It is easy to get confused by the difference between Quality Assurance (QA) and Quality Control (QC). Some use the terms interchangeably, although there is a notable difference between the two. Both QC and QA can help your organization be compliant with the necessary regulations and produce the best products possible. Thus, understanding both terms is increasingly important, especially if you work with Quality Management Systems in Life Science industries like Pharmaceuticals, Biotech, or Medical Devices.

This article covers the definitions of QA and QC, their objectives, in an infographic format. Furthermore, you will learn the main difference between Quality Assurance (QA) and Quality Control (QC), and the purpose of both QA and QC within Quality Management System Software.

What is Quality Assurance (QA)?

The ISO 9000:2015 standard, clause 3.3.6 defines Quality Assurance as:

“part of quality management (3.3.4) focused on providing confidence that quality requirements (3.6.5) will be fulfilled”

Put differently, Quality Assurance (QA) relates to a set of planned activities within the product manufacturing process that ensure the safety and the quality of the product.

What is Quality Control (QC)?

The ISO 9000:2015 standard, clause 3.3.7 defines Quality Control as:

“part of quality management (3.3.4) focused on fulfilling quality requirements (3.6.5)”

In other words, Quality Control (QC) refers to the systematic set of processes used to ensure that the product meets the required quality standards.

Quality Assurance (QA) and Quality Control (QC) are necessary for your Quality Management System. Simply put, you cannot test for the quality of the output by focusing only on one or the other alone.

Difference Between Quality Control and Quality Assurance

The infographic “Quality Control VS Quality Assurance” below illustrates the main differences between the processes.

Quality Assurance VS Quality Control Infographic

If you would like to use this infographic, use the embed code below:

Focus & Nature of QC and QA

The main objective of Quality Assurance (QA) is to prevent any defects before they occur when manufacturing the product. Quality Assurance (QA) is a proactive activity in nature – looking to reduce the number of defects by measuring the processes.

On the other hand, the main goal of Quality Control (QC) is to identify any possible issues, prevent them, if needed, and verify the quality of the product or output. By its nature Quality Control (QC) is a reactive activity, which you would want to complete after the Quality Assurance (QA).

Processes & Orientation of QC and QA

Examples of Quality Control (QC) activities are process-oriented, as they aim to prevent quality defects. Therefore, some of the Quality Assurance (QA) examples include processes like:

  • Following Standard Operating Procedures (SOPs)
  • Supplier Management
  • Training Management
  • Change control
  • Project audits
  • Documentation
  • Process checklists

At the same time, Quality Control (QC) actions are product-oriented. Consequently, examples of Quality Control (QC) associated processes could be the following:

  • Testing process
  • Deliverable peer review
  • Inspections
  • Product sampling

Duration & Life Cycle of QA and QC

Typically, Quality Assurance (QA) is a medium to long term process within the product design period. In contrast, Quality Control (QC) is a much shorter-term activity usually at the final stages when the output is produced. Therefore, you would want to plan such a set of QA activities throughout the whole development life cycle. While QC related procedures you would typically place at the testing life cycle.

QA and QC as Tools

Another way of looking at Quality Assurance (QA) and Quality Control (QC) would be to recognize what type of tools those are. For example, you can perceive QA as a managerial tool for preventing various quality issues. At the same time, QC could be an operational tool, for identifying and correcting the defects before the product enters the market.

Responsibility

Further on, different kinds of personnel from your organization should be involved in both processes. Quality Assurance (QA) requires the whole team involvement. While only the designated testing team is responsible for the Quality Control (QC) procedures.

Your organization can achieve Quality Assurance (QA) by putting into practice a Quality Management System (QMS). This system will help with the prevention of quality issues in all departments of the firm. Furthermore, your company can attain Quality Control (QC) by finding & eliminating sources of quality problems via various activities and techniques like inspections, tests, and reviews, aimed to maintain and achieve quality.

QA and QC Supporting System

You can support Quality Assurance (QA) and Quality Control (QC) by implementing an Electronic Quality Management System (eQMS). Such a system allows preventing, as well as identify and verify issues thanks to fundamental QMS elements like:

  • Electronic Document Control
  • eSignatures
  • CAPA & Issue Management
  • Supplier Management
  • Training Management
  • SOP Management
  • Template Management
  • Equipment Management

QA and QC in the Quality Management System

Quality Management System (QMS) focuses on optimizing the quality of the output and no wonder both Quality Assurance (QA) and Quality Control (QC) are the basis of a QMS. Moreover, together with the industry-specific quality legislations and standards, QA and QC make up the structure of the Quality Management System.

One of the fundamentals of ISO-9001, “continuous improvement” also suggests that the progress concerning Quality Assurance (QA) never stops. This means that you should always have a critical appraisal of your firm’s Quality Assurance (QA) System to ensure consistent improvements.

Final Thoughts

Both Quality Assurance (QA) and Quality Control (QC) are terms many people use interchangeably. However, the difference between the two is significant. You can see the main differences between QA and QC are visualized in the “Quality Assurance VS Quality Control” infographic.

Quality Assurance (QA) is a combination of activities throughout the manufacturing process that ensures the quality of the product. Consequently, Quality Control (QC) is a set of processes used to secure that the product meets the quality requirements. Although, both QA & QC use statistical tools that are explained in the book Quality Control with R (Cano et al. 2015).

The main point of Quality Assurance (QA) is to prevent any defects before they occur. Therefore, Quality Assurance (QA) is a proactive activity by its nature. On the contrary, Quality Control (QC) aims to identify any possible issues and verify the quality of the output. Inherently, Quality Control (QC) is a reactive activity and it is conducted only after the Quality Assurance (QA).