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 http://www.nuhn-.de : Quality Management Systems Selection of Themes Quality Management Systems ISO/ TS 16949: 2002 and others Customer Satisfaction Balanced Scorecard (BSC), BOS, MOS, QOS Internal/ External Auditor (ISO 19 011: 2002) Quality Planning (APQP/ PPAP, Control Plan) Quality Planning (Q-Planning according to your system, PAN Brand Reporting, Phased PSW, ) Failure Mode and Effects Analysis (FMEA) Problem-Solving Techniques (8D, 5-Why, others) Statistical Process Control (SPC) Version: 29.01.07 E:\websites\www.qms-beratung.de\neu\Angebot_01.07E.doc Version 29.01.07-1 -

Quality Management System On the following pages you find a description of the most common versions of our seminars. All seminars are offered as practitioners courses to reflect the special needs of your organization. Examples for typical adaptations: Development of Quality Manuals and preparation of documented procedures Business Plan and Management Review Balanced Scorecard (BSC), or BOS (AIAG), MOS, or Quality Operating System (QOS/ Ford) Quality Planning as part of every Quality Management System for all products, we assist in developing procedures for APQP and PPAP to cover all products of your organization. Facilitator for APQP-Projects Facilitator for FMEAs or Problem-Solving All seminars are offered in English or German. For services rendered we charge 1.280,-- per man-day, plus material (about 8,00 to 17,00 per manual) and travel expenses (car: 0,30 /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: Quality System Tools for Top Management 4 Key Points: Management Review, Internal Audits, FMEA, BSC, 8D/ 5-Why-Method, 6 Sigma, SPC Q2: ISO/ TS 16 949: 2002 Introductory Seminar 5 Q3: Customer Satisfaction (BSC, BOS, MOS, QOS) 6 Q4: Internal Auditor (ISO 19 011: 2002) 7 Q5: Internal Auditor (ISO 19 011: 2002, Supplier Development) 8 Quality Planning A1: APQP Standard Seminar (APQP/ PPAP, Control Plan) 9 A2: APQP Pan Brand Reporting (APQP/ PPAP, Control Plan) 10 A3: APQP Practitioners Seminar: Q-Planning in Your 11 Organization (APQP/ PPAP, DVP, FMEAs, Flow Chart, Control Plan, Work Instructions, PSW) Failure Mode and Effects Analysis FMEA F1: FMEA for Management 12 F2: FMEA Introductory Seminar 12 F3: FMEA Practitioners Seminar 13 Global 8D Problem-Solving P1: Management Seminar 14 P2: Introductory Seminar 15 P3: Techniques for Problem Solving (Tool Box) 16 P4: Practitioners Seminar 18 P5: Problem Solving (Root Cause Analysis) 19 Statistical Process Control S1: SPC Practitioners Seminar 20 S2: Quality s, Process Capability, Process 21 Readiness - 3 -

Q1: Quality System Tools for Top Management The Management of an organization including department supervisors wanting to know more about the most important tools of the existing Quality Management System. The Quality Management System of the Organization according to ISO/ TS 16 949: 2002 is presented. Special emphasis will be given to the opportunities of a process approach within modern Quality Management Systems. Additional information and the importance of Customerspecific Requirements or Sanctioned Interpretations are presented. Important elements of the Quality Management System are discussed in detail and special attention will be given to the following issues: Management Review, Internal Audits, FMEA, customer satisfaction (BSC, BOS, MOS, QOS), Problem-Solving using 8D/ 5-Why-Approach, 6 Sigma, SPC. Goal The Quality Management System is understood by the delegates as an instrument to control processes in the organization. Opportunities for process oriented management will be identified. up to 20 ppl 6 to 8 hours Upon request, other elementes of the might be included in the seminar to focus on special requirements. As an alternative a like ISO 9000 or QS-9000 can be selected as a basis for the seminar. - 4 -

Q2: ISO/ TS 16 949: 2002 Introductory Seminar Employees from all activities of the organization who need to have basic knowledge of the Quality Management System. The Quality Management System of the organization will be presented according to ISO/ TS 16 949: 2002. Special emphasis will be given to opportunities of a process approach within a modern Quality Management Systems. 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 organization. Purpose and necessary steps for a process approach are understood. up to 20 ppl 4 to 8 hrs As an alternative a like ISO 9000 or QS-9000 can be presented. - 5 -

