The example provided in the Practical Guide for the implementation of a “risk-based approach” contains a single, one-paragraph example outlines three steps:
• SWOT “review your QMS to improve or verify compliance.” Back in my day, we called this an internal audit. How is the intent this example different from an internal audit?
• HACCP “an area of improvement in the QMS process then triggers use of a more detailed analysis.” So in the internal audit system, deficiencies and areas of improvement are identified in an audit report. Typically, each item is investigated in an audit response that involves a root cause investigation. Sounds like a “more detailed analysis” to me.
• Project Plan “create a strong project plan for improvement to address identified weaknesses.”Again, most audit response systems I have seen involve a corrective and preventive action plan coupled with effectiveness evaluation. How is a corrective or preventive action plan different from a “strong project plan for improvement”?
I fail to see why the Guide recommends creating a multi-layered risk-based analysis system when existing, long-standing systems within the QMS could be augmented with more risk-based concepts. The last thing small manufacturers need is to reinvent the wheel when existing systems can be utilized to fulfill the intent of the new risk-based approach requirement.
My last point of contention with the example is the number of layers and tools needed to conduct a comprehensive analysis of the QMS. Lets estimate the math.
• 1 SWOT x 5 major subsystems = at least 5 SWOT
• 5 SWOTS x identified 2 areas for improvement per system = 10 HACCP’s
• 10 HACCP’s x identified 3 areas in need of a project plan = 30 project plans
That’s a minimum of 45 new documents to effectively manage. This resource-intense example isn’t practical to small and mid sized manufacturers. And what does modeling a risk of not meeting a regulatory requirement look like? https://wp.me/p6wmF6-eG

Death by Risk-based Approach: The Practical Guide to the ISO 13485:2016 Practical Guide Part 3

This is the third post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide”. (See the first installment and second installment.) This post explores examples and applicat…

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