Quality Management Reviews

Quality Management Reviews (QMR) are regular presentations of the Quality Management System (QMS) to Top Management (or Management with Executive Responsibility) so that they may assess the suitability, adequacy and effectiveness of their quality program.

The respective ISO standards describe what is to be reviewed in the regular QMRs and as a quality manager, you should be literal in applying the requirements of the respective standard to which you are accountable to the QMR agenda. It is equally important to consider respective regulatory requirements.

For example, in the *medical device world, the subparts of 21CFR820 should be included in the agenda of the QMR, as well as any other regulations to which your organization is accountable. I like the IATF 16949:2016 automotive standard, a supplement to ISO 9001:2015. Here the International Automotive Task Force, made up of the major global automakers, puts extra focus on the cost of poor quality as well as equipment maintenance as inputs to the QMR.

In the QMR decks I prepare, I must include a review of the inputs to the QMS which includes a review of the Quality Policy and requirements of interested parties. I include pages on customer feedback, both positives and negatives. A review of quality objectives and the status to plan is a must. And then after covering the required inputs per the respective standard(s), the presentation moves into process performance, followed by outputs and a summary. During the QMR, I ask for feedback from Top Management on their assessment of the suitability, adequacy and effectivess of the QMR, and this feedback becomes a part of the QMR record.

For me, I work with process owners to develop inputs, content and outputs for the QMR. In very practical terms, I create a template presentation with assigned page owners. These pages are typically made up of 4-blockers or quad charts. Process owners will present their respective process performance in form of KPIs for effectiveness and efficiency including actions for any KPIs that are off-target.

As quality manager, my role is also in ensuring the actions from the previous management reviews have been addressed and these actions and their closures are presented in the QMR. I also ensure the dots are connected through the QMS and QMR, illustrating the customer feedback, the connection to continuous improvement and description of how this feedback is incorporated into the next generation design. I also ensure the dots are connected through the complaints to continuous improvement to updated risk management files.

As a quality manager, I find great satisfaction in presenting a solid QMR, demonstrating to Top Management how we are operationally performing, driving improvements in product quality design, in production process quality, in mitigating or retiring risk and in keeping quality momentum moving forward.

*And since I mentioned medical devices, note that the FDA is not privvy to the complete presentation and record of the QMR but rather may review the agenda and outcomes, often described in a separate record.