The updated API Spec Q1-9th edition has raised a number of questions. One of the most frequent questions is what constitutes a critical supplier and how do we verify that their QMS conforms to our internal requirements?
Let’s start by answering what a critical supplier is. Basically, the term “critical” is defined by your organization. If your organization cannot survive without this supplier then this supplier should be considered “critical.” These suppliers should play an integral part in the production of your finished product. Keep in mind that “critical” can also refer to the amount of money that is spent with this supplier. It is important that we regularly evaluate our suppliers to insure that their quality, delivery and response performance meet our internal benchmarks. Maintaining supply chain performance is essential to your bottom line, as well as compliance with Spec Q1-9th edition requirements.
Next, let’s look at how to verify that your suppliers’ QMS conforms to the requirements of your organization. You need to outline the specific certification(s), if any, required of your suppliers. If you require certification, then you can rely on the results of a third party auditor to verify that an acceptable system is in place. If you plan to handle supplier audits internally, then you will need to develop site-specific criteria for each supplier. After your initial audit, you will need to conduct regular surveillance audits to verify continued acceptability of the supplier system.
Supplier management is one of the key components of the 9th edition requirements. It is important that your organization maintains a comprehensive supplier management program with the ability benchmark performance metrics.
To find out about how Accupoint Software can help you with effective supplier management programs, as well as the other requirements of Q1- 9th edition, call 800.563.6250 or visit our website at www.accupointsoftware.com.