OBJECTIVE
To ensure that vendors of critical raw materials are supplying consistently high quality product.
BACKGROUND
One of the critical aspects of a robust quality system is a Vendor Qualification Program (VQP). The key elements of VQP are:
- A list of vendors and the critical materials they supply
- A process to survey the vendor’s quality system
- An ongoing program for assessing the quality of product supplied by the vendors
Many companies will have the first two elements. However, the ongoing assessment of quality is often overlooked or just not done because of the associated costs and complexity of tracking the program.
OUR APPROACH
The DYNALABS VQP is designed to address the three key elements, and to track the ongoing quality of materials supplied by vendors both efficiently and cost effectively. This is accomplished by seamlessly using data generated in the course of testing customer produced products, and applying it to the suppliers and materials that were used in the making of that product. If a product meets all the critical quality requirements, then, by extension, the materials that went into making that product are good. Conversely if a product fails and one of the materials is implicated in that failure, then the supplier may need to be replaced, or at a minimum, monitored more closely. The process is as follows:
- Suppliers and critical raw materials are identified
- Suppliers are surveyed to assess their quality system
- Based on the results of the survey, the suppliers are rated
- Data generated in the course of inspection and testing process is applied to the supplier
- Data is reviewed over time to identify trends
IMPACT TO THE PHARMACY
- Costs of implementing and tracking a VQP are minimized
- Failures, reworks, and discards due to vendor supplied material will decrease over time
- Lower probability of an adverse event and associated litigation costs
- Market the quality of the VQP to gain more business