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Daily decisions determine the success of your Quality System. The Quality System supports making the right decisions but the local Quality Culture determines what is actually done in the organization.
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The average person influence 5-6 people
Even a great Quality System will fail, if the
Quality Cultureis not of equal standard
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DAY-2-DAY
Daily decisions determine the success of your Quality System
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SYSTEM
The Quality System supports making the right decisions …
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CULTURE
… but the local Quality Culture determines what is actually done
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CULTURE
… or ignored
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CONSEQUENCE
This is why sites with same Quality System can display very different compliance levels
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WHAT
But what is a strong Quality Culture?
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DEFINITION
An environment where each and every person understands and embraces their responsibility for protecting product quality and patient safety
Mary Oates, FDA, ISPE CGMP Conference, June 2012
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WHICH PATH?
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The average person influence 5-6 people
How to strengthen
Quality Culture
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1
Challenge 1You cannot change culture by only changing culture
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FEASIBILITY
You must ensure that the culture you want is feasible
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CLOSE GAPS
Protecting product quality and patient safety
Support
Leadership
Management
QMSKnow-ledge
Quality Culture
SolutionClose gaps that prevent the right choices from being made
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CLOSE GAPS
Finding gaps require insight in how the System support the Culture– and vice versa
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INNOVISOR SOLUTION
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2
Challenge 2People listen to peers – not systems
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MOBILIZE INFLUENCE
SolutionEngage and mobilize the most influential employees
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MOBILIZE INFLUENCE
The top influencers influence 10 times as many as the average employee
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MOBILIZE INFLUENCE
Difficult culture change requires support of the key influencers
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MOBILIZE INFLUENCE
However, it is not enough to know the key influencers
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MOBILIZE INFLUENCE
You also need to know the tribes, cliques and communities…
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MOBILIZE INFLUENCE
Then you can select the right 3% to involve as your Quality Ambassadors
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QUALITY AMBASSADORS
Quality ambassadors are the influential employees that colleagues go to if they have questions or concerns - and whose opinion they trust and respect
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INNOVISOR SOLUTION
