Quality Risk Management Training



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IHS OPERATIONAL EXCELLENCE & RISK MANAGEMENT Quality Risk Management Training Identify, analyze, mitigate and monitor quality risks and hazards across your organization. These training programs leverage practical know-how and state-ofthe-art resources to teach you about proven management system concepts and techniques. BENEFITS: Quality Risk Management training is an integral part of the IHS Risk Assessment Solution which enables you to: All courses provide expert instruction in the best-practice professional methodologies to achieve greater quality and reduce costs. Training sessions are taught at your location or an IHS office and cover these topics: FMEA Leadership Advanced Product Quality Planning (APQP) FMEA for Medical Devices Improve quality Root Cause Analysis (RCA) Reduce time to market Identify potential design, process and product failures Additional details on each course can be found on the following pages. Current Scheduled Courses FMEA Leadership Boost productivity Feb 24-27, 2015 Training Location - Chicago, IL Improve customer satisfaction Apr 21-24, 2015 Sept 1-4, 2015 IHS Training Location Detroit, IL IHS Training Location - London, UK Build market share Nov 17-20, 2015 Training Location: TBD Cost A daily training rate of $650 USD/ person applies for these courses. The training fee includes refreshments and lunch. Electronic copies of the training materials are included, as well as the hard copy. IHS reserves the right to cancel the course. Course cancellation notice is provided two weeks in advance of the start date. Questions: Quality Risk Management Training 2-2-2015 1

Failure Mode and Effects (FMEA) Leadership This four-day FMEA Leadership course will empower you, and enable your organization through you, to identify, analyze, mitigate and monitor quality risks and hazards across the company. You will use state-of-the-art quality risk management software from IHS for hands-on exercises and facilitation practice under guidance of experienced professional instructors. You will learn tips and tricks to generate high quality FMEA studies in efficient and effective ways. Prerequisite It is mandatory that you have technical background and/or experience in the automotive, aerospace, medical device, pharmaceutical, consumer goods, power, high-tech, semiconductors, or other discrete manufacturing industries. This course provides practical training for the novice and refresher training for the seasoned professionals, including but not limited to: FMEA Team members FMEA Facilitators and Scribes Quality professionals Managers Engineers Supervisors Operators Maintenance Project Managers Technicians Consultants/ Contractors Day 1 - Basic FMEA Methodology & Workshop Introduction to FMEA, background and history, concepts of risk, overview of risk techniques, standards and regulations, and advanced quality planning, methodology, terminology, procedure, product and process life cycles and types of FMEA, workshop using IHS software. Day 2 - Advanced FMEA Methodology Concepts & Workshop FMEA leadership concepts, FMEA facilitation techniques, team leadership, control plans, advanced FMEA topics such as FMECA, FMEA based RCM, and FMEA and Reliability Prediction, and workshop using IHS software. Day 3 - Software End User IHS software walkthrough and navigation, file management, walkthrough of preformatted industry standard FMEA templates, comprehensive study and practice of IHS software end-user functions, hands-on IHS software exercises. Day 4 - Software Advanced User Introduction to IHS software template configuration engine, walkthrough of a FMEA template creation from scratch and hands-on exercises, comprehensive study of software advanced user functions, template user interface layout design, defining end-user experience. Training Dates Feb 24-27, 2015 Apr 21-24, 2015 Sept 1-4, 2015 Nov 17-20, 2015 Training Location - Chicago, IL IHS Training Location Detroit, IL IHS Training Location - London, UK Training Location: TBD Quality Risk Management Training 2-2-2015 2

Advanced Product Quality Planning (APQP) This course provides a step-by-step overview of the APQP process as well as reviewing the engineering tools required at each step to translate customer wants and expectations into concern-free end products. Reduces design / development and production cost. Assures team input and buyoff. Leads teams to focus on customer satisfaction throughout the entire launch process. Prerequisite It is mandatory that you have either technical background and/or experience in the automotive, aerospace, medical device, pharmaceutical, consumer goods, power, hightech, semi-conductors, or other discrete manufacturing industries. New product launch team members such as management and technical personnel from Product Design, Program Management, Quality & Manufacturing Engineering, Production Operations, Purchasing, Sales and Marketing. Describes the different phases of the APQP process. Identifies the inputs and output deliverables required by various new program team members. Learn how to effectively use the applicable tools and when to use them throughout the APQP process. Learn the applicable customer requirements as outlined within the APQP manual developed by Daimler Chrysler, Ford, and General Motors and published by the Automotive Industrial Action Group AIAG). Quality Risk Management Training 2-2-2015 3

FMEA for Medical Devices This course provides a step-by-step understanding of the FMEA development process and will show how to take full advantage of the features and capabilities within IHS Software. Provides common terminology to guide teams through the FMEA development process. Identifies potential design, process, and product failures at early stages in the process to allow for applicable actions being taken to prevent high failure costs at launch and throughout the life of the program. Provides information on industry best practices in medical devices and pharmaceuticals. New product launch team members such as management and technical personnel from Product Design, Program Management, Quality & Manufacturing Engineering and Production Operations. Describes the methodology used to predict potential risks throughout the product and process design stages. Learn how to effectively engage team members in the FMEA development process. Learn the applicable customer requirements as outlined within standard FMEA guidelines, such as FDA 21 CRF Part 820 QSR (cgmp), ISO 14971, ISO 13485, ISO 9001, EU Directive 2000/70/EC, SAE J1739, ARP 5580, and others. Quality Risk Management Training 2-2-2015 4

Root Cause Analysis (RCA) This course provides a step-by-step methodology to identify both the underlying root causes and the steps necessary to ensure appropriate and adequate preventive actions are taken to prevent recurrence. Ensure time is not wasted by team members chasing falsely identified issues and not addressing the true root cause(s). Minimize the response time and failure chargeback costs associated with customer reported incidents. Provide verified and validated confirmation that concerns have been fully addressed and that appropriate actions have been taken to prevent the issue and other potential similar issues from ever occurring again. Learn the methodologies employed to ignite your company team into accurately understanding the problem, provide fast responsive interim corrective actions, reinforce customer confidence, ensure the real issues are being addressed and that cost effective permanent actions have been validated and implemented to ensure prevention of this and/or other similar concerns in the future. The methodologies taught in this course are applicable to any organization experiencing either internal and or external customer related concerns. Case studies will be used during the course to provide practical application experience related to the methodologies being taught. Quality Risk Management Training 2-2-2015 5