Validation Study for OPRP - Sieving Process

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 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

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!

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

We belong to Ethnic food products – Sweet preserves.

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

HI,

attached documents may be helpful

Hi mahantesh.micro,

There is no attachment on your post.

Sory missed out.

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

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:

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?

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

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

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?

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 -

sieve validation.pdf   77.07KB   380 downloads

Hi Charles,

We are using as manual sieve/sorting by hand.

Hi Charles,

 

We are using as manual sieve/sorting by hand.

thks, pls see the modified post 15

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!

Do we require an accredited laboratory to validate our sieve

Hello,

    we are using 1 mm sieve for powder sieving  such as (sugar ,green cardamom) i need help how to show the validation for this.