Successful completion of the course will result in a certificate for 0.8 CEUs being issued. Auditing experience is not required for the class.

Transcription

1 This course is for those interested in learning basic auditing techniques for determining conformance to a set of requirements. Both manufacturing and service examples will be discussed. The course is designed to provide an understanding of auditing basics for preparing, performing audits, reporting and follow-up of audit results. It may be used as a basic auditor training course. The course is intended for those interested in conducting system audits using any performance standard (such as: ISO 9001, FDA GMPs, FAA, QS 9000, ISO and so on). The course consists of a series of lectures and work shops. Successful completion of the course will result in a certificate for 0.8 CEUs being issued. Auditing experience is not required for the class. LEARNING OBJECTIVES: Identify what is needed to prepare for an audit Determine conflicts of interest that may affect Prepare for and conduct system audits Audit an area or function using interview Prepare organization-specific checklists Determine when a practice or situation Learn techniques for auditing open-ended Determine methods to analyze and classify Prepare nonconformities/findings for presentation Present results of audit Follow-up actions to verify effectiveness ABOUT J.P RUSSELL: J.P. Russell is a quality management professional who specializes in design and presentation of both instructor-led and web-based training programs for professionals. He has over 30 years experience with Fortune 200 corporations and quality management services. Mr. Russell is an ASQ Fellow, on the QualityPress Standing Review Board, a columnist for Quality Progress magazine, past RAB QMS LA and an ASQ Certified Quality Auditor. He holds a BS in engineering from Ohio State University and a Masters of Business Administration, IIT Stuart School of Management. 3

2 QUALITY CONVERGENCE INTEGRATING BALDRIGE, LEAN, SIX SIGMA, AND ISO Designed by Margaret Dospiljulian of Dospil & Associates 2005 As Quality professionals, you have the opportunity to create value throughout your organization, not just on the shop floor. In this participatory workshop Margaret Dospiljulian, Principal of Dospil & Associates will share the tools and techniques needed to successfully guide your organization through the performance excellence world. Included will be The 4 P s needed regardless of the tool or technique you choose. Key insights into each tool. Exercises using either your own or a client organization to better understand the potential benefit each tool may bring, including the top 7 questions to ask everyone in your organization to help optimize performance. Key interrelationships between the tools and how you can leverage them. Key benefits and potential obstacles when using each tool individually or combined. A case study, which demonstrates the strength of using the converged toolset to reap an 80% improvement in quality and tripled productivity in less than two years. Successful completion of the course will result in a certificate for 0.8 CEUs being issued. ABOUT MARGARET DOSPILJULIAN: Margaret Dospiljulian is a multi-degreed engineer (BS in Civil Engineering and MS Industrial Engineering) and Deloitte consulting alum, who has been a management consultant for the past 16 years, as well as a Senior Examiner for Illinois Lincoln Award for Performance Excellence and 2006 Malcolm Baldrige Examiner. Margaret s consulting work has ranged from restructuring large corporations to designing and implementing start-ups in many industries, including: manufacturing, distribution, engineering, service, travel and leisure, insurance, healthcare, education, and government. Included in all her work has been the extensive use of performance excellence tools and techniques. Margaret has also facilitated workshops such as Baldrige, Lean, Supplier Management, Results, Customers, Leadership, and Project Management for various organizations throughout the United States. After making her debut at the 2005 ASQ Annual Audit Conference, she is returning to the October 2006 ASQ Annual Audit Conference as a speaker on Communication Excellence. 4

3 This 2-day course consists of lectures, practices, and role play that help attendees gain an in-depth understanding of how to analyze a system in order to identify the root causes of problems. Key topics include: The difference between problem solving and root cause analysis Some common problem solving models and their weaknesses Five steps for performing root cause analysis Critical tools for performing root cause analysis Successful completion of the course will result in a certificate for 1.6 CEUs being issued COURSE OBJECTIVES This course is designed to: Enhance problem solving effectiveness by providing a model for more deeply analyzing problem situations. Clarify the difference between analytical and creative thinking, and when each is most useful. Promote the ability to provide problem-solving support in situations where one is not an expert in the process or technology involved. Expand the range of tools available for analysis of problem situations. WHO SHOULD ATTEND Quality and process engineers; technicians, corrective action coordinators, or managers; supervisors, team leaders, and process owners; anyone who wants to improve their ability to solve recurring problems. It is recommended that participants have some previous experience with the seven QC tools (pareto, flowchart, cause & effect diagram, histogram, run chart, check sheet and scatter diagram). ABOUT DUKE OKES: The ASQ Audit Division proudly presents a Pre-Conference Tutorial personally delivered by Duke Okes, CQE, CQE, CQ Manager. He is regarded as a leading authority in Root Cause Analysis. Duke Okes has been helping organizations solve technical problems for more than 30 years. He is an ASQ Fellow, and a certified quality manager, engineer, and auditor. 5

