PLM & Risk Management

Pardon my latest rant on Risk Management…

The International Standards Organization [ISO] calls for Risk Management in ISO13485 and in ISO9001-2015.

ISO13485 is focused on medical where it may seem obvious that risk management is an issue.  Mistakes here can cost lives and the accompanying lawsuits can destroy companies.

ISO9001-2015 is focused on manufacturing where mistakes can also cost lives and destroy companies.

Risk Management is more than just that, it is about your company staying in business…

Let’s look at a few examples:

Kodak was a high flyer in the film business.  They sold 85% of all photo paper worldwide.  Someone within Kodak should have seen the potential of digital photography and they should have investigated how Kodak might have been a leader in this new technology.  Adding insult to injury, they were late embracing the technology and are attempting to catch up.

Blockbuster was the leader in video tape rentals.  They hundreds of stores.  Netflix had the vision to rent and distribute movies over the internet.  They even gave Blockbuster time to respond to their vision by renting DVD’s by mail first.  Who was minding the Blockbuster business?

Barnes & Noble was one of the largest book sellers.  Visiting their stores was a pleasant experience.  Was anyone watching what Amazon was up to?  Purchasing books on Amazon is not only easy, their ability to search titles made it fast as well.

This begs the question – Are there people at your company analyzing the market and your competition so that you can stay ahead of the crowd? It makes a lot of sense to have procedures in place to perform your risk analysis on a regular basis.  PLM software can manage that process. 


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