IEC 60601-1 3rd Edition, Part 4 – Risk Management

Posted by on May 27, 2019 in Design, Device Tips

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In a previous Device Tip I mentioned that one of the key Process Collateral Standards of IEC 60601-1 3rd edition is ISO 14971, Risk Management. In fact. I often refer to Risk Management as the “backbone of the 3rd Edition” since it runs through the General Standard (IEC 60601-1), all the Collateral Standards and all of the Particular Standards I have dealt with.

So here’s the tip:

Integrate Risk Management as a standard part of the Design Control, Production and Post-Production processes.

In the past many companies (and Design Teams for that matter) have treated Risk Management as an island, just outside the Design Control process. A place one visits occasionally but doesn’t really live there. Once the Risk Analysis is done, it was left on the island and never looked at again (“whew, glad we got that Risk Analysis done so we can get back to designing”).

Risk Management Island

The following table shows how Risk Management can be integrated as a standard part of the Design Control, Production and Post-Production processes.

Product Life-Cycle Element Risk Management Process Element
Design and Development Planning Risk Management Planning
Design Output Risk Analysis
Design Review Risk Analysis Review
Design Verification Verify implementation and effectiveness of Risk Mitigations
Design Validation
  1. Validate implementation and effectiveness of Risk Mitigations
  2. Create Risk Management Report
Design Transfer Process FMEA
Design History File Risk Management File
Design Changes: Design Change impact assessment Design Change impact to Risk Analyses
Production Implement and verify effectiveness of Process Risks Mitigations
Post-Production
  1. Collect and analyze post-production data
  2. Review and update Risk Analysis

The following table provides a more detailed view of how Risk Management can be integrated as a standard part of the Design Control, Production and Post-Production processes

Product Life-Cycle Element Risk Management Process Element
Design and Development Planning Risk Management Planning
Design Input:
  1. Use/Usability Specification
  2. Product Requirements
 Risk Analysis Input
  1. Initial Hazard Analysis (HAZOP)
  2. Initial Design FMEA
Design Output: Product Design
  1. Risk Analysis elements:
    1. Hazard Analysis (HAZOP)
    2. Design FMEA
  2. Trace Risk Mitigations to Product and Software specifications
Design Review: Risk Analysis Review
Design Verification:
  1. Product Design Verification
  2. Labeling Verification
  3. Packaging Verification
  1. Verify implementation of Risk Mitigations
  2. Verify effectiveness of Risk Mitigations
Design Validation:
  1. Simulated Use testing (Usability Validation)
  2. Actual Use testing (Clinical Validation)
  1. Validate implementation of Risk Mitigations
  2. Validate effectiveness of Risk Mitigations
  3. Create Risk Management Report
Design Transfer: Manufacturing process flowchart Process FMEA
Design History File Risk Management File
Design Changes: Design Change impact assessment Design Change impact to Risk Analyses
Production
  1. Implement Process Risks Mitigations
  2. Verify implementation of Process Risk Mitigations
  3. Verify effectiveness of Process Risk Mitigations
Post-Production
  1. Collect post-production data
  2. Analyzed post-production data from a Risk perspective
  3. Review Risk Analysis for need to update

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