Key takeaways
Short answer: Process validation is the documented proof that a process consistently produces output meeting specification. Process verification is the ongoing check that a specific batch or unit actually meets specs. Validation is event-based, at qualification or after a major change; verification happens every run. Auditors expect both, with distinct documentation, and mixing them up produces findings. See also quality by design vs quality by inspection.
Validation answers a one-time question: does this process, run as documented, consistently produce conforming output? It is established at qualification and re-established after major changes, through validation lots run under normal and challenge conditions, demonstrating capability.
Verification answers a recurring question: is this specific batch or unit within spec right now? It happens every run, through in-process measurements, end-of-batch testing and final inspection, confirming conformance of what was actually made.
A sterilisation process is validated once: three qualification runs prove it consistently achieves the required lethality even at worst-case loading. That validation does not repeat every day. But every cycle thereafter is verified, the temperature and time are checked and the load released only if they meet the validated parameters.
Validation proved the process can do it; verification confirms each cycle did. An auditor who finds verification records but no validation, or vice versa, will write a finding.
The standard lifecycle is design qualification, then installation, operational and performance qualification (IQ/OQ/PQ), then continued process verification. Validation establishes the process; verification maintains confidence that the validated process stays in control.
1. Verification labelled as validation. Per-batch checks presented as proof of capability, an audit finding.
2. Validation never revisited. Process drift after a change goes unnoticed.
3. No documented validation rationale. The auditor cannot find the justification.
4. Verification without a validated process. Out-of-spec results with no clear corrective path.
Process performance shows up in OEE Quality. Validated processes with verification monitoring keep Quality stable; unvalidated processes drift, and the Quality term wanders with them. SPC is the continuous verification that holds it.
Fabrico supports SPC for continuous verification and stores process parameters with an audit trail for validation documentation. Book a demo to see validation and verification data in one place.
No. SPC is continuous verification, not the one-time proof of capability.
After major changes, or periodically per regulatory requirement.
In regulated industries, no; in unregulated ones, you risk inconsistent output you cannot defend.
Quality and engineering jointly, with operations support.
A documented validation lifecycle (DQ, IQ, OQ, PQ, CPV) plus ongoing verification, clearly distinguished.
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