The concept of "validation" is used in various areas of human activity. The main point of validation is to reconcile the exhibited requirements that are required to achieve the set goal.
Basic terms of the term “validation”
Two terms should not be confused - “validation” and “verification”, there is a significant difference between them. Validation - what is it? In simple words, you can say this: this is the process of bringing objective evidence that the requirements of a certain external consumer or user of a service / product / system are fully satisfied.
When is it necessary to validate?
According to the international quality standard ISO 9001, an enterprise is obliged to certify all activities of manufacturing and services, if the final product cannot be monitored by monitoring or subsequent measurement, and, as a result, shortcomings can be identified only after providing the service or application of the product. It follows that for all actions of obtaining products that are being carried out outside the production walls, it is necessary to carry out validation.
What does validation mean? The procedure involves a set of measures that are aimed at proving that all systems, algorithms, equipment, materials used and so on lead to the desired results. If during validation or on the basis of the indicators get a bad assessment, all used resources are written off into losses automatically.
Validation of equipment
In the manufacture of equipment, all manufacturers specify the conditioned properties of the product. These include:
- Network settings and more.
As a rule, users are primarily interested in: performance range, reliability and stability. It is the last two indicators studied during the audit. Validation - what is it in simple terms? Indications:
- For equipment that was first installed, it is necessary to carry out validation, it is also recommended to do this after any movement.
- The frequency of repetitions of the validation performance determines the stability of the equipment performance.
- The frequency of execution of equipment validation and analysis of the results are discussed with the customer. In some cases, the test equipment necessary to carry out before the start or after a long idle.
Validation of production involves the rationale that the process will lead to the achievement of established results. Verification should be carried out when starting a new production process or when making amendments. Terms of secondary validation after making changes are negotiated with the customer or are established on the basis of internal requirements of the enterprise.
For certain types of production process validation is required at each start of the line or after a long idle. In this case, a simplified validation plan is applied, but the assessment is more thorough.
Validation of products differs from other types because in this case (but not replaced) the whole chain of production, including inspection of equipment and process. The objective of the audit is to certify that all procedures and processes will lead to the production of the desired product. Validation of products is a complex research:
- Numerical indicators.
- Qualitative indicators.
The check is carried out at the initial stage of production and is repeated when making any amendments to the product configuration.
Validation in the quality management system in accordance with ISO 9000 samples
Validation is evidence based on the provision of evidence that the requirements that are intended for a particular application or use are fulfilled (ISO 9000: 2005). There is a procedure to confirm the method of examination and the provision of objective information.
- In the development and design of the approval refers to the fact that the examination of the product to determine compliance with the needs of the consumer.
- The approval process is usually carried out on the final product and in the specified operating conditions. In some cases, validation is carried out in the early stages of production.
- The term "approved" is used to denote the corresponding status. With a diverse application of the product, approval occurs many times (ISO 8402: 1994, clause 2.18).
Differences between validation and verification
Verification, as a rule, is an internal process for regulating product quality, which occurs in accordance with instructions, samples and specifications. What is the difference between validation and verification?
- Validation is proof that you have produced the right product.
- Verification - confirmation that the product turned out the way you wanted to make it.
An example of standard verification is the performance of equipment testing.
- Receipt / confirmation of requirements and standards for the product.
- The implementation of the test.
- Record results, check for compliance.
- Results of verification.
Even if the product fully meets the requirements, it is not always possible to use it in a particular situation.
For example, a medical drug passed all the necessary checks and entered into implementation. Does this mean that any patient can take it? No, because any patient has features of the body, and the drug itself can be harmful in its situation, so the patient should consult with the attending doctor, who, in turn, must attest: yes, this patient is shown to use this drug. Here is the answer to the question: what is validation? In simple words, it is a test of the product for use in this situation, that is, the doctor performs the validation process.
Another example: the company is engaged in the production of pipes for laying in the ground according to the technical specifications (technical conditions). The product fully meets the requirements, but an order has been made to lay pipes on the seabed. In this case, can pipes designed to be laid in the ground be used for laying under water? Validation will give the answer to the question.
Another difference of these processes is that verification is always carried out, but the need for validation may be absent. Validation - what is it in simple words, what are the indications for its implementation?
The need arises only in those cases when they arise requirements associated with a particular use of the product. If the factory produces pharmaceutical drugs, it will only check for compliance, and use of certain medications patients will not be engaged.
From here, the following can be distinguished:
- Verification is a continuous process, and executed it by reviewing the characteristics of the product with the set requirements, the result of the decision on compliance/noncompliance with these requirements.
- Validation is performed on demand and is executed by examining the specified conditions of use and conformity assessment of the product characteristics these conditions, the result of a decision about product usage in a particular situation.
To summarize, we answer the question: validation - what is it? In simple terms, this is a confirmation that is created on the basis of objective evidence that the conditions for a particular use or application have been met with accuracy and in full, and this means that the goal has been achieved.