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Voices on Quality: Ode to Quality Managers. In celebration of World Quality Month, members of the InstantGMP team
each wrote pieces on what quality means to them. This post was written by
our Sales Director, Robert Pochadt.

We live in an imperfect world. It’s just that way. Most end manufactured or designed products have no built-in device to ensure standardization or fitness for intended use. Everything is then potentially unique, with no assurance that its promised function would happen or its safe operation or consumption could be guaranteed.

Quality is the serious hand that intervenes and demands predictability and safety, the parents of trust.

Did you ever stop to think what the human casualty list would be if there was no USDA, no FDA? Food, drugs, medical devices would be much more hazardous,  a likely case, for the last two, of the cure being potentially more dangerous than the disease.

It takes much intelligence and effort to create and enforce quality regulations, and a special kind. Quality regulation authoring demands a certain design engineering-like awareness of characteristic potential hazards, and the ability to articulate meaningful, pertinent rules in complete, understandable text. Quality enforcement demands a strong, quick  assessment skillset and mindset, like that of top  professional law enforcers or the best baseball umpires, as well as a deep working knowledge of the regulations. In a way, it is a type of law enforcement, with the applicable regulations being the laws.  The best quality managers are truly quality centered–the subject matter experts emeritus or emerita; they are most likely teaching, consulting, publishing, sitting on the management or directorship of an industry organization or interest group.

So here is a tribute to the uniquely talented individuals that make quality happen–to the team at FDA and other regulatory groups that continuously, and often thanklessly, craft guidance and inspect for it –to the quality manager who shuts down a production line until the cause of the defect is found and fixed–to the wise company that gives him or her the authority to do so–to anyone spending evenings or odd moments studying newly amended regulations–to the rest of us, who make consumer choices based on quality, and petition through ballot, market, and blog for improvements, so that we can all continue to enjoy better quality of life.



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