Why Your QMS System Software Isn't Really Guaranteeing Quality

    Simply having a Quality Management System (QMS) software, or eQMS, is no longer a competitive advantage. QMS solutions have evolved significantly in recent years due to a variety of factors in the market, including increased regulatory factors and the maturity of cloud and analytics technologies. The global market value for QMS software is projected to experience compounded annual growth rate (CAGR) of 13.4% to reach $13.94 billion by 2025, according to Grand View research.

    In the late 1990s, eQMS was generally limited to costly and homegrown solutions developed for use at large organizations. Today, there's a host of flexible, cloud-based solutions suitable for organizations of all sizes. Despite the fact that there are more options than ever, a successful transition to a new eQMS is not guaranteed. Many companies in highly regulated industries suffer from failed implementations or costly projects which don't drive quality improvements.

    The right management systems can deliver enormous improvements in quality, profitability, and organizational performance. An eQMS should provide a positive ROI by helping your company avoid mistakes and waste. However, if you're not achieving value from your current eQMS, you could be facing a host of common pitfalls, including implementation errors or training mistakes.

    Why Your QMS System Software Can't Guarantee Quality

    If you’re asking “which QMS system software can guarantee quality?” you’re asking the wrong question.

    No software solution or management system can guarantee quality. Even the best QMS software for your organization won't create change if you expect it to be a silver bullet. Instead, eQMS can help your organization mitigate quality issues with visibility.

    A better question to ask is "how can an eQMS increase consistency by streamlining processes or offering preventative capabilities?"

    When the right software is implemented correctly, it can drive dramatic quality improvements and cost reduction. An eQMS should help your organization avoid quality-related mistakes and identify opportunities for growth.

    One of the most significant components in achieving quality results with eQMS adoption is your approach to implementation:

    • Empower the quality unit to play an active role in system design, testing, and implementation
    • Encourage employees to become ambassadors and super users to drive adoption
    • Partner with a vendor to design a successful implementation and plan for engagement

    Related Reading: 13 Bottom Line-Boosting Benefits of a Quality Management System

    Making A Clean Transition

    Implementation woes constitute a significant barrier to software success across industries. Researchers have found that over 80 percent of software projects have an unsuccessful or poorly planned implementation phase which can lead to project cancellation. Up to 30 percent of these projects were doomed due to a lack of change control or ineffective project vision.

    It's critical to make a clean transition from your bootstrapped spreadsheets or document control system. A lack of change control when you go-live can result in staff confusion. You could experience duplicated work or lost information if the staff is using both systems in tandem.

    A well-planned implementation is a best practice for eQMS success in any highly regulated industry, but the specifics of an effective transition can vary significantly between software vendors and organizations. To obtain the best results, take a hands-on approach to transition. Work closely with your vendor on software customization to obtain validation before your go-live date.

    Planning can prevent an implementation which exceeds your timeline or budget goals. Set a deadline with your vendor to make sure the transition doesn't stretch on forever. Qualio offers clients a 60-day guarantee.

    Training Your Team

    An eQMS can't drive positive change if your staff is confused by the new system and expectations on your go-live date. Adequate training is a critical step to ensuring your new eQMS delivers quality improvements.

    Your company’s quality unit and project team should work closely with your vendor on creating a customized plan for training before you make the transition. Based on firsthand experience working with a wide range of companies adopting QMS, there’s value to role-specific training and training analytics. Ensure your training plan includes:

    • Role-specific training and simulation of real-world assignments
    • Centralized methods for tracking all training activity
    • Reporting to understand training gaps and avoid compliance risks
    • Assessments to accurately measure role-based competency

    At the end of employee training, each member of the workforce should have the knowledge and experience necessary to perform all of their role-related duties in the new system. The quality unit should be able to proceed with confidence, based on real data on training progress and performance.

    Related Reading: The Essential Tools You Need to Achieve Total Compliance in the Pharmaceutical Industry

    Activating Continual Improvement and Engagement

    Approaching implementation like a one-and-done task is a dangerous mindset. QMS are living systems which require active engagement and continuous improvement efforts. The long-term success of your QMS begins during the adoption phase by planning to activate a quality-driven culture across the quality unit, workforce, and leadership team.

    Empower your quality unit to define workforce responsibilities before your new system goes live. Each individual in the organization should have a clear understanding of their role and responsibilities to create quality products. Strong leadership and transparency can support the creation of a culture where people are obsessed with quality.

    Continuous improvement is a company-wide responsibility which spans management, the quality unit, and the end users of the new QMS software system. Management should play an active role in regular system review and disseminating the QMS vision. By engaging with system users throughout the implementation phase, you can encourage the workforce to play an active role in quality management.

    Get a Live Demo from Providers

    Making the switch to a new QMS represents a significant transition for companies of any size. First-time QMS software adoption can be particularly challenging for highly regulated startups and scale-ups who are switching from less formalized systems for document control or a series of spreadsheets. Finding the right software and vendor can be critically important to obtaining the guidance you need for a successful transition. Your QMS system software vendor should offer extensive first-hand experience with project design and insight into successfully switching over.

    As you narrow your search for the best eQMS, we recommend scheduling a demo before you make a final decision. A live demo can enable your organization to see an eQMS in action and ask questions. This step can offer valuable insight into your vendor's potential as a quality partner and the potential of the software you're considering.