Avoid QMS Automation Failures with the Right Implementation Team

Even after decades of eQMS availability, a staggering number of projects still suffer when the QMS implementation team isn’t right, ready and responsible.  Regardless of your QMS software solution, organization size, or number of quality processes automated, a common element of successful eQMS implementations is strong team organization and management.

Build an Effective QMS Implementation A-Team

First and foremost, solidify executive sponsorship from project inception. Leadership must support the quality vision.

Next, establish an internal team with representation from management, technologists and the user community. Bear in mind that team members will be spending extra time and energy outside of their standard workload, so be sure to secure management buy-in from the start.  Remember, the more time each member can dedicate to the project, and the more realistic the timelines, the less likely they are to feel overwhelmed and become disillusioned.

• Management: Management is tasked with understanding and communicating the quality vision…how will the system benefit our organization? Our stakeholders? Our customers? Management oversees development and delivery of the project plan and are the “champions” of quality management transformation as a company culture.
• Technologists: The technologist(s) will be working in alignment with the QMS vendor’s professional services group. They will oversee design and control, test, audit and monitor the software system.  A tech team may require technical expertise from multiple disciplines. For example, a team implementing CAPA and change control management system for a medical device manufacturer might require knowledge of design and development, supplier management, and FDA regulatory compliance.
• System Users: Involve your users early; they are your “ambassadors.”  These are the people who live and work in the system. Power users provide invaluable input throughout the implementation.  It is a consistent error to wait to solicit system user suggestions and revisions too late downstream; it will lead to project delays and added expense. Engage them early and often.

Assign equal weight to the requirements and concerns of each group.  Also, share the big picture and support inclusiveness and the exchange of information.

Support the Quality Vision

Team leaders must be committed to their roles, responsibility and authority – which should be clearly documented prior to commencement.  In addition, each team member must be accountable to the tasks assigned in support of the total quality vision.  Teams drive productivity and efficiency through communication and high visibility.

Leverage Outside Quality Management & Industry Expertise

Gain valuable input from experts that have “been there and done that” and have deep process and industry expertise.

Vendors: Learn from your QMS software provider. They have implemented the most complex quality and compliance systems. Their insight into the implementation of QMS systems is tested and invaluable.

Quality Organizations and Industry Forums: Dive into the deep pool of global quality standards organizations and industry-specific organizations with deep insight into best practices in the application of quality and regulatory standards.

 

Conclusion:

One of the most critical elements of implementing a quality management software solution is how you form and engage your implementation team.  Create a strong team that not only contributes to the process design, testing, and rollout.  Engage them to becomes the system champions and set the bar high for future expansion of your quality management system software.  Inevitably, the commencement of your first automated QMS will have a lasting impact on the perception of you current and future commitment to a quality vision.

Three-Part QMS Implementation Best Practices Blog Series

The second blog article in our three-part series reviews considerations for documenting quality processes prior to automation.