ISO 9000 & AUDITS WORLD CONFERENCE
Risk Based Approach to Remote Auditing
Presenter: Mark Durivage, ASQ and SRE Fellow, Managing Principal Consultant, Quality Systems Compliance, LLC, Lambertville, MI, USA
Keywords: Nonconformity, Audit, Risk
Industry: Applies to All Industries
Remote audits offer an organization a viable alternative to on-site audits to ensure continued compliance with requirements. This presentation is intended to expose the attendee to the challenges, risks, opportunities, and best practices for performing remote internal and external audits.
Audits are performed to assess compliance to standards, regulations, guidances, requirements, and specifications, evaluate performance of processes and systems, gage the adequacy and effectiveness of quality management systems, and determine conformance with contractual obligations. Audits are also used to qualify potential new suppliers, reassess existing suppliers, and verify the implementation and effectiveness of corrective and preventive actions. Additionally, audits can be used to assess capability of supplier processes.
When regional, national, or global issues restrict or otherwise prohibit travel, tradition on-site audits may not be an option putting the organization at risk for not meeting procedural requirements as well as potentially impacting the organization’s ability to effectively qualify new and monitor existing suppliers.
Remote audits may allow an organization a viable alternative to ensure continued compliance with GMP requirements. Remote audits leverage technology such as video teleconferencing and shared file folders to facilitate interviews and share documents and records.