Tunnell Consulting - Consultants to Management

PHARMACEUTICAL INDUSTRY :
Organizational Transformation

Client:

A major global pharmaceutical manufacturer with a strong biopharmaceutical presence.

Problem:

U.S. biopharmaceutical division plagued by supply issues, process inefficiencies (including declining yield) and low morale. There was corporate concern regarding division's ability to meet production needs to support launch of new 'blockbuster' product.

Approach:

A broad assessment was conducted to evaluate organizational structure, behaviors, leadership and management systems, manufacturing process capabilities and quality systems. The assessment led to the implementation of a comprehensive operational improvement program employing integrated Six-Sigma/SPC and OD approaches focused on improving the technical, compliance, and personal skills performance of organization.

Results:

An effective transformation of the division was achieved within 9 months, including:

Doubling of production capacity

10% - 20% increase in production efficiency (yield)

50% reduction in batch record review cycle time

$2M in specific cost savings

Higher production reliability/product consistency

Improved management and control of operations through the introduction
of a multi-level metrics (monitoring) program

Improved management and staff competency to support sustained
performance and launch of new blockbuster product

Improved morale

Successful FDA Inspection (PAI) for new blockbuster product

10-Fold ROI for client

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See full BioPharm magazine article

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