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The economic impact of Covid-19 is real. Recovery is challenging since the demand for products drop and supply chain gets impacted as countries deal with the pandemic. If the GDP shrinks, the pharmaceutical industry will also feel the pinch:

This might be the time to think of applying effective metric in our industry. The key performance indicators(KPI’s) may need to be further sharpened and trickled down for business success. A study article identified the top KPI’s and key result indicators (KRI’s) for pharmaceutical organizations. They propose a model that includes measurement of KPIs and KRIs for the pharmaceutical industry.

It is interesting that the US FDA quality metrics guidance already provides the industry with usable KPIs for the Quality Unit. Quality is everyone's responsibility, however, it has been proven time and again that diffusion of responsibility undermines responsibility and will result in organizational harm. Therefore it is critical that meeting FDA quality metrics KPI is established as a goal for Quality Unit only, while other quality-focused KPIs are assigned to the different units. The Quality Unit leadership is expected to strategically, technically influence and provide regulatory compliant solutions to the business teams, analytical and formulation development groups, operations teams and other groups in order to maintain the metric.

Similarly, meaningful KPIs for Regulatory Affairs that measure the quality of submissions and the number of post-approval change management protocols incorporated (ICH Q12 for operational flexibility) can provide quick-term and long term value for the organization. Well established Operations, Supply Chain and Engineering KPI’s such as downtime, number of on-time predictive maintenance orders, conversion time and cost are also critical. Indices such as PaCS Index can be applied as KPI for manufacturing site heads. PaCS could be used to determine which site has robust processes. The index can be a component of a periodic performance review by executive management as recommended by ICH Q10.

Is there a need for setting novel KPIs as we go through some uncertain times where the upcoming year's performance may not be possible to be defined by financial indices?

Both macro and micro level KPIs are important for the pharmaceutical business, would you be advising for a higher % of departmental/project-specific (micro) KPIs to be set this year?

Feel free to share, comment and voice your thoughts.

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