2 replies to this topic

[Elsa24]

Working with a company that has a pretty antiquated FS and QA System

I want to validate a Metal Detection Program because they do not have justification for the standards they use. I’m struggling with the following and hoping to get some help Sorry this is loaded

Question 1: There is a lack of information pertaining to the appropriate selection for Wand/Standard Sizes - does anyone have an actual Risk Assessment Template that includes critical limit selection?

Does anyone have examples for Raw Meat?

What do you recommend if they never did a justification within their HACCP and they got away with stating they didn’t need MD due to no customer complaints - pretty crazy to me!

Question 2: How do I differentiate between critical limits and operational limits - trying to make sense in how we use smaller standards and then of there is a failure we run the larger sizes to validate the system is working?

Do you think there is value in different shapes of standards? Squares and Wands for example

Question 3: Is “Learning” the same as Successive Passing of the 3 standards/wands?

Question 4: If historical records show gaps within the previously required “hourly” checks and they are closer to 1.5 hours - No Metal Detector Failures during that time - how do we justify that within a CAPA? Not a CCP and Zero Complaints or MD Deviations - they simply just didn’t do them on time and didn’t have an appropriate record review

This has been changed for quite a while and is now fully compliant but is a CAPA enough with effectiveness checks enough to avoid a BRC NC?

Thank you


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[kingstudruler1]

Question 1.   I doubt you will find this.    Most would tell you to use the smallest standard possible.   Some use FDA sec 555.425 as justification as to the size.   The truth is in most cases the product and size of the package determine the test piece that can be used.   I've seen anything from 0.5mm to 3.5mm. 

 

What do you recommend if they never did a justification within their HACCP and they got away with stating they didn’t need MD due to no customer complaints - pretty crazy to me!   There are plenty of experienced people on both sides of the metal detector isle.   Those that state that the MD must be a CCP and those that say it absolutely can not be a CCP.    It really depends on your operation as to its level of importance in the food safety plan. 

 

question 2.   this is a little odd, but not unheard of.  Saying that you will verify that the unit is working by passing a test piece 3.0 mm or less and then using a 1.5 mm piece is ok.    

 

the shape of the standard doesnt matter.   Ive used plugs for gravity flow and sticks for conveyors.

 

Question 3 learning to me was when you asked the metal detector to reduce the product signal by passing product with NO metal. 

 

question 4.   this is a problem.   you will need to write a corrective action.  Operator retrained, etc.  What i have done in the past is much like question 2.   the procedure says you check it every 2 hours.   the operators are instructed to test it every hour.  An auditor may let a couple over the time checks slide.  if its routine, it will be found as NC

[G M]

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Question 1: There is a lack of information pertaining to the appropriate selection for Wand/Standard Sizes - ... What do you recommend if they never did a justification within their HACCP and they got away with stating they didn’t need MD due to no customer complaints - pretty crazy to me!

 

 

Base your targets on the type and size of FM inclusions you (and the industry) have a history of finding in the materials you use.  You are unlikely to find any regulation or guidance documents telling you what is appropriate for X Y or Z product.  Consumer complaint history, and lack thereof, can frequently be used to guide and justify process standards.

 

Working with various meat and poultry we use 3mm as our critical limits for metal detectors and xray, this is around the size of birdshot which are the smallest items we're likely to encounter in the raw materials.  One facility uses 1.5mm though, because larger inclusions have the potential to damage a piece of equipment.

 

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Question 2: How do I differentiate between critical limits and operational limits - trying to make sense in how we use smaller standards and then of there is a failure we run the larger sizes to validate the system is working?

Do you think there is value in different shapes of standards? Squares and Wands for example

...
 

 

The only place in our programs where there is an operational limit larger than the CCP limit does not count as a CCP itself.  This CP step was just a pre-screening step to remove high moisture material for re-cook (using the electromagnetic properties of the metal detector for quality screening purposes in addition to some metal detection).

 

If your operational standard is smaller than the CCP limit I don't see a problem. 

 

Neither of those sound like what you're doing, so I'm not sure how you justify it either.  I've seen maintenance personnel put large metal items though to make sure they haven't tuned something way out of whack -- but in the end if it's a CCP it has to reach the stated critical limit of detection before it can be used for saleable product no matter what other nonsense testing they do.

 

Different shapes of metal seeds definitely have different effects on the sensitivity.  A 50g sphere will in most cases be much harder to detect than a 50ug spring, wire or sheet.  The test samples nearly always use spheres, even if the encasing material is some other shape -- this, usually low density plastic, is just there to help you keep track of the sample seed so it doesn't become your next FM consumer complaint.

 

 

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Question 3: Is “Learning” the same as Successive Passing of the 3 standards/wands?

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Many new detectors use algorithmic "learning" (I'll assume this is what you're referring to) to help them differentiate false positives from the product from real FM.  This process usually involves passing both "good" product and FM seeded product through the device many times. 

 

 

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Question 4: If historical records show gaps within the previously required “hourly” checks and they are closer to 1.5 hours - No Metal Detector Failures during that time - how do we justify that within a CAPA? Not a CCP and Zero Complaints or MD Deviations - they simply just didn’t do them on time and didn’t have an appropriate record review

This has been changed for quite a while and is now fully compliant but is a CAPA enough with effectiveness checks enough to avoid a BRC NC?

...

 

There are a couple of ways to approach it, broadly speaking you either need to adjust the required frequency to meet what people are actually capable of or willing to do, or fix whatever is preventing them from doing it at the higher frequency.  

 

Not catching this failure to comply with the standard during the record review is a separate problem -- what was the root cause you found for that?  Did it trigger an audit of other items these same people were reviewing?