QMS: Quality Management Systems



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Heribert Nuhn Dahlienweg 2 D-56587-Strassenhaus Tel.: (49) 02634-9560 71 FAX.: (49) 02634-9560 72 Mobil.: (49) 0171 315 77 68 U@AOL.com : Quality Management Systems Seminars: Awareness Seminars ISO/ TS 16949: 2009 - QS-9000 Quality Planning (Maturity Level Assurance (RGA) APQP, Control Clan, VDA 2, PPAP) Customer Satisfaction Balanced Scorecard (BSC), 6Sigma, QOS Internal Auditor (ISO 19 011: 2002) FMEA (according to QS-9000) Problem Solving Techniques Kepner Tregoe Global 8D (Ford) Chrysler 7 Step Corrective Action General Motors` PR&R Field Failures Analysis SPC-Awareness Version: 15.03.10 E:\AA Heribert\B_Homepage\B_Ang_April 2010 E1.doc Version 15.03.10-1 -

Quality Management System On the following pages you will find a description of the most common versions of our seminars offered. All seminars are offered as practitioners courses to reflect the special needs of your organisation. Examples for typical adaptations: Development of Quality Manuals (ISO/ TS or QS-9000) and preparation of documented procedures Business Plan and Management Review Balanced Scorecard (BSC), 6Sigma, Quality Operating System (QOS) Quality Planning as a part of every Quality Management System for all products, we help to develop procedures for RGA (Maturity Level Assurance) and VDA 2 or APQP and PPAP to cover the entire organisation Facilitator for RGA-/ APQP-Projects Facilitator for FMEAs or Problem Solving All seminars are offered in both English or German. For services rendered we charge 1.280,-- per man-day, plus material and travel expenses (car: 0,35 /km, flight: according to special arrangements; hotel, cab etc.) plus VAT. For special preparations additional expenses might be incurred, subject to prior approval. - 2 -

Table of Page Quality Management System Q1: ISO/ TS 16 949: 2009 or QS-9000 Introductory Seminar 4 Q2: Customer Satisfaction (BSC, 6Sigma, QOS) 5 Q3: Quality Planning (Maturity Level Assurance (RGA), 6 VDA 2 or APQP, Control Plan, PPAP) Q4: Internal Auditor (ISO 19 011: 2002) 7 Failure Mode and Effects Analysis FMEA F1: FMEA for Management 8 F2: FMEA Introductory Seminar 8 F3: FMEA Practitioners Seminar 9 Problem Solving Seminars T1: Management Seminar (8D/ 5-Why) 10 T2: Introductory Seminar (8D/ 5-Why) 11 T3: Techniques in Problem Solving 12 (Tool Box) (8D/ 5-Why) T4: Practitioners Seminar (8D/ 5-Why) 13 T5: Problem Solving (Root Cause Analysis) (8D/ 5-Why) 14 T6: T6: Problem Solving (Field Failures Analysis) 15 Statistical Process Control S1: SPC Practitioners Seminar 16 S2: Process Capability, Process Readiness 16-3 -

Q1: ISO/ TS 16 949 :2009/ QS-9000 Introductory Seminar Employees from all activities of the organisation that need to have basic understanding of the Quality Management System. The Quality Management System of the organisation will be presented according to ISO/ TS 16 949: 2009, QS-9000 or VDA 6.1. The structure of the Quality Management System: quality manual, procedures, work instructions and documentation will be demonstrated as an instrument to support the quality policy of an organisation. 10 to 30 ppl 4 to 8 hrs With appropriate preparation and adjustments, 2 seminars can be done in one day. - 4 -

Q2: Customer Satisfaction (BSC, 6Sigma, QOS) Management and members from all activities of an organisation, who have the responsibility in their work to incorporate expectations of owner/ shareholder, customers and employees in a balanced approach. Leading an organisation with measurables that represent common values. Expectations from: owner/ management, customers and employees of an organisation are gathered, presented and common goals defined. Interactions are shown in a case study. Steps to implement the system are presented, a chart to show improvements will be developed to serve as reporting system. A brief description of methods used will be included. Connections to Balanced Scorecard (BSC), 6Sigma und Quality Operating Systems (QOS/ BOS) will be shown. The course ends with a summary of the system in a Management Review and typical checklists. Strategic goals of an organisation are expressed in measurables for all activities and it is shown how they are used to lead the organisation. 10 to 20 ppl 4 to 8 hours Additional days may be reserved to accompany a project introducing Balanced Scorecard (BSC) or Quality Operating System (QOS). - 5 -

