The Role Quality 4.0 has in the Implementation of Industry 4.0

Authors: Charles Golub – Market Development Manager

A smart factory is the desired outcome from implementing industry 4.0, but what does it take to achieve that? And what role does quality play in obtaining this? For many, obtaining Industry 4.0 from a Quality 4.0 approach is not only the most logical step, it is also the most achievable.  When an ISO 13485 certified site is attempting to implement Industry 4.0, misalignment to the quality management system (QMS) can be a show stopper and a barrier to achieving a smart factory. Saint-Gobain has a strong Quality culture, so implementing Quality 4.0 has not had as many hurdles as would be seen if the sites didn’t already have a good foundation. As part of ISO, sites need to be compliant with data integrity and systems validations, which includes electronic systems.  Two systems are critical to obtaining this: 

  • A manufacturing execution system (MES), which communicates to the enterprise resource planning software (ERP); 

  • A supervisory control and data acquisition (SCADA) system which provides real time operational information. 

Integrating your SCADA system into the MES package of an ERP is a critical aspect of Quality 4.0. Capturing data real time with a fully integrated system enables a strong competitive advantage in manufacturing as well as quality services. 

The SCADA system provides a digital and manufacturing floor interface for real time production output. By implementing and validating this, it removes manual recording of production activities such as: the number of parts produced, digital notes during the run, real time color indicators for any problems noted during the run.  For example, if the operator has to stop for maintenance or because of a nonconformance, this is instantly captured and the run time is updated in the system, which in turn will push out future runs planned on the same equipment.  Doing this real time takes much of the guess work out of operational planning and ultimately quoted lead times.  With regards to QMS, this makes the review of the data and information seamless, more accurate, and quicker. It also improves traceability and helps plant audits run much smoother. 

The MES tool communicates to the ERP to provide details about the work order such as when it was made, who made it, and inventory levels (pre- and post-run). SCADA is used to collect all of the machine’s processing and inspection data, specifically around key process parameters you’ve established. The data is captured and then validated as being accurate, so that no transcription errors would be noted.  If an operator had to enter this data manually there is high room for error, as there are numerous process parameters that can be recorded.  There could be typographical errors or even missed data, either of which can have a big impact on the product. Further, it becomes hard for quality assurance to review the paper data. With the SCADA system, continuous data is being collected for the entire run. This data integrity is key and critical when producing high precision medical components. The ability to be able to pull up trustworthy validated electronic processing and inspection data is critical for all aspects of operations. 

A lot goes into bringing each site online with these systems, so time and attention must be paid with local resources and champions working closely with experts for each of these systems. The experts can be either internal or external, and need to provide thorough training at each location the systems are implemented. These systems are completely validated after the QMS requirements are defined and implemented into the sites via an internal QMS Change Management process, which ensures all the required QMS steps are followed. Quality 4.0 isn’t just about the new systems, it is a better way to manage and improve upon an existing QMS and have those communicate to other parts of the operation. These are very much intertwined as there is no method of becoming a smart factory without following all the rules required for a QMS.

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