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Quality Management Systems

1. Introduction to QMS 2. Process-oriented approach 3. Documentation of a Quality Management System 4. Quality Planning 5. Internal Audits 6. Quality tools 7. Management tools 8. Methods for defects prevention and decision making 9. Analysis to measure Quality 10. KVP, Kaizen, Six Sigma, DMAIC-Cycle 11. Motivation, Teamwork
Quality Management Systems Dipl. Ing. B. Baranowski-Gornig 2

Quality Management Systems

. 1. Introduction to Quality Management Systems

Quality Management Systems Dipl. Ing. B. Baranowski-Gornig

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Baranowski-Gornig 4 .. and not your delivered products !!! Quality Management Systems Dipl.. B.Quality Management Systems Quality is. …when your customer is coming back. Ing.

Quality Management Systems Quality Management Systems Dipl. Baranowski-Gornig 5 . Ing. B.

Quality Management Systems

Definition of Quality according to
DIN ISO 8402 Quality is “…the set of “…the characteristics of an entity that give that entity the ability to satisfy expressed and implicit needs.” needs.” DIN EN ISO 9000:2005 Quality is „…degree to which a „…degree set of inherent characteristics fulfills requirements.“ requirements.“
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Quality Management Systems Dipl. Ing. B. Baranowski-Gornig

Quality Management Systems

Quality Management Systems – why?

• Improvement of product quality • Assurance of market position • Organizational development

Quality Management Systems Dipl. Ing. B. Baranowski-Gornig

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Quality Management Systems

Implementation of a Quality Management System Step 1: Decision
Standard DIN EN ISO 9001 VDA 6.1 VDA 6.2 VDA 6.4 KTO DIN EN ISO 13485 ALS 9100 AZWV TL 9000 HACCP ….
Quality Management Systems Dipl. Ing. B. Baranowski-Gornig 8

Branch Not specified, applicable in all industry sectors Automotive industry Automotive industry Mechanical Engineering Medicall Engineering Medical Engineering Aeronautics Education System Telecommunication Food Industry

actual situation Quality Management Systems Dipl. B. Ing. Baranowski-Gornig 9 .Quality Management Systems Implementation of a Quality Management System Step 2: Requirements • • • • Active Support of Management Implication of staff Appointment of Quality Management Representative Identification of current state.

root cause Determination of corrective actions Check if corrective actions are feasible Quality Management Systems Dipl. B. Ing. Baranowski-Gornig 10 .Quality Management Systems Implementation of a Quality Management System Step 3: Analysis and evaluation • • • • • • Identification of current state Detection of weak points Internal and external impact of weak points Analysis of weak points.

competences Generation of Quality Manual Definition of processes Quality Management Systems Dipl. Ing. Checklist acc. Baranowski-Gornig 11 . B. ISO 9000 Definition of responsibilities.Quality Management Systems Implementation of a Quality Management System Step 4: Task schedule • • • • Corrective action plan.

checklists • Training of staff • Internal audits • Continuous improvement Quality Management Systems Dipl. B. instructions. Baranowski-Gornig 12 .Quality Management Systems Implementation of a Quality Management System Step 5: Implementation • Put in place corrective actions • Establish and release Quality Policiy and Manual. Ing. procedures.

Ing.Quality Management Systems Implementation of a Quality Management System Step 6: Certification • Choice of external certification authority • Sending of Quality Manual and other documents to external auditor • Definition group of participants • Staff has to be informed • Audit • Result (Inform staff) • Establish corrective action plan and send it to external auditor Quality Management Systems Dipl. B. Baranowski-Gornig 13 .

Ing. reduced interfaceproblems • Improved control of processes • Optimisation of work flow • Improvement of profitability • Gives the customer confidence that products or services will consistently meet requirements Quality Management Systems Dipl. Baranowski-Gornig 14 . B.Quality Management Systems Possible advantages of a Quality Management System • Motivation of employees • Improved communication.

Baranowski-Gornig 15 .Quality Management Systems Commitment / Implication of Leadership ISO 9001:2008. The leadership should establish an internal environment where employees can become fully involved in achieving the organisation‘s objectives Quality Management Systems Dipl.1 The leadership has to ensure. that .resonsibilities . B. Ing.competences are defined and published.5. chapter 5.

Ing. B. innovation and improvement Implementation of partnerships Responsibilty for the public Quality Management Systems Dipl.Quality Management Systems Quality policy • • • • • • • • Customer orientation Result orientation Leadership and goal-orientation Process-oriented Management Development and involvement of employees Continuous learning. Baranowski-Gornig 16 .

Baranowski-Gornig 17 . Process-oriented approach Quality Management Systems Dipl. B.Quality Management Systems 2. Ing.

B. Baranowski-Gornig 18 . ISO 9000:2005 If you want to implement an organisational structure customer‘s view and the flow of a product is more customer‘ important than the internal point of view or hierarchy. Quality Management Systems Dipl.Quality Management Systems Process-oriented approach A process is a set of activities that are interrelated or that interact with one another. Processes use ressources to transform inputs into outputs. Ing.

Quality Management Systems Identification and Documentation of processes • Determine process owner. Baranowski-Gornig 19 . Ing. involved people. customer and activator of a process? • Which objective has to be achieved? • Who / what is the start-up of the process? • How shall the process be performed? • Determine responsibilities and interfaces • What is the output or result of the process? • When and how is the process performance measured? • The process has to be clear. explicit and traceable • Is the customer satisfied? Quality Management Systems Dipl. B.

Quality Management Systems Deming-cycle • PLAN: Schedule and improvement / corrective action • DO:put into effect • CHECK: verify. Ing. B. if this measure is successful • ACT: Fix the improvement and start the cycle again Quality Management Systems Dipl. Baranowski-Gornig 20 .

do what you say. Baranowski-Gornig 21 . record what you did. check the results. B. Ing. and act on differences (Ian Durand.Quality Management Systems The basis of a Quality system is to… to… Say what you do. US Technical Advisory Group to ISO TC 176) Quality Management Systems Dipl.

B. Baranowski-Gornig 22 . Description of problem Cause Corrective action Date who P D C A Number of scheduled tasks Average completion in % ### ## #### # #### # # # # # # Quality Management Systems Dipl. Ing.Quality Management Systems Corrective action plan: Example Created by: Date: Updated on: N o.

Quality Management Systems 3. Ing. Baranowski-Gornig 23 . B. Documentation of a Quality Management System Quality Management Systems Dipl.

Ing. documents“ Quality Management Systems Dipl. Baranowski-Gornig 24 . B.Quality Management Systems ISO 9001 requires a documented Quality Management System and not a „System of documents“.

magnetic. B.Quality Management Systems Objectives of documentation • Communication and information • Evidence of conformity • Knowledge sharing „…documents may be in any form or type of medium „…documents …and gives the following examples: Paper.“ ISO 9000:2005 Quality Management Systems Dipl. Photograph. Baranowski-Gornig 25 . or master samples.“ samples. Ing. electronic or optical computer disc.

