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ProKit Exam 2 > Quality > Flashcards

Quality Flashcards

1
Q

Quality is largely defined by what?

A

the degree of compliance with the customer’s request

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2
Q

What is the definition of quality?

A

Latin: Qualitas = quality, characteristic, property, state

Definition in DIN EN ISO 8402:
The “set of characteristics of a unit with respect to its suitability to satisfy specified and implied requirements”.

DIN EN ISO 9000:2005 (QM standard): Degree up to which a set of inherent (i.e., intrinsic) characteristics meets requirements

This applies to products, services, concepts, drafts, software, workflows, procedures, and processes

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3
Q

What is the Jidoka (自働化) principle?

A

means stopping a process whenever an anomaly occurs

That way mistakes are not passed on to the next process!
Hence problems can be solved right where they occur and quality is procuded.

It is described as “intelligent autonomation” or, translated literally, as “automation with a human element”

The principles of Jidoka can be applied, beyond systems and machines, to any process, including manual ones: resolution of customer complaints, identification of material defects, etc.

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4
Q

The results of Jidoka include what two elements?

A
  1. Quality right from the start

2. Productivity

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5
Q

What are the advantages and benefits of Q-alarm and Q-stop?

A
  • Fast notification of support in case of problems of any kind
  • Line Stop according to principles of first time quality when problems can not be resolved within cycle time
  • Early detection of problems in combination of the 70% marking
  • Possibility to identify and eliminate top problems by using systematic analysis tables coming from the Q-Alarm system
  • Enhances transparency and active handling of defects
  • Visualization of the status of the station/line visible for management/staff
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6
Q

Andon signal should always fulfill the purpose of what?

A

visually and acoustically alerting team members and foremen to problem incidences and leading them to the site of the problem.

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7
Q

Poka Yoke helps to avoid and identify what type of errors?

A

unintentional errors

Poka = errors, Yoke = avoidance

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8
Q

What are the three Poka Yoke methods/principles?

A
  • Fixed-value principle – recognize deviations from fixed values
  • Contact principle – Parts identified using typical characteristics e.g. shape
  • Step-by-step principle – recognize deviations from standard procedures
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9
Q

In ad­di­tion to er­ror de­tec­tion and re­ac­tion, what is the ba­sis for an or­ga­ni­za­tion?

A

es­tab­lish­ment of a pre­ven­tive qual­i­ty man­age­ment sys­tem (QMS)

  • QMS cer­ti­fied
  • or­ga­ni­za­tion is able to con­tin­u­ous­ly mea­sure and quan­ti­fy the per­for­mance of its QMS
  • The or­ga­ni­za­tion has the op­por­tu­ni­ty to be­come the high­est per­former in terms of qual­i­ty by us­ing a TQM
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10
Q

Which of the following characteristics are requirements for your house that can be used to evaluate quality?

A

Size

Amount of rooms

Color

Price

Amount of garages

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11
Q

What are some examples of good quality?

A

Good quality
• I fulfill all my requirements I got from my customer!
• The house has just one room but I’m alone and I exactly need one room

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12
Q

What are some examples of bad quality?

A

Bad quality
• Last year we had 5000 claims because of a broken edge at our part!
• This steak is really nice but the price is really too high! And it was too small, I’m still hungry
• The house is green with water-protective color but I ordered a red one with standard color

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13
Q

What are some examples where quality doesn’t matter?

A

No information about quality
• This new Mercedes has the new LED-spotlight technology with the best illumination you could imagine!
• The house has a size of 500 m².
• The price of the beach house is 1.5 Billion $ and I have direct access to the ocean

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14
Q

When I talk about quality, what are the two main things I need to know?

A
  • Characteristics

- Customer requirements

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15
Q

How can I check the “set of characteristics of a unit with respect to its suitability to satisfy specified and implied requirements”, on the example of my house?

A

folding ruler
• size

counting
• amount of rooms
• amount of garages

looking
• colour

contract
• price

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16
Q

What is the rule of 10?

A

Af­ter each qual­i­ty as­sur­ance lev­el it will cost 10 times more in terms of time and mon­ey to cor­rect and fix a de­fect than in the pri­or stage. The ear­li­er you can find a fail­ure or a risk, the cheap­er it is for you and the com­pa­ny!

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17
Q

What is failure detection?

A
  • The or­ga­ni­za­tion is able to de­tect fail­ures in process flows (di­rect­ly or in­di­rect­ly).
  • For this pur­pose, tests are in­stalled on or in the process.
  • The or­ga­ni­za­tion de­rives mea­sures on the ba­sis of the de­tect­ed fail­ures.
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18
Q

What is early failure detection?

