Quality Management- Important everywhere?

When it comes to standards and quality management most people think that they are distinct characteristics of a product. In all reality I believe that they are very much alike. The connection between the two is simple: the standards set to regulate certain aspects of production etc are what ensure that high quality is met hence that quality management is effective.  The question however is: when is quality management important? Where are standards made?   How often should an agency check in to make sure that standards are in fact being followed? By standards I mean those regulations used to dictate how a product can be used- most of these standards have to do with safety and supports “differentiation, low cost and response strategies” (slides ch.6 number 1)

With this being said I was intrigued by the video found at the following link: http://www.cnn.com/video/#/video/bestoftv/2012/10/26/exp-erin-new-developments-in-meningitis-outbreak-elizabeth-cohen.cnn

If you take a look at the video you might just be as surprised as I am. There are so many problems wrong with this company’s quality management procedures that there were “25 killed in 18states” (video). So where should the line be drawn or who should the finger be pointed at? Is the FDA responsible for not finding this out before hand? To a certain point I think that all of the sanitary issues found should have been discovered beforehand. For example, the standards are so flawed in this case: “they found greenish blackish growth inside of dozens of veils of medicine”. Were those technicians working their not trained well enough to know how to make the medicine and know when the medicine is contaminated? Is the staff not being thoroughly screened by Human Resources before being hired? Is the staff adequately trained in ethics so that they know the impact that contaminated medicine has on many lives?

So many questions, but the lesson here is that the standards at the company were completely flawed. Not only was it the medicine standards but also the set standards for the sterilization tools and the standards set for hiring staff. All of these standards, although branch from different aspects of the company feed down into the quality of their product which reflects their management of quality. Clear the quality management in this case is completely invisible. Sadly, lives had to be lost in order to find this out.

What can be done so that next time the situation does not get to this extent?

One thought on “Quality Management- Important everywhere?

  1. In dealing with internal medicines the strictest of quality control standards most apply. As we see here both standards and adherence to those standards fell drastically short of expectation with tragic consciences. The firm responsible clearly should have known that the affected batches were some how contaminated. Even with the adoption of safety protocol if a firms quality control personnel are not competent disaster can ensue. More rigorous standards and adherence to those standards most permeate the organization.

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