Our integrated manufacturing process development depends on team integration, seamless communication, real-time data sharing of accessible, accurate data, and early involvement of our testing and manufacturing teams during the prototype and development phases. This allows us to optimize our manufacturing process and collaborate with our product engineers to develop efficient manufacturing processes and detailed work instructions that are distributed to the build teams on touch screens in a mixture of text, illustrations, and photos. These are easy to read and allow us to structure work in cadence on the manufacturing floor so product can be made efficiently without bottle necks.
The IQ/OQ/PQ Method of Manufacturing Qualification Validation
IQ stands for Installation Qualification. This is the first step in the validation process to ensure that the manufacturing process will live up to its expectations. In this phase, you verify the equipment’s design features and make sure it was installed correctly. Often the basis for IQ is the design specification with the installation requirements. Therefore, it is of high importance to verify that all necessary documents, drawings and manuals are available. During installation qualification, equipment maintenance, and calibration, schedules and procedures should be established. Equipment should be calibrated before and after process validation to determine whether the equipment remained in calibration during the entire process validation study.
OQ stands for Operational Qualification. In this phase, we want to verify that the manufacturing process is achieving its operational requirements. Test runs will determine the highest, lowest and median operating parameters. We will use the process parameters to set control limits and action limits. They help us ensure the process is reproducible. We will “challenge” the process by using “worst case” conditions. If the Operational Qualification is successful, it validates that process control limits and action levels have resulted in product that meets all predetermined requirements.
PQ stands for Performance Qualification and is the last phase of the validation process. Here, the equipment will run several times under normal operating conditions and its functions will be challenged. The purpose of the PQ is to demonstrate that the process, under anticipated conditions, consistently (long term runs) produces a product which meets all predetermined requirements for functionality and safety.
In each phase of the process, documents are compiled with detailed results of each qualification test and a judgement if defined acceptance criteria were met. Only after performing IQ, OQ, PQ successfully with a desired result, and documents that verify each phase, can the production get underway. This defined discipline for process validation has proven to be the ideal way to guarantee the best quality of products, constantly over time.
A well-planned and performed process validation is an important work to ensure that we have a well-controlled manufacturing process consistently producing conforming products. Non-conforming products could lead to human injury or result in costly product recalls. By implementing a successful validation process, medical device manufacturers can improve productivity, reduce recalls and consumer complaints and also reduce the burdensome process of investigations.
