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How do you qualify a supplier who is not willing to complete the requested documentation such as a questionnaire and Quality Technical Agreement? (for example, a critical material supplier when there is no back-up option). I find more and more that suppliers will not spend time on this unless lots of money is being spent on their products.
My first instinct would be to say – don’t bother with this supplier and look for an alternative. You cannot run a production without a backup anyways—especially critical materials.
What happens if the supplier shuts down, or you must disqualify it because of quality issues?
But if you really have no alternatives at the moment, I would suggest conducting a risk analysis. You need to convenience yourself and the regulators that the deviations from your procedures and lack of documents won’t impact the product’s quality.
Additionally, make sure you test each batch for the full monograph if it’s a raw material.
I hope that makes sense for you.