ARTICLES BY MARK F. WITCHER

• Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis

  6/2/2025

  Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

• 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.

• 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.

• Designing Highly Agile Bio/Pharma Manufacturing Facilities

  4/5/2024

  In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules. 

• 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).

• When In The Product's Life Cycle Does Continuous Manufacturing Make Sense?

  2/1/2024

  This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.

• Relational Risk Analysis For The Bio/Pharma Industry

  1/29/2024

  Successfully developing and manufacturing biopharmaceuticals depends on identifying, analyzing, and managing a wide variety of risks. This article presents a novel alternative risk analysis approach that provides a simple, easy, and effective method for quickly and efficiently modeling and analyzing any risk.

• 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?

• Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?

  5/19/2020

  This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.