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#1 Chrispy Chips

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Posted 21 May 2018 - 02:32 PM

Hey everyone,

 

I only have about 3 years of food manufacturing experience (all at one facility), so I'm in no way an expert in anything. I have a question about a process at my plant that has caused me a lot of concern. At my facility, there is a key piece of equipment that we use to manufacture our product. When this equipment is set at a recommended feed rate, it runs fine. However, when we schedule, we're sometimes forced to run at a lower feed rate to reduce the amount of overflow/rework we create. The issue with this is that when the feed rate is reduced, this piece of equipment sheds metal like a dog sheds fur. Now, just before the packaging step of our process, we have metal detectors in place to catch the metal. A few months ago, though, we had a particular run during which we had the feed rate set lower than optimal. In one month, we had over 50 metal detector alerts with positive findings by our QA technicians. Some pieces were tiny specks, others were slivers and chunks. Our critical limit for metal is 2.0mm or greater, which is supposedly the highest sensitivity we could set our metal detectors without getting a lot of alleged false positives. The FDA regulation states that foreign matter must be less than 7 millimeters, but this is for choking hazards. Our product is ready-to-eat, for use by the general public - my fear is that, yes we have a CCP, but are we justified in having a process that puts out so much foreign material??? 7 millimeters is the FDA's standard size for a choking hazard, but what about getting a piece of this stuff in your gums? What if it perforates an organ? In the past, I let my kids eat the product I make, but not anymore. Does having a recall procedure make it okay for manufacturers to operate like this? If this is common industry practice, then I don't feel comfortable working in the industry anymore (or purchasing from any "business" that considers customers as metrics rather than people). Any insights from those of you with more industry experience would be greatly appreciated.

 

Regards,

CC



#2 jcieslowski

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Posted 21 May 2018 - 02:46 PM

CC,

 

You have identified a very significant hazard.  It is EXCEEDINGLY likely that SOME metal shavings are put out below the detectable threshold and thus aren't technically in violation of your critical limit but still pose a risk to food safety.  

 

I highly, highly, highly, recommend that you DO NOT RUN THAT MACHINE until you correct the problem.  This is the time you want to put your foot down.  You need to conduct (with help from people more knowledgeable about the machine) a GOOD ROOT CAUSE ANALYSIS.  Why does the machine produce metal fragments when running slow?  Why is there metal on metal contact?  Why? Why? Why?  6 or 7 why's will get you to the root cause which is probably either 'bad design' or 'bad repair'.  You need to get that machine fixed.

 

I'd also be skeptical about it running 'fine' at full speeds but without understanding the design, it's hard to say.

Don't sit on this.  Take action now.



#3 SQFconsultant

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Posted 21 May 2018 - 04:42 PM

You answered your own question when you stated:

 

"In the past, I let my kids eat the product I make, but not anymore."

 

Take action on this issue now, who cares about wasting some product - people are more important.

 

Now, I have been to companies (some rather big big's) that actually looked at people as nothing more than eaters and oh well if 1 in 5000 gets sick or gets a sliver of metal in the roof of their mouth.  I was even at a company that felt it ok to pay owners of dogs upwards of $5,000 for each loss caused by their ham bones splintering.

 

Don't be one of those companies - jump on this issue now, overworking your metal detector will result in failures and peoples lives are at stake here.


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Glenn Oster
 
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#4 Charles.C

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Posted 21 May 2018 - 09:43 PM

Hi CC,

 

I suggest you re-read the complete FDA "manifesto".

 

If you ask the FDA what dimension of metal fragment is acceptable to be found in food the Regulatory answer will be 0.0 mm.


Kind Regards,

 

Charles.C


#5 Chrispy Chips

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Posted 22 May 2018 - 12:15 PM

Hi CC,

 

I suggest you re-read the complete FDA "manifesto".

 

If you ask the FDA what dimension of metal fragment is acceptable to be found in food the Regulatory answer will be 0.0 mm.

