2.3.1.2 Fulfilling product validation requirements - HELP!

Hello,

We are in the process of starting up a new feed/food processing facility, and plan to attempt SQF Level 2 certification as soon as possible.

According to SQF Code 2.3.1.2,  "Product formulation, manufacturing processes and the fulfillment of product requirements shall be validated by facility trials, shelf life trials and product testing."

I am not sure how to fulfill this requirement.

We are going to be producing oat groats (simply taking whole oats and knocking the hull off to leave only the groat), and then using those groats to make steam-rolled oats (literally just oat groats and steam).

This is a very low-risk product and process, as nothing is intended to be, or labeled as, RTE.

I am struggling to figure out how we can fulfill this requirement...breaking down the parts of the code:

"Product formulation" - we simply don't have any formulation.  It's just steamed oats, with nothing else added.

"Manufacturing process" - our process is very simple, and except for the de-hulling and steaming process steps, the rest of the process flow is simply storage, sizing and cleaning steps.

"Fulfillment of product requirements" - we'll do on-site testing for physical characteristics and mycotoxin levels.  I have excellent peer-reviewed documentation that shows we don't need to do microbiological testing on the product.  So, unless we get a customer that wants something more, that's all we're going to do.  So, this constitutes "product testing"...but how do I validate that?

Shelf-life trials" - we have NO need for shelf-life trials, as this is a product that's been made for hundreds of years, so we don't need to re-invent the wheel...do we??

"Facility trials" - is this just observing the process we're currently going through, which is basically testing and fine-tuning the system before we actually flip the switch to go live and produce saleable product?  Otherwise, we have no need to conduct any facility trials beyond that.

Any help or experienced opinions/thoughts would be most appreciated!!

Thanks,

Brian

Hi Brian,

I am sure based on the information given that you will cover most of the requirements off in your commissioning phase.

Some relevant parts from SQF 2.3.1 Implementation Guidance

'New products and revisions to existing products are generally developed in the food research laboratory or at best, in pilot scale. However, commercially produced products are likely to have more process variability than bench or pilot products.
The supplier must have a procedure in place to ensure the safety and quality of products escalated from bench/pilot scale production to full commercial production. This will include a food safety and quality plan for new or revised products, shelf-life trials and validation, label declarations, allergen cross-contact trials, raw material, ingredient and packaging trials.
As the product is being prepared for transition from pilot or test phase to commercial production, any new processes, equipment, additional handling, new packaging or storage conditions must be reviewed with identification of any possible food safety or food quality risks associated with new conditions. These risks must be assessed, and adjustments made to food safety and food quality plans prior to implementation.
Any adjustments to food safety or food quality plans must be validated and verified by the SQF practitioner prior to commercial production of the subject product.'

So in the first place you will have defined food safety and quality plans to check the trial products against. I would still be checking product at end of life to verify/confirm it meets your defined product requirements at end of life.

Your main risks appear to be quality of raw material, deterioration of raw material in storage, contamination from elements in the steam, contamination from foreign bodies and deterioration of finished product such as water ingress and mold growth. Your trials should be confirm any risks are adequately controlled.

Kind regards,

Tony

Good insight, Tony...thanks for your input, I think you're right.

Much appreciated!

Brian