After analyzing a number of RFPs, participating in solution workshops and talking to manufacturing companies, I have noticed that the terms QMS and LIMS are often defined differently depending upon who is speaking, the industry as well as what standards are being referenced. This confusion appears to be especially applicable in the industrial industry, which is where I will focus the discussion for this post.
Most companies now realize that in order to make any enterprise wide quality initiative it takes three components: people, metrics and technology. While the first two are equally important, it’s the latter one that often creates a lot of pain. How do I choose the right software? What components should it include? Should it be one system, or multiple specialized applications?
Traditionally, when speaking about the broad software category of a QMS or a Quality Management System, it is typically defined as a platform covering a wide range of processes. Some examples of capabilities include Non-Conformance/CAPA, Audit Management, Statistical Process Control (SPC), Defect Tracking, Supplier Quality Management, Compliance Management, Document Control, Reporting, and even Risk Management and Employee Training. This is a far and wide encompassing list of functionality, which leads to some of the confusion on this topic. Do manufacturers seek out and succeed in finding a one-for-all QMS solution? In my opinion, I think not.
It is far more likely that as new challenges or issues arise, systems are then purchased and implemented to deal with the matter at hand. Then, over time a group of applications emerge that are collectively referred to as a QMS solution. In reality, these applications probably don’t all work well together, causing challenges with data integrity, real time visibility, continuous process improvement and other integration concerns. As applications age along their lifecycle, it then becomes quite complicated deciding what applications to replace and when as well as what grouping of capabilities makes the most sense to bundle in future purchases.
An Approach to Ease the Complexity
One way to simplify the QMS environment is to think of your applications as being either “data centric” to collect data, “reporting centric” to then drive visibility into performance, and “execution centric” to perform the action. From my experience, not all QMS capabilities are created equal. The most critical QMS components for industrial applications are related to the execution of quality process across the organization. If you can’t act upon an alert, then the value of a notification or report declines significantly in value. Examples of where it is critical to execute a quality process begin with components receiving inspections and supplier performance, and then extend through in-process inspections, visual defect tracking and sampling procedures, to end with SPC and CAPA workflows. Add the quality data intelligence on top of it and you will get something I call “QMS for Manufacturing”.
In conclusion, when you are looking to manage manufacturing quality, the decision to just focus on features and functions that lay under the “QMS” term may not be the right approach. Instead, it might be best to seek solutions to solve your quality problems that are focused on quality metrics. Be sure you have the capability to collect your data, report on it and then act upon it. Ideally, each of these capabilities should be able to grow and adapt as you and your organization’s needs change so as to provide many years of benefits, which will then simplify your need to manage these functions over their respective product life cycles.
What are your observations? I would be interested in hearing from you.
