SQT Blog

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.

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.

A quick look at the Food Safety Authority website gives information on the latest food allergen alerts.

March 15th – Undeclared peanuts in Polish marshmallow vanilla confectionary.

February 9th – Undeclared wheat and gluten in a batch of Weetabix Oatibix Bites Sultana and Apple

The importance of food companies having a good understanding of food allergen control cannot be over-emphasised. BRC Global Standard for Food Safety Issue 6 emphasises for effective food allergen control.

Our next food allergen course on 17th May will cover:
- European Allergen Legislation
- The severity associated with each allergen
- The labelling requirements for Allergenic foodstuffs
- The Allergen Risk Assessment Process
- The cleaning and validation process
- “May Contain” Labelling guidelines
- Making “Free From” claims

More information here. Contact jfeehan@sqt.ie to make a booking.

Our colleagues in Sligo IT are organising a conference:

QUALITY IN IRELAND 2012
March 30th
Clarion Hotel, Sligo.

Quoting Bob Kennedy, the conference organiser:
It is time to recognise the contribution of the quality management profession to the development of a sustainable economy and society for all of us. This one day conference will stimulate a new debate on the great achievements of quality and the possibilities it offers for a better future. Nine speakers representing most sectors of the economy will lead this debate. I hope you can join us and share your own experiences and wisdom.

Details here

Best of luck with it Bob.

Our next NEBOSH International Certificate in Occupational Health and Safety commences on Monday 26th March.

SQT’s pass rate for this course far exceeds NEBOSH average as shown in the table below.

Full course details here.

SQT’s International Certificate course covers International legal frameworks and codes of practice but also Irish legislation.

Contact jfeehan@sqt.ie or telephone 061 339040 if you wish to reserve a place.

We are holding the 1st Annual Irish Lean Six Sigma Conference on Wednesday March 21st 2012 at the RDS in Dublin.

There will be a great line-up of speakers.

Conference topics include:

Lean Six Sigma in the 21st Century

Designing a public sector for tomorrow: Developing a roadmap for Lean implementation in the Irish Health System to uncover hidden opportunities in our Health Service

Embedding Continuous Improvement into the core of your organisation

Challenges and benefits of implementing Lean Six Sigma in a Commercial Semi State

Lean Healthcare – improving the patient’s experience

Maintaining customer focus, through Lean Six Sigma, in a rapidly changing business landscape

Speakers include:
Sherif Gayed, eBay – Head of Continuous Improvement, eBay European Customer

Padraig Kelly, Rotunda Hospital – Head of Quality, ASST – Tutor

Paul O’Brien, Pfizer – Senior Director, Finance & Business Operations

John McConnell, An Post – Head of QualityServices

Mary Hickey, AMNCH (Adelaide Meath National Children’s Hospital) – Process Improvement Manager

Michael Fahy, Syncreon – Executive Vice President Business Development Technology

The full conference brochure is available here.

The conference cost is €250 which includes Conference Presentations on USB, Lunch and all refreshments.

If you would like to book a place, please email jfeehan@sqt.ie or telephone 061 339040.