Q3: Quality Planning (RGA, VDA 2 or APQP, Control Plan, PPAP) Employees from Research and Development, Production, Logistics, Purchasing, as well as internal and external Quality Assurance, including representatives from suppliers should attend to see their part in quality planning. The background for quality planning will be demonstrated according to Quality Management Systems like: ISO/ TS 16 949, QS-9000. General connections to the quality manual, quality procedures, work instructions and documentation are shown. A risk assessment is included to enable the delegates to understand the need for appropriate meassures for all new and changed parts. Typical checklists as shown in the VDA Manual for Maturity Level Assurance (RGA) or APQP Manual (QS-9000), from individual car manufacturers or from other customers and for the most important techniques are included like: FMEA, DVP&SOR, Control Plans. The seminar ends looking at the most common reporting systems linking customers, organisations and their suppliers. The final step in APQP is done summarizing all steps according to PPAP or VDA 2. Present individual planning activities for all Design Phases. 10 to 20 ppl 1 to 2 days The seminar can be prepared in a way that the of an organisation is presented including the quality manual, procedures, work instructions and documentation. - 6 -

Q4: Internal Auditor (ISO 19 011: 2002) Members from all activities of an organisation: Design, Production, Purchasing, Logistic as well as internal and external Quality Assurance, who are expected to work as internal auditors or those who are to gather experience regarding audits. The general understanding about the Quality Management Systems of the organisation will be presented according to (ISO/ TS 16 949, QS-9000, VDA 6.1) as well as special requirements concerning internal audits according to ISO 19 011: 2002. Audits are prepared and should be done within the organisation. The results are presented and experience from the audits is shared. Finally the audit teams will develop suggestions for corrective actions. Train internal auditors and offer an opportunity for those members of the organisation that need to have some extra experience with audits. 8 to16 ppl 2 to 3 days Additional subjects like communication skills can be built into the seminar. (3 days). - 7 -

F1: FMEA for Management upon special request F2: FMEA Introductory Seminar Members from activities like Design, Production, Purchasing, Logistic as well as internal and external Quality Assurance, who want to have an overview of expectations towards the results of Design and Process FMEAs. The seminar demonstrates how FMEAs become an essential part in modern quality management systems, especially during the phases of quality planning (RGA/ APQP). An example shows the the necessary steps for developing an FMEA. Differences between Design and Process FMEA (QS-9000) or System FMEA Product and System FMEA Process (VDA 4.2) are elaborated. The course is based on the FMEA Manual from QS-9000 by DC, Ford, GM, 4 th Edition. Reference is made to the FMEA method by VDA 4.2. The seminar explains the steps of an FMEA and their meanings within quality planning for other techniques like Control Plan or work instructions.. 16 to 20 ppl 6 to 8 hours - 8 -

F3: FMEA Practitioners Seminar Members from activities like Design, Production, Purchasing, Logistic as well as internal and external Quality Assurance and selected suppliers who need to participate in a Design or Process FMEA during the course of a planning project for new or changed parts. After a brief introduction the groups begin to work on tasks from their own projects. Examples will be taken from their fields of work. will analyse the various steps in Design and Process FMEAs (VDA 4.2: System FMEA Product, System FMEA Process). Results are presented and discussed by all. Completed FMEAs are compared to checklists from APQP (QS-9000). The course is based on the FMEA Manual from QS-9000 by DC, Ford, GM, 4 th Edition. Reference is made to the FMEA method by VDA 4.2. Supervising the development of a portion of an FMEA in small groups. Support is given during the phases of quality planning process. 10 to 16 ppl 1 to 2 days Additional days may be reserved for the completion of major FMEAs. - 9 -

T1: Problem Solving: Management Seminar Upper management, plant manager, managment from Sales, Design, Customer Service, Production, Purchasing, Logistic as well as internal and external Quality Assurance. Problem solving methods are shown to be a necessary part of any quality managment system according to ISO/ TS 16 949, QS-9000. Basic concepts of special techniques in problem solving are demonstrated in a case study. Examples of necessary support for problem solving teams are discussed. Differences between problem solving methods like Kepner/ Tregoe, Chrysler s 7 Step Corrective Action, Ford s Global 8D or GM s PR&R are pointed out and explained. Links to Field Failures Analysis are shown during the course of the seminar. The seminar shows how management can improve the results achieved by problem solving teams by providing the necessary support and encouragement for a successful problem solving effort. 6 to 15 ppl about 4 hours This presentation is recommended as a preparation for the Problem Solving: Practitioners Seminar (T4). Especially the selection of teams and problems to be worked on can be done towards the end of this course. - 10 -

T2: Problem Solving: Introductory Seminar Who should Members from activities like Design, Production, Purchasing, Logistic, Customer Service as well as internal and external Quality Assurance, who need to have an overview of problem solving methods. In a case study the seminar concentrates on the characteristic techniques used within problem solving methods. The background for an 8D Report is developped. The link of problem solving methods to quality management systems like ISO/ TS 16 949, QS-9000 is also shown. Differences and and potential opportunities for improvement between the organizations approach towards corrective and preventive action are highlighted and discussed. Differences to other problem solving methods like Kepner/ Tregoe, Chrysler s 7 Step Corrective Action, Ford s Global (8D) or GM s PR&R are pointed out. Links to Field Failures Analysis are shown during the course of the seminar. Demonstrate the key techniques for problem solving. 12 to 16 ppl 6 to 8 hours During the later part of the seminar, groups can work either on a case study or current problems from their activities. - 11 -

