In this article we’re going to cover the new fundamental section for Issue 6 – BRC Packaging corrective and preventive action.
OK, first let’s look at what we mean by fundamental. Fundamental means that it’s crucial that you comply. Failing to meet a fundamental section of the standard can result in failure of your audit all together.
What is corrective and preventive action?
Let’s look at what the difference between a corrective action and a preventive action is.
A corrective action corrects the immediate problem. So, if we link it to something like your car, it would be correcting the immediate problem of a break down. So, fixing the fault with your car so it runs again.
A preventive action, prevents the problem from happening again. So, in our car example, this would be routine servicing to stop it breaking down in the first place.
When to use corrective and preventive action
Corrective action must be used for all non-conformances. However, you need to know when to use preventive action, because to apply preventive action you need to carry out root cause analysis.
Root cause analysis
Root cause analysis works out what preventive actions you need to carry out in order to stop the issue happening again. If the problem is a weed, you can rip the weed up and this corrects the immediate problem, as you can’t see the weed anymore. But the root is still there and over time it will grow back.
The only way you can remove the weed for good, is to dig the root of the weed up. So, the preventive action would be to dig up the weed with the root. Then it can’t grow back.
BRC says that root cause analysis needs to be applied whenever there is a non-conformance which puts the safety, legality, quality or integrity of the product at risk. Which is quite vague.
To do root cause analysis properly it takes a lot of time, so we can’t do it on everything. Therefore, we have to define what we mean by ‘puts the product at risk’.
To do this, we define major and critical non-conformances as those that put the product at risk. To understand why, we need to look at the definitions of minor, major and critical:
- A minor is where you find a small failure to something, that is otherwise working OK.
- A major is where you find a failure which has the potential to contaminate the product or cause a defect.
- A critical is where you find a failure that has already contaminated the product or caused a defect.
So, a minor wouldn’t put the product at risk. Whereas a major and a critical would.
Let’s go back to our car example:
- A minor for our car might be a headlight that’s out.
- A major is a car that’s not been serviced and so it’s dangerous and has the potential to cause an accident, but hasn’t yet.
- A critical is a car that’s dangerous and has actually caused an accident.
So, we would apply root cause analysis to major and critical non-conformances.
But, there are other situations where you would need to use root cause analysis too:
- If you see a negative trend – this could be a trend of non-conforming product or complaints for example
- External audit non-conformances
- When inline testing equipment fails
- Following an incident, which includes any withdrawals or recalls
How to carry out root cause analysis
There are a number of well known methods for root cause analysis, such as:
- The 5 whys
- The fault tree
However, we think that none of these methods are flexible enough to work for what we need. And, they don’t explain step-by-step how to carry out root cause analysis. That’s why we developed our own system, which we called Smart Analysis. If you’d like to learn about Smart Analysis, we cover it in our Best Practice Internal Auditing course.
We hope you’ve found that useful, if you have any questions about this subject, please just pop them in the comments box below and we’ll answer them for you. And remember, you don’t need to put your real name in, so you can stay incognito!
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Example Root Cause Analysis
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Root Cause Analysis
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