Manage Risk before it happens…

In my last blog, I addressed risk management.

To be ISO compliant, risk management is called for in ISO 13485, ISO 14971, ISO 31000 and ISO 9001-2015. This means you must have risk management procedures in place.

The objective of risk management is to create and protect value. All companies get the religion when a risk turns out badly – let’s look at some examples.

General Motors

I wonder if anyone looked at the consequences of airbag failures. If they did, do you suppose they had any idea of what this disaster would cost them in both money and good will? At least this risk hasn’t knocked them out of business.

Silicon Graphics

I happened to be working there at the time that the market for high end graphics workstations fell. Management didn’t see the demise coming until it was too late. Like some other companies, when you are on a roll raking in the profits it is hard to put a priority on risk analysis. However, that is the time you should.


Again, they didn’t see the end of film coming until it was too late. They could have led the digital camera age, but instead they ended up with a ‘me too’ product. Today they are well behind all of their competition.

Oil Companies

They were cruising along nicely with the price of oil at $100 a barrel. I would bet that none of them really believed that oil would get down to $50 or lower. They better be planning to run the company with an oil price of $50 and they better be assessing the risks if the price were to get even lower.

Risk Assessment

Manage risk before you face a disaster. Even though you performed a risk assessment at one time, have you performed one lately? A good strategy would be to visit your risk management plans periodically.

Today’s PLM software includes a very good process management component that can be invaluable. It provides document management with process management. It can simplify the critical and complex activity of risk management.

Contact me to learn more…


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