The
MHRA have produced an interesting blog on quality culture in the historical
perspective, looking at some of the events that have shaped the development of
quality (some of which have had a serious impact upon human health).
The
blog notes that a strong quality culture is built upon:
knowledge
of what is important, and how a process achieves critical quality attributes
diligence,
by fostering awareness that everyone contributes to product quality, and
understanding that “my actions impact the patient and the company”
vigilance
by individuals who know what ‘right’ and ‘wrong’ look like in their process,
and a mechanism for management to be aware of problems
senior
management commitment to being visible and transparent in decision-making so
that positive outcomes can be seen from the diligence and vigilance efforts.
This is more than the company mission statement – it’s ‘walking the talk’.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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