PT  - JOURNAL ARTICLE
AU  - Bernhard Hinsch
AU  - Sven Alexander Moritz
AU  - Ana Isabel Esteban Nunez
AU  - Timothy E. Orzula
AU  - Daniel Taylor
AU  - Alexander Nezlin
TI  - Points to Consider when using KPIs/Metrics
AID  - 10.5731/pdajpst.2020.012401
DP  - 2021 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2020.012401
4099  - http://journal.pda.org/content/early/2021/06/15/pdajpst.2020.012401.short
4100  - http://journal.pda.org/content/early/2021/06/15/pdajpst.2020.012401.full
AB  - Pharmaceutical quality systems (PQS) according to ICH Q10 require the identification of processes that need to be measured. Designing and maintaining a metrics system in a way that serves its purpose well requires careful consideration of various aspects in order to meet expectations. The purpose of using key performance indicators (KPIs)/Metrics can be defined by main aspects that include: a. supporting the achievement of objectives by making them measurable, b. reaching comparability and/or standardization of performance for organizational units, c. achieving objectiveness in assessing performance. The first two aspects are closely linked to management responsibilities. Therefore, management needs to be strongly involved with the activities of setting up and maintaining a metrics system. This paper provides an overview of the points to be considered when setting up and managing a quality-related metrics system.