BIOGRAPHY

Patsy L. Brown

Consultant/Trainer, Brown & Associates Quality Consulting, Inc., Pine Bluff, AR, USA

Patsy Brown has experience in quality engineering and quality management with major corporations and as an independent consultant and trainer. She has provided consulting and training support to companies in achieving registration to one of the ISO 9001-based standards and has assisted them in developing and integrating quality management systems with environmental, occupational health and safety, food safety, supply chain, and other management systems.

Mrs. Brown has extensive audit experience in evaluating management systems for conformity to the requirements of these various standards.Areas of expertise include ISO 9001, IATF 16949, AS9100 FS 22000, ISO 14001, and ISO 45001.

Additionally, she has experience in Six Sigma and other quality-specific topics including Problem Solving and Root Cause Analysis, Statistical Analysis and SPC, Failure Mode and Effects Analysis (FMEA), and the automotive core tools. She provides leadership training for supervisors and managers.

Mrs. Brown holds master’s degrees in industrial engineering and in Engineering Management. She is an ASQ Fellow and a Certified Quality Engineer, Reliability Engineer, Quality Auditor, Manager of Quality/Organizational Excellence, and Certified Six Sigma Black Belt. She holds credentials as an auditor for ISO 9001 quality management systems and ISO 14001 environmental management systems by Exemplar Global.

She is a frequent conference speaker and contributing author to technical publications.

ABSTRACT

Blended Process Audits - Effective Use of Virtual and Onsite Tools and Techniques

Process audits are a specific requirement of the IATF 16949 standard and are certainly a great tool for auditing manufacturing processes in any industry. In this presentation, I will address strategies and methods for performing process audits by blending virtual and on-site audit techniques and will focus on audits of manufacturing processes.

Prior to the pandemic, process auditors were likely to grab a copy of the process documentation and head out to the manufacturing floor to ask questions of the operators. Through the pandemic, virtual audits became the norm and auditors simply read documentation, evaluated online results, and conducted virtual interviews.

Now is the time to blend these two approaches so that our process audits retain the effectiveness of both methods.In this presentation I will recommend that process auditors continue to review manufacturing documentation virtually, but I will suggest that the auditors study this documentation more thoroughly. Work instructions and control plans describe most manufacturing processes, and the process auditors rarely audit the sources of these documents.

My presentation will propose that the auditors review the associated process FMEAs and look for linkages to the information contained in the associated control plans. A review of associated drawings and specifications will help the auditor determine if all the key product characteristics – safety, critical, and special – have been determined and addressed. After a careful document review of the process, the auditor can pursue the results obtained by the process such as quality, efficiency, delivery, and scrap. Evaluate these results and determine if they are the result of the actions that are supposed to take place according to the process documentation.

Throughout this review, the auditor will determine what questions to ask the operators that perform the process as well as the engineers and other personnel who support the process. This process audit will then proceed to the manufacturing floor and to the supporting processes so the live interviews can begin. Because of the auditor’s more complete understanding of the process, the audit can determine cause and effect relationships among the process instructions, supporting documentation, and the results achieved to determine if the actions are driving the results.

The auditor will be prepared to audit the supporting processes, addressing relevant issues that will lead to overall improvements of the process and its results.














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