Quality Assurance (QA) is a framework by which product and service quality is ensured by using a systematic approach.
Quality is a complex concept that can vary significantly depending on the industry, company, or context. Each industry and company define quality based on their specific needs, regulatory requirements, and customer expectations.
Quality in a company is ensured through a system that integrates various processes and procedures. Companies often implement multiple interconnected systems rather than relying on a single standalone approach.
These systems encompass quality assurance, Quality Control (QC), and Quality Management Systems (QMS). While QA, QC, and QMS each have their distinct functions in helping ensure quality, they are interconnected and overlap throughout the product or service lifecycle.
Therefore, a quality assurance system is a system that organizes and integrates all the policies, processes, procedures, and resources necessary to implement and maintain quality assurance activities within a company.
QA systems are implemented across various industries, such as aerospace, finance, and life sciences, covering laboratories, pharmaceuticals, and medical devices.
Various approaches to QA are utilized, including process quality assurance, regulatory compliance quality assurance, product quality assurance, and supplier quality assurance. The QA approach a company implements depends on its industry and compliance needs.
It is important to differentiate quality assurance from quality control because they encompass distinct roles in ensuring the quality of products or services. The main difference between QA and QC is that QA focuses on ensuring that products and services meet the quality specifications, while QC involves controlling and testing to confirm the presence of quality.
QA systems require extensive documentation, which is efficiently managed through QMS software. QMS software automates various QA processes, simplifies document and data management, and reduces errors.
SimplerQMS provides QMS software solutions tailored to Life Science companies. Book a personalized demo to learn how SimplerQMS can streamline your QA system processes.
What Is a Quality Assurance (QA) System?
A Quality Assurance (QA) system is a system supported by policies, processes, procedures, and resources that ensure products and services meet or exceed the quality specifications of the company. The QA system ensures the quality, reliability, and efficiency of products and services throughout their lifecycle.
Companies often implement multiple interconnected systems instead of relying on a single standalone solution. These systems include quality assurance, quality control, and quality management system. While QA, QC, and QMS have different functions in ensuring quality, they are interconnected and overlap throughout the lifecycle of products and services.
QC is included in QA, which itself is part of QMS, ensuring comprehensive quality management throughout operations.
The illustration below represents the relation between QC, QA, and QMS.
What Is the History of Quality Assurance?
Quality assurance dates back to the early 20th century when processes started to be recognized as a part of quality. QA gained importance with the introduction of process control methods by pioneers like Walter A. Shewhart, W. Edwards Deming, and Joseph M. Juran.
The Plan-Do-Study-Act (PDSA) tool, also known as the Deming Cycle or Shewhart Cycle, exemplifies this approach. The PDSA provides a structured method in a systematic series of steps used for the continuous improvement of a product or process.
During World War II, the USA introduced sampling inspection to manage the high production volumes of military equipment. With the help of industry experts, the USA published sampling tables to clarify supplier expectations.
After the war, QA gained momentum during Japan’s reconstruction. Prioritizing product quality over costs led to superior Japanese products. Japanese products were manufactured using the Lean management approach. Lean management was developed in Japan at Toyota to optimize production efficiency and minimize waste.
In response, the Total Quality Management (TQM) approach was developed, which integrated statistical methods and total employee involvement. Further quality improvements followed, including the release of the ISO 9000 quality standard in 1987 and the establishment of the Baldridge National Quality Program in the USA that same year.
Quality assurance has evolved significantly over the years, becoming a cornerstone of the quality management system across various industries, including healthcare, manufacturing, finance, life sciences, and other industries.
Why Is a Quality Assurance System Important?
A quality assurance system is important as it ensures the company and customers that the products and services are safe, fit for the intended use, and compliant with specifications and requirements.
A QA system is essential from several viewpoints:
- Customer Perspective: The QA system ensures products and services are safe and suitable for their intended use, increasing customer satisfaction and trust.
