Quality Management Question Sheet for Exam Preparation

1. Introduction to QMS
What is quality? Define the term quality in your own words!

Quality is degree to which a set of inherent characteristics fulfills

requirements.

when your customer is coming back, and not your delivered

products !!!

How to implement a QMS?! What do we need?!(six steps)

// While implementing--> explain points and why to use those points.
1. Decision
2. Requirements
3. Analysis and Evaluation
4. Task schedule
5. Implementation
6. Certification

1. Decision:
First of all it has to be decided on the field to be improved by a QMS. As there are
different standards formulated in the works of DIN EN ISO, KTO, or VDA.

2. Requirements

Active Support of Management

Implication of staff
Appointment of Quality Management Representative
Identification of current state, actual situation

3. Analsyis and Evaluation

Detection of weak points

Internal and external impact of weak points
Analysis of weak points, root cause

4. Task schedule

Corrective action plan, Checklist acc. ISO 9000

Determination of corrective actions
Definition of responsibilities, competences
Check if corrective actions are feasible
Generation of Quality Manual
Definition of processes

5. Implementation

What do we need to implement a QMS successfully?

The leadership should establish an internal environment where employees can
become fully involved in achieving the organisations objectives

Put in place corrective actions

Establish and release Quality Policiy and Manual,
procedures, instructions, checklists
Training of staff
Internal audits
Continuous improvement

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

2. Process-oriented approach
What are the philosophies in QM sytems (do you know the limits
and the differences in accordance to ISO Standards?)?
Philosophies:

TQM

TPS

DIN EN ISO Standards are international accepted standards including some

issues of philosophies. Philosophies in general can be some certain objective
and goals that companies want to achieve while they rely on their own
philosophy.

What is the difference betwen QMS and ISO?! --> TQM is part of the answer!

3. Documentation of a Quality Management System

If we speak about QMS- we have three levels. What is the
reason/objective for documentation? (pyramide on p.26).

Sharing of knowledge
Evidence of conformity
Communication and information

The three levels of documentation

1. First Level: Minimum content of a QM Manual

Quality policy
Explanation of companys 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

2. Second Level: Procedures or Process description

six procedures to explain.
ISO 9001: 2008 requires the organization to have documented procedures
for the follwing activities:
1. control of documents,
2. control of records,
3. internal audits,
4. control of nonconforming products,
5. corrective actions,
just for internal
6. preventive actions.
use!
3. Third Level: Required Documents

Documents may be work or test instructions, checklists

and for e.g. drawings or BOM.
Work instructions are explicite description of workflows,
including parameters etc. for important,
complicated or sensitive workitems.

What is necessary to have correct sheets?

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

What is the difference between records and documentations in

general?
This is a type of document that provides evidence that activities have been performed
or results have been achieved. Records document the past. They may be used e.g.
that Verification has been done or corrective actions have been carried out. Records
have to be controlled and stored according to legal requirements.

4. Quality Planning
What is important in regard to QM objectives? (SMART)
Quality objectives have to:

be defined,
reflect the quality policy
coherent
in alignment with overall business objectives
consider customer requirements
be communicated and understood
be updated

5. Audits
Different kinds of audits. What types are internal audits?
External audits :
Internal audits:

Customer
--> system, process, product
cert. Authorities
--> system
worker, consultants
--> product, system

Internal audits: create an internal action plan*!

Proces
s
/areas

Import
ance

What

Frequ.

Respon
s.
Person
s

Due
date

Audit
report?
!

Corrective
actions

PDCA

*remark: auditors cannot audit their own work!!

Deming Cycle PDCA--> explain the sence behind the certain

steps.

6. Quality Tools
Quality tools (Q7) Explain the 7 quality tools and the use of it!
(p. 58)

Check sheets
Histogramm
Control charts
Pareto-chart
Cause-and-effect-diagram
Scatter diagramm
Brainstorming

Cause and effect diagramm by Ishikawa

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 causes of a problem. It is a
graphical presentation of causes, that are leading to a result or have a strong
influence on a result.
Advantages of a cause- and effect diagramm

Use of a simple format

Helps to identify root causes
Increases knowledge of a process
Identify, where further data is needed
Different ways of consideration of the problem due to teamwork

Man
Machine
Milieu
Material
Methods
Measurement
s

Everybody, who is involved in the process

All equipment, tools etc. that is required to do a job
Location, time, temperature etc. of the process
Raw materials, parts etc. that is used to produce a
product
How the process has to be performed (procedures,
instructions,)
Process data which is used to evaluate quality

7. FMEA
Name 5 tools to be used in development!
Development
Production

Pareto

FMEA

DOE

SOP

What is a FMEA? What is the objective of an FMEA?

