What KPIs should you monitor for your GMP quality improvement plan?

The fundamental principle guiding improvement is that if something cannot be measured, it cannot be enhanced. Key Performance Indicators (KPIs) play a vital role by quantifying GMP, establishing a baseline, and serving as a foundation for ongoing improvement initiatives. The primary purpose of implementing KPIs in GMP is to identify and define specific parameters that must be measured at regular intervals. These measurements enable the continuous evaluation of adherence to requirements and expectations set by various stakeholders such as regulators, customers, and suppliers.

KPIs are only what matters. It’s not the work, it’s the outcome of the work. Now how can you gauge that outcome? KPIs. For every aspect of the job, ask yourself how success looks like then determine how you will check for it. This is what you need to measure.

When selecting Key Performance Indicators (KPIs) for Good Manufacturing Practices (GMP), clarity of purpose must be there. KPIs should not be chosen just for the sake of having them; they serve as means to achieve specific objectives. KPIs are tools, not ultimate goals in themselves. The selection process should involve a careful consideration of the critical aspects of GMP.

Algo importante a destacar, es que los KPI que se seleccionen realmente deben representar cuestiones en concreto. Medir por medir, no sirve de nada. Lo que medimos debe tener impacto y ser significativo. Otra cuestión a tener en cuenta es la interpretación de los mismos. Me ha ocurrido en múltiples ocasiones que los KPI que se encontraban establecidos, la mayoría del personal no entendían que representaban. Si no entiendo lo que me dice un KPI ?cómo puedo aportar para la mejora del mismo? Lo bueno y simple, dos veces bueno. Me gusta pensar en cada proceso crear al menos 2 KPI, uno de "volumen" (o cantidad) y otro de "control" (?qué tan bien estoy realizando este proceso?). En definitiva, ?vayamos siempre desde lo simple a lo complejo!

For each major process activity, ask yourself: what is the desirable outcome from such process step? Then, ask how do you check for it? That would be how to measure. In many cases you find a gap. That gap is a need to define a standard or a practice.