Example of How a Quality Systems Get Out of Control

Posted by on Jan 3, 2011 in Uncategorized | 0 comments

Last night, CBS’s 60 minutes, aired a piece about a GlaxoSmithKline subsidiary in Puerto Rico that was making drugs for them (Glaxo Whistle-Blower Lawsuit: Bad Medicine – CBSNews: http://bit.ly/fj4AzL).    The piece went on to explain that a Quality Assurance team was sent in to investigate an FDA finding and found much more than they bargained for.  In fact, many errors were found ranging from under-strength doses to mix tablets in the same container.  It made the viewer feel that all the processes in that plant were out-of-control.  After sending a report to upper management and not getting an adequate response, the team leader sent the report to the FDA.  The FDA came in, seized the plant, and shut it down.  As a result, 900 people lost their job.
Many people viewing the program probably were as asking themselves, “How could this happen?”  There could be several reasons for it.  Let me speculate on a few.
First, the plant’s management knew exactly what was going on and hadn’t followed up to make sure the employees were following the proper procedures.  As long as the production quotas where being met, they were satisfied.
If employees had been properly trained, on-going internal audits conducted in the plant would have uncovered these bad practices.  A quality system is something that must be monitored daily, i.e., the processes are working correctly, employees are following the systems, checks are being made, etc.
The Glaxo representative interviewed stated the they had 80 plants world-wide.  It is a huge undertaking to make sure quality levels and systems are maintained in a global organization.  Glaxo would have needed to hire quite a few employees to audit these facilities on some regular basis.  In fact, in the piece, the audit team leader was let-go, supposedly due to downsizing (please!).
Sad to say, many companies are doing the exact same thing in order to be competitive.  As global companies expand, they typically look for low wage countries in which to set up a facility.  The work ethics are not the same and often employees don’t understand why they need to do certain things.  A company team comes in, trains employees, gets the facility started, and then leaves.  Then the plant’s management does what it wants.

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