Smart-QC: Main Goals and
Impact on Enterprise QC:
§ A Standardized application for planning and budgeting across multiple geographically dispersed lab operations.
§ Ability to perform “What-if” analysis at an
aggregate level as well as at the site specific level (i.e., Stability, Raw Material release)
Use common Key Performance
Indicators and terminologies to evaluate
performance across sites and benchmark them against internal and external best practices
Proactively smooth variable work load across sites
with minimal cost and service level impact
One common platform for productivity
improvement projects justification
Resources Modeling - Importance
§ Capacity Modeling is one of the most critical elements in designing a new laboratory, expanding
an existing QC operation, or conducting a feasibility check and "what if" analysis stage.
It combines required capacity from various demand sources
- such as clinical products, current and future commercial products, etc.
Resource Modeling provides the translation of demands
in terms of staffing, instruments, utilities, space, etc.
Smart-QC General Usage
Calculate the required analysts at each lab based on
various forecast scenarios
Define short falls / excess capacity
“What if” analysis
Campaign size effect
Standards changes / process improvements
Forecast changes: volume / mix / new product
Percent of time analysts spend on admin., preparation, set-ups,
calculations: Value Added (VA) vs. NVA
§ General reports / KPI
There are 5 Types
of demand forecasts that affect long term resources planning