Comments for Risk Management in Regulation

Comment on Ethics and drug-trial recruitment by health professionals by Richard Page

Richard Page — Thu, 01 May 2008 18:54:42 +0000

Thanks for reading and leaving your comments. Our view of regulation is that it’s the method by which society manages its most serious risks. I think it’s important to acknowledge that regulators have more of a supervisory role; and that regulatees are fundamentally responsible for their own actions–for operating within terms of their license, or, however compliance is measured. So the regulator is really looking for the exceptions–activities that are outside the boundaries that have been established by statute, regulation, standards, principles, ethics and, more generally, by expectations.
These “expectations” are the expectations of performance: the expectations about performance held by reasonable stakeholders. Establish the expectations, make it clear to regulatees what the expectations are, and then measure the failures (and the successes) in relation to expectations. Various methods, consistent with your objectives, can be used to measure risk — the variance from expectations.
In the end, what you want is a clear/transparent, objective, consistent, efficient and effective way of evaluating the matters that come to your attention. This is a risk-based, decision-support approach to regulation.
Good luck.

Comment on Ethics and drug-trial recruitment by health professionals by Veronica Livingstone

Veronica Livingstone — Thu, 01 May 2008 17:25:29 +0000

I enjoyed your articles on risk management. However, I am interested in risk management as it relates to a self regulatory body, particularly as it relates to investigations into complaints against physicians. Can you direct or advise me on same.

Comment on Veiled truths by Ireneo Funes

Ireneo Funes — Fri, 21 Dec 2007 03:06:37 +0000

I’m skeptical about the power of fiction to reveal truth. The moment you begin to look for “truth” in a story, you are reducing the work to a model; this process is just as susceptible to Taleb’s ludic fallacy. A work can certainly be read in this way, but any truth that is found can only be a reading.

Comment on The Black Swan, by Nassim Nicholas Taleb by Risk Management in Regulation » Veiled truths

Risk Management in Regulation » Veiled truths — Sun, 02 Dec 2007 18:14:34 +0000

[...] The Black Swan, by Nassim Nicholas Taleb [...]

Comment on Context and perception by Richard Page

Richard Page — Tue, 14 Aug 2007 13:07:07 +0000

Thanks for your comment David. I agree with your points about the importance of context. The example provided by the Joshua Bell “stunt” underlines this even more. The real context that was purposefully hidden was that he was a virtuoso violinist. If some of the witnesses to the event cared enough about great music to pay high ticket prices to see him in a live concert, you’d think they’d stop and listen and even ask a few questions. That didn’t happen.
In our area of risk practice, the area of regulation, fraud is an issue. Fraud artists who understand how to make the context seem what it’s not are the problem. The point we’re making with this example is that you can’t always believe what you see. The real context that may be hidden is critical.

Comment on Context and perception by David Smith

David Smith — Tue, 14 Aug 2007 06:04:49 +0000

I think it depends on what you mean by context. If you mean the need to get at the heart of the “problem” then shouldn’t you be using root cause analysis techniques to determine what the real issues are.

This however, cannot occur without a thorough understanding of the context in which the risk occurs. You need to understand the Risk Management Context - what types of risk are you concerned about, and what level of risk are we prepared to tolerate. You need to understand the external risk (something which COSO ignores)because it is how your organization interacts with its environment which will determine the extent, if any of the level and types of risks; and you need to understand the internal risk context of your organization .

Without a thorough understanding and analysis of context you should not proceed with any risk analysis. Assessing risks in isolation can be futile because if the risk is not going to help or hinder your organization in achieving its objectives then worrying about it is frankly a waste of time and money. I work with many organizations who waste huge amounts of money mitigating risks that are “out of context” and forget those that are imperative to the success of their business plan.

David Smith
Managing Director
Risk Matters
http://www.riskmatters.com.au

Comment on Context and perception by Risk Management in Regulation » Do we need to autheticate the source or what the source reports?

Fri, 27 Apr 2007 01:09:21 +0000

[...] Context and perception [...]

Comment on Safe Drinking Water by Bob Baron

Bob Baron — Fri, 22 Dec 2006 14:45:52 +0000

Ron, you have given me the creeps! I must get a copy of Hrudey’s book.

Comment on NANOTECH, The new industrial revolution. HOW WILL REGULATORS RESPOND? by Richard Page

Richard Page — Thu, 07 Dec 2006 22:08:32 +0000

“Nanoparticles: Health Effects-Pros and Cons”
This article appears in the EHP (Environmental Health Perspectives). This is a monthly journal of peer-reviewed research and news on the impact of the environment on human health.

The research is authored by Maureen R. Gwinn and Val Vallyathan of the National Institute for Occupational Safety and Health, Morgantown, West Virginia, USA.

The table of contents lists these items:

* Introduction
* UFPs versus NPs
* Pros: Applications in Biology and Medicine
* Cons: Morbidity and Mortality Due to Cardiovascular Effects
* Cons: Pulmonary Morbidity and Mortality
* Cons: Translocation and Toxicity to Other Organs
* Conclusions

Comment on The “slings and arrows of outrageous fortune…” the risks that you can’t prevent by Larry Kaufer

Larry Kaufer — Tue, 05 Dec 2006 21:38:14 +0000

Great story from real life…reminder that truth is the mother of fiction.

Also reminder of what should be “Standard Operating Procedures” of any event planning or management situation in general.

That is; Plan B essentially needs to exist before Plan A…..not to mention Plans C, D, E, etc.

Contingency planning must be integral to management.

Larry Kaufer,
LAK International
Washington, DC