Thanks for that heads-up, Charles.C. Is that in the 21CFR? I'd love to be able to find and print that to show some of the mid-level management at my facility. I have some individuals with years of experience over me and it would do a lot more to correct this if I had something in black and white to show them. I'll start looking for that today. Thanks again!



#6 FurFarmandFork

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Posted 22 May 2018 - 02:11 PM

The 7-22mm standard comes from a compliance policy guide note which clarifies that the products will be considered adulterated and appropriate for seizure, basically giving inspectors a clear direction when those egregious cases are found at import or during other inspection events. It does not mean that other objects smaller are acceptable, only that those values may play a role in your risk assessment.

 

Added metal fragments of any size would fall under a definition of adulteration:

 

(a) Poisonous, insanitary, etc., ingredients (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.1 (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a) of this title; or © if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title

 

 

Metal is an added substance, it isn't unavoidable, it's not naturally occurring, is not an approved food additive at any usage level, and has the potential to render food injurious to health, even if it isn't in the range identified in the CPG as extremely likely to cause injury. FDA has enforced this position in various warning letters:

 

FDA went after this company for consumer complaints of metal shavings, not pieces: https://www.fda.gov/...4/ucm382794.htm

 

While this company had 7mm pieces in consumer complaints, FDA wrote a scathing warning letter outlining the level of validation and verification they expect from metal detection where it is a known hazard: https://www.fda.gov/...s/ucm349216.htm

 

Fraying pieces of metal mesh without control: https://www.fda.gov/...6/ucm506343.htm

 

 

 

CC's firms warning letter would read something like this:

 

Your firm failed to take effective measures to protect against the inclusion of metal or other extraneous material in food, as required by 21 CFR 110.80(b)(8). Specifically,

 

Our inspector noted consistent metal detector hits on your line which operators explained was common for equipment running slowly. While we recognize that you have implemented controls to prevent the inclusion of metal in your products, the use of equipment in a manner that results in the deterioration of metal surfaces demonstrates that your firm has failed to properly maintain plant equipment as to be adequately cleanable and properly maintained, as required by 21 CFR 110.40(a). 21 CFR 110.40(a) requires all plant equipment and utensils shall be designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. 

 

 

 

So, ultimately, I would be concerned that if you're getting 50 hits that some stuff is making it through, and FDA warns about this as well in the seafood haccp guidance:

Alternatively, metal fragments may be detected in the finished food by an electronic metal detector. The use of electronic metal detectors is complex, especially with regard to stainless steel, which is difficult to detect. The orientation of the metal object in the food affects the ability of the equipment to detect it. For example, if a detector is not properly calibrated and is set to detect a sphere 0.08 inch (2 mm) in diameter, it may fail to detect a stainless steel wire that is smaller in diameter but up to 0.9 inch (24 mm) long, depending on the orientation of the wire as it travels through the detector.

 

 

 

 

Here are additional references below, however they're all guidance, which means FDA does not have to abide by them if you use them to release product, they only have to abide by the adulteration standard and equipment GMP's referenced above, which would clearly consider any metal you add to the food may render it injurious to health and is a result of poor design, construction, and use of equipment.

 

 

 

---------

 

 

 

 

FDA has some notes on metal inclusion in the seafood haccp guidance:

 

Once introduced into a product, metal fragments may be removed from the product by passing it through a screen, magnet, or flotation tank. The effectiveness of these measures depends on the nature of the product. These measures are more likely to be effective in liquids, powders, and similar products in which the metal fragment will not become imbedded. Alternatively, metal fragments may be detected in the finished food by an electronic metal detector. The use of electronic metal detectors is complex, especially with regard to stainless steel, which is difficult to detect. The orientation of the metal object in the food affects the ability of the equipment to detect it. For example, if a detector is not properly calibrated and is set to detect a sphere 0.08 inch (2 mm) in diameter, it may fail to detect a stainless steel wire that is smaller in diameter but up to 0.9 inch (24 mm) long, depending on the orientation of the wire as it travels through the detector. Processing factors, such as ambient humidity or product acidity, may affect the conductivity of the product and create an interference signal that may mask metal inclusion unless the detector is properly calibrated. You should consider these factors when calibrating and using this equipment. Finally, the hazard of metal inclusion may also be controlled by periodically examining the processing equipment for damage that can contribute metal fragments to the product. This measure will not necessarily prevent metal fragments from being incorporated into the product, but it will enable you to separate products that may have been exposed to metal fragments. Visually inspecting equipment for damaged or missing parts may only be feasible with relatively simple equipment, such as band saws, small orbital blenders, and wire mesh belts. More complex equipment that contains many parts, some of which may not be readily visible, may not be suitable for visual inspection and may require controls such as metal detection or separation.

