• Optimize Your Quality Management Review and Increase Management Engagement


Optimize Your Quality Management Review and Increase Management Engagement


Pia Lise Sandau, Corporate QMS Expert, Novo Nordisk A/S, Bagsvaerd, Denmark

Co-Presenter: Yeliz Saföz, Project Manager, Novo Nordisk A/S, Bagsvaerd, Denmark


High Risk Audits, Improved Audit Tools, Process Auditing, Risk-Based Thinking


Aviation/Space, Chemical, Energy



Going from a QMR process perceived as detached and less value adding to a process where trends and improvements are in focus requires a change.

In Novo Nordisk, a global pharmaceutical company with many processes and external requirements, QMR was seen as a massive task. QMR’s were conducted at five levels across the company and often data were evaluated more than once. Management perception was that the review was double work and non-value adding as critical quality issues seldom reached Executive Management. Furthermore, in several areas, management already looked at the performance board once a month, so at the biannual QMRs there were no real surprises.

This called for a change. Although heavily reliant on the QMR for an overview of the performance of all regulated activities, Novo Nordisk acknowledged that the QMR had grown out of proportion. This made it hard for management to identify problems, issues and risks in order act.

Change was initiated using different methods to move the QMR to a more risk based approach that focused on critical quality issues. The foundation of this work was a previously conducted gap analysis that gave an overview of external requirements. This analysis was actively used in the project to narrow in on agenda points. In addition, stakeholders at different levels were interviewed to identify pain points, and several workshops were conducted focusing on the main issues identified during the interviews, such as format of the QMR, data collection and the risk assessment tool.

The change project revealed five actions to optimize the QMR and increase management engagement:

1) Perform a risk evaluation of the frequency and levels of needed QMRs

2) Focus on critical quality issues

3) Incorporate risk assessment in top management QMR

4) Look forward instead of only backward

5) Only look at data once.

The outcome of the change project is that Novo Nordisk now has fewer QMR meetings; a more lean and effective process; and a new focus on possible future issues and risks. QMR remains an important overview of performance of regulated activities but the risk based approach enables management to act faster and thus increases their engagement in the QMR and their perception of the QMR as being value-adding.