Q3: Customer Satisfaction (BSC, BOS, MOS, QOS) Management and members from all activities of an organization - who have the responsibility in their work to incorporate expectations of owners and shareholders, customers and employees in a balanced approach - leading an organization with measurables that represent common values. Expectations from: owner/ management, customers and employees of an organization are gathered, presented and common goals defined. Interactions are shown in an example chosen by the group or in a case study. Steps to implement the system are presented. A chart to show improvements will be developed to serve as a reporting system. A brief description of methods used will be included. Links to Balanced Scorecard (BSC), 6 Sigma and BOS, MOS or Quality Operating Systems (QOS) are shown. The course ends with a summary of the system in a Management Review and typical checklists for the automotive industry. Strategic goals of an organization are expressed in measurables for all activities; it is shown how they interact and how they are used to manage the organization. 10 to 20 ppl 4 to 8 hours Additional days may be reserved to lead a project installing Balanced Scorecard (BSC) or Quality Operating System (QOS). - 6 -

Q4: Internal Auditor (ISO 19 011: 2002) Members from all activities of an organization: Design, Production, Purchasing, Logistics, internal and external Quality Assurance, who are expected to work as internal auditors or for those who like to gather experience regarding audits. As part of the seminar the Quality Management System of the organization will be presented according to ISO/ TS 16 949: 2002 as well as the special requirements concerning internal audits according to ISO 19 011:2002. Audits are prepared (Octopus/ Turtle) and done within the organization. The results are presented and experience from all audits is shared by the audit teams. Finally the audit teams will develop suggestions for corrective actions and audit followups. Train internal auditors and offer an opportunity for all members of your organization that need to have experience with internal, customer or certification audits. 8 to16 ppl 2 to 3 days Additional topics like communication skills can be built into the seminar; for this extra time might be needed. Other s like ISO 9000 or QS-9000 can also build the base for the seminar, as well as VDA 6.1 or VDA 6.3 or ISO 10 011 Part 1to 3 for conducting audits. - 7 -

Q5: External Auditor (ISO 19 011: 2002) Members from all activities of an organization: Production, Purchasing, Logistics, internal and external Quality Assurance, who are expected to work as external auditors. As part of the seminar, Quality Management Systems will be presented according to ISO/ TS 16 949: 2002 including special requirements concerning audits according to ISO 19 011:2002. Audits are prepared (Octopus/ Turtle) and done within the organization or at supplier locations. The results are presented and experience from all audits is shared by the audit teams. Finally the audit teams will develop suggestions for corrective actions and audit follow-ups. Train external auditors and offer an opportunity for an organization and its suppliers to learn from the audit results. 8 to16 ppl 2 to 3 days Additional topics like communication skills can be built into the seminar; additional time might be needed. Other like ISO 9000 or QS-9000 can also build the base for the seminar like VDA 6.1, VDA 6.3 or ISO 10 011 Part 1to 3 for conducting audits. - 8 -

A1: APQP Standard Seminar (APQP/ PPAP, Control Plan) Employees from Research and Development, Production, Logistics, Purchasing, internal and external Quality Assurance including representatives from suppliers should attend to understand their responsibility for quality planning. The background for quality planning will be demonstrated according to Quality Management Systems like ISO/ TS 16 949: 2002. Links between the quality manual, quality procedures, work instructions and other documentation are shown. A risk assessment is included to enable the delegates to understand the need for appropriate measures for all new and changed parts. Typical checklists from the APQP Manual (DC, Ford, GM), from individual car manufacturers or other customers for the most important techniques are included like: FMEA, DVP&SOR, Control Plans, Process Flow Charts or Operator Instructions and Logistic. The most common reporting systems linking customers, departments or plants within the organization and their suppliers are presented. Upon request basic information regarding Pan Brand Reporting, Phased PSW can be included (for more details see seminar A2). The final step in APQP is completed summarizing all documents according to PPAP or VDA 2 requirements. Present individual planning activities for all Product and Process Design Phases. 10 to 20 ppl 1 day The seminar can be prepared in a way that the of an organization is presented including the quality manual, procedures, operator instructions and documentation. - 9 -

