Quality Management Tools

Successful quality management doesn't happen on its own: your quality team needs access to an arsenal of quality management tools and the proper training to effectively diagnose and resolve quality issues at your medical device company.

The FDA mandates that medical device companies establish and maintain a quality system that ensures they deliver safe and effective products to the consumer. Still, even the most perfectly designed quality system falls apart without the right people to run it. Effective quality managers use quality management tools to understand, diagnose, and eventually resolve quality issues. Quality management tools is a relatively broad term that encompasses the full "quality arsenal" - graphical techniques, techniques for analysis, statistical analysis, template documents and personnel management techniques are all imperative to the successful quality manager.

Graphical Analysis Tools For Quality Managers

We could probably write a whole book on graphical analysis tools for quality managers. Graphical analysis is powerful because it allows quality managers to visualize a problem in a way that's easily presentable and communicable to others, and on top of that, it gets results! Here are three the most important graphical analysis tools that every quality manager should master:

  1. The Fishbone/Ishikawa diagram - Also known as a cause & effect diagram, the fishbone diagram encourages quality managers to broaden their thinking when trying to determine the root cause of a discovered quality problem. The analysis includes assessment of the materials, environment, machines, and personnel involved in the process that produced a non-conformance.
  2. Flowcharts - A flowchart is a simple diagram that explains the relationships between steps in a process. Many of the processes of an effective QMS can be designed and described using a flow chart, including the design controls process, CAPA process, risk management, and more.
  3. Pareto Charts - A special type of histogram where the values plotted are organized in descending order and presented with a line graph that tracks the cumulative total. Pareto charts are used by quality managers to monitor the frequency of different types of non-conformance events and their causes. Understanding the most common causes of defects allows quality managers to target their efforts appropriate towards reducing incidences of non-conforming product.

Most Important Document Tools For Quality Managers

Organized quality managers effectively keep tabs on potential sources of non-conformance as a proactive measure. A "living document" is an organizational tool that allows quality managers to keep their fingers on the pulse of the company, making it easier to understand and even predict where quality issues could emerge. Here are three documents that successful quality managers should maintain:

  • Equipment Maintenance Log - Tracking the maintenance status of factory machinery creates accountability around the maintenance process and helps avoid unexpected malfunctions that lose time and money.
  • Vendor Audit Checklist - Quality managers should continuously expand their knowledge of what constitutes an ideal supplier partnership for your company, and update the vendor audit checklist accordingly.
  • Quality Management Presentation (QMP) - QMP is a tool for quality managers to educate and train new personnel on how to properly engage with and execute the organization's quality plan. QMPs should be updated regularly to reflect changes to the quality plan that affect employee workflows and procedures.

Greenlight Guru's QMS Software - The Most Important Quality Management Tool

Back when a medical device company's QMS was stored in a filing cabinet, quality managers spent hours of the day digging through mountains of disorganized paperwork. Greenlight Guru's QMS Software helps quality managers access, organize, modify and update their most important managerial and investigative tools each day, empowering them to focus on the most important aspect of their role: ensuring the quality and safety of medical devices that reach the end user.

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Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →


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