When a medical OEM sets out to conduct an audit for a medical device manufacturer, there can be a multitude of items to examine. Especially when considering the gamut of OEM activities: from simpler manufacturing operations to vertical production facilities. In this article, we cover the most important items to consider in the OEM audit, as well as some additional factors that demonstrate above-average operations.
Maintaining a good level of typical quality checks & controls in place can be challenging. However it’s in more advanced and often voluntary actions that industry leaders differentiate themselves from the rest of the medical device manufacturers. They too can be identified through the audit process and are always a good indicator of quality.
Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) are part of medical device regulations. However, these two are limited in their scope as far as medical device manufacturing is concerned. Medical device manufacturers must apply the required controls in their entirety, eg. in complaint handling or management responsibility.
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are part of GMP. Advanced medical device manufacturers will perform complete and thorough qualifications that go beyond the minimum standard. This demonstrates that they use these qualifications as tools to improve quality and process control, rather than just as mandatory procedures.
Several advanced techniques exist for improving quality & productivity, such as the 5s organization method, kaizen improvement programme, and lean manufacturing practices. Additional factors can be investments in innovation, R&D, and infrastructure. All of these are voluntary, and applying them signals an excellent mentality and true intent to provide world class manufacturing services.
Quasar has been constantly evolving its quality and productivity characteristics, for over 30 years. Contact us to discover how an innovative medical device OEM with modern production facilities and specialized personnel, can help you achieve your goals.