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THE PARKMORE QUALITY FUNCTION NEWSLETTER

Quality begins with Me

Quality isn’t someone else’s responsibility. of sampling across all drug -device combination products
Quality begins with you. So what can you do? in partnership with our regulatory agencies. Laverne
demonstrated Patient Focus QBwM behaviours by ensuring
that there was no impact on product quality assurance levels.
Be courageous. If you see something, say
something Patrick Hynes demonstrated Courageous QBwM behaviors
when he identified that units built for validation purposes
Put the patient first were built prior to the Engineering Build Request (EBR)
being approved and therefore did not meet Quality System
Strive to prevent issues before they arise requirements. His actions correctly resulted in the units not
being used for the validation protecting both his team , the
Hold each other accountable business and ultimately the patient .

Stacy Flanagan demonstrated Patient Focus QBwM
Imagine what we can do for patients when each of us acts behaviours. During shutdown an urgent request was
like quality begins with me – by exhibiting these behaviors. submitted to the Sterile Release department to release a
Every day, we strive to be seen as a trusted partner. One COC to Japan for the launch of Micra product. The inspectors
way we build trust in Medtronic is by continuously striving to trained to complete this task were on annual leave. Stacey
improve our quality performance. Quality Begins with Me willingly acceded to the request to come into work at short
(QBwM) will improve our quality performance by elevating our notice to prepare and release the necessary COC which
quality culture – our “tone at the top” and the way we engage necessitated having to bring her children with her to complete
employees in patient safety, quality awareness and compliance the urgent task.
every day.
Recently Laverne Mullen, Quality Engineer Operations B2, lead
a team to develop a strategy to reduce sampling and reserve
quantity requirements on IN.PACT Admiral product (this is a
drug device combination product).
The development of this pioneering sampling strategy
required collaboration and buy in across several different
functions (including our regulatory agencies) and innovative
thinking from the project team, all of which ultimately
culminated in successful regulatory approval of the new
strategy. The results of this groundbreaking endeavor will
deliver a significant cost savings for the business of up to
$1million annually. Moreover it has paved the way for ongoing
work to develop further innovative and unique strategies Stacy Flanagan, Laverne Mullen, Patrick Hynes

Parkmore Quality Partner in Excellence