Quality assurance simply explained

Quality assurance comprises organizational and technical measures that are used to maintain the consistency of processes used to produce products or provide services. As a rule, these are all processes that are part of the value chain.The organizational tasks essentially include

• Describing the activities in the value chain
• Checking work steps
• Defining test, measurement and safety procedures
• Employee training
• Defining guidelines for production, safety and hygiene standards
• Documentation of measures

The technical tasks essentially include

• Monitoring machine processes
• Test, measurement and safety procedures
• Checking results as quality control

The aim of quality assurance is to identify influences that could potentially affect the quality of an end product in good time and to eliminate them. In this way, quality assurance ensures that quality management specifications are adhered to and implemented.

• Pharmaceuticals
• chemical industry
• medical devices
• Hospitals and care facilities
• Automotive and aircraft construction
• Food industry
• Cosmetics

ISO 9001 is the standard most frequently used in quality management. It regulates the minimum requirements for a quality management system. Companies must implement these in order to meet the requirements of customers and the quality of products and services. The aim of ISO 9001 is to optimize processes and thus ensure their safety. It is therefore the basis for functioning quality assurance.

The main types of quality assurance are statistical and dynamic quality assurance.

1. Static quality assurance

Static quality assurance stipulates that defined quality parameters, which serve to describe processes and products, may fluctuate within a defined range. Statistical (Statistical Process Control) and computer-aided procedures (Computer-Aided Quality) and external auditors check whether the parameters are being adhered to. The resulting audit reports formulate the need for action. Companies can use this method to prove to the outside world that the minimum quality assurance requirements in the quality area in question are being reliably met.

2. Dynamic quality assurance

In the dynamic type, quality assurance follows an optimization cycle. Actual conditions are recorded and evaluated and compared with target conditions. These values are based on measured values obtained on the basis of statistical procedures or customer surveys. If deviations are identified, measures for improvement must be taken as part of quality assurance (often in the form of a balanced scorecard).

• An effective quality management system, ideally certified to ISO 9001, forms the basis. Clear documentation of all processes ensures that they are implemented in a comprehensible and consistent manner.
• The training and continuous professional development of employees is also crucial. Regular training ensures that all employees know and can apply the quality standards.
• Quality controls along the entire value chain are essential. This includes incoming goods inspections, in-process inspections during production and final inspections before delivery.
• A continuous improvement process promotes the regular review and optimization of processes. Feedback systems help to identify potential for improvement through feedback from customers and employees.
• The management of suppliers should also be a focus. Regular evaluations and close cooperation with reliable suppliers help to ensure product quality.
• Customer satisfaction is an important indicator of the quality of your services. Regular surveys and effective complaint management help you to better understand customer wishes and respond quickly to problems.
• Risk management and internal quality audits are also important. They help to identify potential risks at an early stage and ensure that all processes meet the defined quality requirements.
• Modern technologies and automation can further improve quality assurance by minimizing sources of error and increasing the efficiency of controls.
• Finally, a corporate culture should be promoted that anchors quality as a common goal. Managers should act as role models here and promote a strong awareness of quality among all employees.

There are also numerous methods for quality assurance. The best known include

Error collection cards

A defect card enables attributive testing, but only the number of defects can be evaluated. It provides valuable insights for optimizing production processes in the long term.

Process documentation

Documentation can also be important in quality assurance. Documented, planned and implemented procedures make it possible to determine how processes run. They are thus measurable.

Audits

In quality assurance, audits are used to check various parties, such as suppliers but also the company itself, for compliance with standards. A high level of conformity to standards can ensure that products and services are of a higher quality.

Analysis of measurement systems and test process suitability

These two methods ensure that measuring systems and test equipment are suitable and that measurements can be carried out without external influence.

Analysis of error possibilities and the influence of errors

The methods mentioned analyze the possibility of errors occurring or whether they occur. Processes can then be adapted accordingly to avoid these errors.

8D report

An 8D report stands for eight disciplines or process steps that are run through between the supplier and customer when a complaint arises. The 8D report is exchanged as a document. 8D reports make it possible to investigate problems schematically according to the PDCA cycle (Plan, Do, Act, Check; concept to continuously improve processes) and find suitable solutions. Troubleshooting is thus carried out with:

• immediate measures
• Determining the causes
• Measures to eliminate the errors
• Ensuring that errors do not occur repeatedly.

Quality management describes all measures that serve to ensure the minimum quality of products and services.

Quality assurance is process-related and deals with the planning of test mechanisms such as test concepts, test and measurement systems across the entire value chain or the entire manufacturing process. Quality assurance is therefore a phase of quality management

Quality control is also a part of quality management. In contrast to quality assurance, however, it is product-related. Its aim is to ensure the quality of a finished product by means of specific testing mechanisms. Quality control therefore comes into play at the end of the manufacturing process, whereas quality assurance is used as a preventative measure.

Yaveon 365 is the industry-specific ERP specifically for the requirements of companies in the process manufacturing industry. The software supports quality assurance through various functions:

• Batch management and traceability: Yaveon 365 enables seamless tracking of every batch from raw material procurement to the end customer, which is crucial for compliance with quality and safety standards.
• Quality checks and specifications: Companies can define and document specific quality inspections and specifications for raw materials, intermediates and finished products to ensure that all products meet established 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 to ensure 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 in a traceable manner, making it easier to carry out internal and external quality audits.