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#1 selminay

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Posted 12 September 2006 - 11:29 AM

Hi,
One of our CCP is metal detector. According to ISO 22k we have to "document" our mentality while deciding CCPs. (7.6) And I could not find any law, regulation,..etc to refer about critical limits of metal detectors. (Fe:1mm, S-S: 1,5mm) As far as I know it depends on our choice. How can I describe that in CCP Plan?

Thanks,
Selmin


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#2 charlorne

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Posted 15 September 2006 - 12:04 AM

Attached File  Form_10_c_HACCP_Plan___generic_model.doc   34.5KB   235 downloads

Hi,
One of our CCP is metal dedector. According to ISO 22k we have to "document" our mentality while deciding CCPs. (7.6) And I could not find any law, regulation,..etc to refer about critical limits of metal detectors. (Fe:1mm, S-S: 1,5mm) As far as I know it depends on our choice. How can I describe that in CCP Plan?

Thanks,
Selmin


Selmin

Attached is an example of a HACCP plan for your reference.

Please note that at process step #9, the 2nd CCP deals with metal detection.

This example may help you to describe what you need to do.

Cheers
Lorne
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#3 Charles.C

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Posted 15 September 2006 - 05:57 AM

Dear Charlorne,

I agree the CL is a debated issue (see other threads in this forum) and that there is flexibility however I think you have found a nice auditor (or you are one). Mine's typical comment would be 'must specify'. I think many people write the MD machine standard's values assuming they look good enough as compared to, for example

http://www.cfsan.fda...s/haccp-2t.html

(the next version became a bit less exact) see -

http://www.cfsan.fda...mm/haccp4t.html

Perhaps I've been unlucky with auditors. :smile:

Rgds / Charles.C

added - another presentation variation could be like this (step 27) -

http://www.inspectio...hamjam10e.shtml


Edited by Charles.C, 15 September 2006 - 06:22 AM.

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Charles.C


#4 Simon

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Posted 15 September 2006 - 07:38 PM

Was this helpful for you Selminay? Have your questions been answered?



Simon


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#5 Erasmo

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Posted 30 April 2007 - 11:01 PM

Dear Charlorne,

I agree the CL is a debated issue (see other threads in this forum) and that there is flexibility however I think you have found a nice auditor (or you are one). Mine's typical comment would be 'must specify'. I think many people write the MD machine standard's values assuming they look good enough as compared to, for example

http://www.cfsan.fda...s/haccp-2t.html

(the next version became a bit less exact) see -

http://www.cfsan.fda...mm/haccp4t.html

Perhaps I've been unlucky with auditors. :smile:

Rgds / Charles.C

added - another presentation variation could be like this (step 27) -

http://www.inspectio...hamjam10e.shtml



Hi Charles,

I am not agree with the HACCP plan in your first link (From 1998). The Corrective Action column describe a Correction not a corrective action. This is from ISO-15161:2001...

The concept of corrective action in the HACCP method describes the processing of nonconforming products and the nonconformities and the correction of the situation. The concept of corrective action in ISO 9001 -(an now also with ISO-2200)- is based on searching for causes in such a way as to perpetuate the elimination of the problem at the source of the nonconformity.



Also I am not agree with the monitoring Frequency. Metal Detector are usually monitored with std spheres every hour or at least twice a shift. (a similar situation is described in the Verification column).

Verification is usually performed with internal audits, inspections, supervision, etc.

This is From ISOTS-22004

The validation usually includes such activities as:

a) reference to validations carried out by others, to scientific literature, or to historical knowledge,

b) experimental trials to simulate process conditions,

c) biological, chemical and physical hazard data collected during normal operating conditions,

d) statistically designed surveys,

e) mathematical modelling, and

f) use of a guide approved by competent authorities.

Metal detector validation are usually performed with a test with various materials: (304 SS, Nickel, Brass, Chrome steel, etc) Evaluation are performed in order to assess if the device and the rejecting system is capable of deflect metal particles of different characteristics. This could be considered as b) (experimental trial to simulate process condition).