Steps of a FMEA
1
2
3
4
5
6

Creation of a structure (Definition of components or pocess-steps)

Analysis and description of elements of the structure
Analysis of failures
Evaluation of risk
Optimisation /Improvement
Final evaluation

Advantages of a FMEA

Structured, detailed approach

internal customer focused
Bottom up principle
Requires that all known or suspected potential failures to be considered
Relies on the collective expertise of all areas affected by the process
Stimulates open communication of potential failures and their outcomes
Results in actions to reduce failures
Includes a follow up system and re-evaluation of potential failures

8. TQM
What is the definition of TQM?? --> TQM is not a tool!!

TQM is an integrated management philosophy for improving quality

continuously. TQM means involvement of everybody in an organization.
TQM aims for a long term success through customer satisfaction.
TQM may require fundamental changes of the organization regarding attitudes,
practices, structures and systems.

Advantages of TQM

make an organization more competitive

can establish a new culture which will enable growth and long life
provide a working environment in which everyone can succeed
reduce stress, waste and friction
build teams, partnerships and co-operation

Demings 7 deadly deseases

1
2
3
4
5
6
7

No existing constancy in philosophy and targets

Focusing only on a short term economic profit
Management by fear merit systems, yearly appraisal,...
Fluctuation of management staff job hopping
Eliminate setting work parameters, which are unknown ornot realizable in
practice
Excessive medical care
Excessive cost on liability

TQM eight principles

1
2
3
4
5
6
7
8

customer-focused organization
leadership
involvement of people
process approach
system approach
continual improvement
factual approach to decision making
beneficial supplier relationships

Why do we need EFQM? What is the reason behind it?

Consideration of real results

Consideration of further external stakeholders ( environment, society)
Competitive comparison
Sustainability of TQM-concepts

In ISO you just check if you match the standards, but in EFQM you improve the
processes constantly

9. Kaizen
What does Kaizen mean?
Kai change; Zen for the better
Kaizen is a japanese live- and work philosophie which aims for continuous
improvement or change. Main elements of the Kaizen philosophie are quality, effort,
Involvement of employees of all levels, willingness to change and communication.
Ecomomic success is achieved by a step-by-step improvement of product and
services, which fulfill customer requirements due to excellent quality.

Typical tools used in Kaizen

5S
Straighten
Seiri
Sort
Seiton
Shine
Seiso
Sustain
Seiketsu
Standardise
Shitsuke

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

Muda ( waste)
1.
2.
3.
4.
5.
6.
7.
8.

Muda
Muda
Muda
Muda
Muda
Muda
Muda
Muda

of
of
of
of
of
of
of
of

overproduction
not right first time
motion
processing
inventory
waiting
transportation
under-using people`s intelligence

10. Lean Management

Defintion of lean

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)
(Name 5 principles!)

QFD What are the main points of it?!

"Copy the spirit, not the form."
Yoji Akao
It is a structured product development process which translates what the market
requires into a program to create, manufacture, and deliver it. In a QFD process, multiskilled teams collaborate to arrive at a common understanding of the customer needs,
and determine the appropriate technical requirements at each stage.
QFD means: Listening to voice of the customer.
Main points of QFD
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
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, maintenance and training plans to control
operations.

DoE --> what is the main idea and final goal?!

(trying to reduce the time for testings and so on..)

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."
comp. http://www.uni.kassel.de/
Plans of experiments described in detail aiming atbdescribing quality features already
during the design phase of new services and products by focused factors of influence
are calles DoE.
comp. http://www.talessin.de/scripte/qm/doe.html

DOE-Approach
1. Describe initial situation including
Objective
time and money
involved people
project management
existing information
2. Analysis intend

5. Carry out experiments

6. Evaluation of test results

3. Define target and factors

Choice of target
Choice o factors
Determine factor level
Inflential parameters, that are not
analysed

Interpretation
Measures

7. improvement, documentation,
next steps

Securing improvement
Documentation
Further actions

4. Set up design plan

Establish combination of factor

level
Formation of blocks
Randomization
Assessment of expense

11. SPC
What is SPC?
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.
Why should we do it? (To check if processes are stable or not)
CPK- do we match the standards?
Division of certain capabilities