By Steve Gompertz, QRx Partner
As a consulting firm we get courted frequently by eQMS vendors who hope we will introduce our clients to their systems. So, we get to see a lot of demos. Recently, after a demo where a vendor eagerly showcased their latest features, we found ourselves questioning what was truly new. Despite modules for each QMS activity, record-linking capabilities, and some workflow integrations, the fundamental issue remained: no one is genuinely addressing the Process Approach.
The Process Approach
ISO 9001:2000 introduced the concept of a process approach to move thinking from a focus on individual activities to understanding the interconnectivity of those activities to establish a Plan-Do-Check-Act (PDCA) cycle. Rather than sub-optimizing each activity, the intent was to see the quality management system as a system. While it is important that each activity be optimized for efficiency and effectiveness, that can’t happen without considering the activity within the context of the system. For example, putting racing slicks on an economy car won’t make it any faster, and they probably won’t fit in the wheel wells, put excessive stress on the drive-train, and not provide good wet traction. The importance of, and requirement for, applying a process approach is well-established in ISO 9001:2015 and ISO 13485:2016. You just need to read the Introduction sections that everyone typically skips. Oh, and 9001 even includes a picture, as shown here.
What’s Wrong with Most eQMS Solutions?
Most eQMS offerings include modules for every QMS activity: Document Control, Design Control, Audit Management, Training Management, CAPA, Supplier Management, Nonconformance Management, etc. Some address interconnectivity by providing text fields for entering reference information, e.g. – a field for entering a CAPA number in an Audit record. Others make those fields links to actual records, e.g. – picking an existing CAPA record to reference. Too often that’s about all you get in terms of interconnectivity; a connection between “Point A” and “Point B”. Sometimes the chain continues to a “Point C”, e.g. – the CAPA record references one or more NC records. So, at least you get a “trail of breadcrumbs”, but that’s still not really the process approach.
So, what’s missing?
Again, the process approach is about understanding connectivity between activities. The relationship between records is only one piece of that. Most eQMS either expect an organization to proceduralize those interactions (i.e. - not actively managed within the eQMS) or allow for enforcing the relationships (e.g. – requiring a CAPA reference before closing an Audit record containing a Major NC). While the latter creates traceability, it doesn’t really provide the visibility to facilitate interconnection with other QMS processes like Management Review. Even if you have those enforced data relationships in your eQMS, how easy is it to identify trends without exporting or re-entering data into a spreadsheet for analysis? Without this, it’s difficult to answer some of the basic questions. Is the QMS adequate, suitable, and effective? Are there Nonconformance trends that indicate a systemic issue requiring a CAPA? If we make a change, any kind of change, can we easily identify all of the impacts? What percentage of our Change Requests are value-added rather than corrections? And there a many more.
Other eQMS Shortcomings
Besides treating the QMS as a pile of disconnected or lightly connected activities, another area where eQMS solutions fall short is in understanding the requirements and intents of the standards and regulations as regards each process. Training Management is a prime example. Every eQMS includes this module. What’s funny is that there is no direct requirement in the standards and regulations to manage training. Training is an element of the requirement to ensure employees are competent, i.e. – appropriate/necessary education, background, training, skills, and/or experience. We just came out of another demo where we asked about how competence could be managed by the eQMS, and yet again, got a puzzled look. The requirements and intents aren’t about establishing evidence of training, but evidence of competence. The same situation occurs regarding Supplier Management and the ubiquitous “Approved Supplier List”, which also is not an actual requirement. Yet, the ASL is still the focus of most eQMS solutions. Someone recently said to us that eQMS vendors seem more like IT experts than QMS experts. It’s not clear whether that’s accurate, but the perception makes sense.
What’s needed?
The challenge is likely that same seen in many quality management systems and in the outdated thinking of many quality system professionals. The siloed or checklist approach to quality management went away 24 years ago, but it was easy to understand and process thinking is not. When eQMS vendors offer customers solutions that tick all the boxes on our checklist, it seems like an easy decision. But what should excite customers of these systems is if a vendor can show them how to connect all these activities right out of the box and that the vendor understands not just the wording of the requirements but their intent. The vendor that can demonstrate that they truly understand and enable a process-based QMS, will have truly differentiated themselves from the competition, and maybe evolved eQMS to a new level. We have seen a new eQMS demo that does appear to apply the process approach. It’s coming to market soon, but our intent here is not to hype them. We’re hoping it is the first in a line of next generation eQMS solutions that connect activities into processes and apply AI/ML to help us understand our QMS at a more holistic level. Quality leaders shouldn’t settle for mere record management efficiency. Instead, they should demand comprehensive oversight of their QMS, ensuring true process interconnectivity and systemic visibility.
QRx Partners is available to guide both users and developers of eQMS solutions to help with this evolution. Contact us at Contact@QRxPartners.com or 833-779-7278.
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