Quality Assurance vs. Quality Control: Do you need Both?

If you are in the life sciences field, then you have probably heard the two terms quality assurance and quality control quite a lot. As both play an essential role in the health of these life sciences organizations. But what is the different between quality assurance (QA) and quality control (QC), and why is it important to tell them apart? By identifying what each of these two roles, QA and QC, encompass, it will enable your organization to master these two functions. At the same time with the development of an understanding of both, it will in turn help your organization to deliver the highest level of quality products and services possible.

This article will take a further look at quality assurance vs. quality control, and the innate differences between the two. What each of these mean for an organization and why they are so important, will also be looked at, so keep on reading to learn more.

QA and QC Differences

When looking at quality assurance vs. quality control, it is important that we first understand both terms. Let us begin with Quality Assurance (QA), it can be defined as the processes that take place to enable the design and manufacturing of a product that is safe and effective, this is done through a sequence of quality control that are put into place in the product life cycle. Quality assurance activities are incredibly important when creating a product, just as quality control is.

Quality control is defined as the procedures and tests carried out that verify whether or not a product is safe and after, after the manufacturing process is completed. Quality assurance and quality control are both necessary processes and the quality of a product cannot be tested by relying on only one or the other, but instead doing both together is essential. Manufacturers often leave out quality assurance services deeming them unimportant but reading further will help you understand why this is in fact not the case.

1. Proactive and Reactive

When looking at the processes in this sequence, quality assurance services can be referred to as the proactive method of functionality. This is because the aim of this method is to prevent defects from occurring before they can happen through the design process. It is a preemptive task that is taken place, while quality control is a reactive method. QC is reactive because it is a process that identifies the defects after they are already there.

QA on the other hand is more involved in the design aspect of the processes, examples of this include the documentation of standard operation procedures (SOPs). If all the correct procedures are followed due to QA solutions that are put into place, the result will be a safe and effective product. A product must go on to meet certain standards of safety and efficiency, and this is where quality control testing comes in, to ensure these standards are met. Once the quality control steps are carried out, it is determined whether or not a product is safe and useful to then be distributed.

If there is a problem that comes up in the quality control process, this will call into question the quality assurance activities, hence making QC a reactive process. Such a review would result in an investigation of corrective and preventive action (CAPA) to find out the main reason of the quality issue, to revise the process that caused it, and to prevent it from occurring again in the future. While this article may be looking at quality assurance vs. quality control, both processes go hand in hand.

2. Process and Product

Quality assurance is a method that is more process-oriented as it focused on the prevention of quality issues from occurring. QA solutions are developed to focus on the actions of what creates the product. This is not the case with quality control as it is a more product-focused method that is used to identify the quality issues in products that have been manufactured.

QC is focused on the result of the product. When it comes to quality assurance vs. quality control, let us look at some of the different processes that go into each method. Quality assurance activities include documentation, auditing, training of personnel, investigative procedures, supplier management, etc. Quality control activities look vastly different with processes such as laboratory tests, batch tests, validation tests, product tests, etc.

3. System and Parts

Moving on in our quality assurance vs. quality control discussion, let us take a look at another one of the quality assurance services in comparison to quality control. When it comes to QA, there are systems put into place that create methods and procedures which ensure the standard of quality. Procedures that are carried out in QA safeguard that the inputs are safe and effective. While in quality control, methods are used to measure the output i.e., the parts which create the final product.

4. Creation and Verification

Quality assurance and quality control are akin to the creation and verification of a product. QA solutions are a guideline to help create products that are of high quality. The processes help define the set standard for the design of the product, setting the tone for the manufacturing, packaging, distribution, all the way to the marketing and sales of it. While quality control is engaged in the verification process that takes place after manufacturing and before the distribution of the product.

5. Entire teams and Dedicated Personnel

Lastly, when looking at quality assurance vs. quality control we must look at the individuals behind the processes. It takes a whole team to carry out quality assurance services, and not only that but each member of an organization is in fact responsible in their own way for quality assurance activities by following the SOPs. QA determines the standard of the workforce from training, documentation, and reviews. Then we have QC which, unlike QA, is only responsible for certain individuals within the organization. These individuals include those that must follow the SOPs for product testing. The QC staff must ensure that they follow the SOPs laid out for them to ensure quality control.

Conclusion

Looking at it from a life sciences organization and manufacturers perspective, one must not think of it as quality assurance vs. quality control. It is not one or the other because both are imperative for the production process. QA helps to create a set of standards and procedures that result in safe and effective processes to make a product, while QC activities help to validate the end product. They are better together, and each brings their own value.