MDR Remote Audits Welcome to your MDR Remote Audits Name Email 1. Which MDCG guidance is applicable for Remote Audits under MDD? MDCG 2020-4 MDCG 2020-8 MDCG 2020-6 None 2. Which EUC Notice applies to MDR Audits? Commission Notice 2021/C 8/02 Commission Notice 2021/C 8/01 Commission Notice 2021/D 8/02 None 3. What is the main requirement of Commission Notice 2021/C 8/01 Commission Notice 2021/C 8/01 requires NB’s not to perform a case-by-case risk assessment of individual circumstances Commission Notice 2021/C 8/01 requires NB’s to perform a case-by-case risk assessment of individual circumstances Commission Notice 2021/C 8/01 requires NB’s to perform analysis as per MDCG guidance None 4. Based on CIRCABC Remote Audit Analysis May 2021, majority of Remote Audits are successful Yes No None 5. Based on CIRCABC Remote Audit Analysis May 2021, what are examples of successful experiences with Remote Audits? Very effective for non physical processes (like software) and pure QMS aspects Verification of the quality of records is more accurate than in an onsite audit Verification of production records is more accurate 6. Based on CIRCABC Remote Audit Analysis May 2021, what are examples of unsuccessful experiences with Remote Audits? Issues with internet connections Issues with lack of personal contact Issues when there is a large time difference 7. Are there particular clauses of MDR/IVDR related to audits that you think cannot be completed remotely Design and development [ISO 13485 - §7.3] Production and service provision [ISO 13485 - §7.5] Infrastructure [ISO 13485 - §6.3] 8. True or (partially) false: Limitations of remote auditing, such as lack of non-verbal communication or acoustic misunderstanding, may be a threat to the audit effectiveness. Sufficient time should be planned for summarising the audit results, including, for example, close-out of individual topics/threads and follow-up items, debriefing of individual audit days, clarification of any issues of concern, communication of expectations and potential findings. True False None 9. Which of the following statements regarding non-conformities and follow-up activites can be considered as true: Specific follow-up activities, such as on-site verification of particular topics of the audit, should be recommended especially in cases where conformity to a requirement could not be verified as planned. During documentation and grading of non-conformities detected during remote auditing, special consideration shall be given to the fact, that the required information may not have been available to the audit team due to technical difficulties. Recommendation of specific follow-up activities should be documented in the audit report, detailing the processes/activities and/or requirements to be addressed. The certification recommendation should include any limitation arising from remote auditing (e.g. limitation oft he cerfication celidity perio, change of certification scope based on reviewed samples, maintainance of certification under condition). 10. True or (partially) false: Generally, remote auditing should not be considered as sole auditing method where an onsite evaluation of processes may be necessary to obtain the sufficient level of confidence. However, a site tour with a portable camera and the possibility for the auditors to direct the camera or the camera operator are sufficient to substitute for an onsite presence, as long as floor plans are made available to the audit team, too. True False None 11. The audit team should be aware that extraordinary circumstances leading to the need of an remote audit may also have affected the organisation’s ability to respond to auditors’ questions or to provide the required evidence in a timely manner. To mitigate related risks and obstacles, the following items should be considered when preparing for an remote audit: Prepare a contingency plan for any communication failures Have direct phone numbers of the relevant audit participants at hand during the audit Ensure an IT expert is available for quick troubleshooting of any issues, if necessary Ask the manufacturer to have an on-site scanning support for paper documentation 12. Generally, the audit plan for an remote audit should always include the following information: Type and extent of remote auditing technique used. The specific dial-in information for the conferencing calls used during the remote audit. The involved audit team members, including their presence during the audit (off-site/on-site participation) Sufficient time for the auditors to record the audit evidence. Sufficient time reserved for the mandatory site tour. Adequate breaks (continuous sessions should not exceed hours). 13. Which oft he following statements regarding the conduction of remote audits can be considered as false: Documentation shall always be reviewed prior to the actual remote auditing and therefore needs to be provided ahead of time. Documentation can be reviewed either prior to actual remote auditing or in-audit but require the use of adequate video-conferencing tools with screen-sharing capabilities. Documentation could be reviewed either prior to actual remote auditing or in-audit. The use of video-conferencing tools with screen-sharing capabilities is optional but may be beneficial to direclty adress questions. As interviewing may be necessary to ensure proper implementation of processes, the possibility for such during the audit should be addressed at the preparation of remote auditing. Observation of individual operations usually are not necessary during remote auditing, as the focus should be on documentation review. Video quality of modern camera systems allows the review of presented documents and records with sufficient detail. 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 pascaleperspectives2025-02-20T14:16:52+01:00
