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Sheet 1: DFMEA

POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (DESIGN FMEA)

Type of DFMEA - System is a high level combination of various subsystems and components. Examples of systems are chassis system, powertrain system, interior system, etc.
____ System

Subsystem is a subset of a larger system. Examples are front suspension being a subset of the chassis system, or wheel assembly being a subset of the chassis system.
____ Subsystem

Tracking Number. How do we track it?
FMEA Number:

Component is a sub-set of a subsystem. An example would be a shock absorber is a component of the front suspension which is a subsystem of the chassis system.
____ Component ____________________

___________________

Who has responsibility for the design? OEM, your company, supplier, a combination?
Design Responsibility

Person's name, phone number and company that is responsible for the DFMEA
Prepared by:

If known, the vehicle program and model years affected by this product
Model Year(s)/Vehicle(s)

The date the initial DFMEA is due, which is before the scheduled production design release date.
Key Date

Date the original DFMEA was completed
Date (Orig.)

Each team member's name and department
Core Team:

The latest revision date. When was it last updated?
Date (Rev.)

What functions are supposed to be performed by the product?
What is it we are analyzing (feature , characteristic)? What is it supposed to do? regulatory requirements?
Item/ Function

What is the negative or opposite of the function? How can it fail to meet or deliver the intended function?

Potential Failure Mode

What are the effects to the customers if the failure occurs.
Typical effects are: noise, rough, erratic, inoperative, unpleasant, poor appearance, unstable, intermittent, leaks, operation impaired, regulatory non-compliance.
Potential Effect(s) of Failure

What is the level of severity if the failure occurs? Use the table in the worksheet attached.
SEV

Identify any key or significant characteristics and government regulations. Use customer symbols when required. Identify key characteristics whether self identified or customer identified.
CLASS

List all the underlying potential root causes of the failure to the left. May often be more than one. Give each potential cause their own cell or box
Potential Cause(s)/ Mechanism(s) of Failure(s)

Likelihood or probability of the failure occurring. Use the table in the attached worksheet
OCCUR

What is being done to minimize the Occurrence or prevent the failure from occurring?
Current Design Controls Prevention

What is being done to detect the potential failure? What checks, inspections, tests, etc?
Current Design Controls Detection

The likelihood or probability that the potential failure will be detected and caught. Use the table in the attached worksheet.
DETECT

Risk Priority Number that is S x O x D.
Severity x Occurrence x Detection.
RPN #

If the risk is too high what do we plan to do to lower the risk? Also records the results of actions taken.
Recommended Action(s) and Action Results

Who is responsible for taking the action and by when?
This is a high liability concern if action is not taken or is not timely.
Responsibility & Target Completion Date
Action Results

What was actually done and accomplished? This may differ from the Recommended Actions.
Actions Taken

Severity ranking after the action was taken. May be different from what was originally planned and anticipated.
SEV

Occurrence ranking after the action was taken. May be different from what was originally planned and anticipated.
OCC

Detection ranking after the action was taken. May be different from what was originally planned and anticipated.
DET

New RPN after the action was taken. May be different from what was originally planned and anticipated.
RPN

List the function of the item being analyzed to meet the design intent.

Typical failure modes: cracked, deformed, loose, leaking, sticking, oxidized, fractured, slips, inadequate, intermittent, no signal, drift, etc.
Describe in physical or technical terms, not as a symptom necessarily noticeable by the customer

All levels of customers should be considered.
Next operation,
Downstream ops,
Outsources,
Subcontractors,
Assembly plants,
Vehicle owners,
Vehicle drivers,
Gov't regulations.

A key characteristic is a product characteristic or manufacturing process parameter which can affect safety or compliance with government regulations, fit, function, performance, or subsequent processing of the product.

Any Poke-Yokes, mistake proofing, fail-safes?
These process controls justify the OCCURRENCE score and have no affect on Detection scores.
Examples include material certs, specs, checklists, standardized work, preventive maintenance, 5S, tool change notifications, gage calibrations and GR&R, etc.

List all process controls that help detect and prevent the potential failure, including subsequent, downstream controls. All the combined controls justify the detection score. These include controls that detect the failures or causes after they occur.

The score is based on all detections at this process step and downstream that are listed to the left. Subsequent process controls downstream may help reduce the detection score, but must be referenced to the left at this process step.
The detection values must be selected to reflect the robutsness or ability of the detection technique to discover and control the cause of the failure mode or the actual failure itself.

Some customers and companies dictate a threshold score that demands subsequent action (i.e. RPN > 100 requires action because there is an unacceptable level of risk). Best practice is for companies to evaluate all their PFMEAs and paretoize the top scores, then creat action items for the top 2 to 5 every year, in addition to addressing high RPN's above the acceptable threshold or level of risk. Other best practices evaluate S * O >35 for significant potential sources of customer concerns should detection devices fail.

Best practice is to show proposed actions and anticipated RPN change based on the action to be taken (i.e. 7 x 5 x 5). A good record of the plan and risk reduction.

