Supplier qualification processes aren't just recommended precautions to guard against compliance issues, they're a regulatory requirement for most FDA-regulated manufacturers.
"Qualifying" a supplier, in this case, should be thought of as a kind of quality system within a quality system.
Candidate suppliers and vendors should be thoroughly evaluated against your own quality requirements, compared with other options, physically evaluated, and reevaluated on a regular basis to ensure compliance both now and in the future.
Although most drug and device manufacturers have a supplier qualification process in place already, one company's approach can look much different than another's.
We’ve laid out a clear and concise five-step supplier qualification process that can be integrated and expanded upon to meet your organization's unique needs.
Before you can assess a supplier’s ability to address your needs, you need to define and document those requirements thoroughly. Although each situation is unique, consider the following areas when putting together your list:
In most cases, the change control system is the appropriate place to document this information. Avoid relegating this duty to just one person or a small team. Experts from each of these areas should be engaged in creating questions.
Once you’ve fully defined and documented your requirements, begin engaging potential candidates to gauge their level of interest in partnering with you. Present your requirements to those open to a potential relationship.
In return, you should receive not only an explanation of how the supplier can satisfy your requirements but full documentation to support these claims.
If a particular product is involved, request a sample to evaluate it yourself. If your list of potential candidates is lengthy, narrow it down to no more than five companies. Evaluate each of your top candidates to ensure their documentation provides everything needed to perform a thorough assessment.
With a shortlist of top candidates, a more thorough evaluation of each of them can begin. Start by comparing each candidate’s relative ability to meet your requirements compared to the others.
A simple table like the one shown below can be used as a comparison tool. Devise a numeric rating system to apply to each requirement depending on a candidate’s capabilities. This allows for easier comparison between candidates.
Try to keep the comparison system as simple and practical as possible.
Candidates
Requirement #1
Requirement #2
Requirement #3