Professional Documents
Culture Documents
FMEA
** See tab "Form" in this workbook to complete the FMEA. Definitions to aid in completion of that form are below. Contact your Black Belt with additional questions.
What is FMEA? Failure Modes & Effects Analysis, risk analysis, mitigation and contingency plan
Why do FMEA? To document the risks associated with the new To-Be process developed in the IMPROVE phase
so as many risks as possible can be mitigated and controls/contingency plans can be incorporated into the new process as appropriate
Who should do the FMEA? The project team and any other process stakeholders and process experts as reasonable and feasible
When should FMEA be done? After the improvement(s) are selected, before the pilot is carried out
Where should the FMEA be kept? The information recorded in the Form tab of this spreadsheet can be copied into the final presentation of your project document
If the FMEA is too large to reasonably be included in its entirity, copy and paste a sample section of the FMEA into the
project documentation to demonstrate to the reader(s) what was done to document risks of the new process
and record/refer them to the file/location of the complete FMEA document
The information should be communicated to all stakeholders in the To-Be process (and pilot participants)
The FMEA information should be included with any documentation/SOPs for the new process
Recommended actions, owner(s) and timing can also be included in the control plan of the project, as appropriate
How should the FMEA be done? see below
Severity Assign a value to severity of that failure ** (1 = least severe to 10 = most severe, or 1= least severe, 3 = med. severity, 9 = most severe)
Causes of Failure What is the cause of the failure identified above? (if any are known)
Assign a value to the frequency of that failure ** (1 = least frequent to 10 = most frequent - high likelihood of occuring, or 1 = most likely
occurs very infrequently or not at all, 3 = expect that the risk will occasionally occur, 9 = occurs very often, or could potentially occur very
Occurrance often)
Current Control What controls (if any) are already in place to prevent such a failure?
Assign a value to how easily the failure is detected** (1 = easy to detect to 10 = hard to detect, or 1 = easy to detect, 3 = medium difficulty to
Detection detect, 9 = very difficult to impossible to detect)
RPN = Risk Priority Number = Severity * Occurance * Detection (prioritize actions based on this value)
Recommended Action What action is recommended to mitigate the risk of such a failure? What should be monitored or done in order to help reduce the risk?
Responsibility Whose responsibility is that action? (Name or title)
Target Completion Date By when should the action be completed? (date)
Actual Date Action Completed When was the action actually completed? (date)
New Severity # Re-evaluate new Severity number after risk-mitigating action is taken (using the same scale as before: 1-10, 1-3-9 or whatever)
New Occurance # Re-evaluate new Occurance number after risk-mitigating action is taken (using the same scale as before: 1-10, 1-3-9 or whatever)
New Detection # Re-evaluate new Detection number after risk-mitigating action is taken (using the same scale as before: 1-10, 1-3-9 or whatever)
New RPN Calculated the same way as the RPN above, this is a new value for the risk of this line item
Note:
Multiple scales are available for use in the fields Severity, Occurance and Detection to calculate the RPN (Risk Priority Number)
It is more important to consistently apply the same scale to the entire FMEA than it matters which scale you use.
In general, if a lot of information or historical experience is available to know what the risk impact will be,
a more granular scale (1-10) is appropriate (see below). If less is known about the new process,
or time is constrained, use the less granular scale (1, 3, 9)
** Additional Guidelines for using the 1 - 10 RPN Scale for Severity, Occurance and Detection (it is not required that you use this scale):
Severity
1 Is unnoticable by the customer and has no effect on performance
2 Is unnoticable by the customer and has a very minor effect on performance
3 Causes a minor nuisance which can be overcome with no performance loss
4 Causes minor performance loss
5 Causes a loss of performance which is likely to result in a complaint
6 Results in a partial malfunction
7 Causes extreme customer dissatisfaction
8 Renders a product or service unfit for use
9 Is illegal
10 Injures a customer or employee
Occurance
1 Once every 6+ years
2 Once every 3 - 6 years
3 Once every 1 - 3 years
4 Once per year
5 Once every 6 months
6 Once every 3 months
7 Once per month
8 Once per week
9 Once per 1-4 days
10 More than once per day
Detection
1 Defect is obvious and can be kept from affecting the customer
2 All units are automatically inspected
3 Statistical Process Control (SPC) is used as described below with 100% inspection or remediation for out-of-control conditions
4 SPC is used with immediate reaction to out-of-control conditions
5 Process is monitored/SPC is in place and manually inspected
6 Units are manually inspected and mistake-proofing controls are in place
7 All units are manually inspected
8 All units are systematically sampled and those samples are inspected
9 Occasional units are checked for defects
10 Defect caused by failure is not detectable
Risk Categories When thinking about risk for business processes, in addition to your "As Is" or "To Be" process maps, also consider the following potential risk areas
Origination and Sales (see Integrity policies 20.5, 30.7, 30.5 and 20.4)
Vehicle and Service Acquisition (see Integrity policies 20.4 (sourcing) and 30.13)
Tax Planning and Securitization (see Integrity policies on regulatory and compliance)
Service Execution
Billing and Collections (see Integrity policies 20.4, 30.7)
Remarketing Lease Termination (see Integrity policies 20.4, 30.13)
Controllership Processes
Detection #
Severity #
Potential Potential
Failure Failure
Item/ Process Step Mode Effects Causes of Failure Current Control
New RPN
Target Actual Date
Recommended Completion Action
RPN
Process or
Product Name:
Responsible:
Prepared by:
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What are the What are the T
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actions for reducing completed actions E R E R
the occurrence of taken with the R R C P
the cause, or recalculated RPN? I E T N
improving I
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{ use this worksheet to log any additional notes relating to the risk of the To-Be Process }