# Inspect outgoing lots and release them (/docs/quality-release/outgoing-inspection-and-lot-release)

A finished lot cannot ship until two things happen. The QC inspector passes it at outgoing inspection
(OQC). Then the QA manager signs the lot release. The default QC inspector is Siti Rahmah. The default
QA manager is Grace Ooi.

```mermaid
%% title: From finished lot to shipment
flowchart LR
  A[Order at QA Final] -->|Sign · Accept lot| B[Lot waits in Q-FG-01]
  A -->|Hold lot and raise NCR| X[Lot On hold, NCR open]
  B -->|Run release checks| C{All checks passed?}
  C -->|No| D[Blocked]
  D -->|Re-run checks| C
  C -->|Yes| E[Ready]
  E -->|Sign · release lot| F[Released, lot still in Q-FG-01]
  F -->|Store posts the put-away| G[Lot in its finished goods bin]
```

## Inspect a finished lot (OQC) [#inspect-a-finished-lot-oqc]

Open **Quality > Outgoing**. A lot appears here when the operator completes the manufacturing order.
If none is waiting, the screen says so.

<Steps>
<Step>

Read the header: product, quantity, **lot size code** and **sample n**. The sample follows general
inspection level II (ISO 2859-1, normal inspection). Pull that many pieces from the lot.

</Step>
<Step>

Enter what you found in **Critical**, **Major** and **Minor**. The table shows the **AQL** and the
**Ac / Re** (accept and reject numbers) for your sample size. Major is AQL 0.65 and minor is AQL 1.5.
Critical is always accept 0: one critical defect fails the lot.

</Step>
<Step>

If the product's inspection plan has critical characteristics (CTQ), a table lists each one with its
specification and gauge. Measure it on the sampled pieces and type the value. Several pieces can go in one
box, separated by spaces. The verdict shows **In tolerance** or **Out of tolerance** against the plan. You
cannot accept the lot until every CTQ is measured and inside the plan, and its gauge must be in
calibration. If one is outside the plan, hold the lot instead.

</Step>
<Step>

Tick **UDI labels, lot number and pouch count verified on sampled cartons**. You cannot accept the
lot without it.

</Step>
<Step>

Read **Verdict**. If every class shows **Accept**, choose **Sign · Accept lot**. The sign dialog repeats
the sample size, the three defect counts and every CTQ reading, so you see what you are signing. Sign. The system
records an outgoing inspection (for example OQ-2026-0001) with result **Accepted**, and the order
moves to **Completed**. The lot stays in **Q-FG-01** until the lot release.

</Step>
<Step>

If a class shows **Reject**, type the reason in the box that asks why the lot fails outgoing inspection, and
choose **Hold lot and raise NCR**. The lot goes **On hold**. The system opens an NCR with source
**OQC** and disposition **Hold · 100% sort**. Go to [Handle nonconformances and CAPA](/docs/quality/ncr-and-capa).

</Step>
</Steps>

<GuideStep
  title="Outgoing QC"
  description="With no finished lot waiting, the screen lists the recent outgoing inspections and their results. A waiting lot appears at the top with its defect table and the sign buttons."
  src="/guide/outgoing-inspection-and-lot-release/1.png"
  alt="Outgoing QC screen on desktop with no lot waiting and the list of recent outgoing inspections with their results"
  width={1440}
  height={1000}
  callouts={[
    { x: 50, y: 15, caption: "Lots waiting for outgoing inspection appear here." },
    { x: 25, y: 50, caption: "Recent inspections: lot, product, quantity and sampling plan." },
    { x: 93, y: 50, caption: "Result: Accepted, Rejected or On hold." },
  ]}
/>

<Callout type="note">
Only a QC inspector (or someone signing for one) can sign an outgoing inspection, and only if their
training is current. See [Signatures and refusals](/docs/get-started/signatures-and-refusals).
</Callout>

### Clear a hold after the NCR is closed [#clear-a-hold-after-the-ncr-is-closed]

When the NCR of a failed lot is closed, the lot can go back to inspection.

<Steps>
<Step>

Open **Quality > Outgoing**. The lot shows the hold and the NCR number. Close the NCR first, with its
disposition.

</Step>
<Step>

A QA engineer or QA manager chooses **Clear hold** and signs. The lot returns to quarantine, ready to
be inspected again.

</Step>
</Steps>

A lot whose NCR was closed as **Scrap** cannot go back to inspection.

## Keep a retention sample [#keep-a-retention-sample]

Open **Quality > Retention samples**. This register applies while ISO 13485 is on. Each sample has the
lot, quantity retained, location, **Retained on** and **Retain until**.

- **Withdraw sample** (**Retained** to **Withdrawn**): enter the **Withdrawal reason**, the
  **Withdrawal ref.** (complaint or investigation) and **Qty withdrawn**, then sign. The quantity is at
  least 1 and not more than the quantity retained.
- **Dispose** (to **Disposed**): the QA manager signs. It is allowed only on or after **Retain until**.