1 Quality Management Systems Dipl. Baranowski-Gornig 26 . B.2. Ing. 4. operation and control of its processes • Records required by this International Standard.“ ISO 9001:2008.Quality Management Systems „A Quality Management System shall include: • Documented statements of a quality policy and quality objectives • a quality manual • documented procedures required by this International Standard • Documents needed by the organization to ensure the effective planning.“ Standard.

B.Quality Management Systems QM WHAT (in general)? Summary Procedures Process Description Work or test instructions. Checklists How? How (in Detail)? Quality Management Systems Dipl. Ing. Baranowski-Gornig 27 .

Quality Management Systems First Level: Minimum Content of a quality Manual • • • • • • Quality policy Explanation of company‘s documentation structure Policy statement Reference to procedures or process descriptions Assigment of a quality management representative Description of the company`s structure General description of the company and its policy. A quality manual may also inform externals Quality Management Systems Dipl. Baranowski-Gornig 28 . Ing. B.

Not for externals. Baranowski-Gornig 29 . preventive action. workflows and processes.Quality Management Systems Second Level: Procedures or Process description A procedure is a description of responsibilities. control of nonconforming product. Quality Management Systems Dipl. internal audits. B. Ing. corrective action. competences. ISO 9001: 2008 requires the organization to have „documented procedures“ for the follwing activities: procedures“ control of documents. control of records.

g. checklists and thers e. including parameters etc. Baranowski-Gornig 30 . Ing. drawings or BOM.Quality Management Systems Third Level: Required documents Documents may be work or test instructions. for important. B. Quality Management Systems Dipl.These documents are not for externals. Work instructions are explicite description of workflows. complicated or sensitive workitems.

3 Quality Management Systems Dipl. Ing. Baranowski-Gornig 31 . B.2. 4.Quality Management Systems Control of documents • • • • • • Approval of documents Update and re-approval of documents Identification of changes Availability of documents where they are needed Control of documents of external origin Prevention of use of old versions of document ISO 9001.

g. Baranowski-Gornig 32 . B. Ing. that Verification has been done or corrective actions have been carried out. Records have to be controlled and stored according to legal requirements.Quality Management Systems Records This is a type of document that provides evidence that activities have been performed or results have been achieved. They may be used e. Quality Management Systems Dipl. Records document the past.

Ing. B.Quality Management Systems 4. Quality planning Quality Management Systems Dipl. Baranowski-Gornig 33 .

“ EN ISO 9000:2000. 3. Ing.“ objectives.9 Quality Management Systems Dipl.2. Baranowski-Gornig 34 .Quality Management Systems What is quality planning? „…art of quality management focused on setting „…art quality objectives and specifying necessary operational processes and related resources to fulfill quality objectives. B.

Ing.“ quality. Quality is part of the trilogy of Planning. There are no shortcuts to quality.“ Joseph M.Quality Management Systems „Quality does not happen by accident. Baranowski-Gornig 35 . It must be planned. B. Juran Quality Management Systems Dipl. control and improvement.

Baranowski-Gornig 36 . Quality Management Systems Dipl.Quality Management Systems Road map quality panning according to Juran • • • • • • • • • Identify who are the customers Determine the needs of those customers Translate these needs into your language Develop a product that can respond to those needs Optimise the product features so as to meet your needs as well as customer needs Develop a process which is able to produce the product Optimise the process Prove that the process can produce the product unter operating conditions Transfer the process to operations. B. Ing.

Baranowski-Gornig 37 . to Juran • Establish specific goals to be reached • Establish plans for reaching the goals • Assign clear responsibility for meeting the goals • Base the rewards on result achieved Example Quality Management Systems Dipl. B. Ing.Quality Management Systems Illustration of Quality Trilogy via Control chart acc.

Quality Management Systems Quality management plan Document that defines. when and by whom which processes. Ing. B. Baranowski-Gornig 38 . procedures and related ressources are applied to fulfill requirements regarding a certain project or product or process or contract DIN EN ISO 10005:2009 PLP Quality Management Systems Dipl.

Inspection tools .time .method . B.handling of data Quality Management Systems Dipl.place .frequence .Quality Management Systems Inspection planning Define inspection activities and procedures regarding . Ing. Baranowski-Gornig 39 .production flow .

“ quality.“ ISO 9000:2000 ISO 9001:2000 requires. related to quality. or aimed for. Baranowski-Gornig 40 . that quality objectives are established at each relevant function and level. Ing. Quality Management Systems Dipl.Quality Management Systems Definition of Quality Objectives: „Something sought. B.

Quality Management Systems Quality objectives have to • be defined. Ing. B. • reflect the quality policy • coherent • in alignment with overall business objectives • consider customer requirements • be communicated and understood • be updated Quality Management Systems Dipl. Baranowski-Gornig 41 .

Quality Management Systems SMART quality goals • • • • • Specific Measurable Attainable Relevant Time bound Quality Management Systems Dipl. Ing. Baranowski-Gornig 42 . B.

Ing. B. Audits Quality Management Systems Dipl.Quality Management Systems 5. Baranowski-Gornig 43 .

Ing. to which audit criteria are fulfilled. independent and documented process for obtaining audit evidence and evaluating it objetively to determine the extent. Baranowski-Gornig 44 . 3.Quality Management Systems Quality audits A systematic.1 Quality Management Systems Dipl. ISO 9000:2005.9. B.

Ing. Baranowski-Gornig 45 . processes •Quality problems •Production transfer •Survey of corrective or preventive actions •Audit plan Quality Management Systems Dipl. B.Quality Management Systems Internal Audits •Within the Company •(first party) External Audits •Customer audit (second party) •Certifying audit (third party) Requirements •Din EN ISO 9000-9004 •Customer related •Branch related •Object of contract Occasions •New business relation •New product.

Ing.Quality Management Systems Different kind of quality audits Quality audits System audits Process / Procedure audits Product audits Quality Management Systems Dipl. Baranowski-Gornig 46 . B.

B. Baranowski-Gornig 47 . Ing.Quality Management Systems Certification audit: Inspection of entire company (external auditor) Certicate: Proof of successful inspection Internal audits: check on a regular base Re-Certification: prolongation of certificate after succesful partial inspection (external auditor) Certification audit: Inspection of entire company (external auditor) Quality Management Systems Dipl.

as well as the results of previous audits. 8. The audit criteria. taking into consideration the status and importance of the processes and areas to be audited. The audit program shall be planned. frequency and methods shall be defined. Content of ISO 9001:2008.Quality Management Systems Internal audits The organization shall conduct internal audits at planned intervals to determine whether the quality system: • conforms to planned arrangements. Auditors shall not audit their own work. Ing. scope.2. The selection of the auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. to the requirements of this Iso standard and to the quality management system requirements established by the organization and b) is effectively implemented and maintained.2 Quality Management Systems Dipl. B. Baranowski-Gornig 48 .

objective Clear language Create a comfortable atmosphere Motivate Concentrated. Ing. Baranowski-Gornig 49 .Quality Management Systems Attitude of an auditor • • • • • • • • • Friendly. interested Self-confident and open-minded Conduct conversation with question and abstract results Reveal deviation Highlight compliance Quality Management Systems Dipl. B. calm.

