Quality Management in Healthcare
Based on Lecture by Prof. Wang, FH Lübeck, SS 2017, M.sc. Biomedical Engineering I recommend to additionally work on following tasks: - Pareto Analysis (QMH-L2, page 22) - Correlation Diagram - Calculation (QMH-L6, page 8) - Network (QMH-L7, page 23)
Based on Lecture by Prof. Wang, FH Lübeck, SS 2017, M.sc. Biomedical Engineering I recommend to additionally work on following tasks: - Pareto Analysis (QMH-L2, page 22) - Correlation Diagram - Calculation (QMH-L6, page 8) - Network (QMH-L7, page 23)
Explain the affinity diagram.
- The affinity diagram compresses and structures a wide variety of ideas, problems, etc. clearly.
- New ideas and relationships will become visible, and help to develop new solutions
Explain the relationship diagram.
- Relationship Diagram = Inter-relationship diagraph
- The relations diagram illustrates graphically complex processes and their relationships with other factors.
Explain the portfolio diagram
- Portfolio = Matrix Data Analysis = Matrix Data Analysis Chart (MDAC)
- Portfolio chart helps in representing three-dimensional dependencies and deriving strategies.
Explain the tree diagram
- Tree Diagram = System Flow
- The tree diagram visualizes hierarchical dependencies that are shown in different layers
- Systematic error analysis at different levels of detail
Explain the matrix diagram.
The matrix chart helps analysing and evaluating multidimensional interactions
Explain the problem-decision-plan.
- Problem-Decision-Plan = Process Decision Program Chart (PDPC)
- The problem decision plan in advance provides a structured overview of possible malfunctions or failures and the approaches to its prevention.
Explain the network diagram.
- Network Diagram = Activity Network = Critical Path Method (CPM)
- The network analysis helps to systematically describe scheduling dependencies and to discover weaknesses
- Final termination, bottlenecks in scheduling, resource and personnel will become visible.
- software support is advantageous.
Name advantages and disadvantages of the network diagram.
Advantages:
- easy and quick to perform
- clear visualization
- good for solving interdisciplinary problems
- improve team spirit and working environment
Disadvantages:
- results are partly subjective
- result quality depends strongly on the knowledge of the team members
- less suitable for problems with high complexity (CAQ software required)
What is a Process?
DIN EN ISO 9000:2015:
set of interrelated or interacting activities that use inputs to deliver an intended result.
Harrington (1991):
any activity or group of activities that takes an input, adds value to it, and provides an output to an internal or external customer.
What is the difference between an effective and efficient process?
Effective means, producing an output that is wanted, while efficient means producing the wanted output with a minimum of resources, time,..
Name common symbols for QM-documentation used in a flow-chart
Name the different steps to model a process
1. Determine objectives
2. Define process boundaries
3. Define units of flow
4. Choose type of chart
5. Observe process and collect data
6. Map out process
7. Validate chart
8. Analyse process
9. Development of target process
Map the following process in a flowchart:
A wheelchair company wants to analyse the process of one assembling line in their facility. The analysed the current state of the process and got the following information:
A: The first step in their process is to get the raw material from their material storage
B: The next step is the assembling of the wheels
C: Parallel, the chair will be assembled
D: Next, both components will be assembled to one wheelchair
E: A quality check at the end of the assembling line will be executed
F: a second quality check at the quality department will be executed
What are the wastes and non-value adding activities defined by Taiichi Ohno?
Transportation: Minimize material and data movement
Inventory: Minimize stock on hand
Motion: Eliminate unnecessary motion and extra movement
Waiting: Minimize idle time
Over Production: Produce what is needed when it is needed
Over Proxessing: Minimize process complexity and non-value adding activities
Defects: Eliminate rework and scrap; do it right the first time
"anythin other than the minimum amount of equipment, materials, parts, and working time absolutely essential to production"
How to calculate the Process Efficiency?
Theoretical Time * 100% / Actual Time = Efficiency
What is the takt time?
- How long does it take for one unit to come out of the process?
- Average activityy time of the longest activity station
- Throughput rate is the inverse of takt time
- Available production time
\(\text{takt time} = \frac{\text{available production time per day}}{\text{customer demand per day}}\)
A process requires 3 parallel activities:
A = 20min/unit
B = 15min/unit
C = 45min/unit
What is the takt time?
The longest of the processes -> C
Wheelchair manufacturer works 2 shifts/day, 8,5h/shift, 5 days per week. At the beginning of every shift the team has a 15 minutes meeting. Every shift has a 30 minutes break. Weekly demand of wheelchairs is 100pcs.
What is the takt time? And what is the throughout rate?
