Quality Management & ISO 9000

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Questions and Answers

Welche der folgenden Aussagen beschreibt am besten die Beziehung zwischen SOLL (Forderungen) und IST (Eigenschaften) im Kontext der Qualitätsdefinition nach ISO 9000:2015-11?

  • SOLL wird als Idealzustand definiert, während IST die realen Kosten zur Erreichung dieses Zustands widerspiegelt.
  • SOLL und IST werden miteinander verglichen, um festzustellen, inwieweit die inhärenten Merkmale eines Objekts die Anforderungen erfüllen. (correct)
  • SOLL und IST werden unabhängig voneinander betrachtet, um die Eigenständigkeit des Objekts zu gewährleisten.
  • SOLL beschreibt die erwarteten Kundenerwartungen, während IST die tatsächliche Kundenzufriedenheit misst.

Wie unterstützt die Kundenperspektive im Aachener Qualitätsmanagement Modell die Transformation von Kundenforderungen?

  • Durch die Definition von Qualitätsstandards für alle Produkte und Dienstleistungen.
  • Durch kontinuierliche Beobachtung der Transformation und Umsetzung der 'Stimme des Kunden' mit Fokus auf Produktqualität. (correct)
  • Durch die Festlegung der strategischen Ausrichtung des Unternehmens.
  • Durch die operative Ausgestaltung und Umsetzung von Prozessen.

Was ist das Hauptziel des Deming-Zyklus (PDCA) im Kontext der kontinuierlichen Verbesserung (KVP)?

  • Die kurzfristige Reduzierung von Produktionskosten durch Standardisierung.
  • Die Erreichung von kurzfristigen Gewinnsteigerungen ohne langfristige Planung.
  • Die systematische Anwendung eines vierstufigen Prozesses zur fortlaufenden Optimierung von Abläufen und Ergebnissen. (correct)
  • Die einmalige Implementierung neuer Technologien zur Effizienzsteigerung.

Welche Aussage beschreibt am besten die Funktion von Befähigungsprozessen im Rahmen des Qualitätsmanagements?

<p>Sie umfassen alle Tätigkeiten und Ressourcen, die zur Unterstützung der Kernprozesse dienen. (A)</p> Signup and view all the answers

Was ist das Hauptziel eines Qualitätsaudits im Kontext des Qualitätsmanagements?

<p>Die Überprüfung der Eignung von Abläufen und Verfahren zur Entwicklung, Herstellung und Lieferung von Produkten auf Erfüllung interner Ziele und externer Auflagen. (C)</p> Signup and view all the answers

In der RADAR-Logik des EFQM-Modells, welcher Aspekt befasst sich mit der systematischen Nutzung der gewonnenen Erkenntnisse zur kontinuierlichen Verbesserung?

<p>Refine (Verfeinerung) (D)</p> Signup and view all the answers

Was ist der Hauptzweck der Anwendung eines Swim-Lane-Diagramms in der standardisierten Prozessdarstellung?

<p>Die Visualisierung von Prozessschritten über verschiedene Abteilungen oder Verantwortlichkeitsbereiche hinweg. (D)</p> Signup and view all the answers

Welche der folgenden Aussagen beschreibt am besten das Ziel der Fehlermöglichkeits- und Einflussanalyse (FMEA)?

<p>Die frühzeitige und systematische Identifizierung von möglichen Fehlern, deren Ursachen und Folgen, um präventive Maßnahmen zu ergreifen. (C)</p> Signup and view all the answers

Was ist das primäre Ziel der Pareto-Analyse im Qualitätsmanagement?

<p>Die Identifizierung der wichtigsten Fehlerursachen, die den größten Einfluss auf ein Problem haben. (A)</p> Signup and view all the answers

Welche der folgenden beschreibt den Zweck der fünf „Warum“-Fragen (5W-Methode) im Rahmen der Ursachenforschung?

<p>Das tiefergehende Erforschen der Ursachenkette, um die eigentliche Problemursache zu identifizieren. (C)</p> Signup and view all the answers

Flashcards

Qualität nach ISO 9000

Der Grad, in dem ein Satz inhärenter Merkmale eines Objekts Anforderungen erfüllt. SOLL und IST wird verglichen.

