According to Wikipedia “In materials science, creep (sometimes called cold flow) is the tendency of a solid material to move slowly or deform permanently under the influence of mechanical stresses.” With our medical device pouches/bags, we try to understand the various types of creep. Accelerated aging is a way to look for time-linear creep, the subject of material creep is deep and complicated, to learn more read this bit on Wikipedia. There is another type of creep that lands more in my wheelhouse “Process Creep”. This is what happens when system operating procedures are modified or ignored. I have spoken before about my frustrations with quality groups that abandoned their medical device packaging validation program. Creep is insidious as it sneaks up on our total quality plan only to reveal itself as non-conforming processes or product recalls. You may have heard of the boiling frog story, in short, it states that in a laboratory when you put a frog in a beaker of hot water, he will quickly jump to safety. Place the same frog in a cold beaker of water slowly bring the water to a higher temperature, and by the time the frog has realized the water is dangerously hot, it has lost the physiological prowess to leap to safety. Quality teams are notorious Data collectors but often times the data that is being collected is only gathered at the band of activity in which they’re currently engaged. We need to plant sensors throughout organizations, the sensors can be anything including, observe and report employees or empirical testing, scheduled by way of an automated system. As I’ve said before there’s no good reason to develop a brilliant medical device packaging validation program if it is only going to decay under the care of less trained or unskilled employees.
I think most medical device manufacturing organizations well understand the core mission ” develop an efficacious medical device and delivered sterile to the point of care”. I have seen the worst companies manage to do that much of the time, but we are in the always business. My advice to quality teams is just to be certain that nothing is obscuring your view to your medical device packaging program. Finally, ask yourself, is there anything in your organization that is buffering the possible diminution of your quality plan? This can be as simple as an Employee that feels uncomfortable feeding back bad news from the packaging line. We are not in an industry where sycophantic sidekicks benefit our mission. Be certain to create a culture where employees are not only encouraged to bring you bad news, but are rewarded to do so. I should also add a spiff program that grants small rewards for solutions to problems is a great way to get feedback from the frontline.
So look for the bad news, or what Tony Robbins has called “pre-problems” throughout your organization. One of the worst inventions of all time is the expandable waistband for men’s pants. When we disable the “too tight to button monitor” on our pants we enter into the realm of process creep. As the pain of a tightening waistband disappears the more dangerous weight gain begins. This is a perfect analogy of what happens to our organizations when we avoid the bad news. The solution for weight gain perhaps is more salads, but it definitely is not expanding pants. Approach quality with an auditors eye and search for the leaks in your process before they become a deluge.