14 replies to this topic

[elisabethdv]

We had an audit finding as follows (nte Metal Detection is a CCP): 

"Acceptable levels for metal (physical hazard) were confused with critical limits". 

Can someone please explain the difference between acceptable levels and critical limits in relation to metal as a hazard.

 

Thanks

[Scampi]

The critical limits are the MAXIMUM particle size that can pass through the metal detector as per legal/regulatory/best practice  (different for ferrous, non ferrous and SS)

 

Acceptable limits will be anything below that

 

So if you CL are

Ferrous 3mm

Non ferrous  5mm

SS 2 mm

Those values (and anything greater) would initiate corrective actions/deviations

 

Anything below that would not "trigger" the metal detector as they have been determined to be non-harming and would therefore be the acceptable limits

 

NOTE: those values are for illustration only

[Ken Bookmyer]

Scampi,

You do understand that your reply (which matches the industry standard reply)  makes no rational sense. The CCP should be based on the probability of serious injury or death not on the physical limits of the current technology. This is the equivalent of saying our micro test can only detect 10 CFUs of Salmonella so that's the limit despite the fact that 1 CFU could be fatal. It's even more bizarre to set different limits for different types of metal are you more likely to be injured by a piece of SS than a piece of non-ferrous? The current FDA studies indicate 7 mm as the largest size piece of metal that is likely to result in injury. That's what the CCP should be. The working limits (assuming they are lower) should be what the equipment operator says they can detect in your packaging and product. 

ken

[Scampi]

Ken, i think you mis-read my post..........I never said the limit was what the machine was capable of detecting....see below underline and BOLD

 

"The critical limits are the MAXIMUM particle size that can pass through the metal detector as per legal/regulatory/best practice  (different for ferrous, non ferrous and SS)"

 

And yes a CCP needs validated prior to implementation

[Charles.C]

If you ask the FDA what their tolerance for metal in food is the answer will be - NONE.

 

There is confusion over LOD etc which defines the Operational capability for detection.

 

A review of FDA Recall reports regarding metallic contamination may be instructive.

 

https://www.ifsqn.co...on/#entry133891

 

@ Elisabeth - Does S.Africa have any Regulatory Limits ?

[Ken Bookmyer]

If you are using a thermal process that calls for 165 for 30 seconds and you can  use 185 for 60 seconds without hurting product quality  your CCP would still be  165 for 30. Your CCP should be based on what reduces the risk not what can pass through the metal detector.  FDA and USDA regulatory guidance is 7 mm regardless of whether it's ferrous non-ferrous or wood. 

What are you using for validation of your CCP?  

ken

[Ken Bookmyer]

Charles, FDA will also say that there should be no  insect fragments etc in your product and specifically note that it is illegal to dilute a lot with a higher number of fragments with one that has less in order to reach the legal limit. The post you mentioned includes the FDA study that says risk of choking hazard is at 7 mm. 

I agree the working limit for the detector should be as low as possible for each class of metal because the goal is zero but I don't agree with setting the CCP based on the capacity of the machine. 

ken

[FSQA]

 The post you mentioned includes the FDA study that says risk of choking hazard is at 7 mm. 

I agree the working limit for the detector should be as low as possible for each class of metal because the goal is zero but I don't agree with setting the CCP based on the capacity of the machine. 

ken

Ken,

 

The operating limits/acceptable limits in a finished product is usually driven by the type of industry/customer/type of product (as they are usually more restrictive than the regulatory requirements) that the manufacturer is processing. Yes, the goal is to have zero metal in all finished products, while the FDA Compliance Policy Guide #555.425 sets it as a choking hazard at 7mm, it can vary based on the requirements set up by the customer. So a 1.9mm or a 6.9mm reading will still be under the regulatory guidance/CL, most of the customers will only accept the lower limit/detection in your finished product.

 

Following is a good resource on this query and as it states:

As a practical matter it may be advisable to set an operating limit that is more restrictive than the CL. In this way you can adjust the process when the operating limit is triggered, but before a triggering of the CL would require you to take corrective action. You should set operating limits based on your experience with the variability of your operation and with the closeness of typical operating values to the CL.  (Step 14, page # 251)

 

http://seafoodhaccp....le_pdf/Ch20.pdf

 

You are correct , as CCP should be setup based on the validation study, not on the capacity or ability of the machine.

[Charles.C]

Imagine a jar of baby food with 0.5 cm diameter ball bearings in it. You really think that the FDA would consider that product acceptable ?

 

It's called adulteration.

 

One needs to read the FDA document -

 

 USFDA - ucm074554.pdf   15.08KB   253 downloads

 

[Scampi]

Charles, while you're not wrong, that would depend entirely on your target audience (which is what the guidance actually says) like a "special interest group" for infant foods

 

https://www.fda.gov/...t/ucm074554.pdf

[Charles.C]

Charles, while you're not wrong, that would depend entirely on your target audience (which is what the guidance actually says) like a "special interest group" for infant foods

 

https://www.fda.gov/...t/ucm074554.pdf

 

Yes, that was my point.

