Medical Device and Diagnostics manufacturers by law and FDA regulation need to establish and maintain supplier management requirements, including quality requirements, that must be met by suppliers, contractors, and consultants.
Supplier quality criteria are defined by FDA as "the supplier's ability to meet specified requirements including quality requirements.
In other words, what are your documented requirements for each supplier? Perhaps you require that suppliers have insurance, that they are incorporated as a business, or that suppliers have experience in providing the material or activity you are sourcing.
Think of FDA's supplier quality criteria as traits that relate directly to the material or activity you are sourcing. Then you evaluate the supplier to verify that it has those expected traits. This provides flexibility to use basic questionnaires for many low risk, low volume suppliers while restricting more intensive audits to those suppliers deemed critical.
The beauty of supplier regulations are the agency does not dictate to establishments what they must do to support compliance. In fact, the agency gives each of the organizations plenty of rope to support mass hangings, according to Dr. Christopher Joseph Devine.
It begins with organizations defining the requirements appropriate for each supplier. The factors that are involved are: employ risk: (a) business risk; (b) regulatory risk; (c) quality risk; and (d) potential patient risk when establishing supplier requirements and basic requirements for the product and service being procured.
Medical Device and Diagnostic manufacturers need to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements and the evaluation need to be documented.
Drawing on FDA 483 database analyses, warning letter reviews since 2010, and the statements of FDA officials over the past four years, there are eight ways in which companies typically fall short in their supplier oversight and qualification activities
Internal v. external supplier confusion
Inadequate supplier criteria
No ongoing monitoring
Poor supplier control records
No linkages across product activities
Over-reliance on self-questionnaires
Over-reliance on certificates
Not doing anything.
Documenting supplier criteria is critical as it helps prevent four of the eight common failures. At TAGmedica, our most successful partnerships are those with rapidly growing, medical device and diagnostic companies that have outgrown the ability to kit, warehouse and distribute on their own.
Increased compliance and regulatory protocols require partnering with a vendor who can document, trace and manage outsourcing processes under ISO 13485:2003 certification.
Improving accuracy, reducing risk and ensuring compliance is what TAGmedica does.