Company Training Courses

Lean Six Sigma Certification

In order to evaluate and compare Lean Six Sigma course offerings it is important to understand the various certification options associated with them. Whilst course curriculums may appear similar, the requirements for certification can often vary dramatically. CLASSIFICATION OF C...

Quality Conference in October

We are happy to draw your attention to the upcoming Quality in Ireland Conference taking place in the Radisson Blu Hotel in Galway on Tues 21st Oct hosted by NSAI and IT Sligo. This is an excellent event with many great speakers so worth noting in diaries. See http://www.nsai.ie/...

How to transition from Project to Program Management

The world of project management is becoming all too familiar. Yes, there are still challenges and learning to be had but when project management is discussed it is known on how to develop and mature. As a project manager, the biggest driver is being able to deliver under the pres...

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 ...

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