Verification and validation
In the verification ( latin Veritas 'truth' and facere make '), it is checked whether a product in its development with the specified requirements, recorded in the specification of a business matches, while the validation (from latin validus , strong', effectively ',' Fixed ') is a type of field experiment in which it is checked whether defined usage goals are met and thus the requirements of the customer are checked for suitability.
According to quality management standards , the development planning of a product includes successful verification and validation in order to meet the quality requirements. Both are aspects of test procedures and cannot always be clearly distinguished. During product development in a company, verification usually takes place first and then validation. The tests are carried out on a random basis.
In the long term, these procedures can save costs, as, for example, expensive product recalls due to product defects or delayed product launches can be avoided and the guarantee costs remain low. In addition, these processes improve product quality. These factors are particularly important to stay competitive in the market.
verification
Verification is a test procedure with objective means that checks whether specified product properties are fulfilled. This procedure verifies and checks whether a system or product in production has been implemented in accordance with the requirements specified in the specification. This means ensuring that the findings (development results) determined after the test procedure correspond to the theoretical requirements (development inputs).
The aim of verification is the early detection of errors in order to avoid time-consuming and costly corrections in the later production process. The formal verification takes place objectively, i.e. with the help of test equipment, and is based on the level of precise and unambiguous mathematical models according to defined rules.
The verification is not proof of whether a product is free of defects in the interests of the consumer, as only defects that have arisen after the specification was created (description of a product by listing its requirements) can be found. In some cases, the specification itself can be faulty, which means that these errors can run through the entire production process, which results in enormous costs, as it can lead to delays in product launch, for example.
In the specification, for example, it could be specified that a defibrillator must have a certain voltage for a certain period of time. The verification would then be to check whether this voltage is really present for the specified time.
Validation
The validation begins with the selection of specified requirements for the achievement of usage goals and can only be completed after verification of the implemented requirements. It uses objective means to check whether users can achieve the previously defined usage goals in a specific usage context. It can be seen as a kind of field test that checks whether the product really does what the customer expects. Representative users are required for this field test.
The validation consists on the one hand of the classic validation, which is associated with the question “Can I even achieve my usage goals?”. In addition, there is usability validation, which has the character of a field test mentioned above and checks the defined special usage requirements with test persons. In the end, a statement can be made about the applicability of the product for problem solving.
The whole thing can be illustrated using the example of the defibrillator: First of all, it was verified that the correct voltage was present in the specific time span. The classic validation then checks whether the applied voltage can really make the heart beat regularly again before the usability validation lets laypeople in the cold or at night, for example, check the usage target.
Differences between validation and verification
While the verification is used according to the requirements in the internal production process, i.e. checks whether a product is being created correctly, the validation relates to the specific expectations of the customer based on the question: "Are we creating the right product?" In theory, verification is used for authentication , i.e. it is evidence of a property that the product claims to have. The validation is used for referencing. In practice, however, validation is carried out by checking to what extent the procedure is practicable and feasible. The verification is used for precise measurement and testing in order to determine the clear identification of the product.
It should be noted that validation and verification can be successful independently of one another. This becomes clear from the example mentioned above: In a defibrillator, 3000 volts should be applied for 3 milliseconds in order to bring a heart back into its normal rhythm. If the 3000 volts are applied for 3 milliseconds, but the heart does not beat in the right rhythm again after defibrillation, the verification is successful, but the validation has failed. In the opposite case, only 2000 volts would be applied for 3 milliseconds and the heart would beat again in the correct rhythm despite the insufficient voltage. The verification failed and the validation was successful.
Procedure based on an example
Before a medical device can be placed on the market, it must go through certain procedures in order to be approved. This is prescribed in the Medical Devices Act (MPG) to protect users, patients and third parties. The manufacturer must prove that the product is both functionally and hygienically safe and that it fulfills all of the properties described by it. In certain cases, a clinical trial is also necessary if, for example, no other data from comparable products is available yet. The aim is to collect data and then evaluate it.
Example of validation of disinfection processes: In the Medical Device Operator Ordinance (MPBetreibV), Section 4, Paragraph 1 stipulates that medical devices must be reprocessed using validated processes.
- Installation qualification: First of all, it is generally determined whether the product is suitable. This step is carried out by the manufacturer.
- Operational qualification: The products are accepted by the manufacturer under on-site conditions in order to prove that the specified service is also provided on site.
- Performance qualification: The manufacturer assesses the chemical, physical and microbiological effectiveness in order to prove that all products can be cleaned safely.
- All steps are documented in the validation report.
- The manufacturer then works out suitable work steps and work instructions together with the operator.
This example relates to the area of medical devices, but the verification and validation procedures also follow this scheme in other areas of product development. Since verification and validation cannot always be clearly separated, some of these steps can also be included in the verification process.
bibliography
- Gert Schorn: Medical Devices Act . Scientific Publishing Company; 3rd edition (2002)
- Peter Hensen: Quality Management in Healthcare: Basics for Studies and Practice . Springer Verlag (2016)
- Imke Presting, Dorothea Langer: " QM for everyone! 9001: 2008: Quality management - not only - for small companies ". Pro Business, 1st edition (2009)
See also
Individual evidence
- ↑ a b qm-core . Retrieved May 31, 2016.
- ↑ a b Parametric Technology Corporation ( Memento of the original from May 31, 2016 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. . Topic Sheet: Verification and Validation , Retrieved May 31, 2016.
- ↑ a b c Johner Institute . Verification and Validation: Difference & Definition , Retrieved May 31, 2016.
- ↑ ISO 9001 . Quality and Norm , Accessed May 31, 2016.
- ↑ University of Kassel . Introduction to Formal Verification , Retrieved May 31, 2016.
- ↑ University of Paderborn . Validation and Verification , Accessed May 31, 2016.
- ↑ project management . Retrieved May 31, 2016.
- ↑ MPG . Medical Devices Act , accessed on May 31, 2016.
- ↑ bfarm . Medical Devices , Retrieved May 31, 2016.
- ^ Government of Swabia . Validation of cleaning / disinfection processes , accessed on May 31, 2016.
