Can anyone share their procedure regarding offsite or agile audit?
That is something you can discuss with your suppliers. Let them know about you not being able to do onsite, see what their options are.
any available audit methodology? thanks for sharing.
Between us not being allowed to travel and our suppliers not allowing unnecessary visitors, we have been doing 'virtual audits' since last spring. We conducted a risk assessment of all suppliers that were on the schedule to be audited. Those that have a good relationship with, no issues, have visited at least 1 time, we plan on virtual. Those that we have never seen, have had issues or other concerns, we scheduled for Q4 in hopes that maybe we will be able to get there.
For the virtual, we still utilize our normal audit form. We spend about 1 to 1.5 hours discussing with their QA/FS manager. I feel we go more in depth on some sections because we aren't there to see for ourselves. Myself, our QA Manager, and our Purchasing Manager is who completes these. Thus far we have been happy with this process.
We have been requiring our suppliers to provide their full 3rd party audit report. Also, if we are certifying a new supplier, we have been doing Teams meetings in order for them to be able to show us their documentation that they would typically have available for on-site. I also ask them to take general photos of GMP areas (nothing proprietary) so that we can see the condition of the areas being used in production. If they have anything concerning on their 3rd party, I do let them know that as soon as possible after restrictions are lessened, we will conduct an on-site audit.
Hello,
Below is an ISO guidance on remote audits
https://committee.is...mote_Audits.pdf
Depending on the agreement between auditors and auditee, some audit may be divided into two parts: an asynchronous strictly document review where the auditee sends copies of documents, records, and or recorded video demonstrations AND a synchronous interview with the auditee.
The challenges brought by this pandemic also opened up flexibility in terms of auditing.