Here's a mistake!

Talking about mistakes

Every CAPA begins with a failure that requires correction. As the saying goes, you can't make an omelette without breaking eggs. But isn't identifying the mistake in the first place the hardest part of a CAPA?

At the beginning of her career, Amy Edmondson conducted a study into medication errors in hospitals. As she describes in her book The Fearless Organisation, her hypothesis was that the most effective teams would make the fewest mistakes. However, the data from her research showed exactly the opposite. How can that be? The answer is that the most effective teams don't make more mistakes; they just talk about them more. This became the cornerstone of her renowned work on psychological safety.

CAPAs – risk and opportunity

In the context of QM, this means that an organisation with more CAPAs is more effective.

Of course, this does not mean that we should start creating CAPAs indiscriminately and entering every minor inconsistency into the system. After all, quality still comes before quantity. It is better to process a few CAPAs properly than to complete many in a half-hearted manner just to satisfy the system.

By 'properly', I mean carrying out a real root cause analysis. The result should not just be the cause 'carelessness of an employee', who now receives repeat training. This measure, among other things, leads to psychological safety becoming a distant prospect. After all, the employee now has

1. more work
2. a guilty conscience because their boss has more work to do, having to retrain them and deal with the paperwork.
3. fear of having made a bad impression

The result is that he definitely does not want any more of his mistakes to be discovered in the near future. If one does happen, he will probably try to solve the problem 'under the radar'.

By contrast, proper processing involving a thorough root cause analysis would lead to the mistake being permanently eliminated. This will save time and money in the long run. In this sense, the discovery of the mistake was something of a 'stroke of luck' for the company. The QM system could be developed further to make it even more effective in future. There is a much higher probability that the employee will report another mistake next time, giving the organisation the opportunity to develop and improve.

Intelligent and avoidable failure

It is important to note that psychological safety does not mean being overly cautious, avoiding criticism or only being nice to each other. On the contrary, it is about sincerity.

Amy Edmondson distinguishes between intelligent failure and avoidable failure. Avoidable failure occurs when a known process is not followed, resulting in errors. Intelligent failure occurs when something new is attempted but does not work. Complex failure lies somewhere in between. Here, a combination of factors leads to an error. These could have been identified in advance through a thorough risk analysis, for example. While what happened is not desirable, at least we can learn from it.

Intelligent failure enables an organisation to move forward, whereas avoidable failure should be sanctioned. As LeAnn Rimes sang, 'Shame on you if you fool me once, shame on me if you fool me twice'.

Or, as the English proverb says: 'Fool me once, shame on you. Fool me twice, shame on me.'

Creating psychological safety

To achieve this, Edmondson suggests the following three-phase approach for managers:

Create the conditions:

• Show the necessity of not remaining silent
• Formulate expectations regarding failure and uncertainties
• Highlight mutual dependencies
• Show why it is important to be open

Invite participation:

• Be a role model
• Admit your own weaknesses
• Ask good questions
• Listen well
• Create structures and processes

Respond productively:

• Show recognition, appreciation and gratitude
• Do not stigmatise failure
• Impose sanctions for clear violations.

Psychological safety does not happen overnight. The three phases are naturally more complex than the bullet points suggest, and a functioning CAPA system is not enough. However, both factors can positively influence each other.

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