Why Invest in a Quality Management System?

It’s not uncommon for a small- to mid-sized companies to use a paper-based Quality Management System (QMS) with the latest document versions printed, placed in binders, and stored in a secured location. Perhaps your company has digitized its paper QMS with an electronic document management system with features such as automated lifecycles and workflows, audit trails, and electronic signatures. As your company grows—expanding with new products, new sites, new personnel—maintaining a paper system becomes difficult. Manually routing documents within a review or approval cycle means the time to completion of these cycles is unpredictable.  Locating the “source-of-truth” documents and ensuring the controlled copies of these documents remain current becomes a tedious task. Training and maintaining training records becomes almost unmanageable.

An Electronic Document Management System (EDMS) would eliminate most of these drawbacks to a paper system, however it’s not an all-inclusive solution. Such a solution lacks mechanisms to track the resolution and closure of a quality event. Quality processes such as CAPAs, change controls, complaints, and deviations do not come standard with an EDMS.  It also lacks the ability to review key operating metrics. Without easily accessible metrics, it’s difficult to trend quality-related problems or to proactively identify quality-related issues.  You’re likely relying on spreadsheets to track periodic review cycles, training completion, change control approvals and implementation, and those quality metrics mentioned above. This increases the risk to your company of being non-compliant with regulations.

What are the benefits of a robust Quality Management System? 

QMS software is specifically designed to support your quality processes to comply with regulatory standards and offer advantages over a traditional EDMS. The benefits of an ideal QMS software include:

Document management: Documentation is easily created, revised, approved, distributed, and archived within a controlled environment. Record retention policies can be applied, all users will be working from the most current approved version of a document, and periodic review cycles are managed.

Automated workflows and lifecycle management: Quality management workflows standardize processes to ensure consistency, keep documents flowing through review and approval cycles, and reduce the likelihood for human error. Quality events can be traced through its lifecycle from the moment of capture, to corrective actions, to verifying the effectiveness of the resolution.

CAPA management: The CAPA process is automated from root cause analysis, to action planning and implementation, through to monitoring its effectiveness. Every corrective and preventative action can be tracked to completion thus reducing compliance risk.

Real-time metrics: Data is captured as soon as it’s created and is easily accessible. Dashboards can be used for tracking and trending of operating metrics. Reports containing up-to-date data can be generated for management reviews.

Training management: The training process is standardized, training modules can be initiated automatically as SOPs are updated, and each user’s training is tracked to ensure compliance.

Audit management: Streamline the audit process by having the ability to plan, schedule, execute, and generate reports. An integration with the CAPA management process allows for audit findings to be corrected, tracked, and reported.

While customizing an EDMS to support quality processes may seem like a good solution today, you’d need to consider the future state. Would you be able to maintain this solution as your company grows? Would the customizations still function as intended if the base EDMS software was upgraded?

So, where do I start? 

There are many vendors offering Quality Management System software. It is important to select software that aligns with the needs of your quality processes today, and any anticipated growth in the future.  With the correct features, QMS software can help you avoid non-conformances and rework and gain efficiencies in speed and consistency.

Selecting a consulting partner who has helped companies large and small with transitioning from a manual QMS solution to something more sustainable can help you get started. A great consulting partner can guide you in formulating the requirements for your solution and help you in choosing the best vendor for your needs as well as helping you form a vision and execute it into the future.

Contributions by David Patterson and Tony Louie.