How to Conduct an OEM Audit for a Medical Contract Manufacturer

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.

Main Things to Consider in an OEM Audit

  • Regulatory Compliance: The manufacturer should comply with not only the regulations of the region in which they operate, but also of the regions you wish to export your medical device products.
  • Supplier Management & Controls: Enforcement of quality standards upon their suppliers, through both their contract and regular quality controls and audits.
  • Controlled Environment Conditions: It’s easy to understand how controlled environment conditions and overall production areas cleanliness can affect final product quality and why OEMs should demonstrate adhering to those rules.
  • Controlled Manufacturing Processes: These are the set of rules and processes upon which medical device manufacturing is based. It is critical to have organizational documentation, control, and continuous improvement.
  • Personnel Training: The medical device manufacturer should document and demonstrate an adequate personnel training program to which they adhere to, along with regular checks for its effectiveness. 
  • Risk management: OEMs should perform proper risk management in case of critical control points, weaknesses, or out of spec in process control results. Risk management includes Risk Assessments, Deviation Investigation Reports (DIRs), and Corrective and Preventive Actions (CAPAs).
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Quality Differentiators

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.

GMP & GDP Implementation

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.

Meaningful IQ, OQ, and PQ

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.

Advanced Programmes

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.

Your Innovative Medical Device Manufacturing Partner

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.

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