Facility and Asset Management

Lean Biologix has years working with the major CMMS systems. This includes configuration for streamlined performance and compliance, process flows, maintenance plans, spare parts inventory management and purchasing.

Lean Biologix has years of experience working with GMP facilities managers to:

  • Define maintenance and calibration plans and schedules
  • Analyze data to meet reliability centered maintenance objectives
  • Establish best practices in warehouse inventory management and control
  • Incorporate equipment assessments and criticality processes within the system (Direct Impact, Indirect impact, No impact)
  • Define workflows and requirements (GMP, non-GMP, Site services)

 

TOP Documentation Management

For Facility equipment installation and construction projects, the management of the turnover package documentation is oftentimes overlooked or implemented poorly at the end of the project. This leads to costly delays in manufacturing startup.

Lean Biologix works with our clients and the general contractors to bridge the gap and manage the process throughout the project. Our method delivers an electronic turnover package that allows users access from anywhere with an internet connection. Below is a summary of the process and advantages of the Lean Biologix ETOP process.

 

Methodology:

    • Define documentation requirements upfront
    • Establish electronic storage location and structure
      • System specific documentation
      • Vendor packages
      • Project-wide documentation
      • Define location for all required documents
    • Define documentation collection process and requirements a for all vendors/sub-contractors
      • Document approval process and transfer method
    • Schedule regular check-in meetings to:
      • Identify issues
      • Review changes due to construction decisions
      • Eliminate gaps and omissions
    • Continually update system with approved/completed documents
      • Provide clear project status by system
      • Identify risks and issues throughout project timeline

 

Advantages:

  • Lower costs for document collection
    • Eliminate missing documents
    • Efficient flow and process developed upfront with end in mind
  • Lower cost for CQV operations
    • Provide all documentation needed
    • Easily searchable
    • Access from anywhere
  • More complete ETOP for life of the facility
    • Living document storage to track changes and keep documents up to date
    • Update documents for Facilities, Engineering and Metrology to leverage for maintenance, troubleshooting and calibration