 

 

 

Recent preventive controls guidance goes over the CPG guidance again as well:

 

Metal: Metal-to-metal contact during processing can introduce metal fragments into products. For example, metal fragments can break off during mechanical cutting and blending operations, and some metal equipment has parts that can break or fall off, such as wire-mesh belts. FDA’s Health Hazard Evaluation Board (FDA, 2005e; Olsen, 1998) has supported regulatory action against products with metal fragments of 0.3 inches (7 mm) to 1.0 inches (25 mm) in length. Such fragments have been shown to be a hazard to consumers. Metal hazards can be controlled by the use of metal detection devices or by regular inspection of at-risk equipment for signs of damage.

 

 

The Juice HACCP guidance also includes the CPG reference:

 

 

1.2 Metal Fragments

We can recommend several possible ways to establish control measures for metal fragments in juice.

One way involves the use of on-line metal detection equipment. With this method, the equipment continuously monitors the product after the last step at which metal inclusion is reasonably likely to occur (e.g., after bottling and sealing of the juice) at a process step designated for metal detection. The critical limit might be designated as "no metal fragments in the finished product." The following illustrates some of the elements that might be entered into your HACCP plan.

  • What is the critical limit? No metal fragments in finished product (Note: FDA's Health Hazard Evaluation Board has supported regulatory action against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. See also FDA Compliance Policy Guide 555.425).
  • What will be monitored? The presence of metal fragments in containers passing the CCP.
  • How is monitoring done? By the use of metal detection equipment.
  • How often? Continuously. Each container is subjected to detection. We recommend that you confirm that the device is operating correctly at least at the start of each production day.
  • Who should perform the monitoring? Monitoring is performed by the equipment itself. We recommend that a check be made at least once per day to ensure that the device is operating correctly.

A second way to control metal fragments involves the use of a separation device such as a screen after the last step at which metal inclusion is reasonably likely to occur, at a process step designated for screening. For this approach (see example HACCP plans for Pasteurized Refrigerated Apple Juice and Not-from-concentrate Orange Juice in section VII):

  • The critical limit might be designated as "screen is functional."
  • Monitoring may be done by a daily visual check for screen integrity.
  • We recommend that verification include periodic calibration testing to ensure that the screen retains its separation capability for metal particles of a specific size. In establishing this size, we recommend that you consider that FDA's Health Hazard Evaluation Board has supported regulatory action against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. (See also FDA Compliance Policy Guide 555.425).

 


Austin Bouck
Owner/Consultant at Fur, Farm, and Fork.
Consulting for companies needing effective, lean food safety systems and solutions.

Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.

#7 Scampi

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Posted 22 May 2018 - 04:13 PM

I would agree with previous posts---that machine should not run until the problem is solved. The metal detector is only to be used as a safe guard for UNFORSEEN issues, and since your company is aware of the problem, it becomes a negligence/adulterated foods issue and puts you in jeopardy of a mandated recall


Because we always have is never an appropriate response!


