In recent discussions with several engineering and integrators of Safety Instrumented Systems (SIS), it’s become very clear to me that the majority I have spoken to, don’t have any form of Functional Safety Management System (FSMS) in place. This is interesting because one of the changes in the 2016 edition of IEC61511 now requires companies pertaining to be able to offer functional safety-related, lifecycle products and/or services, must demonstrate they have a suitable FSMS in place.
The other interesting point to note is that during these conversations, the question of necessity and need for these companies to have a FSMS in place was being challenged. One point that came up was what legal obligation do they have to implement a FSMS. It should be noted that there isn’t a particular legal requirement, however, end users that come under OSHA PSM in the US need to demonstrate that they are following Recognized And Generally Accepted Good Engineering Practice (RAGAGEP), of which IEC61511/ISA 61511 is one approach.
My response to this was, how then will you be able to “demonstrate” compliance with iEC61511 when designing and/or producing an SIS? How will you prove compliance with IEC61511 if the end client requests that the SIS be supplied in accordance with IEC61511?
The simple to answer to these questions is “no” it will not be possible to prove compliance. It must be remembered that a well-defined and followed FSMS will help in the management and/or prevention of systematic errors being introduced during the design and verification of the SIS. Moreover, most engineering and integrators probably, already have elements of a FSMS in place but just don’t call it that. The FSMS will require a Functional Safety Management Plan (FSMP) to be in place to define how the SIS is designed, manufactured and tested. As well as the installation and commissioning requirements, together with all the relevant procedures in place.
In my opinion, engineering companies and integrators are potentially leaving themselves open to liability and litigation, if there are any issues with the SIS due to design and/or manufacturing problems, which lead to an incident or serious accident in the field.
The good news is that if the engineering company has an established, formal ISO quality management system in place (or equivalent), then they probably have most of the elements of an FSMS. Therefore, it won’t necessarily require a “start from scratch” approach. The simplest way is to have a qualified, 3rd party conduct a “Gap” assessment to identify where the holes are and to make suitable recommendation on how to fill them.
If you are part of an engineering and/or integrator company, which provides functional safety products/services and do not have an FSMS in place, then I strongly suggest you attend the upcoming webinar on this topic to find out more.