Context.

Growing manufacturer of hybrid medical drug-device, rooted in successful entrepreneurial mindset.

Problem.

Acquired by a household-name family of companies and struggling to make the transition.  Problems with FDA relations, public image and poor product quality.  Product was on the verge of being taken of the market.  Product quality was spiraling downward.

Action.

Work with the quality group to build a positive image and reputation with the FDA.  Facilitate mission, vision and values discussion.  Establish a team identity.  Build a central training organization dedicated to sharing best practices and encouraging a focus on compliance, while looking for simple, quick, cheap and effective solutions to manufacturing problems.

Results.

FDA relationship was repaired.  Quality staff head count was ultimately reduced by 30%.  Product remained on the market.  Product quality was stabilized.

Culture change, incorporating: mission, vision and values; best practices; email standards; meeting management and telephone etiquette; ground rules; service level agreements; and, commitment negotiation.

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