Have you heard the terms Quality Assurance (QA) and Quality Control (QC) before? If you have, you are probably guilty of mixing them up in conversation because you think they’re exactly the same thing. Nothing could be further from the truth: even though people (including professionals) use these terms interchangeably, the concepts are different. This article aims to highlight these differences in the clearest possible way.
Both Quality Assurance and Quality Control are two components of quality management. Is there any overlap between both activities? Yes, there are significant differences.
Quality Assurance activities cover every part of the quality system, whereas Quality Control is a subset of the Quality Assurance activities. It’s also sometimes the case that Quality Assurance and Quality Control do not explicitly cover elements in the quality system. Nevertheless, some of the responsibilities will span QA and QC.
In order to get a comprehensive perspective of Quality Assurance and Quality Control, it is necessary first to define "Quality."
“Quality" involves meeting the customer's expectations, needs, and requirements without defects, lacks, and substantial variations. There are standards to comply with to satisfy customer requirements.
Organization management provides assurance as a positive declaration on a product that ensures confidence as regards outcomes. It's the security that a product will serve its purpose in line with expectations or requests and without glitches.
Quality Assurance is the component of quality management that focuses on assuring the fulfilment of quality requirements. There are two prongs to quality assurance:
1. an internal prong, to management, and
2. an external prong, to customers, certifiers, government agencies, and third parties.
Another way to define QA is to say it comprises all “planned and systematic activities” existing within the quality system that definitely provide confidence that a product or service delivers on promises of quality.
To summarize this, quality assurance aims to prevent defects by ensuring that the approaches, methods, processes, and techniques are specific to a project. That implementation is as correct as it's thorough.
The activities of quality assurance monitor and ensure adherence to the processes for managing and creating the deliverables. It also ascertains that these processes are operative.
By highlighting flaws in the process, Quality Assurance is proactive and preventive. Naturally, it precedes Quality Control.
On the other hand, Quality Control is the quality management component mainly concerned with delivering quality requirements. It focuses on identifying defects by ensuring adherence to approaches, methods, processes, and techniques for the project.
For project deliverables to meet minimum quality standards, QC monitors and verifies the entire process.
QA differs from QA in that QC’s primary focus is inspection during quality management, whereas QA considers the making of a product or the forming of a process. Therefore, one may also say that quality control refers to the operational techniques employed to fulfill quality requirements.
Quality Control is reactive and completes after Quality Assurance.
Though it's common for most people to use QA and QC interchangeably, they are not the same. The distinction is often unclear and can be challenging to identify. Nevertheless, they have divergent origins even though they are related.
They are both elements of Quality Management. However, while QA works to prevent defects, QC aims to identify the defects.
Having pointed out that Quality Assurance and Quality Control are different, it's important to highlight how this is so.Here are the most significant differences between QA and QC.
Quality Assurance happens through establishing an excellent Quality Assurance management system and assessing its adequacy. Regular conformance audits of the system’s operations are critical to the process.
On the other hand, Quality Control finds and eliminates sources of quality problems using tools and equipment that ensure meeting customer requirements always.
“Proactive” is the word to define effective quality assurance. The goal of QA is to ensure that defects do not eventually exist, and the means to achieve this is through process design. However, QC is a "reactive" paradigm for identifying defects after they have happened.
There are a few defining elements present in QA, including the design of processes such as documentation of SOPs (standard operating procedures). Observing processes will always result in a safe and effective product.
When it’s time to test that products meet safety and efficacy standards, that’s what QC covers. QC testing exposes quality issues in a way that ensures that an unsafe product does not make it to shipping or distribution.
Quality control issues should ideally lead to quality assurance reviews. Where test results are not in line with expectations, the next step of corrective and preventive action (CAPA) should immediately follow. This investigative procedure will help determine the cause of quality issues and update processes to prevent the problem from happening again.
Quality Assurance pays a lot of attention to the process, making it possible to prevent quality issues. Quality Control is, however, product-oriented, with much consideration for the quality issues in product manufacturing.
An alternative way to crystallize this difference is to contrast action and results. The actions that create the product are what QA focuses on, while QC focuses on the final product. The following table outlines a few examples of each type of activity:
We can see that QA prevents quality problems using planned and systematic activities that include documentation. However, Quality Control encompasses achieving and maintaining product quality, process, and service.
