Abstract:
Demonstartion of a product or product component fulfills its intended use when placed in its intended environment is the sole purpose of validation.
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. 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 user needs.
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, or
simulation). Often, the end users are involved in the validation activities.Both validation and verification activities often run concurrently and may use portions of the same environment.
Where possible, validation should be accomplished using the product or product component operating in its intended environment. The entire environment may be used or only part of it. However, validation issues can be discovered early in the life of the project using work products.
When validation issues are identified, they are referred to the processes associated with the Requirements Development, Technical Solution, or Project Monitoring and Control process areas for resolution.
The specific practices of this process area 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 the methods to be used to perform the validation. The Establish the Validation Environment specific practice enables the determination of the environment that will 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 the methods, procedures, and criteria.
Specific and Generic Goals
SG 1 Prepare for Validation
Preparation for validation is conducted.
SG 2 Validate Product or Product Components
The product or product components are validated to ensure that they are suitable for use in their intended operating environment.
GG 3 Institutionalize a Defined Process
The process is institutionalized as a defined process.
