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Presenter details five QMM practice areas including management commitment and technical excellence
Summary
The presenter outlined five QMM practice areas: management commitment to quality; business continuity and supply-chain reliability; advanced quality systems and risk monitoring; technical excellence; and employee engagement and empowerment.
The agency official described the QMM assessments five practice areas and what each evaluates. For Practice Area 1 the official said assessors look for senior managements company-wide commitment to quality, alignment of quality with business objectives, managements modeling of quality culture, and effective stakeholder communication.
Practice Area 2 focuses on business continuity and anticipatory planning to address supply-chain disruptions, while Practice Area 3 assesses advanced pharmaceutical quality systems, including quality risk management and process/product monitoring. The official described Practice Area 4 as "technical excellence," which examines the development and implementation of fit-for-purpose technologies and novel solutions to optimize operations. Practice Area 5 evaluates employee empowerment and engagement, and whether staff are positioned to take ownership of quality objectives.
"Mature manufacturing establishments do not treat quality, operations, and business as silos," the presenter said, adding that integration of those functions helps prevent downstream product availability problems.
