This blog is part of a three-part series on proven strategies to help avoid QMS implementation failures.  The first blog article describes the best practices approach to building a QMS implementation team. The second blog article reviews considerations for documenting QMS processes prior to automation.


Your organization has found the most functional software available for quality process automation. Your implementation team has mapped out clearly defined processes. Now it’s time for the rubber to hit the road and start implementing your system. What could possibly go wrong now?

A common yet avoidable pitfall in QMS automation occurs when the process deployment strategy is poorly planned. Real-world experience has proven that up-front planning and structured implementation results in long-term quality management success.

Avoid the Rush to the Finish Line

Too often, the temptation is to start automating all quality processes at once to streamline the entire QMS in one massive project. Feedback from any organization that has approached automation this way would advise against it. The sheer scope and detail of a multi-process rollout can become overwhelming.

Assuming all roles and responsibilities of every stakeholder involved in the process have been established in the process mapping stage, keep collaborating. A transparent and accessible hierarchy will enforce accountability during process rollout. This strategic alignment plays a vital role.  Disconnects during process rollouts are found to be the single most point of failure in business process initiatives.

Prioritizing QMS Process Automation: What to Consider

When prioritizing the order of how to deploy your quality and compliance processes, weigh the importance and interconnections each will have.  The genesis of the leading-edge quality ecosystem should start with one core process determined by a key driving factor.  Consider the following types of drivers when organizing your quality management system:

(1) Critical Non-compliant Quality Processes

In the most serious cases, automate the most critical process identified as non-compliant.  Are your processes failing to meet minimum requirements?  Did your company receive an FDA warning letter?

In most of these circumstances, a new system needs to replace the old one to better manage the area of non-compliance. For example, a document management solution may be required to control where documentation has been accessed and destroyed (even accidentally) without authorized access.

(2) Ineffective Quality Processes

Logically, if a process is ineffective, manual, redundant, or exists on a labor-intensive legacy quality management system, automate it.  Look for processes that are essential to moving faster and more efficiently to increase customer satisfaction.

For example, many growing organizations start by centralizing the complaint management process. As they grow, they realize that a systematic, auditable compliant handling is needed to properly document and respond to issues based on risk.  As a result, they see faster root cause analysis and faster product improvements. Furthermore, the company now has a risk-based and post-market surveillance system in place for regulatory compliance.

(3) Good Quality Processes that Should be Better

Organizations not under regulatory compliance pressure will benefit by starting with a process of lesser complexity across the quality value chain.  A process may be working now but could be accelerated within days of automation.  In this case, you achieve a large impact for the least amount of effort.

Perhaps your team just exhausted over 1,000 staff hours conducting a process audit. While the audit may bring other process issues to light, an automated audit workflow will streamline the next process audit by eliminating process gaps and duplication of efforts.

(4) Universal Quality Processes

A universal process like corrective and preventive actions (CAPA) is the FDA’s most expected platform for maintaining GMP compliance and meeting 21 CFR Part 11 requirements. Any manufacturer needs an effective CAPA process to drive the root cause analysis to develop a successful remediation plan for it.

CAPA is a high-value process that reaches beyond organizational departments. It breaks down siloed groups or divisions they may be required to work cross-functionally toward product improvement.

Keep Communicating with Stakeholders

From the moment your organization makes a commitment to implement an electronic quality management system, all internal stakeholders should be in the loop.  Communicating the quality vision from operational and executive management from the start is critical to ease the dissonance that naturally occurs when institutionalized processes are changed. Communicate important milestones and achievements. Create an active community base that encourages questions. Highlight the benefits the system will bring to the organization and how it translates to better products in the market. Start training users and management as early on as possible.

The more engaged users feel in the whole process, the less intimidating using the new system will be.  As a result, when your new processes go live, the transition won’t come as a shock and the on-boarding process will run much smoother.


Put detailed consideration into the deployment of your QMS processes. Be clear about which priority is the most critical and set reasonable milestones and expectations. Set small, achievable milestones and allocate reasonable time for periodic analysis. The investment you make at the outset will be returned faster when processes integrate smoothly to connect the quality ecosystem. For advisement, work in partnership with your QMS vendor to make the project as seamless as possible; their experience is invaluable. The success of your first process launch will set the tone for future system expansion and new initiatives.