6 replies to this topic

[Pete_Rev]

Hi all,

 

We have a inline pipeline metal detector on our diced apple line that we verify using 1.5mm Fe, 2.5mm non Fe and 3mm SS test pieces. Earlier this year we had a failure of the MD where the alarm and siren would sound during routine verification but the reject mechanism would not open, so no product was rejected.  As per our protocol we placed all product back to last good check on hold.

 

Subsequently we sourced a temporary, out of place MD that allowed us to pass the now packaged finished product through. However the smallest test pieces it would reject were 3mm Fe, 3.5mm non-Fe and 5mm SS. As above these are larger than detailed by our HACCP plan. Incidentally MD is an oPRP in our line.

 

We now have a fairly large $$ of stock on hold that has had some metal detection, but not to the sensitivity our HACCP plan states.

 

From a risk analysis point of view, we have no previous history of metal complaints from this line. There was no engineering work completed on the line in the lead up to the MD failure. There are no screens or filters either up or downstream of the MD. Although 5mm SS is quite large, my understanding is 7mm is an oft-quoted size for FM contamination that would pose a food safety risk. 

 

Really interested in peoples opinions on if we could release this stock for sale and how we could justify that decision. 

 

Thanks

[Charles.C]

Hi all,

 

We have a inline pipeline metal detector on our diced apple line that we verify using 1.5mm Fe, 2.5mm non Fe and 3mm SS test pieces. Earlier this year we had a failure of the MD where the alarm and siren would sound during routine verification but the reject mechanism would not open, so no product was rejected.  As per our protocol we placed all product back to last good check on hold.

 

Subsequently we sourced a temporary, out of place MD that allowed us to pass the now packaged finished product through. However the smallest test pieces it would reject were 3mm Fe, 3.5mm non-Fe and 5mm SS. As above these are larger than detailed by our HACCP plan. Incidentally MD is an oPRP in our line.

 

We now have a fairly large $$ of stock on hold that has had some metal detection, but not to the sensitivity our HACCP plan states.

 

From a risk analysis point of view, we have no previous history of metal complaints from this line. There was no engineering work completed on the line in the lead up to the MD failure. There are no screens or filters either up or downstream of the MD. Although 5mm SS is quite large, my understanding is 7mm is an oft-quoted size for FM contamination that would pose a food safety risk. 

 

Really interested in peoples opinions on if we could release this stock for sale and how we could justify that decision. 

 

Thanks

 

Hi Pete,

 

When you changed the MD, you should hv revised yr HACCP Plan to match/validate  the new "critical limit". It's called revalidation.

 

Afaik, the usual corrective action to an MD failure would be to re-run the segregated stock.

 

Using the 7mm "route" for haccp revalidation implies, inter alia, that you are insensitive to the potential risk of rejection for adulteration and additionally hv a non-vulnerable intended consumer. Nonetheless, from comments on this Forum, some haccp plans using this reference do appear to have been US approved.

 

The topic of MD critical limits is a grey area from FDA's POV (and elsewhere) as evidenced by numerous threads on this Forum. In Principle USFDA accept zero contamination of any size of metallic fragments. Period. This however implies the existence of a MD with a LOD "negligibly" different to zero which has yet to be found. Two popular alternative(s) (other than the "7mm" option) appear to be either using the measured LOD (or close to it) or the "best practice" values prevailing in the relevant Industry.

 

Very few countries are prepared to categorically offer a detailed quantitative opinion on what size of metal fragment constitutes a significant hazard for them. Canada is one of the few exceptions and typically selects 2mm as the borderline for appropriate consumers.. At one time i believe this value was also used by FDA/USDA but apparently no longer.

[Pete_Rev]

Thanks for the reply Charles.

 

I should clarify that we have not changed our standard pipeline metal detector. It has been fixed and continues to be used as normal. The testing we did of the finished product was using a temporary metal detector as a way to try and get some metal detection completed on the product.

 

Unfortunately re-running the affected stock through our pipeline MD is not possible. Our product is hot filled so this would require rip and tip of finished product, heating to >80oC, then passing through MD and into VFFS. This would breakdown all structure of the product rendering it useless to customers.

 

I agree that test piece size/MD critical limit is hard to define, and certainly here in NZ there is no legislation defined other than food must be safe for consumption. Our target market is not vulnerable populations. 

 

I guess I am asking that if we as a business were prepared to accept a change in MD critical limit as a one off for this batch, how would we go about documenting that for this specific instance.

[Charles.C]

Thanks for the reply Charles.

 

I should clarify that we have not changed our standard pipeline metal detector. It has been fixed and continues to be used as normal. The testing we did of the finished product was using a temporary metal detector as a way to try and get some metal detection completed on the product.

 

Unfortunately re-running the affected stock through our pipeline MD is not possible. Our product is hot filled so this would require rip and tip of finished product, heating to >80oC, then passing through MD and into VFFS. This would breakdown all structure of the product rendering it useless to customers.