Baranowski-Gornig 50 .Quality Management Systems Attitude of auditee • Be open-minded towards auditor • Objective and target-oriented while answering auditor‘s questions • Allocate all documentation. that is necessary for the interview Quality Management Systems Dipl. Ing. B.

Ing. B.Quality Management Systems Audit introduction • • • • • Audit team presentation Explanation of audit procedure Explanation of audit objective Request for cooperation Create a positive atmosphere Quality Management Systems Dipl. Baranowski-Gornig 51 .

instructions.…) • Check the relevant operation /activity • Try to find improvement opprtunities • Don‘t judge the auditee Quality Management Systems Dipl. B. records. Ing. Baranowski-Gornig 52 .Quality Management Systems Audit / Interview • Usually takes place at workplace • Interview-partner is the person that is responsible for the activity that shall be audited • Objective check of activity in comparison to relevant specification (procedures.

Ing. B. deviations Auditees should acknowledge findings Quality Management Systems Dipl. Baranowski-Gornig 53 .Quality Management Systems Closure of audit • • • • • • Procedure of audit Cooperation of auditees Positive observations Improvement opportunities Nonconformances.

B. implemented or is not effective at all and there is a risk that the customer receives a delivery of nonconforme products • Minor: when the quality system is documented. but auditor finds a random nonconformance. Baranowski-Gornig 54 .Quality Management Systems Different types of nonconformances • Major: when an element of the system has not been documented. implemented and effective. Ing. This nonconformance does not mean a risk for the customer • Comment: an improvement opportunity that is not a major or minor nonconformance Quality Management Systems Dipl.

B. Baranowski-Gornig 55 .Follow-up • Auditor writes a detailed report about all findings (positive and negative) • Auditees implement corrective actions after root cause analysis • Corrective action plan must be sent to auditor and quality management representative • The progess of corrective must be surveyed Quality Management Systems Dipl. Ing.

Quality Management Systems 6. B. Ing. Quality tools Quality Management Systems Dipl. Baranowski-Gornig 56 .

Ing. Baranowski-Gornig 57 . B.Quality Management Systems Quality tools (Q7) • • • • • • • Check sheets Histogramm Control charts Pareto-chart Cause-and-effect-diagram Scatter diagramm Brainstorming Quality Management Systems Dipl.

which seem to be cause of problem • Determine. if assumed defect causes are correct or not • Elimination of defect cause and defect Quality Management Systems Dipl. Baranowski-Gornig 58 . Ing. B.Quality Management Systems Use of quality tools • Identification of a problem • Localization of possible field of problem • Evaluation of elements.

Ing. Baranowski-Gornig 59 . B.Quality Management Systems Quality tool Check sheets Histogramm Control charts Pareto-chart Cause-and-effect-diagram Scatter diagramm Brainstorming Application Collection of data Graphic presentation Analysis of defects Finding of solution Quality Management Systems Dipl.

Baranowski-Gornig 60 . B.Quality Management Systems Check sheets Objective • Collecting data in a simple way • Base for standardized defect lists Application • Determine the problem • Identification of known defects • Determine WHO collects data in which period Quality Management Systems Dipl. Ing.

. B.to identify principles Disadvantages • Dependencies are not visible • Observation of only one characteristic • No consideration of „time“ Quality Management Systems Dipl. Ing. Baranowski-Gornig 61 .to identify core area of distribution .Quality Management Systems Histogramm Objective • Presentation of measured values of a process .to illustrate range and form of variance.

Control charts are used to survey a process permanent for A longer period. B. Baranowski-Gornig 62 . These charts are mainly used in statistical process control. Quality Management Systems Dipl.Quality Management Systems Control charts A control chart is used to observe processes. Ing. Objective is to control the process.

Quality Management Systems Pareto Analysis In a pareto chart are shown e. Baranowski-Gornig 63 . B. The pareto principle bases on the assumption that most of the impact of a problem are caused by a small number of causes.…sorted according to their importance. defects. costs. Ing. Objectives • Evaluation of data collection • Separation of important and inessential features • Graphical representation of data Quality Management Systems Dipl.g.

Ing. B.Quality Management Systems Pareto Analysis Advantages • Presentation sorted by importance • Helps to decide order of problemsolving • Clear classification • Easy application • Minimum time effort Disadvantages • Number of classes representable is limited • No individual weighting of classes • Result depends on defined classes Quality Management Systems Dipl. Baranowski-Gornig 64 .

Quality Management Systems

Scatter diagram

A scatter diagram shows the relation between two features or characteristics. Objectives: • Identification of a relation between two features • Verification of an assumed cause-effect relation

Quality Management Systems Dipl. Ing. B. Baranowski-Gornig

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Quality Management Systems

Scatter diagram

Application • Definition of features that have to be considered • Collection of data (50 – 100 values) • Enter of data in a coordinate system • Interpretation of diagramm and the relation between two features

Quality Management Systems Dipl. Ing. B. Baranowski-Gornig

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Quality Management Systems

Cause-and-effect diagram …is also called Ishikawa- or fishbone diagram. A cause and effect diagram is a tool that can be used to Identify, sort and display possible causses of a problem. It is a graphical presentation of causes, that are leading to a result or have a strong influence on a result.

Quality Management Systems Dipl. Ing. B. Baranowski-Gornig

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Baranowski-Gornig 68 . Ing.Quality Management Systems Advantages of cause-and-effect diagram • • • • • Use of a simple format Helps to identify root causes Increases knowledge of a process Identify. B. where further data is needed Different ways of consideration of the problem due to teamwork Quality Management Systems Dipl.

instructions. B. that is required to do a job Location. who is involved in the process Machine Milieu Material Method Measurement All equipment. of the process Raw materials.Quality Management Systems Cause-and-effect diagram Man Everybody. parts etc. time. temperature etc.…) Process data which is used to evaluate quality Quality Management Systems Dipl. Baranowski-Gornig 69 . tools etc. that is used to produce a product How the process has to be performed (procedures. Ing.

Quality Management Systems Quality Management Systems Dipl. B. Ing. Baranowski-Gornig 70 .

Ing. Definition of a clear outcome. Verification if cause is correct 6. Filling in of main causes 3. Identification of the most possible cause 5. objective 2. Evaluation of efficiency of this method Quality Management Systems Dipl. B. Development of sultions and decision of best solution 7.Quality Management Systems Application of cause-and-effect diagram 1. Baranowski-Gornig 71 . Implementation of thi solution 8. problem. Collecting further causes in a team with brainstorming 4.

