Approval Workflow in Manufacturing

An approval workflow – also called a release process – is a structured sequence of review and decision steps that defines who may approve what before it becomes effective in production. It applies wherever changes affect quality, safety or compliance: recipes, work plans, inspection plans, batch releases, deviations and special approvals.

The purpose is clear: controlled changes, documented decisions and traceable responsibilities – instead of direct interventions without review.

Why Release Processes Are Necessary in Production

In real manufacturing environments, machine parameters, products, quality limits and process sequences change continuously. Without controlled release processes, anyone can make changes effective immediately – with predictable consequences: unstable processes, non-reproducible results, missing traceability and significant risks in complaint handling and audits.

An approval workflow ensures that changes only become effective after review and sign-off by defined roles – typically quality, engineering and production.

Approval Workflows in MES: How Systemic Enforcement Works

In an MES, the release process is not governed by instruction but enforced by the system. Changes do not become active immediately – they are placed into a defined review and approval state. Only after complete sign-off by the configured roles do they enter production use.

This applies to activating new recipes, modifying inspection rules, releasing batches or adopting changed work plans. Every decision is stored with user identity, timestamp and version reference – immutable and immediately retrievable. Cloud-native MES platforms have a particular advantage here: approval workflows apply consistently across sites, so what is required in plant A is automatically enforced in plant B without manual synchronization.

Connection to Quality Systems and Regulation

IATF 16949, ISO 9001 and GMP requirements all demand controlled changes, documented decisions and protection against unauthorized interventions. Digital approval workflows in the MES are the technical implementation of these requirements – transforming a procedural requirement into a systemically secured process.

In audits this means: instead of statements about lived processes, complete digital records can be presented – who approved what, when, at which version, with which roles involved.

FAQ

What is the difference between an approval workflow and simple access restriction? Access restriction prevents unauthorized persons from making changes. An approval workflow goes further: it defines a multi-step review process, enforces the involvement of defined roles and documents every decision with a timestamp. Access control is the foundation – the workflow is the structured process built on top of it.

Can approval workflows be configured industry-specifically? Yes – and in practice this is essential. A food manufacturer requires different approval levels than an automotive supplier. Modern MES systems allow role-based workflow configuration per object type: a recipe change may require a three-step process while a minor parameter adjustment within defined tolerances requires only one.

What happens when an approval step is rejected? The change remains in draft status and does not enter production. The rejecting user can record a reason. The requester is notified and can revise the change or escalate. This rejection event is also fully documented – which in audits is often just as relevant as the approval itself.