Monitoring is usually performed with SS and ferrous metal and is performed in order to challenge the device and the system surround them.

Saludos.
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#6 Charles.C

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Posted 01 May 2007 - 04:28 AM

Hi Erasmo,

Looks like you are doing a lot of researching. :thumbup:

Corrective action / Frequency. I agree yr comments but I think they are mentioned in the link text, eg (Cont.Strat.Ex.1) –

“Attempt to locate and correct the source of the fragments found in product by the metal detector or separated from the product stream by the magnets, screens, or other devices;”

and (Step 15) (sort of covering their back) -

“ Note that the monitoring frequencies that are provided are intended to be considered as minimum recommendations, and may not be adequate in all cases. “

I think yr 3rd comment is relating to the different interpretations of verification / validation?. This topic has a long and continuing history in standard HACCP refs plus this forum (eg http://www.ifsqn.com...amp;#entry15513 ) . I guess the differences relate (but not only) to the American origin of HACCP where more emphasis was placed on verification ( for example http://www-seafood.u...nes/nacmcf1.htm ) whereas the Europeans wished to “upgrade” Validation. I was originally very anti–validation (I like the simple life :smile: ) but the auditors have eventually forced me to regard it as unavoidable as per yr ISO22k list. :crying:

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#7 Erasmo

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Posted 01 May 2007 - 09:15 PM

Hi Erasmo,

Looks like you are doing a lot of researching. :thumbup:

Corrective action / Frequency. I agree yr comments but I think they are mentioned in the link text, eg (Cont.Strat.Ex.1) –

“Attempt to locate and correct the source of the fragments found in product by the metal detector or separated from the product stream by the magnets, screens, or other devices;”

and (Step 15) (sort of covering their back) -

“ Note that the monitoring frequencies that are provided are intended to be considered as minimum recommendations, and may not be adequate in all cases. “

I think yr 3rd comment is relating to the different interpretations of verification / validation?. This topic has a long and continuing history in standard HACCP refs plus this forum (eg http://www.ifsqn.com...amp;#entry15513 ) . I guess the differences relate (but not only) to the American origin of HACCP where more emphasis was placed on verification ( for example http://www-seafood.u...nes/nacmcf1.htm ) whereas the Europeans wished to “upgrade” Validation. I was originally very anti–validation (I like the simple life :smile: ) but the auditors have eventually forced me to regard it as unavoidable as per yr ISO22k list. :crying:

Rgds / Charles.C



well, I really read the first link only...

Saludos.
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#8 BeautyFoo

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Posted 02 May 2007 - 08:27 AM

Hi Charles,

I am not agree with the HACCP plan in your first link (From 1998). The Corrective Action column describe a Correction not a corrective action. This is from ISO-15161:2001...

The concept of corrective action in the HACCP method describes the processing of nonconforming products and the nonconformities and the correction of the situation. The concept of corrective action in ISO 9001 -(an now also with ISO-2200)- is based on searching for causes in such a way as to perpetuate the elimination of the problem at the source of the nonconformity.



Also I am not agree with the monitoring Frequency. Metal Detector are usually monitored with std spheres every hour or at least twice a shift. (a similar situation is described in the Verification column).

Verification is usually performed with internal audits, inspections, supervision, etc.

This is From ISOTS-22004

The validation usually includes such activities as:

a) reference to validations carried out by others, to scientific literature, or to historical knowledge,

b) experimental trials to simulate process conditions,

c) biological, chemical and physical hazard data collected during normal operating conditions,

d) statistically designed surveys,

e) mathematical modelling, and

f) use of a guide approved by competent authorities.

Metal detector validation are usually performed with a test with various materials: (304 SS, Nickel, Brass, Chrome steel, etc) Evaluation are performed in order to assess if the device and the rejecting system is capable of deflect metal particles of different characteristics. This could be considered as b) (experimental trial to simulate process condition).

