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Is X-Ray a must?

Foreign Contamination

Best Answer , 26 October 2021 - 04:29 PM

Hi ,thanks for your response, do you know if it is a requirement to have the X-Ray to be GSFI or HACCP Certified, or  can my Hazard analysis and SOP's be acceptable to keep certification?

I think, you should revise your foreign material control program to switch from x-ray to visual inspection. Even if it's a temporary measure, you'll need to have a written program, procedures, instructions, records, etc. Don't forget to re-train your personnel accordingly. No, it's not a GFSI requirement as far as I know. The idea is to CONTROL foreign matter, but it's up to you how you do it.


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Jorge Manzanero

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Posted 26 October 2021 - 04:01 PM

Hi all, I am facing a dilemma at work. We bottle sauces in 5 and 10oz Woozy Bottles.

The speed of our line is 8 cases of 12X 5 oz sauces per minute. (about 2000 cs. per day).

 

The Bottles are placed on a turn table upright then fed to a bottle Blower machine that spins the bottles upside down then back to the conveyor belt upright, the bottles are passed through to the Automatic Filler/Capper then through an X-Ray machine. 

 

This weekend a lightening storm damaged the motherboard on the machine and the manufacturers said that the board would not be received until November 15th more or less due to supply chain etc.

 

My Question is, is the X-Ray an absolute necessity to continue being HACCP/ IFS Compliant?

 

We have a backup plan of installing 2 light inspection site. One before filling and one after filling but before caps are applied. This is to check the bottle mouths. We redid the Hazard Analysis and considering slow speed and clarity of bottles are very confident that this would detect any broken bottles.

 

Chipped bottles at filling have been zero for the last 6 months. Also no rejected bottles with glass contamination from the last 5 years we have been using the X-Ray. Except false positives.

 

Prior to installing the X-Ray we had been bottling at this speed from 1981 and have had no problems.

 

Can you please give your thoughts as this is a subject we have been pondering over the years.

 

Thanks

Jorge

 



olenazh

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Posted 26 October 2021 - 04:13 PM

We manufacture bottled kefir and manage without either x-ray or metal detector. Of course, we would install one - but our building layout doesn't allow it, not much space. Being GFSI certified for +11 years and having a lot of customers, we haven't had any objections of not having x-ray: it is what it is, and one should be based on real circumstances. 



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Posted 26 October 2021 - 04:17 PM

Hello

 

Is this X-ray your CCP? Did you stablish that the foreign matter is controlled by PR program too? 

 

Is all about your HACCP risk assessment forms 5 to 10



Jorge Manzanero

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Posted 26 October 2021 - 04:18 PM

We manufacture bottled kefir and manage without either x-ray or metal detector. Of course, we would install one - but our building layout doesn't allow it, not much space. Being GFSI certified for +11 years and having a lot of customers, we haven't had any objections of not having x-ray: it is what it is, and one should be based on real circumstances. 

 

Hi ,thanks for your response, do you know if it is a requirement to have the X-Ray to be GSFI or HACCP Certified, or  can my Hazard analysis and SOP's be acceptable to keep certification?



Jorge Manzanero

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Posted 26 October 2021 - 04:23 PM

Hello

 

Is this X-ray your CCP? Did you stablish that the foreign matter is controlled by PR program too? 

 

Is all about your HACCP risk assessment forms 5 to 10

 

Yes we were advised to make it a CCP as we were using Glass Bottles. We have a Foreign Contamination PRP for Control of Foreign Contamination, Glass Policy & Control Procedures, Control of Brittle Material, Records etc. Procedure to take if a bottle should break etc. 



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Posted 26 October 2021 - 04:29 PM   Best Answer

Hi ,thanks for your response, do you know if it is a requirement to have the X-Ray to be GSFI or HACCP Certified, or  can my Hazard analysis and SOP's be acceptable to keep certification?

I think, you should revise your foreign material control program to switch from x-ray to visual inspection. Even if it's a temporary measure, you'll need to have a written program, procedures, instructions, records, etc. Don't forget to re-train your personnel accordingly. No, it's not a GFSI requirement as far as I know. The idea is to CONTROL foreign matter, but it's up to you how you do it.



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Charles.C

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Posted 26 October 2021 - 05:25 PM

Hi all, I am facing a dilemma at work. We bottle sauces in 5 and 10oz Woozy Bottles.

The speed of our line is 8 cases of 12X 5 oz sauces per minute. (about 2000 cs. per day).

