# Handle a customer complaint (/docs/quality/complaints)

Open **Quality > Complaints**. Sales or QA logs the complaint. The QA manager decides what happens
next. The default QA manager is Grace Ooi.

```mermaid
%% title: Complaint status flow
flowchart LR
  A[Received] -->|Start investigation| B[Investigating]
  B -->|Record reportability decision| C[Decision recorded]
  C -->|Send response| D[Response sent]
  D -->|Close complaint| E[Closed]
  C -->|Re-decide reportability| B
```

## Log a complaint [#log-a-complaint]

<Steps>
<Step>

Choose **Add**. Enter **Received**, **Customer**, **Product** and **Complaint** (what the customer
reported). Add the **Lot** if you know it. Pick the **Category**: **Product defect**, **Labelling**,
**Packaging**, **Documentation** or **Delivery**.

</Step>
<Step>

The number is made for you, for example CC-2026-0007. The status is **Received**. Add photos from the
record's Attachments.

</Step>
</Steps>

## Investigate and decide reportability [#investigate-and-decide-reportability]

<Steps>
<Step>

The QA manager opens the complaint and chooses **Start investigation** and signs. The status becomes
**Investigating**.

</Step>
<Step>

Edit the complaint. With ISO 13485 on, answer **Death or serious injury involved** (**No**, **Yes** or
**Unknown**). Set **Reportability** (**Not reportable** or **Reportable**) and write the **Reportability
rationale**.

</Step>
<Step>

Choose **Record reportability decision** and sign. Only the QA manager can sign it. The status becomes
**Decision recorded**. If the decision is **Reportable**, the system sets **Report due**: 10 days after
**Received** when death or serious injury is involved, and 30 days otherwise.

</Step>
</Steps>

With ISO 13485 off there is no reportability assessment. The same button records the outcome as
`ISO 13485 off · no regulatory reportability assessment`.

### Change a decision you already signed [#change-a-decision-you-already-signed]

From **Decision recorded**, the decision is locked. To correct it, choose **Re-decide reportability**,
type the reason (at least 4 characters) and sign. The complaint goes back to **Investigating** with
reportability cleared, and the earlier decision stays in the history. Then record the decision again.

## Raise an NCR or CAPA [#raise-an-ncr-or-capa]

From **Investigating** or **Decision recorded**, choose **Raise NCR**. From **Decision recorded** or
**Response sent**, choose **Raise CAPA**. The new record is linked to the complaint.

- The NCR has source **Customer** and the complaint number and lot as its record.
- The CAPA has source **Customer complaint**, type **Corrective**, and is due 30 days after **Received**.

A complaint takes one NCR and one CAPA.

## Answer the customer and close [#answer-the-customer-and-close]

<Steps>
<Step>

Edit the complaint and write the **Response to customer**. If the complaint is **Reportable**, also
enter **Authority report ref.**.

</Step>
<Step>

Choose **Send response** and sign. The status becomes **Response sent**.

</Step>
<Step>

Link an NCR or a CAPA, or write in the rationale why none is needed (for example "no NCR needed").
Choose **Close complaint** and sign. The status becomes **Closed**.

</Step>
</Steps>

<GuideStep
  title="Customer complaints"
  description="Every complaint with its customer, product and status."
  src="/guide/complaints/1.png"
  alt="Customer complaints list on desktop with customer, product, report due and status columns"
  width={1440}
  height={1000}
  callouts={[
    { x: 82, y: 14, caption: "Add a complaint." },
    { x: 55, y: 40, caption: "Customer and product." },
    { x: 88, y: 40, caption: "Status from Received to Closed." },
  ]}
/>

<GuideStep
  title="A complaint record"
  description="The reportability panel and the next button."
  src="/guide/complaints/2.png"
  alt="Complaint CC-2026-0007 with the reportability panel and the Send response button"
  width={1440}
  height={1000}
  callouts={[
    { x: 82, y: 14, caption: "The next step: Send response, Raise CAPA, Raise NCR or Re-decide reportability." },
    { x: 35, y: 45, caption: "Reportability: decision, harm, rationale and report due." },
    { x: 20, y: 80, caption: "Linked NCR and CAPA." },
  ]}
/>

<Callout type="warning">
A reportable complaint has a deadline. The record shows how many days are left, **Due today**, or how many days it is overdue.
</Callout>

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

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

<NextSteps>

<NextStep href="/docs/quality/ncr-and-capa" title="Handle nonconformances and CAPA" description="What the raised NCR and CAPA need." />

<NextStep href="/docs/quality/recalls" title="Issue an advisory notice or recall" description="When a complaint leads to a field action." />

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

</NextSteps>