What does the QA Form 11A specifically track?

The QA Form 11A is specifically designed to track Controlled Assembly Exceptions. In quality assurance, particularly in manufacturing and assembly processes, controlled assemblies are critical components or assemblies that must meet specific quality standards. When an exception occurs—indicating that a particular assembly deviates from established specifications or processes—the QA Form 11A is utilized to document these deviations. This ensures that all exceptions are tracked systematically, allowing for analysis, corrective action, and maintenance of quality standards within the organization.

Tracking Controlled Assembly Exceptions through this form is vital for maintaining regulatory compliance and ensuring the overall integrity of the assembly process. It provides clarity and documentation that can help teams identify trends or problems within controlled assemblies, leading to informed decision-making and process improvements.