Report: External Pressures Are Changing How Companies View QMS Solutions
Acknowledging that you need an effective QMS solution is the first step on the quality journey
Product quality may be a public reflection of brand values, but companies that don’t optimize quality management, strategy and leadership to fit in with the demands of the modern regulatory and consumer marketplace could become a 21st century anachronism.
A recent state-of-the-market report by Gartner said that disparate elements such as regulatory requirements, changing business models and a heightened visibility to product quality issues within the consumer marketplace are accelerating the need for companies to integrate dedicated business optimization software into their internal and external quality management systems (QMS). Traditional QMS processes such as spreadsheets and physical clipboards are reportedly still prevalent, but there is an acknowledgment that automated solutions are the best way to handle document control, corrective and preventative action (CAPA), employee qualification, internal controls and other critical quality functions.
According to Gartner’s Market Guide for Quality Management System Software, companies recognize that custom-made and homegrown approaches to QMS are often not prepared to handle the fast pace of modern society, with exposure to quality-related incidents or regulatory non-compliance an ongoing source of concern. Many companies don’t have a QMS solution in place, the report said, and the constantly evolving regulatory landscape – that often dovetails with the digital transformation of a company – means that organizations must not only be aware of today’s quality requirements but also keep an eye on the future
As a result, quality and supply chain leaders are aware that they require the right tools to ensure compliance with regulations and established industry standards or policies, the report said.
“Gartner clients report, and QMS solutions providers have observed, that quality management has moved outside the quality function and has more enterprise-level visibility,” said Sam New, Gartner senior principal analyst and report author. “As a result, manufacturers have a heightened desire to avoid quality issues earlier in both the product design and manufacturing processes; they seek solutions that are increasingly focused on predictive qualities and proactivity, as opposed to containment and reactivity.”
QMS software raises the bar
There is a consensus that quality is under pressure, and brand reputation or consumer trust in a product can often be blown away with just one quality mis-step. Add into the mix the potential for a quality failure to digitally spread in minutes, and the stakes could not be higher
Gartner defines QMS as “the business information management system that houses quality policies and standard operating procedures” that includes but is certainly not limited to customer requirements, quality documents, ISO requirements, manufacturing capabilities, product design, auditing procedures and protocols, risk management activities, testing criteria and industry-specific regulations.
The QMS software market has grown significantly in recent years, with companies choosing to invest in options that suit their particular business model or industry. Year-on-year revenue has grown by about 12 percent, Gartner said, but the requirements for QMS vary across industry sectors, company size, business units, product lines, regulatory environments and location.
However, the report said that there are still companies that do not have any sort of QMS solution. Some may rely on spreadsheets or paper-based processes, two “systems” that have no governing process or central repository. As a result, the challenge is to both educate end users and provide them with the resources that allow them to make an informed decision.
“In some cases, Gartner clients report knowing that they need to formalize quality processes and systems, but admit that they are unsure where they should begin,” New said. “In other cases, Gartner clients report actively seeking a commercially available QMS solution, but find the myriad vendors, diverse product offerings, and combination of nascent offerings and traditional core functionalities to be confusing.”
Leveraging functional requirements
For companies that do have a QMS solution in place, the options fall into two camps - on-premise or the cloud (both private and public). Around 51 percent of organizations have an on-premise QMS, Gartner said, while 41 percent opt for cloud or SaaS and 8 percent rely on hosted cloud services.
QMS has a number of functional requirements, but the underlying concept is that an effective solution is “an aggregation of business processes and functions that supports continuous improvement of quality and ensures that customer, product safety and regulatory requirements are met or exceeded.”
QMS functions and goals are varied, but they must include the following elements:
- Defining and improving quality processes
- Housing documents and controlling versions
- Measuring and tracking quality performance
- Ensuring compliance with policies, regulations and industry standards
- Training employees and documenting training
- Lowering costs
- Reducing waste
In addition, Gartner’s report noted that an effective QMS must be user-friendly and, importantly, intuitive. An interface that is not responsive to the casual or infrequent user can be more of a hindrance than a business optimization tool, and the report stressed that this was often a major pain point in terms of integration and creating a culture of quality.
Companies also have to be mindful of emerging technologies.
For example, there has been a lot of industry-generated buzz around artificial intelligence or machine learning, the Internet of Things, digital twins, advanced analytics, blockchain, augmented reality and robotic process automation. However, Gartner said that these technologies remain very much in a hype cycle and wide-spread or mainstream adoption in terms of QMS is still some distance in the future.
Ticking the QMS Boxes
With that in mind, the more robust a solution the better. And although the Gartner report is an overview of the current QMS landscape, it suggests that companies need a platform which does the following:
- Ensures and, importantly, enforces compliance
- Offers the desired functionality, coupled with an ability to adapt quickly to changing circumstances
- Provides a user interface or user experience that supports as opposed to hinders end user adoption
- Promotes transparency across the enterprise
- Can be licensed and/or hosted in a number of specific ways
- Is inclusive of new or emerging technologies – AI, ML, IoT, etc. – without compromising core quality management functionalities
Companies or decision makers that want to take a deeper dive into the report can download the full Gartner QMS Market Guide here, but it is worth noting that overall QMS requirements vary depending on the circumstances.
An electronics company in the United States is going to have different quality needs to a pharmaceutical firm based in Europe, for instance, while an organization with an extensive supply chain network is likely to want its suppliers to follow a standard set of operating procedures and quality processes.
There is little doubt that changing customer requirements and expectations have determined that a QMS solution needs to take account of increased demands on manufacturing and supplier dependency, especially as quality processes are likely to become more related to a requirement for continuous improvement in a competitive marketplace.
Taking that into account, the simple fact is that a solution that is able to tick all the required quality-related boxes will be the one that encourages continuous improvement and fosters a culture of quality throughout an organization. Anything less, and an organization is leaving itself open to avoidable quality pain points.
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