A Case Study Illustrating Effective Virtual Auditing
Dr. Barbara Hurley, Senior Quality Assurance Engineer, GTRI, Atlanta, GA, USA
Co-Speaker: Angel Jaen
Keywords: Auditing, Virtual, Checklists
Although there are many descriptors for virtual auditing (including remote auditing, e-auditing, desk auditing, and document auditing within the context of the ISO 9001 auditing), it is critical that virtual audits are approached with the same attention to detail, preparation, and best practices that apply to in-person audits. This session describes how an applied research organization ensures virtual audits are conducted with the same diligence and effectiveness as the initial face-to-face audits that were utilized for the original ISO 9001 certification in August 2016. Since that time, and long before the COVID-19 pandemic, virtual auditing has been the primary approach in our organization. In fact, more than 350 virtual audits have been completed encompassing twelve Quality Management System (QMS) processes and six business units that employ approximately 600 researchers and staff; including fulltime, temporary, contractor and student employees. Use of a virtual auditing approach has proved effective and is evident from the successful completion of all ISO 9001 third party surveillance and recertification audits since the original registration. Furthermore, continuing success with ISO 9001 audits has coincided with a period in which the QMS has supported record growth with a funding increase of 250% since 2017. The growth in revenue and funding is due to several factors, but can be attributed indirectly to the successful implementation and application of the ISO 9001 standard.
This session will explore internal virtual auditing of a QMS against the ISO 9001:2015 standard using a case study approach from an applied research organization. Applied research organizations typically create “One-Off” hardware systems, provide engineering expertise, develop software, author research studies, and produce prototypical work products. Consequently, audits, compliance, non-conformance resolution, and process improvement methodologies are more aligned with service/knowledge-based organizations rather than typical manufacturing sites. Although the case study is taken from an organization whose focus is research and development of innovative products, many of the tools and techniques that will be presented can be translated for use in other types of industries, including manufacturing.
Based on numerous successes employing virtual auditing, a brief overview of the advantages and disadvantages encountered will be provided. Experience has shown that there are several advantages derived from virtual audits including employee safety and workplace flexibility. Worker safety is improved by removing the requirement for employees to physically meet in potentially hazardous environments (including pandemic conditions) while also providing productivity improvements and flexibility for auditors and auditees who are not required to schedule face-to-face meetings. Additionally, virtual auditing is more aligned with remote working trends and the push to digitize the record keeping process. Conversely, several disadvantages attributed to virtual auditing including access to physical items, response times, and monitoring cycle times need to be recognized and mitigated. In cases where physical items must be examined/verified, there are logistical and technical challenges associated with using video as a means to examine items under audit. Whereas face-to-face auditing can provide immediate responses from auditees and instantaneous monitoring, virtual audits can result in delays while awaiting written feedback from respondents as well as the possibility that auditees will perceive regular remote monitoring as too invasive and unwarranted.
The presentation will continue with a discussion of a case study to illustrate the strategy and methodology employed. Specifically, the organization’s strategy to use virtual audits to reduce the disruption to operations caused by traditional process audits will be discussed. The case study will describe how each step of a traditional audit is accomplished virtually including audit selection, opening meetings, audit interviews, audit checklists, discussion of potential findings, closing meetings, and corrective action follow-up. Examples of key templates, forms and checklists used by internal auditors will be presented. In addition, standardized production-related documents will be presented that were developed to accommodate the varied nature of research and development work while still providing the structure that enables virtual auditing. The case study will also highlight the aspects of the organization’s virtual audit program that facilitated preparation for in-person third-party audits, and minimized the changes required to pivot to remote third-party audits during the Covid-19 pandemic.
The session will finish with a discussion of lessons learned and conclusions derived from the organization’s extensive experience.