Where SPC and heavy business focused analytics tools may be best fit in the enterprise software layer, Quality Management Systems (QMS) now have a lasting home in the MES/SCADA Layer. With the growing capabilities, flexibility, and direct integration to the plant floor, we utilize modern SCADA packages, such as Inductive Automation’s Ignition, to fulfil this role. This is a shift away from a traditional QMS application running independent of the SCADA system. 

 There are many benefits: 

• Inter-software integration of Order Management, Track and Trace, OEE, Recipe Controls, etc.  
• Lighten your complex software stack and cost structure 
• Limit your footprint and potential exposure to cyber security threats 
• Provide integrated access to your quality management solution from your SCADA platform, allowing your operators and shift supervisors to directly and continually interact with your QMS system.  
• Integrate line controls, inspection equipment, alerting systems, etc. into the QMS 
• Minimize training requirements by utilizing common software tools  

 We’ve witnessed clients take full advantage of this tight integration of Quality Management Systems and other MES functions like order management, track and trace, OEE, even document controls within the SCADA layer. Immediate and automated process controls have been put into action to limit the amount of product being produced that doesn’t meet quality standards. Furthermore, uptime for these SCADA systems is as critical as the data that needs to be retained in their historians to comply with federal regulations, making the integration of the quality system into your MES/SCADA layer a foregone conclusion. 

Decentralizing aspects of your quality management system may sound daunting and unnecessary when you can invest in one piece of standalone feature-rich software, but the benefits outweigh the costs when pulling the appropriate functions into the SCADA layer. This means assessing the actions that the QMS will need to take when implementing the system and engineering it to right fit your enterprise and processes for today and into the future. There is no “one size fits all” when it comes to this method. Some of the features to consider keeping within the SCADA layer are system functions that will need to be interacted with regularly by the production teams. This may be the quality checks, automated data collection, integration to hardware for process interrupts due to quality drift, alarming, etc.  

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When approaching the design process and deciding the overall architecture of your new QMS, we have seen the most success from drafting up expansive user stories coupled with Functional Design Specifications that tell which features will be utilized by who, where, and when throughout the process. For example, an operator will need access to the active checks and notification system to input the process information, but they will not be responsible for reviewing, holding, and/or releasing batches. Therefore, the check tool has a place in the SCADA layer whereas the system for holding product and releasing batches post record review may be better suited in your organization’s enterprise layer. Ultimately, the separation of these need to make sense for your organization and who is utilizing the system. We have implemented complete QMS applications, including the tools to create and manage check templates completely within Ignition.  

When implementing a new enterprise-wide QMS, adoption resistance is a very real risk. We have worked with our clients on well-defined implementation strategies prior to installation to mitigate these risks. If you go down this path, consider establishing a team to complete the tasks of digitalizing your quality checks. This is a step that may take substantial effort and requires an individual with great attention to detail who understands the process. This implementation ought to be completed on one production line or area at a time as slow changes over time will be adopted into company culture with far less resistance than an overarching abrupt change. 

With continued innovations and advancements in these SCADA software frameworks, the opportunities are growing vast. Today, we input, collect, analyze, and implement process controls from a QMS integrated into the SCADA application. Tomorrow we may be training an AI agent on your historian, embedding an LLM into the SCADA application, and asking the LLM analytical questions regarding previous batches, seeking ways to optimize production planning.