SQT Blog

It is generally accepted that ISO9001 has passed its ‘sell by’ date for the food industry. A number of companies who have been certified to ISO9001 for the past number of years, are converting their certification to FSSC as Food Safety System Certification, (FSSC = ISO22000:2005 and ISO22002:2009), is now seen as more appropriate and more desirable by their customers.

Both ISO9001 and ISO22000 standards have a lot in common however clause 7 of ISO22000, Planning and realisation of safe products, which demands the seven CODEX principles to be addressed, is where FBOs, (Food Business Operators), need to focus their resource to achieve FSSC certification.

The fifteen pre-requisites as defined in ISO22002 are now viewed as the essential food safety foundation which will control the majority of hazards that exist in any food business.

As per FSSC, all control measures which exist in the food business are either:
Prerequisites which prevent hazards from getting onto products, Operational Prerequisites which by and large remove hazards from products, or CCPs, (Critical Control Points) which control the hazard in the product. It is the combination of these three control measures which essentially makes up a company’s FSMS, (Food Safety Management System.)

The most recent FDA Guidance on Process Validation changes the traditional three validation batch approach. One batch okay was lucky, two batches a fluke & three batches a trend. Anyone involved in manufacturing questioned this as the requirement for three consecutive batches meant there was a very narrow window used in the study i.e. less variation in supplier performance, machine factors etc. But three batches used in process validation studies gave some assurance and was achievable in a short time frame. Now we are looking at a statistically valid run number. The challenge is what number of batches is this & when can a validation study be closed. I think we will be using a combination of three batches, annual product review & continual process verification at least where process variability is well defined. This will be harder to determine where biological processes are involved or new innovative technologies. I guess we are saying validation is continuous as we were always checking that we remained in a validated state!

We deliver Process Validation training on both a Public and In-house basis.

Denis Kiely and his team deliver SQT’s food safety training. When not delivering training Denis is a busy man – recipe testing! Sheila, Denis’ wife has just published her first cookery book, ‘Gimme the Recipe’.

Sheila and Denis have six children so there was no shortage of recipe testers. It’s a great cookery book as the recipes are interesting and very easy to follow. The book was published by Mercier Press. More info here.

Well done Sheila!

Quality Ireland emerged in early 2012 from an initiative at the Quality Management Standards Committee hosted by NSAI. Its members come from a variety of backgrounds. It has now set up a LinkedIn group – Quality Ireland.

According to Quality Ireland, their LinkedIn group is a powerful communication network for people who share their vision of “A better Ireland” and support their mission ‘To promote and foster a culture of quality in Ireland to make life better for individuals, communities, organisations and society in general”.

Membership of the Quality Ireland LinkedIn Group is available, on a moderated basis, to people of all backgrounds who would like to support their work.