quality gates

Quality gates are predefined control points in a process where work products, data, or decisions are evaluated against explicit criteria before they are allowed to move to the next step.

Each quality gate typically defines:

• Entry conditions – what must be available before the review (for example, test results, batch records, analysis reports, drawings, change records).
• Evaluation criteria – measurable or checkable conditions that must be satisfied (for example, all required tests executed and passed, deviations assessed, defect counts below a defined threshold, sign‑offs completed, configuration items under control).
• Approval authority – who is authorized to accept, reject, or defer items (for example, process owner, quality function, independent reviewer, review board).
• Exit conditions – what must be true for the work to proceed (for example, all mandatory criteria met, residual risks recorded, actions assigned, records updated).

In industrial and regulated manufacturing environments, quality gates are commonly applied to design reviews, process validation, batch release, change control, and software or MES/ERP deployments. They help create a repeatable mechanism to verify data quality, documentation completeness, traceability, and alignment with defined standards and procedures before decisions are finalized or operations advance.