Chandrasa Sedyaleksana, APICS-ID@ member who works for VW in Germany, donated this article.

Please ask your friend to learn this subject by sending an email to APICS-ID-subscribe@yahoogroups.com For more information, please visit Indonesian Production and Operations Management Society (IPOMS). http://www.ipoms.or.id/mambo

SECTION ONE

Introduction
To

FAILURE MODE EFFECTS & ANALYSIS

FMEA

1.0

Definition, Purpose, and Practices

FMEA: A SYSTEMIZED GROUP OF ACTIVITIES DESIGNED TO 1. RECOGNIZE and EVALUATE the POTENTIAL FAILURE of a PRODUCT/PROCESS and its EFFECTS 2. IDENTIFY ACTIONS WHICH COULD ELIMINATE or REDUCE the CHANCE of POTENTIAL FAILURE OCCURRING

3. DOCUMENT the PROCESS

1.1

DESIGN FMEA (DFMEA) PROCESS FMEA (PFMEA)

ARE ANALYTICAL TECHNIQUES UTILIZED BY DESIGN RESPONSIBLE ENGINEER/TEAM
OR

MANUFACTURING RESPONSIBLE ENGINEER/TEAM

THESE TOOLS ARE USED TO ASSURE THAT POTENTIAL PRODUCT FAILURE MODES And THEIR ASSOCIATED CAUSES HAVE BEEN CONSIDERED and ADDRESSED IN THE DESIGN OR MANAUFACTURING PROCESS

1.2

DFMEA
SUPPORTS DESIGN PROCESS in REDUCING RISK of FAILURES by
AIDING IN THE OBJECTIVE EVALUATION OF DESIGN REQUIREMENTS AND DESIGN ALTERNATIVES AIDING IN THE INITIAL DESIGN FOR MANUFACTURING AND ASSEMBLY INCREASING THE PROBABILITY THAT POTENTIAL FAILURE MODES AND THEIR EFFECTS ON SYSTEMS AND PRODUCT OPERATION HAVE BEEN CONSIDERED IN THE DESIGN & DEVELOPMENT PROCESS PROVIDING ADDITIONAL INFORMATION TO AID IN THE PLANNING OF EFFICIENT

DESIGN TESTING AND PRODUCT DEVELOPMENT PROGRAMS

1.3

DFMEA
ALSO SUPPORTS DESIGN PROCESS By
DEVELOPING A LIST OF POTENTIAL FAILURE MODES RANKED ACCORDING TO THEIR EFFECT ON THE CUSTOMER, THUS ESTABLISHING A PRIORITY SYSTEM FOR DESIGN IMPROVEMENTS AND DEVELOPMENT TESTING PROVIDING AN OPEN ISSUE FORMAT FOR RECOMMENDING AND TRACKING RISK REDUCING ACTIONS PROVIDING FUTURE REFERENCE TO AID IN ANALYZING FIELD CONCERNS,

EVALUATING DESIGN CHANGES AND DEVELOPING ADVANCED DESIGNS

1.4

PFMEA
THE PROCESS FMEA
IDENTIFIES POTENTIAL PRODUCT RELATED PROCESS FAILURE MODES ASSESSES THE POTENTIAL CUSTOMER EFFECTS OF THE FAILURES IDENTIFIES THE POTENTIAL MANUFACTURING OR ASSEMBLY PROCESS CAUSES AND IDENTIFIES PROCESS VARIABLES ON WHICH TO FOCUS CONTROLS FOR OCCURRENCE REDUCTION OR DETECTION OF THE FAILURE CONDITIONS DEVELOPS A RANKED LIST OF POTENTIAL FAILURE MODES, THUS ESTABLISHING A PRIORITY SYSTEM FOR CORRECTIVE

ACTION CONSIDERATIONS DOCUMENTS THE RESULTS OF THE MANUFACTURING OR ASSEMBLY PROCESS

1.5

FMEA APPLICATIONS
IN

MANUFACTURING SETTINGS
DFMEA
SHOULD BE INITIATED BEFORE OR AT DESIGN CONCEPT FINALIZATION SHOULD BE CONTINUALLY UPDATED AS CHANGES OCCUR OR ADDITIONAL INFORMATION IS OBTAINED THROUGHOUT THE PHASES OF PRODUCT DEVELOPMENT SHOULD BE FUNDAMENTALLY COMPLETED BEFORE THE DRAWINGS ARE RELEASED FOR TOOLING, OR OTHER MANUFACTURING NEEDS ADDRESSES THE DESIGN INTENT AND ASSUMES THE DESIGN WILL BE MANUFACTURED AND ASSEMBLED TO THIS INTENT

DOES NOT RELY ON PROCESS CONTROLS TO OVERCOME POTENTIAL WEAKNESSES IN THE DESIGN, BUT IT DOES TAKE THE TECHNICAL AND PHYSICAL LIMITATIONS OF A MANUFACTURING OR ASSEMBLY PROCESS INTO CONSIDERATION
1.6

