Global QC Strategic Capacity Modeling

Developing a QC Strategic Capacity Model as a strategic-decision support tool for top management 

Background

• Following 2 long term governmental agreements, a biopharmaceutical company expected growing demands for 2 of its major products
• Meeting future demands requires a significant scale-up both in manufacturing capacity as well as supporting functions – QA and QC
• Top management wanted to get an estimation for future requirements in terms of QC capacity (FTE, equipment, footprint) based on different demand profiles for top products
• The company serves customers worldwide – mainly in the EU and US
• Except for capacity model outputs, project included various network strategy analyses; outsource vs. in-house, QC facilities locations, impact of future products, etc

Challenges

• Company was recently acquired by one of the leading global pharmaceutical companies, parent company’s umbrella is not fully established yet and had to be taken into account in the analysis
• Project included 4 different sites in 3 countries, aligning all sites regarding the scope of the work and the objective was crucial for success starting at kick-off
• Future demands and products change rapidly, this required the model to be as flexible as possible to allow usability of the model as a top management strategic decision support tool
• Translating top product demand to QC analyst’s workload required a structured and coherent approach across all sites – especially with non-batch-related activities such as Stability studies, raw materials, lab support activities, etc

What has been done?

• Step 1 was providing training sessions for the analysts in the different sites how to time the different assays in the lab, all together across all sites there were ~200 different assays, for each assay the variable time per sample and the constant time per run was determined
• The project included 4 site interventions, 3 main activities took place in each site:
  • Time studies – measuring the time required to complete different tests
  • MOS – on site observations to determine efficiency levels and identify improvement potentials
  • Staff interviews – mapping current processes and translating top product demand to QC workload in each site
• During site intervention we customized the capacity model and inputted the data gathered to fit each site unique attributes, the process included routine sanity checks with site managements 
• Issues such as shift pattern, seasonality, future technologies, non-test-related activities, etc. were taken into account in the model as an input to allow scenarios analysis in each site
• We compared all the models outputs with Tefen’s  benchmark to enforce model results and provide the client an industry overview

Results
For each demand profile, we provided a detailed capacity requirement: FTE, critical equipment, footprints, as well as a strategic analysis regarding the global QC network impact for each scenario. 
Client was provided an analytical bottom-up calculation for estimated growth of the QC organization as a function of top product demands till 2022. 
Client asked Tefen to continue to a phase 2 project; improving overall performance in the QC labs based on the potential identified during phase 1. This includes: reducing lead times, increasing productivity, saving Capex, avoiding recruiting, etc.