Saturday, 4 May 2019

Quality Culture: Learning from History


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’.

The blog can be accessed here: https://mhrainspectorate.blog.gov.uk/2019/02/28/quality-culture-learning-from-history/

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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