Design Verification and Validation

Programme Summary

Plan evidence that a design meets its specified requirements and works for its intended users and conditions. Participants distinguish verification from validation, establish traceability and select proportionate tests, reviews and demonstrations. A product development case addresses acceptance criteria, representative use and changes, helping teams identify evidence gaps before making design release decisions or unsupported performance claims.

Training Objectives

1 Distinguish verification from intended use validation; 2 Translate requirements into testable acceptance criteria; 3 Select proportionate evidence methods and conditions; 4 Maintain traceability through deviations and changes; 5 Support accountable evidence based design release decisions.

Learning Outcomes

1 Build a requirement to evidence matrix; 2 Draft a verification or validation protocol; 3 Identify representative intended use conditions; 4 Evaluate a failed test and evidence gap; 5 Prepare a justified design readiness recommendation.

Target Audience

Design Engineers; Verification Engineers; Validation Engineers; Product Quality Engineers; Development Project Managers.

Target Industries

Medical Device Manufacturing; Industrial Equipment Manufacturing; Electronics Manufacturing; Automotive Components; Consumer Product Manufacturing.

Course Contents

• Module 1 Design Evidence Framework: Specified requirements and intended use needs; Verification versus validation purposes; Responsibilities and lifecycle decision points.
• Module 2 Requirements and Traceability: Clear measurable design inputs; Requirement to test and review linkage; Completeness and conflicting requirement resolution.
• Module 3 Verification Methods: Inspection analysis demonstration and testing; Method suitability and technical limitations; Independent review and evidence quality.
• Module 4 Validation Planning: Representative users environments and use scenarios; Sample selection and realistic operating conditions; Acceptance criteria linked to intended needs.
• Module 5 Protocol and Execution Controls: Objectives methods conditions and responsibilities; Controlled test records and equipment suitability; Deviations failures and data integrity.
• Module 6 Evaluating Evidence: Pass fail decisions against predefined criteria; Uncertainty limitations and incomplete coverage; Scientific investigation of unexpected results.
• Module 7 Design Changes and Release: Change impact and regression evidence needs; Residual issues and release conditions; Authorised conclusions and record retention.
• Module 8 Design Evidence Workshop: Building a requirement evidence matrix; Reviewing a failed test and use scenario; Presenting a supported readiness recommendation.

Assessment

• 40 single best answer questions, including applied scenarios; one mark per question.
• 60 minute invigilated digital examination with identity verification. Approved accessibility adjustments preserve the assessed competence.
• Supplied reference pack and calculator permitted; external internet and AI prohibited.
• Individual applied assessment (30 minutes): Prepare a requirement evidence matrix and a test protocol, assess a failed result and recommend further evidence or conditions before design release.
• Assessment criteria: Clear verification and validation distinction; Representative evidence and acceptance criteria; Defensible gap and release reasoning.
• Pass each component separately: 30/40 written marks (75%) and at least 70% on the applied task.
• Individual results and feedback are provided. One reassessment may follow coaching under the published enrolment terms.

Certification

• Successful learners receive a TQCSI Arabia digital Certificate of Successful Completion.
• The certificate records the learner name, exact programme title, teaching hours, completion date and unique verification reference.
• Verified identity, full attendance and separate written and applied passes are required; all mandatory critical criteria must be met.
• Proposed issue target: within 30 calendar days of approved results and settlement of applicable fees.
• Records design evidence planning skills; design approval, product conformity and regulatory clearance require separate authorised decisions.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

222

Total teaching hoursTotal teaching hoursTotal teaching hours

12 hours; breaks, pre course work and formal final assessments excluded.12 hours; breaks, pre course work and formal final assessments excluded.12 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 20 delegates.Maximum 20 delegates.Maximum 20 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

Product design, engineering or quality experience is required. Familiarity with technical requirements and development documentation is recommended.Product design, engineering or quality experience is required. Familiarity with technical requirements and development documentation is recommended.Product design, engineering or quality experience is required. Familiarity with technical requirements and development documentation is recommended.

Pre course assignment and assessmentPre course assignment and assessmentPre course assignment and assessment

Review a fictional product specification for 25 minutes and identify requirements that lack measurable acceptance criteria.Review a fictional product specification for 25 minutes and identify requirements that lack measurable acceptance criteria.Review a fictional product specification for 25 minutes and identify requirements that lack measurable acceptance criteria.

End of course assessmentEnd of course assessmentEnd of course assessment

40 question written exam (60 minutes) and individual applied task (30 minutes).40 question written exam (60 minutes) and individual applied task (30 minutes).40 question written exam (60 minutes) and individual applied task (30 minutes).

Passing criteriaPassing criteriaPassing criteria

75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.