Monitoring is usually performed with SS and ferrous metal and is performed in order to challenge the device and the system surround them.

Saludos.


Actually i use the test pieces of Ferous and SUS for verify. The auditor ask me, as u use data logger and Microbiology Lab Test for validation of the CCP1 (Cooking), so how u validated the CCP2 (Metal detection)?
My consultan suggest me that send the finish product to external lab for metal contamination test. But i had check with most lab, they do not have thus testing. they just have heavy metal test only.
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#9 selminay

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Posted 02 May 2007 - 11:40 AM

Was this helpful for you Selminay? Have your questions been answered?



Simon


Dear Simon,
Yes the answers were very useful for me. Thanks for your interest.

Regards,
Selmin
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#10 Erasmo

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Posted 02 May 2007 - 04:54 PM

Actually i use the test pieces of Ferous and SUS for verify. The auditor ask me, as u use data logger and Microbiology Lab Test for validation of the CCP1 (Cooking), so how u validated the CCP2 (Metal detection)?
My consultan suggest me that send the finish product to external lab for metal contamination test. But i had check with most lab, they do not have thus testing. they just have heavy metal test only.


Well, I think the use of the test pieces is MONITORING your control measure (not verification). Let’s see the definitions.



3.12 monitoring: conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended(use of test pieces to confirm if the metal detector are working correctly and take a correction AND corrective action if monitoring shows any loss of control in that device.) see 7.10.1 & 7.10.2.



3.16 verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. (Using supervision, internal audits, internal inspections etc. see 7.8 c))



The use of Microbiology Lab is also a verification when that analysis is performed as a planned activity (see 7.8 d)). Validation is performed only prior to implementation of that control measurement or after any change in the process (see 8.2) and you could use a Micro lab.



You won’t find a lab to evaluate metal contamination, it’s not feasible and it’s useless. You need to validate if your device it’s capable of reject contaminated product at normal conditions.
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#11 Charles.C

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Posted 03 May 2007 - 06:23 AM

Dear Beautyfoo,

I assume the auditor is obliged to follow the text of yr audit standard which is ? Product ?

Whatever, perhaps you should show Erasmo’s previous post extract of ISO2204 to the auditor, in particular (a), (b) seem to basically correlate to yr current procedure although (if you don’t already have it?) an auditor would probably expect certified test pieces something like –
http://www.teststandard.com/
or as in “validation test kits”
http://www.teststand...validation-kits

If yr auditor requires some other objective reference evidence to possible interpretations of “metal detector validation” –

“Yet it’s important that performance integrity not be jeopardized by the frequent washdown. To validate performance, metal detectors are tested every hour with 3-mm ferrous and non-ferrous strips and a 5-mm stainless steel strip.”
http://www.packworld.com/view-19452

Or an actual, but non-food example (ALIS is a metal detector based landmine imaging system) –

“At the CDS site, we could validate the operation of the
ALIS for known targets in various conditions. The climate
when we conducted the field tests was partly rainy, and
water content of the soil at CDS site was about 10% ,
correspond to the dielectric constant of 5.3. Real PMN-2
and Type 72 landmines without booster were buried at the
CDS site at different depths between 0 and 20cm, and we
could find that the metal detector can detect landmines
buried shallower than 15cm, and GPR can show clear
images of landmines, which are buried up to 20cm in
depth. We also found that the metal fragments, which are
included in the soil does dot show clear GPR image,
therefore we could discriminate metal fragments from
landmines by ALIS.”
http://www.itep.ws/p...em2005_Sato.pdf.

The above illustrates the idea of simulating the actual situation which in yr case might correspond to embedding a test piece within a representative product / packaging matrix.

