There are some things you never want to hear.
Words like “uh oh” from your hairdresser when they’re standing behind you during a haircut.
Or “I’ve never seen THAT before” when your doctor is looking at an x-ray.
Or perhaps a guilty-looking family member asking, “How much did you like that (extremely valuable fragile item) really??”
In a lab setting, any issues that arise will be the result of something going wrong in your system. This means that you’ll need to launch an investigation. And if it is a significant issue, that means root cause analysis.
For labs holding accreditation with NATA or certification, this could be anxiety inducing. NATA or your certifier needs you to adequately undertake a root cause analysis. But what does that mean for your lab?
To err is human
We all make mistakes, that’s a given. However, in a lab it’s not enough to say that Dave did the wrong thing. We need to backtrack and work out just why Dave got it wrong. And that’s precisely what a root cause analysis does.
Human error isn’t a cause. It’s a symptom of a breakdown in the system.
Perhaps Dave simply forgot a step in the process of the test he was carrying out because he’s a new father and was tired. Perhaps he was using an older process because he didn’t know that the process had been updated recently. Or perhaps he just doesn’t know how to do the test properly.
Regardless of the reason, the lab needs to drill down into the process and work out the WHY of what happened. That will make it much easier to explain where the process fell down and how it can be fixed.
As well as pointing to a possibly serious flaw in your system, a root cause analysis will allow you to prevent it happening again.
Be honest and upfront
Everyone loves sweet treats, but an assessment is no place for fudge (unless it’s part of morning tea).
Be clear and honest when doing your root cause analysis. Keep it simple and don’t try to sidestep the issue.
If you forgot to update your system when a new requirement came out from a regulator, say so.
Did you overlook Dave when sending out a new testing procedure? Say that too.
And then say how you’ll go about fixing the cause, so it minimises the possibility of it happening again. Document everything so that you can demonstrate to NATA or your external assessment body that you’re on the right track.
Doing this analysis isn’t just about maintaining accreditation. It’s helpful to you, your lab, and your system.
Don’t play the blame game
It’s extremely unhelpful to start pointing fingers during a root cause analysis. If the cause turns out to be an individual, it’s important to look at their role, not their personality.
By using the 5 whys technique, we should be able to get to the source of the problem. For example, perhaps a client complained because their test results weren’t delivered on time. Our analysis could look like this:
|Why weren’t the results delivered on time?||
Because one of the chemicals needed had expired so testing was delayed
|Why was the chemical expired?||
Because the order didn’t get shipped so we could begin on time
|Why wasn’t the order shipped in time?||
Because the order wasn’t placed with the supplier
|Why wasn’t the order placed with the supplier?||
Because the person who does the ordering is on leave and nobody was delegated to carry out their role
|Why was nobody delegated to do the ordering while the normal person is away?||
Because we don’t build redundancies into our system when it comes to resourcing – we run a lean ship!
Now there’s a clear path forward to capture the issue and ensure this doesn’t occur again. In this instance, perhaps the ship is running too lean and the allocation of resources is not quite right. So, management should look more carefully at its resourcing within the lab. There may be areas where there is wastage from which resources can be borrowed, or there may simply be a need to add additional resources to cover people being away.
The 5 whys method is just one technique. Other popular ones include the fishbone (or Ishikawa) diagram, flowcharts, or a cause map. Any thoughtful, systematic review process can be used.
Do it quickly
When something happens that shouldn’t it’s best to begin the root cause analysis as quickly as possible. Specific details can be missed because of memory lapses if the process is delayed. This is particularly true if there are several people involved in the process that led to an incident.
Everyone involved in the process should be involved in a root cause analysis. This doesn’t only mean employees involved in the incident but may also include members of the leadership team or perhaps sometimes customers and other interested parties.
Although employees involved in the work will usually be highly motivated to find a solution, leadership team involvement should ensure prompt and appropriate actions are taken.
It’s not just about what went wrong…
Although a root cause analysis is generally used when an issue arises, a similar process can be used when things are going right.
For example, if a business has an unexpectedly good sales event, unpacking the reasons why this happened means that the process could be replicated.
By listing the possible causes leading up to the event, the business could categorise each touch point and determine whether this was something they could control or not control.
For example, the possible causes could be a new sales team member starting, the first day of Spring, new promotional material being launched or the end of the month. Those events could be categorised by how much influence the business has over them – perhaps calling them internal or external.
Each of those events could then be investigated to determine if it was an unrelated, correlated or contributing factor or a root cause to the successful sales event.
Analysing why things are going well can help to protect the crucial factors in your business success.
MAS Management Systems can support your lab’s quality system. We can carry out internal audits, reviewing your document and yes, even do a root cause analysis!
We also have a training course that can show you how to carry out an effective root cause analysis and defend your findings at your next assessment.
Email us firstname.lastname@example.org and we can discuss how we can support your business becoming better and smarter.
Remember, you don’t have to do this alone!
Download the article How did THAT happen?