“ Quality Management Systems Dipl.Quality Management Systems Brainstorming „Brainstorming is a tool designed the maximum number of ideas relating to a specific area of interest. Baranowski-Gornig 72 . B. Ing.“ „Brainstorming is. where a group of people put social inhibitions and rules aside with the aim of generating new ideas and solutions.“ „Brainstorming is the creation of an optimal state of mind for generating new ideas.

Quality Management Systems Brainstorming – rules to apply • • • • Nobody critizes the ideas of others All ideas are allowed. Ing. Baranowski-Gornig 73 . B. also wild or exaggerated idaes Listen carefully and try build on ideas of others Collect as many ideas as possible (Quantitiy instead of quality) • Everybody in the team and all ideas are equal Quality Management Systems Dipl.

B. choose the best one und define a responsible for implementation Quality Management Systems Dipl. Baranowski-Gornig 74 .Quality Management Systems Brainstorming-procedure • Participants and leader define together a clear question or subject • Each participant gives ideas • Leader writes down all ideas • Collecting of ideas should be finished after 20-25 minutes • Verification of ideas • Participants decide about ideas. Ing.

Ing. B.Quality Management Systems 7. FMEA Quality Management Systems Dipl. Baranowski-Gornig 75 .

Ing.Quality Management Systems FMEA – Failure Mode and Effect Analysis FMEA Failure Mode and Evaluation Analysis Design-FMEA Process-FMEA Product-FMEA Objective: Prevention of failures Quality Management Systems Dipl. Baranowski-Gornig 76 . B.

B.Quality Management Systems FMEA – Failure Mode and Effect Analysis What ProductFMEA DesignFMEA ProcessFMEA Entire product/ system Significant component Step of production process When Who After finish of Development product concept After finish of Design design concept After finish of Production process planning flowchart 77 Quality Management Systems Dipl. Baranowski-Gornig . Ing.

B.Quality Management Systems FMEA: Required pre-conditions • Support of Management • Involvement of specialists from different departments. Baranowski-Gornig 78 . sometimes customer or supplier • Teamwork and ability to communicate Quality Management Systems Dipl. Ing.

Analysis and description of elements of the structure 3. Final evaluation Quality Management Systems Dipl. Evaluation of risk 5. B. Baranowski-Gornig 79 .Quality Management Systems FMEA: Steps of FMEA 1. Creation of a structure (Definition of components or pocess-steps) 2. Ing. Optimisation /Improvement 6. Analysis of failures 4.

Quality Management Systems P-FMEA – Failure Mode and Effect Analysis A P-FMEA is a systematic summary of operations with the following objectives: • Identification and evaluation of possible failures of a product or process and their influence • Definition of measures which have to prevent or reduce the occurrence of failures • Documentation of the entire process Quality Management Systems Dipl. Baranowski-Gornig 80 . B. Ing.

Baranowski-Gornig 81 . B. Ing.Quality Management Systems P-FMEA Step 1: Creation of a structure System Process FMEA Manufacturing Assembly Sub-System Component System Sub-System Component Quality Management Systems Dipl.

B. that all team members are familiar with the process � to identify main components and functions of the process � To assure that all components of the process are considered Quality Management Systems Dipl. Ing. Baranowski-Gornig 82 .Quality Management Systems P-FMEA Step 2: Analysis and description of elements • Review the process components and functions � to assure.

Quality Management Systems P-FMEA Step 3: Analysis of potential failures and effects • Identification of potential failures for each component or function that have been identified in step 1 A failure means the way in which a component or processstep can fail and not perform the necessary function • Identification of the potential effect of failures • Description of effect in detail Quality Management Systems Dipl. Baranowski-Gornig 83 . Ing. B.

Ing.Quality Management Systems P-FMEA Step 3: Analysis of potential failures and effects Checklist Location of failure Where can failure de detected? Type of failure How can failure be identified? Effect of failure What could be effect of failure? Cause of failure Why do we a have a failure? Quality Management Systems Dipl. Baranowski-Gornig 84 . B.

further production steps. employees) • Determine a severity ranking for each identified effect Quality Management Systems Dipl. if effect occurs (consider customer.Quality Management Systems P-FMEA Step 4: Evaluation of risk • Estimate of severity. Ing. B. Baranowski-Gornig 85 .

Ing.Quality Management Systems P-FMEA Step 4: Evaluation of risk • Determine the occurence ranking • Identification of the potential cause for each identified failure � The occurence ranking considers the probability and frequency that the cause will occur Quality Management Systems Dipl. Baranowski-Gornig 86 . B.

Baranowski-Gornig 87 . B.Quality Management Systems P-FMEA Step 4: Evaluation of risk • Determine the detection ranking • Identification and evaluation of controls in place for each identified failure Quality Management Systems Dipl. Ing.

Baranowski-Gornig Almost certain to detect. no controls in place Low chance of occurrence . minor disruption to business High chance of detecting. controls are in place Customer dissatisfied. may have some controls in place Serious hazard to people or damage to equipment How often does the cause or failure mode occur? Very high chance of occurrence Occurrence Detection How well can you detect the cause or the failure mode before passing to next step? Almost impossible to detect. disruption to business Moderate chance of occurrence Low chance of detecting.Quality Management Systems Severity Rating How severe is the effect on the customer? 10 9 8 7 6 5 4 3 2 1 No effect Remote chance of occurrence Quality Management Systems Dipl. Ing. reliable controls are in place 88 Customer may notice but only minor concern. B.

Quality Management Systems P-FMEA Step 4: Evaluation of risk RPN = Severity x Occurence x Detection RPN – Risk Priority Number The higher the RPN. the higher is the potential risk. Ing. B. Baranowski-Gornig 89 . Quality Management Systems Dipl.

Ing. B.Quality Management Systems P-FMEA Step 5: Improvement of RPN • Implement corrective actions which reduces any of the three rankings � How can a reduction of Severity ranking Occurence ranking Detection ranking be achieved? Quality Management Systems Dipl. Baranowski-Gornig 90 .

Quality Management Systems Dipl. B. re-analyse cause of failure etc. implement corrective actions. Baranowski-Gornig 91 . Ing.Quality Management Systems P-FMEA Step 6: Final evaluation • Recalculate the RPN by assessing severity. occurence and detection ranking after implementation of corrective actions • If recalculated RPN represents a high potential risk.

when process can be influenced Quality Management Systems Dipl.Quality Management Systems P-FMEA : Objectives • Process Improvement • Use of error / mistake proofing • Implementation of improvement actions for all high risk failures modes • Consideration of „lessons learned“ • Timing: start of FMEA. B. Baranowski-Gornig 92 . Ing.

Baranowski-Gornig 93 . B. Ing.Quality Management Systems FMEA : Possible weak points • Time-intensive method • Use of large number of documents • Team members have to review and check their own ideas and work • Sufficient training and motivation of team members Quality Management Systems Dipl.

