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. QA (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.
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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, QA (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.
Types of Quality Assurance
Quality Assurance (QA) takes various forms across industries, each tailored to specific processes and products.
Functional Quality Assurance
Ensures the product or service functions as intended, meeting specified requirements and functional expectations.
Process Quality Assurance
Optimises and monitors the processes involved in product development or service delivery to ensure efficiency and adherence to standards.
Software Quality Assurance (SQA):
Specific to the software development lifecycle, SQA involves processes and activities to ensure the quality of software products.
Regulatory Compliance Quality Assurance
Ensures adherence to industry-specific regulations, standards, and legal requirements, avoiding legal issues and ensuring ethical practices.
Supplier Quality Assurance
Evaluating and monitoring the quality of materials and components supplied by external vendors to maintain consistent product quality.
Product Quality Assurance
Concentrates on the final product, ensuring it meets defined quality standards and customer expectations.
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:
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Government agencies
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Technology
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Nonprofit
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Finance
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Manufacturing
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Food and beverage
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Healthy and beauty
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Government agencies
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Technology
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Nonprofit
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Finance
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Manufacturing
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Food and beverage
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Healthy and beauty
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:
Planning and management of product quality compliance as per QA standards
Coordinating with the manufacturing department to ensure QA is carried out at all stages from testing, auditing, and reporting
Review the QA specifications and procedures with quality control
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
Making the Digital Quality Journey in Cell and Gene Therapy: From Bench to Bedside to Benefit
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Quality Assurance Best Practices
Implementing effective Quality Assurance (QA) involves adopting a set of best practices to ensure consistent quality across processes, products, and services. Some key best practices for Quality Assurance include:
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Clearly Defined Processes: Document and communicate standardized processes to ensure consistency and understanding across the organization.
- See Alsoorganization | QAssurance
Set Clear Quality Objectives: Define measurable quality objectives aligned with organizational goals to guide the QA process and measure success.
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Effective Communication: Foster open and transparent communication within the organization to promote a shared understanding of quality goals and expectations.
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Regular Audits and Reviews: Conduct regular internal audits and reviews to assess compliance with processes, identify areas for improvement, and ensure continuous enhancement.
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Customer Feedback and Satisfaction: Collect and analyze customer feedback to understand their needs, expectations, and satisfaction levels, integrating this information into QA processes.
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Risk Management: Implement risk management practices to identify, assess, and mitigate potential risks that could impact product or service quality.
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Use of QA Tools and Technologies: Leverage appropriate tools and technologies for testing, monitoring, and analyzing data to enhance the efficiency and effectiveness of QA processes.
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Collaboration and Teamwork: Encourage collaboration and teamwork to foster a collective responsibility for quality throughout the organization.
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Continuous Improvement: Embrace a culture of continuous improvement, regularly reviewing processes and seeking opportunities to enhance efficiency, effectiveness, and quality.
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
How to Ensure Complete Quality Assurance?
QA (Quality Assurance) 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 Assurance 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 quality assurance system aligns with all the major regulatory standards and its scalable and flexible architecture helps businesses adopt a risk-based approach to ensure:
- Identifying and mitigating risks
- Continuous improvements
- Ease of compliance, thanks to a collaborative and data-driven workflow
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 Quality Assurance System 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.
Ensure product is defect-free by preventing mistakes with Quality Assurance
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Quality Assurance Checklist – Part A (Project Management)
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General Quality Control and Assurance Points for ATMPs
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Quality Assurance Checklist – Part B (Project Deliverables)
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Frequently Asked Questions
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QA (Quality Assurance) Management is the systematic process of ensuring that products or services meet specified quality standards and customer expectations. It involves the development and implementation of policies, procedures, and methodologies to monitor and improve the quality of processes and deliverables.
QA Management encompasses activities such as process audits, quality planning, and the establishment of quality metrics. The goal is to prevent defects, identify and correct deviations from standards, and continuously enhance overall quality. QA Management is integral in various industries, including manufacturing, software development, healthcare, and services, to achieve and maintain high-quality outcomes.
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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
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Quality
Manufacturing
Engineering
Operations
Management
Suppliers
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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.
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