Ever since the first non-conformance was written, we’ve been looking for ways to find the cause, do a corrective action and bid farewell to the profit sucking problem. It’s been a problem closing out non-conformances since I’ve been associated with ISO – 1992. All the studies of ‘Top non-conformances’ from Registrars showed closeouts as the […]
Why Do A Root Cause Analysis – What’s In It For Me? Read More »
Any worthwhile Standard starts with a set of ‘Principles’. ISO 31000 is no exception. Let’s see if we can tie these Risk Principles into a typical ISO Management System. Value Creation and Protection is at the core of this section of ISO 31000 and gives it relevance to any business. Without ‘structured risk management’ an
ISO 31000 – Your Blueprint for Risk Management! Read More »
The path to comfort with your risk management plan can be a complicated on one hand and scary on the other. This may help get you started down this path with a plan to work with. Since the 1960s we’ve used Ishikawa’s fishbone diagram to great benefit. The premise here is that all non-conformances have
How to Design A Process for Protection Read More »
When the final version of ISO 9001 arrived, we saw a new phrase, ‘risks and opportunities’ in clause 6.1. We have seen thousands of posts on ‘risk’, I’ve done webinars and videos on the topic and it is always a ‘hot ticket’. But what about the ‘opportunities’ side of the coin. Turns out they go
Risk and Opportunity Go Hand In Hand Read More »
You may have heard these terms used interchangeably – I know I have. I thought I’d take a look into ISO 31000 to see if any light could be shed on this monumental question! It turns out that the answer is in there…here’s the scoop: Managing Risk… Top management is accountable for managing risk. It
Managing Risk vs Risk Management – What’s The Difference? Read More »
ISO Standards, for the most part have moved to ‘Risk-based thinking’ as one of their themes. It makes complete sense to include this as part of the fabric of our organizations in order to reduce the chaos of unexpected events, as least the ones we can control. ISO 31000:2018 has some ideas that will help
How Can We Create a ‘Risk Based’ Culture? Read More »
Internal Auditing has been around since before dirt. Some organizations really do a great job and find improvements – this earns a return the investment. Others do it to make the Registrar happy and could do without the grief. This approach ends up costing them money and is a drain on resources. To supercharge your
Supercharge Your Internal Audits! Read More »
From James Robb, MD FCAP, a pathologist and molecular virologist. Date: February 26, 2020 at 2:35:50 PM EST Subject: What I am doing for the upcoming COVID-19 (coronavirus) pandemic Dear Colleagues, as some of you may recall, when I was a professor of pathology at the University of California San Diego, I was one of
Coronavirus Protection Tips – Dr. James Robb, MD FCAP Read More »
Yes, and it’ll help us get better at what we do! Well, even though variety is the spice of life, ‘change’ is not always welcomed with open arms. I think that’s why TC 176 included clause 6.3 setting out requirements for managing change. One thing we know for sure – introducing change into a system
What? More Changes ?!? Read More »
Tackling Clause 6.1 in ISO 9001 can be structured by using Ishikawa’s fishbone diagram. You can ‘reverse engineer’ it to create a framework for a simple risk approach. Ishikawa discovered that most non-conformances typically have their ‘root cause’ in one or more of these four areas: People (he called this category Man). This relates to
