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Friday, March 27, 2015

Verification and Validation in QMS

Verification and Validation in QMS

People generally ask difference in verification and validation. These are two terms having the same objective 'confirmation' through the provision of objective evidence. ISO 9000:2005 has defined both terms as under:

Verification: Verification is the conformation through the objective evidence that specified requirements have been fulfilled.

Validation: Validation is the confirmation through the objective evidence that the requirements for a specific intended use or application have been fulfilled.

Verification ensures that the output (or the product) has satisfied the input requirements, the requirements that are specified. Validation ensure that the output (or the product) is capable of fulfilling requirements for the specified application or intended use.

There may be situations where the resulting the output (or the product) during product realization process cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become known only after the product is in use or the service has been delivered. In such situations, validation of processes ensures that the output (or the product) is fit for the intended use. Validation is required where the output (or the product) cannot be verified without damaging or destroying the output (or the product). For example it is difficult to verify the welding output or a product like a gun bullet or a tear-shell.

Verification is done by monitoring and measurement that the output meets input requirements.

Validation of a process requires establishment of certain arrangements, such as defined criteria for review of process, defined criteria for approval of the process, approval of the equipment, approval of qualification of people, use of specific methods, use of specific procedures, requirements for records and re-validation.

Accordingly, we can say that the verification is the confirmation that the right product is produced in accordance with its specifications. And validation is confirmation that the right product is produced that will meet expected results. Verification is the evaluation of whether or not the output (or the product) complies stated requirements. And validation is assurance that the output (or the product) meets the needs what is expected.

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