- Company Perspective: The QA system helps uphold a company’s reputation for delivering uniform and high-quality products or services. QA reduces costs associated with low quality, such as rework, product recalls, and regulatory penalties.
- Employee Perspective: QA systems provide clear guidelines and expectations for employees, contributing to job satisfaction and promoting a positive work environment.
The primary purpose of a QA system is to ensure that products are uniform and high quality. A well-functioning QA system ensures that products or services meet the company’s defined specifications for quality, including safety, compliance, fitness for use, and any additional criteria set by the company.
A QA system helps manage the quality processes, leading to increased customer satisfaction, reduced defects costs, compliance with specifications and regulations, and continuous improvement.
A QA system also helps demonstrate to relevant authorities that a company complies with applicable regulations, standards, and guidelines.
What Is the Purpose of Quality Assurance in Quality Management?
The purpose of QA within a quality management system is to ensure that processes are planned, implemented, and controlled so that products or services consistently meet or exceed the quality specifications.
Quality assurance and the quality management system are interconnected components within a company for ensuring quality. QA is a subset of the broader QMS and plays an essential role in its overall effectiveness.
QA within the QMS ensures that quality specifications are defined and met throughout the processes and activities. The relationship between QA and QMS helps to achieve consistent product or service quality, increase customer satisfaction, and maintain compliance.
What Are the Approaches of Quality Assurance?
The five most common approaches to QA are described below in more detail.
- Process Quality Assurance: Ensures that operational processes are efficient and consistent to prevent errors and improve productivity.
- Regulatory Compliance Quality Assurance: Ensures compliance with requirements to avoid penalties.
- Product Quality Assurance: Focuses on maintaining the quality and reliability of products through testing and inspection processes.
- Supplier Quality Assurance: Involves evaluating and monitoring suppliers to ensure they consistently deliver materials and components that comply with requirements.
- Software Quality Assurance (SQA): Ensures software product compliance by testing, reviewing, and improving software.
Companies can utilize various approaches to ensure quality. These approaches can be implemented at the same time. Companies often use multiple approaches simultaneously, allowing for a more comprehensive and robust quality assurance system.
Process Quality Assurance
Process QA involves monitoring and evaluating production or service delivery processes to ensure they are executed accurately and efficiently according to the applicable requirements.
Process QA focuses on the prevention of defects and issues by monitoring and optimizing each step of the process to maintain consistent quality and operational excellence.
Regulatory Compliance Quality Assurance
Regulatory compliance QA ensures that a company complies with all relevant regulatory requirements.
The role of regulatory compliance QA is to assure quality related to regulatory compliance.
Regulatory compliance QA uses auditing to verify that internal procedures are followed correctly, consistently, and in compliance with quality specifications and regulatory requirements.
Product Quality Assurance
Product QA ensures that products comply with applicable quality specifications, requirements, and customer expectations.
The primary purpose of product QA is to maintain product quality through testing and inspections. Product QA ensures products are suitable for their intended use.
Supplier Quality Assurance
Supplier QA ensures that suppliers consistently provide materials, components, or services that comply with quality specifications.
Supplier QA can involve, among other activities, setting up quality control procedures for incoming goods and establishing quality agreements with suppliers to ensure product and service quality.
Supplier QA aims to foster a reliable supply chain that consistently delivers uniform and high-quality products or services, minimizing risk related to suppliers.
Software Quality Assurance (SQA)
Software Quality Assurance (SQA) ensures the quality of software products. SQA helps ensure that software complies with quality specifications and relevant requirements.
The SQA helps identify and solve issues throughout the software lifecycle, ensuring the software’s quality. For example, a SQA approach to ensuring software quality can be software validation.
What Are the Processes of a Quality Assurance System?
The following are the ten main processes of a quality assurance system that apply to most industries.
The processes of QA are also integral components of the Quality Management System (QMS). With the QMS encompassing both QA and QC, these processes are utilized simultaneously.
