Nicholas Capman of The FDA Group welcomes David Festa, Director of Corporate Quality at Thermo Fisher Scientific, to explore whether pharmaceutical and medical device companies are auditing suppliers too frequently and with the right personnel.

With over 25 years of experience in quality management and oversight of tens of thousands of suppliers, David advocates for a more strategic approach that balances quality, compliance, and business needs through "exception-based" auditing.

Rather than rigidly adhering to calendar-based audit schedules, David suggests companies should assess suppliers based on performance metrics, risk factors, and the criticality of materials they provide. He challenges the industry norm that every supplier must be visited at predetermined intervals, arguing that well-performing suppliers with stable processes may not require frequent on-site visits.

David emphasizes the importance of matching auditor expertise with supplier categories. For example, an auditor with deep knowledge of plastics manufacturing will provide far more valuable insights when evaluating a plastics supplier than someone familiar only with general standards. This targeted approach has helped Thermo Fisher predict quality issues and decrease the percentage of poor-performing suppliers.

The conversation explores how post-pandemic practices have evolved, with companies developing more harmonized approaches to global auditing and implementing centralized audit portals. David also introduces the concept of a "supplier pricing index" that quantifies the true cost of poor quality, providing a more accurate picture of supplier value than piece price alone.

While ISO certifications provide a foundation for quality systems, David cautions against over-reliance on certifications or imposing unnecessary standards on suppliers. The most effective approach focuses on whether suppliers can maintain control of their manufacturing processes and consistently deliver quality products, regardless of certification status.

For companies looking to optimize their supplier quality programs, the key is putting the right people in the right places, implementing quantifiable metrics, and taking a holistic view that integrates quality with other business functions.

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