The concept of "validation" is applied in various areas of human activity. The main point of validation is to reconcile the set requirements that are required to achieve the stated goal.

Validation - what is it in simple words? The validation in the quality management system

The main meaning of the term "validation"

Do not confuse the two terms - "validation" and "verification", between them a significant difference. Validation - what is it? In simple words, we can say this: it is the process of bringing objective evidence that the requirements of a certain external consumer or user of the service / product / system are fully satisfied.

When is it necessary to carry out validation?

According to the international quality standard ISO 9001, the enterprise is obliged to conduct certification of all actions of production and services, if the final product can not be subject to monitoring or subsequent measurement, and as a consequence, defects can only be identified after the service is provided or the product is applied. Hence it follows that for all actions to obtain products that are carried out outside the walls of production, it is necessary to carry out validation.

What does validation mean? The procedure involves a set of activities that are aimed at proving that all systems, algorithms, equipment, materials used and the like lead to the necessary results. In the event that in the validation or as a result of the indicators receive a bad evaluation, all used resources are automatically written off to losses.

Validation of equipment

In the manufacture of equipment, all manufacturers indicate the conditioned properties of the product. These include:

  • Terms of Use.
  • Weight.
  • Dimensions.
  • Power network parameters and stuff.

Typically, users are primarily interested in: the range of performance, reliability and stability. It is the last two indicators that are studied during the audit. Validation - what is it in simple words? Indications:

  • For equipment that was installed for the first time, it is necessary to perform validation, it is also recommended to do this after any movement.
  • The repetition frequency of validation determines the stability of the performance of the equipment.
  • 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.

Process validation

Validation of production involves justification that the process will lead to the achievement of established results. The check should be carried out when starting a new production process or when making corrections. The conditions of secondary validation after making changes are discussed with the customer or established on the basis of internal requirements of the enterprise.

For certain types of production, process validation is required to be carried out every time the line is started or after a long idle period. In this case, a simplified validation plan is applied, but the assessment is more thorough.

Product validation

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 any corrections are made to the configuration of the products.

Validation in the quality management system in accordance with ISO 9000 standards

Validation is a confirmation on the basis of providing evidence that the requirements that are intended for a particular application or use are met (ISO 9000: 2005). There is a procedure for confirming the method of examination and providing objective information.

  • When developing and designing, the statement means that the product has been examined to determine whether it meets 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 indicate the corresponding status. With a diversified application of the product, the assertion occurs repeatedly (ISO 8402: 1994, paragraph 2.18).

Differences between validation and verification

Verification, as a rule, is an internal process of product quality regulation, which occurs in accordance with instructions, samples and specifications. What is the difference between validation and verification?

  • Validation is the confirmation that you have produced the right product.
  • Verification is a confirmation that the product has turned out the way you wanted it to be.

An example of standard verification is the performance of equipment testing.

  • Obtaining / confirming the requirements and standards for the product.
  • Implementation of tests.
  • Fixing the results, checking for compliance.
  • Results of verification.

Even if the products fully meet the requirements, it is not always possible to use it in a specific situation.

For example, a medical product has passed all the necessary checks and entered the implementation. Does this mean that it can be taken by any patient? No, since any patient has features of the body, and the drug itself can be harmful in his situation, the patient should consult with the treating doctor, who in turn must testify: yes, this patient shows the use of this drug. Here is the answer to the question: Validation - what is it? In simple words, this is a product check for the possibility of applying 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 in accordance with specifications (technical specifications). The product fully meets the requirements, but the order for laying pipes on the seabed is made. In this case, can pipes intended for laying in the ground be used for underwater laying? It is the conduct of validation that will answer the question posed.

Another difference between 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 it?

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.

Hence we can distinguish the following:

  • 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.

Summarizing, answer the question: Validation - what is it? In simple words, this is a confirmation, which is created on the basis of objective evidence that the conditions for a particular use or application are met with accuracy and in full, and therefore the goal has been achieved.

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