4 Corrective and preventive action (CAPA) is a major continual improvement tool. Not handled properly, however, it can drain resources and, yet, not satisfy the requirements of ISO Do you work for your CAPA process (prior to your ISO audits), or does the process work for you (and drives continual improvement)? Learn how to run an effective and efficient CAPA process that looks at the organization from a holistic perspective and drives business improvement while meeting the ISO 9001 requirements. Course Objectives Understand the ISO 9001 requirements for corrective and preventive action. Recognize the differences between corrective and preventive action and their relationship to continual improvement. Understand internal and competitive external data sources that may generate the need for both formal and informal corrective action. Stop putting out fires and learn to extinguish the source. Understand how to identify and state a problem. Understand the critical steps in the corrective and preventive action processes. Develop competence in taking a problem through the CAPA process. Understand how to use formal root cause analysis methodology. Develop familiarity in initiating and completing the mandatory CAPA record. Learn not only what is expected from your organization, but also how you can use it to impact the bottom line. Successful completion of the course will result in a certificate for 1.6 CEUs being issued Who Should Attend Recommended for an organization s senior staff, management representative, and staff in: Quality management (QA/QC/QE) Manufacturing operations Internal audit CAPA management Information systems/technology Documentation management ABOUT I. Robert Marash: I. Robert Marash, STAT-A-MATRIX Executive Vice President, Certification and Auditing Services, has over 40 years of experience as an educator, auditor, and practitioner in quality and environmental management systems, with a background in industrial management. Industries he has worked with include biologics, heavy equipment, nuclear, industrial chemicals, automotive, food, healthcare, computers, pharmaceuticals, medical devices, photographic, electronics, telecommunications, aerospace, and defense. Bob is responsible for developing, implementing, and auditing company-wide quality assurance programs. He has trained both industry (Fortune 500 companies) and government personnel in quality programs including courses presented at Princeton, Rutgers, and California Polytechnic University. 6

5 In addition to discovery and invention, human error prevention can be the greatest contributor to improved productivity, safety and quality. This seminar provides the most current developments in human error prevention and error effects mitigation. LEARNING OBJECTIVES: Understand and use human performance and human error prevention terminology; Classify human error from different perspectives; Recognize hazards, and understand and use barriers to human error, as well as techniques by which to strengthen the barriers; Recognize hazards, and understand and use barriers to human error, as well as techniques by which to strengthen the barriers; Recognize error-inducing conditions / error-likely situations, and understand and use behavioral techniques to counteract these conditions / situations; Recognize non-conservative decisions and make conservative ones; Understand and recognize human error causal factors; Understand how to measure human error; Design and implement a Human Error Prevention Program. Successful completion of the course will result in a certificate for 1.6 CEUs being issued. WHO SHOULD ATTEND This seminar is designed for anyone whose objective is to improve productivity, safety and quality. The principles and practices of human error prevention are universally applicable regardless of the type of industrial, commercial or governmental enterprise, and regardless of the type of function performed within the enterprise. ABOUT BEN MARGUGLIO President BW (Ben) Marguglio LLC / High Technology Seminars, Ben has fifty years high technology experience, including current position as a management and technical consultant and seminar presenter, and former position at a large electric and gas utility as an executive level director responsible for the Quality, Environmental Affairs and Management Systems Departments. Originator of a new and unique human error taxonomy, and presenter of the acclaimed Human Error Prevention and Problem Reporting, Root Cause Analysis, & Corrective Action Seminars. Author of numerous technical and management papers and two books: Quality Systems...; American Society for Testing and Materials; 680 pages; 1977 and Environmental Management Systems; Marcel Dekker, Inc; 208 pages;