Ing.Quality Management Systems 8. TQM Quality Management Systems Dipl. Baranowski-Gornig 94 . B.

practices. TQM may require fundamental changes of the organization regarding attitudes. B. structures and systems. Quality Management Systems Dipl. TQM aims for a long term success through customer satisfaction. Baranowski-Gornig 95 . Ing. TQM means involvement of everybody in an organization.Quality Management Systems TQM : Total Quality Management TQM is an integrated management philosophy for improving quality continuously.

E.Quality Management Systems History of TQM • First researches in 1940 by W. Baranowski-Gornig 96 . B. Ing. Deming in USA • Implementation of japanese companies First „Deming Award“ in 1951 • Since 1970 implementation of TQM in US-american companies First „Baldrige Award“ in 1987 • 1988 European Foundation for Quality Management (EFQM) First „EFQM-Award“ in 1992 Quality Management Systems Dipl.

create quality into product in the first place End practice of getting business due to low prices Look for problems: objective is continuous reduction of waste and continuous improvement in all activity (rise productivity and decrease costs) Establish modern methods of staff training (training-on-the-job) Implement leadership with the aim to help employees to make their work efficiently. Quality Management Systems Dipl. Leadership must act immediately when problems occur. 2. 7. Ing. B. 5. 3. 4. .Quality Management Systems Deming‘s 14 point plan for TQM 1. Create company targets (constancy of purpose) in terms of continuous product & service improvement. Baranowski-Gornig 97 6. become competitive Implement / adopt company philosophy Stop 100% inspection to achieve quality.

B. 10. Implement team work and reduce barriers between departments Don’t use slogans without providing methods Don’t set impossible objectives for employees Enable employees to be proud of their work Encourage personal improvement (education) for everyone Clear commitment of management to TQM and management structure. 11. Quality Management Systems Dipl. that work continuously on these points. Eliminate the work atmosphere of worry or fear. 13.Quality Management Systems Deming‘s 14 point plan for TQM 8. 9. 12. Baranowski-Gornig 98 . Ing. 14.

.. Ing. No existing constancy in philosophy and targets Focusing only on a short term economic profit Management by fear – merit systems.Quality Management Systems Deming‘s 7 deadly diseases 1. Excessive cost on liability Quality Management Systems Dipl. Fluctuation of management staff – job hopping Eliminate setting work parameters. Excessive medical care 7. B. 5. 4. which are unknown or not realizable in practice 6. Baranowski-Gornig 99 .. 3. yearly appraisal. 2.

Ing. Baranowski-Gornig 100 .Quality Management Systems TQM: Eight principles • • • • • • • • customer-focused organization leadership involvement of people process approach system approach continual improvement factual approach to decision making mutually beneficial supplier relationships Quality Management Systems Dipl. B.

Baranowski-Gornig 101 . B.Quality Management Systems EFQM Excellence Model Enablers People Results People results Leadership Policy and Strategy Processes Customer results Key Performance Results Partnership and Ressources Society results Innovation and Learning Quality Management Systems Dipl. Ing.

Baranowski-Gornig . Ing.Quality Management Systems EFQM Excellence Model – Criteria Enabler How proceeds an organization to achieve excellent results? • Approach •Deployment •´Assessment + Review Results What was achieved with help from enabler criteria? •Trends •Degree of target completion •Comparison of results with results of other organization •Are results rooted in enablers •Scope and effects of results 102 Quality Management Systems Dipl. B.

Quality Management Systems EFQM Excellence Model – RADAR Define Results Assessment and Review Develop and plan Approach Deployment Quality Management Systems Dipl. B. Baranowski-Gornig 103 . Ing.

Ing. B. Baranowski-Gornig 104 . society) • Competitive comparison • Sustainability of TQM-concepts Quality Management Systems Dipl.Quality Management Systems EFQM Excellence Model • Consideration of real results • Consideration of further external stakeholders ( environment.

waste and friction • build teams.Quality Management Systems TQM: Advantages of TQM • make an organization more competitive • establish a new culture which will enable growth and long life • provide a working environment in which everyone can succeed • reduce stress. Baranowski-Gornig 105 . B. Ing. partnerships and co-operation Quality Management Systems Dipl.

Ing.Quality Management Systems 9. Kaizen Quality Management Systems Dipl. Baranowski-Gornig 106 . B.

Baranowski-Gornig 107 . which fulfill customer requirements due to excellent quality. Quality Management Systems Dipl. Involvement of employees of all levels. Ecomomic success is achieved by a step-by-step improvement of product and services. willingness to Change and communication. Ing. Main elements of the Kaizen philosophie are quality. effort.Quality Management Systems Kaizen Kai – change Zen – for the better Kaizen is a japanese live. B.and workphilosophie which aims for continuous improvement or change.

Ing. Baranowski-Gornig 108 . B.Quality Management Systems Kaizen: Requirements • • • • • Teamwork Personal discipline Employee engagement Quality circles Suggestions for improvement Quality Management Systems Dipl.

B.Quality Management Systems Kaizen • • • • • • • • Process-orientation Management of customer-relationship TQM Improvement and standardisation 5S 7M 7W Muda Quality Management Systems Dipl. Ing. Baranowski-Gornig 109 .

Ing.Quality Management Systems Kaizen: Improvement and standardisation Quality Management Systems Dipl. B. Baranowski-Gornig 110 .

Ing. B. Baranowski-Gornig 111 .Quality Management Systems Kaizen: 5S Seiri Straighten Seiton Sort Seiso Shine Seiketsu Sustain Shitsuke Standardise Remove all unnessary items from the work place Sort the remaining items Keep the work place tidy and clean Make ordeliness and cleanliness to your personal sustainable effort Make 5S your personal effort by standardisation Quality Management Systems Dipl.

Baranowski-Gornig 112 . B.Quality Management Systems Kaizen: 7 W • • • • • • • What – has to be done Who – does it Why – is it done How – is it done When – is it done Where – is it done Why – is it not done differently Quality Management Systems Dipl. Ing.

4. Muda of overproduction Muda of “not right first time Muda of motion Muda of processing Muda of inventory Muda of waiting Muda of transportation Muda of under-using people`s intelligence Quality Management Systems Dipl. 6. Ing.Quality Management Systems Kaizen: Muda 1. B. Baranowski-Gornig 113 . 7. 2. 3. 5. 8.

Baranowski-Gornig 114 . Ing. B.Quality Management Systems Muda Quality Management Systems Dipl.

Baranowski-Gornig . no running cost 115 People involved All employees Scope Expenses Continuous improvement Small investment.Quality Management Systems Feature Speed Timeframe Kaizen Small steps improvement Continuous effort Innovation Break-through change Project-based Few specialists Change of direction Big investment. B. Ing. continuous expense Quality Management Systems Dipl.

Baranowski-Gornig 116 .Quality Management Systems Quality Management Systems Dipl. B. Ing.

