Overcoming The Challenges of IQ and OQ: Two Effective Strategies

Are the challenges of performing IQ and OQ overwhelming your team?

If you are a Production Manager for a medical device manufacturer you are intimately familiar with the challenges of executing and maintaining IQ (Installation Qualification) and OQ (Operation Qualification). Manufacturing processes can consist of multiple steps involving several pieces of equipment and ensuring all equipment fulfills all predetermined functionality and safety requirements, as well as regulatory standards. If you are lucky enough to have a Validation Engineer on your team to manage the process, you are ahead of the curve, however it is still a labor-intensive function even for a dedicated resource. Failing to comply with these standards can have serious consequences, including potential harm to patients and costly product recalls. Therefore, a meticulously planned and executed validation process is essential to maintaining a controlled manufacturing environment that consistently produces high-quality and safe medical devices that meet the necessary standards.

Two effective strategies to minimize the challenges of IQ and OQ:

1. One way to minimize the resource demands of creating the required IQ and OQ documentation is to avoid starting from scratch when possible. During the procurement phase of the project, check with your vendors to see if they offer templatized validation packages for their equipment that can be included as part of your initial purchase. Utilizing pre-designed validation packages tailored to your specific equipment will significantly reduce the workload for your Validation Engineer, saving them valuable time and effort.

2. Consider exploring the option of outsourcing equipment validation support for some or all of your equipment. Some vendors offer a convenient paid service where skilled field service personnel can come to your location and assist in completing the necessary equipment documentation. This can be a highly efficient and cost-effective solution, especially when considering the scope of your production line and the availability of internal resources.

How does Uson help customers minimize time and resource requirements for IQ and OQ?

To ease some of the work involved in collecting and organizing IQ and OQ documentation Uson has created Validation Support Packages for several leak testers including the Sprint mD, Sprint iQ and Optima vT that include protocols, worksheets and other information to allow users to easily validate Uson leak testers for use in their processes. These packages are designed to minimize the resource and time requirements and assist customers in developing the documents and testing to provide assurance that their tester operates to specification and meets regulatory requirements of their applications. You may elect to include these packages as part of your initial purchase or purchase them later.

We also offer onsite support to complete the documentation which can be factored into your initial purchase or purchased later, whichever works best for you and your team. 

Contact us for more information about our Validation Support Packages and how they can streamline your IQ and OQ process.