Nonconformity

‍A Nonconformity (or Nonconformance) is the non-fulfillment of a specified requirement.

In simple terms, a nonconformity is a failure of any product, process, service, or system activity to meet a predefined rule, specification, or expectation. These issues may be referred to broadly as quality problems, product defects, deviations, or complaints.

The concept of Nonconformances is a core element of quality management systems (QMS), requiring formal procedures to identify, control, and prevent deviations from expected standards.

The regulation and control of nonconformances are critical for medical device manufacturers, as addressed by the FDA’s Quality System Regulation (QSR) under Subpart I—Nonconforming Product (§ 820.90).

Mandatory Procedures for Control

Manufacturers must establish and maintain documented procedures to control product that does not conform to specified requirements. These procedures must ensure that nonconforming product is handled systematically:

Identification and Documentation

Procedures must identify and document the nature of the nonconformity.

Evaluation and Segregation

The nonconformance must be evaluated, which includes determining the need for an investigation. The nonconforming product must be segregated to prevent unintended use.

Disposition

Procedures must define the authority and process for determining the final disposition of the nonconforming product. Disposition must be documented.

Disposition Options and Rework

The disposition process outlines what happens to a product once it is identified as nonconforming. Documentation of the disposition process is mandatory.

• Rework/Correction: This is action taken on a nonconforming product so that it will fulfill the specified requirements before it is released for distribution. Procedures for rework must include retesting and reevaluation to ensure the product meets current approved specifications. Documentation of rework and reevaluation activities, including a determination of any adverse effect from the rework, must be recorded in the Device History Record (DHR).
• Use Under Concession: If nonconforming product is accepted or released (used under concession), the documentation must clearly state the justification for use and include the signature of the individual(s) authorizing the use.
• Rejection/Scrap: The product is rejected or destroyed.

Nonconformity as a Driver for CAPA

Nonconformities are primary inputs used to trigger the Corrective and Preventive Action (CAPA) process, which is essential for continuous improvement in a QMS.

• Triggering Events: Nonconformities, deviations, complaints, audit findings, and internal quality control data are sources that trigger the mandatory CAPA system.
• Investigation and Root Cause: CAPA procedures mandate the investigation of the cause of nonconformities relating to the product, processes, and the quality system. This investigation aims to eliminate the underlying factors contributing to the issues (root cause analysis).
• Action and Prevention: The actions identified through the CAPA process must correct the nonconforming product and prevent its recurrence. Examples of CAPA application stemming from nonconformities include resolving issues related to nonconforming raw materials or addressing manufacturing process failures.

Regulatory Integration

Management of nonconformities is integrated across the QMS and required by regulatory standards:

• QMS Integration: Nonconformities and corrective actions are key pieces of information considered in Management Review inputs to ensure continuous improvement.
• ISO Requirements: ISO 13485:2016 requires procedures for identifying, investigating, and addressing nonconformities (Corrective Action, Section 8.5.2). The European Union Medical Device Regulation (EU MDR) similarly requires manufacturers to have systems in place to handle product nonconformities and complaints, taking corrective and preventive actions as necessary.
• Complaint Handling: Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications must be reviewed, evaluated, and investigated, unless a prior investigation of a similar complaint is already available.
• Reporting: If a complaint involving a nonconformity represents an event that must be reported to the FDA under Medical Device Reporting (MDR) (21 CFR Part 803), the manufacturer must promptly review, evaluate, and investigate the issue.

As an analogy, the process of handling Nonconformances is like finding a broken piece in an assembly line. When the defect is found (the nonconformity), the process stops immediately (segregation), and management decides what to do with that specific broken piece (disposition: scrap it, fix it, or, rarely, use it if the flaw is minor and approved). Crucially, the discovery of the broken piece then immediately activates the CAPA team, whose job is not just to fix the broken unit, but to dismantle the entire section of the assembly line (root cause analysis) to ensure that the defect cannot be produced again in the future (prevention of recurrence).

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