B. Baranowski-Gornig 117 . Ing. Lean Management Quality Management Systems Dipl.Quality Management Systems 10.

Lean is really a growth strategy.Quality Management Systems “Many people think that Lean is about cutting heads. Ing.” Ernie Smith. It is about gaining market share and being prepared to enter in or create new markets. Baranowski-Gornig 118 . reducing the work force or cutting inventory. B. Lean Event Facilitator in the Lean Enterprise Forum at the University of Tennessee Quality Management Systems Dipl.

We observe that our competitors often get average (or worse) results from brilliant people managing broken processes. Ing. B. We get brilliant results from average people managing brilliant processes. Baranowski-Gornig 119 .Quality Management Systems Toyota's Lean Strategy "Brilliant process Management is our strategy." Quality Management Systems Dipl.

ed.Quality Management Systems Japanes companies in Japan Productivity (h/car) Quality (defect/car) Teamwork in % Job rotation (0 = no. Jones.9 0. Ing. Baranowski-Gornig 120 .4 12.7 European companies 36 97 0.1 see Womack. D. 7..: The second revolution in automotive industry. 4 = often) Suggestions / employee Absenteism in % 17 60 69 3. B. page 97 Quality Management Systems Dipl.D.J.9 0.6 1. Ross.0 62 5.0 American Companies 25 82 17 0.4 11..

B. pull became push Toyota extended flow production to cope with high variety •simple machines •quick tool change •process sequence by customer demand Lean production was perfected at 1970 and extended across the whole company.Lean Management Quality Management Systems Dipl. •high volumes of parts for assembly. Ford in 1927. Baranowski-Gornig 121 .Quality Management Systems Lean management: Development "You can order your car in every color as long as it is black" Mass production was created by H.big machines •complex coordination. Ing. today known as "Toyota way" .

Baranowski-Gornig 122 . B.Quality Management Systems Lean management • The main idea is to maximise customer's value while minimizing waste • often described as the "second industrial revolution" • focus on waste elimination and prevention led to development of various techniques / tools such as � Just-in-time / just-in-sequence supply & production � KANBAN � Total preventive maintenance � One-piece-flow � SMED (Single Minute Exchange of Die) Quality Management Systems Dipl. Ing.

Ing. B. Baranowski-Gornig 123 .Quality Management Systems Lean management: Targets • waste-free business conduct / production • Integrate the value stream • Create efficient flow of product (supplier to customer) • aims at the "perfect company" Quality Management Systems Dipl.

Quality Management Systems Quality Management Systems Dipl. B. Ing. Baranowski-Gornig 124 .

” Shigeo Shingo Quality Management Systems Dipl. but you have to pay for the skin also. value-reducing performance. B. value adding performance. support performance) “When you buy bananas all you want is the fruit not the skin. Ing. And the customer should not have to pay for the waste. It is a waste.Quality Management Systems Specify value for the customer • Identify exactly for what the customer is willing to pay for • Question every process does it add value (idle performance. Baranowski-Gornig 125 .

Quality Management Systems

Lean Management: Identifcation of value stream 1. Identify the target product, product family, or service 2. Draw while on the shop floor a current state value stream map, which shows the current steps, delays, and information flows required to deliver the target product or service. This may be a production flow (raw materials to consumer) or a design flow (concept to launch). 4. Assess the current state value stream map in terms of creating flow by eliminating waste. 5. Draw a future state value stream map. 6. Work toward the future state condition.
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"All we are doing is looking at the time line, from the moment the customer gives us an order to the point when we collect the cash. And we are reducing the time line by reducing the non-value adding wastes. ” wastes.”
Taiichi Ohno

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production leveling • adjustment of takt-bound • elimination of bottlenecks Quality Management Systems Dipl. B.Quality Management Systems Lean Management: Create flow • • • • • aims for continuous flow apply pull-principles (e.g. Baranowski-Gornig 129 . KANBAN) Reduce setup-times (SMED) JIT/JIS Process stability (standardized work. Ing.

Baranowski-Gornig 130 . Mom didn’t use MRP. Mom didn’t give the didn’ milkman a schedule. She simply didn’ put the empties on the front steps and the milkman replenished them. Lean Event Facilitator in the Lean Enterprise Forum at the University of Tennessee Quality Management Systems Dipl. Ing. B. That is the essence of a pull system ” system” Ernie Smith.Quality Management Systems “Kanban is like the milkman.

B. Baranowski-Gornig 131 . when your parts leave shipping area Quality Management Systems Dipl. Ing.Quality Management Systems Lean Management: Pull from the customer • Start production only.

Quality Management Systems Lean Management: Aim for perfection • No waste • No inventury • Minimum setup-time • . B. "No problem is a problem!" Quality Management Systems Dipl. BUT: when you draw a value stream of your perfect enterprise you will find it is not perfect. Ing.. Baranowski-Gornig 132 ..

Quality Management Systems Manufacturing quality the Volvo Way The Volvo Production System (VPS) is the framework for our manufacturing operations. With the Volvo core value “Quality” as foundation. Ing. B. the 5 principles of the Volvo Production System are: Process stability Teamwork Built-in quality Just-in-time Continuous improvement Quality Management Systems Dipl. including methods such as Six Sigma – reduction of unwanted variation in processes. Baranowski-Gornig 133 . Delivery Precision and Cost-efficiency. VPS is also a toolkit. Its objective is to foster best practice methods and implement advanced manufacturing technology. and Lean – elimination of wasted time and material that help create value for our customers through increased Quality.

Baranowski-Gornig 134 . Muri. Muda. Ing. Mura Quality Management Systems Dipl.Quality Management Systems Lean Management Lean Administartio n Lean Production Lean Development Value-add-analysis Kanban (Jit / Jis) Poka-Yoka. TPM. 5M.5S. B.

I am rebuffed by people who say they are too busy and have no time for such activities.Quality Management Systems “Are you too busy for improvement? Frequently. Ing.” Taiichi Ohno Quality Management Systems Dipl. look. B. I make it a point to respond by telling people. Baranowski-Gornig 135 . you’ll stop being busy either when you die or when the company goes bankrupt.

Quality Management Systems Dipl. sale and delivery of a product. K. a. New York. S. Inc." Ulrich.. Ing. NY. (1995). McGraw-Hill. B. Baranowski-Gornig 136 .Quality Management Systems Lean Management: Development "Product development is the set of activities beginning with the perception of a market opportunity and ending in the production. E. Product Design and Development. 15. Lean product development means use of lean principles and practices to place customer value in the center of product development. p.

B. TRIZ.Quality Management Systems Lean Management: Development Lean Development Simultaneouse Engineering Management of Innovation FMEA. QFD. DoE Road Maps Quality Management Systems Dipl. Baranowski-Gornig 137 Concepts Methods . Ing.

Quality Management Systems Simultaneouse Engineering Simultaneous Engineering is a time-based approach. Ing. Objectives: • reduction of product development time • reduction of costs • improve quality • prevent future product modification Quality Management Systems Dipl. B. Baranowski-Gornig 138 . not separately (in series). All areas involved in a project are considered in parallel.