A2: APQP Pan Brand Reporting (APQP/ PPAP, Control Plan) Employees from Research and Development, Production, Logistics, Purchasing, internal and external Quality Assurance including representatives from suppliers should attend to see their responsibility for quality planning. The background for quality planning will be demonstrated according to Quality Management Systems like ISO/ TS 16 949: 2002. Links between the quality manual, quality procedures, work instructions and other documentation are shown. A risk assessment is included to enable the delegates to understand the need for appropriate measures for all new and changed parts. Typical checklists from the APQP Manual (DC, Ford, GM), from individual car manufacturers or other customers for the most important techniques are included like: FMEA, DVP&SOR, Control Plans, Process Flow Charts or Operator Instructions and Logistic. Emphasis will be given to the APQP Pan Brand Reporting linking the customer and your organization. The final step in APQP is completed, summarizing all documents according to PPAP or VDA 2 requirements. Present individual planning activities for all Product and Process Design Phases. 10 to 20 ppl 1 to 2 days The seminar can be prepared in a way that the of your organization is presented including your quality manual, procedures, operator instructions and documentation. - 10 -

A3: APQP Practitioners Seminar: Q-Planning in Your Organization (APQP/ PPAP, DVP, FMEAs, Flow Chart, Control Plan, Work Instructions, PSW) Employees from Research and Development, Production, Logistics, Purchasing, internal and external Quality Assurance including representatives from suppliers should attend to see their responsibility for quality planning. The background for quality planning will be demonstrated according to Quality Management Systems like ISO/ TS 16 949: 2002. Links between the quality manual, quality procedures, work instructions and other documentation are shown. At the centre of this seminar the delegates work through your Quality Management System, focused on Planning. A risk assessment is included to enable the delegates to understand the need for appropriate measures for all new and changed parts. Typical checklists for the most important techniques are included like: FMEA, DVP&SOR, Control Plans, Process Flow Charts or Operator Instructions and Logistic. Your reporting system is presented linking customers, departments or plants within your organization and your suppliers. The final step in APQP is completed, summarizing all documents according to PPAP or VDA 2 requirements. Working in groups the delegates will see the connecting flow of information between elements. Present individual planning activities for all Product and Process Design Phases of your organization. 10 to 20 ppl 2 days The seminar should be prepared so that the of your organization is presented including your quality manual, procedures, operator instructions and documentation. - 11 -

F1: FMEA for Management see also Q1 F2: FMEA Introductory Seminar Members from activities like Design, Production, Purchasing, Logistic as well as internal and external Quality Assurance, who need to have an overview of expectations towards the results of Design and Process FMEAs. The seminar demonstrates why FMEAs represent an essential part of a quality management system, especially during the phases of quality planning (APQP). An example shows the necessary steps for developing FMEAs. Differences between Design and Process FMEA (DC, Ford, GM) or System FMEA Product and System FMEA Process (VDA 4.2) are elaborated. The course is based on the FMEA Manual from DC, Ford, GM, 3 rd Edition, July 2001. Reference is made to volume VDA 4.2 for FMEAs. The seminar explains the steps of an FMEA and their importance within quality planning for other techniques like Control Plan or Work Instructions.. 16 to 20 ppl 6 to 8 hours - 12 -

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 FMEAs for new or changed parts. After a review about FMEAs the groups begin to work on tasks from their own work environment or current projects. 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. Prepare FMEAs using Boundary Diagram, DVP&SOR, Flow Charts and other tools. Completed FMEAs are compared against checklists from the APQP-Manual or specific OEMs. The course is based on the FMEA Manual for QS-9000 by DC, Ford, GM, 3 rd Edition, July 2001. Reference is made to volume VDA 4.2 for FMEAs. Develop portions of an FMEA in small teams. Support the quality planning process. 10 to 16 ppl 1 to 2 days Additional days can be arranged for the completion of major FMEAs. - 13 -

P1: Problem Solving: Management Seminar see also Q1 Upper management, plant manager, management from Sales, Design, Customer Service, Production, Purchasing, Logistics, internal and external Quality Assurance wanting to understand Supporting Processes and techniques relevant for problem solving. Problem-solving-methods are shown to be a necessary part of any quality management system according to ISO/ TS 16 949: 2002. Basic concepts of special techniques in problem solving are demonstrated in a case study. Examples of necessary support for problem-solving teams are discussed. The necessity for management support to achieve effective problem solving is emphasized. Differences between problem-solving-methods are pointed out. The seminar shows how management can improve the results to be achieved by problem-solving teams, if the necessary support and encouragement are provided. 6 to 20 ppl about 4 to 6 hours This presentation is recommended as a preparation for Problem Solving: Practitioners Seminar (P4). The selection of teams and problems to be worked on during the P4-Seminar can be done towards the end of this course. - 14 -