Deming-Zyklus (PDCA)

Plan: Prozessänderungen planen und Ziele setzen. Do: Änderungen ausprobieren. Check: Wirksamkeit prüfen. Act: Maßnahmen umsetzen.

BigPicture

Methode zur grafischen Darstellung eines Unternehmensbereichs mit Bildern, Verknüpfungen, Stichwörtern und Diagrammen.

EFQM-Modell

Das Modell bewertet die Führung, Strategie und Prozesse eines Unternehmens im Bezug auf TQM.

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RADAR-Logik

Bewertung der erzielten Ergebnisse. Bewertung der Qualität der Maßnahmen. Unterstützung bei der Strukturierung von Verbesserungsprojekten.

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Prozess-Struktur-Matrix

Matrix zum Lösen von Schnittstellenproblemen, basierend auf Swim-Lane-Diagrammen. Diagonaleinträge sind kritisch.

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Kano-Modell

Unterteilung in Basis-, Leistungs- und Begeisterungsmerkmale. Wird für Qualitätsdimensionen verwendet.

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FMEA

Methode zur systematischen Ermittlung von Fehlerursachen und deren Folgen. Funktionen der Bauteile werden bestimmt

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Yield

Anteil der akzeptablen Ergebnisse im Verhältnis zur Gesamtleistung. Misst den Ertrag einer Prozesskette.

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Sigma-Niveau

Kennzahl für Prozessqualität, die die Fähigkeit des Prozesses, Kundenerwartungen zu genügen, bewertet.

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Study Notes

Understanding Quality (2)

  • ISO 9000 Definition should be learned
  • Draw the Aachen Model and work out individual elements based on Fliestet, similar to how it is shown in the application.
  • Name the Deming Cycle

Quality Terminology (ISO 9000:2015-11)

  • "Quality" refers to the degree to which a set of inherent characteristics fulfills requirements
  • The standard compares what should be (requirements) with what is (characteristics)

Corporate Understanding of Quality

  • Sollen (Should): Market demands from the customer perspective
  • Wollen (Want): Corporate direction from a leadership perspective
  • Können (Can): Corporate capabilities from an operational perspective

Aachen Quality Management Model

  • It incorporates three perspectives of corporate quality management (Kundenperspektive, Führungsperspektive, and Betriebsperspektive)

Customer Perspective

  • Customer perspective supports translating customer demands into inspiring products
  • Continuous observation of transformation ensures implementation of the "voice of the customer" with a focus on the quality of the product

Leadership Perspective

  • Leadership perspective describes normative and strategic orientation
  • It focuses on organization's capabilities, system quality, and actively shaping framework conditions

Operational Perspective

  • Operational perspective covers the operative design and implementation of the other two perspectives
  • It focuses on process quality to ensure optimal resource and service availability

Total Quality Management

  • Total describes orientation
  • Quality describes quality
  • Management describes leadership

Deming Cycle (PDCA) - Systematic Approach to Continuous Improvement (KVP)

  • Plan process changes and set goals
  • Try and test these process changes
  • Check effectiveness with controlling and defining the change
  • Derive measures and implement them enterprise-wide to maintain the change

BigPicture - Applying the Aachen Quality Management Model - Assessing the Current State

  • The BigPicture method graphically represents a company or business unit by combining images, links, keywords, and diagrams based on the Aachen quality management model
  • It aims to reveal causal relationships within the company and enhance transparency

The Steps

  • Establishing a scope defining the boundaries for the assessment
  • Identifying key processes contributing to the company's value chain
  • Defining the products and customer requirements
  • Identifying both satisfied and unsatisfied customers
  • Defining company strategy
  • Describing critical support processes

Step 0: Defining the Scope

  • Establishing the scope sets the frame for the whole assessment
  • Scope aspects are: organisational unit or a specific section of the value chain

Step 1: Determining Core Processes

  • Core processes include all activities within a business that create value
  • Examples are production, development, purchasing, assembly, and warehousing

Step 2: Products and Customer Requirements

  • Categorizing products and services broadly divides into tangible goods and services
  • Customer demands include excellent value for money, up-to-date and solid technology, and minimal waiting times

