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This month, Derek looks at death and illness, regulations, audits, and the unfortunate consequences of ‘winging it’!

Derek Richardson, International Sales Director for The IMC Group
Derek Richardson, International Sales Director for The IMC Group

The Foods Standards Agency says that around one million people suffer a foodborne illness each year, with around 20,000 people receiving hospital treatment and 500 dying. The cost of this is apparently in the order of £1.5 billion.

Globally, of course, the figures are massive – in the US alone, 48 million people fall ill each year to foodborne diseases such as Salmonella and Listeria Bacteria.

Professor Elliott’s recently published review into the integrity and assurance of food supply networks unfortunately highlighted cold storage and transportation as being weak links in the supply chain, although Chris Sturman, CEO of the FSDF (Food Storage & Distribution Federation) strongly disagrees, but this has put the regulator’s spotlight on the industry yet again.

Safety is critical for all of us in logistics. And we have to pass daily tests to prove we’re good enough. But if we don’t make even a small profit as well each day then the business will fail, so the cost of those tests is a second critical factor we can’t ignore! Unfortunately, cutting too many corners can cause big problems.

Although food regulations are strict, they could be worse. When I work with pharmaceutical industry customers we have 2,500 pages of validation paperwork to get through. It falls into a thing called 21CFR part 11 which is a FDA (Food and Drug Administration) regulated environment. Fines can range from millions into billions so you don’t upset the FDA that’s for sure!

It is not uncommon for companies to be fined substantial amounts for what appear to be minor breaches of regulations. Fines can range from tens of thousands to many millions.

I share the frustration of food logistics managers who often tell me about – let’s be honest here -overworked and under-trained environmental health inspectors who struggle to properly understand and interpret their own rules and make decisions based on what they ‘discover’ from poking around with some naff eBay-quality thermometer. Ok, so it’s probably not quite that bad… or is it?

While I obviously can’t mention names, I’ve just got back from Europe where we’ve been installing a system in a distribution warehouse. It was all last-minute stuff, where their client needed an FDA compliant monitoring system installed ‘yesterday’.

We hit the deadline and the auditors moved in to check the system, and look at the IQ (Installation Qualification) and OQ (Operating Qualification) documentation. Fortunately for the customer, our system and the software meets all the necessary audit requirements so it will be signed off just in time to move in.

This is a big warehouse, they will be shifting thousands of items a day, pre-packaged all ready to go out. So our essential monitoring centres on temperature and humidity, cold rooms and chiller rooms.

Why was this job all last-minute? Well, amusingly (to me at least!) the facilities people had initially contacted another firm who claimed they could monitor to full validated compliance, including paperwork and software. Now I know that we have a full time technical author and the last part of the paperwork for the Synergy system took seven months to write, with 2,500 pages on software testing alone.

So when I was told that the other firm’s entire workbook was 100 pages long it was easy to see why it was an obvious audit fail. Well, obvious to me. But when you’re a busy stressed logistics boss trying to get a new facility open you probably tend to take people on trust about what they promise, so I can see why they got themselves into this mess. Fortunately we got it all sorted for them just in time and on budget. But maybe if I were choosing a system I’d start by asking myself the question ‘What are the consequences to my business if this system fails the audit?’ before I got too involved and wasted precious time.

Calibration

A reader called me last week to talk about calibration. A lot of people think calibration means adjustment. It doesn’t; calibration actually means checking against the reference.

So we run the system at various temperatures and humidities and set everything against the references. Then we list out exactly what everything is doing against those references. It’s very labour intensive, but without a calibration certificate, what’s the consequence to your business? When an auditor comes along and sees your ‘fridge the first thing he will say is “I need to see your calibration certificate.”

For example, he is going to want to know ‘was that particular instrument reading +0.5C or – 0.5C’?  Pharmaceutical chilled storage is between 2 and 8C, some things are damaged below 2C and certainly below zero; other things above 8C.  The key point is that if you say the accuracy is +/-0.5C and the fridge is at 7.9 and you don’t have a calibration certificate you can’t possibly know if the readings are in spec or not.  It’s the uncertainty that they don’t like and everything in the ‘fridge would be subject to scrutiny. ! It is that critical…

So perhaps you see why I recommend calibration certificates!

In a nutshell – there’s no room to ‘wing it’ and talk your way out of trouble these days. So take the easy route in the long run – get an approved system with the validation done and when the audit happens you will sail through.

Derek Richardson is International Sales Director for The IMC Group

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