A
  • The pre­ven­tive ap­proach in the com­pa­ny turns fault de­tec­tion into ear­ly fault de­tec­tion.
  • The or­ga­ni­za­tion is able to in­stall the er­ror de­tec­tion di­rect­ly af­ter the lo­ca­tion of oc­cur­rence
  • The pass­ing on of an fail­ure to the sub­se­quent process and in par­tic­u­lar to the cus­tomer is ex­clud­ed.
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19
Q

What is failure avoidance?

A
  • The or­ga­ni­za­tion de­tects de­vi­a­tions be­fore they oc­cur at the cus­tomer’s site
  • If a fail­ure has oc­curred at the cus­tomer, the or­ga­ni­za­tion tries to avoid a re­cur­rence of the er­ror. For this pur­pose, the Fail­ure Mode and Ef­fects Analy­sis (FMEA) must be adapt­ed, for ex­am­ple, as new risks arise.
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20
Q

What does FMEA stand for?

A

FMEA (Fail­ure Mode and Effects Anal­y­sis)

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21
Q

What is FMEA used for?

A

is a tool for fail­ure avoid­ance & de­tec­tion at the shopfloor.

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22
Q

What is D-FMEA?

A

Design Fail­ure Mode and Effects Anal­y­sis

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23
Q

What is P-FMEA?

A

Process Fail­ure Mode and Effects Anal­y­sis

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24
Q

What is the output of FMEA?

A

RISKS which are quantified and analyzed

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25
Q

When do you start FMEA in a project?

A

ASAP– find failures and begin actions

The earlier you start the earlier you can eliminate failures

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26
Q

What is the meaning of FMEA RPN and how do you calculate it?

A

Risk Priority Number

Calculated by severity x occurrence x detection

Severity is the input-factor for the RPN that cannot change over a lifetime of FMEA

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27
Q

Why is it important to do a S(severity) x O(occurrence) matrix?

A

To determine how severe the risk is

Low, medium, high, critical

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28
Q

Why is FMEA important?

A

It is a predictive quality tool for failure avoidance; eliminate/minimize risk before they happen

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29
Q

Who do I need for my FMEA project team?

A

FMEA moderator

People who are aware of the customer requirements, design, and knowledge of the process

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30
Q

When you have a high rate of occurrence inside of the D-FMEA, what do you need to do?

A

You must eliminate the causes of the failure or you need to control

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31
Q

Which statements are correct about FMEA?

A
  • The meaning of FMEA is Failure Mode and Effects Analysis
  • When I have a claim of my component I should need to update my FMEA
  • The maximum Risk Priority Number (RPN) is 1000
  • I can have risks with a low Risk Priority Number (RPN) but with a high risk because of Severity x Occurrence
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32
Q

What is the correct sequence for FMEA steps?

A
  1. Part structure
  2. Function tree
  3. Failure tree
  4. D-FMEA with corrective loops
  5. P-FMEA with corrective loops
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33
Q

When referring to quality, which statements are true?

A
  • If I meet the customer requirements, then my level of quality is good
  • In order to evaluate the quality of a product or service, I first need to know what the requirements are for this product
  • If I deliver a cheap car with the basic equipment to my customer without any mistakes, the quality is better than if I deliver a luxury car with the full equipment and a faulty radio
  • Checking quality is good. Avoiding risks in advance is much cheaper for my company
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34
Q

How many quality feedback loops does Daimler have?

A

8 qual­i­ty feed­back loops (QFL) along the val­ue chain

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35
Q

What is the four-eye principle?

A

QFL 1- Worker self-control
QFL 2- Quality Gate
QFL 3- Inline Production Audit
QFL 4- Product audit

36
Q

Which two function hold re­spon­si­bil­i­ty for QFL 1-4?

A

pro­duc­tion and qual­i­ty

37
Q

What is the core idea of feedback loops?

A

is that a lat­er loop con­trols an ear­li­er one.

For that rea­son it is vi­tal that each loop is op­er­at­ed by a dif­fer­ent per­son.

In pro­duc­tion the four-eye prin­ci­ple as­sures in­de­pen­dent views be­tween QFL 1-2 and QFL 3-4.

38
Q

Failure detection eventually becomes what?

A

Early failure detection

39
Q

Early failure detection turns into what?

A

Failure avoidance

40
Q

When aligning organizational structure with customer requirements, what could be the advantage of moving from a hierarchy-based organization to a process/project- oriented organization?

A

Downsides of traditional organization concepts
• Functional isolation
• Coordination problems
• Conflicting priorities between departments
• Not enough customer orientation

Advantages of a process/project-oriented organization
• Customer focus
• Focus on project success instead of department succes

41
Q

What is QMS?

