Objectives of IQ, OQ and PQ in Process Validation for Injection Molding

custom injection molding components<h2> Injection Molding Process</h2>

The process of injection molding must consistently create products that adhere to high quality standards. The performance of parts produced must meet customer specifications.

Only through diligently inspecting and validating every aspect of the injection molding process, as well as the final products, can such standards be ensured. To avoid mistakes, substandard products, and inconsistencies, process validation occurs before production gets underway. After a detailed and successful injection molding process is defined, which produces parts that consistently perform according to specific parameters, production can commence.

IQ, OQ and PQ play critical roles in the injection molding process validation procedure.

IQ – Installation Qualification
During the first stage, the process equipment, along with supporting and sub-systems, are inspected to ensure they conform to the requirements of the manufacturer and are installed appropriately. The molds are validated for their ability to create parts that adhere to strict dimensional, economical and performance necessities.

A few factors that are given consideration during IQ include the installation conditions, design features of the equipment, the conditions of the given environment, and any documents, illustrations or manuals provided by the supplier.

Once installation and design specifications are met which can repeatedly produce parts that will perform up to standard, the process validation can continue to OQ.

OQ – Operational Qualification
This stage tests the newly installed equipment to ensure it operates as expected, and gauges the conditions under which it will continue to do so. Test runs will determine the highest, lowest and nominal operating processes by varying the pressures, temperatures, velocities and other factors from the initial process arrived at during IQ.

Factors considered during OQ include the process control limits, the raw material specifications, the requirements for handling the materials, training, and the short term stability and capability.

If Operational Qualification is successful, it will validate that all aspects of the equipment perform as expected under various conditions.

PQ – Performance Qualification
During Performance Qualification, the equipment will be run several times. Real manufacturing materials will be used, and the equipment will be allowed to cool between each run, to verify that the injection molding process is capable of consistently producing quality products at a range of operating conditions, established during the OQ part of the process.

Considerations during PQ include long term stability, and whether the products produced under the expected levels of operating conditions consistently perform to standards.

At each phase of the validation process, documents must be drawn up which detail inspection results, parameters settings, and any deviations from the expected performance and the reasons for them. Only after IQ, OQ and PQ have been successfully completed, and documents are produced which verify the acceptability of every phase of the injection molding validation process, can production get underway. This detailed process has proven to be the ideal way to guarantee the best quality parts, time after time.

Process validation and utilizing IQ,OQ and PQ is part of the incorporated requirements of Crescent Industries quality management system for injection molding.

To learn more about Injection Molding Process visit

About Frank Spears

The next time your business calls for an injection mold, explore the opportunity that Total Solution Plastic offers to reduce cost, minimize procurement hassles and get your injection mold to specification and on time. You have my word on it.