Integrated Manufacturing System Compliance

An Integrated Manufacturing System is defined as:

“A group of machines working together in a coordinated manner, linked by a material-handling system, interconnected by controls, for the purpose of manufacturing, treatment, movement or packaging of discrete parts or assemblies.”

Background – A Move to System Level Compliance

The contemporary term for what used to be known as a ‘production line’, Integrated Manufacturing Systems or IMS, have grown increasingly more complex as robotics, automation and control system technologies become ever more advanced.

With these increases in complexity has come a reassessment of how safety compliance for IMS should be managed.  Once it was considered acceptable to simply ensure that the individual component elements of an IMS satisfied the appropriate safety and performance regulations, with the logic being that if each separate element was safe to operate the overall system could be considered safe by default.

As IMS have developed however, that principle has been shown to be flawed.  For example; it often resulted in safety risks at the interface points between different components in the system not being considered and adequately mitigated.  Additionally, as more complex, integrated control systems become increasingly common, the potential impact these could have on safety was not being adequately assessed.    As a result, approaches to safety & performance compliance have adjusted and there is now a common expectation that IMS will be assessed as a single unified system, rather than purely at a component level.

In Europe, to reflect this change of approach, Directives and standards have been developed that facilitate these assessments.  Since 2007 the EMC Directive 2014/30/EU has included the concept of a Fixed Installation, with specific conformity requirements. which applies to many IMS.  For Mechanical & Electrical Safety the standard EN ISO 11161, has been harmonised, recognising its requirements as being the ‘state of the art’ when it comes to IMS safety and thereby imposing an expectation that Manufacturing Systems will comply with it.

Outside of Europe, where statutory compliance requirements may be less stringent, the expectation that IMS will be assessed at a system level has been driven by end-users, who have recognised that component-level assessment left both their employees and themselves exposed to unacceptable levels of potential risk.  Many larger, multi-national operators of IMS make it a standard contractual requirement that suppliers demonstrate safety and performance compliance at a system level irrespective of where a Manufacturing System is being installed.

The Impact

The impact of these developments is that parties involved in the commissioning and installation of IMS, who previously passed the issue of safety & performance compliance down to suppliers of components and sub-systems, now find themselves legally responsible for ensuring the overall regulatory compliance of finished systems.  Those parties can and do include end-users commissioning IMS for their own facilities and integrators who do not manufacture hardware themselves but will combine third-party sub-systems to create larger, bespoke IMS for their clients.

These and other parties often now find themselves responsible for assessing and certifying complex systems comprised of hardware that they have not directly designed or manufactured, against regulations they have limited experience of working with.

How Can We Help?

Technology International Europe has evaluated complex IMS against Mechanical & Electrical Safety standards and regulations both in Europe and worldwide, and EMC Fixed Installation requirements applicable within the EU and EEA.  We have assessed a wide range of Manufacturing Systems, from spray-lines for the automotive industry to bakery systems and highly automated robotic cells.  We have supported end-users, integrators and manufacturers and have assessed Systems both in-situ at their final locations and prior to delivery.

This extensive experience has allowed us to develop assessment processes and procedures that are quick and cost efficient, minimising unwanted delays to final commissioning.  Our Consultants understand the common safety risks and performance issues associated with IMS, and can focus their assessments accordingly, avoiding unnecessary testing.  When working for system manufacturers and integrators our Consultants are happy to liaise with End-Users when asked to do so, maintaining trust and transparency between all parties and ensuring that contractual or statutory obligations are clearly understood and met.

By covering Mechanical & Electrical Safety, Control System Safety, EMC and Radio Performance we can provide tailored solutions that cover the key aspects of safety and performance compliance that impact Integrated Manufacturing Systems.