Quality Control and Quality Assurance: What’s the Difference?

Many people get confused about what constitutes quality control (QC) and quality assurance (QA). It’s important to understand the differences and how they both play vital but distinct roles in helping an enterprise achieve the highest quality standards.

QA and QC work together as part of an overall quality management system (QMS) and both are essential for achieving and maintaining regulatory compliance.

What is quality assurance?

Quality assurance is a set of processes that ensure quality in the development of a product. It is proactive because it aims to prevent defects and low quality.

Effective quality assurance builds quality controls into the product’s entire life cycle. These processes and actions – such as documenting standard operating procedures (SOPs) – should ensure the product is safe and effective.

What is quality control?

Quality control is product oriented. It uses test procedures to verify that a finished product is safe, effective and meets standards. QC is reactive because it exists to identify – and correct – defects and errors after they’ve happened.

Key differences between QC and QA

There is overlap between quality assurance and quality control. They both focus on fulfilling quality, but they’re distinctly different.

Timing

Quality assurance is implemented before quality control. The aim of QA is to improve development and test processes to prevent defects and assure quality. Quality control identifies any defects or errors after the product is manufactured and before it’s released.

Process and product

Quality assurance is process oriented. It focuses on the actions that prevent quality issues. QA processes may include documentation, audits, supplier management, training, change control and investigation procedures.

Quality control is product oriented. It focuses on finding quality issues in the final result. QC procedures may include product sampling, batch inspection and validation testing.

For example, consider the manufacture of a children’s toy. Quality assurance focuses on the actions and processes that go into developing and manufacturing the toy. Quality control focuses on identifying quality issues with the final product, the toy itself.

Entire team vs dedicated team

Quality assurance activities involve the entire team. QA activities are incorporated within standard operating procedures and other processes and actions.

Quality control is usually the responsibility of a dedicated team whose duties include following SOPs for product testing and quality control.

Relationship between QA and QC

Neither quality assurance nor quality control are optional. They’re essential and interdependent. Quality assurance is a managerial tool and quality control is a corrective tool.

Quality assurance activities are determined before production work begins. These activities are performed while the product is being developed. Quality control activities are performed after the product is developed. One follows on from the other.

As quality assurance comes before quality control, any non-conformances discovered during quality control should inform quality assurance. Any non-conformances should spark a QA review and corrective and preventive action (CAPA) to find the cause of quality issues. The QA processes should then be updated to prevent recurrence.

If effective QA processes are adhered to, QC testing procedures shouldn’t find unsafe products. But, if QC testing does uncover quality issues, it should prevent an unsafe product from being released and distributed.

Ways a QMS improves quality control and quality assurance

QA and QC work better together. They perform optimally when they’re incorporated into a QMS that ensures end-to-end quality processes.

An optimal enterprise QMS integrates QA and QC processes to ensure each product meets specific quality, safety and compliance requirements. It works as a single end-to-end solution.

A QMS automates, monitors and effectively manages all core areas necessary to maintain quality in processes and products, including:

• Audits are automated, streamlined, tracked and managed throughout the entire process from scheduling to completion.
• CAPA is automated, integrated and managed from identification of a problem to corrective action.
• Document control is automated, integrated and managed to better control all document-related processes in a single repository.
• Training management and tasks are automated and integrated within the rest of the quality control system.
• Risk is identified, tracked, analyzed and mitigated within a centralized repository to give a complete view across all processes and product lines.
• Complaints, non-conformances, deviations and other quality events are more effectively identified, evaluated and handled.

isoTracker’s cloud-based QMS software

isoTracker’s cloud-based QMS software integrates quality control and quality assurance processes to ensure that each product meets quality, safety and compliance requirements.

isoTracker offers modular, subscription-based quality management software that’s secure, cloud-based and affordable. It includes a document control module, as well as complaints management, audit management, and training modules, with built-in CAPA capabilities.

Digital quality management is one, straightforward way for small to medium manufacturing businesses to start realizing value from Industry 4.0 – and with isoTracker’s QMS, it’s easy and cost-effective to implement.

Sign up for a free 60-day trial of isoTracker’s quality management software or contact us to discuss your needs.

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