 

But would you enjoy an equivalent experience from a jar of jam ? I suggest it would still be classified as "adulterated" ?

 

 

afaik, the 7mm limit is not related to a "choking" hazard, eg -

 

https://www.ifsqn.co...mit/#entry86163

[Ken Bookmyer]

Charles,

No consumer or FDA would accept a product full of 1 mm aluminum bearings either. The typical metal detector can't pick them up so does that mean the plant has NO CCP for metal because the detector can't pick them up and they are unacceptable? No, it means 1 mm aluminum is an adulteration and a quality issue but it's still not a hazard reasonably likely to result in serious injury or death. Fortunately these days I'm doing liquid product through a 40 micron filter. 

ken

[Charles.C]

 

Charles,

No consumer or FDA would accept a product full of 1 mm aluminum bearings either. The typical metal detector can't pick them up so does that mean the plant has NO CCP for metal because the detector can't pick them up and they are unacceptable? No, it means 1 mm aluminum is an adulteration and a quality issue but it's still not a hazard reasonably likely to result in serious injury or death. Fortunately these days I'm doing liquid product through a 40 micron filter. 

ken

 

 

Hi Ken,

 

FDA HACCP Plan -

 

 metal inclusion.PNG   96.51KB   9 downloads

 

It's always been a  highly contentious topic on this Forum.

I suspect FDA unintentionally  set themselves up due the results of their own statistics inasmuch as they conceptually had no desire to offer support for a  haccp CL of 6mm. Hence the type of example attached above. The situation was retrieved from a rejection POV via the non-wholesome adulteration criterion as you mention.

 

Afaik no other country has since generated statistical  data to match that of FDA or has officially endorsed the FDA's 7mm cut-off(?)

 

IMEX nominating the highest, consistently attainable, sensitivity setting on the MD as CL  has always satisfied an auditor.

 

For products I have been involved with, none of the customers would accept  a ferrous target of < 7mm.

 

@ Elisabeth,the answer to yr auditor's comment likely depends on the (Operational?) context which you attached to the 2 terms in OP ?

 

PS - some additional threads/file which may be of interest here -

 

https://www.ifsqn.co...ritical-limits/

https://www.ifsqn.co...ndex.php/topic/20798-what-is-the-acceptable-metal-size-in-finished-product/

https://www.ifsqn.co...ndex.php/topic/20992-injury-or-affect-of-metal-contaminants-less-than-7mm/

 

 

 Kraft metal detector CCP, critical limits.pdf   426.98KB   245 downloads

Edited by Charles.C, 13 August 2019 - 02:26 PM.
emended/expanded

[Charles.C]

JFI - one more interpretation from Primus  -

 

3.02.04: Have CCP critical control limits been established with support of relevant sources of information or by validation documentation?

 

Total confirmation (15 points): All CCP's should be supported by validation documentation showing that
the critical control limits (CCL) are scientifically derived and meet any relevant legal requirements. Where
publicly available validation is not available, the auditee should have performed validation studies to
support their stated critical control limits. For example, ORP limits for chlorinated recycled water systems
could be stated in research papers and State documentation e.g. Leafy Greens Marketing Agreement.
Another example, metal detection limits could be supported by validation studies that show that smallest
test probes possible were used and meet the FDA guidelines.

[Charles.C]

 

JFI, USFDA -

 

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).

A third way to control metal fragments involves visually inspecting equipment for damage or missing parts at process steps such as extraction and grinding, where such damage or loss of parts could lead to metal fragments in your juice. This approach may only be feasible for relatively simple equipment that can be fully inspected visually in a reasonable time period. Under this approach, CCPs might be identified as the fruit grinding and extraction steps in a process. The critical limit might be designated as "no broken or missing metal parts from equipment at the CCPs for metal inclusion." If broken or missing metal parts are observed, the line is stopped, the equipment is repaired and, if necessary, adjusted or modified, and the product that has moved through that area since the last inspection is placed on hold for further action as appropriate, e.g., to be run through off-line metal detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a metal detection step. The following illustrates the elements that might be entered into your HACCP plan.

• What is the critical limit? No broken or missing metal parts from grinding (or extraction) equipment
• What will be monitored? The presence of broken or missing metal parts on or near the grinder
• How is monitoring done? By visual check of the grinder and immediate vicinity for broken or missing metal parts
• How often? Check before starting operations each day, check at least every four hours during operation, check at the end of operations each day, and check whenever there is an equipment or other malfunction that could increase the likelihood that metal inclusion could occur.
• Who will perform the monitoring? Any person who has a thorough understanding of the proper condition of the equipment and surrounding area may perform monitoring.
• If broken or missing metal parts are observed at a CCP, the corrective action procedure would be to stop the line, repair, adjust, and modify the equipment as necessary; the product that has moved through that area since the last inspection is placed on hold for further action as appropriate, e.g., to be run through off-line metal detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a metal detection step.

https://www.fda.gov/...s/ucm072557.htm