Category: Risk
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Fallacy of human error
This article was published today on Bywater’s site As professionals with responsibility for developing management systems and for auditing them we often come across instances where the service delivered isn’t what it should have been or we have problems with product quality. As good professionals we investigate and identify root cause as ‘human error’. How…
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Fail to control design = designed to fail?
I had a recent and very specific query recently about design process and effectiveness measures for Management Review in a Medical Devices environment. The question was specifically about demonstrating that outputs of the design process match inputs and whether this was acceptable to present to the Top Management team? The question was also about ISO…