Risk Management Procedure

Plan, document and review medical device risks across design, manufacture and use with this editable Risk Management Procedure and related Word and Excel forms. It covers risk-management plans and files, hazard analysis, evaluation and control, verification, reports, and production and post-production information.

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Editable Microsoft Word and Excel files, with related forms, supplied as a digital download.

The Risk Management Procedure defines departmental responsibilities and required participants for all risk management activities. The procedure includes guidance on risk management flow, risk estimation, risk control and verification, and instruction on the development of: Risk Management Files; Risk Management Plans; and Risk Management Reports.

The Risk Management Procedure also includes instruction on Production / Post-Production activities. The procedure includes multiple forms complete with helpful instruction.

A lifecycle risk process

The core Risk Management Procedure establishes a plan, responsibilities and risk-acceptability criteria. It follows hazards from identification and analysis through estimation, evaluation and control, with documented review of whether the remaining risk is acceptable.

Risk file and feedback

The procedure ties verification of controls to a risk-management report and considers production and post-production information. These records help the team revisit assumptions when a design, process or field experience changes.

The revised risk-management procedure references ISO 14971:2019.

For focused assessments, see the Design Risk Management Procedure and Process Risk Management Procedure.

For biological hazards and evidence specific to device materials and patient contact, see the separately sold Biocompatibility and Toxicity Testing Procedure. Its sample evaluation protocol and report guidance support a focused biological assessment.

See the DESIGN PLUS Quality Management System

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Risk Management: Design and Process Risks for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Risk Management Procedures Bundle. Explore the bundle for the related documents.