Identify Potential Product, Process, or Quality System Nonconformities

The purpose of auditing the Measurement, Analysis and Improvement process is to verify that the manufacturer’s processes ensure that information related to products, processes, or the quality management system is collected and analyzed to identify actual and potential product, process, or quality system nonconformities, that problems and potential problems are investigated, and that appropriate and effective corrective actions and preventive actions are taken.

Objective Evidence

As a result of the audit of the Measurement, Analysis and Improvement process, objective evidence will show whether the organization has:

• Defined, documented, and implemented procedures for measurement, analysis and improvement that address the requirements of the quality management system standard and participating MDSAP regulatory authorities
• Identified, analyzed, and monitored appropriate sources of quality data to identify nonconformities or potential nonconformities and determined the need for corrective or preventive action
• Ensured investigations are conducted to identify the underlying cause(s) of nonconformities and potential nonconformities, where possible
• Implemented appropriate corrective action to eliminate the recurrence or preventive action to prevent the occurrence of product or quality system nonconformities, commensurate with the risks associated with the nonconformities or potential nonconformities encountered
• Reviewed the effectiveness of corrective action and preventive action
• Utilized information from the analysis of production and post-production quality data to amend the analysis of product risk, as appropriate

Links to other processes include:

• Design and Development
• Production and Service Controls
• Purchasing
• Medical Device Adverse Events and Advisory Notices Reporting
• Management