How often have you been involved in a discussion in either the product development phase or later process troubleshooting and improvement where you had to make a decision between implementing a quick-fix solution to manage the problem or a longer term better correction that would make the problem go away? Often you will be expected to work on both, but time is limited and you can only have one number one priority. How do you decide which solution you work on?
I heard an interview with golf coach Karl Morris on sports radio recently. Karl works more on the psychology of playing golf than the mechanics of the swing (themindfactor.net). One piece of advice he gives is that golfers should always keep their eyes over the pin when walking to take their next shot. This is especially true after a bad shot when the tendency is to look down and feel sorry for oneself. This is only likely to make things worse. But keeping your eyes on or over the pin reminds you of your object – to put the ball in the hole and helps maintain a positive frame of mind.
John F Kennedy said “There are risks and costs to action. But they are far less than the long-range risks of comfortable inaction”. One of the most useful and important things to determine early in your project planning process about a proposed change is whether the change is easily reversible. This knowledge can help determine the best course for managing the project.
George Santayana stated that “Those who cannot remember the past are condemned to repeat it”. Nowhere is this more evident than in the execution of projects in any industry if the lessons of previous projects are not remembered. It is important to have a good systematic process to review projects when they are completed, no matter how successful or unsuccessful they were. There are learnings from both successful and unsuccessful projects that will help when carrying out future projects by repeating the things that went well and avoiding the pitfalls.
In 2002 US Secretary of defense, Donald Rumsfeld drew attention to the danger of unknown unknowns when answering a journalist’s questions about the lack of evidence linking Iraq to terrorism and weapons of mass destruction. He said “Reports that say that something hasn’t happened are always interesting to me, because as we know, there are known knowns; there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns—the ones we don’t know we don’t know. And if one looks throughout the history of our country and other free countries, it is the latter category that tend to be the difficult ones.”
Manufacturing support engineers spend much time trying to reduce defects and other operational problems. We are always looking for a quick fix, at what is different since the last time we made good product, at what adjustment within the validated range we can make that will suit the new lot of raw material.
The process is probably not good enough. During the development process, the R&D engineers got the process just good enough and then worked on the next step or next project. They were under time pressure because the product launch was already later than the ambitious target their boss had given marketing. There certainly was no time to improve steps that already worked, sort of.
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.
In recent years there has been considerable interest in improving the processes used to make medical devices and other similar materials. New manufacturing systems such as Total Quality, Six Sigma, Lean Thinking and others have been applied with varying degrees of success.
This book focuses primarily on applying these approaches and others to improve the processes used to make support materials in medical device and similar industries and provides examples from the author’s experience. Many process improvement books look at major innovations or at improving the overall manufacturing system. Often these approaches cannot be applied easily within the regulated manufacturing environment of medical device and allied industries.