How Critical is Vendor Qualification to Your Lab?

How Critical is Vendor Qualification to Your Lab?

When qualifying a vendor, a company must consider many factors. First are straightforward ideas such as, do they have the item I need? Is it the best price? Can they deliver on time? And so on. These qualities are easily identified and readily accessible. There are many suppliers for NaCl, for example, both domestic and imported that offer the product in a variety of container sizes, and can deliver the next day at competitive price via a multitude of shipping companies. This product is suitable if you are making a solution for a High School biology class. If, however, your needs are a bit more complex and you need greater control of your supply chain, then knowing more about your vendor and their capabilities becomes critical:

  • Can my vendor help me identify products manufactured under cGMP or USP? Does my vendor offer the reagents or materials I need, in packaging suitable to my usage, with a reasonable expiry date?
  • Will my vendor notify a small user like me when there is a change to the product's packaging, labeling or components? This is not a big deal when buying tires, but can be critical when buying solutions or reagents.
  • Can this vendor provide a proprietary custom product in a small volume within a reasonable amount of time? Additionally, do they have the capacity to scale up production if the product I have developed takes off?
  • Does the vendor provide adequate quality control? What assays or tests are performed? Will the results of a particular lot be readily available in 5 or 10 years?

These are just a few of the initial concerns to be addressed when choosing a vendor, and there are many others to consider.

Here is an example of poor vender selection that occurred when company XYZ was making a custom kit for a supplier ABC to the Department of Defense. It was a biological test kit that seemed simple enough at the beginning, but became more and more complex as the production cycle began.

ABC supplied the line drawings and a list of suppliers and part numbers as well as lot numbers for the sub assemblies within each production run. Company XYZ, in an effort to control the cGMP product process, assigned internal lot numbers to the raw materials as they were delivered for tracking purposes. Production was running smoothly, the product was delivered, and the customer was happy. The reorders kept coming and supplier ABC requested other products which were developed and supplied by XYZ using the vendors and raw materials that ABC required. Some years later the trouble began.

During an audit by the Department of Defense, the process and production systems were reviewed. XYZ was happy to comply, believing that all was well because ABC had always been happy with the product, as well as the quality control documentation supplied.

A question the auditor raised involved tracking of raw material lot numbers. He wanted to know the lot numbers for the Velcro used in the kits. Well, neither the distributor nor the manufacturer of the Velcro would provide a lot number. Apparently, the manufacturer didn't assign lot numbers to the production runs of the Velcro, an omission that supplier ABC didn't discover, because they did not complete a vendor qualification. This situation created a problem for XYZ, because the DOD required the lot numbers, and ABC chose vendors that could not meet the needs of the project.

Admittedly, most of the time you may not need this level of scrutiny, but it is always a good idea to truly know your supplier's capabilities.

Talk to us about your critical item needs, so we can assist you in the qualification process.