Choose your CAPA wisely – The 5Rs

In the last edition of Quality Rebooted we covered the thorny issue of when is a CAPA not a CAPA. Thank you for all the feedback and I’m sure this debate will rumble on and on.

Leading on, in this edition we are going to look at the different types of CAPA, addressing the tricky issue of what to do when implementing appropriate solutions.?How hard can it be ?

Now not all things in life are equal and that certainly applies to CAPA.

A central concept of risk management is that the risk reduction control measures you apply need to proportionate to the risk of the issue.

Obviously, issues that are likely to cause severe harm - or even death - need proportionate responses and focus to ensure they never happen again. Conversely items that are just minor inconveniences, then you’re not going to boil the ocean, but there is an expectation that you do something.

When contemplating corrective actions you can consider a sliding scale of options, each with a decreasing potential to eliminate the issue from happening again, or in the case of preventive actions not happening at all. I call this the 5Rs.?

In the left-hand side-of-town there are actions which eliminate the issue. Make it go away. Whilst at the other end, you may simply live with the problem and reduce its impact in some way.

As a general rule you should apply CAPA as high up the CAPA effectiveness spectrum as possible, as long as it is both reasonably practical and the effort to implement is proportionate to the risk reduction you need.

These 5RS can be described as:

Removal

Make the potential for the issue to happen again completely go away. For example, error-proofing such as connecting a printer to a balance to eliminate transcription errors.

Replace

Modify the process to reduce potential for errors by redesign. ie: make it simpler.

Refine

Live with the current process, but think of ways to execute the process more effectively eg: visuals / standard work etc.

Recognise

If you cannot easily eliminate the defects / errors from happening, consider ways to recognise and remove these with automated or manual systems.?

Reduce Impact

Think of ways of reducing the impact of the issue. eg: Adding redundancy into the device or process.?

For quality issues that are critical - or related to field actions - you should be considering CAPA that is highly effective on the left-hand side of the spectrum.

And by-the-way training or retraining should never be considered a CAPA in its own right. Ask yourself, is it the individual that needs retraining or is it the process that is unclear and error-prone ??

Taking the above approach isn’t totally dissimilar from the hierarchy of risk control measures described in various risk management standards, such as ISO14971. Your first port of call should be making the device safe by design and manufacture, followed by preventive measures, followed by information. Approach CAPA with a similar mindset. The two QMS subsystems are not so different and have ultimately the same intent: to protect the patient, the business and your compliance standing.

Corrective action is about trying to prevent bad things from happening again. Whilst risk management is about preventing bad things even starting.

So in summary, not all CAPAs are equal, so choose wisely.

This brings me to my top five tips for CAPA.

1: Your correction should address the root cause(s) you identified using the appropriate tools. Didn’t use any tools to get to root cause ? What is a root cause you ask ? Then shame on you. See me after class.

2: Make sure you have the resources lined up to deliver the CAPA. If you as a manager give a CAPA action to a direct report - as a goal or a gift - then give them the time away from their day-to-day job to deliver it, and train them appropriately how to deliver projects. If you can't, then don’t beat them up when it is delivered late or not at all.

As an organisation, don’t take on too much. Consider what you really need to focus on and deliver on this before overloading the system with more.?

3: Make sure that the CAPA is balanced such that it optimally benefits all of the customers of the quality system: end users, your business health and you need to obey regulations and standards.

You don’t just implement CAPA to get a gold star from an auditor, it should also improve your business.

4:??Use eQMS workflows to hard-wire actions and appropriately document items. It will make task delivery more effective and efficient. There are some great systems out there.?

5: Always check your CAPA does what you expected it to do – a sort of post market surveillance for CAPA as it were. More on this in the future.

Most importantly remember a CAPA is your opportunity to make the world a better place. Love it, cherish it, and to make it happen.?

Best regards

matt