> ## Documentation Index
> Fetch the complete documentation index at: https://docs.elevatedsignals.ai/llms.txt
> Use this file to discover all available pages before exploring further.

# Investigate an OOS result

> Record an out-of-specification result, complete Phase I and get it reviewed.

Use this procedure where OOS records are enabled for your organization. For field and status details,
see [OOS Records](https://docs.elevatedsignals.ai/invariant/reference/oos-records.md).

## Record the result

1. Go to **Quality Management → OOS**.
2. In **Record a new OOS result**, enter the original result as it was first reported.
3. Choose the **Analyst account**, or enter an **External analyst name**.
4. Choose the **Phase I investigator** and the **Phase I due date**.
5. Select **Create OOS record**. The record opens in **Phase I open**.

To fix a transcription error before the first submission, use **Correct a transcription error before
submission**. Enter a reason and select **Save audited correction**.

## Complete Phase I

1. Open the record. The investigator or a QA Manager can edit Phase I.
2. In **Phase I laboratory investigation**, set a result and a note for each of the five checks.
3. Enter the **Findings**, the **Phase I outcome** and the **Recommended next step**.
4. Link a deviation or CAPA if one exists.
5. Enter a reason and select **Save Phase I investigation**.
6. Where attachments are enabled, upload supporting evidence in **Attachments / evidence**.

## Submit for review

1. Confirm the source report or certificate of analysis reference is filled in.
2. As the investigator, enter a reason and select **Submit saved Phase I for review**.

The original result is now frozen. Phase I content is frozen while the record is in review.

## Review or return

1. Sign in as an independent QA Manager or Administrator.
2. Open the record and enter a reason.
3. Select **Review Phase I**, then **Sign Phase I review**. Or select **Return investigation**, then
   **Sign return**.
4. Re-enter your password to sign.

A returned record goes back to **Phase I open**. A reviewed record is frozen. Phase I review does not
close the OOS or release a batch: record the next step under your approved procedure.

> [!NOTE]
>
> Where record PDF export is enabled, select **Download OOS PDF** to save a copy of the record for review
> or audit.


This documentation is built and hosted on [Mintlify](https://mintlify.com), a developer documentation platform.