Quality assurance – explained simply

Quality assurance covers organizational as well as technical measures that keep processes stable and reliable – whether for producing products or delivering services. In most cases, this includes all processes that form part of the value chain.

Organizational tasks include:

• Describing activities within the value chain
• Reviewing workflows
• Defining test, measurement, and control procedures
• Training employees
• Establishing guidelines for production, safety, and hygiene standards
• Documenting corrective and preventive actions

Technical tasks include:

• Monitoring machine-based processes
• Implementing test, measurement, and control procedures
• Reviewing results as part of quality control

The goal of quality assurance is to identify and eliminate factors that could affect the quality of the final product at an early stage. In doing so, quality assurance ensures that the requirements of quality management are consistently met and implemented.

Quality assurance is applied in all areas and industries where quality management is required – and it is especially crucial in regulated environments. Ultimately, quality assurance is an essential part of everyday operations for any company to ensure customer satisfaction.

Typical industries for quality assurance include:

• Pharmaceuticals
• Chemicals
• Medical technology
• Hospitals and care facilities
• Automotive and aerospace
• Food
• Cosmetics

The most widely used standard in quality management is ISO 9001. It sets out the minimum requirements for a quality management system. Companies must implement these requirements to meet customer expectations as well as product and service quality standards.

The purpose of ISO 9001 is to optimize processes and ensure their reliability – making it the foundation of effective quality assurance.

The two main types of quality assurance are static quality assurance and dynamic quality assurance.

1. Static quality assurance

Static quality assurance defines that specified quality parameters – used to describe processes and products – may fluctuate within a set tolerance range. Statistical methods (Statistical Process Control), computer-based procedures (Computer-Aided Quality), and external auditors check whether these parameters are met. The resulting test reports outline necessary actions. This method also enables companies to demonstrate externally that the minimum requirements of quality assurance in the relevant quality area are reliably fulfilled.

2. Dynamic quality assurance

Dynamic quality assurance follows a continuous improvement cycle. Actual states are measured and evaluated, then compared with target states. These values are based on statistical data or customer surveys. If deviations are identified, quality assurance requires corrective measures (often in the form of a Balanced Scorecard).

Quality assurance is essential to a company’s success. To ensure long-term quality, businesses can take a range of measures:

• Implement an effective quality management system – ideally certified according to ISO 9001 – as the foundation. Clear documentation of all processes ensures they are transparent and consistently applied.
• Train and continuously develop employees. Regular training ensures that everyone understands and applies quality standards.
• Carry out quality checks along the entire value chain. This includes goods-in inspections, in-process controls during production, and final checks before delivery.
• Establish a continuous improvement process. Regularly review and optimize workflows. Feedback systems help identify improvement opportunities based on input from customers and employees.
• Focus on supplier management. Regular evaluations and close collaboration with reliable suppliers safeguard product quality.
• Monitor customer satisfaction. Regular surveys and effective complaint management provide insights into customer needs and enable quick responses to problems.
• Apply risk management and conduct internal quality audits. Both help identify potential risks early and ensure that all processes meet defined quality requirements.
• Use modern technologies and automation. They minimize sources of error and increase the efficiency of quality controls.
• Foster a company-wide quality culture. Leadership should act as role models, promoting strong quality awareness across all teams.

By applying these measures, companies strengthen quality assurance and ensure that their products and services meet the highest standards.

Quality assurance offers a wide range of methods. Some of the most common include:

Defect collection cards

A defect card enables attribute testing, where only the number of defects can be evaluated. It provides valuable insights to optimize production processes over the long term.

Process documentation

Documentation is another key element of quality assurance. Documented, planned, and executed procedures make it possible to understand how processes work – and to measure them.

Quality audits

Audits in quality assurance are used to check compliance with standards, both within the company and with suppliers. High conformity with standards helps ensure products and services of consistently high quality.

Analysis of measurement systems and test process suitability

These methods ensure that measuring systems and testing tools are suitable and that measurements can be carried out reliably without external influence.

Failure modes and effects analysis

These approaches assess whether and how errors might occur. Processes can then be adapted to prevent such failures.

8D report

An 8D report (eight disciplines) is a structured problem-solving process between supplier and customer when a complaint arises. The report is exchanged as a document and follows the PDCA cycle (Plan, Do, Check, Act) for continuous improvement. It includes:

• Immediate actions
• Root cause analysis
• Corrective actions to eliminate errors
• Safeguards to prevent recurrence

These methods together form a strong toolkit to detect, analyze, and eliminate errors – and to establish continuous improvement as part of company culture.

Quality management encompasses all measures that ensure a minimum level of quality in products and services.

Quality assurance is process-oriented. It focuses on planning inspection mechanisms – such as testing concepts, inspection and measurement systems – across the entire value chain and throughout the manufacturing process. Quality assurance is therefore one phase within quality management.

Quality control is also part of quality management, but unlike quality assurance, it is product-oriented. Its goal is to ensure the quality of a finished product using specific inspection mechanisms. Quality control is applied reactively at the end of the production process, while quality assurance works preventively throughout the process.

Yaveon 365 is the ERP industry solution designed specifically for the needs of companies in the process industry. The software strengthens quality assurance with a wide range of functions:

• Batch management and traceability: Yaveon 365 enables complete tracking of every batch – from raw material sourcing to the end customer – which is essential for meeting quality and safety standards.
• Quality inspections and specifications: Companies can define and document specific quality checks and specifications for raw materials, intermediates, and finished products to ensure compliance with defined standards.
• Inspection orders and quality control processes: The software integrates inspection orders directly into the production process. Automated inspection orders are generated at key production events, ensuring that quality tests are carried out systematically and efficiently.
• Quality management and audit trail: Yaveon 365 supports the management of audit and compliance documentation. All changes and decisions in the production process are logged transparently, making internal and external quality audits easier to conduct.