Corrective action under the microscope

When you get a wicked problem, do you just throw your hands in the air and give up? What about those problems that simply won’t go away? Or the dreaded negative findings in an external audit report, like a NATA report?

Let me help you understand this better with a classic example of a problem in a micro lab.

Microbiological laboratories maintain an in-house reference culture system, to run internal quality control checks. These quality control checks could be for in-house produced media and/or to validate the tests performed on various samples received. More than likely, all labs at some point have the results of testing using their working cultures falling outside the specification of the relevant standard. Either the count is too low or too high or forever inconsistent.

What do you do when you have this as an ongoing issue at your laboratory? Do you stop just documenting this nonconformance, re-assigning the testing back to the relevant staff, and/or re-train the staff to ensure compliance? Or, do you delve deeper?

There is a much better way of handling these situations.

The key to good corrective action – Root Cause Analysis

𝐖𝐡𝐚𝐭 𝐝𝐨𝐞𝐬 𝐢𝐭 𝐢𝐧𝐯𝐨𝐥𝐯𝐞?

A root cause analysis is the process of discovering what is causing a problem at a deeper level. Most times we are presented with a problem, we simply fix the problem and move on. These “fixes” often just address the surface cause.

To ensure a thorough root cause analysis, you must ALWAYS delve deeper!

If we were to do a root cause analysis for this example we might find the following causes.

• The staff member who performed the testing did not receive enough training to ensure competency in the test.
• This begs the question in terms of the content of the training program for staff in this area of testing – is it up to scratch?
• The training program is not up to scratch because we don’t allow enough time between a trainee ‘under training’ to them being deemed competent to perform the testing in our lab.
• And the kicker in all this……this all comes down to the fact that we don’t have enough staff to do the work.

Now, this might not be the answer in your case. But the ‘fix’ of just retesting the sample is a long way from the required solution. The fact is there are simply not enough staff to perform the work.

𝐇𝐨𝐰 𝐝𝐨 𝐲𝐨𝐮 𝐝𝐨 𝐢𝐭?

We use methods including the 5 whys, and cause and effect diagram.

Of these, the 5 whys technique is one of the better-known and used methods. It requires you to ask ‘Why did the problem happen’ in a focused way and answer that question, keeping in mind the problem you’re investigating. You repeat this process 5 times to determine what is happening at a deeper level. No blame is assigned in this exercise – the idea is to find out why something happened not who caused it.

In fact, even if you don’t get to 5 times, it is always worthwhile asking the question ‘WHY?’ at least few times before you conclude on an answer.

For example, reasons such as ‘Working culture concentration and dilution have been adjusted to ensure counts are within spec’. do not really help us next week when the same problem resurfaces. It is wiser to work on the issues methodically, before reaching a conclusion, to save us the time, money and frustration that the repetition of the issue creates.

Most laboratories do hit a dead end with this kind of issue. Remember to slow down and think! What kind of systems does your organisation need in place to overcome these recurring nonconformances? It could be a lack of training, insufficient data recording, improper documentation, or insufficient knowledge of relevant standards.  Or, it could also be a lack of resources such as manpower, IT, budget etc.

Whatever the reason is, it is never too late to dig deeper and find someone who can lead you in the right direction. As science has it, having a different set of eyes on the same situation or problem works wonders!

Is that all there is to a root cause analysis?

Well, no.

It also helps to work in a team. Those extra sets of eyes can open up the analysis to get past the hard places that you might not want to venture into. Like finding that the root cause lies with decisions by management and not the activities of workers. Decisions like not having sufficient staff resources to ensure things like having enough time to effectively train our staff.

Regardless of the method used, the team must be encouraged to ask the right questions and not stop at simply addressing symptoms.

It may also help identify why the problem wasn’t noticed earlier, particularly in the case of a major issue.

Imagine the amount of testing that might have been done in the meantime! ISO/IEC 17025 actually requires an investigation into the effects of this equipment failure. (It’s in clauses 6.4.9 and 7.10.1 (c), in case you’re wondering.) That could be a lot of time spent on investigating this. All because we didn’t have enough staff with enough time to properly train new colleagues. And all very preventable.

Want to know more tips and ways to deal with problems and root cause analysis? Keep your eyes peeled for when we are running our next public course on root case analysis.

At MAS Management Systems, we help rebuild the foundation of your quality management system with our unique skill set, expertise and outstanding quality management package.

Most problems can have effective solutions. With the right guidance and assistance and the right action plan, you are bound to achieve solutions that stick.

Contact us if you’d like help with getting to the bottom of your lab problems and making your business better and smarter.

Remember, you don’t have to do this alone!

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