P2: Problem Solving: Introductory Seminar Who should Members from activities like Design, Production, Purchasing, Logistics, Customer Service, internal and external Quality Assurance, who need to have an overview regarding problemsolving-methods. In a case study the seminar concentrates on the characteristic techniques used within problem-solving-methods. The background for an 8D Approach or the 5-Why-Approach is developed. The link of the problem-solving-methods to a Quality Management System like ISO/ TS 16 949: 2002 is shown. The purpose and contents of a Customer-specific Reporting is demonstrated, for instance: Global 8D Report. Differences to other problem-solving-methods are pointed out. Demonstrate the key techniques of problem-solving in a case study. 12 to 16 ppl 6 to 8 hours During the later part of the seminar, groups can work either on a case study or on current problems from their activities. - 15 -

P3: Techniques for Problem Solving (Tool Box) Members from activities like Design, Production, Purchasing, Logistics, Customer Service, internal and external Quality Assurance, who need to have detailed information about problem-solving-methods and important mathematical, statististical or analytical techniques to evaluate information and make decisions. (Part 1) The seminar shows problem-solving-methods as part of the quality tools of an organization as required by ISO/ TS 16 949: 2002. Sources of Information D-/ P-FMEA Design Verification Plan & Sign-off Report Flow Chart Control Plan SPC Charts Control Charts for Attribute Data Standard Tools for Problem Solving Pareto Analysis Decision Making Process Cause and Effect Diagram Fault Tree Analysis Time Line Chart Team Building Skills Special Tools for Problem-Solving with Global 8D Problem Definition Problem Profile Comparative Analysis Plausibility Testing Escape Point Verification and Validation, Proof - 16 -

P3: Techniques for Problem Solving (Tool Box) (Part 2) Action Taken Emergency Response Action Interim Containment Action Supporting Action Permanent Corrective Action Action to Prevent Recurrence Action for Continuous Improvement for: Products Processes Systems Problem-Solving-Methods Global 8D 5-Why-Approach others like Kepner/ Tregoe Improvement of Quality Processes Reports according to customer requirements During the course of the seminar, time will be spent using the most important techniques supporting problem solving as part of the case studies or on problems chosen by the delegates. 16-20 ppl 2-3 days The seminar has been designed to enable delegates in a short period of time to gain experience in common tools helpful for problem solving. - 17 -

P4: Problem Solving: Practitioners Seminar Members from activities like Design, Production, Purchasing, Logistics, Customer Service, internal and external Quality Assurance and suppliers, who want to study problem-solvingmethods and practice these techniques on day to day problems. The problem-solving-method is presented with its characteristic techniques and a case study. All tools as in P3. Simultaneously, these techniques are applied to problems of the daily work of the delegates. It is intended that as many 8D steps as possible are completed solving actual problems selected by management for the seminar. With each step completed, an 8D Report is 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 (5-Why-Approach) are pointed out and explained. 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 Days 1 and 2 are the same for all groups on 2 consecutive days. Days 3 to 5 will follow in intervals of about 2 to 4 weeks. For days 3, 4 and 5, two groups will come in the morning and 2 groups in the afternoon. Typically this seminar extends over 2 to 3 months. - 18 -

P5: Problem Solving (Root Cause Analysis) Participate Representatives from Sales, Design, Customer Service, Production, Purchasing, Logistics, internal and external Quality Assurance and suppliers, who are trying to identify the root cause of a major problem like a recall or a campaign. Facilitating a problem-solving approach. During the project the team is working to identify and 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 or cost for warranty. - 19 -

S1: SPC Practitioners Seminar People from production directly working with statistical data, i.e., recording, charting and process control. 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, 1995. The delegates will 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. necessary action overadjustment stratification 10 to 16 ppl 1 to 2 days - 20 -

S2: Quality Goals, Process Capability, Process Readyness Process engineers or project managers who need to compute, optimize and report quality goals or customer specific measurables. Selected Measurables like: Capability indices for APQP/ PPAP: p pk, c pk, OEE, FTT, PIST, PIPC,. Quality objectives related to the Business Plan like: Cost of quality, scrap and rework or customer satisfaction. Understand and work with measurables in relation to Advanced Product Quality Planning (APQP), Balanced Scorecard (BSC), Quality Operation System (QOS) and the Business Plan. 10 to 16 ppl 1 to 2 days The contents of the seminar, specifically the measurables to be addressed during the workshop should be defined up front. - 21 -