Re: Template for Vendor (Supplier) Qualification needed
v991,
Could you please elaborate a little bit more on the last two requirements or if you have a sample, that would be great. Also, do suppliers that are ISO certified need to be qualified?
Thanks!
1) i guess you are asking about the product & process assessment...
*) (if required on multiple batches to show the consistency) assessment of an independent(inhouse qC) analysis and comparison of results against supplier provided COA
*) if material is critical, then usage of material in the product (a finished product ) and performance of the FP (both COA and if required stability)
2) sample template...can found online(even within elsmar) ...yet need to be customized to your specific defined procedure of your organization...
3) irrespective of accreditation or the even the regulatory audits, regulators expects you to operate within the purview of your own quality systems.... i.e., you must 'justify' the decision/procedure of not qualifying the suppliers with an accreditation. (or doing through alternative steps...viz., atleast postal audits, doing an assessment on complaints, regulatory observations etc)
hope that it helps...