13485cert

If I had a rocket launcher…

In Elsmar Cove, International Standard, ISO, ISO 13485, Management Representative, Management Responsibility, QA, Quality, Quality Management Systems on January 21, 2011 at 12:53 am

This week’s music video selection was recommended by my friend Greg. We were eating dinner together at 1776, and he was kind enough to share this amazing musician with me. I’m not a guitarist but he pointed out that Bruce Cockburn has a very unique style. He plays three different parts simultaneously. His thumb plays base on the top string while the other fingers play two separate melodies. WOW!

                 Are you frustrated? Do you wish for a rocket launcher? Maybe you would aim it at the C-level offices and pull the trigger.

                Sometimes we hear phrases like: “Well that’s just an ISO requirement.” This obvious lack of support by top management is what frustrates every Management Representative in the world.

                There was a question posted on the Elsmar Cove website on January 10th (see previous blog for the link). In just 10 days there have been 153 postings in response to the original question. As I read through the various postings I saw several comments about a lack of support by top management. Rocket launchers are NOT the answer, but maybe a heavy bat…

                A little over a decade ago I was still learning how to supervise people. In an effort to educate myself further, I read a book (sorry can’t be sure which book anymore). In this book, the boss gave an employee a card with a picture of a baseball bat on it. The instructions provided with this magical card were to use it only when the boss failed to pay attention and the employee had something important to tell him.

                We all wish for a magical baseball bat, but unfortunately we are M-A-N-A-G-E-R-S. Along with the awesome title comes awesome responsibility. Managers are responsible for leading others. Subordinates are not the “others” I am referring to. The “others” are peers. If you cannot persuade your peers to support you, then you will fail as a manager. The Quality Department cannot fix all the problems. In fact, my philosophy is that Quality is responsible for recommending improvements, training people, and helping to implement. We assign corrective actions, but we should be assigning them to the process owner (i.e. – Manager) that is responsible for the area where the problems were created.

                If you need help persuading the unenlightened, try picking a project that is critical to the success of the stubborn one. If you can show someone that is currently a detractor how they can apply the Quality principles to help solve their problems, then you will have a convert. Converts become strong supporters. If the stubborn one happens to be at the top, figure out what the CEO’s initiatives are. Initiatives are easy to identify; they talk about it at least twenty times a week. Try showing the CEO how their initiatives can become Quality Objectives. Show them with graphs. Show up with solutions to their problem. Use the CAPA process as a framework. Show them how the management TEAM can fix it.

                If nothing seems to be working, you can always try reviewing some FDA MedWatch reports too–just to scare the crap out of the boss.

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