Anyone who has conducted a search on ‘risk analysis’, ‘managing risk’, ‘risk management’ or any other permutation would have discovered that the subject of risk analysis has been around for a very long time and has been covered by numerous authors. Still, the daunting challenge remains; how can one conduct process risk analysis without the help of a PhD in statistics? Continue reading
The words “risk” or “risks” have been sprinkled throughout the 2015 revision of the ISO 9000 standard. Although some “requirements” will be easy to satisfy using well-established process monitoring or capability techniques other references to risk are so vaguely stated as to be open to a myriad of interpretations and thus become meaningless. Having read and re-read the current references to risk spread over several paragraphs I wonder if it would not have been better to address risk in one paragraph at the beginning of the standard. I have “cut and paste” most of the current references to risk and included brief comments. Continue reading