Process Validation Summary Report Template (IQ, OQ, PQ) for Medical Devices
The summary report is the document an auditor reads first, and the one that has to stand on its own years later. This template gives you a clear structure for IQ, OQ and PQ outcomes, capability results, deviations and the decision that the process is validated.
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Process Validation Summary Report Template (IQ OQ PQ) for Medical Devices
Process Validation Summary Report
Company: Acme Medical Components Inc. Report number: VAL-RPT-2026-014 Protocol number: VAL-PRO-2026-014 Report date: 2026-10-20
1. Purpose and Scope
This report summarizes the validation of the process Ultrasonic welding of hub to shaft used to manufacture Disposable catheter hub assembly (CAT-210 Rev C). The validation was performed on Ultrasonic welder UW-07 according to protocol VAL-PRO-2026-014, because the process output cannot be fully verified by subsequent inspection and test. It documents the results of installation, operational and performance qualification.
2. Reference Documents
| Document | Number / revision | Title |
|---|---|---|
| Protocol | VAL-PRO-2026-014 | Process validation protocol |
| Device master record | CAT-210 Rev C | Specifications and work instructions |
| Risk file | Process FMEA or risk assessment | |
| Measurement system study | Gauge R&R or test method validation | |
| Equipment records | Ultrasonic welder UW-07 | Calibration and maintenance |
3. Installation Qualification (IQ)
IQ confirmed that Ultrasonic welder UW-07 was installed per manufacturer and user requirements, utilities were verified, calibration was in date and the equipment is under maintenance control.
IQ Results
| Check | Acceptance criterion | Result | Pass / Fail |
|---|---|---|---|
| Installation and utilities verified | Per equipment specification | ||
| Instruments calibrated | Calibration within date | ||
| Software / controller version recorded | Matches approved version | ||
| Preventive maintenance plan in place | Plan approved |
4. Operational Qualification (OQ)
OQ challenged the process at the low and high limits of the parameter window to establish the operating range for Weld pull strength. Specification: Minimum 15 N.
OQ Results
| Run | Parameter settings | Samples | Mean / min result | Pass / Fail |
|---|---|---|---|---|
| Nominal | ||||
| Low limit | ||||
| High limit | ||||
| Worst case combination |
5. Performance Qualification (PQ)
PQ was performed on 3 consecutive lots under normal production conditions, with 30 samples tested per lot for Weld pull strength. Acceptance criterion: Minimum 15 N, and Ppk of 1.33 or greater, lower 95% confidence bound.
PQ Results
| Lot number | Operator / shift | n | Mean | Std dev | Ppk | Pass / Fail |
|---|---|---|---|---|---|---|
| 30 | ||||||
| 30 | ||||||
| 30 | ||||||
| Combined |
6. Deviations
One minor deviation during OQ (DEV-2026-031): fixture temperature log was missing one entry. Impact assessed as none. Closed before PQ.
7. Conclusion
Overall outcome: Validation successful.
The process Ultrasonic welding of hub to shaft has been demonstrated to consistently produce Disposable catheter hub assembly meeting its predetermined requirements within the validated parameter ranges, subject to the monitoring plan below and the conditions stated in the protocol.
8. Ongoing Monitoring and Revalidation
Weld pull test at start of each shift, 5 units per shift. SPC chart reviewed weekly. Revalidate on change of tool, horn, material supplier or after a 10 percent shift in mean strength.
9. Approvals
A starting template, not a regulatory submission. Adapt it to your quality system, your protocol and any customer requirements. Complete the results tables with measured data and attach raw data, charts and deviation records. Confirm the capability criterion with your risk assessment rather than defaulting to a value.
Pull validation data from production systems
Optional: we can extract PQ data and monitoring results from your MES and ERP to populate the report tables.
Optional. The tool and every export work without this. No spam.
How to use the template
Fill in the fields for the product, process, protocol and acceptance criteria, then export to Word. Complete the results tables with your measured data, attach raw data and charts as appendices, and update the deviations section to list every deviation with its disposition and impact assessment. The conclusion must state plainly whether the validation was successful, not merely that testing was completed. Have the approvers named in your validation procedure sign and date.
- Write the report against the approved protocol, not from memory
- Quote acceptance criteria exactly as in the protocol
- List every deviation, including ones that were closed
- State the ongoing monitoring and revalidation triggers
Regulatory and technical basis
ISO 13485:2016 clause 7.5.6 requires validation of processes whose output cannot be verified by subsequent monitoring or measurement, with documented arrangements for qualification, approved methods, records and revalidation. The IQ, OQ and PQ structure follows the global harmonization guidance on process validation (GHTF SG3). Capability criteria such as Ppk of 1.33 are common choices, but the confidence level and sample size should come from your risk assessment, and from a statistical rationale such as a confidence bound on capability or a success-run sample.
Reading and writing a good conclusion
A defensible conclusion links three things: the data met the pre-defined criteria, any deviations were assessed and did not undermine the result, and a monitoring plan keeps the process in control. If a criterion was missed, do not change it after the fact. State that the validation was not successful, investigate, correct the process, and repeat the affected phase under a revised or supplemental protocol. Include the validated operating ranges so production knows what changes require revalidation.
Common mistakes
The most frequent problems are changing acceptance criteria after seeing the data, running PQ on lots built under special attention that does not reflect normal production, and omitting a validated measurement system for the test used. Another is failing to define what triggers revalidation, so a tool change or supplier switch passes unnoticed. Finally, ensure the report references the approved protocol revision and that any raw data are traceable to the equipment, operators and lots listed.
Frequently Asked Questions
What is the difference between a protocol and a report?
The protocol is written and approved before testing and states what will be done and the acceptance criteria. The report is written afterward and states what was done, what the data showed, any deviations, and the conclusion against the protocol criteria.
How many lots do I need in PQ?
There is no single required number. Three consecutive lots are common practice, but the number should be justified by risk and statistics. State the rationale in the protocol and confirm it in the report.
Do I need to validate every process?
Only processes whose output cannot be fully verified by later inspection or test, such as welding, sealing, sterilization, molding of critical features and cleaning. Processes that are fully verifiable can be controlled by inspection, but justify the choice in your procedure.
When must a validated process be revalidated?
On significant change to equipment, tooling, materials, software, location or parameters, after repeated failures or drift, and sometimes periodically. Define the triggers in the report so production and engineering recognize them.
If your validation records and process data are scattered, we can help consolidate them so ongoing monitoring pulls straight from your production data.
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