Quality Assurance (QA)- An Overview

CQ Enterprise Quality Management System (EQMS) & Quality Assurance

Quality Assurance – An Overview

Quality assurance is a means to prevent mistakes and defects in the manufacturing process at every stage of the product life cycle. The term encompasses several aspects of quality such as best practices and methodologies to ensure customer delight and regulatory compliance

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What is Quality Assurance?

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.

How to do 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
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.

Quality Assurance and Quality Control Differences

What is the difference between Quality Control and Quality Assurance?

Both quality assurance and quality control are two aspects of quality management. Although some quality assurance and quality control processes are interrelated, there is a vast difference between the two. While QA facilitates compliance with virtually all of the quality systems, QC is a subset of the QA activities. Quality Control is the fifth phase of the DMAIC model, which is an abbreviation for define, measure, analyze, improve, control. The DMAIC model is used to improve processes as it is a data-driven quality strategy.

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

Quality Assurance Functions

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

Quality assurance methods

Each quality assurance 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

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Quality assurance methods

Each quality assurance 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

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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

Government agencies
Technology
Nonprofit
Finance
Manufacturing
Food and beverage
Healthy and beauty

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 your data for a factual approach to decision making
Gain greater efficiency by getting things right the first time

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 your data for a factual approach to decision making
Gain greater efficiency by getting things right the first time

Consistency

Reduce variability of materials, waste, 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 and increase production yield

Consistency

Reduce variability of materials, waste, 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 and increase 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.

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 to your quality processes, product record, requirements, issues, and related processes
Enable teams to easily confirm designs, adjust plans, and resolve issues fast
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

Risk Reduction

Provide visibility to your quality processes, product record, requirements, issues, and related processes
Enable teams to easily confirm designs, adjust plans, and resolve issues fast
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

How does 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:

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 and improve compliance. 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.

Frequently Asked Questions

Why should businesses automate quality assurance?

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

What are the areas where quality assurance is required?

With a next-generation platform that combines smart, adaptable and flexible connected solutions, CQ Quality Management helps the organization meet every quality management goal across the organization, including

Quality
Manufacturing
Engineering
Operations
Management
Suppliers

What are the regulations and challenges in quality assurance?

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.