T3: Techniques in Problem Solving (Tool Box) Members from activities like Design, Production, Purchasing, Logistic, Customer Service as well as internal and external Quality Assurance, who need to have an overview of problem solving methods and important mathematical, statististical or analytical techniques to evaluate information and make decisions. The seminar shows problem solving methods as part of the quality tools of an organisation. The most common tools are presented in various exercises to cover: - Element ISO/ TS 16 949: 8.5 and QS-9000: 4.14: - systematic work and the benefit of a team approach - characteristic Techniques in Problem Solving, like: - FMEA, Control Plan and SPC, - quality cost, Pareto analysis, decision making process - Cause and effect diagram - steps to improve the QM-System - 8D Report and other reports - case study Differences to other problem solving methods like Kepner/ Tregoe, Chrysler s 7 Step Corrective Action, Ford s Global 8D or GM s PR&R are pointed out and explained. Links to Field Failures Analysis are shown during the course of the seminar. During the course of the seminar examples show the most important techniques supporting problem solving. 16-20 ppl 2-3 days The seminar has been used to enable delegates in a short period of time to gain experience in common tools helpful for problem solving. - 12 -

T4: Problem Solving: Practitioners Seminar Members from activities like Design, Production, Purchasing, Logistic, Customer Service as well as internal and external Quality Assurance and suppliers, who want to study problem solving methods and practice the techniques on day to day problems. The problem solving method is presented with its characteristic techniques and a case study. Simultaneously, the steps are transfered on to problems from the daily work of the delegates. It is intended that as many 8D disciplines as possible are completed for the existing problems from the delegates as well. With each step completed the 8D Report is also updated. Differences to other problem solving methods like Kepner/ Tregoe, Chrysler s 7 Step Corrective Action, Ford s Global 8D or GM s PR&R are pointed out and explained. Links to Field Failures Analysis are shown during the course of the seminar. The seminar shows that problem solving is possible also for day to day problems and not just for case studies. 16 to 20 ppl in 4 groups 5 seminar days Day 1 and 2 is the same for all groups on 2 consecutive days. For the following days, two groups will come in the morning and 2 groups in the afternoon. Day 3, 4 and 5 will follow in intervals of about 2 to 4 weeks. This seminar can stretch over 2 to 3 months. - 13 -

T5: Problem Solving (Root Cause Analysis) Participate Representatives from Sales, Design, Customer Service, Production, Purchasing, Logistic as well as internal and external Quality Assurance and suppliers, who are trying to identify the root cause of a major problem. Facilitating a problem solving approach. During the project the team is working to prove the root cause of a problem. 4 to 10 ppl, depending upon the problem. open It can not be guaranteed that the root cause of a problem is identified. However, it might also be possible to find proof that a root cause presented by a customer can be excluded, thus avoiding downgrading in regard to quality awards, warranty cost and so on. - 14 -

T6: Problem Solving (Field Failures Analysis) Zielgruppe Inhalt Representatives from Design, Customer Service, Production, Logistic as well as internal and external Quality Assurance handling field failures. During the seminar methods will be developped that are needed to analyse field failures caused by interactions of product, processes and systems. Special attention will be given to non-reproducible failures. These failures generally cause a large portion of expenses for warranty and policy, logistisc and problem solving. Field Failure Analysis has to be seen as part of the design process and must be integrated into Maturity Level Assurance (RGA) or theapqp-process respectivly. Zielsetzung Teilnehmerzahl Dauer Hinweis A method will be presented to prepare steps for a systematic approach to analyse field failures. 16-20 ppl 1 day This seminars should be completed before quality planning, i.e. before Maurity Level Assurance (RGA) or at the beginning of the APQP-Process. - 15 -

S1: SPC Practitioners Seminar People from production line directly working with statistical data, i.e., recording, charting and reacting. The basic terms of SPC are explained and practised, doing typical computations. Charts are developed and interpreted. The seminar follows the SPC Reference Manual from DC, Ford, GM, 2 nd Edition, 2005 and Memory Jogger II von GOAL. The delegates are to develop an understanding for the various statistical techniques in a quality system. They see the relationship between measurables and process results and learn to decide when to take action and when not to. 10 to 16 ppl 1 to 2 days S2: Process Capability, Process readyness (in preparation) Process engineers and project leader (APQP) Capability indices p pk, c pk, OEE, FTT, PIST, PIPC,. Computing measurables in relation to Advanced Product Quality Planning (APQP), Balanced Scorecard (BSC), Quality Operation System (QOS). - 16 -