Driving Operational Excellence: Insights on the Real Cost of Poor Quality
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Driving Operational Excellence: Insights on the Real Cost of Poor Quality

Authored by the OSICS Network and inspired from Pharmaceutical Online

In the ever-evolving pharmaceutical industry, quality has always been a fundamental aspect. However, the conversation must go beyond compliance to consider the broader implications on business performance, supply chain stability, and ultimately, patient health. The real cost of poor quality is multifaceted, encompassing not only financial burdens but also the human impact of disrupted treatments and compromised patient safety. Fabrice Le Garrec, a principal consultant at OSICS Network, emphasizes, "Operational excellence is not just a buzzword. It is the cornerstone of sustainable success in the pharmaceutical sector, directly influencing the cost of poor quality."

The Domino Effect of Poor Quality

Poor quality in the pharmaceutical sector often results in supply disruptions, leading to significant challenges for patients. When a preferred treatment option becomes unavailable, patients may resort to alternative medications, potentially causing adverse reactions or treatment failures. This scenario is further complicated by global supply chain issues, rising costs, and regulatory interventions, all of which increase the difficulty of securing necessary medicines.

As highlighted by Samantha Atkinson in her article, "The real cost of poor quality is human health and well-being." The financial impact on companies is significant as well, with quality-related costs ranging from 25% to 40% of total sales revenue in the pharmaceutical industry, according to NSF's 2015 study.

Mitigating the Cost of Poor Quality Through Quality Management Maturity

Quality Management Maturity (QMM) initiatives are gaining momentum, driven by the U.S. FDA and supported by NSF. These initiatives aim to minimize supply disruptions and enhance the overall quality maturity of drug manufacturers. Fabrice Le Garrec remarks, "Achieving operational excellence requires a commitment to continuous improvement and a deep understanding of the factors contributing to poor quality. OSICS has the methodology and the experts to help you in that assesment and delivering the journey"

The OSICS Network recommends a comprehensive approach to QMM with its unique "Quality excellence" approach, including:

  • Strategic Assessment: Evaluating the organization's current quality management practices and identifying areas for improvement.
  • Data Integrity: Ensuring data integrity is crucial for maintaining quality standards. Regular assessments help organizations monitor their progress and align with regulatory expectations.
  • Quality Culture Optimization: Cultivating a quality-focused culture within the organization is essential for long-term success. This involves engaging employees at all levels and fostering a sense of responsibility towards quality.

The Path to Sustained Excellence

Improving quality management practices and culture results in significant cost savings, reduced supply chain disruptions, and enhanced patient outcomes. As Fabrice Le Garrec notes, "Operational excellence is a journey, not a destination. It requires a sustained commitment to quality and a willingness to adapt and evolve."

In conclusion, the pharmaceutical industry must prioritize operational excellence to mitigate the cost of poor quality. By embracing quality management maturity and fostering a culture of continuous improvement, organizations can achieve sustainable success and make a positive impact on patient health and well-being. OSICS Network remains committed to guiding organizations on this path, leveraging its expertise in operational excellence to drive meaningful change.


For more insights on how to enhance quality maturity in your organization, contact the OSICS Network or Fabrice Le Garrec today.

Anthony Cilia

Pharma & Biotechs Operational Excellence Consultant, Buisness Transformation Leader and Change Management

6 个月

Thanks for sharing Fabrice Le Garrec variability manifested in different forms in the quality system(deviations, rejections, IVA, OOS…) is defintely a major waste and a big point of cause thats holds pharma from unlocking potential. Committmwnt to real( not apparent) Operational excellence is a way forward #pharmaceutical #biotechnology

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