Quality control simply explained

Published Jul 14, 2025

Worker in a safety vest uses a tablet in a dimly lit warehouse.

What is quality control?

Quality control is a process that ensures compliance with predefined quality criteria. It checks whether the manufactured products meet these criteria and thus improves their quality. The aim is to ensure that products or services are free of defects.

What are the tasks of quality control?

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

Ensuring that products and services comply with specifications.
Checking conformity by means of test plans.
Monitoring and carrying out the tests.
Documentation and release of products.

What does an example of quality control in production look like?

Inspections are carried out and the results documented.
Measures are introduced to implement corrections and improve quality.
Systematic process and quality problems are identified.
Production is supported in avoiding errors.
Inspection personnel are qualified, supervised and monitored.
Test results are documented and approved.
Tests are carried out.
Measurements are carried out.

For whom is quality control relevant?

Quality controls are particularly relevant for companies in the process manufacturing industry. In principle, every company in every industry can benefit from quality controls. However, quality controls are particularly important and in some cases even required by law for products that could potentially harm people. This is the case, for example, in the microbiology, pharmaceutical (e.g. in the area of drug production) and laboratory, construction, medical device, food and cosmetics industries. The entire quality control process must cover the company's entire value chain in order to ensure maximum safety.

Which specific industries require strict quality controls?

Particularly in the following industries, specific regulations, provisions and legal requirements must be observed in order to guarantee the highest quality standards:

Chemical industry

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

Pharmaceutical industry

Ensuring the efficacy and safety of drugs through clinical studies and process validation.
Compliance with regulatory requirements and standards such as Good Manufacturing Practices (GMP), FDA regulations, EMA guidelines and ICH guidelines.
Avoidance of contamination and safety-related errors through strict hygiene controls and regular inspections.

Food and beverage industry

Ensuring food safety and hygiene through HACCP plans and microbiological testing.
Compliance with health regulations and quality standards such as HACCP, FDA, EU Food Hygiene Regulation and International Food Standard (IFS).
Avoidance of contamination and substances hazardous to health through strict supply chain controls and traceability systems.

Find out more here: Food quality control.

Medical devices

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

Cosmetics industry

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

Biotechnology

Ensuring the quality and purity of biotechnological products through complex validation processes and microbiological controls.
Compliance with regulations such as GMP for biopharmaceutical products, FDA biologics regulations and EMA requirements for biopharmaceuticals.
Avoidance of contamination and undesirable byproducts through strict hygiene regulations and regular monitoring of the production process.

These regulations and legal requirements ensure that quality control in these industries is carried out at the highest level to ensure consumer safety and satisfaction.

Quality control methods

100% test method

The 100% inspection method aims to inspect all items in a series and is therefore very time-consuming. It is used when the acceptance of faulty products incurs high costs or it is certain that a series is faulty.

Acceptance control method

With the acceptance control method, a fixed number of products in a series are tested. If only a few products in the sample are faulty, the entire series is accepted.

Statistical quality control

In statistical quality control, the probability of defects is determined using samples, data analyses and control charts with the aim of monitoring the quality of a facility.

Statistical process control

Using tools such as cause-and-effect diagrams and control charts, statistical process control enables discrepancies to be uncovered.

Total Quality Management (TQM)

This total quality management method focuses on all business areas in order to continually increase customer satisfaction through continuous improvements.

Six Sigma

The Six Sigma method was derived from the classic PDCA cycle (Plan, Do, Check, Act) and uses the following five steps to find and correct deviations:

Define: Define the problem
Measure: Measure the performance
Analyze: Examine the processes and uncover the causes of deviations
Improve: Optimization of processes.
Control: Control the optimized process to prevent relapses.

What are the reasons for quality controls?

There are five main reasons why quality controls are carried out:

Consistent quality: they ensure that the quality of products and services remains consistently high.
Satisfied stakeholders: They ensure that products and services meet both internal and external requirements.
Exploiting potential: They make it possible to identify and eliminate weak points in the process chain.
Compliance with legal regulations: Quality controls support compliance with legal regulations.
Prevent damage: Quality controls make it possible to identify defective goods at an early stage and remove them from circulation. This prevents both economic and personal damage.

What is the procedure for quality control?

A classic quality control process usually consists of three steps:

Incoming inspection: The incoming product or the components of the materials are checked.
Inspection during production: Quality is checked throughout the course of production or assembly.
Outgoing inspection: Before a product leaves the company, it is checked and approved in order to avoid complaints.

Abstrakte blaue und pinke, kreisförmige Linien.

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What costs can arise from poor quality control?

Prevention costs that may arise from quality and process planning, the review of product specifications or training.
Inspection costs that arise when suppliers or customers check whether a purchased product meets the specified requirements.
Internal failure costs if a product or service does not meet the quality requirements and the customer is therefore not satisfied. For example, this may involve production downtime or the sorting out of rejects and missing stock.
External failure costs if defects are found in a product or service. Examples include the processing of complaints, returns and penalties.
Loss of license/approval for the industry

What facilitates quality control?

Software makes things much easier compared to manual quality control. The potential of artificial intelligence is also being used more and more. They make it possible to carry out quality controls (partially) automatically. ERP systems are particularly suitable for quality control and have proven their worth, as they often already include the necessary functions.

A suitable ERP solution should include the following functions:

Settings for the quality inspection of procured and produced goods
Availability display of approved items
Processing of service orders for complaints
Notifications when an item needs to be checked
Statistics that show, for example, the complaints per supplier or employee
Supplier relationship management in order to be able to react quickly to possible quality changes
Checks on incoming products
Possibility to quarantine products and/or batches

Difference between quality control and quality assurance

Quality assurance is part of the development and creation of products and is therefore a process-related concept. It is concerned with planning the use of testing concepts, testing and measuring systems and other testing mechanisms in advance across the entire value chain or the entire manufacturing process.

Quality control, on the other hand, is a product-related concept whose aim is to check whether a manufactured product meets the predefined quality criteria. Quality assurance is therefore a process upstream of product development, while quality control comes into play downstream at the end of the manufacturing process. However, quality assurance and quality control are both part of quality management.

Effective quality control with Yaveon 365

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

Traceability: Track every batch throughout the entire production process. This allows you to quickly identify the affected batches in the event of quality problems and take appropriate action.
Batch logs: Document all relevant data and events for each batch to provide complete evidence for quality audits and inspections.

Quality control

Quality inspection plans: Define inspection plans for different product types and batches. These plans can include specific tests and inspection procedures to ensure quality standards are met
Inspection processes/inspection origin: Comprehensive quality controls can be carried out along the entire value chain, including warehouse receiving, in-process and shipment inspections as well as stability test orders. It is possible to carry out both full and partial inspections.
Inspection results: Record and manage the results of quality inspections centrally. Deviations can be recognized immediately and measures can be initiated.
Inspection types: Both test equipment and test objects as well as articles and batches can be flexibly inspected in order to ensure detailed inspections in all relevant areas of production as required.

Workflow management

Automated workflows: Implement automated workflows for quality inspections and release processes. This ensures that no batch is released without the necessary quality checks.
Notifications: Automatic notifications immediately inform the responsible employees of quality problems or deviations so that action can be taken quickly.

Reporting and analytics

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

Compliance and certification

Regulatory requirements: Ensure that relevant regulatory requirements and industry standards are met. Yaveon 365 supports you in providing the necessary evidence and documentation.
Audit trail: A complete audit trail allows you to track and document every change and event related to quality control.

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