Quality  >  Quality Assurance

Quality Assurance (QA)

Quality assurance is an integral component of quality management. Organizations across industries, including manufacturing, technology, government agencies, food and beverage, health and beauty, finance, nonprofit, and government agencies must conduct QA checks.

quality assurance
quality assurance
quality assurance video

What is Quality Assurance?

Quality assurance (QA) is a systematic process that ensures products, services, or processes meet or exceed established quality standards. It involves activities and techniques aimed at preventing defects, identifying and resolving issues, and improving overall quality throughout the entire lifecycle of a product or service. Quality assurance aims to ensure consistent and reliable performance, customer satisfaction, and compliance with regulatory requirements.

Quality assurance is defined by ISO 9000 as a “part of quality management focused on providing confidence that quality requirements will be fulfilled.” With QA, manufacturers can ensure that customers receive a defect-free product by preventing mistakes at the time of manufacturing. Businesses can improve compliance to standards by monitoring processes and use feedback to improve efficiency and effectiveness.

Request an Online Demo

Related Assets

What is the difference between Quality Control and Quality Assurance?

Quality Control (QC) and Quality Assurance (QA) are two distinct but complementary aspects of quality management.

Quality Control focuses on the identification and correction of defects in finished products or services. It involves activities such as inspections, testing, and measurements to ensure that the product or service meets specific quality standards. QC is reactive and occurs at the end of the production process.

On the other hand, Quality Assurance is a proactive process that aims to prevent defects from occurring in the first place. It involves establishing and implementing processes, procedures, and systems to ensure that products or services are designed, developed, and produced consistently and reliably. QA focuses on planning, defining quality objectives, implementing quality control measures, conducting audits, and continuously improving processes to enhance overall quality.

quality assurance vs quality control

What industries does quality assurance apply to?

Quality assurance focuses on both administrative and procedural activities that are implemented in a quality system to meet the requirements and purpose of a product, service, or activity. QA includes systematic measurement, standard comparison, processes monitoring, and drawing feedback with the intent to prevent errors. To that end, quality assurance can be implemented across industries including:

Power of Cloud Quality

The Power of Cloud for Deploying Quality 4.0 & Industry 4.0 Practices & Why it is So Important

What are the functions of Quality Assurance?

The functions of quality assurance are defined by the objectives laid out. These functions include:

quality assurance planning

Planning and management of product quality compliance as per QA standards

quality assurance coordination

Coordinating with the manufacturing department to ensure QA is carried out at all stages from testing, auditing, and reporting

quality assurance review

Review the QA specifications and procedures with quality control

conduct audit on quality assurance

Conduct technical audits to ensure the standards are met consistently

What are the methods of Quality Assurance?

Each method has its own advantages. Some of the most commonly used quality assurance methods are mentioned below:

  • Statistical sampling
  • Operations analysis
  • Quality management methodologies, e.g., Six Sigma, Lean Manufacturing
  • Business process re-engineering
  • Specifications
  • Standard operating procedures
  • ISO accreditation
  • Benchmarking
  • Cost-benefit analysis
  • Ishikawa diagrams
quality assurance methods


cell and gene webinar

Webinar

Making the Digital Quality Journey in Cell and Gene Therapy: From Bench to Bedside to Benefit

cell and gene webinar
Watch Webinar

What are the best practices for Quality Assurance?

Quality Assurance covers the whole product lifecycle and does not pertain to any particular phase. It is established to ensure that processes are being performed and the business is continuing to adhere to the regulatory and corporate standards. For its successes, the businesses should:

  • Have a clear understanding of Business Goals

  • Cleary define Acceptance Criteria

  • Be aware of Supported Platforms

  • Create a Test Plan

  • Incorporate Test Cases/Checklists

  • Establish Continuous Integration + Continuous deployment

  • Constantly update Test Cases/Checklists

  • Share Release Notes with clients

  • Practice Exploratory Testing

What are the advantages of quality assurance systems?

Noncompliance to the new price transparency requirements can lead make the business vulnerable to public disclosure and exposure of trade secrets. A cohesive strategy that focuses on value-based contracts (VBCs) by relating payment to its value is necessary and requires businesses to create a model that helps forecast and conduct scenario analysis for possible VBCs. It should be able to predict the financial impact and share it with a cross-functional team to understand the implications for the business. This will have an impact on the contract arrangements and needs current processes, documentation, and systems to be updated. It will require change management for any new contracting approach that is implemented.

By using a quality QHSE system by CQ, businesses can significantly reduce the effort involved in maintaining ISO 9001:2015 Quality System by automating the required processes to maintain full traceability. In addition, the system also provides a complete view of the organization’s data concerning the performance and effectiveness of the quality and compliance management system. Some of the primary advantages of using a quality assurance system include:

Improved products and business

  • Innovate with an adaptable quality platform
  • Drive continuous improvement and business growth
  • Deliver exceptional customer experiences to build customer loyalty
  • Leverage data for a factual approach to decision making
  • Gain greater efficiency

Consistency

  • Reduce variability of waste, materials, and rework to cut time and costs
  • Keep quality processes repeatable to increase knowledgeable staff and reduce human error
  • Prevent delays by minimizing disruptions to stay on time and under budget.
  • Improve process control to reduce quality gaps
  • Reduce lead time with an increase in production yield

Effective compliance

  • Ensure quality standards are being met
  • Experience total traceability
  • Turn insights into action
  • Provide historical audit trails to speed compliance
  • Become adaptable to changing or emerging market conditions and to environmental and other government regulations.

