Integrating Quality Management and Manufacturing Operations

Manufacturing and quality management are inextricably connected in process and theory, but often poorly or informally connected in data systems. Manufacturing Operations have deployed Manufacturing Operations Management (MOM) systems to manage manufacturing maintenance, operations and functional quality. Quality Management has deployed an Enterprise Quality Management System (EQMS) to provide overarching quality management, including manufacturing quality governance activities such as Non Conformance (NC) and CAPA. Unfortunately, although both play a vital role in quality management and share certain processes, they are often disconnected systems.

According to LNS Research Principle Analyst Andrew Hughes’ research, manufacturing leaders most commonly identify quality management as the most critical area of MOM software responsible for their company’s success, equal with Production Execution Management.

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From a quality perspective, those that have implemented closed loop systems across design, manufacturing and suppliers have 48% more successful new product introductions. However, the majority haven’t implemented these yet. Integration of quality systems with other “disparate data sources” is consistently cited as the single top challenge in meeting quality objectives at 38% of respondents.

Where is the Overlap?

Often a company may have many MOM or MES systems, as well as hopefully one EQMS. Each MOM will track maintenance, production, quality, and inventory, often at a plant level. Quality data includes processes such as in-line and off-line inspections, Non-Conformances (NCs), as well as possibly CAPAs and SPC. The focus of MOM NCs are on manufacturing, and CAPAs are typically lean, lightweight corrective actions. Referring to the quality Infographic based on the ISA-95 framework, specifically under the make portion of the value chain. MOM primarily operates in the “Functional Quality” portion, although it does have overlap with the “Enterprise Quality” portion.

The EQMS will capture core ISO quality processes such as Audits, Change Management, etc, as well as NC and CAPA. EQMS processes are corporate-wide and as such have tentacles across the corporation. For instance, the NC process in EQMS can be associated with manufacturing, but also Audits and other inputs. Therefore, EQMS primarily operates in the “Enterprise Quality” portion, although because some EQMS solutions support inspection tracking it also dips into the “Functional Quality” portion.

Which System Should Master Quality Information?

Our recent blog “What System Should Own Our Quality Data?” discussed the need to determine data mastery and traceability, as well as consideration of use scenarios when deciding system overlap. In the case of MOM and EQMS, how should we establish quality information mastery and traceability such that we maximize plant, business unit and corporate quality? Here are some considerations related to:

• Inspections- In most organizations, the high value of connecting Level 3 Quality Inspection data to maintenance, production and inventory will likely result in Level 3 quality data being mastered in the MOM.

• Non Conformances- The NC process is an overlap area between MOM and EQMS. Given that many NCs are generated by manufacturing quality personnel in context of other MOM data including Inspections, there is value in Mastering NCs from within MOM. However, manufacturing NC data is also critical to corporate quality, quality reporting, connections to CAPAs, and regulatory requirements. Additionally, manufacturing NCs are not the only types of quality Non Conformances, and if MOM were to be the data master there could be many resulting data masters.
  Therefore, it may be determined that although manufacturing NCs are initiated from within MOM, at some point in the NC workflow EQMS system becomes the “system of record” and becomes the data master. When to transition data mastery is individualized based on the EQMS and MOM system capabilities and deployment landscape as well as the user roles and use scenarios.
  Regardless of mastery decision, traceability should be established from all systems to the master data.
• CAPAs- CAPAs will most commonly be mastered in EQMS for a number of reasons. Again, the CAPA ideally has traceability to NCs, audits, Complaints, etc. so that visibility is maintained. With appropriate traceability to all source data systems, our quality manager can not only prioritize more efficiently, but also use traces to improve quality by identifying trends.

One of the top challenges in quality management is “disparate systems and data sources.” However, with careful consideration of system interfaces in the interest of maximizing plant, business unit and corporate quality, systems and data sources are no longer disparate and all stakeholders can benefit.

NEW Research Spotlight on strategies and recommendations for minimizing risk through a migration away from monolithic, single-plant MOM architectures through exploration of Cloud and IIoT technologies that are advancing in manufacturing today.