## Run the release checks [#run-the-release-checks]

Open **Quality > Release checks** and choose **Add**. Pick the **Finished lot** and, if you know it,
the **Manufacturing order**. The record is numbered LRL-2026-nnn and your name is **Requested by**.

<Steps>
<Step>

Choose **Run release checks**. The system reads the lot's records and writes the result. The status
becomes **Ready** (**All checks passed**) or **Blocked** (**N checks failed**). A line starting with a
cross is a blocker. A line with a tick passed.

</Step>
<Step>

Fix each blocker in its own record. Choose **Re-run checks**. Repeat until the status is **Ready**.

</Step>
<Step>

The QA manager chooses **Sign · release lot** and signs. The status becomes **Released**. The lot
stays in **Q-FG-01** until the store confirms where it goes: the release leaves a **Draft** movement
of type **Put-away** (suggesting **FG-01**) in **Inventory > Movements**, and the store keeper is
told. The store keeper opens it, changes **To** to the bin the lot is going into if it is not
**FG-01**, and chooses **Post movement**. The lot then moves, and the delivery order can be packed
from it. A lot not yet put away is refused when a pack is built.

</Step>
</Steps>

### What blocks a release [#what-blocks-a-release]

| Blocker the screen shows | How to clear it |
|---|---|
| `Lot is on hold`, `Lot is rejected` or `Lot is expired` | Clear the hold or disposition the lot. |
| `No outgoing inspection record` or `OQC {no} is {result}` | Pass the lot at outgoing inspection. |
| `No in-process checks for {mo}` or `{no} failed` | Record the in-process checks of the order. A failed check blocks the release. |
| `Open NCR {no}` | Close the NCR. |
| `Open first-article NCR {no}` | The first article of the order was rejected and its NCR is still open. QA reviews the cause and closes it. |
| `Process validation {no} is {status}` | The process that made the lot (product, machine, mould) has a validation that is not **Validated**. Complete and approve it. A lot with no validation on file shows "No process validation on file for this process" as a passed line. |
| `Labels not reconciled ({no} {status})` | Finish the label reconciliation of the order. |
| `Gauge {id} was out of calibration on {date}, the day of {record}` | The gauge of a first article, first piece, in-process check or outgoing inspection of the lot was past its calibration due date on the day of the inspection. Find the effect on the product, raise an NCR if necessary, and inspect again with a calibrated gauge. The passed line `Gauges in calibration when used: {ids}` names the gauges that were good. |
| `Gauge {id} of {record} is not in the gauge register` | Add the gauge in **Quality > Calibration** with its calibration ([Gauges and calibration](/docs/quality/gauges-and-calibration)), or inspect again with a registered gauge. |
| `Gauge {id} was out of tolerance after {record} ({calibration}). Close its impact assessment first` | A calibration after the inspection found the gauge out of tolerance. Write the impact assessment on that calibration record and close it. |
| `Validation lot: {pv} is {status}. Release it after QA approves the validation.` | The lot was made by a validation run, see [Validate the process](/docs/product-development/process-validation#make-the-pq-lots-with-a-validation-run). Approve the validation, then run the checks again. |
| `No device history record` or `DHR {no} not approved ({status})` | Compile and approve the DHR. See [Compile and approve the DHR](/docs/quality-release/device-history-records). ISO 13485 only. |
| `DHR {no} is for order {mo}, which did not produce lot {lot}` | Use the DHR of the order that made the lot. |
| `Open disposition {no} ({status})` | Complete the material review disposition. |

<GuideStep
  title="A lot release check"
  description="Blocked and passed checks, and the sign button."
  src="/guide/outgoing-inspection-and-lot-release/2.png"
  alt="Lot release check LRL-2026-031 with its list of checks and the Sign · release lot button"
  width={1440}
  height={1000}
  callouts={[
    { x: 82, y: 14, caption: "Run release checks, Re-run checks and Sign · release lot." },
    { x: 50, y: 45, caption: "Checks that failed come first; checks that passed follow." },
    { x: 20, y: 70, caption: "Status: Ready, Blocked or Released." },
  ]}
/>

## If the system refuses [#if-the-system-refuses]

The messages are in [Release and DHR refusals](/docs/quality-release/refusals#outgoing-inspection).

<NextSteps>

<NextStep href="/docs/quality-release/device-history-records" title="Compile and approve the DHR" description="The record that lets a lot be released." />

<NextStep href="/docs/quality-release/refusals" title="Release and DHR refusals" description="Every message and what to do." />

<NextStep href="/docs/quality/ncr-and-capa" title="Handle nonconformances and CAPA" description="What to do with a held lot." />

</NextSteps>