Economist Paul Romer said in 2004 that ‘a crisis is a terrible thing to waste’. Now we are hearing many saying that we should strive to achieve long term benefits from the current COVID-19 crisis. Whatever about that, in regulatory industries we are only too familiar with CAPA’s, Corrective and preventative actions, which are crises that occur frequently.
But do we waste most CAPA’s? A CAPA is a great opportunity to improve your process by eliminating a source of pain. But do our corporate goals favor speed of closure rather than seeking the best solution? There are three possible categories of solution to a CAPA. Elimination of the problem is self-explanatory and obviously the ideal. Lesser solutions are Mitigations, a reduction of frequency or severity of the problem, and Inspections, improved detection of the problem.
One of the lesser solutions is usually quickest and easiest to implement. If the quality department is judged on speed of closure, these solutions will be favored. But these can either defer the problem to a later date or add cost and inefficiencies to the process. Addition of a new HVI, human visual inspection, is often the solution. This will reduce the occurrence of defective product reaching the next step in the supply chain but will not eliminate the cause of the problem. It will add cost by reducing yield and adding labor. And as we all well know, HVI’s are seldom 100% effective, so we will not eliminate the problem.
But adding an inspection is a quick easy solution that helps speed to closure metrics. The same can be said of other mitigations that may reduce the problem but not eliminate it. They may be quicker and easier than complete elimination. And they may only be temporary solutions. In the future the required standard may increase, so a future occurrence of the defect, even though it is now occurring at a reduced frequency, may require another CAPA.
Improving quality by eliminating defects inevitably reduces the cost of production. This is a topic explored in detail by Phil Crosby in ‘Quality is Free’ and is the best solution for any CAPA. But such solutions may not be obvious and will take longer. They may require a higher degree of regulatory review, although such solutions are nearly always preferred by regulators because they represent a genuine improvement.
We need to be wiling to give the time to seek an elimination solution. This may require extensive use of problem investigation techniques, like five whys and Ishikawa fishbone diagrams to identify the underlying causes, and brainstorming techniques, like de Bono’s hats and TRIZ to find novel solutions.
Input from anyone who may have a fresh perspective should be sought. A team with a broad range of skills and outlooks should have the task of finding better solutions. In many cases you may find that the whole process can be changed for the better by taking a fresh look at it with new eyes.
But the only way you are going to get better solutions for your CAPA’s is by looking for them. CAPA solutions need to be judged in accordance with a broader range of criteria than just speed and ease of closure. They should also be judged in accordance with their long-term effectiveness, cost of implementation, and applicability to improve other processes.
A CAPA is a terrible thing to waste. View CAPA’s as opportunities to make genuine improvements to your process.