“Quality is not an act. It is a habit.” Aristotle

At its worst, quality-related incidents may lead to large scale product recalls, lawsuits and claims amounting to millions of dollars, permanent loss of customers and substantial damage to brand identity and market goodwill. But even in the slightest of incidents, quality-related events may lead to rework, loss of material, unplanned downtime, delay of shipments and customer complaints, all of which create tangible and measurable short term monetary loss and longer term, may impact the brand and goodwill of the company.

Aristotle rightly stated that quality has to be a habit. In the context of a manufacturing operations, it needs to be ingrained into the culture becoming so deeply entrenched in all the activities pertaining to daily operational affairs that it becomes the habit and a way of life.

In highly regulated industries, most manufacturers already have a Quality Management System (QMS) in place. Any modern QMS is expected to reduce the cost of poor quality, move the process towards zero defects and enable an environment where process innovation is the outcome of the quality process, not just for process improvements. Not too long ago, QMS would traditionally exist either as a paper-based or semi-automated system, where everything from work instructions to SOPs and shop floor transaction records to CAPA (Corrective and Preventive Actions) would reside. However, from an ideal Industry 4.0 perspective, the approach which is highly recommended is to have the QMS data reside within the MES itself, rather than as a siloed system. Since an MES contains both the master data and the process data which it captures in real time, it is the single source of truth feeding other IT applications, including the QMS.

Manufacturing is becoming more and more complex with consumers requiring personalized products, fast delivery times, and a mix of products on a single production line; fast changeovers and spec changes to conform with real-time issues in the production process; and a higher degree of customization and complexity. Dynamic manufacturing lines with hundreds of product variants all manufactured with varied specifications and quality parameters, demand from the modern QMS to provide updated and correct work instructions pertaining to each product. Operators demand the capability of viewing, executing and recording inputs on the go, and modern QMS systems aspiring to be Industry 4.0-ready must be able to accommodate and exceed these expectations.

When the QMS is tightly integrated with the MES, it has access to all the process data and data from beyond the process being captured and fed to the MES instantly. Any out-of- spec event which is recorded by the MES can help the QMS trigger containment and invoke corrective actions the very instant the issue event occurs, thereby eliminating any lag created by the need to manually feed the data to the system or for the data to be transferred through some integration mechanism. Faster detection of events leads to faster resolution, but since MES adds context, it will also provide the QMS additional information, which may lead to actions beyond basic containment and help detect and eliminate a root cause, which otherwise would have taken far longer to be removed.

MES+QMS meets all the expectations set by Industry 4.0 of being fast, being agile, being accurate and being available at all times. We invite you to read our white paper on why the MES/MOM platform is the best for Quality Management to gain further insight:


Quality is Everyone’s Business

Outlining 10 Reasons Why the MES /MOM Platform is best for Manufacturing Quality Management

by Critical Manufacturing