Quality event

A Quality Event is any occurrence that involves the quality, performance, or conformity of a product, process, or system (planned or unplanned). In regulatory and medical device contexts, "quality event" is often used synonymously with an issue that triggers investigation and action within the Quality Management System (QMS).

A Quality Event is an identified incident, outcome, or finding—such as a nonconformity, a deviation, an audit finding, or a customer complaint—that necessitates a formal evaluation and often triggers the Corrective and Preventive Action (CAPA) process or mandatory regulatory reporting.

Quality Events serve as the primary inputs to the continuous improvement process within an organization, particularly through the CAPA system, ensuring risks are mitigated and quality standards are maintained.

Sources and Types of Quality Events

In the medical device industry, Quality Events are generally defined by their origin (internal versus external) and their outcome (adverse event versus nonconformity).

A. Events that Trigger CAPA

The Corrective and Preventive Action (CAPA) system is specifically designed to identify, investigate, resolve, and prevent quality issues related to medical devices. CAP CAPA is triggered by several types of Quality Events:

Deviations and Nonconformities: These are fundamental triggers. A nonconformity means the non-fulfillment of a specified requirement. Examples include identifying nonconforming raw materials (e.g., medical-grade silicone failing purity standards) or manufacturing process failures (e.g., misaligned machinery producing defective plungers).

Complaints: Customer complaints are critical inputs to the CAPA process. For instance, users reporting insulin pump malfunctions affecting dosage accuracy can trigger a CAPA investigation.

Audit Findings: An FDA inspection finding missing documentation (e.g., for sterilization validation) is a quality problem that triggers a CAPA plan to ensure regulatory compliance.

Post-Market Surveillance (PMS) Issues: Data gathered after product release can identify trends or issues that require CAPA. This may include events necessitating remedial action to prevent an unreasonable risk of substantial harm to public health, which can be identified through trend analysis.

Service Reports: Manufacturers must analyze service reports and automatically consider any report that represents a mandated reporting event (under Part 803) as a complaint, processing it accordingly.

B. Medical Device Reporting (MDR) Reportable Events

A specific category of serious Quality Events are those deemed MDR Reportable Events (or reportable events) under FDA regulations (21 CFR Part 803).

Definition: An MDR reportable event is one that reasonably suggests that a device has or may have caused or contributed to a death or serious injury [51(1), 52(i)].

Malfunction: For manufacturers or importers, an event is reportable if the device has malfunctioned and the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur [52(ii), 66(1)].

Causes: An event may be attributed to a device failure, malfunction, improper or inadequate design, manufacture, labeling, or user error.

Serious Injury: A serious injury is one that is life-threatening, results in permanent impairment of a body function or damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment or damage.

Reporting: Manufacturers must have written procedures for determining when an event meets the criteria for reporting under Part 803.

Management and Documentation of Quality Events

Quality Events are the data inputs for systematic management, documentation, and continuous review within the QMS.

Evaluation and Investigation: Manufacturers must review and evaluate all complaints (Quality Events) to determine if an investigation is necessary. Complaints involving the possible failure of a device, labeling, or packaging to meet specifications must be reviewed, evaluated, and investigated, unless already performed for a similar complaint.

HCT/P Deviations: For Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P), a deviation is a specific type of quality event defined as an event that represents a deviation from regulations, standards, or established specifications related to preventing communicable disease transmission or HCT/P contamination [244(1)]. It can also be an unexpected or unforeseeable event potentially related to the transmission of communicable disease or HCT/P contamination [244(2)]. These deviations must be investigated, documented, and corrective actions implemented to prevent recurrence.

Documentation in CAPA: All activities related to the CAPA process—from issue identification to effectiveness checks—must be thoroughly documented.

Complaint Files: Manufacturers must maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints. Complaints that are reportable to the FDA under Part 803 must be promptly reviewed, evaluated, and investigated by a designated individual and clearly identified within the complaint files.

Immediate and Remedial Actions

When a significant Quality Event occurs, rapid action is often necessary:

Remedial Action: Remedial action is defined as any action other than routine maintenance or servicing of a device, where such action is necessary to prevent recurrence of a reportable event.

5-Day Reporting: Manufacturers must submit a report no later than 5 work days after becoming aware of an MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health [56(2)(i), 80(a)]. Awareness can come from any information, including trend analysis [49, 80(a)].

Recalls: Product recalls due to defects (e.g., implantable cardiac device battery defects) are examples of severe Quality Events requiring a CAPA investigation leading to stricter controls, validation, and supplier audits. If a manufacturer voluntarily decides or is required to recall a product implicating a supplier's process, the supplier must fully cooperate.

Analogy for Understanding a Quality Event

If the entire Quality Management System (QMS) is a large, complex security system for a facility, a Quality Event is any time an alarm is triggered.

It could be a minor alarm (a nonconformity, like a door being left slightly ajar), triggering a small investigation and a simple fix (a quick CAPA). Or, it could be a major alarm (a device malfunction leading to serious injury), which immediately triggers mandatory regulatory reporting (MDR) within days, requires immediate remedial action (a product hold or recall), and launches a full-scale, documented investigation (Root Cause Analysis) to overhaul the security process (systemic CAPA) and prevent that specific failure from ever recurring.

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