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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Flashcards
Requirements of DIN EN ISO 9001:2015 (8.2.1 Customer communication)
Scenario:
A tool manufacturer has specified in its documents: when the employees receive planning documents provided by the customers they have to do a plausibility check of the contents.
What would be your decision as an auditor?
Requirements of DIN EN ISO 9001:2015 (8.2.1 Customer communication)
Scenario:
In an audit, a project manager couldn´t present the plausibility check protocol for a randomly selected project.
What would be your decision as an auditor?
Requirements of DIN EN ISO 9001:2015 (8.4 Control of externally provided processes, products and services)
Scenario:
A subsidiary of a large manufacturing company has defined procedures on how to regularly evaluate their suppliers. The evaluation includes, among others, results of the incoming goods inspection and results of supplier audits.
What would be your decision as an auditor?
Requirements of DIN EN ISO 9001:2015 (8.4 Control of externally provided processes, products and services)
Scenario:
The Central Purchasing Department of the manufacturing company decides about the framework shopping agreements with all suppliers. The subsidiary does not inform the Central Purchasing Department about the results of the supplier assessment.
What would be your decision as an auditor?
Requirements of DIN EN ISO 9001:2015 (9 Performance evaluation)
Scenario:
A manufacturer company controls all ten described performance processes (development, production, sales, etc.) by one indicator "customer satisfaction score". This score is determined by a questionnaire survey.
What would be your decision as an auditor?
Give the definition of AUDIT.
TO AUDIT means "to hear" and is: "a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled". (ISO 19011:2011)
Name different types of audits
- System audits
- Internal Audit ("First Party" Audit)
- External Audit / Supplier Audit ("Second Party" Audit)
- External Audit / Certification Audit ("Third Party" Audit)
What is the validity of a certificate or the extension of a certificate given in an audit?
Why is there a DIN EN ISO 13485?
Why don´t we just take the DIN EN ISO 9001?
The DIN EN ISO 13485 is following the systematic of the DIN EN ISO 9001, but they are not equal to each other.
The DIN EN ISO 13485 focuses on medical devices and the "constant improvement" is not a must have.
What is an CORRELATION DIAGRAM?
see figure
What is the Cause and Effect Diagram?
Cause and effect diagram = Ishikawa diagram or fishbone diagram
- It is a tool which can be used to analyse facts with a view to identifying the cause of a defined effect
- The problem, or the effect, is entered in the head of the fish; the bones represent the main influencing variables.
- The individual causes are entered inside the bones
- The principle influencing variables frequently correspond to the 6 M checklist
What kind of tool do you use?
a. A team wants to identify possible causes for a problem (e.g. paint defects of cars in the end control). The team´s thinking becomes routine-blinded.
b. A team wants to collect data on the frequency of different kinds of rework over a week in a production process.
c. You are responsible for the cutting process. You want to controlling ongoing processes by finding and correcting problems as they occur.
Name the seven management tools.
- Affinity Diagram
- Relationship Diagram
- Portfolio
- Tree Diagram
- Matrix Diagram
- Problem-Decision-Plan
- Network Diagram
Which of the following management tools are used for data analysis?
Which of the following management tools are used for development of solutions?
Which of the following management tools are used for deployment of solutions?
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:
\(r=1\)