B. Baranowski-Gornig 139 . Ing.Quality Management Systems Simultaneouse Engeneering: Strategies (PSI) • Parallelisation � complete overlapping � partial overlapping � overlapping by splitting • Standardisation • Integration Quality Management Systems Dipl.

Processinnovation aims at improvement of effectiveness and efficiency of processes and procedures. B.Quality Management Systems Management of innovation Innovationsmanagement is the systematic planning. Innovation-management aims at the application of ideas. Productinnovation aims at satisfaction of customer requirements. Baranowski-Gornig 140 . implementation and control of ideas in an organization. Quality Management Systems Dipl. Ing.

Quality Management Systems Dipl. not the form. QFD means: Listening to voice of the customer.Quality function deployment "Copy the spirit.Quality Management Systems QFD . multi-skilled teams collaborate to arrive at a common understanding of the customer needs. and determine the appropriate technical requirements at each stage. B. Ing. manufacture." Yoji Akao It is a structured product development process which translates what the market requires into a program to create. Baranowski-Gornig 141 . In a QFD process. and deliver it.

Ing. • ensure the costs are within the budget • improve customer satisfaction by to making sure the customer requirements are matched 100% • reduce time spent in development phase Quality Management Systems Dipl. cheaper and in a better manner • ensure that the correct product/process is released from the product launch.Objectives • understand customer requirements better in a faster.Quality Management Systems QFD . B. Baranowski-Gornig 142 .

Quality Management Systems QFD . deduct project tasks • American supplier institute Quality Management Systems Dipl. Ing.g.approaches • Akao approach involves entire company . Use of further quality tools or methods e. Transfer of customer requirements in all processes • Bob King emphasis development of matrices and integration of different departments.priority is customer orientation. Baranowski-Gornig 143 . FMEA. B. prioritise. value analysis • Zultner approach known as "flash-QFD": gathering of customer requirements. analysis.

Quality Management Systems QFD .according to American supplier institute Phase 1: Product planning (House of quality) Gathering and translation of customer requirements into product / technical requirements Phase 2: Product design Translate these technical requirements into key part or component characteristics Quality Management Systems Dipl. Baranowski-Gornig 144 . B. Ing.

Quality function deployment (ASI) Phase 3: Process planning Definition of key process operations necessary to obtain key part or component characteristics Phase 4: Production planning and control Establishung of process control plans. Ing. Baranowski-Gornig 145 . B. Quality Management Systems Dipl. maintenance and training plans to control operations.Quality Management Systems QFD .

Quality function deployment . Baranowski-Gornig 146 . 1989] Quality Management Systems Dipl. B. Ing.ASI QFD and software development life cycle [Betts.Quality Management Systems QFD .

Ing. Baranowski-Gornig 147 .Quality Management Systems Quality Management Systems Dipl. B.

Road maps may be adjusted with evolution over time and are thus dynamic plans for the business. Ing.Quality Management Systems Road maps Road maps are a type of business planning that integrate business requirements with technology or other developments with short and long-term scope. Quality Management Systems Dipl. They describe the business targets to be met. both in time and quantity and also describe the way how to achieve them. B. Baranowski-Gornig 148 .

Quality Management Systems Road maps 1. e. Ing. 3. 5. technological breaktrough 4. Select one or more concepts. Assess external influences. Articulate your business goals. Refine and test the design.g. Generate alternative concepts. B. Understand customer needs. Baranowski-Gornig 149 . Quality Management Systems Dipl. legislation. 2. 6.

talessin.Design of Experiments DoE is defined as "planning and plans of experiments which are described in detail and in which factors of influence are assigned systematically to reach quality features by focused tuning of these inflential factors. B.de/scripte/qm/doe.de/ Plans of experiments described in detail aiming at describing quality features already during the design phase of new services and products by focused factors of influence are calles DoE.kassel. Baranowski-Gornig 150 . comp. http://www.Quality Management Systems DoE ." comp. Ing.html Quality Management Systems Dipl. http://www.uni.

in many industrial applications.g. http://www.qm-world. http://www-ra.Quality Management Systems DoE . Ing. Comp.informatik.Design of Experiments Test methodolgy that aims at reducing the amount of tests and hereby contributes to a more economical design process with focus on quality.de/lexikon/ DoE aims at planning tests and experiments in such a manner that minimum efforts in measuring ensure an as high as possible statistical quality of data.uni-tuebingen. This is especially important when experimental cost is high as e. B. comp. Baranowski-Gornig 151 .de/ Quality Management Systems Dipl.

Design of Experiments . B. Analysis intend Quality Management Systems Dipl. Describe initial situation including • objective time and money • involved people • project management • existing information 2. Ing. Baranowski-Gornig 152 .Approach 1.Quality Management Systems DoE .

Define target and factors • Choice of target • Choice o factors • Determine factor level • Inflential parameters.Design of Experiments . that are not analysed 4. Set up design plan • Establish combination of factor level • Formation of blocks • Randomization • Assessment of expense Quality Management Systems Dipl.Quality Management Systems DoE . Baranowski-Gornig 153 . Ing.Approach 3. B.

Design of Experiments . improvement. next steps • Securing improvement • Documentation • Further actions Quality Management Systems Dipl.Quality Management Systems DoE . Evaluation of test results • Interpretation • Measures 7. Carry out experiments 6. Baranowski-Gornig 154 . B. documentation.Approach 5. Ing.

B. Ing.Experimental strategies Trail and Error Height of bread in average 6cm Problem: Target: Solution: Height of bread > 7cm modify baking temperature other baking ingredients other baking dish change mix time change amount of water Quality Management Systems Dipl. Baranowski-Gornig 155 .Design of Experiments .Quality Management Systems DoE .

Ing. B.2cm 7.0 156 .5cm 6. Baking temperature 200°C 250°C 200°C 200°C Mix time 5 min 5 min 10 min 10 min Amount of water Result 250 ml 250ml 250 ml 200ml Quality Management Systems Dipl.Experimental strategies:One-factor-at-a-time (OFAT) One factor is varied and the result is observed. Baranowski-Gornig 7. The better setting is maintained and the next factor is examined.Quality Management Systems DoE .9 cm 7.

an optimum is detected by hazard . Ing.Quality Management Systems DoE .proceed little systematic .with luck one is fast at the goal Disadvantage .individual effects remain unknown .interactions are not recognized Quality Management Systems Dipl. B.Experimental strategies:One-factor-at-a-time (OFAT) Advantage .simple . Baranowski-Gornig 157 .

Experimental strategies: Fractional factorial design For the factors which are to be examined are specified two levels.Quality Management Systems DoE . Not all possible combinations of factors are tested. B. Baranowski-Gornig .3 6.3cm 7.9 cm 6.0 cm 6. Baking temperature temp 200°C 250°C 200°C 250°C Mix time 5 min 5 min 10 min 10 min Amount of water 250 ml 200ml 200 ml 200ml Result 7.6 cm 158 Quality Management Systems Dipl. Ing.

