What is Quality Assurance?

Quality assurance involves a set of activities such as:

• Defining Standards: Establishing the quality standards that products or services must meet.
• Implementing Processes: Setting up processes and procedures to ensure the established standards are achieved.
• Monitoring and Evaluating: Continuously observing and assessing results to ensure compliance with quality standards, including evaluating customer interactions such as service calls and chats.
• Auditing: Conducting audits to compare actual conditions with requirements and reporting the findings to management.
• Creating Processes: Designing and implementing workflows for manufacturing or service delivery that enable consistent production with minimal issues.
• Improving Processes: Identifying and addressing sources of quality problems to refine operations and enhance outcomes.
• Proposing Improvements: Recommending measures and changes to improve efficiency, reduce defects, and elevate overall quality.

A robust quality assurance process is essential for fostering a culture of continuous improvement in an organization. It helps to improve product reliability and ensures that organizations can more consistently deliver high-quality products. This enhances the brand reputation and drives ongoing quality, efficiency, and satisfaction improvements. 

A robust QA process also reduces the costs associated with errors and defects, such as safety incidents that result in legal liabilities. This increases the organization’s profitability and reduces the chance of significant unexpected financial losses.

QA focuses on preventing defects by improving and maintaining processes to ensure consistent quality throughout production or service delivery. In contrast, QC is focused on detecting defects in the finished product or service through inspection and testing to ensure it meets the required standards. QA is proactive, while QC is reactive.

One example of quality assurance in action is during the medication manufacturing process in the pharmaceutical industry.  First, the raw materials sent from suppliers must be inspected, tested, and validated to ensure they meet quality standards. Once approved, they can be used in the manufacturing process. 

Throughout the manufacturing process, strict controls and procedures help to ensure that medications meet the required specifications. Testing is conducted regularly throughout the process to monitor variables such as temperature, pH, and pressure.  Following the manufacturing process, further comprehensive testing is carried out. This helps to confirm the medication’s potency, stability, and purity to ensure that it is suitable for its purpose before it reaches the consumer. 

Throughout the process, QA teams work closely with regulatory departments to ensure compliance with current regulatory standards. Records and testing results must be maintained to ensure traceability throughout the entire product lifecycle and provide a thorough audit trail.

It is common for organizations to encounter challenges associated with quality assurance. For instance, many organizations struggle to maintain high-quality standards despite tight budgets and limited resources. As a result, they may be unable to invest in the required infrastructure, tools, training, and employees required to carry out QA-related processes thoroughly. 

Meanwhile, industry standards are constantly changing and evolving. Organizations must keep up with these complex requirements and ensure they comply with multiple standards. This can be complex, time-consuming, and expensive. While an increasing number of tools are available to help organizations carry out quality assurance, successfully integrating these new technologies and processes into the organization can be difficult. 

Many employees lack the necessary training and skills to use these tools effectively, and many feel resistant to changing how they work. Without solid support from leadership, even the best quality assurance initiatives will likely fail to gain traction.