Process validation is the process in which objective evidence is established that a process consistently produces a result or product meeting its predetermined specifications. If a manufacturer cannot provide this evidence, the results can be disastrous by costing the customer thousands of dollars, increase the risk of product failure and recall and potential loss of market share.
The process validation procedures utilized include Installation & Operational Qualification, Process Performance Qualification and Product Performance Qualification.
Installation & Operational Qualification (IQ/OQ) is the first stage of process validation, where documented evidence is established that process equipment and ancillary systems are capable of consistently operating within the established limits and tolerances. The Critical Process Parameters are validated for each mold in order to demonstrate the ability to create parts that adhere to strict dimensional, economical and performance necessities. Test runs will determine the highest, lowest and nominal operating processes by varying the pressures, temperatures, velocities and other factors. Other considerations in addition to the process control limits are raw material specifications, material handling requirements, training and calibration.
Process Performance Qualification (PQ) involves establishing documented evidence that the process is effective and reproducible. During this time the equipment will run several cycles with real manufacturing materials and the equipment is 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.
Product Performance Qualification is establishing documented evidence through appropriate testing that the finished product produced by the validated process or processes meets all customer specifications. Upon approval of the PQ, the parts are considered saleable.
At every stage documentation must be kept which details inspection results, parameter settings and any deviations from the expected performance and reasons for them. Only after all process validation procedures have been successfully completed and approved, can production get underway.
Process validation procedures are more than just ISO and FDA requirements, process validation is a proven way to ensure consistent quality plastic injection molded parts.
Process validation and utilizing IQ, OQ and PQ are part of the incorporated requirements of Crescent Industries quality management system for injection molding. To learn more about Crescent’s quality certifications and procedures, please click here.