are aware) is not going to get away from them easily even though you have a critical control point. In their mind, what will happen if the CCP failed (and it is possible)? You need to have another screening process - either control the incoming material or a secondary CCP. Controlling the incoming material seems easier.

We just completed our stage 2 audits for ISO 22000 and one of the findings was in relation to a biological hazard that we know exists on an incoming ingredient but we have a kill step and keep it segregated in its raw form.

The finding is written as (with some changes to protect the innocent):
Hazard assessment includes the use of "ingredient", and recognized the fact of the likelihood of contamination with "biological hazard", but there is not any action to control this hazard.

The auditor feels we should test the incoming ingedient to show that it is contaminated but than we would never be able to use the ingredient because there is a high chance we will find the hazard. The industry the ingredient comes from will not even test it or provide a COA becuase they know that they will find the hazard.

So my question is this:
If we address the hazard as if it always exists and take the precautions necessary to prevent contamination through segregation of the ingredient from all other ingredients or processes, as well as verification and validation after the kill step, why would we need to test it to prove it is there before the kill step?


Can I know which ingredient are you talking about ? From your post, it looks like that you are in the food industry - so none of the ingredients should have biological hazard, isnt it ? :tg:

I have no idea of the OP's specific issue, but it's well known that certain spices and grains are commonly contaminated on bulk arrival in the US. Swordfish and other seafood may be contaminated with heavy metals. Certain vitamins in bulk form have been found in the past to be incidentally contaminated with lead. For a number of years after the era of above-ground nuclear testing ended, radionucleide content in many crops required testing and vigilance.

The FDA commonly assigns a Tolerable Level or a Tolerable Daily Intake to a potential contaminant. Many food-chain raw materials have more than a zero level of contaminants when received by processors. Some contaminants can be rendered objectively harmless (or tolerably low risk) by means of treatment, and the presence of the deactivated contaminant is not required to be disclosed because it would just lead to consumer distress and market disruption. Other contaminants of course can only be controlled by means of testing and acceptance standards.