PathWise Blog

Archive for February, 2010

Demystifying the Root Cause Process.

Tuesday, February 16th, 2010

Step One - The Problem Statement

Last month, we talked about “chart fright” - the struggle I see teams have in dealing with the form. I’d like to continue that theme today and in the months ahead.

The first step in the root cause process is the problem statement. Albert Einstein is credited with saying “If I had one hour to save the world, I’d spend 55 minutes defining the problem and only five minutes finding the solution.” I believe this statement is very indicative of the challenge facing in our investigation teams. You have to start well to end well. And often teams want to get right into the investigation without fully understanding the problem.

My advice: Remember the goal. Find out what’s wrong with what - object and defect. In order to do this, you may need get out of the conference room. Go to where the problem occurred if at all possible. The Japanese call that “Gemba.” At the very least, bring pictures, videos or the problem itself to the room (as a show and tell). Let the team see it, experience it. Storyboard the problem if that helps. Lastly, challenge assumptions. Too many times I see teams assume they all have the same understanding, and it’s not until later in the investigation that this comes out. You’ll hear comments like “I thought we were working on this - or that”! Often it means starting over. Save a lot of time and frustration by fully understanding the problem statement before investigating it.

The new ISO 9001: What’s the difference?

Friday, February 12th, 2010

In 2008, the International Organization of Standardization issued a new standard to which all medical device manufacturers should comply. Yet many organizations are struggling to keep up with ISO 9001 2000. What, in your experience, are the critical areas that organizations need to address in order to comply with the new standard?

What tools do you find most useful when managing risk?

Monday, February 1st, 2010

Effective Risk Management is a critical initiative for those under increased regulatory scrutiny. In the past decade, ISO 14971 and ICH Q9 have been recognized by the FDA as the standards to which all life science organizations should comply. Now, more than ever, companies need a strong risk system in place and the right resources to allow them to make the right decisons.

What tools do you find most useful when managing risk?

Vote at http://www.surveymonkey.com/s/PC7LYT8

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