32 replies to this topic

[GMO]

I think CCP's are supposed to be determined based upon Likelihood, Severity and Plant History.
If the likelihood is low, the severity is low and the plant history is negative on that line, then it's not a CCP.

Marshall

But the severity wouldn't be low. It would cause injury, e.g. cuts, tooth damage or possibly choking.

[GMO]

I think CCP's are supposed to be determined based upon Likelihood, Severity and Plant History.
If the likelihood is low, the severity is low and the plant history is negative on that line, then it's not a CCP.

Marshall

But the severity wouldn't be low. It would cause injury, e.g. cuts, tooth damage or possibly choking.

[mgourley]

But the severity wouldn't be low. It would cause injury, e.g. cuts, tooth damage or possibly choking.

From the description of the processing line given by the OP, there would be no metal contamination large enough to be more than a low severity.

[bergman]

From the description of the processing line given by the OP, there would be no metal contamination large enough to be more than a low severity.

This is how I'm looking at it. All the suppliers of the products processed on this production line have metal detection.. all suppliers have MDs that detect below the FDA's "hazard" limit (metal between 7 - 25 mm in any dimension). The only processing that happens prior to packaging is blending, and the ribbon blender is designed such that it should not introduce additional metal into the process i.e. there is no metal-to-metal contact that may create shavings, and there are no removable/breakable parts (that is, they aren't breakable with normal, reasonable use) in contact with the product. PMs are performed regularly, and pre-op inspections are in place prior to use (part of the inspection is looking at the condition of the blender, visible contamination, etc.). As has been noted, there is no history of the blender contributing to metal inclusion in the product.. we can't prove this based on the processing line in question, as it doesn't have MD (though we have never had complaints regarding metal with products processed on this line), but we do know from the lines that have MD that the only metal we ever see is aluminum, which comes from a supplier that does not have metal detection (I have confirmed this on a supplier audit, and have statements in writing). All of our equipment is S/S (the food contact points at least), so any aluminum is not from us. This supplier's product is not used on the line w/o MD. Also, we maintain an archive of any isolated metal picked up by the MDs - looking back at the archive, there is only one instance in 3 years of metal that came from our processes. This metal came from one of our vertical form-fill-seal machine - the most automated piece of equipment we have, with the highest likliehood of depositing metal in the product.

So, based on the historical evidence, the conditions of processing, our suppliers' metal detection, and our own PMs, storage controls, and GMPs (e.g. no items in pockets above waist, etc.), I would say that metal inclusion is low risk on this production line. However, despite this, I do think that metal detection would be wise and beneficial to have on this production line just to have the added control and peace of mind. It just makes my job easier in the end :)

Yes, GMO is right - the powers that be are not willing to invest in MD for this line (or at least, not until the volumes increase), but I am also not interested in making a big to-do about this situation based on the low risk. Would I prefer to have it? Yes. Can I sleep at night without it? Yes - the risk, based on the evidence I have, is low enough to where I feel comfortable.. but I'd be lying if I said that having a MD wouldn't make me feel a bit better (even though they're of course not a fail-safe and have their own limitations).

[GMO]

Well I think you've come to a conclusion and best of all managed to test out your reasoning on lots of stroppy techies (I'm putting myself in that camp btw ). I'm not saying you've 100% convinced me that the risks are small enough but at least an auditor is likely to be impressed by your reasoning and the fact you've really thought it through. What's best of all is you've come to a conclusion you're happy with. I got the feeling earlier on that it was against your will but having talked it through has solidified your standpoint (which again makes you more likely to be able to justify it at audit.)

I love IFSQN...

[Larry007]

IMO it is NOT an issue of passing audits vs. food safety IF you can demonstrate that your potential metal hazard is in FACT (i.e historically) not a hazard and that it is the only potential source of hazard. However, if an incident with that potential hazard happens. All bets are off, because you can no longer point to history. Based on the info you have given that is where i would consider delisting the products or investing in the equipment.

We had a similar situation where machines ran for 15 years without a problem (Pm'd) then sudenly a bolt was shorn and deposited into the food. Our metal detection captured it. At that time it wasn't a CCP, even after the incident we did not consider it a CCP since it was a "One-off" situation. A year later the same thing happened twice in one week. Both times metal detection captured it but it was no longer a "lighting strike" but a "rain storm" and we adjusted our program accordingly making metal detection a CCP.

There is a reason why all the HACCP classes are called "Practical" HACCP. Theory and the real world have to meet somewhere. And that somewhere is occasionaly where the risk remains present but siginifcanlty low enough to justify continued manufacturing. That is the grey area of "likely to occur". Is it reasonable to assume that a machine is LIKELY or UNLIKELY to deposit metal into your product when, to your knowledge, it never has before? That's a question only your analysis can answer.

Larry

[Larry007]

P.S. I posted this after reading the last response ont he first page... not realizing all of this was convered in the next three pages.

I, like GMO, love IFSQN. I have learned so much from his site.

I might have missed it but Did you tell us if you passed your audit or not?

Larry

[bergman]

Thanks to all for the responses. This has been a great conversation, and has really shown me the unbelievable wealth of information/experience that is at our disposal at IFSQN!

I argued the point as stated in my posts to the auditor, showed him the equipment, our metal logs, the supplier audits/statements regarding their own metal detection, basically everything that I mentioned in my justification for not having metal detection. He said it was a well-thought out response, and he could not argue against my assertions based on the evidence presented. So, we weren't dinged in the audit for not having metal detection (and thus, a CCP) for that processing line.

In the end, we ended up doing very well on the Silliker audit - we scored a 97.7%, which was "Excellent" , the highest rating based on their criteria! Again, I really appreciate the responses and the friendly debate - it helped solidify my response and prepared me better for how to approach the auditor regarding this situation. Thank you IFSQN!