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QANewHopeMills

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Posted 27 February 2015 - 09:50 PM

I am wondering if anyone has experience in loosening their CCP critical limits on their HACCP plan specifically under SQF (level 2). 

We are a small (about 50 employees total) dry ingredient mix company working with baking mixes and hot cocoa, and have 1 CCP which is metal detection.

We package in sewn bags, canisters, and poly bags, and work with 5 allergens (Egg, Milk, Soy, Tree nut, and Wheat).  In the past we have used either metal detectors or X-Ray machines (only able to find metal given product density and characteristics) at our current critical limits.

 

About 4 years and several QA managers ago we set our metal detection limits at 1.0 mm FE and non-FE and 1.5 mm Stainless steel, and are looking at replacing the current detection equipment. During this purchasing process, our maintenance department discovered that we would have a substantial financial (about 25%) and equipment foot print savings by increasing our critical limits up to 2.0 mm for all 3 categories.  The equipment foot print savings would allow us to reduce the amount of time and distance the open packaging travels between metal detection and sealing (from about 8-10 feet down to 3 feet) and our risk assessment shows that additional risk is minimal.  

 

My questions are how badly does it look when you loosen up your critical limits, and what are the physical contaminate critical limits that others are using in their facilities?



Snookie

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Posted 27 February 2015 - 10:13 PM

The limit of detection is usually selected based on several factors, what is industry expectations, the capability of the equipment with the product, and customer requirements.   A risk assessment is your best tool in this case.  Can you make a case that the limit you want to change to is not increasing the risk to an unacceptable level, since it sounds like you can, will your customers accept it?  I had a machine once that just could not detect at the level a customer wanted, a small increase in size significantly reduced our false rejects and increased production speed. 


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Charles.C

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Posted 28 February 2015 - 03:30 AM

Dear Trace,

 

Conceptually I agree with Snookie.

Practically I suspect the auditor / referee for yr Production is USFDA (??).

 

Previous threads here on the US scenario have suggested that FDA  occasionally exhibit various accept/reject criteria, eg -

 

(a) the product should be free of metallic contamination, ie absent.

(b) metallic contamination may be defined by the relevant compliance directive, frequently linked on this site. From memory 7-25 mm has on occasion been actionable. Special cases (eg sensitive consumers)  are also defined where limits < 7mm may also be implemented.

© The Federal Food, Drug, and Cosmetic Act (the FFD&C Act) prohibits interstate commerce of adulterated foods (21 U.S.C. 331).  Under the FFD&C Act, a food containing foreign objects
is considered adulterated (21 U.S.C 342).

 

The last one seems to be a proactive cause of many Company-initiated recalls since it  minimizes public concern.

 

Other US bakerists may have further light to shed on yr specific query ?

 

Rgds / Charles.C

 

PS - I don't understand how yr financial savings change so much / Do you get a lot of (correct) rejects at current limits? This would suggest a RCA is needed..?


Kind Regards,

 

Charles.C


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QANewHopeMills

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Posted 02 March 2015 - 03:10 PM

The cost of the equipment itself is the source of the financial savings.  According to our maintenance department there is a steep jump (25%) in machine cost rated for 1.0 mm vs those rated for 2.0 mm, as well as units that detecting 1.0 mm being at least 3x larger than those rated for 2.0 mm.  

 

Auditors we will need to keep satisfied are:

FDA (which we don't expect being an issue - our products are for general population, and the limits are still well below the 7 mm FDA action limit)

New York State Department of Agriculture and Markets (which generally agree to what ever FDA says is acceptable)

and SQF / Certification body (which is where we have our concerns)



cazyncymru

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Posted 02 March 2015 - 04:15 PM

I would agree with Snookie, but I would also take into consideration historic complaints & historic issues.

 

As with everything else in food safety, it depends on your risk assessment. So together with any regulatory stuff, white papers, COP I'd write a justification stating why I had increased the detection size.

 

As long as you can justify it (and show all documentation) there's no reason why you couldn't loosen the tolerances.

 

I did something similar in a previous life. I documented the number of false positives we had (by doing wash outs on all rejected product) and trended against 1mm and less rejections. I could show that false rejections far outweighted rejections of 1mm and less (which didn't really happen). But that when we altered the tolerance to 2mm we had no false rejections. I also took customer complaints into consideration and requested everything returned so I could run through metal detector. All returned pieces were rejected by metal detector. (I also do a magnet test!)

 

Caz x



Charles.C

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Posted 02 March 2015 - 09:25 PM

Dear Trace,

 

I think you are forgetting option © of my previous post. In practice this may well be a commercial "killer".

 

It seems to me that yr Manufacturing Dept's comments only make sense if you are envisaging the purchase of new equipment. otherwise yr current unit is surely OK if it already works for 1mm.