 

The Bottles are placed on a turn table upright then fed to a bottle Blower machine that spins the bottles upside down then back to the conveyor belt upright, the bottles are passed through to the Automatic Filler/Capper then through an X-Ray machine. 

 

This weekend a lightening storm damaged the motherboard on the machine and the manufacturers said that the board would not be received until November 15th more or less due to supply chain etc.

 

My Question is, is the X-Ray an absolute necessity to continue being HACCP/ IFS Compliant?

 

We have a backup plan of installing 2 light inspection site. One before filling and one after filling but before caps are applied. This is to check the bottle mouths. We redid the Hazard Analysis and considering slow speed and clarity of bottles are very confident that this would detect any broken bottles.

 

Chipped bottles at filling have been zero for the last 6 months. Also no rejected bottles with glass contamination from the last 5 years we have been using the X-Ray. Except false positives.

 

Prior to installing the X-Ray we had been bottling at this speed from 1981 and have had no problems.

 

Can you please give your thoughts as this is a subject we have been pondering over the years.

 

Thanks

Jorge

Hi Jorge,

 

You omitted to mention which GFSI-recognized Standard is in use (if any). It may relate.

 

The obvious ideal solution is to have a backup.

 

Assuming you retain as CCP, validation of critical limits is required. If > a PRP, validation maybe Yes/maybe No depending on Standard.

 

Not a user of X-ray but In my analogous experiences of justifying having no MD, auditorial acceptance  ( and particularly if XYZ had previously been in use) will relate to (a) any reference justifications (b) supporting  history based on result records, (c) "best practice" considerations, (d) preliminary implemented screening controls, (e) auditor experiences with other analogous processes.

 

Just as a worst case example, if (e) happens to be positive for the presence of X-ray detector, can expect a difficult "sell". And the converse.


Kind Regards,

 

Charles.C


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Charles.C

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Posted 26 October 2021 - 05:25 PM

Hi Jorge,

 

You omitted to mention which GFSI-recognized Standard is in use (if any). It may relate.

 

The obvious ideal solution is to have a backup.

 

Assuming you retain as CCP, validation of critical limits is routinely required. If > a PRP, validation maybe Yes/maybe No depending on Standard.

 

Not a user of X-ray but In my analogous experiences of justifying having no MD, auditorial acceptance  ( and particularly if XYZ had previously been in use) will relate to (a) any referential justifications (b) supporting  history based on result records, (c) "best practice" considerations, (d) preliminary implemented screening controls, (e) auditor experiences with other analogous processes.

 

Just as a worst case example, if (e) happens to be positive for the presence of X-ray detector, eg it's the usual set-up, can expect "no have" to be a difficult "sell". And the converse.


Kind Regards,

 

Charles.C


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Jorge Manzanero

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Posted 26 October 2021 - 07:07 PM

I think, you should revise your foreign material control program to switch from x-ray to visual inspection. Even if it's a temporary measure, you'll need to have a written program, procedures, instructions, records, etc. Don't forget to re-train your personnel accordingly. No, it's not a GFSI requirement as far as I know. The idea is to CONTROL foreign matter, but it's up to you how you do it.

Thank you. These cover the steps we have taken.



Jorge Manzanero

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Posted 26 October 2021 - 09:50 PM

Hi Jorge,

 

You omitted to mention which GFSI-recognized Standard is in use (if any). It may relate.

 

The obvious ideal solution is to have a backup.

 

Assuming you retain as CCP, validation of critical limits is required. If > a PRP, validation maybe Yes/maybe No depending on Standard.

 

Not a user of X-ray but In my analogous experiences of justifying having no MD, auditorial acceptance  ( and particularly if XYZ had previously been in use) will relate to (a) any reference justifications (b) supporting  history based on result records, (c) "best practice" considerations, (d) preliminary implemented screening controls, (e) auditor experiences with other analogous processes.

 

Just as a worst case example, if (e) happens to be positive for the presence of X-ray detector, can expect a difficult "sell". And the converse.

Thanks, at the moment to be HACCP Compliant.



Charles.C

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Posted 26 October 2021 - 11:13 PM

Thanks, at the moment to be HACCP Compliant.

Hi Jorge,

 

Sorry but I don't quite understand what the above means ? Probably should be a verb in there somewhere. :smile:

 

Frankly, from a control POV, I would have said that obtaining a backup is the first priority. Rental ? 2nd-Hand ?

 

Or perhaps X-Ray should never have been implemented in the 1st Place. Justified, customer requirement, showpiece ?

 

PS - ^^^ OK, I got it. Needs insertion of "requirement is". That was the point of course.


Kind Regards,

 

Charles.C





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