Purpose:

Demonstrate that a product or product component fulfills its intended use when placed in its intended environment.

Objective:

Establishes organizational expectations for selecting products and product components for validation; for selecting validation methods; and establishing and maintaining validation procedures, criteria, and environments that ensure the products and product components satisfy end user needs in their intended operating environment.

Description:

Validation activities can be applied to all aspects of the product in any of its intended environments, such as operation, training, manufacturing, maintenance, and support services. The methods employed to accomplish validation can be applied to work products as well as to the product and product components. (Throughout the process, where the terms “product” and “product component” are used, their intended meanings also encompass services, service systems, and their components.) The work products (e.g., requirements, designs, prototypes) should be selected on the basis of which are the best predictors of how well the product and product component will satisfy end-user needs, and thus validation is performed early (concept/exploration phases) and incrementally throughout the product lifecycle (including a transition to operations and sustainment).

The validation environment should represent the intended environment for the product and product components as well as represent the intended environment suitable for validation activities with work products.

Validation demonstrates that the product, as provided, will fulfill its intended use; whereas, verification addresses whether the work product properly reflects the specified requirements. In other words, verification ensures that “you built it right”; whereas, validation ensures that “you built the right thing.” Validation activities use approaches similar to verification (e.g., test, analysis, inspection, demonstration, simulation). Often, the end users and other relevant stakeholders are involved in the validation activities. Both validation and verification activities often run concurrently and can use portions of the same environment.

Refer to the Verification process for more information about ensuring that selected work products meet their specified requirements.

Whenever possible, validation should be accomplished using the product or product component operating in its intended environment. The entire environment can be used or only part of it. However, validation issues can be discovered early in the life of the project using work products by involving relevant stakeholders. Validation activities for services can be applied to work products such as proposals, service catalogs, statements of work, and service records.

When validation issues are identified, they are referred to processes associated with the Requirements Development, Technical Solution, or Project Monitoring and Control process for resolution.

These  processes build on each other in the following way:

    • The Select Products for Validation specific practice enables the identification of the product or product component to be validated and methods to be used to perform the validation.
    • The Establish the Validation Environment-specific practice enables the determination of the environment to be used to carry out the validation.
    • The Establish Validation Procedures and Criteria specific practice enables the development of validation procedures and criteria that are aligned with the characteristics of selected products, customer constraints on validation, methods, and the validation environment.
    • The Perform Validation-specific practice enables the performance of validation according to methods, procedures, and criteria.

Entrance Criteria:

  • Test Management Tools
  • Test Case Generators
  • Test Coverage Analyzers
  • Simulators
  • Lad, Stress, and Performance Testing Tools

Exit Criteria:

  • Lists of Products and Product Components Selected for Validation
  • Validation Methods, Procedures, and Criteria
  • Validation Reports

Process and Procedures:

Tailoring Guidelines:

Organizations may choose to purchase a validation process and procedures rather than develop them.  Using the Causal Analysis and Resolution process, they can tailor the process to fit their organization. 

Process Verification Record(s):

  • Product component prototype
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  • Percentage of time the validation environment is available
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  • Number of product defects found through validation per development
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  • Validation analysis report
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  • Validation reports
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  • Validation results
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  • Validation cross reference matrix
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  • As-run procedures log
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  • Operational demonstrations
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  • Validation deficiency reports
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  • Validation issues
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  • Procedure change request
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Process Verification Record(s)

  • Validation reports
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  • Validation results
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  • Validation cross reference matrix
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  • As-run procedures log
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  • Operational demonstrations
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  • Validation deficiency reports
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  • Validation issues
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  • Procedure change request
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Measure(s):

  • Compare actual results to expected results.
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  • Based on the established validation criteria, identify products and product components that do not perform suitably in their intended operating environments, or identify problems with methods, criteria, or the environment.
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  • Analyze validation data for defects.
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  • Record results of the analysis and identify issues.
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  • Use validation results to compare actual measurements and performance to the intended use or operational need.
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  • Provide information on how defects can be resolved (including validation methods, criteria, and validation environment) and initiate corrective action.
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  • Compare actual results to expected results.
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  • Based on the established validation criteria, identify products and product components that do not perform suitably in their intended operating environments, or identify problems with methods, criteria, or the environment.
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  • Analyze validation data for defects.
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  • Record results of the analysis and identify issues.
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  • Use validation results to compare actual measurements and performance to the intended use or operational need.
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  • Provide information on how defects can be resolved (including validation methods, criteria, and validation environment) and initiate corrective action.
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  • Number of validation activities completed (planned versus actual)
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  • Validation problem report trend (i.e. number written, number closed)
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  • Validation problem report aging (i.e. how long each problem report has been open)
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  • Schedule for a specific validation activity
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References: