Quality control explained simply

As part of quality management, quality control essentially covers the following tasks:

• Ensuring that products and services meet defined requirements
• Checking conformity using inspection plans
• Monitoring and performing inspections
• Documenting results and approving products

• Inspections are carried out and the results documented.
• Corrective measures are initiated to implement improvements and enhance quality.
• Systematic process and quality issues are identified.
• Production is supported in preventing errors.
• Inspection staff are trained, supervised, and monitored.
• Test results are documented and released.
• Tests are performed.
• Measurements are taken.

Quality control is especially relevant for companies in the manufacturing sector of the process industry. In principle, though, businesses in any industry can benefit from quality control.

It is particularly important – and in some cases even legally required – for products that could potentially cause harm to people. This applies, for example, to the fields of microbiology, pharmaceuticals (e.g. drug manufacturing), laboratories, construction, medical technology, food, and cosmetics.

To ensure maximum safety, the entire quality control process must cover the company’s complete value chain.

Strict regulations, standards, and legal requirements must be observed in the following industries to ensure the highest quality standards:

Chemical industry

• Ensure product purity and compliance with environmental and safety standards through strict monitoring of production processes and regular analyses
• Comply with legal requirements such as the REACH regulation, CLP regulation, and GHS (Globally Harmonized System)
• Prevent environmental damage and safety-related risks through comprehensive risk assessments and safety management systems

Pharmaceutical industry

• Ensure the efficacy and safety of medicines through clinical trials and validation procedures
• Comply with regulatory requirements and standards such as Good Manufacturing Practices (GMP), FDA regulations, EMA guidelines, and ICH guidelines
• Prevent contamination and safety-related errors through strict hygiene controls and regular inspections

Food and beverage industry

• Guarantee food safety and hygiene through HACCP plans and microbiological testing
• Comply with health regulations and quality standards such as HACCP, FDA, the EU Food Hygiene Regulation, and the International Food Standard (IFS)
• Prevent contamination and harmful substances through strict supply chain controls and traceability systems

Learn more here: Quality control for food products

Medical technology

• Ensure the safety and effectiveness of medical devices and instruments through risk assessments and validation methods
• Comply with regulatory requirements and quality standards such as ISO 13485, FDA 21 CFR Part 820, MDR (Medical Device Regulation), and CE marking
• Prevent errors that could endanger patients through regular quality checks and corrective measures

Cosmetics industry

• Ensure the safety and effectiveness of cosmetic products through toxicological assessments and ingredient testing
• Comply with legal requirements and quality standards such as the EU Cosmetics Regulation (Regulation (EC) No. 1223/2009) and GMP for cosmetics (ISO 22716)
• Prevent harmful ingredients and product defects through regular safety assessments and strict raw material controls

Biotechnology

• Ensure the quality and purity of biotechnological products through extensive validation procedures and microbiological testing
• Comply with regulations such as GMP for biopharmaceutical products, FDA biologics regulations, and EMA requirements for biopharmaceuticals
• Prevent contamination and unwanted by-products through strict hygiene rules and continuous monitoring of the production process
• These regulations and legal requirements ensure that quality control in these industries is carried out at the highest level – safeguarding both consumer safety and satisfaction. 

100% inspection method

This method aims to check every single item in a series and is therefore very resource-intensive. It is used when defective products would cause high costs at acceptance or when it is certain that a series contains defects.

Acceptance sampling method

Here, a defined number of products from a series is inspected. If only a few defects are found in the sample, the entire series is accepted.

Statistical quality control

This approach uses sampling, data analysis, and control charts to calculate the probability of defects, with the goal of monitoring the quality of a facility.

Statistical process control

With tools such as cause-and-effect diagrams and control charts, statistical process control helps uncover inconsistencies in production.

Total Quality Management (TQM)

TQM takes all business areas into account, with the aim of continuously improving processes to steadily increase customer satisfaction.

