When evaluating an automated QMS, the question to invest in configuration vs. out-of-the-box (OOTB) is a core functional consideration. Should you configure your own processes, use an OOTB solution, or do you need a little of both?
For many manufacturers, the answer involves several factors, including industry regulations, process maturity, and resources. The nature of operating within a regulatory framework is that change is inevitable. The QMS you use should be adaptable to new regulation that require process modifications and scalability. FDA harmonization of quality regulations to ISO 13485, the Quality Management System Regulation (QMSR), is one of the latest examples.
In this article, we’ll look at what to consider when evaluating these options among enterprise QMS vendors.
Defining Configuration vs. Out-of-the-Box
The terminology for configuration vs. out-of-the-box is relatively consistent. In addition, customization may be a consideration, and for that reason it is included here.
- Out-of-the-Box (OOTB; also referred to as commercial-off-the-shelf (COTS) solution): Workflow functionality that comes “built in” from the software vendor. Processes are pre-built and represent standard operational best practices. The solution contains built-in workflow tools and templates. Some fields may require basic configuration (e.g., approval routing, notifications, etc.,) but core processes are designed to be used with little variation. IT resources are generally not required.
- Configurable: Functionality that can be created using built-in workflow tools developed by the vendor. The complexity of the software may require either IT resources or may be done by the quality team. Configuration requires no changes to source code, and is forward-compatible with future releases.
- Customizable: Functionality and features are performed through core software code changes. The software relies on the vendor performing those changes as opposed to configuration tools supplied by the vendor. This method is used by the less-configurable platforms and often requires the vendor to reapply these changes in the event the customer wants to upgrade the platform.
Regulatory and Industry Factors
Recent industry trends show that many QMS vendors are evolving towards preconfigured, OOTB solutions. However, this strategy doesn’t make sense for every industry and every company. No two businesses operate the same.
For example, the preference for an on-premise system still exists. Regulated companies with stringent compliance and security guidelines may opt for an on-premise solution with the option to migrate to cloud later. In this case, a modern, robust QMS solution architecture should allow for a smooth migration from on-premise to cloud with no impact to the core system. A flexible, automated QMS is the goal, and regardless of platform, it’s a wise choice.
QMS configuration vs. out-of-the-box process requirements vary widely across different industries and products. The practicality of using an out-of-the box solution depends on multiple factors, including:
- Type(s) of product
- Geographic locations
- Scope and complexity of the QMS
- Internal compliance requirements
- Regulatory requirements
The quality processes for regulated products (FDA, ISO, MDR, etc.) rarely fit into an OOTB process that offers limited configurability. Continuous regulatory changes require configuration changes to workflows, which demands an iterative approach to managing a quality system.
For instance, medical device manufacturers require a comprehensive complaint management solution because of the associated risk to health. In this case, continual updates and changes in global regulations are not ideal for OOTB QMS. Functional requirements will change, and the native solution is likely to need updates to the workflow.
Conversely, a non-regulated manufacturer of products with minimal risk may find the same process unnecessarily complex. In that case, and an OOTB solution may be effective
Process Maturity & Complexity
Out-of-box use has become more practical for specific processes that have become standardized in many industries, including:
In these cases, an OOTB solution that meets your requirements with minimal changes will allow you to get up and running faster. Standardization also makes it easier to train people, and therefore easier to implement overall. However, it’s still important to understand the limitations of the software.
Commonly, vendors with depth and breadth of experience are more likely to offer a robust OOTB solution for standardized processes. Their templates are continually reviewed and revised based on best practices to meet new requirements in new releases. They have the deep expertise to help companies leverage both industry-specific and cross-industry learnings in these processes.
However, forward-thinking quality leaders should consider the requirements of additional processes they will need to integrate within the QMS . For instance, investigating deviations, managing complex quality supply chains, and managing customer complaints.
Configuration vs. Out-of-the-Box QMS: Short and Long-Term Strategy
A QMS is meant to be a system of integrated, bi-directional processes that mature and become more intuitive over time. In simpler terms, a quality system is never “set it and forget it” software. Instead, the QMS must be able to grow with the company as business needs and requirements change. This enables a company to leverage existing quality processes when scaling. The result is new quality improvement opportunities at greater economy of scale, with lower risk and total Cost of Quality (COQ).
Many organizations deploy quality software solely to address an immediate need. For example, a manufacturer may have received an FDA observation for insufficient corrective actions process. This may result in a reactive response to procure an inexpensive, OOTB solution to efficiently resolve the immediate CAPA issues.
However, the low up-front cost savings for a pre-configured solution based on price can often turn into a significant expense. The OOTB CAPA process may satisfy the company’s immediate needs and receive FDA acceptance. But as the business matures, management may become concerned about the increasing number of CAPAs and their resolution times. It may be determined that a detailed root cause analysis workflow is absent OOTB. Therefore, configuration must be done to insure sound impact assessments. The cost to engage the vendor to build the workflow can be high if the architectural foundation isn’t highly configurable.
Internal Resources for QMS Configuration vs. Out-of-the-Box
Another thing to keep in mind when evaluating QMS software is that prices can differ greatly. Many OOTB solutions will be lower if the capabilities are limited. Often, they are designed for the needs of start-ups and small businesses, and offer limited configurability. As mentioned in earlier sections, bear in mind your potential for expansion and future needs.
The question becomes, how will you get it done? Many manufacturers significantly underestimate the total cost of the solution they need. However, they can avoid this with a complete RFP to understand the QMS is managed as it matures. It is as true in quality management software as it is with any other software: you get what you pay for.
Consider these questions when evaluating OOTB vs. configuration:
- What is included in my initial purchase price?
- Am I purchasing a platform of solutions or paying for per-module implementation?
- If the latter, how much will it cost to add all the quality components we expect to use in the future?
- Does the OOTB solution meet my process map, or do we have to make significant changes to our business operations to use it?
- Are we making too many concessions for a less expensive OOTB solution?
- How easy and cost-effective is it to train my internal staff?
- Alternatively, can the vendor support my QMS on a timely basis?
- Is the vendor proficient in custom configurations for my industry should we need them?
M&A Activity and Impact
While not always top of mind, mergers and acquisitions may be a consideration in QMS selection. Integrating operations is easier with a configurable QMS, allowing you to easily add a new site within the solution that meets the unique needs of the business unit. The QMS should make it simple to integrate quality solutions.
Onboarding a new site may mean simply adding a new location name, new user(s), form field, or field title. Alternatively, consider the importance of scalability for enterprise adoption. In any case, the easier it is to make these changes, the quicker the adoption of the process will be. The result is harmonization of quality systems, continued leveraging of best practices, and economy of scale.
The reality is that most companies will utilize both out-of-box and configurable QMS options. A general rule of thumb is that 80% of your requirements should be met out-of-box, with the remaining 20% met through configuration, customization, or changing the business requirements. Ultimately, ease of configuration is the key to scalability.
There’s nothing wrong with out-of-box solutions. However, a quality management system is an investment that yields hard and soft returns. While you may not need it now, QMS configurability will likely be required at some point. Flexibility and planning are essential to help you adapt to the one constant in manufacturing: change.
About the Author
Sal Lucido is Co-Founder and Executive Vice President AssurX. Sal is an unequivocal product evangelist and an expert in the area of quality process automation. He holds a broad array of responsibilities, ranging from overseeing strategic plans and operational improvements to managing tactical alliances.