The process is institutionalized as a defined process.
Commitment to Perform
GP 2.1 (CO 1) Establish an Organizational Policy
Establish and maintain an organizational policy for planning and performing the validation process.
Elaboration:
This policy establishes organizational expectations for selecting products and product components for validation; for selecting validation methods; and for establishing and maintaining validation procedures,
criteria, and environments that ensure the products and product components satisfy user needs in their intended operating environment.
Ability to Perform
GP 3.1 (AB 1) Establish a Defined Process
Establish and maintain the description of a defined validation process.
GP 2.2 (AB 2) Plan the Process
Establish and maintain the plan for performing the validation process.
Elaboration:
Typically, this plan for performing the validation process is included in (or referenced by) the project plan, which is described in the Project Planning process area.
GP 2.3 (AB 3) Provide Resources
Provide adequate resources for performing the validation process, developing the work products, and providing the services of the process.
Elaboration:
Special facilities may be required for validating the product or product components. When necessary, the facilities required for validation are developed or purchased.
Examples of other resources provided include the following tools:
· Test management tools
· Test-case generators
· Test-coverage analyzers
· Simulators
· Load, stress, and performance tools
GP 2.4 (AB 4) Assign Responsibility
Assign responsibility and authority for performing the process,developing the work products, and providing the services of the validation process.
GP 2.5 (AB 5) Train People
Train the people performing or supporting the validation process as needed.
Elaboration:
Examples of training topics include the following:
· Application domain
· Validation principles, standards, and methods
· Intended-use environment
Directing Implementation
GP 2.6 (DI 1) Manage Configurations
Place designated work products of the validation process under appropriate levels of configuration management.
Elaboration:
Examples of work products placed under configuration management include the following:
· Lists of products and product components selected for validation
· Validation methods, procedures, and criteria
· Validation reports
GP 2.7 (DI 2) Identify and Involve Relevant Stakeholders
Identify and involve the relevant stakeholders of the validation process as planned.
Elaboration:
Select relevant stakeholders from customers, end users, developers,producers, testers, suppliers, marketers, maintainers, disposal personnel, and others who may be affected by, or may affect, the product as well as the process.
Examples of activities for stakeholder involvement include the following:
· Selecting the products and product components to be validated
· Establishing the validation methods, procedures, and criteria
· Reviewing results of product and product-component validation and resolving issues
· Resolving issues with the customers or end users
Issues with the customers or end users are resolved particularly when there are significant deviations from their baseline needs for the following:
· Waivers on the contract or agreement (what, when, and for which products, services, or manufactured products)
· Additional in-depth studies, trials, tests, or evaluations
· Possible changes in the contracts or agreements
GP 2.8 (DI 3) Monitor and Control the Process
Monitor and control the validation process against the plan for performing the process and take appropriate corrective action.
Elaboration:
Examples of measures used in monitoring and controlling include the following:
· Number of validation activities completed (planned versus actual)
· Validation problem report trends (e.g., number written and number closed)
· Validation problem report aging (i.e., how long each problem report has been open)
GP 3.2 (DI 4) Collect Improvement Information
Collect work products, measures, measurement results, and improvement information derived from planning and performing the validation process to support the future use and improvement of the organization’s processes and process assets.
Verifying Implementation
GP 2.9 (VE 1) Objectively Evaluate Adherence
Objectively evaluate adherence of the validation process against its process description, standards, and procedures, and address noncompliance.
Elaboration:
Examples of activities reviewed include the following:
· Selecting the products and product components to be validated
· Establishing and maintaining validation methods, procedures, and criteria
· Validating products or product components
Examples of work products reviewed include the following:
· Validation methods, procedures, and criteria
GP 2.10 (VE 2) Review Status with Higher Level Management
Review the activities, status, and results of the validation process with higher level management and resolve issues.
