AUTOMATION CASE STUDY

 

Preventing a Critical

Automation Safety Failure

Before Production Startup

 

EL Engineering was engaged to independently review the automation and safety control architecture of a highly automated production line for a leading medical device manufacturer.

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INDUSTRY
Medical Device Manufacturing
SERVICE
Automation & Safety
PROJECT FOCUS
Independent Safety Control Review

Client Context

A highly automated production environment

A leading medical device manufacturer was preparing to commission a highly automated production line supplied by a global OEM.

The project relied on complex automation software, integrated safety controls and distributed communications to manage production while ensuring personnel protection and operational reliability.

THE SYSTEM INCLUDED

 

Industrial Robotics

Multiple industrial robots operating within the production environment. 

 

Safety-Controlled Access

Guard doors and access points integrated into the safety control architecture. 

 

Nitrogen-Controlled Areas 

Process areas where the integrity of the safety system was critical to personnel protection. 

The Challenge


A critical weakness in the safety control architecture

EL Engineering identified concerns regarding how safety guard unlock requests were being processed within the safety control system architecture.

The guard door unlock request originated from the Standard Task of the Safety Controller rather than the dedicated Safety Task. This meant the safety-related door release function could potentially be manipulated, compromising the integrity of the safety system.

WHY IT MATTERED

01 - Incorrect source

The request originated from the Standard Task rather than the dedicated Safety Task.

02 - Potential vulnerability

The approach could potentially allow the safety-related door release function to be manipulated.

03 - High-risk environment

The production line incorporated industrial robots and nitrogen-controlled environments, making the integrity of the safety architecture critical to personnel protection and operational safety.

EL's Approach


Independent review of the safety control architecture

EL Engineering carried out an extensive review of the automation software, safety software and overall guard-locking control system architecture.

The review examined how the systems operated together, including their behaviour under abnormal conditions and the integration between automation and safety communications.

THE REVIEW INCLUDED

 

01 - Automation software analysis

02 - Safety controller software review

03 - Guard-locking functionality and limitations

04 - Validation under abnormal conditions

05 - Integrated automation and safety communications

06 - Verification against machine safety requirements

 

The Outcome


A critical vulnerability identified before production startup.

EL Engineering's detailed review triggered a wider investigation involving the safety relay and controller OEM, as well as the safety controller supplier.

The safety controller was extensively redesigned and recertified over an eight-month period.

PROJECT IMPACT

✓ Personnel safety protected

✓ Critical vulnerability identified before production startup

✓ Industry-level redesign triggered

✓ Critical control system redesigned and successfully re-certified

Independent expertise. Practical impact.

EL Engineering's independent review identified a critical automation safety vulnerability before production startup, helping protect personnel and prompting a wider redesign and re-certification of the control system.