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ERP and the 9-step model as VP of a pharmaceutical company

I need your opinion on this: You are the Vice President of Enterprise Risk Management of a large pharmaceutical company. You are in Bermuda on vacation.

You are advised by your chief of staff that the chief technology officer may have intentionally and knowingly allowed certain chemotherapeutic products to be sold knowing that they contained only fifty percent of the active ingredient of the product.

Do you contact law enforcement or conduct your own investigation? Fire the Chief Technology Officer?

Should HR be doing something? Should you terminate your vacation and return?

Do you have any special responsibilities as V.P. or ERM? Should you call your Public Relations agency?

Do you call a Board Meeting? Do you notify any other regulatory agencies?

Please analyze in the context of the nine step model.

Solution Preview

As the VP of ERM it is your responsibility for establishing standards for assessing risks, ensuring risk management alignments are defined, and standards are set. Don't forget formulating and monitoring risk management strategies, directing corporate actuarial functions, and leading the enterprise risk management group (which is usually responsible for the implementation of an enterprise risk operating plan). This is no small affair and therefore, time to pack up and head home - the vacation is over.

Step 1 - Identify your objective
Validate the claim
Cease production
Implement damage control

Step 2 - Do a preliminary survey of your options
Determine physical affects of only having half the active ingredient
Determine legal aspects of false claim
Determine disciplinary action
Recall the product
Issue public apology
Issue free product coupons for customers affected

Step 3 - Identify the implicated values
The company's image and reputation are at stake. If one thing is wrong, chances are something else is as well. There could be bad press, loss of FDA approval, legal ...

Solution Summary

Step 1 - Identify your objective
Validate the claim
Cease production...

...Step 9 - Make your choice - on time, on budget
Start by getting the ball rolling from Bermuda.

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