This article is written to meet the following sections of the Standards:
|BRCGS Food Safety Issue 8||No direct reference|
|BRCGS Packaging Issue 6||4.7.4 Revalidation of equipment|
|BRCGS Agents & Brokers Issue 2||Not applicable|
|BRCGS Storage & Distribution Issue 4||6.1.4X Changes to equipment|
|FSSC22000 Version 5.1||ISO 22000:2018 6.3 Planning of changes|
|IFS Food Version 7||4.17.5 Equipment change control|
|SQF Edition 9||No direct reference|
Change control – what is it?
A change control system ensures that any changes are thought through and approved before they happen. This allows any actions that are needed, to manage the change, to take place – before the change is put in place.
For example, let’s take the change of a material supplier. Your procurement team decides to buy a material from a new supplier. It’s a like-for-like swap – so no big deal? Wrong.
That means that all the stock management systems need to know to run out the old stock from the previous supplier and then move onto the new material. The codes may need to be different, so it’s clear when that change happens. The goods-in team need to know that the delivery will be coming from a new supplier. The technical team need to approve the new supplier. The operations team need to get a sample in to make sure it performs the same. The product safety team need to check that there are no new hazards. The specifications team need to update customer specifications. And so on.
What the Standards say
In our opinion, change control is a huge gaping hole in all of the Standards. And it wouldn’t take a lot to fix it. We have most of the aspects of a change control system, but what we’re missing is the pre-emptive mindset. We’ll come onto that in a minute. But first – let’s look at what the Standards, do and don’t say about change control.
The interpretation of clause 4.7.4 is about revalidation of equipment following maintenance work and that sites should consider their ‘maintenance and change management procedures’.
BRCGS Storage & Distribution
The interpretation of clause 6.1.4X says that updates should be made to manuals and schematics when changes are made to equipment.
Clause 4.17.5 says that where changes happen to equipment, that the process must be reviewed, to ensure that customer requirements are met.
Funnily enough, the ISO Standard is the only one that has a section about change control. It’s funny, because the ISO Standard is the only one that’s not GFSI recognised on it’s own.
It states that when changes occur, including changes to personnel – these must be communicated and that the company must think about the change in 4 ways:
- Why the change is happening and what the consequences are.
- If the change will impact compliance to the Standard.
- If required resource is in place to manage the change.
- Ensure that the responsibilities are clear – so that the change is managed effectively.
BRCGS Food, Agents & Brokers and SQF
None of these Standards talk about change control specifically. However, it’s implied in many places – as systems and documents must be “kept up-to-date”. Without change control, systems and documents inevitably won’t be up-to-date – because the change hasn’t been communicated and so people won’t know to make a change at their end.
Change control procedure
To ensure that a robust change management system is in place, a procedure must be written which identifies the steps of change and how they must be managed.
The first part of the procedure needs to identify what a change is – so that the right people can be involved in the change management.
How change is going to be communicated is a huge aspect of an effective system. A change may impact your role, but if you don’t know about it, you won’t know to do anything about it.
To develop a good change control system, you’ll need to include all relevant parties. This may take some time, but it’ll definitely be worthwhile and save the company a huge amount of time, money and stress for everyone involved.
The change management procedure must also control changes to digital data. The document control section of the Standards expects digital data to be secure so it can’t be changed by anyone who’s not authorised. And that changes must be recorded and approved before they’re implemented.
If engineering work takes place on validated equipment, the change management process must consider if the equipment needs to be revalidated before it’s used. This is really important where equipment that manages Product Safety Controls is used. For example, ovens that are used for cooking, or blast chillers that are used to chill product.
Records must be kept of changes. This must include what amendments have been made, why, when, how, who was involved in the review and who gave the final approval. This includes schematic plans and equipment used.
Where validated equipment is involved in a change, then the records must also detail the results of the revalidation, or – justification as to why revalidation wasn’t necessary.
Finally, we said we’d talk about the pre-emptive mindset. To help to explain pre-emptive, let’s look at few other terms first.
To be reactive, means that you react to something that’s already happened. You have to take action when something goes wrong. Most of us know this as firefighting.
A reactive action is a corrective action.
The opposite of reactive is to be proactive. This means you act before something has happened. Typically, to prevent it going wrong.
A proactive action is a preventive action.
This is where you use data to help you predict the future. Horizon scanning is a form of predictive behaviour.
Quality control systems, which track when the product is starting to go out of specification is another example. This allows you to see that the product is going to be out of specification if action isn’t taken.
Trending of KPIs is another good example – where you use data to your advantage, to help you to prevent problems from happening.
So, to be reactive – is acting after an event. To be proactive, is to act before the event.
A pre-emptive mindset is to be both reactive and proactive at the same time. It’s bit like the ‘near miss’ philosophy that you find in a H&S system.
It’s about looking at a situation and thinking ‘that was a near miss, we were lucky there – the worst didn’t happen this time, but what could have gone wrong?’
Let’s take an example.
An employee is driving a company vehicle and it’s snowing. The traffic stops in front of them and because of the snow they skid into the vehicle in front. The vehicle is damaged, but the driver is fine.
- A reactive company would fix the vehicle and move on.
- A proactive company may look to only purchase vehicles with anti-lock braking system and/or fit snow chains – to minimise the risk of the accident happening again.
- A pre-emptive company may look at that situation and think – that was lucky, in a different circumstances that person could have been seriously injured or worse. Let’s send all our drivers on an advanced driving course, so they know what to do in poor driving conditions.
Or let’s try a maintenance example.
A ball bearing fails on a piece of equipment and causes product contamination.
- Reactive would be to replace the failed ball bearing.
- A proactive approach would be to find out the life-cycle of the ball bearings that are used (3 years), and put a 2-yearly service contract in place.
- A predictive option would be to apply condition-based monitoring to predict the failure.
- A pre-emptive mindset may look at how often the ball bearings have failed or been replaced in the past 3 years. Using historical data; it could be estimated how much down-time, cost and resource would be needed to manage this option in the future. And look to redirect that investment into retrofitting a more durable bearing or implementing a solution that doesn’t need ball bearings at all.
The above reactive, proactive, predictive and pre-emptive behaviours are often used in what’s called a maturity model. This is because ‘immature’ companies are seen to be working at the lower end of the model – reacting to events. Whereas a mature company with the right type of culture, would work at the upper end of the model – being more proactive and pre-emptive in their approach.
You may be able to see how introducing a maturity model into your company, would be a good action to put on your culture plan. You can use it to identify where you are now and what steps you need to take to move up the model.
If this is a subject you would like to look into further, we would also recommend that you read up about the change curve. It’s a really useful topic to understand if you’re looking to change culture.
Change control is such a huge topic – but we hope we’ve given you a good taster and that you can see why change control is so valuable. And why you should implement it, even if the Standard you work to – doesn’t necessarily say you have to.
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