A

Quality Management System

The or­ga­ni­za­tion has a pre­ven­tive qual­i­ty man­age­ment sys­tem with the goal of en­sur­ing cus­tomer re­quire­ments, e.g.: align­ing the struc­ture with the cus­tomer’s re­quests and not with func­tion­al ar­eas

The or­ga­ni­za­tion checks the ef­fec­tive­ness of its process­es pre­ven­tive­ly and con­tin­u­ous­ly reg­u­lates against de­vi­a­tions (PDCA log­ic).

42
Q

What are three examples of a Quality Management System (QMS)?

A
  • PDCA
  • In­ter­nal au­dit
  • Process in­di­ca­tors
43
Q

What does ISO 9001 de­scribe?

A

what you need to do to implement a successful QMS

44
Q

What are the prin­ci­ples for the op­er­a­tion of a QMS?

A 
— customer focus
— leadership
— engagement of people
— process approach
— improvement
— evidence-based decision making
— relationship management
45
Q

Who is re­spon­si­ble for op­er­at­ing a QMS and thus en­sur­ing cus­tomer sat­is­fac­tion?

A

Top management

Drive QMS

46
Q

What is the re­la­tion­ship be­tween IATF 16949 and ISO 9001?

A

IATF 16949 is an add on for the automotive sector

47
Q

How im­por­tant is work­ing with FMEA seen in IATF 16949?

A

If you want to be certified, it is a must

48
Q

What can you use to measure the effectiveness of my organization in terms of customer satisfaction?

A
  • Average lead time for customer orders
  • Number of errors at customer
  • Number of new customers
  • Number of regular customers
49
Q

What possibilities do I have in a consulting project to check the effectiveness of my processes?

A
  • Carry out an internal process audit, identify and eliminate deviations
  • Recording of process key figures such as lead time or process errors and verification of their development
  • Checking the number of interfaces within processes
50
Q

What statements are correct when talking about the QMS?

A
  • The ISO 9001 drives the PDCA-Thinking.
  • Process and customer focus are a important focus of IATF 16949.
  • Top management shall demonstrate leadership and commitment with respect to the quality management system
51
Q

What is TQM?

A

To­tal Qual­i­ty Man­age­ment

The or­ga­ni­za­tion strives to de­vel­op its QMS from the min­i­mum lev­el of cer­ti­fi­ca­tion to ex­cel­lence.

52
Q

What is EFQM model?

A

Eu­ro­pean Foun­da­tion for Qual­i­ty Man­age­ment

53
Q

EQFM model is broken up into which 4 sectors?

A

Sharing
Training
Recognition
Assessment

54
Q

EQFM excellence model is comprised of which 3 components?

A

The Fundemental Concepts of Excellence
The 9 Criteria
The RADAR Logic

55
Q

What are statements that describe classical quality assurance?

A
  • People make failures
  • Individual employees are responsible for errors
  • Zero failures are not feasible
  • Parts procurement from many suppliers
  • Customers must take what the company delivers in terms of quality
56
Q

What are statements that describe total quality management (TQM)?

A
  • Processes provoke errors
  • All employees are responsible for errors
  • Zero failure is the goal
  • Partnership with a few suppliers
  • Everything is geared towards complete customer satisfaction
57
Q

Reflection on quality, detection of failures and avoidance of failures: Which statements are correct?

A
  • The type of organization has a significant impact on my quality.
  • ISO 9001 includes the logic of continuous improvement with PDCA.
  • There are industry-specific standards according to which I can align my QMS. For automotive this is the IATF 16949.
  • A TQM supports me to develop my company to excellence.
  • The structure of a QMS is the task of top management.
58
Q

You can avoid failure using which two methods?

A

Jidoka and Poka Yoke

59
Q

What does fail­ure avoid­ance through Poka Yoke mean?

A

100% in­spec­tion and im­me­di­ate re­ac­tion are core el­e­ments of the Poka Yoke con­cept

The Poka Yoke method­ol­o­gy is based on the firm be­lief that all er­rors are avoid­able

60
Q

What does fail­ure avoid­ance through Ji­do­ka mean?

A

The Ji­do­ka prin­ci­ple de­scribes the abil­i­ty of a ma­chine, a plant or an en­tire sys­tem to switch it­self off in the event of faults, qual­i­ty and pro­duc­tion prob­lems.

Sen­sors, lim­it switch­es or oth­er de­vices are used to de­tect mal­func­tions or oc­cur­ring faults. This in­creased de­gree of plant au­ton­o­my is re­ferred to as:

au­ton­o­my (au­toma­tion + au­ton­o­my)
in­tel­li­gent au­toma­tion
au­toma­tion with a hu­man touch

61
Q

If you don’t have quality, what do you have?

