DFMEA

PURPOSE OF DFMEA (DESIGN FAILURE MODE EFFECTS ANALYSIS)
Define and guide a logical design process Identify, quantify, and reduce design risk Provide a traceable document for design and development Justify design activities Provide a means for continuous product improvement
RESPONSIBILITY AND SCOPE OF THE DFMEA The DFMEA is a team function

All team members must participate Multi-disciplinary expertise and input is beneficial
Input from all engineering fields is desirable Representatives from all areas (not just technical disciplines) are generally included as team members
The DFMEA is not a one meeting activity

The DFMEA will be refined and evolve with the product Numerous revisions are required to obtain the full benefit of the DFMEA
The DFMEA should include all systems, sub-systems, and components in the product design
DFMEA INPUTS Product Design Requirements

Design requirement document (if available from customer) Legal and technical regulations
Bill of Materials (BOM) and Specific Hardware

List of components Components and/or samples as supplied by the customer
Product Definition
Drawings, sketches, animations, and simulations Description of systems and components
What are the functions of the components listed on the BOM?
Previous Experience (Lessons Learned from Others)

Experience with similar concepts, designs, and DFMEA Customer and supplier inputs Design guides and design standards (for example ASME codes)
DFMEA OUTPUTS RPN: Risk Assessment Number

RPN = (Severity) x (Occurrence) x (Detection) Identification of both systems and components with high RPN values represents a summary of high risk items. Ranking of RPN to provide guidance on critical design issues
Address the highest RPN items first!
Identification of Critical and Significant Characteristics

This is also normally required by a customer
The DFMEA is An Output to Your Customer

Be aware that your customer may be internal or external
Internal customers may include other engineering groups or nontechnical groups such as procurement, manufacturing, safety, etc.
DFMEA METHODOLOGY (1.) Complete the top of the form

Project, year, team members, date, and DFMEA iteration
(2.) List items and functions

Start with the system, then subsystems, and finally components
(3.) Document potential failure modes

How could the design potentially fail to meet the design intent Note: this might be the cause of failure at a higher level (i.e. component to subsystem) or the effect of a failure at a lower level. Consider all types of failure
(4.) Document the potential effects of failure

How would the design potentially fail to meet the design intent.
DFMEA METHODOLOGY: (CONTINUED) (5.) Rate the severity of the failure effect
See attached page for ranking guidelines Severity ranking is linked to the effect of the failure
(6.) Document potential causes and mechanisms of failure

Failure causes and mechanisms are an indication of design weaknesses Potential failure modes are the consequences of the failure causes A single failure mode may have multiple failure mechanisms Use group brainstorming sessions to identify possible failure mechanisms Dont be afraid to identify as many potential causes as you can
This section of the DFMEA will help guide you in necessary design changes The output of the DFMEA will indicate on which item to focus design efforts
DFMEA METHODOLOGY: (CONTINUED) (7.) Rate the occurrence

See attached page for ranking guidelines Things that may help you rate the occurrence
Are any elements of the design related to a previous device or design? How significant are the changes from a previous design?
(8.) List the design controls

Design controls are intended to:
Prevent the cause of the failure mode (1st choice solution) Detect the cause of the failure mode (2nd choice solution) Detect the failure mode directly (3rd choice solution)
Applicable design controls include

Predictive code analysis, simulation, and modeling Tolerance stack-up studies Prototype test results (acceptance tests, DOEs, limit tests) Proven designs, parts, and materials
DFMEA METHODOLOGY: (CONTINUED) (9.) List any critical or special characteristics

Critical characteristics: Severity > 8 and Occurrence >1 Special characteristics: Severity > 6 and Occurrence >2
(10.) Detection rate

See ranking guidelines (consider making your own)
(11.) Calculate the RPN of each potential failure effect

RPN = (Severity) x (Occurrence) x (Detection) What are the highest RPN items?
(12.) Define recommended actions

What tests and/or analysis can be used to better understand the problem to guide necessary design changes ?
DFMEA METHODOLOGY: (CONTINUED) (13.) Assign action items

Assemble team Partition work among different team members Assign completion dates for action items Agree on next team meeting date
(14.) Complete Action Results Section of DFMEA

Note any work not accomplished (justify incomplete work) Change ratings if action results justify adjustment, but the rules are:
Severity: May only be reduced through elimination of the failure effect Occurrence: May only be reduced through a design change Detection: My only be reduced through improvement and additions in design control (i.e. a new detection method, better test methodology, better codes)
Include test and analysis results with with DFMEA to validate changes!!
DFMEA METHODLOGY: (CONTINUED) (15.) Repeat: undertake the next revision of the DFMEA Your DFMEA is an evolving document! Revise your DFMEA frequently!
Diligence will eliminate design risk!

