Key Takeaways by Kapil Venkatachalam from EtQ’s Annual User Conference

The global quality management software market is estimated to reach over $12 billion by 2024, according to Grand View Research. As industries like automotive, healthcare, pharma, biotech, energy, food and beverage, and chemicals are becoming more sophisticated, quality management has become a large-scale phenomenon around the world for companies of all sizes.

Purpose-built Enterprise Quality Management Software (EQMS) platforms enable organizations to collect key quality indicators, monitor them and proactively address root causes of deviations from the norm. “This approach becomes a strategic asset when it is adopted across the organization,” says Matthew Littlefield, President and Principal Analyst at LNS Research. It can also have a symbiotic effect across related functions within an enterprise, such as R&D, product design, and manufacturing. LNS Research, for example, has found that companies using EQMS see measurable and significant improvements in everything from product compliance and manufacturing defect rates to engineering and service metrics. In LNS’s most recent research, Building the Executive Business Case for EQMS, Principal Analyst Dan Jacob analyzes over 1,000 manufacturing companies, showing that those that deployed EQMS have reduced the Cost of Poor Quality (COPQ) by 11% and increased the share of successful New Product Introductions (NPI) by 21%.

I recently had a chance to connect with leading-edge quality experts across multiple industries at EtQ’s User Conference. We talked about the forces driving radical changes in how companies think about their products, how quality can be a competitive advantage, and the trends companies need to focus on with regards to quality management.


Quality and Brand: One and the Same

One of the strongest themes was that quality is no longer a late-stage process of weeding out defects at the end of a production line—today, it’s a proactive concern of senior management. Quality and reliability have become a differentiator between equally priced products and a reason you’d buy Brand A over Brand B. For some companies, quality goes beyond brand reputation because their products can be a matter of life and death. Case in point: the brakes in your car. They must work without fail, regardless of the price or brand of the car.

Meanwhile, market-side communication about products and services now operates at digital speed. Customer mishaps with a brand-name product can go viral and create a crisis for the manufacturer overnight. Examples include General Motors’ ignition switch recalls and Chipotle Mexican Grill’s food safety issues which sickened customers and pushed the stock down dramatically since the first outbreak was reported.

Source: CNN Money, Yahoo Finance


The Factors of Quality Management Systems (QMS) Growth

Some trends, I think, are driving the increased adoption of better quality management software:

  • Companies now go through more external inspections and validations than ever before, and regulators increasingly want direct access to companies’ QMSs. This speeds things up and makes inspections more efficient, compared to plowing through reams of paper documentation. In addition, regulatory rigor is rapidly spreading around the world, using industrialized economies as models. India, for example, passed new legislation regulating medical devices in early 2017—just a few months before the European Union updated its own rules.

 

  • Digitization is another major driver of how companies are now thinking about quality. Today, growth in sensors and Internet of Things (IoT) in manufacturing processes generate billions of data points along the supply chain. Companies now have access to information in digital format that is allowing them to track and make informed decisions in real time, so they can manage and optimize their assets more effectively and deliver consistent products aligned with regulations.

 

  • A shift in the social mindset around risk. For example, a toy manufacturer that manages to maintain strict quality control of its products might hear about a child that ended up getting injured, even though the product had no defect and was designed for children. The toy manufacturer might use that as a learning point to design the next version of the toy, taking into consideration these corner cases, even though it might not be mandated to do so by any kind of regulation. Arguably, society has become more aware and less tolerant to risk than ever before.

 

From Control to Assurance: A Shift in the Approach to Quality

With many factors driving the adoption of quality management, companies have shifted their approach to quality as well. Quality management used to mean inspecting products at the end of the assembly line. That was Quality Control, and it was reactive and not very efficient.

Now, big pharma companies (among many others) start from the very conception of the product in R&D and manage quality through production and all the way to eventual product retirement. In other words, quality is now managed end-to-end. This is what the industry now calls Quality Assurance.

In line with that strategic approach, some quality managers are pushing themselves to look at quality beyond regulatory requirements. “You have to imagine there is no FDA,” said a quality executive at a major supplier of healthcare consumables. “That’s the way you have to think. For some products, our company services up to 20 million accounts. How do we make sure every one of our medical gloves, for each of those accounts, has the same quality, reliability, and characteristics as the next glove?”

Companies Implement New Org Structures and Technology to Rise to the Challenge

Companies have spent decades answering the above-mentioned question of delivering consistent quality by throwing more people and processes at the issue. Today, a large company might have a technical quality team that assesses products from an R&D perspective, a regulatory team focused on the supply chain of materials, quality engineers in production processes, a compliance team doing internal audits, and post-market surveillance to close the quality feedback loop.

The proliferation of quality assurance processes has driven responsibility for quality management higher up in the organization. When quality leadership ultimately landed in the C suite, so did the need for integrated, on-demand reporting of key quality metrics. Many companies I spoke with have done surveys of their entire quality teams, only to find more than hundreds of different systems were being used for quality. The need to streamline processes has therefore become key to delivering operational excellence.

Quality managers related their struggles to developing an internal quality management software system or getting their existing ERP suppliers to provide it, before they discovered EtQ’s platform solution. EtQ makes it easy to integrate data streams from existing quality processes, create new ones, and present management with a clear picture of key metrics.

“We had one of the large ERP systems,” explained a manufacturing quality manager, “and we were told they offered a quality management software. That came with a $3,000 per day development cost. We didn’t want something that rigid, because we already had some processes in-house that included a lot of existing data. Newer platforms like EtQ’s give you that flexibility. As an end user you can play around with the platform to create your own processes.”

Looking ahead, conference participants predicted that quality management will continue to become even more strategic while also getting more mobile and more granular, right down to the electronic device history records for every part of a product. Companies like EtQ will continue to drive this innovation in quality management software because, as many conference attendees concluded, “quality is non-negotiable.”

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