Supplier Qualification SOP

Supplier qualification is often based on a total quality manage- ment system that assures that a supplier’s product is produced, packaged, and shipped under a controlled process that results in consistent conformance to customer requirements. The supplier qualification program is based on the principle of defect prevention, as opposed to defect detection and selection. It supports the concept of quality at the source by ensuring adequate controls and systems are in place the first time around. It substantially reduces or eliminates the need for final quality inspections by the supplier or the customer. Finally, if successfully implemented, sup- plier qualification should be designed to achieve the desired ob- jectives of product quality improve- ment, delivery performance improvement, increase in productivity, and cost reduction.

The primary objective of sup- plier qualification is to assure consistent high quality as demonstrated by predictable confor- mance to customer requirements. The basic premise of supplier qualification is that when the customer and supplier work together to establish the proper design characteristics, specifications, test criteria, and process controls, the result will be a product that is consistently fit for use and free of defects. While the customer is responsible for assuring the suitability of the item for its particular use or application, it is the supplier’s sole responsibility to meet customer requirements.

It is important to have a good working relationship with a supplier, and a carefully constructed purchasing policy will help to achieve this goal. A system of single or multiple sourcing of components and packaging materials can have a significant effect on the final quality of the purchased materials. A supplier must be capable of current and future production requirements. If a supplier attempts to produce at a rate that exceeds equipment or operator capability, this inevitably leads to quality problems.

Download the accompanying article, "Establishing a Supplier Qualification Program"

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