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Validation Study for OPRP - Sieving Process


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#1 Elyss Justo

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Posted 24 February 2020 - 03:24 AM

Hi,

 

Do you have any samples for Validation of OPRP - Sieving?

We are using a filter screen (manually visual inspection) for controlling the physical contaminants originated from raw materials such as tapioca pearl and beans. I assessed this as on OPRP since we still have a QC Table Inspection as final control for physical contaminant but I don't know how to validate this. We are implementing FSSC 22000.

 

Please help.

 

Thanks a lot!



#2 Tony-C

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Posted 24 February 2020 - 05:26 AM

Hi Elyss,

 

:welcome:

 

Welcome to the IFSQN forums.

 

First of all I would suggest changing your username from your email address as you may find yourself getting some spam.

 

As I understand it, you are using manual screening by visual inspection as a control measure to prevent physical contaminants. This might be quite difficult to validate unless it is recommended in an Industry Code of Practice as an acceptable control measure (which I doubt).

 

Are you not filtering with a sieve at all?

 

Kind regards,

 

Tony



#3 Elyss Justo

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Posted 24 February 2020 - 05:45 AM

Hi Tony,

 

We're using a sieve (3.5x2.5mm mesh) to filter the foreign materials originated from the raw mats. Do you have any idea how to validate our OPRP?

 

 

Thanks!


Edited by Elyss Justo, 24 February 2020 - 05:47 AM.


#4 Tony-C

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Posted 24 February 2020 - 06:39 AM

Hi Elyss,

 

A 2.5mm x 3.5mm sieve seems reasonable. Are any of your products intended for special groups?

 

I use FDA Guidelines in the absence of Industry Accepted standards: CPG Sec. 555.425 Foods, Adulteration Involving hard or Sharp Foreign Objects

 

This is for seafood but contains useful additions: https://seafood.oreg...arp-objects.pdf

 

Kind regards,

 

Tony



#5 Elyss Justo

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Posted 24 February 2020 - 06:45 AM

We belong to Ethnic food products – Sweet preserves.

In validation, can I use the records of found contaminants on finished goods?



#6 mahantesh.micro

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Posted 24 February 2020 - 07:25 AM

HI,

attached documents may be helpful



#7 Elyss Justo

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Posted 24 February 2020 - 07:31 AM

Hi mahantesh.micro,

 

There is no attachment on your post.



#8 mahantesh.micro

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Posted 24 February 2020 - 08:06 AM

Sory missed out.

Attached Files



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#9 Charles.C

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Posted 24 February 2020 - 08:06 PM

Hi,

 

Do you have any samples for Validation of OPRP - Sieving?

We are using a filter screen (manually visual inspection) for controlling the physical contaminants originated from raw materials such as tapioca pearl and beans. I assessed this as on OPRP since we still have a QC Table Inspection as final control for physical contaminant but I don't know how to validate this. We are implementing FSSC 22000.

 

Please help.

 

Thanks a lot!

 

Hi EJ,

 

haccp status of Sieves is always a contentious issue.

 

There is an (iso) possibilty of PRP, CCP/OPRP.

 

Offhand I suggest the choice is likely to be PRP or OPRP since I anticipate you are unlikely to achieve real-time monitoring in case of a CCP/OPRP.

 

Whether PRP or OPRP may relate to yr specific flowchart which is unknown.

 

A choice of PRP will clearly resolve yr problem.

 

if OPRP, I suggest that the action criterion for sieve may be integrity/construction of mesh, ie broken or not ? (there is a Codex procedure which uses a metal detector to confirm effectiveness of sieve but I anticipate that you have no MD).

 

See -

 

https://www.ifsqn.co...ccp/#entry23187

https://www.ifsqn.co...sc/#entry109374

https://www.ifsqn.co...sc/#entry109374

https://www.ifsqn.co...rp/#entry133208


Kind Regards,

 

Charles.C


#10 Tony-C

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Posted 25 February 2020 - 05:12 AM

We belong to Ethnic food products – Sweet preserves.

In validation, can I use the records of found contaminants on finished goods?

 

Hi Elyss, That information would be useful as would sieve analysis to show that it is removing foreign bodies larger than 3.5mm.

 

Hi EJ,

 

haccp status of Sieves is always a contentious issue.

 

There is an (iso) possibilty of PRP, CCP/OPRP.

 

if OPRP, I suggest that the action criterion for sieve may be integrity/construction of mesh, ie broken or not ? (there is a Codex procedure which uses a metal detector to confirm effectiveness of sieve but I anticipate that you have no MD).

 

 

I agree Charles but if the hazard of foreign body contamination is judged to be significant then it is likely to be a CCP or OPRP. 

 

8.5.2.4.1 Based on the hazard assessment, the organization shall select an appropriate control measure or combination of control measures that will be capable of preventing or reducing the identified significant food safety hazards to defined acceptable levels.

The organization shall categorize the selected identified control measure(s) to be managed as OPRP(s) (see 3.30) or at CCPs (see 3.11).

