Nonconformances

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

The concept of Nonconformances is central to quality management, as it represents a failure within the Quality Management System (QMS) that must be identified, contained, assessed, and ultimately corrected to ensure product quality and regulatory compliance.

In simple terms, a nonconformity occurs whenever a product, process, service, or system activity fails to meet one of the organization’s predetermined rules, specifications, or regulatory expectations.

Nonconformities include quality problems, product defects, deviations, or findings resulting from audits or complaints.

Managing nonconformities is a mandatory part of maintaining an effective QMS, as required by standards like ISO 9001 and regulatory frameworks such as the FDA’s Quality System Regulation (QSR) (21 CFR Part 820).

Mandatory Procedures for Control (QSR)

Manufacturers must establish and maintain procedures specifically to control product that does not conform to specified requirements (known as Nonconforming Product).

These procedures must address the following critical steps:

Identification

Recognizing and defining the nonconforming issue or defect.

Documentation

Recording the nature of the nonconformity and the subsequent actions taken.

Evaluation and Segregation

Assessing the nonconformance and determining the need for an investigation. The product must be segregated (or contained) to prevent unintended use or delivery.

Disposition

Determining the final fate of the nonconforming product.

Disposition and Rework

The disposition of nonconforming product must be documented, and the responsibility and authority for this decision must be defined by established procedures.

Options for disposition include:

Correction/Rework:

Action taken on a nonconforming product so that it will fulfill the specified requirements before being released for distribution. Procedures for rework must include retesting and reevaluation to ensure the product meets current approved specifications. Rework and reevaluation activities must be documented in the Device History Record (DHR).

Use Under Concession:

Obtaining authorization for use or release, despite the nonconformity. If nonconforming product is used, the documentation must include the justification for use and the signature of the individual(s) authorizing the use.

Scrapping/Return:

Segregation, containment, return, or rejection of the product.

The Link to Corrective Action (CAPA)

The management of nonconformities is directly linked to the Corrective and Preventive Action (CAPA) subsystem, which is the mechanism for continuous improvement.

Trigger for CAPA

Nonconformities, complaints, deviations, and audit findings are key sources that trigger the mandatory CAPA process.

Investigation

CAPA requires a thorough investigation to determine the root cause of the nonconformities relating to the product, processes, or the quality system itself.

Prevention

The core purpose of CAPA regarding nonconformances is to identify action(s) needed to correct and prevent recurrence of the nonconforming product or quality problem.

Data Analysis

CAPA procedures mandate analyzing sources of quality data, such as quality audit reports, complaints, and returned product, to identify existing and potential causes of nonconforming product.

Regulatory Severity and Reporting

The severity of a nonconformity dictates its regulatory impact, particularly for medical devices.

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 similar complaint has already been investigated.

Recalls

Non-Conforming Materials/Components are documented as among the most frequent causes for device recalls.

MDR Reporting

If a nonconformity detected via a complaint or malfunction represents an event that must be reported to the FDA under Medical Device Reporting (MDR) (Part 803), the complaint must be promptly reviewed, evaluated, and investigated by a designated individual and clearly identified in the complaint files.

Analogy for Understanding Nonconformance

Think of Nonconformity management as the Error Check and Repair Station in a complex production line.

If your process specification calls for a bolt to be tightened to exactly 10 Newton-meters (the requirement), and an inspection tool checks a unit and finds the bolt is only at 8 Nm (the non-fulfillment), that unit is nonconforming.

The management system immediately tags the unit (identification), sets it aside (segregation), and documents the problem. Management must then decide its disposition: either scrap it, or fix it (rework) and re-check the torque, or formally approve its use despite the fault (concession, with justification). Crucially, the nonconformity data is then sent to the CAPA team, whose job is to investigate why the machine tightened it incorrectly in the first place (root cause analysis) to prevent it from happening again throughout the system.

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