Risk Mitigation in IVD Manufacturing Through Supply Chain and Supplier Management

Successful supply chain management in the in vitro diagnostic (IVD) industry is no longer simply a case of having the right material in the right place at the right time to guard against production delays. Additionally, IVD manufacturers must partner with suppliers who continually evaluate, monitor, and control their own supply chains to mitigate risk.

In response to the unique and changing needs of IVD manufacturers, the basis of our supply chain offering includes:

  • Robust relationship management with our suppliers
  • Management of our incoming raw materials
  • Risk mitigation support for IVD manufacturers through supply chain controls

Although there will always be a drive to reduce costs, we recognize the increasing importance of creating relationships with many specialized partners, drawing on their core competencies to improve overall customer service and expand our capabilities. Through ongoing consultations with our suppliers to collaborate on materials and specifications, we work to closely align supply and demand, increasing service, efficiency and visibility, while reducing cost and improving product quality.

Compliance for Raw Material Supply

In the past, many IVD raw materials were sourced from manufacturers who did not always notify clients of product changes. This problem would be exacerbated when lot-to-lot differences were not examined until well into product development or manufacturing. Increasingly, IVD manufacturers are demanding that their strategic suppliers comply with the same stringent standards or regulations as their own, such as GMP, ISO 13485, or FDA 21 CFR 820.50 regulations.

IVD manufacturers choose to mitigate these risks by using materials that are fit-for-use, secure in the knowledge that the processes and materials used will not be arbitrarily changed without prior determination of the impact of each change. By understanding that controllable, repeatable, reliable processes are key to compliance, we further reduce the risk of manufacturing errors through improved process documentation, taking appropriate actions when deviations occur, and establishing critical process parameters.

Supply Chain Quality Management

Our supplier management program details evaluations of our supplier quality systems and manufacturing processes. This includes how our suppliers manage their own suppliers even further upstream in the supply chain. On-site audits and quality questionnaires form a key part of this process, along with sample testing and certificate of analysis (COA) verification. Raw material specifications are communicated to our suppliers with each purchase order, while strategic suppliers who provide critical components receive customized specifications and test methods.

Quality performance measures are an important part of our supplier scorecards. These criteria include records of:

  • all non-conformances, including specification non-compliance, incomplete documentation, improper packaging or labeling
  • quality and technical support during investigations
  • corrective and preventive actions (CAPA)

Performance data are reviewed regularly and formally with our suppliers, according to our supplier management program guidelines. The program incorporates processes to manage consequences, rewarding high-performing suppliers and either improving poorer performers or finding superior alternative suppliers. This rigorous system also includes regular market and category assessments as well as a formal risk management process.

The traditional cost-focused supply chain has evolved into a center for value creation. IVD manufacturers create value for their organizations by choosing suppliers that understand the importance of safeguarding supply continuity.

To learn more about how to mitigate your supply chain risk, visit our website or contact us.