FOPAT Adopts New Method to Conduct ISO Audits...

Traditionally, when companies first started implementing ISO 9001 within their organizations in the early 90’s, the internal auditing process was based on a series of formatted questions that followed a standard checklist procedure; element (clause) by element (clause) to achieve compliance. According to Tim
Large, Quality Systems Manager and Lead Internal Auditor at FOPAT Production Inc. (FPI) and Inc. (BCI), Miamisburg, OH; many companies found this to be an impractical and ineffective approach to assessing their quality management system (QMS) efficiently. This was mainly due to the lack of knowledge and understanding among internal auditors and their management team.
They realized that many of their day-to-day activities performed, whether they were a large and/or small business, have interrelated processes (interactions) that provide both inputs and outputs to the overall operations and/or QMS of the organization.

Tim alluded to the fact that many internal auditors and/or internal audit teams within a particular business are normally made up of shop floor/production staff members and support personnel outside of the traditional quality department. Once trained, (which typically involves a fast pace 2-day course), they begin their journey as new internal auditors trying to grasp the details and subtleties of their company’s quality management system (QMS). As a result, most of these internal auditor students come away from the training confused and frustrated due to improper training methods that traditionally focus on general
compliance issues. The training should be focused on process auditing techniques that can help them understand the flow and process performance which will lead to further added-value in improving their companies QMS.

In 2000, the International Standards Organization (ISO) released a new version of the Quality Management Systems standard promoting a “process approach” to conducting assessments (audits) to improve upon the effectiveness of a quality management system. This new approach was aimed at enhancing customer satisfaction by meeting customer requirements through efficient feedback that would become essential for recognizing the need and potential for further improvement. The idea here was to identify and manage numerous linked activities between individual processes within the value stream system for achieving customer satisfaction and sustaining the organizations quality objectives. This was accomplished by transforming the previous version’s 20 activity-focused elements into 5 major interdependent processes that would create a method for exploring the QMS more in-depth, including:
Clause 4.0 – QMS Documentation; Clause 5.0 – Management Responsibility; Clause 6.0 – Resource Management; Clause 7.0 – Product Realization; and Clause – 8.0 Measurement Analysis and Improvement. The transformation was based on Shewhart's "PDCA Cycle” (which in Japan became known as the “Deming Cycle”) that stands for “Plan, Do, Check, Act.” Today, PDCA has become a staple of the quality and business planning process within many organizations across the United States and throughout the World.

Only until recent years, since the release of ISO 9001:2008 in November of 2008, has this “process approach” to conducting internal audits been embraced as a standard way of practice. For years, internal auditors and audit teams have relied on traditional methods of using a checklist approach to formulate a
series of questions around each element (now clause’s or sub-clause’s). Many companies still use this method today as a basis to start their assessment process. “You may say that old habits are hard to break,” as mentioned by Tim Large, in referring to the various types of internal audit training materials
and resources available that still utilize this format for conducting ISO 9001:2008 audits.

Recently, FOPAT adopted the PDCA approach to their internal auditing process. This new approach using PDCA, has now taken on a complete new method and meaning, thanks to Author Paul C. Palmes, who recently released his second edition book entitled: Process Driven Comprehensive Auditing: A New Way to
Conduct ISO 9001:2008 Internal Audits.

This book was written for the novice internal auditor, as well as for the experienced auditor in search of a more significant approach to conducting highly effective QMS audits. It simplifies a complex series of actions through examination and guided application of Shewhart and Deming’s PDCA Cycle. According to Tim, this book is not only a great reference tool for understanding the foundational aspects of conducting internal audits, but provides excellent guidance in the planning, implementation, evaluation, and actions for effective process management in achieving real performance results.

The use of these new PDCA methods has enabled FOPAT’s internal audit team the ability to effectively communicate and deliver precise and competent information to top management in preventing and uncovering risks factors while providing measureable data for continuous process improvement for their QMS. It has also been instrumental in demonstrating their conformity to the requirements for certification under the ISO 9001:2008 standard, which FPI achieved in January 2011. These same PDCA methods are now being applied to the overall processes within the entire organization as the parent company, buyCASTINGS (BCI), enters the journey towards ISO 9001:2008 registration/certification later this year.
Tim indicated that using this new approach coupled with proven quality methodologies such as APQP (advanced product quality planning) and PFMEA (process failure mode and effects analysis) has eliminated the obstructions once encountered and allowed the internal audit team to achieve meaningful results towards the success of implementing a sound quality management system they can rely on!

To learn more about the implementation process of PDCA approach and/or using Process Driven Comprehensive Auditing techniques, please feel free to contact Tim Large, Quality Systems Manager, FOPAT Production Inc. (FPI) & Inc. (BCI) at or you can obtain information about this publication and others through the American Society for Quality (ASQ).