by Charlie A. Webb, CPP, CMC
From the greasy pulpit of my dad’s garage came some very sage advice. Lessons covering the care and proper use of tools and engine preventive maintenance became metaphors for important management skills. Later, these lessons would show their intense value in nearly every corner of my life. Only after obtaining a degree in management and becoming a certified management consultant did I really realized how important those lessons were. I think of all the lessons that I gleaned setting cross-legged on an oil-stained floor, which was that of preventative or sometimes called periodic maintenance. The concept of PM reaches far beyond the change of motor oil every 3 thousand miles. It has value against fiscal and life management models.
The lessons of PM stuck with me early as my father repeated to me over and over again. I’ll never forget how a day of motorcycle riding was cut short by a broken chain. My father dutifully pointed out that a meager few amber drops of 30-weight motor oil would have kept me riding all afternoon. Preventative maintenance is embedded in all aspects of our lives. Ask any 60-year-old man who recently suffered a heart attack from a life of excess and sloth. A little preventative maintenance could have prevented this event. For years, his physician told him over and over again, “lose weight, change your diet, and exercise regularly,” but sadly he needed a more meaningful event to evoke a change in lifestyle.
At the point of failure, we’re all willing to start a maintenance program, but post ex facto is too late. Health clubs across America are full of people dedicated to exercise after a critical illness. The trick is to time travel into the future to imagine what might happen if one was to not work with a PM mindset. The cost to the individual is clearly high, but consider the cost to our fiscally burdened nation. Forbes magazine reports the cost of fat is high. I mean real high, how about $93 billion dollars, or 9% of our total medical bill. We need to ask ourselves, if you do not maintain the things of importance in our lives, what is the likely outcome? In medical device manufacturing, our facilities are chocked full of critical machineries that build, form, and package our medical devices. If we do not maintain this equipment, what’s at risk? A 483? A warning letter? A product recall?
Maintenance of this critical equipment is paramount in order to assure that our products maintain their original efficacious nature and in the case of packaging machines, arrives at the point of use in a sterile condition. Considering how little is really required in order to maintain this equipment, it is astonishing that we drop the ball on our PMs. Many companies even provide a PM template, as we do, in order for manufacturers to keep their equipment running in original repeatable state. In the beginning of the validation process, quality teams are very keen on the IQ compliance aspect of their validation. They want to make sure that the machines they have purchased meet their purchase specification and are able to repeatedly perform under the ISO 11607 guidelines.
Quality teams seem to be very diligent during the procurement stage of medical packaging equipment, but somewhere the ball gets dropped once the machine is sent into production. Quality has a duty to closely manage the maintenance of this equipment, as the most beautifully written validation will collapse under the weight of a program that does not closely perform and monitor PM issues. Companies need to bring all aspects of the packaging triad together each month. Production, maintenance and quality need to sit at a table each month and ask how the original validation is performing over time. Are there any possible creep issues with the validation plan? At this time, PM schedules should be evaluated with open discussions regarding things such as worst-case scenarios. If, for instance, a hip joint is inadvertently sealed in the jaw of the machine, what impact will that have on the machine’s performance after such an event? How is this event reported back to maintenance and quality? Rounding out the communication between quality, production and maintenance is vital in order to keep the so-called life-cycle approach intact.
As a certified management consultant and also a certified packaging professional, I’ve had the opportunity to look outside of the engineering aspects of packaging and evaluate these functional models as a manager. The issue that continues to come up over and over again is the often-egregious breakdown in communication between departments.
Utilizing scheduling software is a great tool to prompt maintenance to perform needed PM functions. Reporting back to quality on a regular basis is also critical. Another possible hole in critical packaging machine maintenance seems to be that of calibration. Although a manufacturer may only recommend calibrating a device once a year, as our company does, it’s still important to periodically inspect temperature profiles at the sealing platen. Let’s face it, a lot can happen over a year’s time and we don’t want 5 months to roll out only to find out that the machine was operating 30 degrees below expected temperature performance.
It is our duty as medical device manufacturers to monitor this equipment and to ensure that it is performing as expected and as was written during the development of the sterile packaging validation. So, take the time to evaluate your PM program and ask yourself the following questions:
Is your PM being performed per the manufacturer’s recommended guidelines?
Are the personnel performing the PM qualified to do so?
Are maintenance personnel reporting back to quality and production the schedule and outcomes of their PM program?
Is the equipment’s calibration being evaluated before the annual official calibration?
If you can answer these questions with confidence, then you may well save your company of the 483 concerns or the unspeakable product recall. Ask your vendor for any support they can provide your company regarding PMs. Any solid company that provides critical machinery typically has a very competent engineering staff and may also be able to provide some template boilerplates for your staff to use. In my hectic workday I am far too busy to be burdened by the tyranny of a problem that would have never been though prudent prevention. I will leave you with a quote from