Guest Blog: Plan for SuccessGuest Blog: Plan for Success
In the summer of 2001 my 27 year old son, Randy, was at my place on a Sunday evening. We were watching an edition of Sunday night football and having some refreshments. Randy brought up the fact that there was a marathon in Colorado Springs planned for two weeks from that weekend. During the summer, we had both completed a couple of 5k’s but never anything longer. We naively decided that doing a marathon should be no big problem for us. After all, upon reviewing the course map, we noticed that it was all nearly down-hill.
August 5, 2011
In the summer of 2001 my 27 year old son, Randy, was at my place on a Sunday evening. We were watching an edition of Sunday night football and having some refreshments. Randy brought up the fact that there was a marathon in Colorado Springs planned for two weeks from that weekend. During the summer, we had both completed a couple of 5k’s but never anything longer. We naively decided that doing a marathon should be no big problem for us. After all, upon reviewing the course map, we noticed that it was all nearly down-hill.
So we enthusiastically signed up and arrived in Palmer Lake, Colorado at the appointed date and time. Needless to say, we had no concept of what we were in for. The first couple of miles were just fine but about the 12 mile marker, bad things began to happen. At mile 16, I totally cramped up in my right hamstring muscle and started to walk. I was unable to run anymore and I finished the course by walking the last 10 miles. My finish time was an embarrassingly slow 5:37. After the race I decide to sit for about 15 minutes before embarking on the journey to my vehicle. This turned out to be problematic as I was barely about to stand up and walk by now. With much effort, I eventually was able to get into my vehicle and drive the 30 minutes home. By this time, I was even in worse shape and literally had to crawl out of the truck, across the yard and up to my house. After about 3 weeks my legs had finally recovered….but with much agony along the way.
Some medical device companies approach process validation with a similar amount of pre-planning as above. Suddenly they are about to manufacture a device when someone realizes they need to consider FDA requirements for process validation. Confusion in this context is rampant. Should we validate, verify, or qualify the process? Can we just 100% test? What about suppliers? Can we afford to do all of this? What about a hazard analysis? Where do we start?
Much like being successful in a marathon, effective, low-cost, risk reducing process validation requires great cross-functional team work, appropriate tool applications to support product and process design, profound technical knowledge, and a passion for low-cost, risk mitigating excellence.
Process validation planning needs to begin long before the product design is completed. Process flow charts, detailed process maps, DFMEA, PFMEA, hazard analysis, control planning, requirements maps, VSM, VMP’s, DOE characterization studies all need to be completed before Process Validation is initiated. In this way an organization can provide low-risk, low-cost, compliant products that delight the customer.
Robert G. Launsby is the founder of Launsby Consulting (Colorado Springs, CO). He is also the author of "The High Cost of Outsourcing to China" and "Breaking Out of Silos: Overcoming Organizational Segmentation."
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