 

Realistic "typical", ie likely to be commercially unquestioned, limits depend on product/process/MD. Try comparing yr process/MD machine to the table Pg16 of the met1 attachment (Tesco) here -

 

http://www.ifsqn.com...ge-2#entry68189

 

@Caz - RA is fine but not if trumped by Regulations. (Although i guess not too many Babies are drinking hot cocoa. :smile: )

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


Snookie

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Posted 02 March 2015 - 09:52 PM

I am not sure that SQF is where the main concern is.  Main concern would be customers.  If the industry expectation is 1.0 or it is heading that way you want the more sensitive equipment.  You can lose or miss out on a lot of business if your equipment is not able to meet industry standards.   Also I believe (someone correct me if I am wrong) the FDA 7mm standard is based on choking.  If you have the possibility of sharp, everyone will want smaller. 


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Charles.C

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Posted 02 March 2015 - 10:12 PM

I am not sure that SQF is where the main concern is.  Main concern would be customers.  If the industry expectation is 1.0 or it is heading that way you want the more sensitive equipment.  You can lose or miss out on a lot of business if your equipment is not able to meet industry standards.   Also I believe (someone correct me if I am wrong) the FDA 7mm standard is based on choking.  If you have the possibility of sharp, everyone will want smaller. 

 

Dear Snookie,

 

it's a good point. IMEX I have never, from memory, met a customer who required 1mm, so i have never offered it. :smile:

 

And 7mm/choking, i think you are wrong. :smile: Anyone ?

 

Rgds / Charles.C

 

PS - added - maybe -

 

Attached File  Chapter-28-Hard-or-Sharp-Objects-1.pdf   149.03KB   89 downloads

 

 


Kind Regards,

 

Charles.C


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Posted 02 March 2015 - 10:17 PM

Loosing CCP is  critical non-conformance. There is 2 possibilities for loosing up CCP in a system :

First you have determined your CCP in your Food Safety Plan and you have loosen to monitor and control it. At this stage if Auditor raise this issue you will fail your Audit.

Second is you find new CCP while you were reviewing HACCP plan which is fine. Then you have to  add that CCP in your plan and will create a monitoring steps or procedure for that.


Atessa

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Charles.C

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Posted 02 March 2015 - 10:26 PM

Loosing CCP is  critical non-conformance. There is 2 possibilities for loosing up CCP in a system :

First you have determined your CCP in your Food Safety Plan and you have loosen to monitor and control it. At this stage if Auditor raise this issue you will fail your Audit.

Second is you find new CCP while you were reviewing HACCP plan which is fine. Then you have to  add that CCP in your plan and will create a monitoring steps or procedure for that.

 

Dear Atessa,

 

Not quite sure what you mean by "loosing" ?

 

I think the OP referred to changing (increasing) the Critical Limit

 

Rgds / Charles.C.


Kind Regards,

 

Charles.C


Snookie

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Posted 03 March 2015 - 12:10 AM

Dear Atessa,

 

Not quite sure what you mean by "loosing" ?

 

I think the OP referred to changing (increasing) the Critical Limit

 

Rgds / Charles.C.

 

Charles, think she misspelled loosening and this thread is about reducing the critical limit from 1.0 to 2.0. 

 

Dear Snookie,

 

it's a good point. IMEX I have never, from memory, met a customer who required 1mm, so i have never offered it. :smile:

 

I have and in an environment where the technology did not support that size with the product.   Maybe this thread will help. 

 

http://www.ifsqn.com...metal-detector/

 

While as I said in my original post it may be possible.....I don't think its advisable. 


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Charles.C

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Posted 03 March 2015 - 05:02 AM

Charles, think she misspelled loosening and this thread is about reducing the critical limit from 1.0 to 2.0. I

 

Hi Snookie,

 

Alternative - "loosing" (CCP) = "losing" = "failing". ? (But "loosen to monitor" defeated me)

Alternative -  Reduce and Prosper ? :roflmao:

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


cazyncymru

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Posted 03 March 2015 - 09:21 AM

http://www.fda.gov/I...l/ucm074554.htm

 

Here you are Charles, their not dreaming the 7mm choking hazard!

 

From the non-American!



Charles.C

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Posted 03 March 2015 - 12:35 PM

http://www.fda.gov/I...l/ucm074554.htm

 

Here you are Charles, their not dreaming the 7mm choking hazard!

 

From the non-American!

 

Hi Caz,

 

It is possible you are getting confused with US - Physical Hazard sub-terminologies.

 

Here are a couple of USFDA  authored extracts relating to "choking" -

 

Attached File  Physical hazards.doc   160KB   120 downloads

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


cazyncymru

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Posted 03 March 2015 - 12:50 PM

Sorry Charles if I mixed up my American legislation / guidelines etc, but to be honest, I don't have the time (nor the inclination) to trawl the internet to check up if someone's quoted the right or wrong guideline / legislation!

 

Its enough for me to keep up with all the legislation and standards that DOES affect me

 

Maybe I should refrain from commenting on what I don't know diddly squat about!



Snookie

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Posted 03 March 2015 - 04:32 PM

Hi Caz,

 

It is possible you are getting confused with US - Physical Hazard sub-terminologies.

