Using Your Lab Quality System to Reduce External and Internal Remakes – quality connection

A device that doesn’t meet specified requirements is referred to in a Quality System as:

GMP stands for:

The basic purpose of the system of corrective and preventive actions is to:

A complaint file can address these issues:

As referred to in a Quality System, data sources are used to:

The systemic approach for identifying issues, analyzing data, and resolving problems is referred to as:

The method used to determine why a failure existed is referred to as:

When investigating root cause these factors can contribute to a complaint or non-conformance:

If a medical device causes death or serious injury to a patient, FDA requires the manufacturer of the device to initiate:

The document completed to begin a trend analysis is: