10 Major Considerations to Kick Off Every EQMS Solution Selection

For years, we’ve been advising industry executives on the Enterprise Quality Management Software (EQMS) selection process. And for years, each one that we speak with typically asks some form of this question: Which solution is best for my company?

In reality, there’s no one-size-fits-all approach to an EQMS solution selection. Before even thinking about the vast market of vendors, we generally advise executives to take a step back and understand which type of solutions provider they should be considering in the first place.

Follow @m_littlefield

We say type because there are, in fact, a variety of solutions provider categories that offer some form of EQMS functionality or business process.

In this post, we’ll break down the different types of solutions providers that offer EQMS. Then we’ll inspect a list of qualifying questions to ask yourself, which will help you understand which approach to EQMS is best for you.

The Different Types of EQMS Solutions Providers

In today’s increasingly competitive and globalizing economy, leaders continuously find themselves requiring better and more integrated quality, risk, and compliance processes across the value chain. The EQMS market has matured alongside these needs, and organizations now have a variety of options for meeting them.

To accommodate the different types of EQMS approaches available to companies today, we’ve identified four different buckets most solutions fall into:

1. Stand-Alone EQMS Vendors

This type of solution provides capabilities for managing quality processes across the value chain from a centralized “hub.” Typically, stand-alone EQMS vendors have shown strength in understanding the needs of quality leaders and corporate quality organizations by provide extensive suites of automated EQMS functionality, including supplier quality management, corrective and preventive actions management, document management, audit management, reporting, and more.

Although these functionalities can be delivered modularly, these vendors have strength in enterprise rollouts. These solutions are also made to integrate with existing enterprise systems such as ERP, PLM, MOM, SCM, and CRM, and are increasingly being delivered over the cloud.

There are also important differences to be aware of between the stand-alone EQMS vendors, including:

• Document vs. Process Centric
• Integration with existing Document Management
• Industry Expertise: Life Sciences, Discrete Manufacturing, Process/Batch Manufacturing
• Cloud, Hosted, On-Premise
• Pricing Models - Licensing, modules, etc.

Finally, to add confusion in the market, many stand-alone EQMS vendors have been purchased by ERP or PLM vendors over the past several years. These solutions should still be considered stand-alone EQMS as long as they can be implemented independently, which is different than the categories below, where the capabilities are built into the existing PLM, MOM, or ERP offerings.

2. PLM-Based EQMS

PLM solutions, among many other things, provide strong workflow capabilities to manage every stage of the engineering process. Although some PLM vendors today are still engineering- and product-centric, many leading PLM vendors are extending the scope of offerings to include service, warranty, reliability, and quality management. These forward-looking PLM vendors are building EQMS functionality like CAPA, SQM, Change Control, and Document Management on top of the existing workflow platform.

For companies that have made corporate committments to extending the PLM platform outside of engineering and across the value chain, deploying PLM-Based EQMS can often be the optimal approach. This is especially true for companies that have highly engineered or complex products, where there is tight collaboration between engineering or R&D groups and quality.

For companies that have limited PLM deployments or PLM is still only limited to the engineering organization there can be challenges in deploying PLM-Based EQMS. Specifically some companies have reported challenges with cost, licensing, and time to implement if the PLM implementation wasn't already mature, but leading PLM vendors are actively addressing these concerns.

3. MOM-Based EQMS

Manufacturing Operations Management (MOM) based applications have become more common on the shop floor over the past decade. Many MOM vendors that offer MES software are facilitating the need for better quality management by extending complementary EQMS functionalities with these solutions sets. EQMS functionalities included here are generally statistical process control, CAPA, traceability, and SQM.

For companies that have made a corporate commitment to MOM and are rolling out a globally harmonized solution, MOM-based CAPA or other functionalities is often the optimal approach. This is especially true for companies that are focused on reducing non-conformances in manufacturing and have an Operational Excellence or Continuous Improvement group that is looking to improve quality processes and performance in manufacturing.

For companies that are still undecided on the scope and value of MOM, deploying EQMS in this way can be a challenge. Users in this situation have reported challenges harmonizing quality processes across the enterprise, providing real-time visibility, and extending quality outside of manufacturing.

4. ERP-Based EQMS

Most global manufacturing organizations today have an extensive ERP footprint that acts as the system of record and manages Financial, HR, Procurement, Manufacturing, and Inventory Management processes among many others. Over time, ERP vendors have extended the scope of solutions into many different areas of the organization, including EQMS. Today, most ERP vendors offer considerable capabilities in EQMS, including NC/CAPA, Document Management, SQM, Complaint Handling, and more.

For large organizations, ERP-Based EQMS is usually included as part of the broader ERP deployment. The challenge can be for quality executives to get the attention and focus in a software deployment that touches so many other areas of the enterprise. If the needed focus isn't provided, companies often report shelf-ware in this arena. If the attention is given during the deployment, it can often be successful. The key to success is generally dependent on choosing the right integration partner. This is because many ERP-based EQMS solutions focused on large global organizations are highly configurable and require significant professional services during implementation.

For small and medium sized organizations (less than $1 billion in revenue), one of the primary benefits of ERP-based EQMS is the use of a single platform, which reduces the need for multiple systems and costly integrations. It should also be noted that there are a number of ERP-based EQMS providers that specifically target this SMB market with cloud-based solutions that offer significant EQMS and MOM capabilities beyond the traiditional ERP capabilities.

Questions to Ask When Determining Your Approach to EQMS

Now that we’ve covered the different solutions categories, it’s important to understand the factors that should go into your decision for choosing one. Like I mentioned, there’s no one solution that’s best for everyone, so to determine your optimal approach, you’re going to want to consider and weigh the different factors below.

It is also important to note that the typical answers provided below are not universal and often similar companies can answer these questions very differently. Finally, most companies will have to answer all of these questions simultaneously along with many other questions, so it is important to effectively balance the importance of all these different factors. A software decision such as this is never binary, even though some of these questions may seem like a simple yes or no.

1. Which department or function is driving the need for quality management?

Basically, this factor speaks to identifying the center of gravity when it comes to quality in your organization. If it’s engineering or manufacturing, it may make more sense to choose a PLM-based or MOM-based EQMS. If it’s corporate quality, stand-alone or ERP-based EQMS may be your best option.

2. Is there a particular pain point that dominates your need for enterprise quality?

If you’re highly focused on manufacturing or engineering, again PLM-based or MOM-based EQMS may be your best option. If you’re leveraging contract manufacturers and suppliers, and want visibility into upstream operations, PLM-based or ERP-based EQMS may still be the way to go.

However, the more you want your solution to span the value chain and are looking for that “hub” for managing quality content and data, the more you may want to err on the side of stand-alone EQMS.

3. Are you more focused on compliance and risk or driving business value and product quality?

Many organizations—particularly those in highly regulated or asset-intensive industries—aim to take a proactive approach to compliance and risk with EQMS functionalities. If this is the case, the best option may be to leverage stand-alone EQMS. If business value and product quality are your motives for a quality implementation, you probably have more flexibility in terms of your solution approach.

4. What’s your existing IT footprint and maturity look like and in which projects are you already investing?

It’s common for an organization to make IT investments that support its core competency. If your company is in the middle of an ERP deployment, ERP-based EQMS should be considered. If your company generates the most value through its design or production efforts, then you’ve likely got a significant PLM or MOM footprint already in place. In this scenario, extending EQMS via those platforms will be the most cost-effective. If you aren’t pouring a lot of resources into an existing system, then the value provided by stand-alone EQMS may be easier to justify.

5. What are your speed and cost requirements for an implementation?

Most IT budget holders will require a specific time to solution value. The timeframe in which you’re required to show a return on your implementation will play a large role in your solution approach. In both cases—speed and cost—pure play tends to win. Again, time to value is tightly connected to existing IT investments. Often stand-alone EQMS providers have a leg up in this area but there are a number of PLM, MOM, or ERP vendors today that are looking to expand quality capabilities and willing to be flexible with new customers in this arena.

6. What’s your quality vision?

When you’re determining which solution approach is best for you, it’s important to think about your long-term quality vision. Our recent quality management survey showed that nearly half of all executives feel their existing, disparate IT architecture is a major roadblock to quality improvements.

The point is, don’t continue on this path and just make an investment to fill a need. Rather, do your due diligence and invest in a scalable solution that will continue to deliver cross-functional value over time.

The Next Steps in the Solution Selection Process

Determining your solution approach is only your first step in the solution selection process. Next, you’ve got to identify several vendors in one or more of these categories that could fill your needs and also build a business case based on your needs and those vendors’ capabilities.

Our EQMS Solution Selection Guide has analyses of the top vendors in the space and will help to put these questions into perspective. It can be downloaded by following the button below: