Scenario
A new grinding machine was acquired, and the equipment vendor stated, "It can directly start production after installation." Your factory skipped verification and proceeded directly to trial production. The thickness deviation of the first 500 products exceeded specifications by 20%. It was later discovered that the levelness was not checked during installation, and the machine base was slightly tilted.
Skipping three days of verification resulted in two weeks of anomaly investigation and 500 scrapped parts.
What are IQ / OQ / PQ?
IQ (Installation Qualification)
Confirms that equipment is installed correctly according to specifications.
OQ (Operational Qualification)
Confirms that equipment operates correctly within its defined operating range.
PQ (Performance Qualification)
Confirms that equipment can stably produce products meeting specifications under actual production conditions.
The three stages are sequential: first, confirm it's installed correctly; then, confirm it can operate; finally, confirm it can produce good products.
Detailed Explanation of Each Stage
IQ Installation Qualification
Checklist:
- Equipment model, serial number consistent with procurement specifications
- Correct connection of utilities such as electrical, gas, and cooling water
- Equipment levelness and fastening bolt torque meet requirements
- All safety interlocks function correctly
- Original manufacturer documents (manuals, drawings, parts list) are complete
- Software version verification
Signatories: Equipment Engineer + Equipment Vendor Representative
OQ Operational Qualification
Checklist:
- Dry run test: Axis movement range, speed, accuracy
- Limit position test: Confirm travel limiters are functional
- Alarm function test: Simulate various anomalies to confirm alarm triggering
- Process parameter range scan: Run one set each at the upper/middle/lower limits of the specification range
- Measurement equipment calibration verification
Acceptance Criteria: All operational parameters are within design specifications, and alarm functions are normal.
PQ Performance Qualification
Checklist:
- Use actual production materials and process parameters
- Continuous production of X batches (usually 3 or more batches)
- Measure Critical-to-Quality (CTQ) characteristics
- Calculate Cpk (Cpk ≥ 1.33 is usually required for mass production release)
- Reproducibility verification across shifts and operators
Acceptance Criteria: Product CTQ Cpk ≥ 1.33, with no significant differences between batches.
Differences Between Semiconductor and Pharmaceutical Industries
| Aspect | Semiconductor | Pharma/Medical Device |
|---|---|---|
| Regulatory Requirements | Customer audit requirements | FDA 21 CFR Part 11 / GMP |
| Documentation Depth | Engineering-driven | QA approved, complete approval chain |
| PQ Batch Count | Usually 3 batches | Usually 3 batches, requires statistical validation |
| Computer System Validation | Optional | Mandatory (CSV) |
Golden Quote
"IQ/OQ/PQ is not just red tape; it's an engineer's first in-depth understanding of the equipment. Skipping verification means skipping problems, only to discover during mass production that the equipment wasn't even installed correctly—that's the real waste."