- Document Management
- Training Management
- Change Control
- Supplier Management
- Equipment Management
- Risk Management
- Complaint Management
- Nonconformance and Deviation Management
- Audit Management
- CAPA Management
Below, we provide detailed explanations of each QA system process and examples demonstrating how SimplerQMS streamlines each process by improving its management and integration within other processes.
Document Management
Document management is the systematic control and organization of documents throughout their lifecycle, from creation to retirement. Document management begins with the creation, review, and approval of documents and extends through their active use, storage, retrieval, and eventual archival. Key functions of document management include ensuring documents are accessible yet secure, maintaining version control, and upholding compliance with relevant regulatory requirements.
Effective document management supports organizational efficiency by reducing the risks of document duplication, loss, and unauthorized access while enhancing the traceability and auditability of documentation practices.
SimplerQMS document management module streamlines and automates document control and records management processes. Automated notifications for document release, review, and approval streamline document cycles. SimplerQMS solution offers electronic signatures, time-stamped audit trails, and controlled printing capabilities.
Training Management
Training management is the process of planning, executing, and monitoring training programs within a company. Training management involves identifying training needs, developing training materials, scheduling training sessions, and assessing the effectiveness of the training and the trainees’ performance.
Effective training management ensures that employees are competent and capable of performing their tasks.
SimplerQMS training management capabilities enable companies to monitor current and overdue training requirements efficiently. The QMS software tracks employees’ training statuses, allows assigning employees to specific training groups based on job roles or departments, and ensures that personnel receive relevant training tailored to their responsibilities.
Change Control
Change Control is the systematic process of managing changes to processes, procedures, documents, products, templates, and other components within a company. Change control involves creating change requests, assessing potential impacts, implementing changes, and verifying their effectiveness while maintaining comprehensive records of all changes made.
Effective change control ensures that changes are managed in a controlled manner to prevent unintended consequences, maintain product quality, and comply with customer and regulatory requirements.
The change control module in SimplerQMS simplifies monitoring of change status and updates documentation with automated notifications and task reminders. The eQMS software fosters department collaboration, ensuring comprehensive employee involvement in the change management process.
Supplier Management
Supplier management is the process of organizing and overseeing all interactions with third-party companies that supply products and services. Supplier management entails selecting, evaluating, and monitoring suppliers to meet internal, customer, and regulatory requirements.
The goal of supplier management is to ensure that suppliers consistently provide goods and services that comply with relevant requirements, meet delivery timelines, and align with cost expectations.
SimplerQMS supplier management module enables companies to centralize supplier data, streamline evaluations and audits, manage approved supplier lists (ASL), and identify critical suppliers for quality assurance. The eQMS automates notifications and reminders for re-evaluations and supplier follow-up actions.
Equipment Management
Equipment management oversees a laboratory or manufacturing facility’s equipment to maintain quality, safety, and compliance. Equipment management involves scheduling maintenance, calibration, and validation to ensure equipment operates effectively within specifications, minimizing downtime and issues.
SimplerQMS equipment management capabilities provide notifications for impending maintenance or calibration tasks, preventing oversights in these activities. SimplerQMS software centralizes equipment records, simplifying access to historical data, maintenance logs, and compliance documents for efficient retrieval and review.
Risk Management
Risk management systematically identifies, assesses, scores, and mitigates risks impacting products, processes, suppliers, and equipment. The risk management process involves analyzing issues, evaluating potential impacts, and developing strategies to manage adverse effects.
The main goal of risk management is to minimize potential hazards, ensure product safety, maintain product quality, and comply with customer and regulatory requirements.
The risk management module in SimplerQMS offers pre-defined workflows for the timely handling of risk-related tasks. Notifications and reminders keep relevant employees informed about risk-related tasks. The eQMS integrates risk-related records with processes, documents, nonconformances, deviations, and CAPAs, offering a comprehensive overview of risk management activities.
Complaint Management
A complaint can be an expression of dissatisfaction, feedback, or suggestion to improve a company’s product or service. Complaint management entails systematically handling, investigating, and resolving complaints.