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#12 Erasmo

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Posted 10 May 2007 - 01:46 AM

Hi Erasmo,

Looks like you are doing a lot of researching. :thumbup:

Corrective action / Frequency. I agree yr comments but I think they are mentioned in the link text, eg (Cont.Strat.Ex.1) –

“Attempt to locate and correct the source of the fragments found in product by the metal detector or separated from the product stream by the magnets, screens, or other devices;”


Rgds / Charles.C



Hi Charles,



This could be part of a corrective action. But in a corrective action derived from a failure, you need to eliminate the cause of the problem (why that device fails?) not only the source of the metal fragments.



Saludos.
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#13 Charles.C

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Posted 10 May 2007 - 12:17 PM

Dear Erasmo,

Yes indeed. Somebody else probably spotted it like you, the later version has –

“AND

Make adjustments to the materials, equipment, and/or process, as needed, to prevent future introduction of metal fragments;”

I suppose “as needed” also includes people, whatever. Good text for covering the back. :smile:

Strangely, I couldn’t see any mention of “root causes” in I22k although I think it has always been a key concept in I9k ? Perhaps the terminology is becoming old-fashioned.

The practical difficulty IMEX is that root causes often end up as “random events”.

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#14 GMO

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Posted 11 April 2008 - 04:51 AM

Stumbled across this topic, I know it's old but it's something I've done work on.

Validation is about "can the system work?" and you presumably have documentation regarding the capabilities of your detectors. Also you need to justify your critical limits (which in this case is the piece size). In this, you're always limited by your product but you have to be sensible. I think anything bigger than 4 or 5 mm diameter and it's fairly pointless as a CCP. Remember anything up to the size of the piece you test with can get through. Stainless steel will always be the hardest to detect but you should have stainless steel, ferrous and non ferrous test pieces.

Verification of metal detectors; I always take this as being our yearly service in which they ensure the detectors are working properly with the test pieces we use. They provide certification for this too.

The testing (which I always have as start and end of run and every 30 mins) of the metal detector with the test pieces is the monitoring, however, you should also check every shift that failsafe systems are working.


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#15 rkb555

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Posted 29 November 2012 - 04:31 PM

Actually i use the test pieces of Ferous and SUS for verify. The auditor ask me, as u use data logger and Microbiology Lab Test for validation of the CCP1 (Cooking), so how u validated the CCP2 (Metal detection)?
My consultan suggest me that send the finish product to external lab for metal contamination test. But i had check with most lab, they do not have thus testing. they just have heavy metal test only.


Verification and validation of a metal detector as a CCP..A metal detector properties can be broken down into 2 functions. 1. It's ability to alarm and/or kick off product suspect for metal contamination to determine functionality of the metal detector. 2. How effective is it ? Once a product goes through a properly functioning metal detector, it either has metal in it or it doesn't. Property 1 is the verification of a metal detector. You are verifying if the machine is working correctly or not. Property 2 involves validation. Is there actual metal in the product that has passed through the machine ? If the machine is assumed to be working properly, you won't know. There are a couple of ways to know - customer complaints and product testing. If product testing is done, one can take X amount of samples based on a company's sampling policy if they have one and have the product x-rayed or tested for metal contaminants on a periodic or routine basis such as quarterly semiannual or annual. These documented results would validate the effectiveness of the metal detector.
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#16 sevket

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Posted 13 November 2014 - 08:46 PM

Stumbled across this topic, I know it's old but it's something I've done work on.

Validation is about "can the system work?" and you presumably have documentation regarding the capabilities of your detectors. Also you need to justify your critical limits (which in this case is the piece size). In this, you're always limited by your product but you have to be sensible. I think anything bigger than 4 or 5 mm diameter and it's fairly pointless as a CCP. Remember anything up to the size of the piece you test with can get through. Stainless steel will always be the hardest to detect but you should have stainless steel, ferrous and non ferrous test pieces.

Verification of metal detectors; I always take this as being our yearly service in which they ensure the detectors are working properly with the test pieces we use. They provide certification for this too.

The testing (which I always have as start and end of run and every 30 mins) of the metal detector with the test pieces is the monitoring, however, you should also check every shift that failsafe systems are working.

Could you please post the Verification of metal dedector certification ?


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