Avoid Automation Failures with the Right QMS Implementation Team

After decades of eQMS availability, a staggering number of projects still suffer without the right QMS implementation team.  Regardless of your QMS automation solution, organization size, or number of quality processes, a common thread among poor QMS implementations is team organization and management.

Build a QMS Implementation A-Team

First, and most importantly, 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. Team members will be spending extra time and energy outside of their standard workload; be sure to secure management buy-in from the start.  The more time each member can dedicate and the more realistic the timelines, the less likely they are to feel overwhelmed and become disillusioned. Your QMS implementation team should include:

Management: Management is tasked with understanding and communicating the quality vision.  They need to promote how the system will benefit our organization, stakeholders and customers. Management oversees development and delivery of the project plan, and they are the best 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 oversee design and control, test, audit and monitor the software system.  A technology team may often 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 power users early; they are your ambassadors because they live in the system.  System users will provide valuable input throughout the implementation.  Experience proves that it’s a mistake to solicit system user suggestions and revisions too late downstream. Inevitably , it will lead to project delays and added expense. Engage your power users early and often.

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

A successful QMS implementation engages quality and compliance management, technologists and system users.

A successful QMS implementation team engages quality and compliance management, technologists and system users.

Support the Quality Vision

Team leaders must be committed to their roles, responsibility and authority.  Therefore, their expectations should be clearly documented prior to commencement.  Each team member must be accountable for their assigned tasks to support the total quality vision.  Promote your implementation and drive support through communication and high visibility.

Leverage Outside Quality Management & Industry Expertise

Learn from experts that have “been there and done that” and have deep process and workflow knowledge  combined with extensive vertical industry expertise.

Vendors: Learn from your QMS software provider because they have implemented the most complex quality and compliance systems. Their best practices approach to QMS implementation 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.


White Paper: Automating Your QMS - Pitfalls and Essential Strategies

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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 roll-out, but becomes the system champion and the model for future expansion of your quality management system software.  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.

[Part One in a Three-Part Blog Series]

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