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Quality Assurance vs. Quality Control: Top 5 Differences

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QA and QC processes are inseparable parts of the overall Quality Management System (QMS), and they are often used interchangeably. However, while these processes feature some overlap, it’s essential to note that they are two separate entities and take place at different times. Elements of the QMS may not be specifically composed of QA or QC activities and responsibilities, but instead involve a combination of the two. 

Both QA and QC play vital and distinct roles in the health of life sciences companies. As such, it’s good to know the difference between these two processes. According to ISO 9000:2015 – Quality management systems – Fundamentals and vocabulary, QA and QC are both part of the QMS yet focus on different subjects. QA activities mostly focus on providing assurance that quality requirements will be fulfilled, while QC activities focus on actually fulfilling quality requirements.

Understanding the roles of QA and QC can help your organization improve each process and deliver the best possible products. To effectively manage your quality processes—including Quality Assurance and Quality Control activities—you need to implement a QMS according to ISO standard requirements. If you're a medical device company, you've probably known or already implemented the ISO 13485 Quality Management System within your organization; however, other life science organizations might implement ISO 9001, which is another QMS standard. 

 

Illustration that represents the quality management systems (QMS) by Scilife.

 

What Is Quality Assurance?

Quality Assurance consists of a series of activities carried out by the organization's QMS in order to confirm the product meets quality standards. In short, QA is a pre-planned process that defines the product in its development stage and determines whether it meets the necessary requirements. 

The quality assurance process is part of the organization’s overall quality management. In the QA stage, all activities involved in your quality management plan should verify that your product is ready to be approved  and get through the manufacturing process. 

Assurance has two purposes: internal and external. The internal role of QA involves management, while QA’s external role pertains to the customer, government, agencies, regulators, notified bodies, and third parties.

 

What Is Quality Control?

The Quality Control process features a series of operational techniques and activities needed to meet the parameters of a product's quality and verify that the product is safe and effective after production. In simple terms, the QC process is the inspection stage of the QA process. 

Typically, the QC process is designed to help teams identify deficiencies in the product and eliminate them in an effort to comply with the organization’s quality standards.

All elements involved in product development should be considered during the review. The product must undergo testing to identify the deficiency right after it’s produced. If any deficiency is disclosed, it should be documented and shared with management, so that they can decide whether to approve and release the product or reject it. 

 

Differences Between Quality Assurance and Quality Control

Although we were quite general in our explanation of both terms, many still find them confusing when listing related tasks. Here are some activities involved in each concept so that you can learn to recognize the differences between QA and QC.

Basis for Comparison

Quality Assurance

Quality Control

Meaning

Guarantees the preferred level of product quality is fulfilled at each process phase

Ensures the product quality aligns with the set standards

Approach

Proactive

Reactive

Focus 

Process

Product

Concept

Prevents defects

Identifies defects

System

Prevention-based system

Correction-based system

Activity

Verification

Validation

Function

Staff function

Line function

Creation of Quality

Design stage

Control stage

Emphasis

Customer

Standard

Responsibility

Organization-wide

Team-wide

Development Stage

Throughout the development cycle

After the development and testing cycles

Focus

Provides assurance that quality will be achieved as requested

Fulfills the quality as requested

Techniques 

Manages quality

Verifies quality

Program Execution

Not involved 

Always involved

Deliverables

Creates the deliverables

Verifies the deliverables

Timeframe

Performed before QC

Performed after QA 

Standards 

Defines standards and methodologies for meeting customer requirements 

Ensures all standards are followed while working on the product

 

Main motive is to prevent defects in the system, less time-consuming 

Main motive is to identify defects or bugs in the system, more time-consuming

 

Low-level activity, able to identify errors that QC cannot

High-level activity, able to identify errors that QA cannot

 

Ensures you are doing the right things

Ensures the results of what you've done are as expected

 

Responsible for the full software development lifecycle

Responsible for the software testing lifecycle

 

Ensures everything is executed the right way (considered a verification activity)

Ensures actions taken are per the requirements (considered a validation activity)




The 5 Major Differences Between Quality Assurance and Quality Control

To provide the full picture, we’re going to examine the five major differences between quality assurance and quality control. The two processes share common goals but work interchangeably. Let’s take a closer look at what they are. 

