Critical Suppliers and API Spec Q2

The API Spec Q2 standard has created some confusion regarding the implementation of certain requirements.  One frequent conundrum centers around the definition of a critical supplier, as well as the QMS requirements of said supplier.
 
The standard defines critical, in 3.1.6, as follows: That deemed by the organization or customer as indispensable or essential, needed for a stated purpose or task, and requiring specific action.
 
Let’s start with a simple definition of a critical supplier. The term “critical” and the criteria used in the designation should be determined by your organization and/or customer.  That being said, if a supplier is integral to the process or you cannot survive without them that would be a pretty good indicator that the supplier is “critical.” Keep in mind that “critical” can be defined in a variety of ways, so development of internal criteria is essential.
 
Next, let’s look at how to verify that your critical suppliers’ QMS conforms to your internal requirements. You may require your suppliers to have a third party certification in order to be approved.   In this case, you can outline the standard(s) required to satisfy your conditions. If you do not require certification, you should develop an audit checklist to verify that their QMS meets expectations.
 
The API Q2 standard requires the following, in section 5.6.1 Purchasing Control:
For critical services or service-related product, the criteria for the initial evaluation and selection of suppliers by the organization shall include the following prior to initiation of the purchase agreement:

1. Assessment of the supplier at supplier’s facility to meet the organization’s purchasing requirements, and
   
2. Verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization.
   

 
Remember, you’re only as good as your weakest link.  Q2 requires the management and monitoring of the supply chain.  Understand that this can create burdens and require additional resources to verify.   It is important that you develop a simple process to evaluate and monitor your vendors.
 
To find out about how Accupoint can help you streamline your supply chain management process, call us at 800.563.6250 or visit www.accupointsoftware.com