CMMS or Dedicated Calibration Software?

Data wasn’t just that guy on Star Trek you know.

Did you know that data is now estimated to be more valuable than oil, or even gold?

Everything runs on data, your laptop, phone or tablet you are reading this on, the internet itself obviously enough, but what else?

Football teams are now identifying talent by analysing performance data and then using this data as the basis for multi-million pound investments. Banks are using data such as time stamps, IP addresses or location data to protect your digital piggy bank. Well, if you think about it, you don’t really have money, you have some data on your banking app!

Businesses like Amazon are utilising data to gain user profiles on their customers (so if you are reading this Jeff any chance you can increase my Amazon video capacity?). This tracks what adverts users respond better to, which ones get them to buy in less time, with less clicks and with less resource required from any sales support to keep costs per transaction down.

This enables custom advertisements for specific products, at specific times at which the customer has bought in the past etc.

As Tidal scale write of data,

“Data is the new oil even in the oil and gas industry, where companies are drilling into data to cut operating costs, do a better job identifying drill sites, and reduce business risk.”

So the value of data has grown as a result of the direct impact it can have on a business.

Process industries are no different in this respect. When we talk about calibration data specifically, companies are seeking to make gains in relation to efficiency, data integrity, auditability, safety, sustainability and all the other bilities.

The digitalisation wave has started to crash for many companies and, with over 14,000 customers in  140+ countries, we have seen A LOT of processes. The good, the bad and the ones that only a motherboard could love.

For some businesses, they managed this transition with a considered approach looking toward the next 5, 10 or even 20 years, at least as much as they could, all things considered. They identified that industry 4.0 was coming and they readied themselves. They asked questions like “where might this transition lead?” “If we implement changes now, can we future proof this process to enable us to adapt in relation to potential future requirements?” “Can we put in place processes to enable us to adopt these future enhancements easily and with minimal disruption?” “Can we standardise? “Can we put a succession plan in place to harvest the knowledge acquired via and within these processes?” These early adopters had the luxury of a slight buffer of time, giving them the safety of considering their landing before they jumped.

For other businesses, the change was not quite so soft. They awaited the push of a regulatory audit. This unearthing of a problem, most commonly, a data integrity issue brought about by a process which required the manual entry of data, meant that now, they needed a plan and fast. "But we have always done it this way" was no longer sufficient. The shift from ALCOA to ALCOA+ came at speed. Technology has evolved and with evolution must come progress. Businesses that had not progressed their calibration process along with technological advancements, quickly found themselves falling behind. Regulations such as FDA 21 CFR part 11 became a frequent point of concern.

Calibration data manually captured was largely dead data, not easy to analyse or use in any constructive sense. It was kept in files and folders, offices full to the brim with them just there waiting for an auditor to ask to see them and then fingers crossed the information is all there. Hoping for the best.

This data integrity problem was a nagging one that kept coming back, often seen as operator failure, "the data was captured incorrectly by the technician". This, however, was not the root cause of the problem, and neither was it going to be the solution. People are imperfect, we all are, (hence why I have edited this article) so to expect them to attain perfection in relation to their capture of thousands or tens of thousands of individual data points every year, year in year out just isn't realistic or achievable.

But just how impactful can this data integrity issue be? By all accounts, it is a showstopper.

Within the life science sector, as Colm Timmons, the Engineering and Facilities Lead for Astellas, put it at our recent Beamex CAL Day event in Dublin,

"Two key areas of focus for us, ultimately, are product quality and patient safety. In relation to what we produce, finished product testing is not possible as it is destructive in nature, therefore quality assurance is determined by two things, batch sample testing and in process measurement" - Colm Timmons

So, if in-process measurement is critical, then of course so is having a high level of data integrity. If the captured data is not true to the test that has been carried out, then what is point of carrying out the test in the first place? So the data integrity issue is crucial to your in-process measurement and as such, directly linked to both the quality of the product you produce and the safety of those patients who consume it.

"But, we still have that issue of data being incorrectly captured by the technicians". Well, yes that might be the case, but the problem does not lie with the technician, as mentioned, none of us are quite as perfect as our Instagram feed would have you believe.

According to Rick Friedman the Deputy Director for Regulatory Compliance for the FDA, who presented the following slide at an ISPE conference in Dublin in April 2019, the problem is the process, not the person...

So why expect a technician to be perfect, when he or she is being tasked with using a process that in all likelihood, prepares him or her to fail by actively creating barriers to meeting data integrity requirements such as FDA 21 CFR part 11? Manual data entry, repetition of tasks, multiple data entry points, legibility errors, missing dates, missing signatures, sometimes missing calibration certificates, the list goes on.

