PDCA Process Implementation for a Pharma QC Department

PDCA Process Implementation for a Pharma QC Department

Situation

  • A global pharmaceutical was looking to challenge the operational performance of their Quality department, specifically the Quality control area.
  • Pressures on improved productivity and cycle time were raised; the site was anticipating a 50% increase in demand whilst also needing to reduce lead times by 8 days (a 30% reduction). There was a requirement to assess the feasibility of whether the extra demand could be absorbed by the current available resource, given a shifted paradigm of improved performance.
  • Due to the lengthy process required for training, both internal area and cross- area flexibility was weak amongst analysts, which resulted in poor resource utilisation levels. The need for a designed flexibility amongst analysts was required so that training could be targeted to needed areas and more specifically to the correct individuals.


Challenge

  • The entire department was split into 3 main areas, which were further divided, making a total of 12 individual and unique labs. Each lab was divided by scientific specialities; hence analysts were pigeonholed into knowledge of their position only.
  • Given the functionally spilt organisation, product focus objectives could not be administered resulting in poor delivery performance.
  • Product specialists were also distributed across the 12 labs; communication was lacking to consolidate the entire sights internal and external demand data, hence foresight of upcoming workload was poor.
  • Lack of oversight of the quality control end to end process, made it extremely challenging to identifying the issue areas in the organisation. Improvement initiatives lacked any solid quantitative evidence that they were being focused at the correct areas.


Approach

  • Rather than providing a one-off solution, Tefens approach was to implement a PDCA continuous improvement process. Once fully established, this framework had the potential to correct the current issues the client was facing as well and form a vehicle for sustained future benefit.
  • The implementation was initiated with a capacity modelling exercise. Demand data across the site was consolidated and an owner to continue this exercise was elected; approximately 200 unique test timings were also measured. By coupling the demand data and test times, 12 individual capacity plans were built, indicating for each lab the capacity requirements to fulfil the current and anticipated future demands.
  • WIP management tools were also provided to high volume labs, to allow for easy management and scheduling of incoming workloads. Product centric focus was re-established and delivery performance terms were agreed with management and customers.
  • A key performance indicator (KPI) tool was implemented to each lab, measuring performance against a consistent set of metrics, designed to a balance scorecard layout.
  • A coinciding reporting structure was implemented to provide a forum where the entire organisation could transfer knowledge and resource to tackle quantifiably identified issue areas.


Results

  • Area based improvement were seen all lab. Best case saw a 30% improvement in cycle time with a 50% improvement in productivity.
  • Creating a holistic capacity overview, provided a means of size the Quality testing operation on a quarterly basis. This allowed management to make proactive decisions on training requirements as well as organisational shifts towards where demand was highest.
  • Identifying structural bottlenecks and critical path tests redirected the focus of improvement investment.
  • Significant cultural shift; global optimisations are address rather than local optimisations.