Selecting the type of Audit
Remote audits may not suit every situation, and the first step is to assess whether an onsite audit is required or if a virtual audit would be appropriate. The initial assessment of a new critical supplier or facility to determine if the quality management system is adequate and the site capable of manufacturing or storing the product to be supplied may require an in-depth multi-day onsite audit. The company and its QPs/RPs need to get a feel for the general levels of housekeeping, cleanliness, and maintenance. They must determine if the facility is well designed and laid out and has the capacity to manufacture or hold the volumes required to GMDP standards. Follow up routine audits of suppliers initially deemed GMP/GDP compliant (with minimal observations from the initial assessment) would be lower risk. In this situation, it would be appropriate to conduct a remote audit. The most essential tool in determining what type of audit to complete is the periodic audit risk assessment. The company should assess the risks associated with individual new suppliers through the change control program and determine if an onsite audit or virtual audit should be added to the audit program. Also, periodically the entire program should be assessed to determine if the types of audits are appropriate and if in-person visits or virtual assessments can be completed.
For virtual audits, it is critical to plan for success and ensure the site to be audited will have appropriate recording equipment and adequate broadband/Wi-Fi availability to allow the entire site to be visited virtually. It is also essential to verify with the site to ensure that SOP’s, records, data and other documentation can be shared with the auditor using a secure data sharing program such as OneDrive or SharePoint. Often suppliers who supply large numbers of customers and who, as a result, have frequent audits will have detailed documentation packs and walkthrough videos prepared that can enhance this process. This will allow the initial site tour and document reviews to be completed offline and free up the auditees. The interviews of key personnel and question and answer sessions can then follow this.
The organisation needs to determine who will conduct the audit or audits, assess their capabilities and approve the individual plans or audit programs. Also, an evaluation of whether to use their in-house team, QP/RPs or engage outsourced specialist consultants will be required.
Orion Consulting has a panel of highly experienced auditors with many decades of GxP, laboratory, and facility assessment experience. We can work closely to identify the right expert for your audit requirements, whether supplier assessments, storage sites, testing laboratories or internal or external manufacturing sites.
If you need an immediate assessment of your audit program or have a critical or urgent audit that you need to address then, please contact us at firstname.lastname@example.org
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