During the product development pipeline, a lot has to go smoothly. Everything from the planning, design, tweaking, and especially implementation hinges on the quality and safety of your product. Whether your industry includes health science, app development, or even space, nuclear, or automotive sectors, understanding how quality control versus quality assurance works, and how they are different, is crucial. Quality planning is part of quality management. Organizations should set quality objectives and then specify the necessary requirements for operational processes, including related resources to achieve those quality objectives.
An organization focused on quality promotes a culture that results in the behavior, attitudes, activities, and processes that deliver value through fulfilling the needs and expectations of customers and other
relevant interested parties. Delivering a quality product refers to a product’s ability to meet consumer demand, expectations, and requirements while satisfying certain criteria like safety and consistent functionality. These standards not only ensure that your product or services satisfy consumers, but that it remains consistent throughout development and launch. Assurance and control are how quality is determined and kept. The quality of products and services includes not only their intended function and performance but also their perceived value and benefit to the customer.
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What is Quality Control?
Quality control, sometimes abbreviated as QC, is a process by which manufacturers identify and correct defects in a product. Its focus is on the product or service itself. Quality control focuses on fulfilling quality requirements. The quality control pipeline ensures that the manner in which a product or service is developed, maintained, and implemented are followed closely and accurately. Quality control is also an important step for verifying that deliverables meet standards set by your company.
Quality control is a mainly reactive process since it is done in response to a known failure or defect. You are, in essence, controlling for the mistake or defect in order to prevent it from happening again. This is crucial since no product can survive development and launch if it is riddled with problems that remain unsolved.
Consult with an expert to learn strategies to identify and solve problems to get your product launched.
What is Quality Assurance?
Quality assurance, also known as QA, is the cousin of quality control, in that both are needed in order to make doubly sure a product works as promised. The main goal of quality assurance is to prevent a problem or a defect before it even happens. Its focus is on processes. It works alongside quality control procedures in order to correct and plan ahead for issues that could lead to problems with the product. Quality assurance protocols monitor the activities, procedures, and processes that create the product are being followed appropriately. Quality assurance focuses on providing confidence that quality requirements will be fulfilled. Quality assurance departments are required to manage the compliance of government regulations and maintain production costs to ensure quality and patient safety. QA professionals oversee operations, so products and services meet current Good Manufacturing Practices (cGMP), for example, and internal company standards. They are also responsible for training, audits, documentation, and communication to leadership.
Quality assurance, due to planning for defects rather than reacting to them as quality control does, is a proactive manner of correcting mistakes. It prevents the defects from happening, recognizing potential failures that could arise in the pipeline, and may include contingency instructions for personnel involved.
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Quality Assurance vs. Quality Control
Now that we have reviewed what quality control and quality assurance are in principle, it’s time to go over how they differ exactly between each other. Both have the same end goal of correcting problems and creating a better product. However, how and when quality control or quality assurance is implemented is what sets them both apart.
Learn how our quality management service can play a significant role in helping you get your products approved.
Proactive and Reactive
Quality assurance is what is known as a proactive process, meaning that it aims to prevent problems before they happen through the design and construction of a product. Quality control is a reactive process, in that it responds to and corrects problems that have arisen already. Both are needed for quality to be maintained effectively.
Quality assurance includes the design of documentation procedures like standard operating procedure (SOP) that all personnel must follow. These are preventative measures that keep things running smoothly. Quality control usually includes consistent and constant testing of products in order to not only find faults and areas for improvement but to confirm the product is performing as intended. The general order of things is that a quality control test sparks a quality assurance inquiry that corrects the documentation to include the results of the testing.
Process and Product
The other most obvious difference when explaining quality assurance vs. quality control is that quality assurance procedures are focused more so on the processes that lead to a product’s quality, while quality control is concerned with the issues of the product itself. In other words, quality assurance concerns itself with the process, while quality control cares more about the product.
Quality assurance can include detailed documentation, auditing, training, and implementations of engineering of administrative controls. Quality control involves a lot of product and laboratory testing in order to elucidate common problems that may occur.
System and Parts
Quality assurance is concerned with the systems and procedures in place that establish quality standards. This process then tailors each pipeline towards creating better, more unified products. Quality control protocols are more focused on the individual parts that may fail within a final product; for instance, during testing of medical device systems that contain many components to support access, delivery, deployment, and then withdrawal. Finding areas of a component or part failure is an element of quality control. QA procedures will usually lead to these instances of QC by modifying the system to include different parts.
Creation and Verification
Quality assurance activities spark changes in the pipeline for creating better-quality products. Quality control verifies that this created system works as intended. It is used to build better products in the future. QC is done post-manufacture for verification, while QA occurs early on prior to manufacture during the planning process.
Team and Personnel
Quality assurance protocols usually involve the efforts of the entire team; every member of the group works together to develop and adhere to QA documentation and SOPs. Quality control is usually the responsibility of individual personnel by testing products and following the SOPs for product verification. QA’s training across the entire workforce is part of this machinery.
What is The Role of an eQMS?
An effective Quality Management System marries QA and QC together to ensure that they are followed appropriately. An enterprise quality management system (eQMS) allows leaders to oversee and document the process by way of cloud-based oversight. This system will ideally integrate all aspects of QA and QC to track changes.
If you do choose to use electronic systems, which I support regardless of the size of the company, make sure you use them consistently. Do not make exceptions for certain individuals, e.g., selected healthcare employees or senior-level management. It creates new levels of inefficiency and risks. This requires documents to be signed electronically or manually, scanned, and attached to records. Emails are required to document notification times or escalation of issues. It is inefficient and consumes the use of additional personnel resources. It sets a very poor example for employees that are being informed by management about the importance of quality.
Take-Home Message
Quality planning is part of quality management which focuses on setting quality objectives and specifying necessary operational processes, and related resources to achieve the quality objectives. Quality control and quality assurance are essential parts of unifying the process for product creation and streamlining testing for better products. Both are critical for implementing new and exciting products for consumers.
Contact us today to learn how you can get your products approved with the proper quality assurance and quality control techniques.