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How to Justify Metal Detection as a PRP and not a CCP?

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pau

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Posted 16 May 2011 - 04:02 AM

We do have metal in our facility and are using metal detectors. However we are trying to avoid making metal detection a CCP. What supporting information would I need to justify the metal detection process as a prerequisite program not a CCP?



Charles.C

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Posted 16 May 2011 - 04:39 AM

Dear pau,

Yr post can be interpreted in two ways.

(1) Well, if you can justify (ie validate) that yr process / related equipment / environment has no significant risk in adding “dangerous” metal to yr finished product, the use of a metal detector does not imply a CCP.

The details obviously depend on documentation regarding things like what you are producing / who for / how its done / existing records / scientific publications etc ??

Also be prepared for an immediate argument with the auditor, especially if many comparable processes to yours exist where the use of a metal detector is invariably classified as a CCP.

(2) If you are considering categorisation as a PRP because you are routinely finding "dangerous" metal contamination, it implies that immediate corrective action is required for the process and that the MD step should hv been previously designated as a CCP :rolleyes: (and possibly other steps also depending on yr individual HACCP philosophy).

Rgds / Charles.C


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Charles.C


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mgourley

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Posted 16 May 2011 - 01:06 PM

We do have metal in our facility and are using metal detectors. However we are trying to avoid making metal detection a CCP. What supporting information would I need to justify the metal detection process as a prerequisite program not a CCP?


The Codex guidelines define a critical control point (CCP) as "a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level".

"Essential" is the key word here. Let's say your metal detector is calibrated to detect and reject a 4mm stainless test wand but will not reject a 3mm stainless test wand.
Is a 3mm piece of stainless steel a food safety hazard? Perhaps. In that case the metal detector is not "essential" to prevent or eliminate a food safety hazard. Therefore it is not a CCP.
Science is also key here. Will the metal detector reduce a food safety hazard to "an acceptable level"? HACCP is supposed to be "scientific and systematic". I have not been able to find any scientific study that says ingesting a 3mm piece of stainless steel is either "safe" or "unsafe". That makes setting a Critical Limit for the metal detector rather difficult.

Also, a metal detector is probably not going to reject a product that is contaminated with glass, brittle plastic, etc., Once again the metal detector is not "essential" to prevent or eliminate a food safety hazard".

If a hazard has been identified at a step where control is necessary for safety/and if no control measure exists at that step or at any other, then the product or process should be modified at that step, or at an earlier or later stage, to include a control measure.

If you have documentation that there have been instances of metal contamination in your product, then the metal detector should indeed be a Control Point. I just don't think, based on the above, that it's "Critical".

AFAIK, the distinction between a Control Point and a Critical Point is purely legal. If you say your metal detector will "prevent or eliminate a food safety hazard or reduce it to an acceptable level", and someone is injured by a 3mm piece of stainless steel, you open yourself up legally.

All that being said, in the baking industry here in the USA, metal detection as a CCP is pretty much the industry standard.


Marshall


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Charles.C

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Posted 16 May 2011 - 02:09 PM

Dear mGourley,

There are numerous posts on this forum which reference the US-FDA’s actionable criterion max. of 7mm. IMEX, other people (particularly buyers!) often prefer to nominate the sensitivity minima as a reference limit, ie << 7mm. Take yr pick, as long as you can validate.

AFAIK, the distinction between a Control Point and a Critical Point is purely legal.


This may be correct in some specific situations (??) however I think in general it depends on yr haccp definitions. Many people might say the CCP decision is made according to Codex or ???. Codex chooses to ignore the aspect of control points in its presentation (although it does include "control measure" strangely enough, a forewarning of ISO 22000 perhaps).

I anticipate yr last sentence pretty much summarises the situation for most auditors. Q.E.D. :smile:

Rgds / Charles.C

Kind Regards,

 

Charles.C


GMO

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Posted 16 May 2011 - 02:29 PM

I think as Charles said, get used to having arguments. IMO if all the prerequisites on metal control are followed and rigorous then yep, metal detection would not be a CCP, however, IME I've never had a factory where there have not been lapses in GMP particularly from engineers who will often be the direct or indirect cause of metal contamination. Also I've had machines where the manufacturer has told me "that part never breaks" when it had already broken into my product 6 times!

