Process Risk Management Procedure
Analyze production-process risks and document their controls with this editable Process Risk Management Procedure and Excel worksheets. It follows the manufacturing flow and possible process failures through risk estimation, control measures and reassessment after controls.
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Editable Microsoft Word and Excel files, with related forms, supplied as a digital download.
Manufacturing process risks and control worksheets
The included Excel worksheets and related forms guide the following steps:
Preparation Steps
Risk Identification
Risk Estimation
Preliminary Risk Level
Risk Control Measures
Re-Estimation of Risk Post Implementation of Controls
The process risk assessment starts with a manufacturing flow and the functions of the product and process. Team members identify possible process failures, hazardous situations and harms, estimate and evaluate risk, then define controls and evidence that those controls work. A later process or product change prompts review of the assessment. The worksheet gives production and quality personnel a common place to record the reasoning behind the controls.
Use this production assessment with the overarching Risk Management Procedure and the Design Analysis Procedure.
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.
