What can go wrong during product validation – and how to avoid it
Validation is an essential step in product development. It ensures that products fulfil the required quality and safety standards. In this article, we offer you a comprehensive insight into the most important aspects of validation, explain possible challenges and show how these can be successfully overcome.
What is validation?
Validation is a systematic process that aims to confirm that a test procedure or test system reliably fulfils the specified requirements. It ensures that products are tested under realistic conditions and meet the desired quality standards. This is particularly important in regulated sectors such as the automotive, medical technology and aviation industries.
Why is validation so important?
Without careful validation, serious quality and safety issues can arise, jeopardising not only the product itself, but also the company and its reputation. An inadequately validated process could lead to defects being recognised late in the development cycle – or worse still, only after market launch. This can lead to costly recalls, loss of reputation and legal consequences.
The validation process: a deeper look
The validation process is divided into several phases, all of which must be carefully planned and executed in order to achieve the desired results:
1. Planning phase
Planning is the foundation of a successful validation process. The objectives of the validation are determined, time and budget frameworks are defined and the necessary resources are planned. Well thought-out planning ensures that validation is not just a formal step, but an integral part of the entire development process.
Important considerations:
- Time and budget: Validation should be included in the project plan from the outset. Insufficiently planned validation can lead to considerable delays and budget overruns. As a rule, at least three to six months should be planned for validation.
- Specifications and requirements: All relevant standards and requirements must be clearly defined from the outset. This applies to both technical specifications and legal requirements.
2. Provision of the necessary test specimens
Comprehensive validation often requires numerous test specimens, all of which must fulfil the same quality requirements. The early procurement and testing of these test specimens is crucial to ensure that they meet the defined specifications and that the validation can be carried out under the intended conditions.
Important considerations:
- Availability: It must be ensured that all required test specimens are available in good time in order to avoid delays in the validation process.
- Test equipment: The required equipment, such as power supply units, test setups or measuring devices, must be planned and provided at an early stage. The calibration and validation of the equipment should also be part of the preparation.
3. Carrying out the validation
The validation process comprises the actual tests and inspections in which the test specimens are subjected to the defined loads and scenarios. Careful documentation is crucial here in order to make the results traceable and verifiable.
Step-by-step implementation: As it is often difficult to provide and test all test specimens at the same time, it is recommended that validation is carried out in stages. This reduces the risk of failures and ensures that the results are consistent and comparable for each test item.
Documentation: Each phase of the validation process must be carefully documented to demonstrate compliance with the standards and to keep the results available for future audits or certifications.
Challenges during validation
Wie in jedem komplexen Prozess gibt es auch bei der Validierung potenzielle Herausforderungen, die es zu meistern gilt. Unsere Erfahrungen bei enveon haben gezeigt, dass besonders die folgenden Themen immer wieder kritisch werden:
- logistical coordination: The provision of test samples at the right time is a challenge that should not be underestimated. Missing or late test samples often lead to interruptions and unnecessary delays. Our advice: Ensuring the availability of test samples in good time saves time and avoids stress.
- unexpected technical problems: It is not a question of whether technical problems will occur during validation, but when. Defective test specimens or other unforeseen difficulties are part of the process. At enveon, we have learnt that it is crucial to have clear protocols for such cases in order to react quickly and keep the process running.
- changes in the specifications: There are often necessary adjustments to specifications during validation. These changes must be integrated quickly and seamlessly into the process without affecting the tests that have already been carried out. Close coordination with the customer and a flexible approach are essential here.
- Cost and complexity: Another common mistake is trying to save costs by unnecessarily complicating the validation process. In practice, we often see companies avoiding duplicate tests or artificially shortening the process for fear of high costs. However, our experience shows that these supposed savings often come back with a factor of 10 in the end because unforeseeable problems occur.
Relevance for the automotive industry
The validation of test processes is particularly relevant in the automotive industry, as the safety and quality requirements are extremely high.
Components such as control units, sensors or battery systems must function reliably, even under extreme conditions.
Careful validation helps to identify potential errors at an early stage and rectify them before they can lead to major problems.
This not only reduces the risk of recalls, but also strengthens consumer confidence in the reliability of vehicles.
Relevance for the commercial vehicle industry
Validation is also essential in the commercial vehicle industry.
Vehicles such as trucks, buses or agricultural machinery are exposed to high loads on a daily basis and their components must be extremely robust and durable.
From braking systems to passenger information systems and door controls – all components must work reliably in different environmental conditions.
Well-founded validation can not only increase operational safety, but also avoid unnecessary downtime and expensive repairs.
Relevance for industry
Reliable testing processes play a crucial role in industry, especially when it comes to high-performance systems, robots or control units.
These components must function permanently in often extreme environments – heat, cold, humidity or vibrations.
A faulty component can stop production and lead to high costs.
Careful validation helps to avoid production downtimes and ensure the longevity of the systems.
In all of these sectors – from the automotive industry and medical technology to commercial vehicles and industrial applications – validation not only enables smooth operation, but also ensures trust and safety at all levels.
Relevance for medical technology
In medical technology, the validation of test processes is even vital.
Devices such as ventilators, data loggers or diagnostic devices must meet strict regulatory requirements and work with absolute reliability.
Failure here can have dramatic consequences.
Validation ensures that the products function smoothly even in critical situations or under extreme conditions.
Comprehensive testing ensures that patients and medical staff can rely on the devices, which significantly increases confidence in medical technology.
enveon: Your partner for successful validation
Validation plays a central role at enveon. With our extensive experience and state-of-the-art equipment, we support you in validating your test processes precisely and efficiently. Our flexible resources enable us to respond quickly to your requirements, whether it’s planning, providing the necessary test specimens or carrying out the validation.
We know that every project is unique and has individual requirements. That’s why we offer customized solutions that are precisely tailored to your needs.
Get in touch with us
If you have any questions about validation or need support in carrying out your validation processes, we are always at your disposal. Contact us at the telephone number: +498935647938 . Our team looks forward to helping you select the right tests and successfully implement your projects.
