Quality Management Tools

Definition

Quality management tools are the techniques, charts, and documents quality teams use to collect data, find the root cause of problems, and keep processes under control. At a medical device company, they support investigations inside your medical device QMS.

FDA requires medical device manufacturers to establish and maintain a quality system, and that system is only as good as the people and tools that run it. Quality managers rely on tools that cover graphical techniques, statistical analysis, template documents, and personnel management techniques.

Quality Management Tools vs. QMS Tools

Quality management tools are techniques for analyzing and solving problems, such as Pareto charts and control charts. QMS tools are the software modules that run your quality system, such as document control, CAPA, and training management. For the software side, see our guide to QMS tools for MedTech.

The Seven Basic Quality Tools

Kaoru Ishikawa first highlighted these tools in his Guide to Quality Control, and ASQ still lists them as the foundation of quality problem solving.

Tools for Finding Root Causes

• Cause and effect diagram: Also called a fishbone or Ishikawa diagram. It helps teams determine the root cause of a quality problem by grouping possible causes such as materials, environment, machines, and people.
• Pareto chart: Bars sorted from most to least frequent, with a line for the cumulative total. It shows the most common causes of defects so quality managers can focus effort there.
• Scatter diagram: Plots pairs of values to show whether two variables are related.

Tools for Collecting and Sorting Data

• Check sheet: A structured form for tallying events, such as defect types, as they happen.
• Histogram: A bar chart of how often values fall within set ranges, showing the spread of process data.
• Stratification: Separates data by source, such as shift or supplier, to expose hidden patterns.

Tools for Monitoring Processes

• Control chart: Also called a Shewhart chart. It plots process data over time against control limits to show when a process drifts.
• Flowchart: Maps each step of a process, such as design controls, CAPA, or risk management. ASQ notes that many current lists include it in place of stratification.

Advanced Quality Tools and Methods

• Failure mode and effects analysis (FMEA): Ranks potential failures by severity, occurrence, and detection. Design FMEA covers the product; process FMEA covers manufacturing. See our FMEA guide.
• Quality function deployment (QFD): Translates customer needs into design requirements. Its main matrix is the House of Quality.
• Matrix diagram: Shows how two or more groups of items, such as requirements and tests, relate to each other.
• Benchmarking: Compares your processes and results with leading organizations to set improvement targets.
• Taguchi loss function: Estimates the cost of deviating from a target value, even when a part is within specification.

Quality Documents to Maintain

Living documents help quality managers spot likely sources of nonconformance before they become problems. Three are worth maintaining:

• 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: Update it as you learn what constitutes an ideal supplier partnership for your company.
• Quality management plan: Defines how the organization meets its quality objectives. Use it to onboard new staff, and update it as procedures change. See how to build a quality management plan.

Greenlight Guru's QMS Software: One Home for Your Quality Tools

When a QMS lived in a filing cabinet, quality teams spent hours digging through mountains of disorganized paperwork. Greenlight Guru's QMS Software keeps these tools and their records in one place, so quality managers can focus on what matters most: the quality and safety of the devices that reach patients.

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