The short answer
Hold management review more often, keep it short, and make every item end in a decision. A monthly or quarterly rhythm with a one-page dashboard, a short list of exceptions and a clear decision log turns it into the place where leadership steers the business.
Management review is a requirement in ICH Q10 and in ISO 9001 clause 9.3. Yet at many sites it has become a once-a-year event: a long slide pack, a long meeting and a set of minutes that mostly say "noted". It meets the requirement on paper and changes very little in practice.
Three patterns show up again and again. The meeting is too infrequent, so the data is months out of date. The pack is too long, so leaders can't see what matters. And the agenda is built around the standard's list of inputs rather than the decisions the business needs to make.
“A management review that changes nothing is just a very expensive meeting.”
Craig Jacobs, Founder and Chief Momentum Officer, Affirm8
The standards set out what management review must consider, including audit results, customer feedback, process performance, CAPA status, changes that could affect the system and opportunities for improvement. A regular review covers these naturally over the year. Map each required input to the meetings where it is discussed and you have clear evidence for auditors and inspectors.
A strong management review is short, typically sixty to ninety minutes. It focuses on trends and risks rather than individual events. It results in visible decisions on resources, priorities and improvement projects. And leaders leave the room knowing exactly what they committed to.
Most leadership teams welcome a shorter meeting that achieves more. A trial also lowers the barrier to change, because it doesn't ask anyone to abandon the existing process until the new one has proved itself.
Management review is one of the few meetings where quality and senior leadership sit at the same table by design. Used well, it is the most powerful tool a Quality Director has for steering the business. Used badly, it is an annual box-tick that everyone quietly dreads.
The standards do not set a fixed frequency, only that it happens at planned intervals. Many high-performing sites hold a short monthly or quarterly review with a fuller annual summary.
Senior leaders who can make decisions on resources and priorities, including the site head, operations and quality leaders, and representatives from functions such as supply chain, engineering and finance.
Affirm8 helps quality and operations leaders across pharmaceuticals, supplements, medical devices and cosmetics redesign management review, build decision-ready dashboards and facilitate reviews that drive fast, fact-based decisions. Start with the free Always Audit-Ready Diagnostic at affirm8.co.uk.