Contract Manufacturing Roundtable
management participation in governance and communication
forums. Collectively, we develop a performance management process that integrates input from operations, quality, management,
procurement, supporting groups such as EHS (environmental,
health, and safety), and supplier counterparts. Key to the overall
success of the collaboration is the Relationship Manager who
focuses on a big picture view, is aware of day-to-day operations but
not actively involved, and is the center of the formal communication matrix. Critical to quality metrics that clearly define whether
or not a product or process is under quality control at all times,
together with a periodic review and assessment of improvements
based on audits and inspections, is important to the success of
the model.
WHEN THESE AREN'T BEING ACHIEVED,
WHAT STEPS SHOULD BE TAKEN TO RESOLVE?
Bruno: If you plan to implement some type of system (e.g. OPEX, Six
Sigma, total quality) and the metrics that must go along with it, start
with the people doing the work and make sure you get their input and
gain their buy-in. Often the simplest solutions come from necessity
and the workers know what that is. Understand the operation and the
system and make sure that what you are trying to do makes sense for
the factory and that the concept is carried forward from top to bottom.
Casebier: You need to improve projections and coordination with
clinical/commercial. Get a better understanding and control of
manufacturing projections and timing by modeling manufacture and
distribution, as well as assess the duration assigned to activities in a
timeline.
Llew Keltner, EPISTAT: Depends, of course, on the situation —
but in a successful manufacturing campaign plan, virtually all of the
responses to process failure should be built in at the initiation. There
should be no doubt, in virtually every failure, of the response.
Kempinski: Ideally, the client and CMO are working in a collaborative partnership and a forum for discussing OPEX exists. Regular
engagement with top management is critical. It is important to
communicate your experiences to your CMO — both strengths
and weaknesses — and share in the plan for continuous improve-
PRODUCTIVITY.
Excellence in API Development
& Manufacturing
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The CMO Leadership Awards 2013
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