Repeat Concessions Are Not Permissible

When nonconforming products are discovered during incoming inspection in medical device manufacturing, manufacturers must select one of three disposition options: scrap, rework (manufacture again), or concession. Among these, a concession—formally known as a deviation approval or exception—allows the use of existing nonconforming product under specific conditions without correction.

However, through regulatory audits and consulting work, the author has frequently observed cases where manufacturers have repeatedly granted concessions for the same nonconformance. This practice is not acceptable.

While regulatory requirements may not explicitly state “concessions must not be repeated,” the recurrence of concessions for identical reasons indicates fundamental deficiencies in a manufacturer’s quality management system. Specifically, it reveals either inadequate rigor in design specifications or a failure to implement manufacturing process improvements. A concession should be an exceptional, temporary response to unforeseen circumstances. When the same nonconformance repeatedly occurs, it is clear evidence that the manufacturer has not addressed the root cause. This pattern indicates systematic failure in the organization’s approach to quality assurance.

Corrective Measures Required

To prevent the recurrence of identical nonconformances, manufacturers must implement one or both of the following corrective measures.

First, manufacturers should review and revise their design specifications to more realistic yet adequately stringent levels. Second, manufacturers must implement formal Corrective and Preventive Actions (CAPA) to achieve sustainable process improvements and eliminate the root cause. Only through these comprehensive interventions can manufacturers avoid repeating concessions for the same issues.

Essential Conditions for Valid Concessions

It is critical to emphasize that concessions are only considered appropriate when they satisfy two essential conditions simultaneously.

First, explicit customer agreement on the concession must be documented, demonstrating that the nonconforming product genuinely meets customer requirements. Second, the concession must comply with applicable regulatory requirements in the relevant jurisdiction. Concessions that fail to meet both conditions constitute regulatory violations and cannot be justified under any circumstances.

Hierarchical Structure of Quality Specifications

Understanding the hierarchical structure of quality specifications is equally essential. As a fundamental principle, customer specification limits represent the broadest tolerance band, and design specification limits must be narrower than customer requirements. Manufacturing process limits must then be narrower still than design specifications.

This relationship must be expressed as follows:

Manufacturing limits < Design limits < Customer specification limits

When properly established and maintained, this hierarchical structure ensures that manufacturing consistently delivers products meeting customer requirements and regulatory expectations. Repeated concessions for the same issue provide unmistakable evidence that this foundational structure is not functioning as intended. Addressing this breakdown requires thorough root-cause analysis and systematic remediation across the entire quality management system.