Vendor Relationships

Exposure

The quality of a medical device or pharmaceutical depends on the quality of the components, raw materials, and services. Manufacturers must establish and maintain procedures to ensure that app purchased or otherwise received products and services conform to specified requirements (as set forth in the code of Federal Regulations (CFR) Title 21). This includes:

  • Evaluating supplies, contractors, and consultants

  • Establishing and maintaining data that clearly describes or references the specified requirements - for purchased or otherwise received products and services

Companies must take responsibility for the condition and quality of items or services purchased from source supplies and third party manufactures or processors. Poor purchasing decisions lead to circumstances where companies may not meet regulatory or quality requirements and, therefore, may be subject to litigation.  

What Can Happen

When due diligence is not performed to ensure the quality of components and materials used in creating products, the result may be injuries or death related to unsafe products, as well as time-consuming regulator agency reporting procedures, product recalls, litigation, and loss of revenue.

 

How to Reduce Risk

 

  • Invest in building partnerships with vendors who have clearly demonstrated the capability to provide acceptable products or services

  • Establish and implement a vendor certification and verification process

  • Keep tiered lists of both qualified and unqualified suppliers

  • Create contractual agreements regarding vendor expectations and risk transfer 

  • Conduct vendor audits at intervals consistent with the significance of the product or service being provided

Top Three Supplies Issues

  • Not having clearly established quality requirements for supplies - this can be especially true of visual inspection, which tend to be subjective if criteria are non well-defined

  • Outdated vendors specifications - this is particularity critical during the early phase of a product's life when changes are implemented more frequently  

  • Lack of vendor participation in a meaningful validation program

Contact us to learn more about how we can help protect your organization.

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