Sheet 2: Severity

SUGGESTED DESIGN FMEA SEVERITY RANKINGS

Severity Effect
Criteria: Severity of Effect on Product (Customer Effect)
Ranking

Failure to Meet Safety and/or Regulatory Requirements
Potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning
10

Potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning
9

Loss or Degradation of Primary Function
Loss of primary function (Vehicle inoperable, does not affect safe vehicle operation).
8

Degradation of primary function (vehicle operable, but at reduced level of performance).
7

Loss or Degradation of Secondary Function
Loss of secondary function (vehicle operable, but comfort/convenience functions inoperable).
6

Degradation of secondary function (vehicle operable, but comfort/convenience functions at reduced level of performance).
5

Annoyance
Appearance or Audible Noise, vehicle operable, item does not conform and noticed by most customers (>75%).
4

Appearance or Audible Noise, vehicle operable, item does not conform and noticed by many customers (50%)
3

Appearance or Audible Noise, vehicle operable, item does not conform and noticed by discriminating customers (<25%).
2

No effect
No discernible effect.
1

Sheet 3: Occurrence

SUGGESTED DESIGN FMEA OCCURRENCE RANKINGS

Probability of Failure
Likely Failure Rates
Likely Failure Rates
Ppk
Ranking

Very High: Persistent Failures
> 100 per thousand pieces 100,000 ppm or 10%
More than one occurrence per day
<0.55
10

50 per thousand pieces 50,000 ppm or 5%
One occurrence every 3 to 4 days
>0.55
9

High: Frequent Failures
20 per thousand pieces 20,000 ppm or 2%
One occurrence per week
>0.78
8

10 per thousand pieces 10,000 ppm or 1%
One occurrence every month
>0.86
7

Moderate: Occasional Failures
5 per thousand pieces 5,000 ppm or 0.5%
One occurrence every three months
>0.94
6

2 per thousand pieces 2,000 ppm or 0.2%
One occurrence every six months
>1.00
5

1 per thousand pieces 1,000 ppm or 0.1%
One occurrence per year
>1.10
4

Low: Relatively Few Failures
1 in 2,000 pieces 500 ppm or 0.05%
One occurrence every 1 to 3 years
>1.20
3

1 in 10,000 pieces 100 ppm or 0.01%
One occurrence every 3 to 5 years
>1.30
2

Remote: Failure is Unlikely
1 in 100,000 pieces 10 ppm or 0.001%
One occurrence greater than 5 years
>1.67
1

Note: Likely failure rates are based on internal occurences only, not frequency of defect escapes to

the customer

Note: Same table as PFMEA

The words contained in this file might help you see if this file matches what you are looking for:

...Sheet dfmea potential failure mode and effects analysis design fmea type of system is a high level combination various subsystems components examples systems are chassis powertrain interior etc subsystem subset larger front suspension being the or wheel assembly tracking number how do we track it component an example would be shock absorber which who has responsibility for oem your company supplier person s name phone that responsible prepared by if known vehicle program model years affected this product year date initial due before scheduled production release key original was completed orig each team member department core latest revision when last updated rev what functions supposed to performed analyzing feature characteristic regulatory requirements item function negative opposite can fail meet deliver intended customers occurs typical noise rough erratic inoperative unpleasant poor appearance unstable intermittent leaks operation impaired noncompliance effect severity use table i...

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SUGGESTED DESIGN FMEA SEVERITY RANKINGS

Severity Effect	Criteria: Severity of Effect on Product (Customer Effect)	Ranking
Failure to Meet Safety and/or Regulatory Requirements	Potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning	10
Failure to Meet Safety and/or Regulatory Requirements	Potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning	9
Loss or Degradation of Primary Function	Loss of primary function (Vehicle inoperable, does not affect safe vehicle operation).	8
Loss or Degradation of Primary Function	Degradation of primary function (vehicle operable, but at reduced level of performance).	7
Loss or Degradation of Secondary Function	Loss of secondary function (vehicle operable, but comfort/convenience functions inoperable).	6
Loss or Degradation of Secondary Function	Degradation of secondary function (vehicle operable, but comfort/convenience functions at reduced level of performance).	5
Annoyance	Appearance or Audible Noise, vehicle operable, item does not conform and noticed by most customers (>75%).	4
	Appearance or Audible Noise, vehicle operable, item does not conform and noticed by many customers (50%)	3
	Appearance or Audible Noise, vehicle operable, item does not conform and noticed by discriminating customers (<25%).	2
No effect	No discernible effect.	1

SUGGESTED DESIGN FMEA OCCURRENCE RANKINGS

Probability of Failure	Likely Failure Rates	Likely Failure Rates	Ppk	Ranking
Very High: Persistent Failures	> 100 per thousand pieces 100,000 ppm or 10%	More than one occurrence per day	<0.55	10
Very High: Persistent Failures	50 per thousand pieces 50,000 ppm or 5%	One occurrence every 3 to 4 days	>0.55	9
High: Frequent Failures	20 per thousand pieces 20,000 ppm or 2%	One occurrence per week	>0.78	8
High: Frequent Failures	10 per thousand pieces 10,000 ppm or 1%	One occurrence every month	>0.86	7
Moderate: Occasional Failures	5 per thousand pieces 5,000 ppm or 0.5%	One occurrence every three months	>0.94	6
	2 per thousand pieces 2,000 ppm or 0.2%	One occurrence every six months	>1.00	5
	1 per thousand pieces 1,000 ppm or 0.1%	One occurrence per year	>1.10	4
Low: Relatively Few Failures	1 in 2,000 pieces 500 ppm or 0.05%	One occurrence every 1 to 3 years	>1.20	3
Low: Relatively Few Failures	1 in 10,000 pieces 100 ppm or 0.01%	One occurrence every 3 to 5 years	>1.30	2
Remote: Failure is Unlikely	1 in 100,000 pieces 10 ppm or 0.001%	One occurrence greater than 5 years	>1.67	1

Note: Likely failure rates are based on internal occurences only, not frequency of defect escapes to
the customer

Note: Same table as PFMEA

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