SG 1 Prepare for ValidationPreparation for validation is conducted. Preparation activities include selecting products and product components for validation and establishing and maintaining the validation environment, procedures, and criteria. The items selected for validation may include only the product or it may include appropriate levels of the product components that are used to build the product. Any product or product component may be subject to validation, including replacement, maintenance, and training products, to name a few. The environment required to validate the product or product component is prepared. The environment may be purchased or may be specified, designed, and built. The environments used for product integration and verification may be considered in collaboration with the validation environment to reduce cost and improve efficiency or productivity.
SP 1.1-1 Select Products for ValidationSelect products and product components to be validated and the validation methods that will be used for each. Products and product components are selected for validation on the basis of their relationship to user needs. For each product component, the scope of the validation (e.g., operational behavior, maintenance, training, and user interface) should be determined. The requirements and constraints for performing validation are collected. Then, validation methods are selected based on their ability to demonstrate that user needs are satisfied. The validation methods not only define the technical approach to product validation, but also drive the needs for the facilities, equipment, and environments. This may result in the generation of lower level product-component requirements that are handled by the requirements development processes. Derived requirements, such as interface requirements to test sets and test equipment, can be generated. These requirements are also passed to the requirements development processes to ensure that the product or product components can be validated in an environment that supports the methods. Validation methods should be selected early in the life of the project so that they are clearly understood and agreed to by the relevant stakeholders. The validation methods address the development, maintenance, support, and training for the product or product component as appropriate. Typical Work Products
Subpractices
SP 1.2-2 Establish the Validation EnvironmentEstablish and maintain the environment needed to support validation. The requirements for the validation environment are driven by the product or product components selected, by the type of the work products (e.g., design, prototype, final version), and by the methods of validation. These may yield requirements for the purchase or development of equipment, software, or other resources. These requirements are provided to the requirements development processes for development. The validation environment may include the reuse of existing resources. In this case, arrangements for the use of these resources must be made. Examples of the type of elements in a validation environment include the following:
Early selection of the products or product components to be validated, the work products to be used in the validation, and the validation methods is needed to ensure that the validation environment will be available when necessary. The validation environment should be carefully controlled to provide for replication, analysis of results, and revalidation of problem areas. Typical Work Products
Subpractices
SP 1.3-3 Establish Validation Procedures and CriteriaEstablish and maintain procedures and criteria for validation. Validation procedures and criteria are defined to ensure that the product or product component will fulfill its intended use when placed in its intended environment. Acceptance test cases and procedures may meet the need for validation procedures. The validation procedures and criteria include test and evaluation of maintenance, training, and support services.
Typical Work Products
Subpractices
SG 2 Validate Product or Product ComponentsThe product or product components are validated to ensure that they are suitable for use in their intended operating environment. The validation methods, procedures, and criteria are used to validate the selected products and product components and any associated maintenance, training, and support services using the appropriate validation environment. SP 2.1-1 Perform ValidationPerform validation on the selected products and product components. To be acceptable to users, a product or product component must perform as expected in its intended operational environment. Validation activities are performed and the resulting data are collected according to the established methods, procedures, and criteria. The as-run validation procedures should be documented and the deviations occurring during the execution should be noted, as appropriate. For users of the continuous representation, this is a capability level 1 specific practice. Validation processes at capability level 1 or 2 may not include procedures and criteria, which are created in the Establish Validation Procedures and Criteria specific practice at capability level 3. When there are no procedures or criteria established, use the methods established by the Select Products for Validation specific practice to accomplish capability level 1 performance. Typical Work Products
SP 2.2-1 Analyze Validation ResultsAnalyze the results of the validation activities and identify issues. The data resulting from validation tests, inspections, demonstrations, or evaluations are analyzed against the defined validation criteria. Analysis reports indicate whether the needs were met; in the case of deficiencies, these reports document the degree of success or failure and categorize probable cause of failure. The collected test, inspection, or review results are compared with established evaluation criteria to determine whether to proceed or to address requirements or design issues in the requirements development or technical solution processes. Analysis reports or as-run validation documentation may also indicate that bad test results are due to a validation procedure problem or a validation environment problem. Typical Work Products
Subpractices
|