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Failure Mode & Effects Analysis
FMEA (Failure Mode and Effects Analysis) is a systematic method for identifying potential failure modes and documenting their severity of impact, likelihood of occurrence, and undetectability. The tool is used during the Improve phase of the DMAIC cycle to determine mitigating actions being taken to minimize severity, likelihood, and undetectability, then record the impacts of the mitigating actions on those attributes. FMEA makes preemptive improvements before failures occur to minimize risk.
Design FMEA, or DFMEA, is used to minimize the risks of failures in designed products or services. Process FMEA, or PFMEA, is used to minimize the risks of failures during processes.
Outside of business process improvement and lean six sigma, FMEA can be used for projects in general. Project FMEA is used to minimize risks of failures in the implementation of projects. All these types of FMEA could use the same template; however, DFMEA would address design features, PFMEA would address process steps, and Project FMEA would address project tasks/activities.
Before you begin, be sure to review the following resources
:
Use one of the opportunities for improvement (OFIs) that you discovered during your Benchmarking Report assignment or Eight Wastes assignment as a project. You are working on the Improve phase of this project, trying to itemize failure modes so you can improve them with mitigating actions. Use the template provided to perform Process FMEA (PFMEA) by listing process steps and failure modes for each. You can use the same process that you used for your SIPOC Map assignment or Process Flow Chart assignment if you would like.
Your Failure Mode & Effects Analysis must include:
Organization Name
Project Title
Process Steps (minimum 2)
Two tools used in the Control phase of the DMAIC cycle are the Control Chart, often called Statistical Process Control (SPC) Chart, and the Process Audit. You will use both tools to complete this assignment.
The Control Chart shows how a variable changes over time. Data are plotted in time order. A Control Chart always has a central line for the average. The chart also shows an upper line for the upper control limit (UCL) and a lower line for the lower control limit (LCL). This data helps to control processes, to predict outcomes, and to monitor the process. You will analyze a Control Chart provided in the assignment template.
You are analyzing the Control Chart as part of a Process Audit. You will be looking for “out of control” conditions and where the process is not working. You want to make sure the process is stable and meets requirements, so you will do some problem solving to figure out where and how to make changes in the process.
Before you begin, be sure to review the following resourcesUpload your document following the submission instructions below.Use one of the opportunities for improvement (OFIs) that you discovered during your Benchmarking Report assignment or Eight Wastes assignment as a project. You are working on the Control phase of this project, trying to make sure that the process improvements you made during the Improve phase are working and stay working. Use the template provided to perform a Process Audit, including analysis of the Control Chart and solving problems with out-of-control conditions. Follow the question prompts in the template to work through the problem and bring the process back under control. Fill out the yellow areas to complete the assignment. Your Process Audit report must include:Organization NameProcess TitleVariable Being TrackedOut-of-Control ConditionsFive-Why Root Cause AnalysisContainment Actions (to “rope off” or secure the situation)Corrections (to get the situation back under control)
Corrective Actions (to prevent recurrence of out-of-control conditions
Streamline a Process with Line Balancing
Lean Six Sigma organizations can streamline their operations to be more efficient and/or effective using lean manufacturing techniques. Lean focuses on minimizing batch size, work-in-process inventory, lead time, and bottlenecks. It utilizes pull scheduling systems to dictate the flow of products and services.
Line Balancing, also known as heijunka in Japanese, is a lean tool that helps with several of these issues at once by reorganizing operations and resources to match the Takt time established by the customer.
You are working on an improvement project where there are three problems: the total cycle time (TCT) per unit is higher than the Takt time for some of the operations, there is some non-utilized resources waste visible at some of the production stations (station downtime), and there is transportation waste visible with people moving parts back and forth all over the place from station to station for the next operation. You will use line balancing to tackle all three of these problems.
