SQT Blog

The recent revision of the Global Food Safety Standard is perhaps the most significant revision to date where an attempt has been made to simplify the standard yet make it more effective at controlling hazards within the manufacturing environment.

Many people would be very critical of the fact that BRC auditing over the past number of years has focussed too much on the actual documented Food Safety Management System (FSMS) as opposed to getting down onto the factory floor to see what is actually going on. Combine this with the reality that the vast majority of BRC Food Safety audits have been announced, raises questions as to the value of the audit for major UK/Irish and International retailers.

The new unannounced split audit option of:
– Day 1 Factory floor unannounced
– Day 2 Systems audit announced,
allows companies to demonstrate that their manufacturing environment is up to best practice standards every day, and that we have nothing to fear from our customers/certification bodies inspecting us any day. The announced systems audit allows FBOs (Food Business Operators) to demonstrate that they have best practice FSMS, which is effectively controlling the hazards which exist in the manufacturing environment.

When I ask people who attend my HACCP training courses what feeling do you get in your gut when you hear the word HACCP, a nice warm fuzzy feeling, or a knot? The vast majority, be they the most competent technical manager or a production supervisor who is reluctantly sitting in front of me, say a knot. All of these people are responsible, motivated people, who understand the importance of food safety, otherwise they wouldn’t be in their positions. So why does HACCP instil negative feelings in so many people?

The simple answer to this question is that people simply do not understand HACCP … as I didn’t. However my exposure to FMEA, (Failure Mode and Effect Analysis), helped me sort out in my own head what I believe to be the single most important concept in HACCP – failure and the effect of failure. This is one idea that I believe we do not engage enough with in HACCP. To do this, the first thing we must establish is what does failure mean? Failure in my world means ‘loss of control’.

To explore this concept I will take two examples; pasteurisation and metal detection.

Pasteurisation
With pasteurisation if my controls fail i.e, I do not achieve the time/temperature combination, the pathogens that are present in raw milk, will survive. Hence if I lose control i.e., failure, the effect is very significant as the hazard will be present in the finished product.

Metal detection
With metal detection if my controls fail i.e., metal detector malfunctions, the effect of failure is less significant as the likelihood of metal being present in the product in the first place, is low. This does not mean metal detection is not important. It is, but, the risk to public health from metal detection failure is much lower than the risk to public health from pasteurisation failure.

In the case of pasteurisation, the effect of failure is very significant. In the case of metal detection, the effect of failure is less significant. Hence I would call pasteurisation a Critical Control Point (CCP) and metal detection an Operational Prerequisite (OPRP).

To fully understand HACCP one must be able to visually conceptualise it i.e., draw it. Once you can draw it, you will no longer get the knot in your gut!

I have noticed on training courses this year that the recent publication of EN ISO 13485:2012 (Medical Devices – Quality Management Systems – Requirements for Regulatory purposes) is causing some confusion.

ISO 13485 :2003 is still the global standard. This is due for revision sometime in 2015.

The EN version of the standard contains a revised foreward & revised Annexes ZA, ZB & ZC. This is to link the European harmonised version of the standard with the European Directives:
– Annex II & V of Directive 90/385/EEC Active Implantable Directive
– Annex II,V & VI of Directive 93/42/EEC Medical Device Directive, &
– Annex III,IV & VII of Directive 98/79/EC In Vitro Diagnostics Directive.
There is no text difference between ISO 13485:2003 & EN ISO 13485:2012.

Our next training course on ISO 13485:2003 & The Medical Devices Directives is on 22-23 May 2012 in Galway. Please contact jfeehan@sqt.ie or telephone 061 339040 if you would like us to reserve you a place.