# Compile and approve the DHR (/docs/quality-release/device-history-records)

A device history record (DHR) is the proof that a lot was made as planned. It applies while ISO 13485
is on. The lot release needs an **Approved** DHR. If ISO 13485 is off, the screen says device history
records do not apply.

```mermaid
%% title: DHR status flow
flowchart LR
  A[Draft] -->|Compile DHR| B{Open items?}
  B -->|None| C[Compiled]
  B -->|Some| D[Incomplete]
  D -->|Re-compile| B
  C -->|Re-compile| B
  C -->|Review · approve DHR| E[Approved]
```

## Compile a DHR [#compile-a-dhr]

Open **Production > Device history** (the list) or **Quality > Device history** (the lot screen). Each
record belongs to one manufacturing order and one finished lot. People with write access to Production
or to Quality can create it from the lot screen with **Create DHR record**, and both can compile it. The
QA engineer and the QC inspector can therefore compile the record the QA manager later reviews.

<Steps>
<Step>

Choose **Add**. Pick the **Manufacturing order** and enter the **Lot**. The number is made from the lot,
for example DHR-2609-1127. A lot has one record.

</Step>
<Step>

Choose **Compile DHR** and sign. The system reads the order's records and fills **Contents** and
**Open items**. You are named **Compiled by**.

</Step>
<Step>

If **Open items** says `None`, the status is **Compiled**. If it says `{n} open`, the status is
**Incomplete**. Read **Contents**: a tick line is complete, a cross line is open.

</Step>
<Step>

Fix each open item in its own record, then choose **Re-compile**. Repeat until the status is **Compiled**.

</Step>
</Steps>

You can also create the record from **Quality > Device history**: pick the lot or order and choose
**Create DHR record**. That screen also prints the record with **Print device history record**.

### What the DHR pulls in [#what-the-dhr-pulls-in]

| Section | Complete when |
|---|---|
| **Manufacturing** | The order is on the record. The work instruction is named. The line clearance is **Verified**. A process validation is approved. |
| **Materials** | Material was issued from the store for every bill of materials line (lots are listed). |
| **In-process QC** | Every in-process check passed and no SPC reaction is open. |
| **Labels** | Labels were reconciled. |
| **Outgoing QC** | The latest outgoing inspection is **Accepted**. |
| **Release** | No NCR is open against the lot or order. |

## Review and approve a DHR [#review-and-approve-a-dhr]

The QA manager reviews. The reviewer cannot be the person who compiled it.

<Steps>
<Step>

Open the DHR. The status must be **Compiled**.

</Step>
<Step>

Choose **Review · approve DHR** and sign. The system compiles it again first. If anything is open it
refuses and the record goes back to **Incomplete**.

</Step>
<Step>

The status becomes **Approved**, and you are named **Reviewed by (QA)**. The lot and order of an
approved DHR cannot change.

</Step>
</Steps>

<GuideStep
  title="Device history records"
  description="Every DHR with its lot, open items and status."
  src="/guide/device-history-records/1.png"
  alt="Device history records list on desktop with lot, open items and status columns"
  width={1440}
  height={1000}
  callouts={[
    { x: 82, y: 14, caption: "Add a new DHR." },
    { x: 55, y: 40, caption: "Open items: None, or the number still open." },
    { x: 85, y: 40, caption: "Status: Draft, Incomplete, Compiled or Approved." },
  ]}
/>

<GuideStep
  title="A compiled DHR"
  description="The checklist and the approve button."
  src="/guide/device-history-records/2.png"
  alt="Device history record DHR-2609-1127 with its checklist of complete and open items"
  width={1440}
  height={1000}
  callouts={[
    { x: 82, y: 14, caption: "Review · approve DHR and Re-compile." },
    { x: 40, y: 45, caption: "Contents: ticks are complete, crosses are open." },
    { x: 20, y: 75, caption: "Compiled by and Reviewed by (QA)." },
  ]}
/>

<Callout type="note">
Compiling a DHR is a signed step too. Your signature must be set up and your training current.
See [Signatures and refusals](/docs/get-started/signatures-and-refusals).
</Callout>

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

The messages are in [Release and DHR refusals](/docs/quality-release/refusals#device-history-records).

<NextSteps>

<NextStep href="/docs/quality-release/outgoing-inspection-and-lot-release" title="Inspect outgoing lots and release them" description="The release that needs an approved DHR." />

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

</NextSteps>