Six Sigma

Derived from the classic PDCA cycle (Plan, Do, Check, Act), the Six Sigma method uses five steps to identify and correct deviations:

• Define: Define the problem
• Measure: Measure performance
• Analyze: Examine processes and identify causes of deviations
• Improve: Optimize processes
• Control: Monitor the optimized process to prevent relapse

There are essentially five key reasons why quality controls are carried out:

• Consistent quality: Ensure that the quality of products and services remains consistently high.
• Satisfied stakeholders: Guarantee that products and services meet both internal and external requirements.
• Unlock potential: Identify and eliminate weaknesses in the process chain.
• Compliance with legal regulations: Support companies in meeting regulatory requirements.
• Damage prevention: Detect and remove defective goods at an early stage – preventing both economic losses and harm to people.

A classic quality control usually consists of three steps:

1. Incoming inspection: The delivered product or material components are checked.
2. In-process inspection: Quality is continuously monitored during production or assembly.
3. Final inspection: Before a product leaves the company, it is tested and released to prevent complaints.

• Prevention costs: Costs for quality and process planning, checking product specifications, or employee training.
• Inspection costs: Incurred when suppliers or customers verify whether a purchased product meets requirements.
• Internal failure costs: Arise when a product or service does not meet quality standards and customer expectations are not fulfilled – for example, production downtime, scrapping defective goods, or handling stock discrepancies.
• External failure costs: Occur when defects in a product or service are discovered after delivery – such as handling complaints, processing returns, or paying penalties.
• Loss of license/industry approval: In regulated industries, inadequate quality control can even lead to the withdrawal of licenses or certifications.

Compared to manual quality checks, software provides a significant advantage. Increasingly, the potential of artificial intelligence is also being used, enabling (partly) automated quality controls. ERP systems are particularly well-suited and proven in this area, as they often already include the required functionality.

An effective ERP solution for quality control should include features such as:

• Settings for testing purchased and manufactured goods
• Availability display of approved items
• Processing service orders for complaints
• Notifications when an item requires inspection
• Statistics, e.g. complaints per supplier or employee
• Supplier relationship management to react quickly to potential quality changes
• Inspection of incoming goods
• Ability to quarantine products and/or batches

Quality assurance is part of the development and creation of products and therefore a process-oriented concept. It focuses on planning inspection concepts, test and measurement systems, and other quality mechanisms across the entire value chain and throughout the manufacturing process.

Quality control, on the other hand, is product-oriented. Its goal is to check whether a finished product meets the predefined quality criteria. Quality assurance is thus a preventive process that takes place upstream in product development, while quality control is reactive and takes place at the end of the production process.

Both quality assurance and quality control are integral parts of quality management.

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

Batch management

• Traceability: Track every batch throughout the entire production process. This enables you to quickly identify affected batches in the event of quality issues and take corrective measures.
• Batch logs: Document all relevant data and events for each batch to provide a complete record for audits and quality checks.

Quality control

• Quality inspection plans: Define inspection plans for different product types and batches. These can include specific tests and inspection procedures to ensure compliance with quality standards.
• Inspection processes and sources: Carry out comprehensive quality controls across the entire value chain, including incoming goods, in-process, and pre-shipment inspections, as well as stability tests. Both full and partial inspections are possible.
• Inspection results: Record and manage quality test results centrally. Deviations can be detected immediately, and corrective actions initiated.
• Types of inspections: Flexibly test inspection tools, test objects, articles, and batches to ensure tailored and detailed quality checks in all relevant areas of production.

Workflow management

• Automated workflows: Implement automated workflows for inspections and release processes, ensuring that no batch is released without the required quality checks.
• Notifications: Automatic alerts immediately inform responsible staff about quality issues or deviations, enabling fast response.

Reporting and analytics

• Quality reports: Generate detailed reports on the quality performance of your products. These can be used for internal evaluations, quality audits, and communication with customers and suppliers.
• Trend analyses: Evaluate quality data over different time periods to identify trends and drive long-term improvements in production processes.

Compliance and certification

• Regulatory requirements: Ensure compliance with relevant regulations and industry standards. Yaveon 365 helps you maintain required records and documentation.
• Audit trail: A complete audit trail enables you to track and document every change and event related to quality control.