As companies are trying to remain leaner, what are some steps they can take now to ensure they’re getting the most out of their quality system? One consideration is to conduct a current assessment of a system’s maturity. In this piece, our quality experts outline the steps to effectively determine your quality system’s maturity and how a quality system maturity assessment can bring value to your organization today.  

What is a Quality System Maturity Assessment? How is it measured? 

A Quality System Maturity Assessment is a status check for your Quality organization. It delves into your quality systems to determine what phase of maturity the systems are in, and if they are in a state of control. For example, are the systems you have in place for deviations or CAPAs (corrective and preventative actions) in accordance with industry standards? Are all regulatory requirements being met? Are there any gaps that need to be addressed? An internal audit will help you assess your quality system’s maturity and is a great way to gain answers to these questions. You will get valuable insight as to whether your systems are immature or in a state of control.  

Determining Your Quality System’s Maturity  

The first step to determine your quality system’s maturity is to look at what type of quality system is in place. Are your organization’s quality systems paper-based, or do you have an electronic Quality Management System (eQMS)? If you are paper based, is everything just as organized as it would be in a computer system? Can you retrieve documents quickly? Are events closed out with appropriate level approvals and supporting documentation attached? If you have an eQMS, does it align with computer system validation (CSV) requirements? 

The next step is to determine where your quality system falls within the stages of maturity: Unaware, Developing, Managing, Optimizing, and Leading.  

For example, if you have a paper-based document management system with formal process ownership and use external benchmarks to evaluate your processes, your document management system is in the Managing phase. In order to progress to the Leading phase, your document management system must set the best practice benchmark through continuous process improvement at a pace that is faster than your competitors. When the Leading phase is achieved, the final step is to apply the concepts and methodology used for your document management system to the rest of your quality system.  

How does a Quality System Maturity Assessment bring value? 

The maturity of your quality system should be assessed continuously, regardless of what stage of development your organization is in. Repeating assessments periodically allows you to be proactive rather than reactive and prevent issues before they occur. These assessments can reveal gaps and identify areas of improvement, which can aid in audit preparedness.  

Developing and tracking metrics can also assist in revealing the health of your quality system. If you see that metrics begin to trend down, show no improvement, or remain stagnant at a less than optimal level, it may be time to do a deep dive and look for systemic issues. No matter what type of quality system you have in place, a Quality System Maturity Assessment helps to differentiate an immature system from one that’s in a state of control.  

  Explore Our Maturity Model Framework

Assessing the maturity of your quality system can be a tedious process. Clarkston Consulting has a team of experienced consultants that can help ease complexity and determine what approach is best for you.