Today Team Notified Body (NB) published a position paper on hybrid audits, primarily brought about due to the COVID-19 pandemic: HERE
The paper promotes the continuation of hybrid audits, citing reasons such as increased auditor capacity, more efficient use of subject matter experts and reduction in ‘burnout for auditors’.
Examples of aspects that should be conducted onsite include:
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- Infrastructure
- Work environment
- Production and incoming/in-process/final inspection
- Servicing
- Design transfer to manufacture (if internal testing facilities are involved for verification and validation)
- Warehouse/storage facilities incl. verification of purchased products
Examples of items that could be addressed remotely include:
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- Management, e. g. general quality management system requirements, regulatory affairs
- Improvement, e. g. internal audit, management review, corrective and preventive actions
- Human resources, e. g. qualification and training
- Purchasing, e. g. review of supplier files
- Design and development (except design transfer if internal testing facilities are involved)
- Traceability and batch records
The Team NB paper further notes:
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- Eligibility for hybrid audits depend on the manufacturer’s system, e.g., paper-based versus electronic-based quality systems
- At least 25% of the audit should be conducted onsite, to allow sufficient duration to audit the production and service controls; it may be increased based on the manufacturer’s activities
- Onsite time may also be reduced in certain cases; for example, where no production activities physically occur onsite, such as standalone software devices (SaMD) or where all manufacturing activities are contracted out
This is in line with the MDCG’s recent request for continued use of hybrid audits, in order to increase Notified Body capacity, as reported: HERE
We recommend reading the full position paper for more details on when the onsite portion of an audit may be increased, reduced, and other criteria surrounding hybrid audits.
