Root cause analysis is often taught poorly and the methods used do not equip people with tools that are ready for them to use. The DMPI DIGR® method is an answer to this. It is simple, elegant and based on proven approaches. I run bespoke training courses on this approach using many examples from clinical trials and helping teams work through specific issues. The approach in summary:
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- Define the problem. You need to make sure everyone is focused on the same issue for the RCA. This sounds trivial but is an important step. What is the problem you are focusing on? You would be surprised how often this simple question brings up a discussion.
- Is – Is Not. Consider Is – Is Not from the perspective of Where, How Many and When. Where is the issue and where is it not? How many are affected and how many not? When did the problem start or has it always been there?
- Go step-by-step. Go step-by-step through the process. What should happen – is it defined? Was the process followed? Were Quality Control (QC) steps implemented and does data from them tell you anything? If an escalation occurred earlier was the issue dealt with appropriately? This is where a process map would help.
- Root cause. Use the information gathered to generate possible root causes. Then use why questions until you get to the right level of cause – you need to get back far enough in the cause-effect process that you can implement actions to address the cause but not to go back too far. This is where experience becomes invaluable. Narrow down to one or two root causes – ideally with evidence to back them up.
Once you have your root cause you will want to develop actions to address the root cause and to monitor the situation. The DMPI Blog discusses the DIGR® method in more detail. Want help with training or implementation of the DIGR® approach? Contact us.
Some background to DIGR®
Some people seem naturally good at seeking out root cause. And when you try to formulate the method it is not easy. In DIGR® I have brought together various approaches. Define comes from the D in DMAIC as part of Six Sigma. It is also part of A3 methodology. Is – Is Not comes from the approach described by Kepner and Tregoe in “The New Rational Manager”. Go Step-by-Step comes from Lean Sigma’s process and systems approach and from the idea of walking the process (“Gemba”) – to quote W. Edwards Deming, “If you can’t describe what you’re doing as a process, you don’t know what you’re doing”. Root Cause is, in part, the Five Whys approach – but only used after gathering critical information from the other parts of DIGR® and without a need for five. To look at DIGR® it from the approach of 5WH: D=Who and What, I=When and Where, G=How, R=Why.
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