Any work flow is handled in processes. Therefore, it is critical to know the relevant processes and link them appropriately to work efficiently and effectively. There needs to be an aligned break down of all processes so that they all work to contribute to the intended targets and create value for the company. Analysis of existing processes and continuous improvement is the most relevant success factor in any enterprise. 

Services provided in this area:  (individual/single projects or in more general combination)

  •   Process Analysis and identification of improvement factors
  •   Revision of existing processes as improvements of compliance are needed
      (e.g. deviations, CAPA, audit observations, 483 remediation, warning letters)
  •   Investigation, Trouble-shooting, Ishikawa-Analysis, Root cause identification
  •   Support in performance improvement projects to enhance operational excellence

                  Focus on the work processes

                  Increase efficiency and productivity

  •   Risk Analysis

                 General process analysis for risks and impact in areas/departments

                 FMEA process analysis

                 Consideration for using risk analysis as a management tool

  •   Value Stream maps
  •   Analysis of supplier-customer processes (internally/externally)
  •   LEAN/6sigma to support continuous improvement (DMAIC)
  •   Balanced Score Card Analysis, establishment of vision, strategy, and goals

  •   Set up and optimization of compliant and efficient laboratory processes,
      technological and scientific support in all laboratory systems

  •   Cleaning Validation 

  •   Product and technology transfers between sites or companies
      e.g. R&D to production, within production network, or to/from 3rd party 

Services provided in

Knowing Process