CERM ® RISK INSIGHTS | Future of Quality: Risk™

#112 – LEAN SIX SIGMA AND THE SIPOC TOOL FOR HIGHER ED – NORMA SIMONS

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Posted on October 25, 2015 by greg

The Lean Six Sigma (LSS) methodology that was originally developed in manufacturing is slowly making its way to the education space. As the concepts of Lean Six Sigma spread and provide the template for improving efficiency and enhancing institutional performance, the SIPOC tool is invaluable for changing the thinking and approach to project management, process improvement and LSS implementation. Continue reading →

#111 – VW ‘ROGUE ENGINEERS’ MADE THE DECISION – PAUL KOSTEK

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Posted on October 17, 2015 by greg

“To the best of my knowledge today, this was not a corporate decision,” he said. “This was a couple of software engineers who put this in for whatever reasons and I would also like to find out.” Continue reading →

#111 – WHAT IS ISO 9001: 2015 AUDITABILITY? – GREG HUTCHINS

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Posted on October 16, 2015 by greg

This is the #1 question for CB’s with the new revision of ISO 9001:2015 standard. Most management experts acknowledge that ISO 9001:2015 is a significant change.

Auditability implies consistent outcomes from auditing management systems. If outcomes are different among CB’s, then the quality of the assessment and the reliance on the outcomes may be called into question. Continue reading →

#111 – FDA REQUESTS PUBLIC INPUT ON QUALITY METRICS GUIDANCE – OLIVER WOLF

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Posted on October 16, 2015 by greg

In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points. Continue reading →

#111 – WHAT IS QUALITY MANAGEMENT? – IAN WALKER

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Posted on October 16, 2015 by greg

‘Quality Management’ is a generic term, and the word ‘Quality’ means nothing on its own.

‘Quality’ is an individual’s perception. Take a wrist watch for example. What is its purpose?

My first initial thoughts are to tell the time, however for others a wrist watch is much more than that it may often be viewed a piece of jewellery and the more expensive the exclusive the brand name the better. Continue reading →