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#1 Samurai Sam

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Posted 28 September 2017 - 11:00 AM

we are a company which does puddings in ceramics and unfortunately metal detector won't work for us to detect broken ceramic pieces. 

We are using X ray, but we don't send all products currently through it.

we have sieving food mix as CCP with a fine mesh 1mm.

 

Can we consider the below Canadian link , and consider 2mm as scientific evidence for the critical limit? how do we justify the finding of unacceptable and acceptable? 

also, we couldn't get any evidence from the manufacturer that the mesh size is 1mm which is a problem.

 

http://active.inspec...introe.aspx?i=8

 

also, how do we check the integrity of sieve?. we check it on a daily basis in opening and closing checks.will this be enough or do we need to check it for every batch?. also, it will be a manual visual check for the sieves. will this be enough?.

 

After sieving comes depositing in ceramic ramekins which also can have broken ceramic shards which will again be a ccp as it will be a risk if not checked. this ccp will be a visual check for any object or cracked piece to be removed if it is more than 2mm although we remove and take every precaution to remove every piece. how do we justify the acceptable to not acceptable in haccp?. we can't demonstrate to auditor that we check size of every particle to see if it is above 2mm?.

 

any help is appreciated.

 

Regards

Vikram


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#2 Charles.C

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Posted 28 September 2017 - 02:11 PM

 

we are a company which does puddings in ceramics and unfortunately metal detector won't work for us to detect broken ceramic pieces. 

We are using X ray, but we don't send all products currently through it.

we have sieving food mix as CCP with a fine mesh 1mm.

 

Can we consider the below Canadian link , and consider 2mm as scientific evidence for the critical limit? how do we justify the finding of unacceptable and acceptable? 

also, we couldn't get any evidence from the manufacturer that the mesh size is 1mm which is a problem.

 

http://active.inspec...introe.aspx?i=8

 

also, how do we check the integrity of sieve?. we check it on a daily basis in opening and closing checks.will this be enough or do we need to check it for every batch?. also, it will be a manual visual check for the sieves. will this be enough?.

 

After sieving comes depositing in ceramic ramekins which also can have broken ceramic shards which will again be a ccp as it will be a risk if not checked. this ccp will be a visual check for any object or cracked piece to be removed if it is more than 2mm although we remove and take every precaution to remove every piece. how do we justify the acceptable to not acceptable in haccp?. we can't demonstrate to auditor that we check size of every particle to see if it is above 2mm?.

 

any help is appreciated.

 

Regards

Vikram

 

 

Hi vikram,

 

Offhand it looks preferable to pass all product through Xray if sensitivity adequate. Then only one CCP.

 

Note Canadian limits vary from 0-2mm depending on product/consumer.

 

sieve integrity is typically visually evaluated.

 

Sieves are typically marked by Grade/mesh size.

 

frequency of checking relates to yr capability to recheck X kgs in the event of a failure in critical limit.


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Charles.C


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#3 Samurai Sam

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Posted 28 September 2017 - 02:26 PM

Hi vikram,

 

Offhand it looks preferable to pass all product through Xray if sensitivity adequate. Then only one CCP.

 

Note Canadian limits vary from 0-2mm depending on product/consumer.

 

sieve integrity is typically visually evaluated.

 

Sieves are typically marked by Grade/mesh size.

 

frequency of checking relates to yr capability to recheck X kgs in the event of a failure in critical limit.

Hi Charles,

 

Unfortunately due to the factory layout, the X ray cannot be repositioned any time soon. so we need to work around it.

FDA says 7mm which we consider as too stretched. 0-2mm Canadian limits vary as you said, so we can't treat this as any scientific evidence for critical limit.

Sieve from vogue doesn't have any grade nor they provide mesh size officially which is a headache to prove.

 

Regards

Vikram


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#4 Charles.C

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Posted 28 September 2017 - 03:39 PM

Hi Charles,

 

Unfortunately due to the factory layout, the X ray cannot be repositioned any time soon. so we need to work around it.

FDA says 7mm which we consider as too stretched. 0-2mm Canadian limits vary as you said, so we can't treat this as any scientific evidence for critical limit.

Sieve from vogue doesn't have any grade nor they provide mesh size officially which is a headache to prove.

 

Regards

Vikram

 

Hi vikram,

 

The Canadian 0-2mm is a Legislatory requirement so can presumably be assumed to have been based on some validatory data (albeit unstated). Hence IMO it can act as a reference within its stated context.

 

But if the product is specifically intended for infants I guess that will define the limit for Canada/USA. And i daresay UK also.

 

In addition there is another reference (Dutch IIRC) mentioned elsewhere on this forum which also supports 2 mm max. based on, IIRC, mentioned statistical data.

 

As you say USFDA have a somewhat different interpretation, as do various other countries. The fact is that opinions vary.

 

I think you will find for the general case that most auditors are flexible on the numbers providing that they can be "justified" and seem intuitively not "unreasonable".

 

Many global users of MDs seem to fall back on quoting "Best Practice values" for their respective industries, others use maximum sensitivity values (LODs) of the relevant instrument.

I guess a sieve of unknown mesh size could be approx. calibrated against standard sieve units. Or measured with a microscope ?

 

But the monitoring of last stage you describe is certainly more problematic. :dunno:


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Kind Regards,

 

Charles.C


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