Process validation
Hi all,
I am a fresh graduate and a newbie in this industry. Currently, i'm working in frozen food industry. My job scope is related to the process validation. However, no guidance given to me, so i'm truly clueless. Therefore, i just proceed to follow the format and ways of previous process validation but the method of the validation being carried out and the report writing seems to be lacking.
Based on the previous OPRP validation for primary packaging, it was done by placing 3 pieces of plastic packaging into the whole stack of plastic packaging with similar to each other in terms of colour and product name, but the allergen info was different. The observation was done for triplicate determinations with printing staffs. I wonder is this the correct way of carry out this OPRP validation? Are there other OPRP validation? I tried to search for more journal and example but mostly not the same as what done above and not that helpful for me to understand and refer...
Meanwhile for the steaming, blanching and frying validations, what have been done now was inserted data logger into the thickest product, shortest time (steaming, frying) or lowest temperature (steaming, blanching, frying) at coldest point in one selected machine (steaming chamber, blanching tank or frying machine), then done for the triplicate determinations and sending sample for microbiological testing. Is this the proper way? Should the validation have done for every machines? Is the triplicate data enough to prove the data is truly validated? Is the validation done on the thickest product enough to represent all other products? Or it is better to done for others?
I have consulted my manager all above, but he said it's all okay as long as follow what the previous have been done...
I wonder all above suit for FSSC, VHM and EU audit...
Thank you.
Sincerely,
Yuna
Hi all,
I am a fresh graduate and a newbie in this industry. Currently, i'm working in frozen food industry. My job scope is related to the process validation. However, no guidance given to me, so i'm truly clueless. Therefore, i just proceed to follow the format and ways of previous process validation but the method of the validation being carried out and the report writing seems to be lacking.
Based on the previous OPRP validation for primary packaging, it was done by placing 3 pieces of plastic packaging into the whole stack of plastic packaging with similar to each other in terms of colour and product name, but the allergen info was different. The observation was done for triplicate determinations with printing staffs. I wonder is this the correct way of carry out this OPRP validation? Are there other OPRP validation? I tried to search for more journal and example but mostly not the same as what done above and not that helpful for me to understand and refer...
Meanwhile for the steaming, blanching and frying validations, what have been done now was inserted data logger into the thickest product, shortest time (steaming, frying) or lowest temperature (steaming, blanching, frying) at coldest point in one selected machine (steaming chamber, blanching tank or frying machine), then done for the triplicate determinations and sending sample for microbiological testing. Is this the proper way? Should the validation have done for every machines? Is the triplicate data enough to prove the data is truly validated? Is the validation done on the thickest product enough to represent all other products? Or it is better to done for others?
I have consulted my manager all above, but he said it's all okay as long as follow what the previous have been done...
I wonder all above suit for FSSC, VHM and EU audit...
Thank you.
Sincerely,
Yuna
Hi Yuna,
Sorry but it is unclear what you are specifically trying to validate.
I am guessing CCPs/CLs as in ISO-HACCP but there is no mention of such elements.
If so, you will likely need some technical awareness as to HACCP vis-a-vis fssc22000.
Please clarify.
PS - "VHM" = ?
Hi Charles, C,
Yes. It's about CCP validation. VHM is "Veterinary Health Mark" issued by Department of Veterinary Services Malaysia.
Hi Charles, C,
Yes. It's about CCP validation. VHM is "Veterinary Health Mark" issued by Department of Veterinary Services Malaysia.
Hi yuna,
Thks feedback.
To enable comment on Validation will likely need to know some process detail,eg -
an idea of the individual process flow stages, the designated CCP-CLs/OPRPs, the storage requirements and whether final product is RTE or not.
I deduce you are seeking certification to fssc22000.
To illustrate the haccp procedure you can see a model example of a hazard analysis (for fssc22000) to evaluate CCPs/OPRPs for manufacturing yoghurt here -
Generally speaking, a CCP validation study needs more than 3 sets of data to make a determination as a VALIDATION
particularly where a kill step is the CCP
Yes, you need to validate each machine by taking repeated sampling and then analyzing the data to determine the process WILL NOT FAIL the CCP (and then you create deviation procedures for when it does)
And since you mentioned a VHM, are you processing meat?
... inserted data logger into the thickest product, shortest time (steaming, frying) or lowest temperature (steaming, blanching, frying) at coldest point ... Is the validation done on the thickest product enough to represent all other products? Or it is better to done for others?
...
The goal of that approach is to test and sample under the most challenging circumstances, or those parameters that are the least likely to achieve lethality (or whatever the CCP pass/fail criteria is).
For example, if you can achieve the minimum acceptable temperature in the part of the product that will be the coldest because it is thickest and placed in the coldest part of the fryer, you can reasonably presume that the thinner pieces of product in the hotter areas will also be acceptable.
You could replicate the study for the high end if there was reason to believe it could produce unacceptable safety or quality risks.
...
Yes, you need to validate each machine ...
I would argue that part. If you have ten of the same model fryer and have records for their maintenance and calibration, one fryer validation study should apply equally to them all. If it didn't, it would imply that either the equipment was out of spec or the sampling criteria above wasn't well chosen.
Hi yuna,
Thks feedback.
To enable comment on Validation will likely need to know some process detail,eg -
an idea of the individual process flow stages, the designated CCP-CLs/OPRPs, the storage requirements and whether final product is RTE or not.
I deduce you are seeking certification to fssc22000.
To illustrate the haccp procedure you can see a model example of a hazard analysis (for fssc22000) to evaluate CCPs/OPRPs for manufacturing yoghurt here -
Hi Charles,
Basically, the products (fish and fisheries product and meat product) in this company undergo:
weighing --> mixing --> forming --> setting --> frying (CCP, ≤75 celsius) --> cooling --> freezing (CCP, ≤-18 celsius) --> packing --> metal detection (CCP) --> secondary packing --> storage (frozen)
The final product is not RTE product.
Yes, currently seeking for the FSSC certification and also planning for BRC application.
≥Generally speaking, a CCP validation study needs more than 3 sets of data to make a determination as a VALIDATION
particularly where a kill step is the CCP
Yes, you need to validate each machine by taking repeated sampling and then analyzing the data to determine the process WILL NOT FAIL the CCP (and then you create deviation procedures for when it does)
And since you mentioned a VHM, are you processing meat?
Hi Scampi,
Noted and thanks.
Yes. This company is producing seafood product (surimi, squid and prawn) and meat (chicken).
The goal of that approach is to test and sample under the most challenging circumstances, or those parameters that are the least likely to achieve lethality (or whatever the CCP pass/fail criteria is).
For example, if you can achieve the minimum acceptable temperature in the part of the product that will be the coldest because it is thickest and placed in the coldest part of the fryer, you can reasonably presume that the thinner pieces of product in the hotter areas will also be acceptable.
You could replicate the study for the high end if there was reason to believe it could produce unacceptable safety or quality risks.
I would argue that part. If you have ten of the same model fryer and have records for their maintenance and calibration, one fryer validation study should apply equally to them all. If it didn't, it would imply that either the equipment was out of spec or the sampling criteria above wasn't well chosen.
Hi G M,
Thanks for the infos. :spoton: