Company Training Courses

Don’t Set Threshold RPN’s for Actions to be Taken in FMEA

It is common practice in organizations where Failure Mode Effect Analysis (FMEA) is used as a quality improvement tool, to set thresholds on the Risk Priority Numbers (RPN’s), above which actions should be taken to reduce the RPN. I don’t believe that setting such thresholds ...

EN 14971: 2012 Content Deviation #5: Risk Control Options

During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the Medical Devices Directives (MDDs), namely 90/385/EEC, 93/42/EEC and 98/79/EC. Seven discrepancies were identified; these ...

Household Energy Saving Tips

Save Energy – Save Money – Help the Environment Light, Electrical Appliances & Energy Tips: Turn lights on only when you need them and turn off when you leave the room. Keep your lamps and lamp shades dust free – more light in less time. If you want...

Don’t Expect to Find a Single Root Cause when Solving Problems

I think that because of the emphasis in the literature on “Root Cause” analysis some teams working on problem solving tend to believe that they are expected to identify a single root cause of the problem. I don’t believe that they should expect that outcome. Over the years ...