Month: February 2017
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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…
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Management Review – it’s all in the name
I was in a discussion with a very earnest young man a while back and one of the topics we covered was Management Review as part of the ISO 9001 quality management system he had responsibility for. Let’s just say the conversation was a little heated in places and that lead me to write an…
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Is your internal auditor role a dead end job?
This article was published on the 13th February on Bywater’s site With this article I’m hoping to prompt discussion about the auditor pool we select from, particularly internal auditors. This started after a comment from a 3rd party certification body where I was told their issue was succession planning and how to deal with an…