 

1. Proactive (QA) vs. Reactive (QC)

The QA process is proactive. Its goal is to establish a framework for minimizing issues from the beginning—preventing defects before they arise via process design. For example, the QA process documents standard operating procedures (SOPs) according to ISO standards (ISO 9000, and ISO 13485).

The QC process is reactive, and its purpose is to determine defects in product quality after they’ve occurred. It tests products to ensure they meet the QA-defined requirements. If any quality issue is identified, then several (preventive and corrective) actions need to be taken in order to fix it. Additionally, the outputs of the non-confirmed product can trigger a QA step in order to evaluate and investigate the issue further. The idea behind this is to identify the root cause of the problem and improve the current process to avoid similar issues in the future. 

To summarize, QA is proactive, while QC is reactive. Additionally, QA takes place during the development of the product, while QC takes place after the final product has been produced.

 

2. Process (QA) vs. Product (QC)

QA is process-oriented, and it primarily focuses on processes and procedures for improving quality and preventing quality defects before they occur. 

QC is product-oriented and focuses on products by determining quality defects in finished products that might affect customer satisfaction. Here are a few examples of each type of activity:

 

QA Processes

QC Processes

Documentation

Audits

Supplier management

Personnel training

Change control

Investigative procedures

Batch inspection

Product sampling

Validation testing

Laboratory testing

Software testing

Beta testing




3. System (QA) vs. Parts (QC)

QA systems primarily include procedures and methods that are defined using ISO standards and/or regulatory requirements, while QC systems measure parts—which can be outputs of the system or used to create the final product (for example, raw material from a supplier). The QA system aims to ensure inputs are always safe and effective (for example, supplier audits).

 

4. Creation (QA) vs. Verification (QC)

The QA process features the definition of standards for each production step—from design, manufacturing, assembling, packaging, storage, and distribution, to marketing and sales. The objective is to consistently produce high-quality products. 

QC, meanwhile, involves measuring activities to verify the finished product before distribution.

 

5. Entire Team (QA) vs. Dedicated Personnel (QC)

The QMS is the responsibility of the Quality department—specifically, the leadership of the team—while QA activities consist of standards for training, documentation, and review throughout the team. QA activities are therefore performed by the entire team. They represent an organization-wide effort whereby each team member must follow the defined SOPs. 

QC is the responsibility of specific personnel within the organization. These individuals must follow SOPs to perform QC product testing.

 

Similarities Between Quality Assurance and Quality Control

Organizations always want to produce high-quality products that deliver maximum customer satisfaction. While both processes play different roles in a QMS, they ultimately share the same goals and objectives. 

 

1. Policies, Procedures, and Methodologies

Both processes follow standards defined by the organization to achieve high quality, but they each feature a unique approach. 

 

2. Securing High-Quality Product

There should be several QA and QC steps in place in order to release a high-quality product. QA activities guide organizations on how to do this, while QC helps organizations to ensure their finished product complies with all the necessary requirements. 

In this way, both QA and QC help to deliver a high-quality product to the customer. This is important because having satisfied customers can help organizations sustain their position in the market.

 

3. Preventing Major Issues 

Defects can be minor, major, or massive disruptions. The cost and time needed to fix the problem correlate with how early you identify the defect. Problems mitigated in earlier steps have lower costs and are typically more fixable. When a defect is identified in later process steps, the cost is usually higher. And when it’s identified by a customer, the solution won’t come cheap.

The crucial role of QA and QC activities is to prevent, identify, and fix issues as early as possible in order to reduce costs.

