# Change a released product (/docs/product-development/engineering-changes)

A released product, method or work instruction cannot be edited. To change it, raise an engineering
change note (ECN). The note says what changes and why, which documents it affects, and who must agree.
When the change board approves it, draft revisions of the affected documents start by themselves.
The engineer (Daniel Tan) raises it. The QA manager (Grace Ooi) and the change board sign.

```mermaid
%% title: Status of an engineering change note
flowchart LR
  A["Draft"] -->|"Submit for assessment"| B["Impact assessment"]
  B -->|"Send to change board"| C["CCB review"]
  C -->|"Last member signs"| D["Approved"]
  D -->|"Mark implemented"| E["Implemented"]
  E -->|"Close · verified"| F["Closed"]
  B -->|"Reject"| R["Rejected"]
  C -->|"Reject"| R
  C -->|"A member returns it"| B
```

The stage bar on the note names the same steps: **Request**, **Impact assessment**, **Change board**,
**Implementation**, **Verification** and **Closed**. Choose a stage to read what ISO 13485, ISO 9001,
IATF 16949 and 21 CFR 820 ask for at that stage.

## Raise the note [#raise-the-note]

<Steps>
<Step>

Open **Engineering** and choose **Engineering change notes** (`/engineering/chg`). Choose **Add**. The
number is `ECN-2026-` and four digits. `ECN-2026-015` is a Draft in the demo data.

</Step>
<Step>

Fill in the **Change**, the **Type** (**Product**, **Process**, **Material**, **Mould / tooling**,
**Document** or **Supplier**), the **Reason** (**Customer request**, **CAPA**, **Supplier change**,
**Process improvement** or **Regulatory**) and the **Description**. Choose the **Product** the change
applies to. For a change to a document only, set the **Type** to **Document**.

</Step>
<Step>

Under **Affected items**, choose **Item type** (product, production method, work instruction, QMS
document or drawing), the **Document**, and **Add item**. The action is **Revise**, **Obsolete** or
**New**. A drawing or specification has **Update** and a **New revision**. **Revise** starts a draft
revision when the change board approves.

</Step>
<Step>

Choose **Submit for assessment**. The note needs the change, type, reason, affected items and
description. If you typed the document in **Source record** or **Affected documents** and have not
added it under **Affected items**, submitting adds it there with the action **Revise** (a product,
production method, work instruction or QMS document that is not obsolete). If the text names no
document, add it yourself first. The status becomes **Impact assessment** and the note records where
the product is used (open orders, stock, routings).

</Step>
</Steps>

<GuideStep
  title="Engineering change notes"
  description="The list of notes with their status."
  src="/guide/engineering-changes/1.png"
  alt="Engineering change notes list with note number, change, type, risk and status columns"
  width={1440}
  height={1000}
  callouts={[
    { x: 12, y: 18, caption: "Add raises a new note." },
    { x: 40, y: 32, caption: "The note number and what changes." },
    { x: 85, y: 32, caption: "Risk and status. Open a note to work on it." },
  ]}
/>

## Complete the impact assessment [#complete-the-impact-assessment]

On the note, fill in the impact the board will review:

- **Impact on safety and performance**, **Risk** (**Low**, **Medium**, **High**) and **Revalidation**
  (**None**, **FAI only**, **PQ**, **OQ + PQ**, **IQ + OQ + PQ**). If revalidation is needed, enter the
  **Validation / FAI record** before implementing.
- **Regulatory impact**, and **EHS impact** (**Not assessed**, **None**, **Yes**). If **Yes**, add the EHS
  review notes, the updated **Risk assessment / aspect updated** and the **EHS reviewer**.
- **PFMEA reviewed (doc · rev)** for a product, process, material or mould change.
- **Customer notice** (**Not required**, **Required · pending**, **Notified · approved**) and the
  **Customer approval ref.**
- **Existing stock and WIP** (**Use up**, **Rework**, **Scrap**, **Hold for disposition**,
  **Not affected**), **Retraining needed**, and **Effective by** (**Immediate**, **Date**, **Lot**,
  **Stock run-out**) with the **Effective date** or **First lot**.

Then choose **Send to change board** (a signed step) or **Reject** (also signed).

