Articles by Mark F. Witcher

1. 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.

2. 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.

3. 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.

4. 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.

5. 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. 

6. Using Relational Risk Analysis To Control Procedure Failures 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).

7. 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.

8. 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.

9. How To Evaluate & Manage Safety Risks In Biopharma 5/2/2022

   Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).

10. 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.