 

I agree that test piece size/MD critical limit is hard to define, and certainly here in NZ there is no legislation defined other than food must be safe for consumption. Our target market is not vulnerable populations. 

 

I guess I am asking that if we as a business were prepared to accept a change in MD critical limit as a one off for this batch, how would we go about documenting that for this specific instance.

 

Hi Pete,

 

Thks. I see. The lack of re-run option is unfortunate. I am slightly curious as to yr current , documented, corrective action for segregated goods - write-off?

 

In most haccp plans there is somewhere, eg system verification, a requirement that a significant process change requires a revalidation of haccp plan. A change in MD critical limit (CL) would normally IMO fall into that.

 

I suggest to issue an appropriate, retrospective, revalidated, haccp plan (with the changed, validated critical limits) pertinent to cover the times of temporary change in MD.

 

The logical revalidation is to interpret  the critical limit as the LOD of the detector as per yr (I assume) available test results.(I don't know what yr current method of haccp CL validation is)

 

I suppose an auditor may complain about (a) the relatively low sensitivity of backup MD and (b) the belated late issuance of relevant documents but perhaps you can balance those negatives against yr own estimated risk of (i) there actually being some contamination and (ii) the cost of a write-off.

 

As long as there is no regulatory MD/hazardous metal/best practice critical limit, the choice (within reasonable bounds, eg FDA)  for (a) is IMO defendably based on the instrument only. There are, I think,  published haccp opinions to support this logic. With the slight exception of the 5mm SS value, I think most auditors will be anyway satisfied with yr secondary CLs (my experience is only belt conveyor systems, i assume pipeline MD similar).

 

PS - customer specs which match yr upper MD limits wud also probably help but IMEX customers rarely quantitate such details except for the Big Boys..

 

PPS - a couple quite readable theads on MD / CL here (there are many more) -

 

http://www.ifsqn.com...-food-industry/

(esp post 7)

 

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

[Pete_Rev]

Hi Pete,

 

Thks. I see. The lack of re-run option is unfortunate. I am slightly curious as to yr current , documented, corrective action for segregated goods - write-off?

 

In most haccp plans there is somewhere, eg system verification, a requirement that a significant process change requires a revalidation of haccp plan. A change in MD critical limit (CL) would normally IMO fall into that.

 

I suggest to issue an appropriate, retrospective, revalidated, haccp plan (with the changed, validated critical limits) pertinent to cover the times of temporary change in MD.

 

The logical revalidation is to interpret  the critical limit as the LOD of the detector as per yr (I assume) available test results.(I don't know what yr current method of haccp CL validation is)

 

I suppose an auditor may complain about (a) the relatively low sensitivity of backup MD and (b) the belated late issuance of relevant documents but perhaps you can balance those negatives against yr own estimated risk of (i) there actually being some contamination and (ii) the cost of a write-off.

 

As long as there is no regulatory MD/hazardous metal/best practice critical limit, the choice (within reasonable bounds, eg FDA)  for (a) is IMO defendably based on the instrument only. There are, I think,  published haccp opinions to support this logic. With the slight exception of the 5mm SS value, I think most auditors will be anyway satisfied with yr secondary CLs (my experience is only belt conveyor systems, i assume pipeline MD similar).

 

PS - customer specs which match yr upper MD limits wud also probably help but IMEX customers rarely quantitate such details except for the Big Boys..

 

PPS - a couple quite readable theads on MD / CL here (there are many more) -

 

http://www.ifsqn.com...-food-industry/

(esp post 7)

 

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

Hi Charles,

 

Thanks again for your reply and thoughts.

Our current procedure is to either dump or rework depending on risk and processes available to accept rework. 

Are you suggesting re-validating the entire HACCP plan or merely the process step where metal detection occurs?

I was thinking a risk analysis report or similar outlining MD CL and risk (or lack of) of actual FM contamination would be acceptable. 

[Charles.C]

Hi Charles,

 

Thanks again for your reply and thoughts.

Our current procedure is to either dump or rework depending on risk and processes available to accept rework. 

Are you suggesting re-validating the entire HACCP plan or merely the process step where metal detection occurs?

I was thinking a risk analysis report or similar outlining MD CL and risk (or lack of) of actual FM contamination would be acceptable. 

 

Hi Pete,

 

The revalidation normally only relates to the system process changes and their haccp significance as spelled out in the (updated) haccp plan.

 

An auditor will presumably expect to see that you had an appropriate haccp plan (somewhere) while using the back-up MD.

 

The only (obvious) problem will be the dates of issue of the various amendments. My previous (generic) MD sensitivity definition might make that part simpler.

 

Alternatively, similar to yr idea, you cud treat the use of 2nd MD as an "aberration" and generate an additional haccp plan just for that incident/revalidation. So no need to interfere with the normal haccp plan. If you think it will not happen again, this may be less hassle. In reality, the only operational change is a lower sensitivity but which can still  be "justified" .

[Kiran]

Hi Pete,

 

The product is said to be packed.  Not sure of the pack size.  Depending on pack size, you may be able to get better sensitivity with x-ray, which could be similar to your inline MD.