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Evaluating an Observation

Assign reviewers, capture any review input, and decide whether to escalate the Observation to a Quality Event or close it.

Who is this for?

  • Initiator / Owner - assigning reviewers

  • Reviewers - completing Initial Intake when assigned

  • Observation Inbox Owner - escalating, closing or reopening the Observation

How to do it?

Evaluating an Observation covers assigning reviewers, completing any review, and deciding whether to escalate the Observation to a Quality Event or close it.

The initiator or owner of the observation can add additional reviewer(s) who can help with adding additional comments on the initial observation either to provide more information or to aid the assessment process.

Assign reviewers (Initiator / Owner)

  1. Select the pencil (edit) icon in the Observation Access section, then add the appropriate users or groups as Reviewers, if a review is needed, and select Save.

Assigning reviewers in the Observation Access section.

Assigning reviewers in the Observation Access section.

💡Tip: Use Reviewers to pull in subject-matter experts before you decide on escalation. Their intake is recorded and attributed, which strengthens the evaluation record.

Review the Observation (Reviewers)

Reviewers are optional and can complete an Initial Intake at any time before the Observation is escalated or closed.

  1. On My Work, a review action is assigned to the reviewer. Open the Observation from this action.

  2. After reviewing the issue, select Complete Intake and add the recommendation in the intake form.

Completing the Initial Intake as a reviewer.

3. The intake is recorded on the Reviews tab, attributed to the reviewer. To amend it, open the intake and select Edit intake.

The recorded intake on the Reviews tab.

Escalate the Observation to a Quality Event (Observation Inbox Owner)

If an Observation requires formal handling, escalate it to a Quality Event. The system creates a linked Quality Event and moves the Observation to the Escalated state.

  1. Open the Observation and select Escalate to Quality Event.

The Escalate to Quality Event action.

Complete the Escalate to Quality Event dialog:

Escalate to Quality Event

Field

Description

Note

Quality event type

The type of Quality Event to create (for example Complaint, Deviation, Nonconformity).

Available types are configured in Settings.

Quality process

The process the Quality Event belongs to.

Available processes are configured in Settings.

3. Select Escalate. The system creates the Quality Event in the Assessment state and sets the Observation to Escalated. The new Quality Event records the source Observation under Originating Observation.

The escalated Observation and its linked Quality Event.

Close or reopen the Observation (Observation Inbox Owner)

Close an Observation that does not require escalation to a Quality Event. A closed Observation can be reopened if further evaluation is needed.

  1. Select Close observation, enter the reason in Closing justification, then select Close. The Observation state changes to Closed.

Closing an Observation with a justification.

Reopen the Observation (Observation Inbox Owner)

A closed Observation can be reopened if reevaluation is needed.

  1. To reopen a closed Observation, open it and select Reopen. The Observation returns to Initial Review with its data and attachments retained.

Reopening a closed Observation.

💡Tip: Always consult your procedures on incident management to determine the correct handling of the observations.

❗The decision to escalate or close should follow your documented incident- or nonconformity-handling procedure. A closed Observation still requires a recorded closing justification as the justification, not just the outcome, is what keeps the decision defensible during an audit.

What's next?

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