Step 3: Identifying Customers and Their Development

  • Groups of customers are identified and categorised such as how trend, age, and number affect them

Step 4: Describing Company or Department Strategy

  • Strategies are long-term planned activities designed to achieve corporate goals, such as market share and customer ratings

Step 5: Describing Important Qualification Processes

  • Qualification processes include all activities and resources that support core processes, like training, infrastructure, and facilities

Step 6: Deriving Corporate Context and Weaknesses

  • Derived are used to improve company orientation
  • Identifying focuses on three perspectives of corporate quality
    • How well the company’s core processes fit customer demands
    • How well customers taken up
    • Is the resources are being used for goal attainment?

Examples of Weaknesses

  • High dependency on a single customer group
  • Conflict between customer demands and product portfolio
  • Product range expansion instead of focusing on customer group

Quality Management Systems (3)

  • Evaluate using EFQM
  • Create process matrix & SWIMLANE
  • Describe DIN EN ISO 9001
  • What is Audit in quality
  • What is a QMS (Quality Management System)

Why & Where are Quality Management Systems Used?

  • It can be used to produce consistent high-quality goods for sale, shopping, production, and logistics

Factors Regulated by Quality Management Systems

  • Proper & meaningful working instructions for assembly (methods & processes)
  • Using correct tools includes machinery and equipment
  • Detection of errors in subsequent checks
  • Implement worker training and experience (data and information)
  • Conception of production processes & on-time delivery of functioning components (processes & activities)
  • Organisation of manufacture layout & monitoring(organisational units)
  • Arranging adequate personnel for each step of assembly process

DIN EN ISO 9001:2015 - Quality management systems

  • Customer orientation
  • Inclusion of people
  • Improvement
  • Relationship management
  • Leadership
  • Process-orientated approach
  • Evidence-based decision making

Quality Audit

  • Audit is attributed suitability assessment of the processes and procedures to meet internal/external needs in development of products
  • Audit is made into three sections
    • Product Audit: - Product features assessment
    • Process Audit- procedure assessment
    • System Audit- assessment of managerial tasks

EFQM Model (European Foundation for Quality Management Model) - TQM Rating

  • The overall assessment of a company is only useful in relation to other assessments i.e compared with
    • prior evaluations of the same company and comparable companies
  • Strength & Improve
  • Evaluate with EFQM Excellence Model
    • Rate how well the standards are met
    • Calculate individual products and weights of rate score
    • Summarize result
    • Interpret result and individual rankings

RADAR Logic - Structured Approach

  • To asses criteria, following questions are to be used
    • What do you want to reach?
    • How to assess, how’s it implemented?
    • Continuous safety improve by

Common Areas

  • Appraised of results
  • Assessed on implemented actions
  • Support structured improvement projects

Swim-Lane-Diagram

  • Number of department is Number of Lane
  • Follow flow up to choice available/conditions applied
  • (Swim-Lane-Diagram) based on Process-Structure-Matrix

Symbols for Flowchart

  • Beginning and end states are
  • Branch or Choice
  • Process step
  • Action Arrow

Process-Structure-Matrix

  • Insert items of modeled process into diagonal
  • (Bsp.: Relation 1-2 write therefore at the upper right)
  • (Bsp.: Relation 5-2 write therefore at the bottom left)
  • Critical Entry are dark

Preventative Methods (4)

  • Describe Kano model
  • Create OFD model
  • Complete FMEA model

Kano Model

  • It divides into three basis of quality
    • Basis
    • Performance
    • Excitement

Quality Function Deployment (QFD)

  • Voice of the Costumer: Determine Customer needs simply and reliably example
  • Good Antitheft
  • Antitheft Importance determine customers
  • Higher payer is bigger
  • Engineer importance- Determine qualitative and features to customer. Example: Number of pinions set optimisation.
  • Matrix and evaluate which properties of the new set most.
  • Customers are the circle and competitions arw the square.

