Why is a supplier audit program necessary?

Why is a supplier audit program necessary?

A supplier audit program is a must-have in medical devices and pharmaceutical manufacturers, especially those that outsource their processes. Being such an important element in the supply chain; a supplier audit program is the driving force towards ensuring quality and consistency in the supply chain, and is a very important component of the quality.

Expect to carry out a supplier audit program for these reasons

That a supplier audit program is certainly required is a given. If you are a manufacturer, why do you need a supplier audit program and what should you look out for? It is the manufacturer who has to undertake a supplier audit program because the FDA has NO regulatory requirement for a supplier audit. So, it is up to the manufacturer to ensure that he carries out a supplier audit program himself.

A supplier audit program could become necessary for these reasons or situations:

Initial: Things to consider could include whether you should pay a visit to the supplier at the start of the contract. Or do you make visits at regular intervals? How much time to you spend at the supplier’s facility?

Instances of noncompliance: At some point of time, you could come across a supplier who has failed to deliver to requirements. When say, the first shipment is not up to requirements, how do you tackle the issue?

History: It is possible that the supplier has consistently delivered negative results. If you have had a bad history of working with a supplier, what do you do? How do you haul him up? How do you correct the issue?

Criticality of the product or service: This could be another reason for which the manufacturer will need to carry out a supplier audit program.

 

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