---
id: KB-IU-008
url: https://app.codecontract.io/help/manufacturing/change-control-in-production
idioma: en
categoria: sector-industria
subcategoria: farmaceutica
audiencia: usuario
nivel: avanzado
actualizado: 2026-08-13
tambienEn: [es]
relacionados: [KB-IU-002, KB-IC-009]
citadoPor: [KB-IU-009, KB-IU-023, KB-IU-030]
---

# Change control in production

_Changing a supplier, a parameter or a machine, without it becoming an audit finding._

**Responde a:** documented change control · changing a validated supplier · modifying a production process paperwork · change management in manufacturing

In any regulated manufacturing, change is not the problem: the problem is the change that happened with no record that anyone assessed it. An auditor will not fault you for changing an excipient supplier; they will ask who assessed the impact and against what criteria.

## The changes that slip through

| Change | Why it slips | What should have remained |
| --- | --- | --- |
| A raw material supplier | Purchasing decides on lead time or price | Impact assessment and approval |
| A parameter adjustment | Done on the floor and it works better | Justification and who authorised it |
| A repair with a different part | The original was not arriving in time | Equivalence and later verification |
| A software or version change | Done by maintenance or IT | Impact on records and validations |

> [!IMPORTANT]
> The fourth row grows fastest and is least treated as a process change. An equipment or software update can alter how data is recorded, and that affects validation even though the machine still does the same thing.

## What a change record must contain

1. **What is changing and why** — In one line understandable by someone who was not there.
2. **What impact it may have and on what** — Product, process, records, validations, other areas.
3. **Who approves it** — With a name and a date; an approval without an author is not an approval.
4. **And how it is verified afterwards** — Later verification is what closes the change; without it, it stays open.

> [!WARNING]
> The usual error is not doing the record badly: it is doing it afterwards. Change control signed three weeks later, with production already run, assesses nothing — it documents a decision already taken, and it shows.

## How to sustain it without slowing the plant

**En corto**

- A fast lane for minor changes, decided in advance.
- A clear threshold for what is minor and what is not.
- And assessment before applying, however brief.

Without a fast lane, people bypass the process to get work done, and then you do not have a strict system: you have a system that is not followed. A light procedure that is followed beats a perfect one that is dodged.

> [!NOTE]
> The same approach suits medical devices, cosmetics, certified food schemes and automotive: the reference standard and threshold change, not the logic of assessing before and verifying after.

**What about emergency changes?**

Do them and document immediately after, with that condition stated.

**Is it needed for a packaging supplier change?**

If it touches the product or its preservation, yes. It is among the most underestimated.

**Who should approve?**

Whoever answers for product quality, not whoever makes the change.

## Ejemplos

**A plant changes a component supplier because of lead times.**

- Records the change with impact and approval before using it
- Verifies the first batch made with the new one

→ The audit finds the change assessed and closed, instead of a finding.

**Something changes and is documented weeks later.**

- Records the change before applying it

→ The file describes what is done.

**Nobody knows from which batch a change applies.**

- Records from which unit it takes effect

→ You can say what each batch carried.

**A change affects documentation nobody reviews.**

- Reviews which documents describe what changes

→ The papers keep describing the product.

**The client asks to be told of any change.**

- Records what was communicated and when

→ The commitment is demonstrable.

**A review asks about an old change.**

- Keeps the change history with its dates

→ You answer from the record.