> ## 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. # OOS Records > Record an out-of-specification result and its Phase I laboratory investigation. The **OOS** page records an out-of-specification result exactly as it was first reported, then guides a Phase I laboratory investigation and an independent QA review. It is available where OOS records are enabled for your organization. It is off by default and is enabled per organization on request. Open it from **Quality Management → OOS**. The list page is titled **Out-of-specification results (OOS)**. > [!NOTE] > > Phase I review does not close the OOS or release a batch. Phase II investigation, result invalidation, > final closure and batch disposition are not recorded in Invariant. A reviewed record shows that its > overall outcome is unresolved. ## Who can do what | Action | Roles | | - | - | | View and create OOS records | Administrator, QA Manager, Reviewer, Operator | | Edit the Phase I investigation, correct the original result before submission | The Phase I investigator, or a QA Manager or Administrator | | Submit Phase I for review | The Phase I investigator only | | Review or return Phase I (signed) | An independent QA Manager or Administrator | ## Original result Each record holds one original result. Required fields are **OOS title**, **Product**, **Batch / lot**, **Test**, **Method identifier and version**, **Specification reference**, **Acceptance criterion**, **Original reported result** and **Test date and time (UTC)**. Optional fields include the sample reference, units, instrument reference, source report or certificate of analysis reference, and a linked material. The source report reference is optional at creation but required before Phase I can be submitted. Name the analyst by choosing an **Analyst account** or entering an **External analyst name**. A name-only external analyst cannot be checked for account independence. You also set the **Phase I investigator** and the **Phase I due date** when you create the record. The investigator cannot be reassigned during Phase I. Before the first submission, a transcription error in the original result can be fixed with **Correct a transcription error before submission**. The correction needs a reason and is written to the tamper-evident audit trail. After the first submission the original result is frozen, even if the investigation is later returned. ## Phase I investigation The **Phase I laboratory investigation** section has five checks: **Calculation**, **Method and specification**, **Sample integrity**, **Equipment and calibration** and **Records**. Each check takes a result (**Not assessed**, **OK**, **Issue found** or **Not applicable**) and a note. The investigator also records: * **Findings**. * **Phase I outcome**: **Assignable laboratory cause**, **No assignable laboratory cause** or **Inconclusive**. An assignable cause also requires the laboratory cause. * **Recommended next step**: **Phase II investigation**, **Retest or resample plan**, **Invalidation proposal** or **No further laboratory action**. This is a recommendation; Invariant does not run the next step. * Optional links to a deviation and a CAPA. Linking does not change the linked record. All five checks, the findings, the outcome, the next step and the source reference must be complete before Phase I can be submitted. Each save of the investigation needs a reason for change. ## Statuses | Status | Meaning | | - | - | | Phase I open | The investigator is working on Phase I. | | Phase I in review | Phase I is submitted. Its content is frozen while QA reviews it. | | Phase I reviewed | An independent QA Manager or Administrator signed the review. The record is frozen. | A reviewer can also return a submitted investigation to **Phase I open** with a signed return. Review and return each need a reason of at least 10 characters and password re-entry. The signature covers the original result, the Phase I content, the follow-up links and the reason. The review or return must be signed by an independent QA Manager or Administrator. The record's creator, investigator, account-linked analyst, submitter and anyone who edited its content cannot sign. After review, an empty deviation or CAPA link can still be filled once with **Add follow-up link**. A link added this way is labelled as added after Phase I review and is not part of the signed snapshot. ## Attachments, PDF and reminders (where enabled) These extras need a second organization setting for OOS records, which is also off by default. * **Attachments:** the **Attachments / evidence** panel accepts PNG, JPEG or PDF files up to 25 MB, in any Phase I status. The file content must match its type. Adding evidence does not change existing Phase I signatures. Attachments also require the attachments feature. * **Record PDF:** where record PDF export is also enabled, **Download OOS PDF** produces a PDF of the record fields, the Phase I review, signatures, attachments with their SHA-256 digests and linked records. The PDF states that Phase I review is not the final OOS disposition and does not include the full activity timeline. * **Phase I reminders:** where in-app notifications are enabled, the Phase I investigator gets a notification in the **Notifications** menu when the Phase I due date is within 3 days and again once it has passed. Reminders stop once Phase I is reviewed. * **Quality Calendar:** **Show OOS Phase I dates** adds each record's Phase I due date to the calendar. See [Quality Calendar](https://docs.elevatedsignals.ai/invariant/reference/quality-calendar.md#oos-phase-i-dates). For the step-by-step procedure, see [Investigate an OOS result](https://docs.elevatedsignals.ai/invariant/how-to/investigate-an-oos-result.md). This documentation is built and hosted on [Mintlify](https://mintlify.com), a developer documentation platform.