Quality Flashcards
Quality is largely defined by what?
the degree of compliance with the customer’s request
What is the definition of quality?
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
What is the Jidoka (自働化) principle?
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.
The results of Jidoka include what two elements?
- Quality right from the start
2. Productivity
What are the advantages and benefits of Q-alarm and Q-stop?
- 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
Andon signal should always fulfill the purpose of what?
visually and acoustically alerting team members and foremen to problem incidences and leading them to the site of the problem.
Poka Yoke helps to avoid and identify what type of errors?
unintentional errors
Poka = errors, Yoke = avoidance
What are the three Poka Yoke methods/principles?
- 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
In addition to error detection and reaction, what is the basis for an organization?
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
Which of the following characteristics are requirements for your house that can be used to evaluate quality?
Size
Amount of rooms
Color
Price
Amount of garages
What are some examples of good quality?
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
What are some examples of bad quality?
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
What are some examples where quality doesn’t matter?
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
When I talk about quality, what are the two main things I need to know?
- Characteristics
- Customer requirements
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?
folding ruler
• size
counting
• amount of rooms
• amount of garages
looking
• colour
contract
• price
What is the rule of 10?
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!
What is failure detection?
- 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.
What is early failure detection?
- 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.
What is failure avoidance?
- 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.
What does FMEA stand for?
FMEA (Failure Mode and Effects Analysis)
What is FMEA used for?
is a tool for failure avoidance & detection at the shopfloor.
What is D-FMEA?
Design Failure Mode and Effects Analysis
What is P-FMEA?
Process Failure Mode and Effects Analysis
What is the output of FMEA?
RISKS which are quantified and analyzed
When do you start FMEA in a project?
ASAP– find failures and begin actions
The earlier you start the earlier you can eliminate failures
What is the meaning of FMEA RPN and how do you calculate it?
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
Why is it important to do a S(severity) x O(occurrence) matrix?
To determine how severe the risk is
Low, medium, high, critical
Why is FMEA important?
It is a predictive quality tool for failure avoidance; eliminate/minimize risk before they happen
Who do I need for my FMEA project team?
FMEA moderator
People who are aware of the customer requirements, design, and knowledge of the process
When you have a high rate of occurrence inside of the D-FMEA, what do you need to do?
You must eliminate the causes of the failure or you need to control
Which statements are correct about FMEA?
- 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
What is the correct sequence for FMEA steps?
- Part structure
- Function tree
- Failure tree
- D-FMEA with corrective loops
- P-FMEA with corrective loops
When referring to quality, which statements are true?
- 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
How many quality feedback loops does Daimler have?
8 quality feedback loops (QFL) along the value chain
What is the four-eye principle?
QFL 1- Worker self-control
QFL 2- Quality Gate
QFL 3- Inline Production Audit
QFL 4- Product audit
Which two function hold responsibility for QFL 1-4?
production and quality
What is the core idea of feedback loops?
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.
Failure detection eventually becomes what?
Early failure detection
Early failure detection turns into what?
Failure avoidance
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?
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
What is QMS?
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).
What are three examples of a Quality Management System (QMS)?
- PDCA
- Internal audit
- Process indicators
What does ISO 9001 describe?
what you need to do to implement a successful QMS
What are the principles for the operation of a QMS?
— customer focus — leadership — engagement of people — process approach — improvement — evidence-based decision making — relationship management
Who is responsible for operating a QMS and thus ensuring customer satisfaction?
Top management
Drive QMS
What is the relationship between IATF 16949 and ISO 9001?
IATF 16949 is an add on for the automotive sector
How important is working with FMEA seen in IATF 16949?
If you want to be certified, it is a must
What can you use to measure the effectiveness of my organization in terms of customer satisfaction?
- Average lead time for customer orders
- Number of errors at customer
- Number of new customers
- Number of regular customers
What possibilities do I have in a consulting project to check the effectiveness of my processes?
- 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
What statements are correct when talking about the QMS?
- 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
What is TQM?
Total Quality Management
The organization strives to develop its QMS from the minimum level of certification to excellence.
What is EFQM model?
European Foundation for Quality Management
EQFM model is broken up into which 4 sectors?
Sharing
Training
Recognition
Assessment
EQFM excellence model is comprised of which 3 components?
The Fundemental Concepts of Excellence
The 9 Criteria
The RADAR Logic
What are statements that describe classical quality assurance?
- 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
What are statements that describe total quality management (TQM)?
- 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
Reflection on quality, detection of failures and avoidance of failures: Which statements are correct?
- 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.
You can avoid failure using which two methods?
Jidoka and Poka Yoke
What does failure avoidance through Poka Yoke mean?
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
What does failure avoidance through Jidoka mean?
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
If you don’t have quality, what do you have?
Failure
At what point in the quality triangle is FMEA used?
Failure Avoidance
What are the 8 fundamental concepts of the EFQM model?
- Taking responsibility for a sustainable future
- Achieving balanced results
- Adding value for customers
- Leading with vision, inspiration, and integrity
- Managing by processes
- Succeeding through people
- Nurturing creativity and innovation
- Building partnerships
What is RADAR?
Results- Approaches- Deploy Approaches- Assess and Refine Approaches
A simple but powerful management tool that helps drive continuous improvement
What are the 4 steps of RADAR?
- Define results you want to achieve
- Develop approaches deliver results
- Deploy approaches
- Refine impact of approaches based on analysis and learning
What are the 9 principles of the EFQM excellence model?
Enablers
- Leadership
- People
- Strategy
- Partnership/resources
- Process, products, services
Results
- People results
- Customer results
- Society results
- Business results
- No criteria can be isolated
- develop strategy
- Focus people, partners, resources on products that create value
EFQM excellence model works as a cause and effect relationship between what?
Enablers and results
In order to change result you must change enabler
An increased degree of plant autonomy is referred to as what?
- autonomy (automation + autonomy)
- intelligent automation
- automation with a human touch
What are the two core elements of the Poka Yoke concept?
100% inspection and immediate reaction
The aim of Poka Yoke is to?
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
Poka Yoke serves to monitor what?
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).
When referring to Poka Yoke, what is the fixed-value principle?
recognize deviations from fixed values
When referring to Poka Yoke, what is the contact principle?
Parts identified using typical characteristics e.g. shape
When referring to Poka Yoke, what is the step-by-step principle?
Recognize deviations from standard procedures
What are the potential benefits to an organization of implementing a quality management system?
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
When referring to a QMS, what process does it mainly use?
Process approach which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking
What does the process approach do for an organization?
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
What does the PDCA do for an organization?
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
What does risk-based thinking do for an organization?
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
The application of the process approach in a quality management system enables what?
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
In the PDCA cycle, PLAN is?
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
In the PDCA cycle, DO is?
Do: implement what was planned
In the PDCA cycle, CHECK is?
Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results
In the PDCA cycle, ACT is?
Act: take actions to improve performance, as
necessary
What are the requirements for a QMS system for an organization?
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.
When determining the scope of a QMS, the organization shall consider what?
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
