QA + QC = QM  The Quality Equation for an Effective Quality Management Program 

How would you define quality? We bet that if we asked ten of you, we’d get ten different answers ranging from doing the right thing to ensuring patients are protected and data integrity. Why is there no clear-cut answer? Why are we getting so many different responses?  

Think of quality this way: you may not be able to explicitly define it, but you know it when you see it. And while there are seven elements, as the Office of Inspector General will tell you, quality assurance (QA) and quality control (QC) are not explicitly included. Much like the terms that define quality, QA and QC are often used interchangeably. Although similar, there are distinct differences between the two and we argue that you need both for an effective quality management program.  

Quality Assurance Explained 

According to the American Society for Quality (ASQ), QA is defined as “part of quality management focused on providing confidence that quality requirements will be fulfilled.” An alternate definition is: “all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality.” The confidence provided by quality assurance is twofold—internally to management and externally to customers, government agencies, regulators, certifiers, and third parties. 

My current organization defines QA as the specification of standards for quality of service and outcomes, and a process throughout the organization for assuring that care is maintained at acceptable levels with those standards. QA is ongoing, both anticipatory and retrospective, in its efforts to identify how the organization is performing – including where and why facility performance is at risk or has failed to meet standards. Quality activities such as daily rounding, environment care, and infection control reviews ensure that internal and external standards are fulfilled.  

The Role of Quality Control 

ASQ defines QC as “part of quality management focused on fulfilling quality requirements.” While quality assurance relates to how a process is performed or how a product is made, quality control is more the inspection aspect of quality management. An alternate definition is: “the operational techniques and activities used to fulfill requirements for quality.” 

QC is hard to grasp for some organizations; they say they do it, but they do not have a tangible product to inspect and control. For example, QC in an educational setting would be the process of maintaining and improving the quality of education. It can include:  

• Teacher education: QC programs for pre-service teachers assess their knowledge, skills, attitudes, and values to predict their suitability as teachers. They also include systematic reviews like self-evaluations, external evaluations, teacher and school leader evaluations, and student assessments.  

• Quality management: This would refer to policies and systems that maintain and improve the quality of education and research. Quality management can help clarify responsibilities, work processes, and improve transparency. 

• Curriculum development: QC in curriculum development ensures that actual results  
  are close to desired results. This includes student outcomes, such as how well students perform at different grade levels and what they can do when they graduate high school. Data is collected in a variety of ways, including scatter diagrams and control charts.  

QA + QC = QM 

QA sets guidelines and standards and establishes a foundation for an entire team to follow. This approach slightly differs from QC, which identifies and corrects defects or deviations in the final product or service. Unlike QA, which works to prevent issues throughout the entire process, QC is specifically concerned with evaluating the result to ensure it meets the predefined quality criteria. 

For example, your organization probably has an internal audit program. QA would pertain to creating a plan and process to ensure that a procedure is being followed. QC would be routinely checking data to ensure that the appropriate data was entered within a specified time frame. 

Understanding the differences between QA and QC helps organizations implement effective quality management systems, ensuring high-quality products and services that meet customer expectations. Both of these are tools in your toolkit, so why limit yourself to one or the other? Determine which of the two is the best tool for your organization and use it appropriately. Use QA to prevent problems and ensure adherence to standards – and take a proactive approach and use it before you start. Use QC to identify and correct issues after the product or service is produced and the work has started.  

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John R. Nocero, Ph.D., and Andrea L. Bordonaro, MAT, blog on LinkedIn as “The Q-Kids,” discussing everything related to clinical research education, inspiration, and professional connection.