ARTICLES BY MARK F. WITCHER

• Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis

  2/18/2025

  Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

• A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices

  2/3/2025

  Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

• A New Approach To ISO 14971 For Better Medical Device Risk Analysis

  10/23/2024

  This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.

• System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks

  6/26/2024

  Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.

• Managing Supply Chain Risks Using Relational Risk Analysis

  4/5/2024

  In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.

• Using Relational Risk Analysis To Control Procedure Failures In The Bio/Pharma & Medical Device Industry

  2/15/2024

  In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).

• Using System Risk Structures To Evaluate COVID-19 Pandemic Risks

  12/15/2021

  This article's discussion demonstrates how system risk structures (SRS) can be used to understand complex risks and how SRS might be applied to understand the very complex risk landscape of the COVID-19 pandemic. It includes analysis of risk of personal infection, risk of disease progression or spreading, risk of vaccination, and more.

• Principles And Concepts Of System Risk Structures For Understanding & Managing Risks

  12/6/2021

  A truly effective risk analysis method for the biopharma industry should provide insights to and understanding of the fundamental properties and attributes that underlie every type of risk. This article describes how system risk structures (SRS) can be used to understand and manage both simple risk situations as well as complex risk landscapes quickly and efficiently.

• FMEA Vs. System Risk Structures (SRS): Which Is More Useful?

  9/24/2021

  In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?

• Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs

  4/23/2021

  The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits. 

• Rating Risk Events: Why We Should Replace The Risk Priority Number (RPN) With The Adjusted Risk Likelihood (ARL)

  4/7/2021

  While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.