Smart-QC: Main Goals and Impact on Enterprise QC:

  • A Standardized application for planning and budgeting across multiple geographically dispersed lab operations.
  • Identifies capacity expansion needs
  • 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

Smart-QC: 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

- Resources requirements:

  • Calculate the required analysts at each lab based on various forecast scenarios
  • Instruments requirements
    • Define short falls / excess capacity

- What-If-Analysis

  • Campaign size effect
  • Standards changes / process improvements
  • Forecast changes: volume / mix / new product
  • More …

- 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