Risk Management: your limits, measured every night

The question

• Risk-based quality management asks one question every day: where should we look first?
• In MAESTRO, Risk Management answers with two things: indicators that are measured, and a register of the risks you manage.

Indicators

• 11 indicators are built in: quality events by site, overdue corrective actions, training compliance, visit window adherence, missed visits, and more.
• Each night, MAESTRO takes a reading for every active indicator, and keeps the numbers behind it.

Limits

• You decide what is too much. Set a warning limit and an action limit, and you can record why.
• As you type, the form shows what those limits would flag today.
• Limits cascade: a site limit comes first, then the trial, then the whole organization.

Signals

• When a reading crosses a limit, MAESTRO raises a signal, and notifies your quality managers.
• One excursion is one signal. Three weeks out of limits is still a single record, counting its periods.
• Acknowledge it, and say what is being done. It stays open until someone resolves it.
• Even when the numbers recover, the signal does not close itself. Resolving it needs a conclusion.
• From a signal, you can raise a quality event, or raise a risk.

Register

• In the register, each risk carries a rating, justified by its likelihood, detectability and impact.
• Issues are logged with their escalations. And when similar issues repeat, MAESTRO offers to raise a risk from them.
• A periodic review freezes the register, collects its sign-offs, and is filed to the trial master file.

Risk Management in MAESTRO: your limits, measured every night, and nothing closed silently.