The complaint management process provides direct insights from end users, customers, and others, highlighting potential areas of improvement and non-compliance with customer expectations and regulatory requirements.
The SimplerQMS complaint management module provides capabilities that streamline the logging, tracking, and resolution of complaints. The eQMS solution enables seamless communication across departments, maintains a centralized repository of all complaints for easier access and analysis, and ensures timely response through automated alerts and reminders.
Nonconformance Management and Deviation Management
A nonconformance or deviation is an event that diverges from established processes, procedures, or established requirements. Nonconformance and deviation management are the processes that include a thorough investigation, analysis, and resolution of these issues.
An effective deviation and nonconformance management process enables companies to identify the root causes of issues and apply corrective actions. Deviation and nonconformance management facilitate the implementation of preventive actions to avoid similar quality problems in products or services.
SimplerQMS provides nonconformance management and deviation management modules that enable efficient management of issues throughout their lifecycle. SimplerQMS offers automated workflows for recording, investigating, reviewing, and closing issues. The QMS software seamlessly integrates with other interconnected QMS processes like CAPA (Corrective and Preventive Actions), ensuring a comprehensive resolution of issues.
CAPA Management
CAPA (Corrective and Preventive Action) management is a systematic process designed to identify and address deviations and nonconformances, correcting the current issue and preventing similar ones from recurring. The CAPA process typically involves key steps such as identification, evaluation, investigation, analysis, action plan development, implementation, and assessment.
Effective CAPA management helps companies maintain quality and compliance by resolving current issues and implementing measures to prevent future occurrences.
SimplerQMS CAPA management capabilities streamline the entire CAPA process, from issue identification to resolution and closure. The eQMS automates workflows, increases accountability, and ensures CAPA-related tasks are completed on time. With SimplerQMS, companies can efficiently manage all steps of the CAPA process, including root cause analysis, action planning, implementation, effectiveness checks, and closures.
Audit Management
Audit management involves the systematic planning, scheduling, conducting, documenting, and follow-up of audits within a company.
The purpose of audit management is to systematically assess and verify the quality management system’s compliance with customer and regulatory requirements. Audits encompass internal audits for self-assessment, external audits for regulatory purposes, and supplier audits for ensuring supplier compliance and performance.
The audit management module of SimplerQMS simplifies scheduling audits, assigning tasks, documenting findings, tracking actions, and maintaining time-stamped audit trails. The eQMS securely stores audit records for easy access and thorough review and analysis.
What Are the Examples of Quality Assurance in Use by Industry?
Examples of quality assurance employed by various industries include the laboratory, pharmaceutical, medical device, and software development sectors.
Laboratory Quality Assurance
Laboratory quality assurance ensures consistent compliance with internal, customer, and regulatory requirements within a laboratory environment. Laboratory QA ensures that laboratories produce accurate, consistent, and reliable test results and data.
The primary purpose of a laboratory QA is to maintain the quality and integrity of all laboratory testing. A Laboratory QA program can also be implemented to ensure that laboratory testing is performed in compliance with the principles of current Good Laboratory Practices (cGLP) if required.
Pharmaceutical Quality Assurance
Pharmaceutical QA is utilized to ensure pharmaceutical products and services are safe, effective, and of uniform and high quality.
The aim of pharmaceutical quality assurance is to ensure quality throughout the entire pharmaceutical product lifecycle. The pharmaceutical product lifecycle includes the development, manufacturing, distribution, and post-market stages.
Pharmaceutical QA ensures products and services meet the quality specifications and comply with relevant requirements, such as ICH Q10, FDA 21 CFR Part 210 and 211, ISO 9001:2015, GxP, and more.
Pharmaceutical QA is also used in biotechnology industries, which often share the same regulatory requirements. Biotechnology industries adopt pharmaceutical QA practices to ensure product quality and compliance.
Medical Device Quality Assurance
Medical device QA ensures the medical device’s quality, safety, effectiveness, and compliance with specifications and relevant requirements.
