BRC V7 4.10.3.4 Basis of risk?

I read a post regarding calibration of Metal detectors and x-ray equipment having searched for this clause (and charles if you read this post i agree the standard talks about validation not calibration from my understanding)

But the new V7 requies that test pieces be of a known spherical diameter be selected on the basis of risk.

How do you determine this risk?  

i read somewhere that the size can be of a certain diameter FSA or FDA that would make it safe to consumer by accident but that cant be all that you need otherwise all test pieces would be the same size for all products? 

Our detector specialist gave us the sticks to use for our product also.

Not sure exactly how to comply with this, any examples welcome.

Hi David,

This is another BRC "You thought we'd never ask didn't you?"  type question. Minimum one more per every new version, sometimes >>1

It reminded me of the comments on the  play "6 Characters in Search of an Author"

https://en.wikipedia...ch_of_an_Author

See this near-identical thread -

http://www.ifsqn.com...zes/#entry91749

Note the (lack of) conclusion.

In truth, it's a valid question but with vexed solutions (eg Customer, Industry, MD/LOD). The "risk" factor / test metal size from a haccp POV should clearly relate to the hazard. The hazard aspect is debatably quantifiable biologically but may be prioritised by regulatory requirements. It is surely also limited by machine capabilities / finance / product matrix.

Easiest to answer if you live in Canada or the Netherlands perhaps. I suspect UK gives no official recommendations.

This reverse philosophy is maybe an appropriately evasive response  -

http://www.ifsqn.com...ate/#entry56043

I anticipate that BRC's actual expectation (Guidance ?)  is simply trite, eg lowest value of all relevant industry regular customers.

Thanks Charles,

I live in the UK and although its great to keep track of other countries and how they define limits for sizes, this GLOBAL standard makes it hard for us especilly when as far as i am aware have no official standards set, FSA seems a little vague on this subject too.

My conclusion untill i see reason to work diffrently is to consider what our supplier of the metal detector says is most suitable for our type of products and to consider what actual hazards are known within our environment.

Example we use a metal tray (no alternative solution available) that fatigues over time due to cleaning process, this results in weak areas causing bits of metal to fall off in to boxes (maybe once a month) these bits are always about 1/2cm in lengh by width by depth and are  always detected. our test pieces have to be small enough to ensure this is captured.

This summarised in a RA would probably suffice to an auditor?  i think anyways..

Hi David,

I admire yr confidence in predicting BRC’s expectations.

This little, vaguely BRC-related, snippet might assist yr theory –

metal detection.pdf   102.84KB   207 downloads

Additionally the pdf below documenting a  recent minor catastrophe for UK consumers implies that the expected MD sensitivity for retail products is at least > 1mm despite some related public opinions  which perhaps would prefer a zero tolerance level, eg the following link

Managing Foreign Body Contamination,2015.pdf   110.31KB   181 downloads

http://www.mirror.co...y-meals-5748793

Hi All;

I  also like David in his situation, it is needed from me a risk assessment for chosing the size of the metal detector pieces we have ( 2 mm for ferrus - 2mm for non-ferrus - 2.5mm for st.st metals )

Our field is sugar refinery.

In my openion, the previous steps befor the metal detector affect risk assesment as we also have a magnet finger before the sugar backed or it is depend on the acceptable limit for matal found on products

Thanks

This "what size test pieces should I use" has been going on for years with no resolution.

The "correct" size really depends on your industry and your products. 

In bread, bun, roll and cookie bakeries I have worked in, size has ranged from 1.5mm Fe to 4mm Stainless.

You always want to go as small as possible, but usually you are stuck with what you have for equipment. I think most auditors live in the real world and understand this.

Do a validation study (after the fact) to show that the test pieces you use are the smallest your equipment will detect. Call around to some similar companies and see what they are using.

Package it into a short Memo stating that the test pieces in use are generally industry standard best practice and that you have verified that your metal detector will not detect any thing smaller than the pieces you have.

That should be sufficient.

Marshall

Hi Marshall,

I agree that auditors tend to be somewhat unconcerned as to MD test limits if not “excessive” although I have found their intuitive limit is nearer "3mm". Fast food chains are usually rather more demanding in their specifications IMEX. It is also my experience that auditors are well-conditioned to the assumption that stainless steel is substantially more difficult to detect than ferrous.

Nonetheless,  from a HACCP POV, it seems logical to prepare  some consideration as to the hazard itself in case the auditor requests.

It is clearly unrealistic  to assert that one absolute limit can cover all safety related possibilities. Existing opinions are based on statistical analysis of  safety related incidents/data.

The only specific regulatory limit based on safety incident data which I have seen published is 2mm as in Canada and some European locations. IIRC this value was also at one time used in USA following the FDA’s  detailed studies ca.2000  although both FDA and USDA(?)  now seem to be implementing  FDA’s menu of interpretations.

With the exception of USA which is a special case, it seems to me that the above evidence offers validatory support for setting a target limit which I believe is routinely, practically, attainable for  the majority of commercial MDs for Ferrous iron if handling typically sized retail products.