Before you begin, be sure to review the following resources:
Your Line Balancing document must include:
All 18 Operation Blocks Inside the Green Block
All 16 Operations Arranged in Chronological Order
No Resizing of Any Blocks (blocks have dimensions so any tampering will be evident)
Upload your document following the submission instructions below. Failure Mode & Effects Analysis
Organization Name
Project Title
Student Name
Process Step/
Feature
Failure
Mode
Severity
Likelihood of
Occurrence
Undetectability
Risk Priority
Number (RPN)
0
0
0
0
0
0
0
0
0
0
ffects Analysis
Action to
Improve
Revised
Revised
Severity Likelihood
Revised
Undetectability
Revised
RPN
0
0
0
0
0
0
0
0
0
0
Instructions:
Fill in yellow areas
1=Not severe
10=Very severe
1=Not likely to occur
10=Very likely to occur
1=Very detectable
10=Not detectable
Select ratings from in-cell dropdown
Process Audit
Variable You Are Tracking in Your Process →
Organization Name
Process Title
Jonathan Darnell
Assume the process control chart shown above represents a new process you and your team developed as part of an
improvement project. You must audit or monitor the new process, using the control chart to make observations about
how well the process is staying in control. You will determine which “time” attributes are out of control (above the
upper control limit and below the lower control limit). I.e., which dots are out of control? For these fictitious out-ofcontrol conditions, follow the question prompts below to work through the problem and bring the process back under
control. Fill out the yellow areas to complete the assignment.
What is the variable that you are tracking over time?
E.g., Hole depth, number of customers waiting in line, coffee temperature, etc. It needs to be a measurable variable that
has a range of acceptability.
Add text
Which “time” attributes on the chart shown above are out of control?
Add text
What does this out-of-control condition mean for the variable you have chosen?
E.g., If a dot is out of control for the variable of coffee temperature, that would mean that the coffee is too hot to drink.
Add text
Perform five-why root cause analysis to determine why the variable is out of control:
Why is the variable out of control? Add text
Why? Add text
Why? Add text
Why? Add text
Why? Add text
What containment actions will you put in place to prevent further injury, damage, or propagation of the out-ofcontrol condition? These are actions to “rope off” or secure the situation.
E.g., Set aside coffee that is too hot to drink and do not allow it to be served to customers.
Add text
What corrections will you make to the out-of-control condition to get it back into control? This can be rework, scrap
and replace, etc.
E.g., Add an ice cube to the extra hot coffee and leave it aside until it is cool enough to drink. Adjust temperature setting
on coffee pot so the next batch of coffee does not come out as hot when it is ready.
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What corrective action will you take to minimize the likelihood that the variable will go out of control again? This can
be procedural change, training content change, engineering control put in place, design change, administrative
control, equipment change, etc.
E.g., Tape down the temperature setting knob on the coffee pot so it does not get bumped out of position again.
Add text
Instructions:
• Look at the existing production process below before line
balancing. You can see that Operation (OP)5 and OP9 are
exceeding the Takt time dictated by the customer because
they are taller than the green dotted line.
• You can also see that there is some unused green space
representing non-utilized resources waste between parts
being processed at each station. E.g., Station 1 has 20
seconds of downtime between parts.
• There are also 16 stations being used, which means there
are 15 instances of transportation waste moving parts
from one station to the next.
• Proceed to the next slide to complete the line balancing
activity.
Total Cycle Time per Unit →
Takt Time = 30 seconds
Line Balancing – Before
Jonathan Darnell
OP5
OP9
OP4
OP8
OP6
OP1
OP2
OP3
STATION 1
STATION 2
STATION 3
OP10
OP11
OP7
OP12
OP13
STATION 4
STATION 5
STATION 6
STATION 7
STATION 8
STATION 9
STATION 10
STATION 11
STATION 12
STATION 13
Instructions:
• Your improvement project team has already reduced the total cycle
time (TCT) per unit for OP5 by splitting it up so that it is being run on
2 machines at once.
• The team has also reduced the TCT for OP9 by splitting it up so that it
is being done by 2 people at once. The blocks for OP5 and OP9 have
been duplicated and resized accordingly. This means that all
operations are now within the Takt time.
• Your team still needs to reduce non-utilized resources waste and
transportation waste. Reducing the amount of green space leftover
will reduce non-utilized resources waste. Reducing the number of
stations being used will reduce transportation waste. Rearrange the
blocks on the right to fit inside the green rectangle below.
Operations must be shown in order, but you can stack them
vertically in order from bottom to top as needed. Do not resize any
blocks. All blue blocks must be used.
Line Balancing – After
Student Name
OP13
OP14
OP15
OP9
PERSON
OP1
OP2
OP3
OP6
OP7
OP11
Takt Time = 30 seconds
STATION 2
STATION 3
OP12
OP4
Total Cycle Time per Unit →
STATION 1
OP16
STATION 4
STATION 5
STATION 6
STATION 7
STATION 8
STATION 9
STATION 10
STATION 11