Ing.Quality Management Systems DoE .less effort in comparison to full factorial design Disadvantage . Baranowski-Gornig 159 .Experimental strategies: Fractional factorial design Advantage .main effects may be overlaid by interactions .impact of factors can not be identified Quality Management Systems Dipl. B.

9 cm 7.0 cm 6.6 cm 160 .3 cm 6.2 cm 7.Quality Management Systems DoE .Experimental strategies: Full factorial design Baking temperature Mix time 200°C 250°C 200°C 250°C 200°C 250°C 200°C 250°C 5 min 5 min 10 min 10 min 5 min 5 min 10 min 10 min Amount of water 200 ml 200 ml 200 ml 200 ml 250 ml 250 ml 250 ml 250 ml Quality Management Systems Dipl. Ing.4 cm 6.9 cm 6.6 cm 7. Baranowski-Gornig Result 6. B.

Ing. influential parameters. control parameters Quality Management Systems Dipl. Baranowski-Gornig 161 .Experimental strategies: Full factorial design For the factors which have to be examined are specified two levels. All possible combinations are tested. B.Quality Management Systems DoE . Advantage .high expenditure with increasing number of factors.all main effects and interactions can be calculated Disadvantage .

It was developed in the former USSR by Genrich Saulowitsch Altschuller. Quality Management Systems Dipl. TRIZ attempts to turn invention into a systematic method by reducing it into a series of principles. B. Baranowski-Gornig 162 .Quality Management Systems TRIZ: Theory of inventive problem solving (TIPS) Aim is structuring of the creative part of innovation management on the basis of 40 innovative priniples. Ing. TRIZ is based on the idea that problems and their solution are repeated across all industries. and so solutions to many problems that arise may have been solved in some other application.

the second that patterns of technical evolution are also repeated across industries and sciences. B. Ing. innovations use scientific effects outside the field in which they were developed.Quality Management Systems TRIZ: Theory of inventive problem solving (TIPS) There are three primary findings of this research: research: 1. 2. 3. Baranowski-Gornig 163 . Quality Management Systems Dipl. problems and solutions are repeated across industries and sciences.

SPC Quality Management Systems Dipl. Baranowski-Gornig 164 .Quality Management Systems 11. B. Ing.

B. Quality Management Systems Dipl.Quality Management Systems SPC . Baranowski-Gornig 165 .Statistical Process Control SPC is a method of monitoring and controlling a process through statistical analysis to ensure that it operates at its full potential to produce conform products. Ing.

Quality Management Systems

SPC - Approach 1. Determine process and characteristics 2. Define where to measure (point in process) 3. Determine sample size and interval 4. Determine method of measuring 5. Check capability of measuring system / equipment 6. Create form to record measurements (software) 7. Define procedure 8. Train involved people

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Machine capability - short term capability Capability of machines is expressed in Cm and Cmk. Target value: min 1,67 Cm: includes only the variation, without regarding the location of the average. (Cm = T / 6 * s) Cmk: considers also the location of the average toward the tolerance limit.

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Quality Management Systems

Machine capability - usually done before start of production - minimum 50 parts - one operator - "ideal conditions"

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Minimum 100 parts. short pre-production run. Target value: min 1. better 25 samples of 5 parts. Quality Management Systems Dipl. Ing. Pp verify if the sample generated from a process is capable to meet Customer requirements. B. Process Performance is only used when process control cannot be evaluated.33. e.g. Baranowski-Gornig 169 .Quality Management Systems Temporary process capability Temporary process capability is expressed in Pp and and Ppk.

B. When the Cpk is greater than or equal to one. Conversely. it is considered potentially inccaptable of meeting specification requirements. the process has the potential of being capable. Baranowski-Gornig 170 . Cpk less than one.0.Quality Management Systems Process capability Process capability is expressed in Cp and and Cpk.0. when a process Cp is greater than or equal to 1. the process is considered capable of producing a product within specification limits. Quality Management Systems Dipl. Ing. Cp: value less than 1. the process is referred to as incapable.

B.Quality Management Systems Machine capability What Scope of investigation Aim Component / production unit one sample of min 50 parts Assessment of a machine regarding capability Temporary process capability Production process Several samples over a longer period of time (25 x 5 parts) Assessment of a process regarding capability Longterm process capability Production process continuous taking of samples to control process Comparison process / long term changes running process When new machine before release of production Cm. Baranowski-Gornig Characteristics Cp. Cmk Pp. Cpk 171 . Ppk Quality Management Systems Dipl. Ing.

Balanced Scorcard Quality Management Systems Dipl.Quality Management Systems 12. B. Ing. Baranowski-Gornig 172 .

B. Baranowski-Gornig 173 . Ing. system” As defined by Kaplan and Norton (1996) Quality Management Systems Dipl.Quality Management Systems “The Balanced Scorecard translates an organization’s mission and strategy into a organization’ comprehensive set of performance measures that provides the framework for a strategic measurement and management system ”.

and in some cases realistically." Quality Management Systems Dipl. Baranowski-Gornig 174 . B. Ing. "More cynically. pious hopes of a company's vision/mission statement into the practicalities of managing the business better at every level.Quality Management Systems A definition often quoted is: 'A strategic planning and management system used to align business activities to the vision statement of an organization'. a Balanced Scorecard attempts to translate the sometimes vague.

Quality Management Systems Vision Targets. B. Baranowski-Gornig 175 . Strategy Prorities Balanced Scorecard Operational planning Measures Strategy feedback Quality Management Systems Dipl. Ing.

why do we exist Core values .where we want to be."game plan".Quality Management Systems Mission . strategic success factors.prioritisation: what we have to do Personal targets . Ing. Baranowski-Gornig .what I have to do Innovation & learning Customer perspective Internal business perspective Financial perspective 176 Quality Management Systems Dipl. cause and effect relations Strategic measures .perspectives.what we believe in Vision . our schedule BSC . strategic indicators and targets. B. what is important for us Strategy .

Ing. B.Quality Management Systems Financial perspective Customer perspective Internal business perspective ROCE Customer loyalty Delivery in time Process quality Cycle times Innovation & learning expertise levels of Staff Quality Management Systems Dipl. Baranowski-Gornig 177 .

org Quality Management Systems Dipl. B. Baranowski-Gornig 178 .balancedscorecard. Ing.Quality Management Systems BSC: Cause-and -effect www.

Quality Management Systems Quality Management Systems Dipl. Baranowski-Gornig 179 . B. Ing.

Quality Management Systems Quality Management Systems Dipl. B. Baranowski-Gornig 180 . Ing.

B. Ing.Quality Management Systems Quality Management Systems Dipl. Baranowski-Gornig 181 .

Baranowski-Gornig 182 . B.Quality Management Systems Dipl. Ing.