TestingV&V

Verification and Validation

Verification confirms a design meets its specifications; validation confirms the product meets user needs.

Verification and Validation (V&V) are two distinct quality assurance activities that together confirm a product is built correctly and is the right product to build. Verification answers the question 'did we build the product right?' — it checks that the design outputs (specifications, drawings, code) satisfy the design inputs (requirements). Validation answers 'did we build the right product?' — it confirms that the finished product meets the needs of its intended users in its intended use environment.

Verification methods include: testing (exercising the product against acceptance criteria), inspection (physically examining the product against drawings and specifications), analysis (using calculations or simulations to demonstrate compliance), and demonstration (showing that a function works in the presence of reviewers). Each requirement should specify its verification method. Hardware requirements are most commonly verified by test, but structural requirements may be verified by analysis (FEA) when destructive testing is impractical.

Validation goes beyond meeting specifications — a product can meet every written requirement and still fail validation if the requirements themselves were incomplete or wrong. Clinical trials for medical devices, field trials for industrial equipment, and beta programs for consumer electronics are all forms of validation. The distinction matters for regulatory compliance: FDA requires both design verification (outputs meet inputs) and design validation (product meets user needs in actual or simulated use conditions).

Standard reference: IEEE Std 1012-2016 'System, Software, and Hardware Verification and Validation'; FDA Design Controls Guidance (1997).

Practical Example

Requirement: 'Battery life shall exceed 8 hours at maximum load.' Verification: Lab test at calibrated load, 23°C, 100% SOC — PASS (9.2 hours). Validation: User trial with 12 field operators performing standard work cycles over 10 days — PASS (average 9.7 hours, minimum 8.4 hours observed).

How SpecZero handles this

SpecZero's requirements and acceptance criteria fields define what must be verified. The decision log captures validation-related findings — user feedback, field trial results, and stakeholder acceptance — as locked decision entries that document the validation evidence.