Operational metrics are critical for evaluating, sustaining and improving the performance of a manufacturing operation. Common examples of operational metrics include schedule adherence, cycle time, yield, reject rate and loss for each unit operation. The way metrics
are chosen, defined and used varies greatly across the biopharmaceutical industry. PDA believes that the industry could benefit from
suggestions related to the identification, definition and use of operational metrics.
With this in mind, in late 2016, PDA’s Manufacturing
Science and Operations Program (MSOPSM) established a small cross-industry operational metrics team to discuss how metrics can be
used to improve operations on the shop floor, at the manufacturing site and across the globe.
The operational metrics team includes members from Eli Lilly, Genentech/Roche, Merck, Neurocrine Biosciences and Sanofi, representing expertise in drug substance, drug product, device assembly, packaging, operational excellence, continuous improvement and supply
chain. In 2017, the group conducted an all-day benchmarking workshop at Genentech/Roche that addressed such concerns as the definition of metrics, their use in driving improvement, and the pitfalls and benefits of using them—all in the context of real-world examples
spanning segments of the biopharmaceutical the industry.
The initial set of metrics targeted in the workshop consisted of overall equipment effectiveness (OEE), yield and cycle time. Key outputs
from the benchmarking workshop include a compilation of best practices and approaches to using metrics to drive performance. Some
examples of the insights from the workshop are: (1) OEE trending has been successful in driving benefits from better line uptime to better assay selection, and (2) using a balanced scorecard with “competing” metrics can help counteract behaviors that can otherwise result
from focusing on a single key performance indicator. The group also reached a shared understanding of challenges in using metrics and
how to overcome them, such as the visibility of metrics related to contract manufacturing, or the way yield indicators are defined in drug
substance processes (either batch or perfusion) compared to drug product manufacturing.
In 2018, the operational metrics team has continued to work under the guidance of the MSOPSM to address additional metrics such as
schedule adherence, end-to-end cycle time, reliability and employee engagement. The 2018 action plan developed by the team includes
a variety of outreach efforts to engage internally within PDA and across the industry as a whole through benchmarking. The ultimate intent is to share the outputs of the operational metrics team with PDA membership in ways that make them useful, relevant and practical.
In the meantime, the operational metrics team is actively looking for additional participation from the PDA member community and is
exploring ways to incorporate member feedback into its efforts.