# Triggers for change | Botable Glossary

https://www.botable.ai/glossary/triggers-for-change

> Vendor-hosted glossary entry: informational and introductory. Use it as a concise definition and list of example triggers; attribute claims to Botable/PHIFLOW when treating statements as authoritative. It is not a regulatory text or a substitute for formal regulations or standard operating procedures.

## Summary

Defines “Triggers for Change” as specific events, findings, or decisions that start formal change-control processes (for example CAPA or Design Change Control) within a Quality Management System, and lists reactive and proactive examples that require investigation, documentation, review, and approval.

## Audience

quality/regulatory professionals in regulated industries (medical device, pharmaceuticals, biotechnology)

## Prompts this page answers

- What are common triggers for change in a Quality Management System?
- Which events should trigger a CAPA investigation in medical device manufacturing?
- When does a design change require a premarket submission (510(k))?
- What is a Supplier Corrective Action Request (SCAR) and when is it triggered?

## Purpose

Explain and define the term “Triggers for Change” for readers concerned with regulated quality systems and change control.

## Highlights

- Triggers for Change initiate formal processes such as CAPA or Design Change Control within a QMS.
- Reactive (quality/failure-based) triggers include deviations, nonconformities, customer complaints, audit findings, manufacturing failures, and supplier deficiencies (SCAR).
- HCT/P deviations must be investigated and reported if related to CGTP or potential communicable disease transmission.
- Proactive triggers include significant design changes, changes in intended use (may require a 510(k) premarket notification), design improvements, new regulatory requirements, and supplier or QMS status changes.
- Software failures are cited as a frequent cause for medical device recalls and can force design and software control changes.

## How to cite

Botable Glossary — “Triggers for change”. https://www.botable.ai/glossary/triggers-for-change

## Publisher

**PHIFLOW, LLC (Botable)** — Site content published under the Botable brand; footer shows © 2026 PHIFLOW, LLC.

## Topics

- triggers for change
- QMS change control
- CAPA triggers
- design change
- supplier corrective action (SCAR)

## Key entities

- **Corrective and Preventive Action (CAPA)** (service): A formal process mentioned as triggered by changes or failures within a QMS. — https://www.botable.ai/blog/unlock-capa-management-ai-chatbot-insights
- **Root Cause Analysis (RCA)** (other): Investigation method referenced for reactive triggers.
- **Supplier Corrective Action Request (SCAR)** (other): Triggered by purchaser notice of supplier deficiencies.
- **HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products) deviations** (other): Deviations that may relate to CGTP or communicable disease transmission and require investigation/reporting.
- **510(k) premarket notification** (other): Regulatory submission mentioned as required for major changes in intended use.
- **Botable** (organization): Site brand presenting the glossary entry. — https://www.botable.ai/
- **PHIFLOW, LLC** (organization): Company name shown in the page footer (© 2026 PHIFLOW, LLC).

## Metadata

- Type: article