ASQ Boulder 2024-Nov-21 Section Web Meeting

When:  Nov 21, 2024 from 05:45 PM to 07:30 PM (MT)
Associated with  Boulder Section

Topic: Factors to Consider When Choosing a Software Tool for Risk Management
Cost: Free
Note: Thursday 5:45pm to 7:30pm US-MT meeting
RSVP on Boulder Section’s meeting "Meetup Link"
RSVP note: Please provide your Name and Hometown. Same for any guests
5:45 pm Web Conference Start: Networking, Welcome and Section Business
6:00 pm Presentation

  • Speaker: Byron Murray, Medtronic
  • Topic: Factors to Consider When Choosing a Software Tool for Risk Management 
  • Presentation Slides and Video posted after meeting
  • Abstract:
    •  Medtronic has been successfully using an integrated, requirements,
      standards, change, failure mode and effects analysis, risk analysis, test, verification and validation tool since 2017.
    • Medtronic had 10 years of prior experience of using requirements with another tool.
    • When considering a tool for risk management the following should be considered:
      1. The tool should contain at a minimum, requirements, risk analysis and verification.  The requirements become risk controls in the risk analysis. Because the requirements are in the same tool as the risk analysis when the requirements are verified the verification column of the risk analysis is automatically updated with the verification report.
      2. The tool should ideally contain Failure Mode and Effects Analysis, Use Error Analysis, Security Analysis, Process Failure Mode and Effects Analysis. All of the types of FMEA are potential inputs to the risk analysis.
      3. The tool should ideally contain standards. Standards are another input to the risk analysis. Having standards in the tool will simplify tracing between the requirements, standards and the risk analysis. Some of the new standards clause by clause require inspection of the risk management file. If using a tool you can automatically link the applicable risk record.
      4. The tool should ideally contain change, test and validation. Ideally you want change, test, and verification all in the same tool to simply tracing.
      5. The most useable risk analysis is one that is structured with one hazard to one harm to one cause. Because a tool is used it is easy to duplicate a risk record and modify for a harm or cause.
      6. The risk analysis is a derived from ever changing standards and internal risk management policies and procedures, so you need to have a tool configuration that is adaptable and maintainable. The tool should be able to adapt to the ever-changing policies and procedures. When the policy or procedure changes you want to maintain the tool with internal staffing so that changes are timely and inexpensive.
      7. The tool needs to produce a risk analysis chart with filter formatted and conditionally formatted columns that enable simple filters and searches. Not all users will have access to the risk management tool so you need to have a risk analysis artifact available to all users.
  • BIo:
    • Byron Murray has been with Medtronic for 8 years as a Systems Quality engineer supporting risk management. 
    • Before joining Medtronic, Byron held many quality roles with data storage or environmental tech companies around Boulder, Colorado. 
    • Byron is a Colorado native and has been on the Winter Park Volunteer Ski Patrol since 1986
    • When not at work Byron can be found in the mountains skiing, rock climbing, mountain biking, and or camping with his two boys and wife.
  • References:
    • None Yet

7:15 pm After Presentation Networking
7:30 pm Web Conference End: meeting over

Place: Web Conference Webex
- Meeting link: TBA
- Meeting number: TBA
- Password: TBA

Meeting also posted on ASQ Boulder Meetup's 21 Nov 2024 meeting



Arnold Miller