6 This class is focused on methods and techniques to conduct successful quality, safety, and environmental process audits as well as process auditing techniques for system audits. Internal and external process audits and techniques provide very valuable information to management and oversight organizations. Topics include preparing and performing process audits, identification of poor performance indicators and risk. Students should have already completed a basic audit training class or be an experienced auditor. The techniques presented in this class can be used by auditors who conduct internal and external audits. The class is not specific to any performance standard but ISO 9001 example controls are used for convenience. A book comes with the class. The class will take approximately 8 hours and upon successful completion a certificate for 0.8 CEUs will be issued. LEARNING OBJECTIVES Audit process Demonstrate knowledge of the characteristics of a Use tree diagrams during the audit Prepare process flow diagrams Apply PDCA and ACDP techniques Collect audit evidence Evaluate adequacy of controls with and without Use techniques to audit open-end requirements Apply techniques to identify risk Identify process inefficiencies using process performance indicators Compose and audit report assessing compliance, controls, risk and process optimization Apply techniques to add value ABOUT J.P. RUSSELL J.P. Russell is a quality management professional who specializes in design and presentation of both instructor-led and web-based training programs for professionals. He has over 30 years experience with Fortune 200 corporations and quality management services. Mr. Russell is an ASQ Fellow, on the QualityPress Standing Review Board, a columnist for Quality Progress magazine, past RAB QMS LA and an ASQ Certified Quality Auditor. He holds a BS in engineering from Ohio State University and a Masters of Business Administration, IIT Stuart School of Management. 8

7 Without a doubt, the Sarbanes-Oxley Law (SOX) is the single most important piece of legislation affecting corporate governance, financial disclosure, and the practice of public accounting since the U.S. securities laws of the early 1930s. This one-day workshop will explain how elements of the Sarbanes-Oxley Law (SOX) can be supported by the effective management and auditing of quality and environmental management systems (QMS/EMS). It will show how the requirements of ISO 9001:2000 (and ISO 14001:2004) support the system of internal controls mandated by the regulations, and how the QMS and EMS audits can be combined with internal financial audits to reduce the risks to an organization. Case studies will be presented and a panel discussion will close the workshop. LEARNING OBJECTIVES To provide an awareness of how quality and environmental management systems (QMS/EMS) can support the compliance of the Sarbanes-Oxley Law (SOX). Identify the business value of QMS/EMS support of SOX compliance Identify the business value of QMS/EMS support of SOX compliance To provide examples of QMS and EMS experts experiences in the SOX effort. To provide reference material and define terms useful for supporting SOX compliance. Successful completion of the course will result in a certificate for 0.8 CEUs being issued. WHO SHOULD ATTEND Quality managers, operations managers, internal quality auditors, internal environmental auditors, risk managers, and financial managers. ABOUT DONNA SPENCER: Donna Spencer is the Corporate Quality Performance Manager for The NORDAM Group. The NORDAM Group is a privately held international aerospace company headquartered in Tulsa, OK with divisions in Wichita KS, Singapore, and Wales. She has 20 years experience as a quality and customer service professional. Donna has been instrumental in developing a process that integrates all audit groups to help determine the effectiveness of internal controls without mandating a merger of these groups. ABOUT JOHN WALZ: Mr. Walz is a Senior Consultant of The Sutton Group after retiring from Lucent Technologies as a Senior Manager, Quality Strategy. John has over 20 years experience in quality management and measurements. He has worked for AT&T, Lucent Technologies, and SBC. He is a Subject Matter Expert in TL 9000, ISO 9001, Baldrige National Quality Award criteria, Software CMMI, and IEEE Software Engineering Standards. He has experience in Business Process Management, Integrated Management Systems, Sarbanes-Oxley implementation and auditing, Software Assessments, Risk Management, and Information Technology (IT) process improvements. Mr. Walz is involved in standards development for ISO 9001, TL 9000, and IEEE Software and Systems Engineering and participates in their committees. 9

8 The Audit Division Certified Quality Auditor (CQA) Exam Refresher Course will be taught by instructors, trained, and certified by the Audit Division in the CQA Body of Knowledge. Potential instructors include: Janet Muschlitz Book, John F. Mascaro, Ruby Ivens, Don Mutziger, Wendy Finnerty, Cindy Miller, and/or Dennis Welch. The Certified Quality Auditor refresher course is two-day course to help experienced auditors become better prepared for the CQA examination. Attendees of the refresher course will receive a copy of the Quality Audit Handbook, current edition, and become thoroughly familiar with the Body of Knowledge (BoK) for the CQA examination. Class discussion will include an in-depth overview of the exam process. Example test questions and answers will be provided to offer participants a better understanding of the basic principles and applications that will appear on the CQA examination. TOPICS COVERED: CQA Overview Auditing Fundamentals Audit Process Auditor Competencies Audit Program and Business Applications Quality Tools and Techniques Take advantage of the ASQ s most popular examinations!!! Certified Quality Auditor Certified Quality Engineer Certified Manager of Quality/Organizational Excellence Certified Quality Six Sigma Black Belt Certified Quality Improvement Associate These ASQ Certification Examinations will be offered on Saturday, October 21, Application deadline is September 22, To register for these exams, contact ASQ Headquarters at: or through the ASQ Internet link: Don t delay, SIGN UP TODAY! There will be no on-site registration. 10