If the product/MD configuration prevents achieving this “ideal” target, the discrepancy may still be able to be satisfactorily validated within the context of the frequently quoted sensitivities in table attached (ex Tesco). Specific industries may have their own validated product sensitivities to extend the table. :smile:

Metal Detector Limits.doc   28KB   144 downloads

given the general feeling that "nobody really can!" apply definitive acceptable metal piece sizes in particular products within UK atleast, I am leaning towards validating the fact i have the right machine for the job (as advised by Loma) and b) the smallest test piece detectable i can get to work for my products consistantly 100% of te time.

Providing this is validated using concise method / approach, and untill some piece of legislative or customer specific requirement comes our way (like tesco, M&S) which will come from new section on customer focus, how could anyone argue this isnt acceptable?

Even then there is still potential that somone may have adverse reaction to metal contamination smaller then detector is able to detect. Its just the work done shows we could do nothing else with current rules and information to prevent it!

 

 

Providing this is validated using concise method / approach, and untill some piece of legislative or customer specific requirement comes our way (like tesco, M&S) which will come from new section on customer focus, how could anyone argue this isnt acceptable?

Hi David,

Not sure if the fall-back Regulatory rejection due to "Adulteration" also exists in UK.? It seems to be a powerful lever in USA.

Greetings all, sorry to dredge this post up again but im stil lstruggling with it.

I have done as i stated before put through test pieces of all sizes through with a wide range of products to determien the size which will detect 100% of the time.

Interestingly enough it proved to my colelgues that although CCP is working detecting metal fragments the test pieces we were told to use by Loma back in the day were conservative at best. we use 3.0mm across the board but my results showed that in some cases i can detect 100% time 1.5mm pieces.

Going forward i will change our system to accept new data but in terms of comlpiance to the clause

"selected on the basis of risk"

im stuck as to how i present a risk assessment document to an auditor that would give enough information to justify their use.

Does anyone have already a document template "risk assessment" i could see for ideas?

Just noticed this prematurely ended thread while passing so i hv added a few thoughts.

I daresay acceptable BRC interpretations/responses to their "risk" element are in their interp. guidelines. Possibly including a "industry best practice" option.

In addition to Post 6 above, i suggest to consider these posts in other threads -

http://www.ifsqn.com...our-processing/

(esp. Posts 3,4)

http://www.ifsqn.com...ctors-accepted/

(esp Posts 8,9)

http://www.ifsqn.com...tor-test-sizes/

(esp Post 5)

One caveat is that a MD can only perform to its "best" capabilities, eg LOD. Situations such as vulnerable consumers may need to be handled as "exceptions" such as by procedures presented in the frequently quoted USFDA guidelines.

https://www.fda.gov/...l/ucm074554.htm

M&S have attempted to come up with test piece sizes according to the product height.  I'm yet to be convinced that this is based on any scientific conclusions though.

One thing many people aren't aware of is simply because you're using a, say 5mm test piece size in your machine, does not mean the maximum contaminant size is 5mm in all orientations.  Wires particularly can be very hard to detect.  I have a Metler Toledo book somewhere which shows the length of wire which can go through a machine and it's significantly larger than the size of the ballbearing.  A note of caution for HACCP plans and also for your metal controls which should be factory wide not just at your CCP.

Suggested "solution" for the OP's query.

Metal detector (MD) - Choice of  reference test piece/sphere on "risk-basis"

Following is a generic response to the requirement of 4.10.3.4 with respect to “basis of risk” element. (Other specific Regulatory/ “Best Practice” values for given Industries may be equally audit satisfactory if validatable).

The Regulatory answer as to what size of metal contaminant in a food is acceptable is typically "zero".

For a metal detector CCP, attempts could be made to set the critical limit (CL) as the absence of metal in the product. However, absence is simply not practical, as the sensitivity of the equipment will limit the size of the test pieces that are appropriate, ie detectable, by that particular metal detector. (Sensitivity is typically expressed as the minimum sphere diameter that can be detected “100%” of the time).

Nonetheless, while accepting the above limitation, it is evident that operating the MD at its maximum sensitivity for a given machine set-up/food matrix should minimise the risk of any metal passing into the finished product (as far as the MD is concerned).

Accordingly, in order to assure the consumer a  maximum safety level (with respect to specific metal contaminants),  the critical limit for a given, reference, test piece material will be the smallest size that can be consistently detected/rejected by the MD. A  procedure to determine this optimum test piece was previously posted by Marshall/mgourley  and IMO is a reasonable response for this requirement (see the 3rd link in Post 11 above).

(the  operational  portion should probably be expanded somewhat as detailed in,for example, the Tesco MD methodology -

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

(Note1 - there are other factors, eg food matrices, which may cause the CL to vary with different product type).

(Note2 - the above assumes that the MD is well "maintained" and not an antique inasmuch as the result should obviously be "realistic" in the context of, for example, typical customer specifications for retail packs. 20kg sacks may require some further thought :smile:)

Nonetheless, while accepting the above limitation, it is evident that operating the MD at its maximum sensitivity for a given machine set-up/food matrix should minimise the risk of any metal passing into the finished product (as far as the MD is concerned).

 

Accordingly, in order to assure the consumer a  maximum safety level (with respect to specific metal contaminants),  the critical limit for a given, reference, test piece material will be the smallest size that can be consistently detected/rejected by the MD.

I would agree but also taking industry best practice, manufacturers’ guidelines and specific customer requirements into consideration.

Kind regards,

Tony