## Sign as the change board [#sign-as-the-change-board]

The board route lists who signs. By default: **Engineering**, **Production** and **Quality assurance** always;
**Regulatory** when there is a regulatory impact; **EHS** when the EHS impact is Yes. The organization can
change the route and choose **Sequential** or **Parallel** signing in the Engineering settings.

<Steps>
<Step>

Open the note in **CCB review**. Under **Change board** find your function.

</Step>
<Step>

Choose **Approve · sign**. A dialog shows who signs and the meaning of the signature (**Approved**);
choose **Sign · Approve** to e-sign for your function. In a sequential route the next function in the
list signs first. One person can sign one function only, and the person who raised the note does not
sign its board: another person holds the seat. The one exception is a seat only the requester can fill
(a plant with a single engineer); the note then records that the requester signed it.

</Step>
<Step>

To send it back, choose **Return**, write the reason (at least 4 characters), and choose
**Return to impact assessment**. All signatures are cleared.

</Step>
<Step>

When the last member signs, the note is **Approved**, the approver is recorded, and a draft revision
starts for each item marked **Revise**.

</Step>
</Steps>

<GuideStep
  title="A note in impact assessment"
  description="ECN-2026-014 with its stage bar, impact assessment and affected items."
  src="/guide/engineering-changes/2.png"
  alt="Engineering change note ECN-2026-014 in Impact assessment with the stage bar, affected items and the Send to change board button"
  width={1440}
  height={1000}
  callouts={[
    { x: 20, y: 12, caption: "The stage bar. Impact assessment is the current stage." },
    { x: 80, y: 12, caption: "Send to change board and Reject are signed steps." },
    { x: 40, y: 45, caption: "Affected items with their action and revision." },
    { x: 40, y: 78, caption: "The standards for this stage, and the evidence list." },
  ]}
/>

## Implement the change [#implement-the-change]

After approval the page shows **Effectivity and orders** and the **Implementation checklist**, one list
per affected item. Lines you do by working in the document have an **Open** button. A line for an item
you obsolete has **Make obsolete**. A line that is a manual step has **Tick**.

- For **Revise**: the draft revision starts, the changes are made and submitted for review, and the new
  revision is released. If retraining is needed, the training matrix lists who is due.
- For **Obsolete**: the document is made obsolete.
- For **New**: created, reviewed and released.
- For a drawing or specification: the updated copy is received, checked and filed, and superseded copies
  are withdrawn.
- Tick the **Stock and WIP disposition** when the stock decision is done, if the note needs one.

Orders saved after the effective date are blocked until the new revisions are released. Obsolete work
instructions cannot be put on an order.

Fill in the **Implementation record**, then choose **Mark implemented** (signed). The page counts the
lines left, for example `2 lines left before Mark implemented`.

## Close the note [#close-the-note]

Enter the **Verification evidence**, check that retraining is complete, and choose **Close · verified**
(signed). The note is **Closed** and is kept as a record. `ECN-2026-011` is a closed example.

## What an approved note unlocks [#what-an-approved-note-unlocks]

On a released document, **New revision** asks you to pick an approved change note that lists it, or that
is for the same product. Without one the app says `A new revision needs an approved engineering change
note`. If none exists, the picker offers **Raise an engineering change note**. The new revision starts as a
**Draft**, the released revision stays effective until the new one is released (production, planning and
the floor keep using it while the new revision is a Draft or in review), and the note keeps the from and
to revision. See [Release the product documents](/docs/product-development/document-release).

## Change board route [#change-board-route]

The organization manager sets the route in the Engineering settings (`/engineering/cfg`): the **Function**,
the **Approver** and **Required when** (**Always**, **Risk high**, **Regulatory impact**, **EHS impact**,
**Customer approval required**, **Revalidation needed** or a **Type**). A new route applies to notes
sent to the board from now on. Notes already in review keep the route they were sent with.

If the system refuses a step here, see
[Engineering changes: why the app refuses](/docs/product-development/engineering-changes-refusals).

<NextSteps>

<NextStep href="/docs/product-development/engineering-changes-refusals" title="Engineering changes: why the app refuses" description="Every message on the note, the change board and the checklist." />

<NextStep href="/docs/product-development/document-release" title="Release the product documents" description="Release the new revisions the note starts." />

<NextStep href="/docs/product-development/process-validation" title="Validate the process" description="Revalidate when the change needs it." />

</NextSteps>