My point of view is also coloured by the legal side. In UK law there is a concept of "due diligence" ie, have you done everything reasonably practicable to prevent the issue? If you had a metal find which caused injury, yet you didn't have a metal detector as a CCP, I think you could be on shaky ground and what for? Would you actually get rid of your metal detector? No. Would you have it as an oPRP but continue with the same monitoring and corrective actions? Probably. So why bother? Yes, on an intellectual basis it is probably wrong to have it as the automatic CCP it normally is but on a practical basis, I just think "why argue?" If x-rays were half as good as some manufacturers claim at detecting glass I'd have them as a CCP for glass too tbh.



mgourley

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Posted 16 May 2011 - 02:43 PM

Charles and GMO,

I don't disagree with either one of you.
It was an intellectual point more than anything.
As far as FDA's 7mm criterion..that's all fine, well and good but I'm not sure I'd want to ingest a sharp 6.9mm piece of metal :unsure:

I guess my other point would be that you would not get rid of the metal detector and you would not monitor it any differently as you would if it were a CCP.

Marshall



esquef

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Posted 16 May 2011 - 03:02 PM

I've found that the traditional decision tree for determining whether a potential hazard represents a CCP can result in a different result that the SQF-suggested Food Safety Risk Analysis Matrix. With the matrix, when determining metal detection should or shouldn't be a CCP you can see that as long as the consequence is either a customer complaint or insignificant, and the frequency of occurance is less than "common", the resulting score is =/> 14, which by definition means that metal contamination is probably not a definitive justification for use of metal detection as a CCP.

If there are other CP's (or OPRP's) such as magnets, sifters, etc,combined with a strong history that suggests that nothing more serious than a low number of customer complaints along with a low level of detecting metal during processing and no recalls or serious injuries reported, I believe that a strong case exists to not make metal detection a CCP.

Below is the type of matrix we use for our risk analyses ours attaches a bried definition to the letters/numbers:

(sorry, I can't import the Excell chart properly in this thread from my computer, but if you open this IFSQN thread


http://www.ifsqn.com...essment-matrix/

and go to Charles' post #7 the chart is on page 17, or in that area at any rate, you'll see the matrix)

A = Common
B = Known to Occur
C = Could Occur (Published)
D = Not Expected to Occur
E = Practically Impossible

1 = Fatality
2 = Serious Illness
3 = Product Recall
4 = Customer Complaint
5 = Insignificant


Edited by esquef, 16 May 2011 - 03:47 PM.


mgourley

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Posted 16 May 2011 - 11:59 PM

Good Post.
I think what my posts come down to are the legal aspects. Full disclaimer.. I am not a lawyer.
IMO, metal detection should be a CP, not a CCP. If you monitor the detection device as you would if it were a CCP, but do not call it a CCP, where is the harm?
Once you designate it as a CCP you are saying that this is "a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level".
IF someone is injured AND you have that CCP in place, then you have not done "due diligence".

Marshall




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mgourley

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Posted 17 May 2011 - 12:28 AM

I'm on vacation this week so I am a little bit slow :whistle:

If the FDA has set an actionable level of 7mm for metal contamination, and most metal detectors are calibrated for anywhere from 2-4mm, isn't the point moot?

If your metal detector is set to detect and reject metal that is almost half of what the FDA considers "actionable" then how can metal detection be a CCP unless your Critical Limit is 6.9mm or greater?

If a CCP is defined as "a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level", then metal detectors should all have critical limits of 6.9mm or greater.



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Posted 17 May 2011 - 02:38 AM

Dear mgourley,

If your metal detector is set to detect and reject metal that is almost half of what the FDA considers "actionable" then how can metal detection be a CCP unless your Critical Limit is 6.9mm or greater?


Because opinions differ ? :smile:

(Personally i agree with yr previous image of swallowing even a 5mm ball bearing although many global babies seem to hv "monetarily" proven the low internal health risk)(obviously sharpness etc is relevant and i am not recommending this as a validatory measure :smile: ). As a counter example, there appear to be many recalls undertaken by manufacturers in USA for metallic contamination of food products where the size is far below the FDA's criterion. A pre-emptive procedure which i understand allows for remaining below the official radar.

I daresay the FDA would be unlikely to criticise a producer for implementing a stricter control limit than their own (actually their original usage/interpretation of the 7mm was, i think (?), not necessarily intended to be in direct correspondence to a haccp/CCP). In some texts the sensitivity option might be categorised as an "operational" limit to be appended to the FDA "CCP" as a fail-safe procedure. From memory, in the official US-FDA HACCP Guide for Seafood producers, 3 (equally acceptable [to them]) alternative interpretations are offered for MD critical limits. Other industries may differ of course.

There are other facets to this issue such as "when is a CCP's monitoring only a validation" as already discussed in detail elsewhere on the forum.

However i am perfectly happy if you wish to conclude the discussion as a moot point ( http://www.phrases.o...moot-point.html ). :smile:

Rgds / Charles.C

Kind Regards,

 

Charles.C




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