Industry 4.0 and ISO 9001 Quality Management (Part 2)



quality-tablet.jpgIn a recent blog post, we explored Industry 4.0 technologies from the perspective of Quality professionals, highlighting the importance of planning before implementing. This follow-up blog takes a closer look at the impact some of these technologies might have on the world of the typical Quality department and how they can be used to support Quality initiatives.

Big Data has the potential to make the Quality department’s work a lot more cost-effective. Take calibration of measuring and test equipment, for example. Controlling everything such as co-ordinate measuring machines, calipers, plug and ring gauges, micrometers and so on can be overwhelming – especially when arranging for annual calibration. Additionally, it can be costly to have an ISO/IEC 17025-accredited laboratory come on-site to perform calibrations or to send equipment to the laboratory itself, resulting in production disruptions. This is where the use of Big Data and analytics can help in effectively organizing calibration events to save costs as much as possible.

Calibration is required in the specifications of ISO 9001:2015 and also as a means to avoid product quality rejections (internally or by customers). The control and calibration of measuring and test equipment has been the subject of much debate in technical circles and can be a monster to manage (cost) effectively. A common, almost default, approach is to assign a recall date when the item is withdrawn from use and submitted for a recalibration. Although it’s common for manufacturers to use date-based equipment recalls, this fails to take into consideration the actual use of the equipment during that period. The danger is the item may go out of specification within that timeframe, with a resulting impact on product quality. Or, conversely, money is simply thrown away checking a device that has not been used significantly since its last routine calibration.

So, how can this equipment use be accurately monitored and tracked? The application of some form of digital tag – an RFID tag, for example – can track the number of times a measuring device is used and, when used in conjunction with sensors, the usage data can be logged. With this data tracked, workers can better identify when equipment is in need of checking. This helps save time, efforts and costs, while lengthening the “life” of gauging considerably.

Similarly, if a process is being controlled through a technique such as Statistical Process Control and product measurements are being made at a set frequency to evaluate variation,  the same equipment RFID tag data can be generated to demonstrate that the checks are being performed as required.

No one in manufacturing wants to produce non-conforming products. It’s costly, disruptive and creates extra work. The burden of reporting non-conforming products, generating rework/repair/scrap documentation, carrying out the chosen disposition, performing secondary checks and so on can be a tortuous route to navigate – a long and winding road, in fact.

Having methods in place to detect and codify the details of non-conforming product can lead to more effective control and enables the rapid correction of problems, which saves money. The administrative burden of dealing with non-conforming product alone can cost larger manufacturers millions each year! This only includes costs related to:

  • Recording and processing the non-conforming product reports
  • Evaluation for action, including correction/scrap/rework, etc.
  • Disruption to the “down-stream” processing

The actual cost could be higher – when everything is on hold as the quality problem is resolved, what happens to the natural “cadence” of the work later in the processes? It becomes fractured, and that allows errors to be introduced. By using real-time reporting of quality issues, resolution tracking and corrections, the impact on down-stream processes can be kept to a minimum and unplanned costs avoided.

While Industry 4.0 technologies may seem new and foreign to many, they can be easily applied to existing processes and operations to provide additional support to Quality efforts. For assistance with your Quality management and Industry 4.0 implementations, The Center can help. Visit to learn more or contact our experts at


Nichols_A.jpgAndy Nichols, Quality Program Manager
To The Center’s clients, Andy Nichols, CQP MCQI, brings 40 years of expertise in a wide variety of roles and industries, with a particular focus on quality management systems in manufacturing organizations. Prior to joining the Michigan Manufacturing Technology Center, he was the East Coast Regional Sales Manager for NQA, a “Top 5” Global Certification Body, responsible for significant sales growth in a highly competitive marketplace. He has authored two books, “Exploding the Myths Surrounding ISO 9000 – A Practical Implementation Guide” (published by ITG in April 2013) and “A Guide to Effective Internal Management Systems Audits" (published May 2014).


Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at

Categories: Industry 4.0, Quality Management