Skip to main content

Risk Management in Matrix Quality

Manage risk across your quality system — embedded within modules like Supplier, Change Control, and CAPA, or as a standalone company risk register. Built for life sciences and medical device compliance.

For taking a demo with our team.

Matrix Quality: risk matrix on a change control, likelihood by severity

The challenge

Risk management that lives outside the quality system is hard to maintain and audit

  • Risk is disconnected from quality activitiesWhen risk assessments sit in standalone spreadsheets, links between risks and quality events, supplier issues, or changes are maintained manually — if at all.
  • No consistency across the organisationDifferent teams use different formats and criteria, making it impossible to aggregate risk at a company level.
  • Risk registers go staleWithout integration into daily quality workflows, risk registers are updated infrequently and rarely reflect the current state of the business.

Our solution

Risk management embedded across your quality system — and as a standalone register

  • Embedded risk in quality modulesRisk assessments are built into Supplier Management, Change Control, CAPA, and other modules — so risk is captured at the point of decision, not retrospectively.
  • Company risk registerA standalone risk register gives leadership a consolidated view of company-level risks, with full traceability to the underlying quality activities.
  • Consistent risk criteria across the organisationDefine your risk scoring methodology once, and it applies consistently across all modules and teams.

Core capabilities

Risk management that works with your quality system, not alongside it.

Embedded risk in quality modules

Risk assessments are integrated directly into Supplier Management, Change Control, CAPA, and other quality workflows — capturing risk at the point of decision.

  • Supplier risk assessment in qualification workflow

  • Change risk assessment in change control

  • Risk scoring linked to CAPA priority

Company risk register

A standalone, organisation-level risk register for tracking strategic and operational risks — with links to the underlying quality events and activities that inform them.

  • Centralised company risk register

  • Link risks to quality events, suppliers, and changes

  • Management review-ready risk reporting

Configurable risk criteria

Define your own risk scoring methodology, probability and severity scales, and acceptability thresholds — applied consistently across all modules.

  • Custom probability and severity scales

  • Configurable risk score formulas

  • Consistent criteria across all teams and modules

Risk reporting and visibility

Track risk levels over time with dashboards and exportable reports. Always know your risk landscape before an audit or management review.

  • Risk dashboard with live data

  • Trend tracking over time

  • Exportable reports for management review

Hear from our customers

Matrix One is trusted by 500+ Life Sciences & Medical Device Companies