Is Scientific Literature Enough for ISO 22000 Validation, or Is Practical Testing Required?

Dear All,

I have a question related to the concept of validation in ISO 22000.
 

As per the definition,

My question is:

Is the required evidence strictly limited to scientific literature, or can it also be based on internal testing?

For example, if I have a scientific reference stating that cooking at temperatures above 75°C effectively reduces microbial hazards, is this reference alone sufficient for validation, or is it still necessary to perform practical validation testing under our actual processing conditions?
 

Your feedback is highly appreciated.
 

Best regards,
Suhaib

I would say both.  You'll want to use the scientific literature to set your parameters, but ultimately you need to validate your process does what you say it does.  Prove internally that the product is fully cooked to that 75C standard using your time/temp parameters for whatever equipment is being used, especially critical if you're using something like an oven or cook equipment that automatically conveys or starts/stops the process.  The literature you reference will need to be specific in all of the microbial hazards from all of your ingredients (including various spices) in order for you to claim the 75C is sufficient for your finished product.

While it is possible to use just outside references to validate your process, you need to follow their materials and methods as exactly as possible.

Most locations will need to do some internal validation to complement external studies, because their product formulation or chemistry is different, they use different equipment, etc.

Hi Suhaib,

Your initial validation should come from external supporting literature if possible. If not available then internal validation is acceptable.

As indicated in the previous posts, most people will carry out internal validation on commissioning as well and the requirement for commissioning is included in FSSC 22000 Part 2 | Requirements for Organization to be Audited Section 2.5.15 EQUIPMENT MANAGEMENT (ALL FOOD CHAIN CATEGORIES, EXCLUDING FII):

In addition to clause 8.2.4 of ISO 22000:2018, the organization shall:

a) Have a documented purchase specification in place,… etc.

b) Establish and implement a risk-based change management process for new equipment and/or any changes to existing equipment, which shall be adequately documented including evidence of successful commissioning. Possible effects on existing systems shall be assessed and adequate control measures determined and implemented.

I posted quite a lot of relevant information in this topic so have a read through that: FSSC 22000 Validation and Verification Procedure Templates and Forms

Also note from ISO 22000:

Note 3 to entry: Distinctions are made in this document between the terms validation (3.44), monitoring (3.27) and verification (3.45):

— validation is applied prior to an activity and provides information about the capability to deliver intended results;

   — monitoring is applied during an activity and provides information for action within a specified time frame;

— verification is applied after an activity and provides information for confirmation of conformity.

3.44 validation

Note 1 to entry: Validation is performed at the time a control measure combination is designed, or whenever changes are made to the implemented control measures.

Kind regards,

Tony