\(\text{Available Time per shift} = 8,5\frac{h}{shift}-0,25\frac{h}{shift}-0,5\frac{h}{shift}=7,75\frac{h}{shift}\)
\(\text{Available Time} = 2 \frac{shifts}{day}*7,75\frac{h}{shift}*5\frac{days}{week}=77,5\frac{h}{week}\)
\(\text{Demand}=\frac{100}{week}\)
\(\text{Takt Time} = \frac{77,5\frac{h}{week}}{100week}=0,775h\)
Takt time: Wheelcharis must be made every 0,775h (46,5min).
Throughput rate: 1,29 wheelchairs/h
What kind of parameters would you consider to measure the performance of the processes?
If the strategic goal of the process is:
a) increasing througput
b) increasing customer satisfaction
c) increasing employee satisfaction
Give the tresholds which define the correlation coefficient in the correlation diagram
Perfect negative correlation:
\(r=-1\)
Strong negative correlation:
\(-1< r\leq-0,7\)
Medium negative correlation:
\(-0,7< r \leq -0,3\)
Weak negative correlation:
\(-0,3< r< 0\)
No correlation:
\(r=0\)
Weak positive correlation:
\(0< r \leq 0,3\)
Medium positive correlation:
\(0,3< r\leq 0,7\)
Strong positive correlation:
\(0,7< r <1\)
Perfect positive correlation:
\(r=1\)
Give the defintion of QUALITY
QUALITY is the degree to which a set of inherent characteristics of an object fulfils requirements.
What is an INHERENT characteristic?
INHERENT, as opposed to assigned, means existing in the object.
Which of the following charateristics is inherent?
(quality characteristics of a pencil)
What is special about an ASSIGNED characteristic?
ASSIGNED, a characteristic assigned to an object is not a quality characteristic of that object. (cf. DIN EN ISO 9000:2015).
What of the following can be an object? (related to the definition of quality)
Give the definition of REQUIREMENT
REQUIREMENT is the need or expectation that is stated, generally implied or obligatory.
Which of the following characteristics of a pencil is a requirement?
Give the definition of QUALITY CHARACTERISTIC.
QUALITY CHARACTERISTIC is an inherent characteristic of a product, process or system related to a requirement (DIN EN ISO 9000:2015).
Which of the following characteristics is a quality characteristic?
If the hardness and the colour of the pencil lead are the quality characteristics of a pencil, what is the quality of the pencil?
The Quality of the pencil is the degree to which the hardness and colour of the pencil lead fulfill the customer requirements.
"A 4 star hotel is of better quality than a 3 star hotel."
-> What do you think about the statement?
Give the definition of GRADE. (related to the definition of quality)
GRADE is the category or rank given to different requirements for products, processes or systems having the same functional use.
Give the definition of CUSTOMER SATISFACTION.
CUSTOMER SATISFACTION is the customer´s perception of the degree to which the customer´s expectations have been fulfilled.
Is it possible that the customer does not know his customer expectations until the product is delivered or the service is provided?
Complaints are a common indicator of low customer satisfaction. Does the absence of complaints imply high customer satisfaction?
When customer requirements have been agreed with the customer and fulfilled, does it mean that customer satisfaction is guaranteed.
What is the Kano Model/Diagram ?
(make a small sketch)
see figure
Explain the DEMING CYCLE.
See figure
Which of the following are tools used for failre collection?
Which of the following tools are used for failure analysis?
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Cartes-fiches
Give the defintion of QUALITY
QUALITY is the degree to which a set of inherent characteristics of an object fulfils requirements.
What is an INHERENT characteristic?
INHERENT, as opposed to assigned, means existing in the object.
Which of the following charateristics is inherent?
(quality characteristics of a pencil)
What is special about an ASSIGNED characteristic?
ASSIGNED, a characteristic assigned to an object is not a quality characteristic of that object. (cf. DIN EN ISO 9000:2015).
What of the following can be an object? (related to the definition of quality)
Give the definition of REQUIREMENT
REQUIREMENT is the need or expectation that is stated, generally implied or obligatory.
Which of the following characteristics of a pencil is a requirement?
Give the definition of QUALITY CHARACTERISTIC.
QUALITY CHARACTERISTIC is an inherent characteristic of a product, process or system related to a requirement (DIN EN ISO 9000:2015).
Which of the following characteristics is a quality characteristic?
If the hardness and the colour of the pencil lead are the quality characteristics of a pencil, what is the quality of the pencil?
The Quality of the pencil is the degree to which the hardness and colour of the pencil lead fulfill the customer requirements.
"A 4 star hotel is of better quality than a 3 star hotel."
-> What do you think about the statement?
Give the definition of GRADE. (related to the definition of quality)
GRADE is the category or rank given to different requirements for products, processes or systems having the same functional use.
Give the definition of CUSTOMER SATISFACTION.
CUSTOMER SATISFACTION is the customer´s perception of the degree to which the customer´s expectations have been fulfilled.
