Hybrid audits training Welcome to your Hybrid audits training Name Email 1. Which MDCG guidance can be considered as applicable for remote auditing due to temporary extraordinary measures during quarantine orders or travel restrictions? MDCG 2020-4 MDCG 2020-8 MDCG 2020-6 None 2. Which of the following EU Notice clarifies on the use of remote auditing under Regulation (EU) 20177745 and Regulation (EU) 2017/746? Commission Notice 2021/C 8/02 Commission Notice 2021/C 8/01 Commission Notice 2021/D 8/02 None 3. What is the main requirements according to Commission Notice 2021/C 8/01 for Notified Bodies to consider remote auditing techniques? The use of remote audits should be limited to the time strictly necessary to allow for a proper on-site audit to take place as soon as possible NBs are required to perform case-by-case risk assessments and documentation of individual circumstances Commission Notice 2021/C 8/01 requires NBs to perform a risk analysis as per MDCG 2020-4 4. The following statement is true according to MDCG 2022-17: A ‘hybrid audit’ should be understood as an audit on the premises of the manufacturer or its supplier(s) and/or subcontractor(s) with at least one auditor present on the premises and other members of the audit team participating from elsewhere using information and communication technologies (ICT). Yes No None 5. The following areas can be effectively audited by using ICT according to NBCG-MED 2024-1: Handling communications with authorities, notified bodies, other operators, customers and or other stakeholders Clinical evaluation Resource management, qualification and training of human resources Processes for monitoring and measurement of output, data analysis and product improvement Management of corrective and preventive actions Design transfer to production Traceability and batch records In-process and final inspection Incoming inspection 6. Which areas of the audit should be be included in the on-site part of the hybrid audit according to NBCG-MED 2024-1? Verification of the existence of facility Processes for monitoring and measurement of output, data analysis and product improvement Processes for reporting serious incidents and field safety corrective actions on-site testing facilities Process for the UDI assignment Incoming inspection 7. Which section of the MDR requires an audit on the manufacturer’s premises? Annex I Annex IX section 2.3 Annex VII section 3.2 Annex VII section 4.5.2 None 8. What are the benefits of hybrid audits? Hybrid audits are more sustainable and reduce the environmental impact of auditing Hybrid audits reduce the risk of travel to high-risk areas Save auditor capacity and burnout All of the above None 9. Which of these activities is most suited to inclusion in the on-site part of the audit? Review of supplier files Qualification of sub-contractors Incoming inspection and verification of purchased products Purchasing procedures None 10. Which of these activities is most suited to inclusion in the remote part of the audit? Verification of the existence of the facility Design transfer to production Final inspection Management of corrective and preventive actions None 11. Which of these makes it risky to perform a hybrid audit? Manufacturer has a clean room Manufacturer has a paper-based system Manufacturer has a multi-national workforce Manufacturer has one quality manager None 12. Regarding the requirements for qualification of auditors during a hybrid audit: It doesn’t matter which auditor is on-site and which is remote, so long as they cover the qualification requirements between them The on-site auditor should be qualified for the MDT/IVT codes appropriate to the processes in the scope of the audit which physically occur at the site Both the on-site and remote auditors should be qualified for all the MDT/IVT codes appropriate to the processes in the scope of the audit which physically occur at the site The codes should be assigned depending on whether it is a surveillance or recertification audit None 13. The relevant IAF document for Use of Information and Communication (ICT) for Auditing/Assessment Purposes is: IAF MD4 IAF MD5 IAF MD9 IAF MD1 None 14. Which tools do you typically need for a successful remote audit? A ticketing system A chat tool A tool to exchange files A tool for video and audio communication 15. What can you do in case of bandwidth issues in a remote audit? Disable incoming video Disable outgoing video Disable incoming audio Change your background image Switch to an alternative network (e.g. LTE hot spot) 16. What are typical causes of audio issues beside low bandwidth? Webcam microphone used instead of PC microphone Microphone muted somewhere Person speaking is not close enough to the microphone Outside noise 17. What is true for moving cameras? Can cause nausea Need a stable bandwidth Are typically used to inspect work instructions Can be used to audit production activities 18. Which aspects belong to a proper technical preparation of a remote audit? Agree on the tools Perform a dry run if needed Agree on the dress code Agree on a backup channel Time's up pascaleperspectives2025-02-20T14:19:21+01:00
