Nonconformity Management

‍Nonconformity Management refers to the comprehensive, structured process required within a Quality Management System (QMS) to handle instances where requirements are not met. This process is mandatory across international standards like ISO 9001 and specific regulatory frameworks like the FDA's Quality System Regulation (QSR) (21 CFR Part 820) and the EU Medical Device Regulation

In simple terms, Nonconformity Management is the official system an organization implements to define, document, evaluate, and dispose of product, process, or system deficiencies, and to determine the necessary actions to prevent their recurrence.

It is a crucial process that governs what happens immediately after a deviation (a nonconformity) is identified, up to the point where the deficiency is permanently addressed and eliminated from the system.

Nonconformity management acts as a closed-loop feedback system, ensuring that immediate problems are contained while simultaneously driving structural improvements within the organization.

The Core Components of Nonconformity Management

Nonconformity Management involves procedures that are typically structured into two main phases: Control of Nonconforming Product (immediate actions) and Corrective Action (long-term prevention).

A. Control of Nonconforming Product (Containment)

The initial phase, as detailed in FDA QSR Subpart I, focuses on managing the product or item that has failed to meet specifications. Procedures must be established to address four critical steps:

1. Identification and Documentation: Nonconforming items or issues must be recognized, and the nature of the nonconformity must be documented.
2. Evaluation and Segregation: The nonconformance must be evaluated, which includes determining the need for an investigation and notifying the responsible parties. The nonconforming product must be segregated to prevent its unintended use or distribution.
3. Disposition: A defined responsibility and authority must exist for determining the final disposition of the nonconforming product. Disposition options include rejection/scrap, rework, or use under concession.
   3. Rework: If a product is reworked (action taken on a nonconforming product so it can fulfill specified requirements), the procedure must include retesting and reevaluation to ensure the product meets approved specifications. Rework activities must be documented in the Device History Record (DHR), including a determination of any adverse effect.
   3. Use Under Concession: If nonconforming product is authorized for use despite the nonconformity, the documentation must include the justification for use and the signature of the individual(s) authorizing it.

B. Nonconformity as the Trigger for CAPA (Prevention)

Nonconformities (deviations, complaints, audit findings, manufacturing process failures, or nonconforming raw materials) are key recorded issues that trigger the Corrective and Preventive Action (CAPA) subsystem. CAPA is the systematic approach designed to identify, investigate, resolve, and prevent the recurrence of these nonconformities and other quality problems.

The systematic steps involved include:

1. Issue Identification and Evaluation: Identifying nonconformities from various quality data sources (complaints, audit reports, service records, concessions, etc.).
2. Root Cause Analysis (RCA): Conducting a thorough investigation to determine the underlying causes of the nonconformities related to product, processes, or the quality system.
3. Action Implementation: Developing and implementing corrective action(s) to eliminate the existing cause and preventive action(s) to mitigate future risks.
4. Verification of Effectiveness (VoE): Checking that the implemented actions are effective and do not adversely affect the finished device.
5. Documentation and Review: All activities and results must be documented. Relevant information concerning quality problems or nonconforming product must be submitted for management review.

Regulatory Requirements and Documentation

Effective Nonconformity Management relies on comprehensive documentation and adherence to international standards:

• ISO 9001:2015/ISO 13485:2016: These standards mandate procedures for managing nonconformities and corrective actions. ISO 13485 addresses corrective action under Section 8.5.2 and preventive action under 8.5.3. ISO 9001 requires the organization to retain documentation describing the nature of nonconformities and the results of any subsequent corrective actions taken.
• FDA QSR (21 CFR Part 820): Part 820 includes a dedicated subpart (Subpart I, §820.90) for Nonconforming Product and requires documented CAPA procedures (§820.100). Failure to comply with these QMS requirements renders a device adulterated.
• EU MDR/IVDR: Manufacturers must establish a QMS that ensures systems are in place to handle product nonconformities and complaints, with corrective and preventive actions taken as necessary. Postmarket surveillance and vigilance reporting must integrate with the CAPA system to systematically investigate and resolve serious incidents and nonconformities detected after delivery.

Software Tools for Management

Given the complexity and regulatory scrutiny, managing nonconformity and CAPA often involves dedicated software systems, which may be integrated within an Enterprise Quality Management System (eQMS).

Nonconformance management software streamlines workflows, centralizes documentation, and ensures seamless connections with other QMS processes like Design Control, Training Management, and Audits.

Analogy: Nonconformity Management is like a restaurant health and safety department. When a health inspector (auditor) finds spoiled food (the nonconforming product), the manager must immediately segregate it and decide its disposition (throw it out or rework it if possible). Crucially, the discovery then triggers the CAPA system (the investigation). The restaurant doesn't just throw out that one piece of food; they must investigate the root cause (e.g., the refrigerator setting was too high) and implement actions (repair the refrigerator, change the temperature monitoring schedule, and retrain staff) to prevent that spoiled food (nonconformity) from ever being produced again. This ensures continuous, systemic improvement.

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