Your aging quality management system (QMS) and the problems caused by it are keeping you up at night. You would love to be able to upgrade or replace your QMS software, but that’s not an option right now. A good QMS is your key to regulatory and cGMP compliance, but what do you do when you realize your aging QMS is adequate, but not ideal?

There are many options to make the most of your aging QMS, without upgrading or investing in new technology. Many actions you take now can set you up for success when you do upgrade or migrate to a new QMS in the future.

Understand Your QMS Current State

The first step is to fully understand the current state of your QMS and supporting processes. Think about what is working well and what is not working. What are the pain points in the use of your system? Identify the areas that are not providing the necessary information to act on potential quality issues.

Review the original user requirements and design specifications and compare to the current state to determine if your process has evolved away from original design over time. Review key regulatory and quality standards, and internal requirements to conduct a gap analysis verifying the system is still in compliance. Include people external to the process in the evaluation of the system to provide a fresh look and help identify areas for improvement.

Look at the full capabilities of your current software system. The software may have more functionality and resources than are currently enabled. The vendor user manuals may be helpful to identify features that were not activated at the time of installation. You may be able to use some of these additional functions without needing to fully upgrade. Review your current work processes with the system tools in mind — other changes may be needed or possible.

Optimize the Quality Basics

The next step is to optimize the basic quality processes that support or provide input to the QMS software. Analysis and mapping of key processes will help streamline and increase efficiency, and assure that the process output is valid, complete, and accurate. Take this opportunity to harmonize processes across the organization.

Documentation

Review and optimize the policies, procedures, work instructions, training materials, and data entry requirements that support the quality system. Verify these documents are complete, clear, and supply adequate information for the user. It is important to provide proper instruction without becoming too burdensome for use in daily operations or increasing the likelihood of human error.

Data entry rules and standards are needed to provide a consistent format and terminology of data input. This data standardization and cleansing will result in optimal sorting, searching, and data analysis using your current QMS.

Deviation and Change Control Management

Analysis of deviations, determination of causal factors, implementation of corrective and preventive actions, risk assessment, and control of changes are critical parts of your quality system. The investigation and analysis you do before entering information into your quality system is vital to success.

Assure that your root cause analysis process is robust and drills down to the true source of the deviation. The investigation must not only look at the specific issue identified, but be broad enough to identify and address systemic issues as well. Corrective and Preventive Actions (CAPA) must address the true root cause to prevent recurrence. It is also essential to implement timely effectiveness checks for significant CAPAs to verify that the issue has truly been eliminated. Ensure there is a process in place to address any repeating occurrences. Statistical analysis of root causes can aid in identifying trends and repeating issues.

Customer Feedback

Customer complaints and other types of feedback are also important inputs to the quality system. Assure that customer complaints or product returns are being properly documented and analyzed. Utilize statistical analysis of the root causes to allow for significant trends to be identified and addressed efficiently. Involve the source of the product or service in the analysis of the issue to help identify and implement needed improvements.

Continuous Improvement Loop

Once you have a solid process in place, assure there is a continuous improvement feedback loop to maintain and improve the systems. Perform periodic reviews, assessments, and updates of quality system processes. The use of lean / six sigma tools such as DMAIC for process improvement can aid in this effort. Confirm actions are taken after identification of any issues or trends. Optimize training for all personnel to enhance the quality culture of the organization. All these efforts are necessary to ensure your quality system is robust.

Plan for Future QMS Updates

While you may not be able to upgrade or replace your QMS software today, there are many things you can do now to enable a smoother transition during future updates or system replacement.

Integrate and link the complaints, deviation, CAPA, change control, documentation management, and other organizational processes as much as possible. This is an effective method of ensuring consistency between workflows to streamline future automation and implementation of digitized workflows.

Where possible, continue to utilize your continuous improvement loop to incorporate updates based upon the new information you are learning. Ensure you have mitigation measures in place on your current system for any significant gaps uncovered during your research.

Establish the user requirements for future QMS updates or replacement.

Execute a data integrity assessment and ensure your system and process is free of any “bad data”. The future system must be capable of analyzing and trending data to generate information for analytics, metrics, and reporting, so you will want to start with clean data.

Attend webinars on the latest technology and tools to stay up to date on enhanced system offerings and become familiar with QMS system vendors. The marketplace for quality management systems has evolved rapidly and the current technology is significantly more powerful and user friendly that previous systems. Even the validation effort is greatly reduced by use of cloud-based systems.

The Bottom Line

A robust QMS is the key to compliance. Even if you can’t update now, you can take actions to help you make the most of your current system. These actions will also set you up for success when you do upgrade or migrate to a new QMS in the future.

This can be a difficult and time-consuming process, but Clarkston Consulting has the experience and resources to support you. We can help you assess and optimize your current processes, procedures, and system, plan for continuous improvement and/or future updates, and when the time is right, assist in developing your transition strategy, vendor selection, and implementation of a quality management system upgrade or replacement.