 

As you have indicated Charles, the feasibility for establishing limits, monitoring and taking corrective action need to be taken into consideration:

 

8.5.2.4.2 In addition, for each control measure, the systematic approach shall include an assessment of the feasibility of:

a) establishing measurable critical limits and/or measurable/observable action criteria;
b) monitoring to detect any failure to remain within critical limit and/or measurable/observable action criteria;
c) applying timely corrections in case of failure.
 
So:
a) in place and intact 
b) @ start and end of production run
c) corrections in case of failure - end of production run - all product on hold
Would in this scenario indicate an OPRP.
 
I do see a scenario where filtration could be a CCP but this would be for liquids where the pressure across the filter is constantly monitored and confirms it is in place and intact.
 
Kind regards,
 
Tony


#11 Elyss Justo

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Posted 26 February 2020 - 02:25 AM

Hi All,

 

Thanks for the information.

 

Yes

 

 

Hi Elyss, That information would be useful as would sieve analysis to show that it is removing foreign bodies larger than 3.5mm.

 

 

I agree Charles but if the hazard of foreign body contamination is judged to be significant then it is likely to be a CCP or OPRP. 

 

8.5.2.4.1 Based on the hazard assessment, the organization shall select an appropriate control measure or combination of control measures that will be capable of preventing or reducing the identified significant food safety hazards to defined acceptable levels.

The organization shall categorize the selected identified control measure(s) to be managed as OPRP(s) (see 3.30) or at CCPs (see 3.11).

 

As you have indicated Charles, the feasibility for establishing limits, monitoring and taking corrective action need to be taken into consideration:

 

8.5.2.4.2 In addition, for each control measure, the systematic approach shall include an assessment of the feasibility of:

a) establishing measurable critical limits and/or measurable/observable action criteria;
b) monitoring to detect any failure to remain within critical limit and/or measurable/observable action criteria;
c) applying timely corrections in case of failure.
 
So:
a) in place and intact 
b) @ start and end of production run
c) corrections in case of failure - end of production run - all product on hold
Would in this scenario indicate an OPRP.
 
I do see a scenario where filtration could be a CCP but this would be for liquids where the pressure across the filter is constantly monitored and confirms it is in place and intact.
 
Kind regards,
 
Tony

 

Hi All,

 

Thanks for your all your reply.

 

I included the scenario that Tony mentioned on my OPRP Plan, however i don't know how can i validate the effectiveness of this plan. We have a monitoring of finished goods wherein all contaminants found were listed. What are the information needed on my validation study?



#12 Elyss Justo

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Posted 26 February 2020 - 02:44 AM

I attached here the sample i made for validation study of our OPRP, what im missing?

Attached Files


Edited by Elyss Justo, 26 February 2020 - 02:50 AM.


#13 Tony-C

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Posted 26 February 2020 - 05:46 AM

Hi Elyss,

 

So you are saying that you have analysed all those batches of finished product and only found - Sack 2.5mm and Chipped off paint 0.4mm?

I would have recorded the batch sizes and what was retained on the filter screen.

 

Kind regards,

 

Tony



#14 Elyss Justo

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Posted 26 February 2020 - 06:06 AM

Hi Tony,

 

In the table, i am talking about the finished goods that are visually inspected. This is the only point where i can validate the effectiveness of sieving, right? 

And yes, i recorded the contaminants found during sieving. Do you think it is enough to validate the OPRP?



#15 Charles.C

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Posted 26 February 2020 - 07:46 AM

Hi Tony,

 

In the table, i am talking about the finished goods that are visually inspected. This is the only point where i can validate the effectiveness of sieving, right? 

And yes, i recorded the contaminants found during sieving. Do you think it is enough to validate the OPRP?

 

 I am bit unclear as to where you use the (3.5 x 2.5 mm) sieve mentioned within the actual process flow ?

 

The validation is ideally done on a trial process scenario and typically requires (a) justification of an appropriate mesh size from a hazardous safety POV (b) evidence of effectiveness, (c) evidence of maintenance of  integrity of mesh.

 

As already noted in post3, size for (a) is not unreasonable unless, perhaps, intended consumer is "vulnerable" , eg children.

(c) appears justified from  yr Table.

(b) as Tony mentioned, useful to record sample size tested/retained/passed extraneous material(s) size/weight.

 

Here is an example of a  Procedure to illustrate a (basically) similar approach -

 

Attached File  sieve validation.pdf   77.07KB   50 downloads


Edited by Charles.C, 26 February 2020 - 09:07 AM.
added

Kind Regards,

 

Charles.C


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#16 Elyss Justo

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Posted 26 February 2020 - 08:42 AM

Hi Charles,

 

We are using as manual sieve/sorting by hand.



#17 Charles.C

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Posted 26 February 2020 - 09:05 AM

Hi Charles,

 

We are using as manual sieve/sorting by hand.

 

thks, pls see the modified post 15


Kind Regards,

 

Charles.C


#18 baltanakts

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Posted 05 March 2020 - 04:56 PM

Hi Tony,

We're using a sieve (3.5x2.5mm mesh) to filter the foreign materials originated from the raw mats. Do you have any idea how to validate our OPRP?


Thanks!

We produce liquid eggs products and we have 4 inline sieves (DRILLED SIEVES) .every filling line has such sieve. Hole diameter 1 mm.
And...we dont need x-ray and dont need metal detector.

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