# Issue an advisory notice or recall (/docs/quality/recalls)

An advisory notice, field correction or recall tells customers about a problem with shipped product.
It applies while ISO 13485 is on. The QA manager approves and closes it. The default QA manager is
Grace Ooi.

```mermaid
%% title: Notice status flow
flowchart LR
  A[Draft] -->|Trace shipped lots| A
  A -->|Approve notice| B[Approved]
  A -->|Confirm no customers affected| A
  B -->|Customers notified| C[Customers notified]
  C -->|Start effectiveness check| D[Effectiveness check]
  D -->|Close notice| E[Closed]
```

## Trace a lot [#trace-a-lot]

Open **Quality > Trace**. The screen follows a lot in both directions.

<Steps>
<Step>

Choose a **Lot** and read **Trace forward**. The chain runs **Input lot**, **Orders**, **Shipments**,
**Customers**. A shipment with no lot you can trace says so. Under **Backward trace**, choose a
**Shipment**: the **Input lot** panel below moves to that shipment's first input lot (picking an
input lot yourself keeps it). The chain links the **Sales order**, the **Supplier** record and
goods **Receipt** of each input lot, and any **NCR** raised against the order, its lots or their
inspections, open or closed.

</Step>
<Step>

Check the suspect work in progress. Under the suspect range, choose **Place on hold** on each line
until QA dispositions it. A held line shows **On hold**.

</Step>
<Step>

If product has shipped, choose **Start recall or notice**. The system makes a **Draft** notice (numbered
RCL-2026-nnnn) with the customers, lots and quantities the trace found. If the lot already has a
notice, you are taken to it.

</Step>
</Steps>

<GuideStep
  title="Lot trace"
  description="Input lot, orders, shipments and customers."
  src="/guide/recalls/2.png"
  alt="Lot trace screen on desktop with the chain from input lot to customers"
  width={1440}
  height={1000}
  callouts={[
    { x: 20, y: 18, caption: "Pick the lot and Trace forward." },
    { x: 55, y: 45, caption: "Orders, shipments and customers that received the lot." },
    { x: 85, y: 80, caption: "Start recall or notice." },
  ]}
/>

## Issue the notice [#issue-the-notice]

Open **Quality > Recalls**. You can also choose **Add** and fill in **Action** (**Advisory notice**,
**Field correction** or **Recall**), **Product**, **Lots affected** and **Reason**.

<Steps>
<Step>

On a **Draft**, enter **Lots affected** (separated by commas or spaces) and choose **Trace shipped
lots**. The notice lists **Customers and quantities affected**.

</Step>
<Step>

If the trace finds no shipped delivery order, check the lot numbers. If you are sure no customer
received the lots, the QA manager chooses **Confirm no customers affected** and signs. That is allowed
only when the trace found no delivery.

</Step>
<Step>

Set **Authority notified**: **Not required**, **Pending** or **Notified**. Choose **Approve notice** and
the QA manager signs. The status becomes **Approved**.

</Step>
<Step>

Send the notice to each customer. If the authority must be told, notify it and enter **Authority ref.**.
Choose **Customers notified** and the QA manager signs. The status becomes **Customers notified**.

</Step>
<Step>

On **Quality > Trace**, choose **Record acknowledgement** for each delivery as the customer replies.
The screen counts how many customers have acknowledged. An acknowledgement is only allowed after the
customers are notified, for a delivery that has shipped and carries a lot of the notice.

</Step>
<Step>

Choose **Start effectiveness check** and sign. Write the **Effectiveness check** (replies received,
stock returned or corrected). Choose **Close notice** and sign.

</Step>
</Steps>

<GuideStep
  title="An advisory notice"
  description="The trace result and the next button."
  src="/guide/recalls/1.png"
  alt="Advisory notice AN-2026-0002 with its affected customers and the next-step button"
  width={1440}
  height={1000}
  callouts={[
    { x: 82, y: 14, caption: "Trace shipped lots, Confirm no customers affected and the next step." },
    { x: 40, y: 45, caption: "Customers and quantities affected." },
    { x: 20, y: 75, caption: "Authority notified and its reference." },
  ]}
/>

<Callout type="note">
If you change **Lots affected** after a trace, trace again. An approval relies on the trace of the lots
now on the notice.
</Callout>

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

The messages are in [Complaints and recalls refusals](/docs/quality/complaints-and-recalls-refusals#recalls).

<NextSteps>

<NextStep href="/docs/quality/complaints-and-recalls-refusals" title="Complaints and recalls refusals" description="Every message and what to do." />

<NextStep href="/docs/quality/complaints" title="Handle a customer complaint" description="Where many notices start." />

<NextStep href="/docs/quality/ncr-and-capa" title="Handle nonconformances and CAPA" description="Held stock needs an NCR." />

</NextSteps>