Wednesday, October 27, 2010

How Does Something Like This Get So Bad?

The news yesterday included an item about GlaxoSmithKline's penalty of $750 million dollars. They were fined for selling adulterated pharmaceuticals and ineffective pharmaceuticals. Apparently it involved 20 some drugs and had gone on for years. It included making false claims about the benefits of some of the drugs (the ineffective part of the allegations).

Their press release said they worked for years to resolve the issues, but it still took a whistleblower to resolve the issue.

Not knowing more, I can only speculate. However, "where there's smoke, there's fire" or at least could be.

Let's assume you're the quality guy in the GSK plant making the drugs, or the marketing manager, or somebody else who knows some of the details. You complain. You write reports. You talk to managers, directors, executives. You mention to other people. The data is available for everyone to review.

Somehow in this organization, there's either a culture that says, "Don't rock the boat" or "Shut up and do what we tell you" or "That's not what the data is saying" or...some other thing that kept the news quiet, the data ignored, the apathy for bilking customers out of effective remedies encouraged. What values does a corporation that finds itself in this situation have? What talk is it walking?

GSK in its statement: "GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes".

It shouldn't have taken 4 years to resolve these issues.

I remember visiting a problem supplier many years ago. They delivered deep-drawn steel parts. We experienced high variability in their products. The general manager told us that the process has a lot of variability and that it would be impossible to do better. During the visit, we reviewed their inspection reports and found no variability. I applauded them and asked that they provide parts with this great process control. The general manager admitted that the inspection reports were wrong, and advised us that he would fire the inspector. I quickly replied that the problem wasn't with the inspector, but with the atmosphere in the factory. If the inspector thought that false data was expected and desired, that recording data that wasn't actually obtained through inspection was okay and tolerated...there was a problem with the management.

In our situation, we switched suppliers because we couldn't trust the management.

I also had a situation where I was asked to keep two sets of data--one real, one to show to the UL inspector when he visited the factory. I refused: 1) it's not right; 2) we would be caught; 3) it wouldn't force us to improve.

I don't know what happened at GSK's plant. But it obviously wasn't a "commitment to continuous improvement."

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