Quality issues are inevitable - but how they're handled determines whether they become recurring problems or opportunities for improvement.

This micro-training introduces the purpose of Quality Events, explains how they fit into a Quality Management System (QMS), and demonstrates how to manage them in SimplerQMS.

You will also learn how Observations can be used to report a potential issue and, when appropriate, escalated into a Quality Event.

The course contains the following chapters:

Quality issues can happen in every organization - even when processes are well controlled.

A customer complaint, audit finding, manufacturing deviation, or nonconformance can all indicate that something needs to be addressed.

But not every concern needs to become a formal Quality Event. The first step may simply be to report what was observed so it can be assessed by the appropriate person.

This is where Observations and Quality Events work together.

An Observation provides a simple way to report something that may be a quality issue. Based on the assessment, it can either be closed or escalated into a Quality Event when further investigation or action is needed.

This gives organizations a structured path from identifying a concern to resolving a quality issue.

Managing quality events helps regulated organizations:

Without a consistent process, issues can be overlooked, repeated, or resolved without proper documentation.

A Quality Event creates a single record that captures:

Observations support the beginning of this process by making it easy to report something that may need further attention.

For example:

These concerns can be reported and assessed before determining whether a Quality Event is required.

Quality management standards expect organizations to identify, investigate, and resolve quality issues in a controlled manner.

This includes:

A structured Quality Event process provides the evidence needed to demonstrate these activities during inspections and audits.

A quality issue can start as an Observation.

An Observation captures what was noticed, along with relevant details and supporting evidence. The appropriate Observation owner then assesses whether further action is needed.

If the concern requires formal investigation or follow-up, the Observation can be escalated into a Quality Event.

Once escalated, the Quality Event follows its own controlled lifecycle:

A quality event may include:

By viewing the video above or following the steps below, you'll learn how to create and manage a Quality Event in SimplerQMS.

An Observation is a simple way to report something that may require attention. It can be submitted with a description and supporting evidence, such as a photo or screenshot.

Describe what was observed and provide any relevant supporting information or attachments.

The appropriate Observation owner reviews the information and determines what should happen next.

The Observation can either be:

When a Quality Event is needed, select the appropriate Quality Event type and process and escalate the Observation.

The Observation remains connected to the Quality Event, providing context about the original issue.

Once the Observation has been escalated, the Quality Event follows its controlled workflow.

Assess the newly created Quality Event and document the issue, including relevant details, affected processes, and supporting information.

Send the Quality Event for Review so the appropriate stakeholders can evaluate the information, provide feedback, and request any necessary updates.

After revisions are complete, submit the Quality Event for Approval. Verify that all required information has been documented before approving.

Some Quality Events require additional follow-up beyond documenting the issue.

Describe what happened using factual information and avoid assumptions or conclusions before the investigation is complete.

Assign reviewers and approvers who have the appropriate knowledge and responsibility for evaluating the issue.

Ensure investigations, decisions, corrective actions, and supporting evidence are recorded before closing the Quality Event.

For detailed instructions on creating, reviewing, approving, and managing Quality Events in SimplerQMS, visit the Quality Events section of the Help Center.