Risk Management in ISO 9001 and ISO 14001
In the years since ISO 9001 and ISO 14001 were first published, many organizations have followed the models of these standards in designing their own management systems. However, many of those systems haven’t been utilized to effectively manage risk.
Some Thoughts on FMEAs and Unknown Risks
Anyone who has done an online search using the terms “risk analysis,” “managing risk,” “risk management,” or any other variation will have discovered that the subject has been around for a long time and been covered by numerous authors.
Building a Practical Risk Management Process into Your QMS
Editor’s note: Tim Lozier will be a guest on Quality Digest Live this Friday, Oct. 18, 2013, at 11 a.m. Pacific
Linking Quality Management and Risk Management
Much has been written and discussed about “risk” being the future of “quality.” But what does this really mean, and how does it work?
Statistical Tools for Pharmaceutical Manufacturing
Story update 12/13/2011: Additional information was added to the first paragraph pointing out the connection between FDA requirements and statistical tools.
AS9100:2009: Managing Risk in Manufacturing
Printed circuite board (PCB) manufacturing is moving rapidly up the technology ladder. Keeping internal processes current (and compliant) with new requirements, without disrupting existing customer demands, presents ongoing risks.
Root Cause Analysis: Addressing Some Limitations of the 5 Whys
The 5 Whys is a well-known root cause analysis technique that originated at Toyota and has been adopted by many other organizations that have implemented lean manufacturing principles.
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