A

Failure

62
Q

At what point in the quality triangle is FMEA used?

A

Failure Avoidance

63
Q

What are the 8 fundamental concepts of the EFQM model?

A
  1. Taking responsibility for a sustainable future
  2. Achieving balanced results
  3. Adding value for customers
  4. Leading with vision, inspiration, and integrity
  5. Managing by processes
  6. Succeeding through people
  7. Nurturing creativity and innovation
  8. Building partnerships
64
Q

What is RADAR?

A

Results- Approaches- Deploy Approaches- Assess and Refine Approaches
A simple but powerful management tool that helps drive continuous improvement

65
Q

What are the 4 steps of RADAR?

A
  1. Define results you want to achieve
  2. Develop approaches deliver results
  3. Deploy approaches
  4. Refine impact of approaches based on analysis and learning
66
Q

What are the 9 principles of the EFQM excellence model?

A

Enablers

  1. Leadership
  2. People
  3. Strategy
  4. Partnership/resources
  5. Process, products, services

Results

  1. People results
  2. Customer results
  3. Society results
  4. Business results
  • No criteria can be isolated
  • develop strategy
  • Focus people, partners, resources on products that create value
67
Q

EFQM excellence model works as a cause and effect relationship between what?

A

Enablers and results

In order to change result you must change enabler

68
Q

An in­creased de­gree of plant au­ton­o­my is re­ferred to as what?

A
  • au­ton­o­my (au­toma­tion + au­ton­o­my)
  • in­tel­li­gent au­toma­tion
  • au­toma­tion with a hu­man touch
69
Q

What are the two core el­e­ments of the Poka Yoke con­cept?

A

100% in­spec­tion and im­me­di­ate re­ac­tion

70
Q

The aim of Poka Yoke is to?

A

de­sign process­es and prod­ucts in such a way that er­rors due to hu­man er­ror and care­less­ness can be ex­clud­ed

Process­es and prod­ucts must be de­signed in such a way that the er­rors are ei­ther im­pos­si­ble from the out­set or are dis­cov­ered di­rect­ly

The de­tec­tion of er­rors leads to im­me­di­ate ac­tion

71
Q

Poka Yoke serves to mon­i­tor what?

A

pos­si­ble caus­es of er­rors and starts di­rect­ly at the point of po­ten­tial er­ror orig­i­na­tion.

Er­rors are di­rect­ly iden­ti­fied and are not passed on to sub­se­quent op­er­a­tions. (avoid­ance of ex­pen­sive con­se­quen­tial er­ror costs lat­er on).

72
Q

When referring to Poka Yoke, what is the fixed-value principle?

A

recognize deviations from fixed values

73
Q

When referring to Poka Yoke, what is the contact principle?

A

Parts identified using typical characteristics e.g. shape

74
Q

When referring to Poka Yoke, what is the step-by-step principle?

A

Recognize deviations from standard procedures

75
Q

What are the potential benefits to an organization of implementing a quality management system?

A

a) the ability to consistently provide products and
services that meet customer and applicable
statutory and regulatory requirements

b) customer satisfaction
c) addressing risks and opportunities

d) the ability to demonstrate conformity to
specified quality management system
requirements

76
Q

When referring to a QMS, what process does it mainly use?

A

Process approach which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking

77
Q

What does the process approach do for an organization?

A

Enables an organization to plan its processes and their interactions

This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced

78
Q

What does the PDCA do for an organization?

A

The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on

79
Q

What does risk-based thinking do for an organization?

A

Risk-based thinking enables an organization to
determine the factors that could cause its processes
and its quality management system to deviate from
the planned results, to put in place preventive
controls to minimize negative effects and to make
maximum use of opportunities as they arise

80
Q

The application of the process approach in a quality management system enables what?

A

a) understanding and consistency in meeting
requirements

b) the consideration of processes in terms of
added value

c) the achievement of effective process
performance

d) improvement of processes based on evaluation
of data and information

81
Q

In the PDCA cycle, PLAN is?

A

Plan: establish the objectives of the system and
its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies and identify and address risks and opportunities

82
Q

In the PDCA cycle, DO is?

A

Do: implement what was planned

83
Q

In the PDCA cycle, CHECK is?

A

Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results

84
Q

In the PDCA cycle, ACT is?

A

Act: take actions to improve performance, as

necessary

85
Q

What are the requirements for a QMS system for an organization?

A

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements

All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

86
Q

When determining the scope of a QMS, the organization shall consider what?

A

a) the external and internal issues
b) the requirements of relevant interested parties
c) the products and services of the organization

The organization shall determine the boundaries
and applicability of the quality management system
to establish its scope

ProKit Exam 2 (9 decks)

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