Risk reduction

  • Provide visibility between quality processes, product records, requirements, and related processes
  • Enable teams to adjust plans and resolve issues faster
  • Quickly find the root cause and speed up resolution
  • Reduce the risk of probable quality failure through predictive analysis of data
  • Limit damages to profits, reputation, and existing relationships

A great QMS package

CQ has proven to be intuitive, easy to use and customization is as easy as speaking to the CQ team. The validation scripts are straightforward and easy to edit to meet our organizations particular needs. The system feels familiar while delivering the QMS system tools that we need and the CQ team is responsive to any questions that arise.

Dorothy Wilson,
Quality Assurance & Document and Records Specialist

origen testimonial
origen testimonial

How to ensure complete quality assurance?

QA can be ensured using the PDCA (Plan, Do, Check, and Act) cycle, a four-step methodology that helps control and improve the quality of products and services. It is an effective process to ensure that the organization maintains high standards of quality for the products, thus improving the reputation of the organization in the long run. It can be conducted when

  • Starting a new quality improvement project
  • Developing improvements for a process, product, or service
  • Planning collection and analysis of data to rectify problems or root causes
  • Defining repetitive work process
  • Implementing any quality change in the organization

The PDCA cycle can be implemented as follows:

  • Recognize a quality improvement opportunity and plan a change
  • Do a test run with the change by carrying out a small-scale study
  • Review the test and check the results
  • Defining repetitive work process
  • Act on the new information by taking necessary action

Using PDCA has become a fundamental principle of quality management as it ensures consistency across business activities. Through continuous feedback to analyze, measure, and identify areas of improvement, manufacturers can take corrective action to meet customer requirements.

How does CQ's Next-Gen Quality Management System help quality leaders?

In life sciences industries, the top three priorities are:

  • Maintaining compliance
  • Bringing new products to market, and
  • Improving manufacturing/production performance

A solution such as the ComplianceQuest’s EQMS aligns with all the major regulatory standards and its scalable and flexible architecture helps businesses adopt a risk-based approach to ensure:

It empowers quality leaders with transparency and traceability, with integrated root cause analysis and CAPA management where required. Change management, inspection, and audit management also automate the workflows, improve compliance, and ensures quality assurance. Document management is also made intuitive and facilitates reporting in a timely manner.

In the complex world of stringent regulatory requirements that can vary from region to region and requires the same organization to manage the variations in their different units in a centralized manner, ComplianceQuest’s EQMS can provide the flexibility and scalability they so need to minimize the risk of non-compliance and the resulting product recalls, penalties and brand erosion.

next gen quality management system to help leaders in quality assurance

Ensure product is defect-free by preventing mistakes with Quality Assurance

Request an Online Demo



Related Checklists

Quality-centric Companies Rely on CQ QMS

  • affinivax mono
  • verily mono
  • 3m logo mono
  • tupperware mono
  • continental logo mono
  • vyaire mono
  • lifescan mono
  • janssen mono
  • lundbeck mono
  • cdc logo mono
  • qlik mono
  • csa group mono
  • impossible mono
  • fluence mono

Frequently Asked Questions

  • ComplianceQuest – A 100% modern cloud Enterprise Quality & Safety Management System (QHSE) meets every requirement for ISO 9001:2015. By automating the entire ISO 9001 Quality Management System requirements, CQ EQMS significantly reduces the effort involved in maintaining ISO 9001:2015 Quality System and improves traceability. Also, it provides a complete view of the organization’s data, enhancing the performance and effectiveness of quality and compliance management processes. While ISO 9001:2015 is still based on the same seven quality principles, there is increased attention to the transformation of business methods over the past decade. ISO 9001:2015 changes the focus from documentation to managing and mapping processes with risk-based thinking. The new standards place a heightened emphasis on the importance of formal risk analysis. An end-to-end quality management system such as the one from ComplianceQuest provides a comprehensive and enterprise-wide view that enables life sciences companies with the ability to create strategies around pricing and enables VBC. The key reasons for adopting ComplianceQuest’s solution included its:

    • Comprehensive yet flexible approach to designing a workflow that works for your enterprise

    • Platform capabilities that enable a roadmap for product innovation with a deep focus on quality

    • A best practices-based integration strategy and validation

    • Quality

    • Manufacturing

    • Engineering

    • Operations

    • Management

    • Suppliers

  • ISO 9001:2015 is the most internationally recognized quality assurance standard. Quality assurance affects different aspects of business, including finance, quality, brand, and time. Providing the advantage of evolving, agile, and next-generation technology capabilities, CQ Quality Management Software acts as the building block for a ‘Continuously Improving’ quality management process to deliver a high-quality product.

Astronut

Related Insights

Agile Quality Audits: Improve Responsiveness with AI-powered Insights
Blog | March 21st, 2023

Agile Quality Audits: Improve Responsiveness with AI-powered Insights

A 20% time saving on regulatory audits and a 10% saving on audits of standards like ISO 9001 – who…

View All Resources

Connect with a CQ Expert

Learn about all features of our Product, Quality and Safety suites. Please fill the form below to access our comprehensive demo video.

contact-img

Please confirm your details

In Need of Smarter Ways Forward? Get in Touch.

Get a Demo Today
spinner
Request Demo