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X-ray as CCP point


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kuokht

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Posted 21 February 2013 - 02:11 PM

I am working with my contract manufacturer to developed their CCP point.
Theirs line are equipped with X-ray inspector after the product are packed into the primary packaging for foreign material detection.
Although their line are fixed with the x-ray inspector, the inspector was not their ccp. They reason given is they afraid if the x-ray inspector broke down,their don't have spare or expert to repair the inspector and will cause the line can't run the production.
My question is
1.is the inspector must be a ccp? They line was installed with siever and metal detector before cooking, I assume the likelihood of the presence of FM will be very low.
2.can the production continue if the x-ray inspector broke down? My proposal to them is put it as ccp, if it broke down, they can still run the production, but do more intensive sampling on FM inspection.Is this practice allowed?

Thanks you for your advice.
Peter



Tony-C

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Posted 21 February 2013 - 03:42 PM

I am working with my contract manufacturer to developed their CCP point.
Theirs line are equipped with X-ray inspector after the product are packed into the primary packaging for foreign material detection.
Although their line are fixed with the x-ray inspector, the inspector was not their ccp. They reason given is they afraid if the x-ray inspector broke down,their don't have spare or expert to repair the inspector and will cause the line can't run the production.
My question is
1.is the inspector must be a ccp? They line was installed with siever and metal detector before cooking, I assume the likelihood of the presence of FM will be very low.
2.can the production continue if the x-ray inspector broke down? My proposal to them is put it as ccp, if it broke down, they can still run the production, but do more intensive sampling on FM inspection.Is this practice allowed?

Thanks you for your advice.
Peter


Hi Peter,

:welcome:

Some more information on the product and the process would be useful & ultimately what they are aiming to remove using the X-ray inspector.

Regards,

Tony


john123

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Posted 21 February 2013 - 04:05 PM

If it's deemed a CCP, I think your customer would have a hard time justifying skipping it or bypassing it at any point. Compare it to a place that uses a cooking process as a CCP to eliminate micro, there's really no reason they should skip it if it were to break down. Moreso, when a CCP breaks down during a production run there is typically a shutdown and a method of reworking or discarding potentially failed material (i.e. if your md fails to reject a test piece, you rework all the product produced since the last successful test).

You say they have sizing and MD prior to cooking. What happens after cooking? Is the product immediately packaged? Is it conveyed or stored post cooking in any manner that could introduce FM? I think if the risk is low, you're typically not going to end up with a CCP step later in the process.

Might be nice as a regular control point, especially from the quality standpoint.



Charles.C

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Posted 21 February 2013 - 04:09 PM

I am working with my contract manufacturer to developed their CCP point.
Theirs line are equipped with X-ray inspector after the product are packed into the primary packaging for foreign material detection.
Although their line are fixed with the x-ray inspector, the inspector was not their ccp. They reason given is they afraid if the x-ray inspector broke down,their don't have spare or expert to repair the inspector and will cause the line can't run the production.
My question is
1.is the inspector must be a ccp? They line was installed with siever and metal detector before cooking, I assume the likelihood of the presence of FM will be very low.
2.can the production continue if the x-ray inspector broke down? My proposal to them is put it as ccp, if it broke down, they can still run the production, but do more intensive sampling on FM inspection.Is this practice allowed?

Thanks you for your advice.
Peter


Dear kuokht,

I agree with Tony-C's query. My comments might depend on response to his query.

1.(a) Regarding CCP or not, a textbook answer is that it depends on yr haccp risk assessment, eg is the FM a significant hazard?, if so where is it (fully?) controlled? What do the operational results show ?

In practice, if the XRD is located at end of packing line, many haccp plans will automatically set it as CCP (assuming that it is fully capable of controlling the "hazard"). And many (probably most) auditors will probably agree. Especially if you determine yr CCP via the Codex tree.

(b) Alternatively, it is theoretically possible to interpret the detector as an initial validation stage for a previous control step, eg sieving, and then for haccp verification purposes, eg see pg13 of attachment below. Depends also on the actual results of course. You may have an argument from the auditor.
(attachment coming soon, upload not working at this moment for me :smile: )
(file can be found [1st attachment] here -
http://www.ifsqn.com...indpost&p=56871 }

2. If a CCP’s associated control measure, eg a functioning XRD, totally fails, the logical corrective action IMO is to stop the line, service / repair / adjust / revalidate the XRD and segregate (for off-line re-testing) any product “passed” since the previous (satisfactory) machine validation check.
(Obviously if you have a spare XRD, the line could be diverted.)

Rgds / Charles.C

Kind Regards,

 

Charles.C


moskito

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Posted 02 March 2013 - 02:07 PM

Hi,

I agree with Charles C.
No auditor and no authority will accept production if a CCP is out of order. In your risk analysis you have demonstrated that it is necessary to have this equipment to reduce foreign body risk to an acceptable level.
I don't see a difference in using sieves, MD or x-ray - if the equipment is defect you have to stop the line.
We are using x-ray for in-process-controls. Each line ends with MD (bakery). I have had similar thought while thinking about stability of x-ray equipment. Today I would say that our equiment runs with similar stability.
Do you have an additional MD which is used e.g. for reexamination/-anlysis of products thrown out? We have such equipment to do such examinations in each plant.
Perhaps it can be an idea to put an alternative root (x-ray or MD) into the risk analysis. So if the technical surrounding fits (e.g. belts etc.) it is possible to switch to another continuous control.

moskito






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