Include documentation of your results!
SEVERITY CRITERIA Score Rank

1 2 3 4 5 None Very Minor Minor Very Low Low
Comments
6 7
Moderate High
8 9
Very High Hazardous (With Warning)

Hazardous (Without Warning)
10
No Effect Fit/Finnish Do Not Conform. Defect Noticed By Discriminating Customer. Performance Nominal. Fit/Finnish Do Not Conform. Defect Noticed By Average Customer. Performance Nominal. Fit/Finnish Do Not Conform. Defect Noticed By Most Customers. Performance Nominal. Device Operable, But Convenience Options Operate At Reduced Performance Levels. Customer Experiences Some Dissatisfaction. Device Operable, But Convenience Options Inoperable. Customer Experiences Some Dissatisfaction. Device Operable, But At Reduced Performance Levels. Customer Dissatisfied. Device Inoperable With Loss Of Primary Function A Potential Failure Mode Makes Operation Unsafe To Operator And/Or Involves Non-Compliance With Government Regulations With Warning A Potential Failure Mode Makes Operation Unsafe To Operator And/Or Involves Non-Compliance With Government Regulations With Warning
OCCURRENCE CRITERIA Score 1 2 3 4 5 6 7 8 9 10 Rank Comments Failure Rate Remote Failure Is Unlikely <1 in 1,000,000 Very Low Relatively Few Failures 1 in 150,000 Low Not Uncommon 1 in 15,000 Moderate Occasional Failures 1 in 2,000 Moderate Frequent Failures 1 in 500 Likely Frequent Failures 1 in 100 High Failure Is Typical 1 in 25 Very High Repeated Failures 1 in 10 Severe Failure Is Almost Inevitable 1 in 5 Extreme Failure Is Normal > 1 in 2
DETECTION CRITERIA Score Rank

1 Almost Certain
Comments
Design controls will almost certainly detect a potential cause/mechanism and subsequent failure mode. 2 Very High Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode. 3 High High chance the design controls will detect a potential cause/mechanism and subsequent failure mode. 4 Moderately High Moderately high chance the design controls will detect a potential cause/mechanism and subsequent failure mode. 5 Moderate Moderate chance the design controls will detect a potential cause/mechanism and subsequent failure mode. 6 Low Low chance the design controls will detect a potential cause/mechanism and subsequent failure mode. 7 Very Low Very low chance the design controls will detect a potential cause/mechanism and subsequent failure mode. 8 Remote Remote chance the design controls will detect a potential cause/mechanism and subsequent failure mode. 9 Very Remote Very remote chance the design controls will detect a potential cause/mechanism and subsequent failure mode. 10 Absolute Uncertainty No Control. Design control will not and/or can not detect a potential cause/mechanism and subsequent failure mode.

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PURPOSE OF DFMEA (DESIGN FAILURE MODE EFFECTS ANALYSIS)

RESPONSIBILITY AND SCOPE OF THE DFMEA The DFMEA is a team function

The DFMEA is not a one meeting activity

DFMEA INPUTS Product Design Requirements

Bill of Materials (BOM) and Specific Hardware

Previous Experience (Lessons Learned from Others)

DFMEA OUTPUTS RPN: Risk Assessment Number

Identification of Critical and Significant Characteristics

The DFMEA is An Output to Your Customer

DFMEA METHODOLOGY (1.) Complete the top of the form

(2.) List items and functions

(3.) Document potential failure modes

(4.) Document the potential effects of failure

(6.) Document potential causes and mechanisms of failure

DFMEA METHODOLOGY: (CONTINUED) (7.) Rate the occurrence

(8.) List the design controls

Applicable design controls include

DFMEA METHODOLOGY: (CONTINUED) (9.) List any critical or special characteristics

(10.) Detection rate

(11.) Calculate the RPN of each potential failure effect

(12.) Define recommended actions

DFMEA METHODOLOGY: (CONTINUED) (13.) Assign action items

(14.) Complete Action Results Section of DFMEA

Diligence will eliminate design risk!

SEVERITY CRITERIA Score Rank

Very High Hazardous (With Warning)

DETECTION CRITERIA Score Rank

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