Equipment qualification (DQ/IQ/OQ/PQ) for Swiss MedTech manufacturing
Qualified equipment means audit-ready evidence that the installed baseline, operating window, and performance meet URS and risk controls. DQ/IQ/OQ/PQ plus aligned FAT/SAT creates a clean chain of evidence that QA can approve without guesswork.
For supplier-built equipment, qualification succeeds only when acceptance criteria, as-built configuration, and execution records are locked down before release.
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Where qualification fails in real life
- Vendor documentation is missing, outdated, or arrives after FAT.
- Acceptance criteria are not tied to URS, risks, or critical process limits.
- The as-built configuration does not match drawings, versions, or the URS.
- Calibration status is unclear or measurement traceability is incomplete.
- Work instructions (WIs) and SOPs do not reflect the qualified state.
- Utilities readiness is assumed instead of verified (power, air, network, cleanroom).
- FAT evidence does not transfer to SAT and the punch-list never closes cleanly.
- PLC/HMI/firmware versions drift without a controlled impact assessment.
Deliverables
- URS review and documented gaps
- Risk-based qualification scope
- DQ / IQ / OQ / PQ protocols and data sheets
- FAT/SAT criteria plus punch-list workflow
- Execution support (on-site or remote)
- Reports and a QA-ready evidence pack
- Requalification and maintenance recommendations
FAT vs SAT vs IQ/OQ – how they fit together
FAT proves the supplier build meets the URS before shipment. SAT confirms the same criteria after installation and utilities hook-up. IQ locks the installed baseline (as-built, utilities, calibration), while OQ challenges the operating window with controlled tests. PQ, when required, verifies performance under routine process conditions. Together they create a traceable release path.
How I work
Clarify the outcome
Lock requirements, constraints and acceptance criteria.
Plan & de-risk
Risk-based scope, test strategy and documentation map.
Execute & document
Protocols, evidence, deviations and reports.
Handover
Clean package + recommendations for requalification/maintenance.
Related insights
- IQ vs OQ evidence: what counts (and what does not)
- FAT vs SAT acceptance criteria that prevent surprises
- Qualification documentation gaps that delay equipment release
Related services
- Test stands & fixtures for verification & manufacturing
- CSV/CSA for product and manufacturing support systems
FAQ
What is the key difference between IQ and OQ evidence?
IQ proves the installed baseline (utilities, configuration, calibration). OQ proves performance in defined limits using controlled tests and calibrated measurements.
What does QA typically expect for acceptance criteria?
Criteria must be measurable, tied to URS and risk controls, and mapped to a specific test method with objective pass/fail data.
How should acceptance criteria be structured for FAT/SAT?
Use the same URS-linked criteria across FAT and SAT, with a shared punch-list and clear closure rules so evidence transfers cleanly.
What if the equipment includes software or data flows?
We align the qualification scope with CSV/CSA expectations so software, PLC/HMI versions, and data integrity controls are covered without over-testing.