The primary purpose of medical device quality assurance is to ensure the quality of each device, encompassing procedures to verify that devices function according to their intended use, are free from defects, and pose minimal risk to patients and users.
Software Development Quality Assurance
Software development quality assurance ensures the quality and functionality of software products. Software QA can be applicable across various industries, such as pharmaceuticals, medical devices, biotechnology, and others.
The primary goal of software development QA is to ensure that the software functions as intended, with high quality, reliability, performance, security, and usability in all stages of the development lifecycle. Various approaches are used to ensure quality, such as software validation and compliance with ISO 25010:2023 for software engineering.
What Are the Benefits of an Effective Quality Assurance System?
Four of the main benefits that highlight the essential role of an effective QA system are listed below.
- Assure Quality: An effective QA system ensures that products and services are of uniform and high quality. QA system helps ensure all processes, procedures, products, and services consistently meet quality specifications and relevant requirements.
- Ensure Compliance: QA processes ensure quality, safety, and compliance across the product or service lifecycle. Core QA processes such as CAPA management, audit management, document management, change control, and supplier management are essential for complying with customer and regulatory requirements.
- Increase Product Reliability: Effective QA systems improve product reliability by systematically identifying and addressing potential quality issues throughout the product lifecycle. Through rigorous testing, validation, and continuous improvement processes, QA helps improve the product’s consistency and performance.
- Improve Customer Satisfaction: The QA system increases customer satisfaction by ensuring products and services are high-quality and fit for their intended use, reducing customer complaints.
These benefits collectively emphasize the importance of investing in and maintaining an effective QA system.
Is There a Difference Between Quality Assurance (QA) and Quality Control (QC)?
Yes, there is a difference between Quality Assurance (QA) and Quality Control (QC). QA and QC focus on different areas of quality and serve different purposes.
Both QA and QC are essential components of the Quality Management System (QMS). QC is a subset of QA, which, in turn, is part of the overall QMS.
What Is the Difference Between Quality Assurance and Quality Control?
The differences between Quality Assurance (QA) and Quality Control (QC) encompass their focus, timing of activities and objectives.
QA focuses on ensuring processes are in place to produce uniform, high-quality products and services.
QC is concerned with controlling and testing the quality in all stages of the product, incoming goods, or services lifecycle.
What Is a Quality Control System?
A Quality Control (QC) system consists of a set of measures, procedures, and work instructions to ensure that the quality of a product, material, or service complies with specifications and relevant requirements.
The primary objective of a quality control system is to control and test the quality of products and services. QC system helps maintain and improve quality and consistency throughout the product or service lifecycle.
What Is the Role of QMS Software in Supporting QA System Processes?
Quality Management System (QMS) software supports quality assurance system processes by providing a centralized and integrated digital platform to manage, document, and streamline all quality-related activities.
QMS software streamlines key processes such as document management, change control, CAPA management, audit management, and training management. By digitizing these processes, QMS software improves efficiency, reduces human error, and helps ensure compliance with requirements.
SimplerQMS provides an eQMS software solution tailored for the life science industries, such as pharmaceutical, medical device, and biotechnology, including laboratories and others.
With its interconnected QMS modules, our Life Science QMS software offers key capabilities that support QA processes. QMS modules include document management, change control, training management, CAPA management, audit management, supplier management, and others.
SimplerQMS supports compliance with several life science requirements, such as 21 CFR Part 211, 212, and 820, ISO 9001:2015, ISO 13485:2016, MDR and IVDR, EU Volume 4 GMP Part I, ICH Q7, ICH Q10, and more.
SimplerQMS software solution helps companies comply with requirements by providing pre-defined workflows supporting the QMS processes.
SimplerQMS is a fully validated solution, according to ISPE GAMP 5 guidelines. All software validation is managed by SimplerQMS, eliminating the need for customers to allocate additional resources, time, or costs for software validation.
If you are interested in learning more about SimplerQMS and how it can streamline your QA system processes, book a personalized demo and talk to SimplerQMS Quality Solution experts.