In Quality Assurance management, there is a clear distinction between “the system” and its “parts.” The methods and procedures of QA control systems contribute to the maintenance of quality standards. QC systems measure parts that include the outputs of the system.
The parts of concern for quality control might be those for creating the final product, such as raw materials from a supplier. The quality management QA system may provide guardrails or parameters that ensure inputs are consistently safe and effective. Such activities may include supplier auditing and batch sampling for raw materials.
Quality Assurance activities culminate in a roadmap for churning out high-quality products. Typical elements will include defining product design standards, manufacture, packaging, marketing, sales, and distribution.
QC itself comprises product verification after manufacture prior to distribution. It may also be about guaranteeing safety and efficacy targets.
Every team member has a role to play in assuring quality. Each person is responsible for QA activities through a commitment to following standard operating procedures. The quality management system (QMS) may be responsible for the quality unit and who leads it. QA activities will cover the following:
2. training standards, and
3. a review covering all personnel.
Quality Control is often the primary responsibility of specific staff. A core part of these staffs' job is to follow SOPs for product testing and quality control. They then document their findings using standardized procedures for product validation and product testing.
We can discuss the entire theory of QA and QC and still not clarify the subtle differences that exist between them. We’ll turn to simple real-life examples to drive home the hazier points of this article. These examples are from software development.
Let's consider a team, X, to develop a brand new software technology for an upcoming medical project. If we assume all team members are new to technology, we need to create a plan to train the team members in the novel technology.
We’ve shared here that we need to fulfill preliminary steps such as collecting a Document of Understanding (DOU).We also need to collect the technical requirement document and the functional requirement document. We'll also collect a few others, but we have to share them all with the team members.
The team members would find these documents to be significant throughout the process of developing the new technology. The collection and distribution of documentation, along with the commencement of the training program, all constitute part of the QA process for the medical software development.
As soon as the initial training is complete, we need to ensure it was successful for every team member.
Statistics are essential at this stage of the program. We can look at each training program participant's score, along with the expected minimum score of participants upon completing the training series.
We may also ensure ample participation in the training by verifying the attendance records for every participant.
If the candidates perform well based on trainer evaluation, we may conclude that the training was successful. Otherwise, we must refine the process to guarantee high-value training.
An alternative way to make the training better would be to interview the trainees as soon as the program ends to collect feedback. Their feedback would highlight the positive aspects of the training. Similarly, they can reveal where the training needs to improve.
These are the aspects of a typical Quality Assurance process.
When weighing enterprise solutions, one relevant question is whether there’s a need to perform Quality Control after Quality Assurance. This question is really saying, "We have followed correctly pre-defined processes, standards, and policies. Do we still need to perform Quality Control?"
Doing Quality Assurance permits the following:
1. Process definition
2. Policy and strategy development
3. Adopting standards,
All of these come into play during the lifecycle of a project. While performing the Quality Control processes, policies, and standards that derive from Quality Assurance, there's a uniform goal. This goal is to maintain the project's high quality, ensuring that the outcome meets the expectations of the right customer.
It might be tempting to decide to select one of Quality Assurance and Quality Control. However, neither is optional. It's also not possible to tell whether any is more valuable. What matters more is knowing what role each one plays and how to maximize its potential. Quality Assurance helps to create standards and processes that guarantee an effective yet safe product. On the other hand, Quality Control activities validate the product.
Organizations can connect the dots by finding ways to use Quality Control to inform Quality Assurance.
While this article has covered a fair amount of detail on Quality Assurance (QA) and Quality Control (QC), here’s a chart that succinctly captures their differences:
Quality Assurance and Quality Control are two sides of the same coin. Yet, they differ in significant ways and are both indispensable to the Quality Assurance management process. QA beams a spotlight on the process, whereas QC wholly addresses the end-product. There’s every reason to discontinue the use of both terms as if they were interchangeable.
We can rehash by saying that Quality Assurance has the singular goal of preventing issues from in the future by improving the process. Quality Control would then inspect a product or service to guarantee that it is in a desirable working state. Where it's not the case, it's important to fix the issue or eliminate it to fulfill conformance standards. In a nutshell, Quality Control detects and corrects problems.
In summary, Quality Assurance is not a substitute for Quality Control, so it doesn't eliminate a need for it. Instead, Quality Control is the nucleus of Quality Management.