 

Here are a couple of USFDA  authored extracts relating to "choking" -

 

attachicon.gifPhysical hazards.doc

 

Rgds / Charles.C

 

These reference CPSC standards which generally don't apply to food standards.  These more often apply to what is called hardlines  such as consumer items. 


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Charles.C

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Posted 03 March 2015 - 07:13 PM

These reference CPSC standards which generally don't apply to food standards.  These more often apply to what is called hardlines  such as consumer items. 

 

(somewhat OT)

 

Dear Snookie,

 

The CPSC portion is an adjunct to the main thrust.

The point is that 2 particular classes of  hazards are recognized – (i) injury or trauma related due to hard/sharp foreign objects and (ii) choking.

The well-known "CPG Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign Objects" is directed towards class (i).

 

For clarity, source document for first extract in my previous post  attached below.

 

Attached File  Regulatory-Action-Criteria-for-Filth-and-Other-Extraneous-Materials.pdf   201.71KB   97 downloads

 

PS - the original docs are quite old (ca. 2001-3) but afaik still largely relevant (to present context). The USDA at that time apparently had a slightly different interpretation (2-7mm) of hazardous but maybe now coincident. :unsure:

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


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Posted 03 March 2015 - 09:09 PM

Hi Snookie,

 

Alternative - "loosing" (CCP) = "losing" = "failing". ? (But "loosen to monitor" defeated me)

Alternative -  Reduce and Prosper ? :roflmao:

 

Rgds / Charles.C

hahaha such a fun... Yes  you are right .. :roflmao:


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At-Gh

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Posted 03 March 2015 - 09:29 PM

Charles, think she misspelled loosening and this thread is about reducing the critical limit from 1.0 to 2.0. 

 

 

I have and in an environment where the technology did not support that size with the product.   Maybe this thread will help. 

 

http://www.ifsqn.com...metal-detector/

 

While as I said in my original post it may be possible.....I don't think its advisable. 

thank you :)


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DPK

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Posted 05 March 2015 - 12:56 PM

Hello Trace -

 

What we have found at our bakery is that 1.0 F and NF gives us way too many false positives. We discovered this is due to the humidity of the product passing through the detector. So we raised the level to 3.0 F and NF and no more false positives. 99% of our positives came from recycled boxes with tiny pieces of metal in their corrugation. Granted: We'd like to be at 1.0 but too many boxes (from 5 different manufacturers) are too time consuming to find the metal bits and do in fact waste production time.



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Charles.C

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Posted 05 March 2015 - 02:35 PM

Hello Trace -

 

What we have found at our bakery is that 1.0 F and NF gives us way too many false positives. We discovered this is due to the humidity of the product passing through the detector. So we raised the level to 3.0 F and NF and no more false positives. 99% of our positives came from recycled boxes with tiny pieces of metal in their corrugation. Granted: We'd like to be at 1.0 but too many boxes (from 5 different manufacturers) are too time consuming to find the metal bits and do in fact waste production time.

 

Dear DPK,

 

Thks for input.

 

Not my product area but a  3mm Fe tolerance sounds rather process "generous" unless large apertures mandated. Regardless of false positive difficulties.

 

i appreciate that baked products can be tricky for MDs (attachment mdt1) but also note the "representative" sensitivities in attach. mdt2. It is maybe possible that your MD performance is either intrinsically inadequate or needs some tuning.?

 

I suggest that, worst case scenario, RTE bakery products containing 2.9 mm metal particles would be considered adulterated, even if not considered (hazard) actionable (which may itself be debatable).

 

Is there any validatory data to support that such a (Fe - 3mm) limit is regulatory acceptable within the US baking industry ? I daresay the OP would like to know also. :smile:

 

Attached File  mdt1 - Baked-Goods-Snacks-White-Paper.pdf   1.53MB   80 downloads

Attached File  mdt2 - metal detector comparison sensitivities.doc   83KB   78 downloads

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


QANewHopeMills

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Posted 06 March 2015 - 04:58 PM

Thank you everyone for help and valuable information so far.

We are still finalizing our assessment, but it appears highly likely that we will be changing our critical limits to 2.0 mm for all 3 categories.

It is probable that smaller pieces of metal will still be found and removed (just as our current equipment can find items small than our critical limits) but if we go with this new equipment we don't want to rely on / require capabilities beyond equipment rating.

 

P.S.

After reviewing 4 more of our suppliers we discovered they are using:

4 mm , 2.5 mm, 2.0 mm, 1.5 mm as critical limits



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Philip Jones

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Posted 17 March 2015 - 06:45 PM

Not sure if this got mentioned, but your hazard analysis should have identified the type and likely size of any metal which could find its way into the product.  That takes away the debate about operating limits for the metal detector (not a fan of metal detectors being a CCP unless the hazard analysis and decision tree genuinely come to that conclusion.

Also, going back to the engineering point about cost of equipment, if you do have to go down that route, can you reduce your aperture? Many metal detectors are oversized for the product going through them  You may actually be able to increase sensitivity at a reduced cost by looking hard at your product and its movement though the detector.

 

Regards,

Philip





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