Roughly ten years ago Quality Management System (QMS) software was still primarily paper-based, focused strictly on plant floor manufacturing operations. The market began to transform, and along came the term “eQMS” to designate it was “electronic” or did not require the use of paper. As the next iteration, the “e” has grown up to be a capital “E,” as part of an enterprise software solution. An EQMS brings together numerous quality-related processes to operate with a far wider reach than ever before – across the entire value chain.
An Enterprise Quality Management System or EQMS could now, depending on the supplier or the end-user perspective, encompass a greater set of manufacturing-centric functionalities, such as:
- Statistical process (or quality) control (SPC/SQC)
- Compliance management
- Nonconformance reporting and management
- Corrective action and preventive action management (CAPA)
- Quality reporting and analytics
- Change management
- Document control
- Calibration management
- Failure modes and effects analysis (FMEA)
Not only can an EQMS software be considered to help with these functions, but it could also be part of more value-chain oriented functionality such as:
- Supplier Quality Management (SQM)
- Advanced Product Quality Planning (APQP)
- Post-production failure tracking and reporting
Other near upstream or downstream quality-related activities could also be included. As EQMS has taken root in the manufacturing industry over the past decade, the quality function has grown in importance and reach to become a critical enterprise-level activity. Yet there still appears to be a shortcoming with how quality management is seamlessly incorporated into all enterprise activities. This is evident in the slew of EQMS software that exists as a standalone offering.
We must remember quality’s role in activities that take place outside of an enterprise’s four walls. Complex fabrication and automated manufacturing processes are increasingly being performed by both suppliers and OEMs, as part of their respective production workflow. When production grows outside the enterprise, too often the quality focus is on the downstream aspects versus at the source. Quality compliance should not only be driven by field service activities but rather, be incorporated into the sub-tier supplier’s processes to ensure First Time Quality.
Once again, it’s time to redefine the “E” in EQMS! This time, the “E” should now stand for “Ecosystem.” Not only must quality be managed across the entire enterprise value chain, but greater emphasis must now be placed on the upstream aspects of quality.
Quality Management Starts with Quality Components
Every manufacturer must meet its customer’s quality expectations if it wants to survive. In today’s global economy, competition means your customers can always look elsewhere if you cannot meet their requirements. This has driven manufacturers to focus on quality throughout their entire production and assembly process.
It is not uncommon to perform product quality inspections on received raw materials, components, or sub-assemblies. In some environments, companies have even resorted to inspecting 100 percent of the incoming materials instead of sampling regimens in the quest for perfect quality.
Read this Success Story on Lockheed Martin’s Flight to Perfect Quality
There is recognition that if you don’t start with quality components it will be extremely difficult to build in quality later, as you proceed. This concept is at the heart of First Time Quality and the importance of inspecting at the source. The best way to achieve high quality in your manufacturing operations is to ensure you start with perfect, high-quality raw materials and components.
Quality Isn’t Inspected – It is Designed, Made, and Maintained
It is a well-accepted fact in manufacturing operations that quality cannot be achieved just by inspection. It happens only through proper design, well-controlled manufacturing processes, and proper maintenance over the lifecycle of a product. But this simple mantra exemplifies the challenge most manufacturers face – you must look inward at the mirror.
You also need to extend the “Design, Make, Maintain” paradigm to your supply chain as well. This means you must qualify your suppliers as part of your design efforts. You need to ensure their manufacturing processes provide you with the materials, components, and accompanying quality assurance data that are at or above the level you need to meet your customer expectations. Consuming sub-par quality components will not result in a high-quality end unit.
Quality in the World of Industry 4.0 – Operating as Part of an Ecosystem
As businesses adopt Industry 4.0, they are embracing digitalization. The roughly 65-year-old GIGO maxim (Garbage In, Garbage Out) has never been more relevant in the context of Industry 4.0. If a manufacturer wants to provide high-quality products for their customers, they need to be part of an entire ecosystem that puts quality at its center. Having tools that let you manage quality across an ecosystem means Quality Management – and EQMS – must be once again redefined to look beyond the enterprise and out across the digital ecosystem.
Read more about the importance of ecosystems today in this article, 3 Reasons Why the Single Vendor Model is Losing Ground to the Digital Ecosystem
This means picking vendor solutions built to support the exchange of data, the integration of end-to-end processes, and the ability to offer APIs to support and ease configuration across processes, applications, and workflows.
The Future of Quality Management
What we have seen is an evolution of quality management that has continued to grow, evolve, and adapt to ever-increasing quality standards and requirements. Supplier Quality Management, Advanced Product Quality Planning, and general quality tracking are now occurring several layers upstream. As Quality becomes managed at an ecosystem level, delivering quality to your customers means you become part of the solution instead of a potential facet of their quality problems. Make sure your EQMS investment is sufficiently future-proofed to grow and evolve with your entire ecosystem in mind.
