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Quality Risk Management in Life Sciences

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Tech-Clarity’s new report Quality Risk Management in Life Sciences: Preventing Failures, Protecting Patient Health reviews manufacturers’ experiences in using Quality Risk Management (QRM) to proactively reduce risk in the Life Sciences industries. Explains how QRM software can be used to efficiently manage risk by sharing quality knowledge across the enterprise and closing the loop on product quality.

Please enjoy the Executive Summary below, or click the report title above to download the full PDF (free of charge, no registration required).

Table of Contents

  • Executive Overview
  • Mitigating Risk
  • From Compliance to Quality Risk Management
  • Sharing Quality Knowledge
  • Closing the Loop on Quality
  • Enabling QRM
  • Conclusion
  • Recommendations
  • About the Author

Executive Overview

It is an undeniable truth that defects are inherent to manufacturing processes. Manufacturing is a risky business, and issues come up that can lead to product failure. In the Life Sciences industry, these failures can put patient health at stake. It is the responsibility of the manufacturers of these products to ensure product quality, and the implications are serious for both corporate executives and for patients. “Even the most harmless of medical devices can be fatal,” explains Andy Jobson, GM of Medical Operations for contract manufacturer Moll Industries. “People can end up in jail.” Life Sciences executives recognize the importance of quality, and that they are responsible and liable for ensuring safety.

While patient health is the primary concern for all, product quality also has significant cost implications. Recalls and retrofits can be exceedingly expensive and drastically cut into profits. “Nobody wants to be responsible for a defect that results in a recall,” Mr. Jobson explains, “A device failure can put a lot of smaller companies out of business, one recall can wipe you out.” Due to the risk to patient and corporate health, manufacturers of all sizes need to be vigilant in preventing defects, but more importantly preventing the resulting impact a defect can result in.

Because of the potential consequences, Life Sciences companies must aggressively pursue quality. The good news is that there are best practices available, including FMEA (Failure Modes and Effects Analysis) and CAPA (Corrective Action and Preventative Action). Many companies, unfortunately, fail to leverage these tools to their fullest extent because they view these practices as compliance “checklists” instead of embracing a more proactive Quality Risk Management (QRM) approach. Wallace Torres is the Global Head of the Integrated Risk Management program for Pharma Technical Operations for global healthcare company F. Hoffmann-La Roche Ltd. Mr. Torres explains the essence of QRM, “You must start thinking proactively to identify what can go wrong.” By systematically identifying what can go wrong, manufacturers can prevent issues from occurring in the first place.

The first place to start for most companies should be leveraging the knowledge they have across their own organization. Most manufacturers can gain a lot of insight simply by “closing the loop” by communicating knowledge in Manufacturing, Quality, and other departments back to Engineering to design quality into products up front. In the same way, the information should be fed to Quality and Manufacturing to develop control plans to prevent issues from occurring in the first place. For this reason, QRM processes require sharing knowledge across the enterprise. Making information easy to search and reuse is critical to prevent defects and repetitive errors.

Unfortunately, quality processes are often manual or rely on spreadsheets and are both poor at sharing information across the enterprise and inefficient. Increasing the efficiency of quality processes through an enterprise QRM infrastructure helps reduce cost, and can also allow Quality, Engineering, and Manufacturing personnel to focus on mitigating risk instead of filling out forms. More importantly, it can also prevent recalls. Most importantly, though, it can help fulfill the mission of protecting patient health and quality of life. As Moll Industries’ Jobson summarizes, “If you aren’t highly focused on risk management, you have no business being in this industry.”

QRM, also known as Quality Lifecycle Management (QLM), is a systematic approach to proactively reduce risk and protect patient health. It is also a significant part of Product Lifecycle Management (PLM) that is missing in many companies, as clearly quality and risk management are lifecycle issues. As Roche’s Mr. Torres states, “We are using QRM to evaluate the risk in the whole lifecycle of the molecule starting from clinical trials.”

 

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