Is it possible that the customer does not know his customer expectations until the product is delivered or the service is provided?
Complaints are a common indicator of low customer satisfaction. Does the absence of complaints imply high customer satisfaction?
When customer requirements have been agreed with the customer and fulfilled, does it mean that customer satisfaction is guaranteed.
What is the Kano Model/Diagram ?
(make a small sketch)
see figure
Explain the DEMING CYCLE.
See figure
Which of the following are tools used for failre collection?
Which of the following tools are used for failure analysis?
Explain the HISTOGRAM
- Histograms help to interpret the reasons for scatter by displaying the distribution of data values.
- The data values are divided into classes in accordance with statistical rules (abscissa of the diagram)
- The number of data values per class is shown on the y-axis
Explain the CONTROL CHART
Control chart = SPC chart (statistical process control)
- They are used to take samples at regular intervals and enter the measured values or the statistical parameters into the SPC chart
- It may become necessary to intervene in the process, depending on the control limit specified and the characteristic progress of the data values
Explain the PARETO ANALYSIS
Pareto Analysis = ABC Analysis or Lorenz Distribution
- Objective: to deal with the greatest, most important or most cost-intensive problem first.
- Pareto Analysis visualizes the rank order of the influencing variables of relevance to one particular issue.
- The issues are listed in order of the level of influence they exert and their numerical significance and cumulative percentage are shown accordingly.
Explain: What is TOTAL QUALITY MANAGEMENT?
"TQM is a management approach for an organization, centered on quality, based on the participation of all its members and aiming at long-term success through customer satisfaction, and benefits to all members of the organization and to society."
International Standardisation Organisation
Give the definition for SUSTAINED SUCCESS.
SUSTAINED SUCCESS is the result of the ability of an organization to achieve and maintain its objectives in the long term.
-> The sustained success of an organization is achieved by its ability to meet the need and expectations of its customers and other interested parties, over the long term and in a balanced way. Sustained success can be achieved by the effective management of the organization, through awareness of the organization´s environment, by learning, and by the appropriate application of either improvements, or innovations, or both.
GIve the definition of BUSINESS EXCELLENCE.
State of an organisation, whose character shows a long-term and sustainable success and a top position on the market.
(as a result of a high-quality management system, as described in the EFQM Model)
Which principles and basic concepts of quality management do you know?
see figure
Name differences between QM and TQM (Old and New Perspectives)
see figure
How to assess Quality?
To asses quality one has to:
1. concentrate on the essentials
2. perform well comprehensible measurements
3. focus on customer benefit
4. identify with the chosen parameters (Developed by users)
5. communicate the initials and results of measurements
Give a sketch which explains the amount of technical realisation needed to meed the customer requirements.
see figure
Give the definition of QFD.
Akao 1990:
QFD is defined as a method for developing a design quality aiming at satisfying the consumer and then translating the consumers demand into design targets and major quality assurance point to be used throughout the production phase.
American Supplier Institute (ASI) 1989:
QFD is a system for translating customer requirements into appropriate company requirements at every stage, from research through production design and development, to manufacture, distribution, installation and marketing, sales and services.
Name a tool to implement QFD
House of Quality
Name the steps of the House of Quality.
- Identifying customer requirements
- Deriving quality characteristics
- Defining target quantities
- Checking for interaction
- Product evaluation
(More information in QMH-L4, pages 14-26)
Name Application fields of QFD
I forgot to write it down.
Please E-Mail me ([email protected]) if you have good answers.
How does QFD differ from zero defect initatives?
I forgot to write it down.
Please E-Mail me ([email protected]) if you have good answers.
Why do medical device manufacturers need a quality management system?
In a quality management system companies define specifications and requirements for their products, services and processes with the aim of:
- to obtain reproducible results -> product specifications are achieved reliably
- to identify defective products in time and react accordingly -> traceability by QM-systems
Give the definition of MANAGEMENT SYSTEM and QUALITY MANAGEMENT SYSTEM.
management system:
set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives.
quality management system:
part of a management system with regard to quality
Name standards of the EN ISO 9000-Family
ISO 9001: Quality management systems - Requirements
ISO19011: Guidelines for auditing management systems
ISO 9004: Quality management systems - Guidelines for performance improvement
ISO 9000: Quality management systems - Fundamentals and vocabulary
Why are the Standards of the EN ISO 9000 - Family needed?
- To assist organisations of each kind and size to develop and maintain effective quality management systems
- To construct a comprehensive set of quality management standards to improve the mutual understanding and to facilitate national and international trade
Requirements of DIN EN ISO 9001:2015 (7.2 Competence)
Scenario:
A director appointed a department manager to examine by sampling wether the employees have understood the previous trainings and can apply the learned content. The effectiveness of training is therefore not examined at all employees.
What would be your decision as an auditor?
