Triggers for change

‍Triggers for Change are specific events, findings, or deliberate decisions that initiate the formal investigation and structured management processes, such as the Corrective and Preventive Action (CAPA) system or Design Change Control, within a Quality Management System (QMS).

These triggers signal that a modification to a product, process, or quality system procedure is necessary to correct a problem, mitigate a risk, or implement an improvement.

Understanding Triggers for Change

In regulated industries, particularly medical device manufacturing, changes cannot be made arbitrarily; they must be identified, documented, reviewed, and approved via formal change control procedures before implementation. Triggers initiate this regulated process.

Quality and Failure-Based Triggers (Reactive)

These triggers arise when performance deviates from expected standards or results in defects, necessitating a formal Root Cause Analysis (RCA) and resolution through CAPA.

Nonconformities and Deviations

The CAPA system is directly triggered through issues such as deviations, nonconformities, customer complaints, and audit findings. These nonconformities can include receiving nonconforming raw materials.

Manufacturing Process Failures

Discovering a manufacturing process failure, such as an automated assembly line producing defective plungers due triggers a CAPA investigation to determine the root cause.

Complaints and Adverse Events

Complaints are defined as communications alleging deficiencies related to the identity, quality, safety, or performance of a device. Failures related to Software are cited as one of the most frequent causes for recalls in the medical device industry, which forces changes to the design and software controls.

HCT/P Deviations (Communicable Disease Risk)

For Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), an HCT/P deviation must be investigated and reported if it relates to core current good tissue practice (CGTP) requirements or is an unexpected event that may relate to the transmission of a communicable disease or contamination.

Supplier Deficiencies (SCAR)

A Supplier Corrective Action Request (SCAR) is triggered by the purchaser upon notice of any deficiency in the supplier’s quality system, product, or service.

Planned Modifications and Systemic Changes (Proactive)

These triggers originate from internal decisions to alter the established design, composition, or use of a product, or from new regulatory or business requirements.

Design Changes/Modifications

A significant change or modification in the device that could significantly affect its safety or effectiveness (e.g., a change in design, material, chemical composition, energy source, or manufacturing process) mandates a review and often requires a new premarket submission.

Major Change in Intended Use

A major change or modification in the intended use of the device requires a premarket notification submission ($510(k)$).

Design Improvements

Beyond simple fixes, Design Changes are formal steps for the identification, documentation, review, and approval of modifications to the device design before implementation.

New Regulatory Requirements

Changes must be addressed in a timely manner, including responding to changes in European standards. For instance, a quality system revision must address new requirements, procedures, and activities documented by applicable regulatory requirements.

Supply Chain and QMS Status

A purchaser requests advance notification when a supplier makes changes in its quality system pertaining to registration/certification or changes its supplied product or service. This also includes a supplier notifying the purchaser of changes in the supplier’s management structure.

Analogy for Understanding Triggers for Change

If a Quality Management System (QMS) is like maintaining a complex aircraft fleet, the Triggers for Change are everything that alerts the engineers that a modification is necessary.

A Reactive Trigger is a warning light on the dashboard (a major complaint or adverse event), or a maintenance log showing a critical component unexpectedly failed (a process deviation). These force an immediate investigation (RCA) and correction (CAPA).

A Proactive Trigger is a scheduled engineering update or a new flight path (new intended use). These originate from the design team, not a failure, but they still necessitate an extensive review, documentation, and approval process (Change Control) before the aircraft can fly in the new configuration.

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