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The Quality Event workflow in Simploud manages the full lifecycle of a quality event, from initial reporting to final resolution.
Any type of Quality Event can be reported and linked to other processes, such as initiating a CAPA.
This page provides a clear overview of each stage in the workflow and guides you through the transition steps, ensuring comprehensive management and resolution of quality events.
Workflow Stages
Identification
The owner creates the record, capturing all pertinent event information such as the date, location, and description of the incident.
This includes categorizing the event type and noting any immediate actions taken.
Quality Review
The record is opened for the Quality Reviewer, who examines the event details thoroughly.
The reviewer evaluates the information, ensures compliance with quality standards, and verifies the accuracy of the data.
Once the review is completed, the reviewer electronically signs (e-signature) the record to confirm their approval, marking the event as reviewed and ready for the next stage in the workflow.
Investigation
A detailed investigation may be required to understand the root cause and implications of the event.
Investigation tasks are created and assigned to specific investigators, who are responsible for gathering evidence, conducting interviews, and analyzing data.
Each investigator’s findings are documented in the system. Once all investigations are concluded and closed, the results are analyzed and summarized, providing a comprehensive overview of the event’s causes and impacts.
This summary forms the basis for any corrective or preventive actions needed to address the issue and prevent recurrence.
CAPA Plan
Based on the investigation, a Corrective and Preventive Action (CAPA) Plan is created as a child of the quality event to address and rectify the identified issue. This includes immediate corrective actions to fix the current problem and preventive measures to avoid recurrence.
Specific steps may involve updating calibration procedures, enhancing staff training programs, implementing regular audits, and introducing more stringent quality control checks.
Note that CAPA is a distinct process within the system and can be created from the record.
CAPA Plan Approval
Before implementation, the CAPA plan undergoes a rigorous review process.
Designated approvers assess the thoroughness of the proposed corrective and preventive actions, verify that all root causes have been addressed, and ensure that the plan aligns with organizational policies and regulatory requirements.
The CAPA plan can be implemented only after this comprehensive review and formal approval.
Closed
The quality event is then concluded and marked as “closed,” indicating the issue has been resolved.
However, the CAPA can continue to run, ensuring long-term effectiveness and monitoring, while the event record itself is closed.
Cancelled
The record has been officially withdrawn and is no longer recognized within the organizational system.
The cancellation ensures that no further actions are taken based on outdated or incorrect information, maintaining the integrity and accuracy of the quality management system.