#8 Charles.C

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Posted 23 May 2018 - 05:31 AM

Hi CC,

 

Actually I probably underestimated FDA's semantic capabilities since such a question would probably result in a "pivot" . :smile:

 

The thread which prompted my comment was this -

 

http://www.ifsqn.com...nished-product/

 

I slightly "mis-remembered" this quote in Post5 which was taken from a (2011) FDA warning letter and stated -

 

B. Your HACCP plan for seafood salads at the "Vegetable Processing" CCP lists the critical limit of "No metal particles in excess of (b)(4) mm". This critical limit is not adequate to control metal fragments that may cause trauma or serious injury. FDA recommends a critical limit at metal detection of "no detectable metal fragments" because foreign objects that are less than (b)(4) mm may cause trauma or injury to persons in special risk groups, such as infants, surgery patients, and the elderly.

(full letter is attached [= mc1] to the post5) (I anticipate that the "coded" (b)(4) = 7mm).

(obviously the above avoids consideration of MD detection limits)

 

One might interpret the above as supporting a proposition that fragments < 7mm may be  acceptable for non-vulnerable consumers however as 3F illustrates in the previous Post, such an event is anyway further "trapped" by an adulteration "element"  within the Regulatory Guideline CPG Sec. 555.425 Foods. The latter contains this  ingenious end paragraph - 

 

REMARKS:
If CFSAN review finds no health hazard associated with a sample containing a hard or sharp foreign object that meets criterion c., or d., above, the sample should [still] be considered adulterated within the meaning of *21 U.S.C. 342(a)(3)* if a CFSAN review finds the article unfit for food.

The CFSAN review in this case will consider various factors including subsequent processing steps, extent of contamination, and intended use of the product.

 

(I have inserted the red / blue /  [still] )

 

The starred blue ref. is (see first quote in previous Post) -
 

21 U.S. Code § 342 - Adulterated food

 

A food shall be deemed to be adulterated—

 

(a) Poisonous, insanitary, etc., ingredients

-----------

-----------

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food

 

In practice, (3) appears to typically yield a predictable conclusion.

 

PS - The CPG document is attached -

 

Attached File  CPG Sec.555.425 Foods.pdf   15.11KB   31 downloads

 

PPS - I subseqently noticed this quite eloquent summary of the situation -
 

One point that needs to be made before moving forward is that foreign material in foods will render the food adulterated. It doesn’t matter if the item is very, very small; the food is now adulterated, and distributing a food that is known to be adulterated is a violation of the Federal Food, Drug and Cosmetic Act (see “Definitions of Adulteration”[4]).

Food safety and quality professionals should follow the recall notices posted on the FDA, U.S. Department of Agriculture and the Canadian Food Inspection Agency websites. There are many examples of recalls for incidents where the material in question is tiny. The food may be safe using the criteria that FDA have established in its Compliance Policy Guide[5] for hard and sharp objects, but it is adulterated.

 

https://www.foodsafe...safety-or-both/


Kind Regards,

 

Charles.C


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#9 Gerard H.

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Posted 23 May 2018 - 08:34 AM

Dear CC,

 

In the actual state, the "key piece of equipment" is inadequate to produce a food safe product. In the case of an external inspection, your production line will be blocked (at least).

 

A modification or substitution of this piece is necessary, to avoid serious problems.

 

I would advise a multi-disciplinary approach to solve this serious issue (Direction, Quality, the Food Safety team and the Engineering).

 

Kind regards,

 

Gerard Heerkens



#10 Chrispy Chips

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Posted 06 June 2018 - 07:22 PM

Thanks to all who provided insights and guidance with this issue. I've taken several of your examples to my senior mgmt. for review. Production with the affected equipment was stopped shortly after my original post, a CAPA was launched and our site Process Engineer has already drawn up a design that should fix the piece inside the equipment that was causing the problem. All CCP monitoring is being reviewed by corporate mgmt weekly (at a minimum, I've been told). I'll continue to monitor as well and if I have any other questions, I'll continue further on this thread. Thanks again!

 

-CC



#11 Scampi

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Posted 06 June 2018 - 08:07 PM

It is so refreshing to see a company doing the right thing!!!  Give yourself a pat on the back for sticking with this issue and following it through!


Because we always have is never an appropriate response!






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