Design Review, Verification and Validation

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ISO 9000:2015 Definitions:

1. Review:

determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.

  • EXAMPLES: Management review, design and development review, review of customer requirements, review of corrective action and peer review.

2. Verification:

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

  • The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.
  • The word “verified” is used to designate the corresponding status.

3. Validation:

confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

  • The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.
  • The word “validated” is used to designate the corresponding status.
  •  The use conditions for validation can be real or simulated.
Aspect Review Verification Validation
ISO 9000:2015 Definition Determination of the suitability, adequacy, or effectiveness of an object to achieve established objectives. Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
Purpose To evaluate the design's ability to meet objectives and identify areas for improvement. To ensure the product meets all specified design and requirement specifications through objective evidence. To ensure the product performs satisfactorily in its intended use environment, through objective evidence.
Focus On evaluating design documentation, processes, and plans for their capability to meet objectives. On assessing the product against specific requirements and specifications. On confirming that the product meets user needs and intended use in real or simulated environments.
Activities Management reviews, design and development reviews, reviews of customer requirements, and peer reviews. Inspections, testing, reviewing documents, and performing alternative calculations. Testing, performing alternative calculations, reviewing documents, and scenario-based assessments.
When it Occurs Throughout the design phase and at key milestones in the development process. After the completion of development stages, prior to validation. At the end of the development process, before product release.
Outcome Identification of improvements, confirmation of design adequacy, and suitability for objectives. Evidence that the product meets specified requirements. Evidence that the product is capable of meeting its intended use in specified conditions.
Responsibility Carried out by the design team and stakeholders involved in the development process. Conducted by quality assurance teams, engineers, and testers. Involves end-users, customers, and sometimes independent validators.

Review, Verification and Validation:

Reviews are conducted to evaluate the ability of the results of design and development to meet requirements;

Review: Will this design achieve the required objective?

Verification activities are conducted to ensure that the design and development outputs meet the input requirements;

Verification: Whether output meets input requirements (e.g. codes, specifications)

Validation activities to ensure that the resulting products and services meet the requirements for the specified application or intended use;

Validation: Does the product serve the required purpose? (live test)






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