 

4. Continuous Improvement

QA and QC processes offer opportunities to improve in areas like defect detection, requirements gathering, and customer experience. This means your organization can potentially improve your processes to become more efficient and effective with each iteration. 

 

Benefits of Quality Assurance and Quality Control

QA and QC have the same main purposes, but their activities are performed at different stages—and each takes a unique approach. Both, however, are crucial and complementary. Here are some of the benefits of QA and QC:

  • Deliver a high-quality output
  • Eliminate waste
  • Increase operational efficiency 
  • Provide customer satisfaction
  • Ensure less rework and after-sale support 
  • Encourage a high level of confidence and a motivated team 

Illustration that represents typical Quality Control (QC) steps by Scilife.

Illustration that shows typical Quality Assurance (QA) steps by Scilife.

 

Quality Tools for Process Improvement 

Generally, there are three main techniques involved in the quality control process. These techniques include inspection, statistical sampling, and seven basic tools of quality. 

Inspection involves physically examining the deliverable for any defects to see if it matches the requirements. In statistical sampling, you select a random number of items from a batch and inspect them for defects and conformance issues. 

Quality pros have many names for these seven basic tools of quality, which were initially outlined by Kaoru Ishikawa, a professor of engineering at Tokyo University, and the father of “quality circles.” Start your quality journey by mastering these tools, and you'll have a name for them too: indispensable. 

The seven basic tools of quality include a scatter diagram, control chart, histogram, checklist, Pareto diagram, cause-and-effect analysis, and flow chart. These tools are designed to help you find defects and promote conformance of the product.

 

1. Cause-and-Effect Diagram 

Also known as an Ishikawa or fishbone diagram, is a diagram used to identify many possible causes of an effect or problem and sort ideas into useful categories. 

 

2. Checklist

A structured form for collecting and analyzing data; a generic tool that can be adapted for a wide variety of purposes.

 

3. Control Chart

A graph for studying how a process changes over time—comparing current data to historical control limits, resulting in conclusions on whether the process variation is consistent (in control) or unpredictable (out of control, affected by special causes of variation). 

 

4. Histogram

The most commonly-used graph for showing frequency distributions, or how often each different value in a set of data occurs. 

 

5. Pareto Chart

A bar graph that shows which factors are most significant.

 

6. Scatter Diagram

Graph pairs of numerical data, with one variable on each axis, designed to identify a relationship. 

 

7. Stratification

A technique that separates data gathered from a variety of sources so that patterns can be seen (some lists replace stratification with a flowchart or run chart).

 

Illustration which represents quality assurance (QA) vs quality control  (QC) by Scilife.

 

The Role of QA and QC Processes Within Your QMS

When you decide to implement a QMS in your organization, the QA and QC processes are not optional—you need to include both. Additionally, neither one is more valuable than the other. By using both processes when needed, the output of the QA should feed the QC activities; the output of a QC activity can feed QA activity as well. 

For instance, say you’ve defined the procedures, or the methods for the product according to standards as a QA activity. Then, you simply verify the product by using those procedures. Furthermore, if you identify a defect in the product, then you need to investigate the nonconformance as a QA activity. As you can see, an output can serve as an input of the other process. 

Both QA and QC play a key role in an organization’s QMS for end-to-end quality processes. Scilife integrates both processes to ensure and control quality throughout document control and training, CAPA management, and complaint handling—that is, throughout the entire product lifecycle. 

Interested in learning more about these functionalities?

Book a demo here!

 

Conclusion

Every organization aims to deliver an exceptional customer experience—because a great customer experience translates into satisfied customers. Nowadays, both companies and users are becoming increasingly sensitive to quality, avoiding products that do not meet quality standards. Quality Assurance and Quality Control are tools that, when they are well-implemented and understood by the whole team, will allow you to succeed in providing quality products and services that address your customers’ needs and concerns. 





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