ABSTRACT
Effective and efficient utilization of assets by pharmaceutical research or manufacturing organizations is fundamental to the early delivery of new products to market and to satisfying customer demand once those products have been approved for release by the relevant regulatory authorities. A carefully designed strategy is essential for optimizing and maintaining system reliability, capability, and performance consistency; that is, assets must:
• Be available when needed and must not fail during use • Function consistently to predefined performance criteria • Meet performance criteria without undue stress, risk of failure, or reduced asset life
The continuous improvement of asset reliability, consistency, and capability, either mutually or simultaneously, is the basic objective of the engineering management strategy in order to reduce operation and maintenance costs and increase regulatory compliance. The foundation for continuous improvement is information, without which it is impossible to establish a rationale for change. This foundation must be established at the start of the project with the definition of the business need in measurable terms, i.e., performance criteria, without which there is no basis for design, testing, operation, maintenance, compliance, and consequently continuous improvement.
