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Case study · Medical devices

Documentation that moves at the speed of production.

Coloplast embedded REWO in its internally developed MES as the delivery layer for QMS documentation. Updates reach every production point at once, document distribution takes around 85% less time, and the same instructions supported a production-line transfer to Costa Rica.

Industry

Medical devices

Size

16,000+ employees

Footprint

Europe, Asia, Americas

Deployment

Integrated — in-house MES

Coloplast is a global medical device company making products for people with intimate healthcare needs. It employs over 16,000 people across Europe, Asia and the Americas, and runs highly automated production under strict quality and compliance requirements.

The challenge

Production changed faster than the paper could.

As automation accelerated and production expanded globally, the way work changed outpaced the way it was documented.

Documentation lagged automation

New automated workflows changed operator roles faster than documents and training could be updated.

Paper on the shop floor

Instructions were printed and physically replaced at every workstation whenever something changed.

The QMS didn't reach the line

Documentation lived in the QMS, but operators in production couldn't access it.

A line transfer to Costa Rica

Moving production lines abroad needed a scalable way to transfer standardised processes.

The solution

A digital layer inside their own MES.

REWO runs as a web-based module inside Coloplast's internally developed MES, delivering both video and written QMS documentation at the point of use.

Embedded in the MES

Operators open work instructions inside the interface they already use, without switching systems.

Updates distributed instantly

A change reaches every production point at once, so operators always see the latest version.

Video for complex steps

Complex processes in automated environments are documented as video, alongside written QMS documentation.

Defined rules for authoring

Standard creation rules keep instructions consistent and cut time spent on formatting.

Deployment: IntegratedSystem: In-house MESSource: QMSFormat: Video + writtenScope: Multi-site

The results

Execution that keeps up with the process.

~85%

Less time spent distributing documents

Instant

Updates reach every production point on publication

One interface

Video and written documentation inside the MES

Multi-site

Standardised instructions supported the Costa Rica line transfer

Distribution effort cut by ~85%

No more printing and physically replacing instructions on the shop floor.

Documentation keeps pace

Instructions are created and updated as fast as production changes.

Clearer execution in automated cells

Operators understand process changes through visual instructions, with less ambiguity in complex tasks.

Consistent across sites

Visual, multilingual instructions supported consistent execution during the line transfer to Costa Rica.

Customer perspective

“Operators can now immediately understand process changes through visual instructions.”

Ágnes Edina Stankovicsné Pintér, Senior Process Engineer — Coloplast

Bottom line

Knowledge that moves with the line.

Coloplast turned operational knowledge from a static, paper-based system into a digital layer inside its production workflows. Operators always reach the latest standard way of working, however quickly processes change — across processes, teams and sites.

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