Risk & Figure Out

  • To define the system it will check the force on tension pull on cable

Risk evaluation

  • Risk is RZB. it occurs with failure follow up actions

Fehlermöglichkeits- und Einflussanalyse (FMEA)

  • Analysis with organisational prep and system structure

Risikoarten

  • technical- cracking at high load even though FE method
  • Deadlines being too close
  • The personnel is assigned otherwise
  • External person in charge cannot pay
  • Purchase only possible one which are cheap

Methodend

  • ABC-Method and check the risk for value

Risk & figure

  • Can be seen with chart

Method

  • If Quality checks fails check
  • Rework check tool
  • Only buy parts which are certified
  • Always set ware input

Methods in the Problem Solving Process (5)

  • Name and draw types of failure
  • Draw an Ishikawa diagram
  • Put though Pareto Analysis
  • Put though Weibull analysis

How to Check for Failure Occurrence - Durability Test

  • The lifespan indicates the period after which individual products fail over time
  • Data visualization (logarithmic)
    • Record lifespan across x-axis
    • Percentage of failed objects across y–Achse

Failure-Graphs

  • The higher the point shows a larger issue

Weibull-Analysis

  • It displays distribution function
  • Calculate at which the parts will break or not

Pareto-Analysis

  • (80% chance)
  • is the higher amount to gain from the high level

Find Cause

  • Diagram will show the connection

Methode 6-3-5

  • Larger range for solutions each

Progressive

WEibull-Analyse

  • Formula show

Pareto-Analyse

  • Chart is to see importance' cause of accidents

Ishikawa-Diagramm

  • Add issues and reason or causes

Ishikawa

  • Draw chart

Statistical Methods (6)

  • Distribution
  • Process ability

Distribution

  • The frequencies of different chassis weights are shown; the sample values are normally distributed
  • The density function of the normal distribution is described by:
    • Sample mean: x
    • Standard deviation: s
  • The number of classes (k) results from the number of samples (n) according to k = √n

Process Check

  • Process is good when stable
    • Value is constant

Process Ability

  • It can work fast

SPC

  • Rule chart and check when to act

Proess is valid

  • When Chart is correct

Statistik und Six Sigma (7)

Descriptive and Inductive Statistics

  • Descriptive statistics derive characteristic values to describe a population or sample
  • Inductive statistics draw inferences about population parameters from sample data

Important

  • A statistic yields certain estimate however no method of making sure to have the real value

Stichproben

  • Reduce by grund gesamheit by stick proven
    • Costs
    • Time
    • Chance
    • Not exactly

Process ability

  • The more distance a higher number of issues are solved

Sigma Level

  • the ability to supply the customers need

Short-Term/Long-Term Quality

  • Usually, a business standard says that projects have to be carried out

DMAIC-Zyklus

  • (all six sigma)

6 sigma level

  • Is for determining amount problems

Data

  • Distinguish one point from another/ what are properties
    • If it doesn't require a large test its is ok to use Variable is the amount of data will be different
    • Test is needed to determine/how big force must is

QPM

  • (Anzahl Fehleteir)

Zusammenhang von Yield und Sigma

  • Dpmo

  • It needs all

  • But it will happen so here is the best time to solve those

Yield Method

  • Yield performance will do it

First Time Yield

  • How many parts are correct

Zusammenhang

  • The performance will have change here at this state

Einfuhrung Projket -ManageMent (8)

  • To write best
  • Projekt plan
  • It check or not
  • Good quality is to add all
  • What should a project need

Definition

  • DIN 69901
  • Organisation

Projects Arten

  • Intern/extern
  • Invest,organisation,research

Stages

  • Sketch (ziele)
  • Test (ziele)
  • Steps and more
  • control check

List

Definition

Plan/sketch

Objectives

Ablauf

Risk.and more

  • Look up

Plan and start

List

Proess

List and test

  • To take it to test

Zielarten

Types and more

More To check what to buy or not

To take what the company can sell

To make the business grow

Methods

To show the way.

Make more to check

Now it what have.

Steps To Do

  • Make matrix (to show list)
  • Chose right step and go

Lasten -Pflichten heft

Main list

what are they

All needed

how long we need it

  • Make short all

Mile Stone

All is do to this time not more

Arbeit

  • It needed all not less

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