Another day…another woefully non-compliant EPCIS message supported by some of the ‘biggest’ players in the space. Most will say “Hey Scott, lighten up, it gets the job done so who cares if a few things here-and-there are not compliant”
So as a year-end message I’ll get back on my soapbox
again- The reality is most of these ‘infractions’
(except the last one discussed below) likely don’t have a material impact on how
the EPCIS communicates the necessary information from point A to point B…. the real risk/concern is this is yet again
just one small example in an absolute ocean of examples where the industry is
not just lax in its attempts to strictly adhere to EPCIS but is fully welcoming
of it.
I’m not some private investigator with special tools that
can detect these issues- I’ve praised/linked to the FREE tool that will reveal
most of the issues below in a matter of seconds (https://epcisworkbench.gs1.org/ui/home)….so
this can’t be about it being too hard to root out non-compliance…its simply
that:
1) To this point, there hasn’t been
an overwhelming reason to be air-tight on EPCIS compliance- No EPCIS police to come around and stop
product from flowing and not nearly enough interconnectivity across the
industry for these issues to start causing bigger issues.
2) It’s hard to push back when some
of the ‘biggest’ players in the space are the ones openly generating
non-compliant EPCIS and/or willing to accept non-compliant EPCIS
Previously I’ve raised the notion of one simple way that
non-compliance with EPCIS directly impacts the industry:
Take the last issue highlighted below. Its black-and-white- both entries are simply
not compliant. But it’s happening out
there in the wild (which by the way I would be interested to know if either the
sending or receiving vendors are ‘certified’ by an EPCIS conformance testing
service) which means the system generating this EPCIS was built in such a way
that allows that to happen and, even worse, the system receiving these messages
either A) didn’t catch these as issues and/or B) was built (and even possibly ‘enhanced’)
to support receiving these messages. The
development it takes to support not only compliant EPCIS but now also the ocean
of non-compliant EPCIS costs money. And do
you think the vendors just eat those costs?
Of course not, it goes back on the industry through increased annual fees
or baked into some new ‘module’ that will be marketed.
Now extrapolate that out over the massive number of ‘connections’
that have to be put in place by 2023 for the US market to achieve
compliance. If every vendor can go off
and define what they feel is acceptable use of EPCIS then it’s the pharma
industry who ultimately feels the pain.
In this space, 2021 will be the year of collaboration (or
non-collaboration depending on how it plays out). The technical issues below are likely viewed
by many (not me) as minor, but what needs to be in focus is whether the
industry maintains the mindset that’s been attached to EPCIS compliance…. There
should be no ‘minor’ or ‘major’ non-compliance- it needs to be black-and-white…
you’re either compliant or you’re not….and unfortunately, we are long past the
point where non-compliant practices have become the norm.
I wrote a blog post nearly a year and a half ago that
pondered whether EPCIS had lost its value as a standard within pharma
serialization…. Instances such as below
would seem to indicate nothing has really changed….and I still think we are
just at the tip of the iceberg when it comes to understanding the impact that
these seemingly insignificant and incredibly detailed ‘misses’ will have when
trying to accomplish end to end traceability in pharma.
My last few posts have focused on the need for the industry
to do a reality-check on whether we are moving forward with serialization/traceability
in pharma in the best way possible.
Non-compliance with EPCIS is yet another reason why this reality check is
needed.
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Note: X’s are mine- used to preserve confidentiality
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