Evolve or die, as the saying goes. Is that true for quality management and for quality management systems software? In today’s rapidly changing world, I have to say that it absolutely is. Many of us have heard the phrases “Industry 4.0” or even “Quality 4.0” or simply “Digitization.” The current trend is to connect the Industrial Internet of Things (IIoT) and automation so that we humans can do what we do best—create and improve!

Quality management systems (QMS) have developed over the years as computers have revolutionized our lives. Let’s take a look at how electronic quality management systems (eQMS) have evolved over the years.

Homegrown Systems

From basic spreadsheets to homegrown access based or SQL based systems, manufacturers embraced the digital era early by utilizing documents with embedded hyperlinks or linked spreadsheets with embedded macros (depending on the competency of the builder). However, these “systems” ran into many issues, including the proliferation of duplicate systems across divisions and departments, and of course, the dreaded issue best summarized as: “The person that built this has left the company and we have no idea how it works.”

Point Solutions

Once the opportunity was identified, software providers flooded the marketplace with point solutions for everything from document control to audits to process FMEAs. Companies bought software developed by professionals, supported by 24/7 support staff, but in reality they ended up with 15 different solutions to do the work and none of them could communicate with each other!

Modular Solutions

In response, companies were told: “Hey, we can fix that. Our software is modular. Just buy what you need and upgrade later.” Unfortunately that was not always the case. Modular systems relied on updating all the modules in the suite to the same build/release as the new module and guess what? The first three modules were customized to fit the business model (let’s face it, everyone is different right?) and suddenly the upgrade requires re-implementing the first modules and rebuilding all the customizations!

Vertically Integrated Solutions

“Let’s take the burden off the customer.” Now we are getting there—a system where all the key components work together: Documents to training, audits to documents, process failure mode effects analysis (PFMEA) to control plan to inspection etc., etc. Best Practices built to the needs of the specific industry by industry experts plus 24/7 support with service level agreements to boot! But is there still room for improvement? What comes next?

Enterprise Quality Management System Solutions (EQMS)

Note that the “E” stands for enterprise not electronic. These are the current state of the art solutions. They are backed by large software companies with seamless integrations to other key enterprise level platforms (think PLM, ERP, MES, MOM, etc.). Embedded metrics and KPIs tailored to the user’s role and best practices with optional tailoring to meet the organization’s needs. Cloud-based solutions with accessibility from any location and of course, full supply chain collaboration. Is this the ultimate system? Probably not. There is always room for improvement. But, hey, we are a long way from where we started.

Bear in mind that this change has occurred over the past 30 years, with advancements ramping up as technology advances, escalated at the same rapid pace. Many of these technological enhancements have had a major impact on how quality management practices have evolved and have been brought out of the back office to allow quality practices to be embedded into the operational landscape. Examples of these include smartphones, tablets and touch screen terminals that have allowed practices such as inspections, audits and nonconformance management to be conducted in real time with fully integrated linkage to escalation practices at the pace the business needs to operate efficiently. No longer do we need to wait for the information to trickle in and waste time and effort with follow-up or worse still, have products inspected under out-of-date standards because someone hoarded a bunch of printed forms!

Additionally, the shift to cloud-based operations has had a major impact on supply chain management and IT support. The supply chain can now collaborate in real time with suppliers granted safe and secure access to their customers’ systems. These suppliers can access the latest data and work in areas such as new product introductions, sourcing/RFQs or corrective actions and chargebacks for when things do go wrong. IT teams can focus on supplying the business with the support they need rather than being focused solely on data security, database management or infrastructure requirements. Software as a Service (SaaS) has revolutionized the way we work and also where we work from. Imagine trying to cope with something as disruptive as the COVID-19 pandemic without cloud-based solutions.

As technology has changed so has our use of data. Operations no longer have to wait for a week or more to see a printed report formulated on Excel spreadsheets by quality engineers who spend more time reporting on past issues than on continually improving the current state. Metrics and key process indicators (KPIs) are now available at the speed the business needs to be truly proactive. In addition, key management can be informed in real time on the status of the business, with access to dashboards that are tailored to their specific role and needs. Data drives action, action drives performance. From the CEO to the manufacturing floor, this access to data empowers the organization to improve. Translating data to information at the velocity required is key to remaining competitive in today’s disruptive manufacturing environment.

Finally, quality management software alleviates the need to design the system yourself. Many software providers now employ industry experts to ensure that the software is designed and built with best practices built in. These best practices are based on experience from many industrial verticals, for example, advanced product quality planning from the automotive industry being used to mitigate risk in the medical device/life science industry. They provide the knowledge and experience required to ensure that your system will continue to address the challenges your organization faces and eliminates the risk of homegrown software or paper-based solutions. EQMS software is now focused on mitigating risk and enabling a truly proactive, prevention-focused operation.

What does the future hold for this quality software? Businesses are constantly changing and systems must be able to evolve and adapt just as quickly. Software solutions that can be tailored to our current operational profile must also allow the system to remain upgradable to take advantage of new technology. As technology advances continue, EQMS systems will become crucial to operations, just like ERP systems. A truly integrated and flexible solution will drive manufacturers forward with visually-based systems driven by artificial intelligence that will mine data for insights and trends. Systems will make suggestions based on machine learning at a pace that we have not seen before and will help develop our key resources, our people, by training them on key skills and advising them on data-driven decision making.

Our systems will also have to change to embrace the rich, visual engaging preferences of the new generation of employees (millennials, Gen Z and onwards). These people will not want to focus on field-based systems of old. Augmented reality may provide the solution to help new employees become highly skilled very quickly. Software providers must change and adapt or face losing in the new marketplace. My hope is that the systems will mitigate the compliance/regulatory risk so that we can focus our energy on creative thinking and continual improvement for the good of society while doing so in such a way that engages and develops our people.