April 11, 2017

Industry-leading quality management systems (QMS) are built with clearly defined processes and workflows developed by the implementation team. While initially it may seem overwhelming, a successful QMS implementation depends on documenting all current systems in place, and how they can be improved.

This blog is part of a three-part series that focuses on proven strategies to help avoid QMS implementation failures.  The first blog article offers a best practices approach for organizing and managing a QMS implementation team.

Kick-Start Quality Process Improvements

If you’re not currently using an automated QMS, it’s likely your organization is handling information in a way that is decelerating your ability to correct issues, manage risk, and achieve compliance. Remarkably, manual and resource-intensive quality management procedures are still not uncommon, even in the most regulated industries.

These include:

  • Manual, paper forms that are copied and filed (or possibly scanned)
  • Excel spreadsheets and Word or other document formats that are not versioned and reside “somewhere on the network”
  • Legacy homegrown systems that are complex and buggy
  • Any combination of the above, and often with multiple ways of doing things among business areas

Define Your Current Quality Processes

Start your QMS assessment by defining all processes in your current quality management system.  Establish a list of all tasks, who manages them, how they are performed today, and where bottlenecks commonly arise. The outcome will help identify the scope of your automated QMS.  Furthermore, you will target the gaps and issues that need immediate attention, which will help you prioritize the processes you will automate.  In addition, estimate how long each process is taking now to establish a clear baseline for improvement. Additionally, work with an experienced QMS vendor team like AssurX to utilize their depth of real-world expertise to identify common points of weakness and risk.

When documenting your processes, consider the following:

  • Where does information originate? Does it enter the system timely and correctly?
  • How long does it take for corrective action to commence? What is the system for prioritization?
  • Is there duplication based on several points of ingress?
  • Is the information reliable/unchanged as it goes through a process?
  • How is information shared and reconciled if it concerns multiple organizational units?
  • How is an issue closed and where does the information reside? Is it secure?
  • Is all information readily accessible by authorized people at any given time? How long does it take to access?
White Paper: Automating Your QMS - Pitfalls and Essential Strategies

Download the AssurX White Paper: Automating Your QMS – Pitfalls and Essential Strategies

A Successful QMS Implementation – 10,500 Manual Work Hours Saved

The benefits of a complete and thorough assessment and documentation of current processes can’t be understated.  It accelerates eQMS implementation time, and also provides baseline metrics needed to clearly determine ROI and success rates of your eQMS program.

For example, a pharma and chemical company completed a thorough assessment of their pre-electronic processes for managing adverse events. They created an outline of each workflow, times to completion, and noted areas where delays and disconnections existed.  This set the baseline by identifying all points for improvement.

Prior to implementing their automated system, the company was tracking and managing their adverse events using Excel spreadsheets and Word Documents.  In addition, they would hold frequent meetings to discuss new and pending issues, made extensive telephone calls to resolve issues, and spent an average of 800 hours per regulatory audit in preparation.

As a result of a successful QMS implementation for corrective and preventive actions (CAPA) and supplier management, the organization reports that within one year,  manual work hours were slashed by 10,500. This time is now spent proactively improving quality. Read the story.


In summary, documenting all your current quality procedures in practice leads to the successful adaptation to eQMS.  It enables your integration team, along with your QMS solution provider, to identify the best starting point for establishing an automated workflow for each process.  Always focus on gathering the most information from inception for continual upstream progress, rather than having to perform downstream damage control.

[Part Two in a Three-Part Blog Series]

Read the first blog which recaps a best practices approach for organizing and managing a successful QMS implementation team. Continue to the third blog which details considerations pertaining to deciding which quality or compliance process to automate first.