Scope and Purpose of IQ
Installation Qualification for a tablet compression machine confirms that the equipment, as actually installed in its intended location, matches its approved design and purchase specification, and that everything needed to safely and correctly operate it is in place — before any operational performance testing begins. IQ is fundamentally a documentation and physical verification exercise, not a performance test; performance and functional behavior are the domain of OQ and PQ that follow, and conflating IQ's documentation-and-installation-verification purpose with OQ's functional testing purpose is a common source of poorly structured qualification protocols.
Because IQ establishes the factual, verified baseline that OQ and PQ testing will subsequently build upon, gaps or unresolved discrepancies at the IQ stage should generally be resolved before proceeding — building operational test results on top of an unconfirmed or non-conforming installation undermines the validity of everything that follows, even if the operational tests themselves happen to pass. Many facilities formally gate progression to OQ on a documented, signed-off IQ completion specifically to enforce this discipline.
Documentation Verification
IQ typically confirms that key documentation is present, accurate, and matches the actual installed equipment: the purchase order and specification against which the equipment was ordered, manufacturer's documentation such as operating and maintenance manuals and engineering drawings, certificates of conformance, calibration certificates for any factory-installed measuring instruments such as compression force sensors, and — critically — that the equipment's model, serial number, and specific configuration, including tooling type, number of stations, and any optional features ordered, match precisely what was approved during the URS and DQ stages.
Software and firmware versions installed on any equipment control system should also be documented and confirmed to match the approved, validated configuration where the equipment includes a computerized control system — an unrecorded firmware version discrepancy discovered only later, during an audit or investigation, can create genuine uncertainty about whether the equipment currently installed is actually the configuration that was originally qualified. Where the vendor supplies a factory test certificate, that document should be cross-checked line by line against the receiving facility's own IQ observations rather than simply filed unread.
Installation Checks
Physical installation checks generally include: correct utility connections, with electrical supply matched against the equipment's rated voltage, phase, and current requirements, and compressed air supply verified for both pressure and, where relevant, air quality per the facility's compressed air specification where the press uses pneumatic systems; proper environmental placement with adequate space for operation and maintenance access, appropriate ventilation, and confirmation the location meets any classified-area requirements applicable to the specific product being manufactured; safety feature verification confirming guards, emergency stop functions, and any interlocks are physically present and mechanically functional; and confirmation that the turret, tooling, and other critical components installed match the approved configuration recorded in the equipment's documentation.
Environmental conditions at the installation location — temperature and humidity, if the equipment or the product being run is sensitive to either — should also be verified against any requirements stated in the URS or equipment manufacturer's specifications, since a tablet press installed in an environment outside its rated operating range can show degraded performance or reliability that would not be apparent from documentation review alone. Leveling and vibration isolation should also be confirmed where the press's own specification calls for it, since a poorly leveled installation can introduce mechanical stress that shortens component life even without producing an immediately obvious operational symptom.
Instrumentation and Calibration Status
Any instrumentation integral to the equipment's operation — compression force sensors, punch and die position sensors, speed sensors — should be confirmed calibrated and within its calibration due date at the time of IQ, with calibration certificates retained as part of the IQ documentation package. Where the equipment's own control system displays or records values from these sensors, such as compression force during operation, IQ should confirm the displayed and recorded values are consistent with the sensor's actual calibrated performance, not simply that a calibration certificate exists somewhere in a file.
For equipment transferred from another location or a prior use, rather than newly purchased, IQ should additionally confirm the equipment's condition and calibration status were appropriately re-verified after the move, since transport and reinstallation can plausibly affect sensor calibration and mechanical alignment even for equipment that was fully qualified and functioning correctly at its prior location. A pre-move and post-move comparison of key instrumentation readings, where feasible, provides more direct evidence of unaffected performance than assuming the prior qualification simply carries forward unchanged.
Safety and Interlock Verification
Beyond simple presence-of-guards confirmation, IQ should include functional verification that safety interlocks actually perform their intended protective function — for example, confirming that opening a safety guard during operation genuinely halts compression, rather than merely confirming the guard and its associated switch are physically installed. This functional check, though sometimes treated as an OQ-stage activity depending on a facility's specific qualification protocol structure, represents exactly the kind of basic safety-critical verification that should not be deferred or assumed complete simply because the equipment passed a similar check during the manufacturer's own factory testing before shipment.
Documentation of this safety verification should be specific and unambiguous — recording the specific test performed and its actual observed outcome, not a general statement that "safety features were checked," since the latter provides no genuine, auditable evidence of what was actually verified and confirmed to function correctly. Where a facility's risk assessment identifies additional safety-critical functions beyond the vendor's standard set, those should be added to the IQ or OQ test scope explicitly rather than assumed to be adequately covered by generic testing.
Acceptance Criteria and Deviation Handling
Each IQ check should have a clear, predefined pass/fail criterion established before testing begins — for example, "electrical supply voltage measured within manufacturer's specified tolerance of the rated value" rather than a vague, subjective "checked and found acceptable" — so that the IQ result is objectively verifiable by an independent reviewer working from the documented criteria and observed data alone.
Deviations identified during IQ should be formally documented through the facility's deviation or discrepancy management process and resolved, or, where appropriate, formally risk-assessed and justified as acceptable, before OQ begins. Proceeding to OQ with an unresolved, undocumented IQ discrepancy is a common and avoidable weakness in poorly managed qualification efforts, one that can require expensive, disruptive rework if the underlying installation issue turns out to materially affect operational performance discovered only later during OQ or PQ testing.
Roles and Responsibilities During IQ Execution
A well-structured IQ protocol clearly assigns responsibility for each verification step — typically involving engineering or facilities personnel for utility and physical installation checks, metrology or calibration personnel for instrumentation verification, and quality assurance for overall protocol review and approval — rather than leaving execution loosely defined and assuming whoever happens to be available will perform each check competently. Cross-functional execution of this kind benefits from a kickoff meeting before IQ begins, aligning all participating functions on the protocol's scope, schedule, and each party's specific responsibilities.
Vendor field service representatives are often present during IQ execution, particularly for complex equipment, and their role should be clearly defined in the protocol — typically supporting physical installation and initial startup, while the actual qualification verification and sign-off remains the responsibility of the receiving facility's own qualified personnel, since a vendor representative confirming their own installation work is not an independent verification in the sense a qualification protocol is intended to provide.
Linking IQ Outcomes to the Broader Qualification Package
The completed, approved IQ report becomes a permanent part of the equipment's overall qualification package, referenced by subsequent OQ and PQ protocols and by any future requalification or change control activity affecting the equipment. A clear, well-organized IQ report — one an auditor or a new team member years later could review and understand without needing supplementary explanation from whoever originally executed it — is a genuinely valuable long-term asset, distinct from simply satisfying the immediate procedural requirement to complete IQ before proceeding to OQ.
Common Documentation Pitfalls
A recurring weakness in tablet press IQ documentation is recording results in vague, narrative form — "installation checked and found satisfactory" — rather than capturing the specific measured value or observation against its predefined acceptance criterion. This kind of vague documentation cannot later support a meaningful independent review, and if questioned during an audit, leaves the facility unable to demonstrate exactly what was actually verified beyond the original executor's now-unrecorded memory of the event.
Another common pitfall is treating IQ as a one-time paperwork exercise disconnected from the equipment's ongoing life — the original IQ documentation should remain readily retrievable throughout the equipment's operational life, since it is frequently referenced again during later investigations, requalification efforts, or when assessing the impact of a proposed future equipment modification against the originally qualified and documented baseline configuration.
Relationship to Preventive Maintenance Program Setup
IQ execution is also a natural point at which the equipment's ongoing preventive maintenance program is formally established or confirmed — manufacturer-recommended maintenance intervals, spare parts requirements, and lubrication schedules are typically documented and entered into the facility's maintenance management system as part of, or immediately following, IQ completion, rather than left to be figured out reactively once the equipment is already in routine production use and a maintenance need first arises.
Establishing this maintenance baseline at IQ, alongside the equipment's qualified installation configuration, gives the facility a documented, traceable starting point for evaluating whether any future performance degradation reflects normal, expected wear addressed by routine maintenance, or a genuine deviation from the originally qualified and installed state warranting a more formal investigation.
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