So when the auditors began to ask questions that previously they had not, it became apparent to the business that the goalposts had been moved significantly. The process that had not progressed through the years was not ready and not capable of meeting these new regulatory requirements. Hands up, you got us.

"Need to go digital guys, it will solve everything!

Yeah sounds like a plan."

Now if the only tool you have is a hammer, everything can look like a nail, so in order to "go digital" companies firstly looked towards what they already knew. The CMMS of course!

Removing paper was largely seen as the box to tick. So these businesses looked at how they could incorporate calibration data into their CMMS. There were bolt-ons for this, and whole departments full of specialists for blueprinting, outlining, work flowing, blue skying, planning, deploying and out of the boxing it. Quick upgrade it. Technologic.

Moving calibration into the CMMS also meant that there was less software to manage within the business and this is frequently a concern for IT departments. The less software the better! But calibration being specialised and as we have already established, a potential show stopper on site, is this really an I.T lead concern?

Not necessarily, I would suggest potentially more of an engineering, quality, compliance and maybe continuous improvement initiative with input from I.T.

In any case, if you’re working in one of these businesses, now you’re digital and loving it.

It’s all in the CMMS, great. Look at all that lovely data in there and we’re saving paper so David Atts and Greta will be pleased. The system works. We have almost got all the bilities too.

But, wait, it's not automated, it is still manual data entry though?

Yes.

But what about data integrity?

Well, we are capturing less data manually than we did before so it is an improvement.

Ok, but we are not certain that the data being recorded is true to the test that has been carried out?

No we are not, but it is better than it was.

Ok but what now? We’re full steam ahead on the digital informationway, where are we going though?

Not sure.

Can’t we look at that lovely data to see where we go from here? It’s all in the CMMS.

No, we can’t do that.

Why not?

It is static data, we can’t analyse it.

Ah, but isn’t there a bolt on for that too?

Er, no. but you can look at it and see what you can learn?

But that is what we had with the old process. So what do we do now? How do we improve things further?

Wait for the next audit I guess, they will tell us when we need to make more improvements.

Ok….

For these companies, they went full steam ahead with digital familiarity, they incorporated their calibration process into a system that was not specifically designed to ensure that they remain compliant with their regulatory requirements when it comes to calibration. They did however manage to validate that process for use and get on with it nonetheless.

But what if they had a better way to manage this?

What if they took a dedicated calibration data management system which was customized to fit their process and then they simply integrated it into their CMMS?

By book ending Beamex CMX calibration data management software into your CMMS, you create a completely end to end digital flow of calibration data throughout your business. This, removes any manual data entry and with it, any likelihood of error within your data.

But what does it mean Aidan?

Ok here goes!

To summarise the above graphic…

The PM is sent from the CMMS to Beamex CMX calibration software, associated instrument data for this PM is then sent digitally from CMX to calibrator, test performed, digital result data is then documented by the calibrator at the point of test, all time and date stamped and electronically signed to the profile of the technician who performed the test. The result data is then sent back and signed off digitally, and Beamex CMX calibration software closes off the PM in the CMMS. Lovely job. Time left for a cup of tea and bit of Daft Punk.

This is where things get interesting. By carrying out essential work such as calibration, you are harvesting a huge amount of live data points on your process. As this data is now living in the CMX calibration database, it can be analysed extensively to enable you to gain all kinds of advantages from it. More valuable than gold remember!

Use this data to then optimise assets, optimise calibration frequency periods, to better manage resources, to identify problematic instruments, or to pick up minor trends within your process that can then be addressed long before they begin to impact production. This avoids loss of production time and the costs associated with this along with the ripple effect on maintenance, quality, etc and other teams on site. As you utilise this information to make enhancements it enables a culture of continuous improvement within your business.

So better data integrity via Beamex Integrated Calibration Solution means "true to test" data going in, and usable data coming back out.

More efficient, more traceable, better data integrity, more sustainable, you get the idea.

As sure as one wave crashes there will be another one not far behind it. IOT, AI, digital twins, who knows where it will lead.

What we do know is that by working extensively with operational leaders to help them to not only implement better processes, but smarter processes, this will actually help and guide them on where and how to improve further, no need to wait for that slap on the wrist from a regulator.

This also means that we and our users have the flexibility to adapt to the changing trends within industry. By being able to adopt changes more easily we can address the "future proofing" question, but in the meantime, businesses can utilise a digital calibration solution, to enhance their process whilst ensuring that they remain compliant with regulatory requirements, such as FDA regulation 21 CFR part 11.

Your CMMS is great, of course it is, but ask yourself, what more could you gain from it by integrating it with specialised tools to enable you to enhance your process and further future proof your business?

I hope you enjoyed reading, now I am off for a cup of tea and some Daft Punk.