Virtual Site Inspections / Audits in Times of Pandemic, et al

an approach ...

         Virtual Audits / Inspections, if applicable:  Using the information in a Vendor Audit SOP /

         Attachment, develop an Audit Plan / Script that can be conducted by a video

         conferencing tool, e.g., Skype®, Zoom®, WebEx®,  GoToMeeting®, MS-Team®,

         and/or the use of a phone camera or similar.  Enlist the help of a QA/QC contact

         person at the vendor to assist with the video. 

         Then:

·     Obtain e-copies, pdf, or paper copies pre-sent of the QM, SOP Index / Titles, specific applicable SOPs, Establishment Registration Number, applicable 510(k) K numbers / dates, catalog (or website screen captures), certifications, last US FDA 483 if available, and so on;  

·     “Tour” their facility, with their contact person taking visuals with the digital camera;

·     Focus on areas of interest to you, e.g., IQC, Inventory Storage, Manufacturing, specific work stations, FG QA, post-production activities, if applicable, and similar;

·     Video, smart phone photo, specific activities, specific documents related to your product (or obtain e-copies, pdf, or paper copies pre-sent;

·     Request additional supplemental videos, if needed, during course of desk audit.

                        ·     Compile a written “narrative” of the video for the file (or the actual video in 21                                    CFR11/system-validated storage.  

    -- jel@jelincoln.com  

Note:  The above should be considered an addition to the remote audit's use of a check list and questions and answers.  I've done several such remote inspections / audits, working off a check list, e.g., a general verbal description of their operation, and then the checklist's questions tied to 820 's 15 subparts (A-O),  and/or ISO 13485's 4 key operational sections (4-8).  I ask how they've addressed each, asking additional supplemental questions to fill in my understanding of their QMS, in some cases using their descriptions to flow chart the operation (which I include in the Report).  It's where I have unanswered questions or need additional verification that I utilize the above "tour" and visual / camera copies of documentation.

I always review my draft report with their team prior to the "visit's" conclusion, and prior to submitting my final, formal report. - 06/07/2022