FMEA APPLICATIONS
IN

MANUFACTURING SETTINGS
PFMEA
SHOULD TAKE INTO ACCOUNT ALL MANUFACTURING OPERATIONS, FROM INDIVIDUAL COMPONENTS TO ASSEMBLIES DOES NOT RELY ON PRODUCT DESIGN CHANGES TO OVERCOME WEAKNESSES IN THE PROCESS DOES TAKE INTO CONSIDERATION A PRODUCTS DESIGN CHARACTERISTICS RELATIVE TO THE PLANNED MANUFACTURING OR ASSEMBLY PROCESS ASSURES THAT, TO THE EXTENT POSSIBLE, THE RESULTING PRODUCT MEETS CUSTOMER

NEEDS AND EXPECTATIONS

1.7

KEY RESOURCES NECESSARY TO CONDUCT SUCCESSFUL FMEA PROGRAMS

COMMITMENT OF TOP MANAGEMENT KNOWLEDGEABLE INDIVIDUALS, I.E. EXPERTISE IN: DESIGN MANUFACTURING ASSEMBLY SERVICE QUALITY RELIABILITY INDIVIDUALS ATTENTIVE TO FMEA TIMELINESS, I.E. ACHIEVE GREATEST VALUE: BEFORE A DESIGN OR PROCESS FAILURE MODE HAS BEEN

UNKNOWINGLY DESIGNED INTO THE PRODUCT PEOPLE RESOURCES MAY BE INTERNAL OR EXTERNAL TO THE BUSINESS, OR A COMBINATION THEREOF
1.8

FMEA ADVANTAGES (AND LIMITATIONS)

ADVANTAGES:
ENHANCE DESIGN AND MANUFACTURING EFFICIENCIES ALLEVIATE LATE CHANGE CRISES MINIMIZE EXPOSURE TO PRODUCT FAILURES AUGMENT BUSINESS RECORDS

IMPROVE BOTTOM LINE RESULTS ADD TO CUSTOMER SATISFACTION

1.9

FMEA ADVANTAGES (AND LIMITATIONS)

LIMITATIONS*
EMPLOYEE TRAINING REQUIREMENTS INITIAL IMPACT ON PRODUCT AND MANUFACTURING SCHEDULES FINANCIAL IMPACT REQUIRED TO UPGRADE DESIGN, MANUFACTURING, AND PROCESS EQUIPMENT AND TOOLS

*These LIMITATIONS should be recognized and treated as short term and minimal interruptions to a business, and understood to ultimately offer dynamic ADVANTAGES!

1.10

SECTION TWO

FMEA PLAN
UTILIZING KEY PRODUCTION PROCESSES AND PRODUCT EVALUATION TOOLS

2.0

QUALITY MANAGEMENT PROCESS

PRINCIPLES DRIVING CUSTOMER SATISFACTION

TEAMWORK MANAGING PROCESSES STATISTICAL PROCESS CONTROL

2.1

FMEA REQUIRES

TEAMWORK

BUILD QUALITY INTO PEOPLE THROUGH

TRAINING and COMMITTED LEADERSHIP

2.2

MANAGING PROCESSES
UTILIZE A STYLE OF MANAGEMENT THAT IS ALSO PEOPLE ORIENTED IN CONTRAST TO ONE THAT IS SOLELY ORIENTED TOWARD RESULTS

PROCESS-ORIENTED MANAGEMENT
SUPPORT AND STIMULATE EFFORTS TO IMPROVE THE WAY EMPLOYEES DO JOBS REINFORCES LONG TERM OUTLOOK

MANAGEMENT CRITERIA

DISCIPLINE TIME MANAGEMENT SKILL DEVELOPMENT PARTICIPATION & INVOLVEMENT MORALE COMMUNICATION
2.3

STATISTICAL PROCESS CONTROL

(SPC)
STATISTICAL TOOLS PARETO Diagrams CAUSE-AND-EFFECT Diagrams HISTOGRAMS CONTROL Charts SCATTER Diagrams

GRAPHS CHECKSHEETS

2.4

PROCESS INCORPORATION
A PROCESS INCLUDES SOME COMBINATION OF:

METHODS MATERIALS MACHINES MANPOWER ENVIRONMENT MEASUREMENT

THESE ARE INCORPORATED TO COMPLETE TASKS, SUCH AS PRODUCING A PRODUCT OR

PERFORMING A SERVICE. A PROCESS HAS MEASURABLE INPUTS AND OUTPUTS.

2.5

FMEA PROJECTS SELECTION & PURPOSE

TANGIBLE EFFECTS
SUCCESSFUL DEVELOPMENT OF NEW PRODUCTS SHORTENING OF PRODUCT DEVELOPMENT TIME INCREASED MARKET SHARE INCREASED SALES VOLUME DEVELOPMENT OF NEW MARKETS INCREASED PRODUCTION VOLUME FEWER PROCESSES

IMPROVED QUALITY REDUCED DEFECT COSTS FEWER CUSTOMER COMPLAINTS

2.6

FMEA PROJECTS SELECTION & PURPOSE

INTANGIBLE EFFECTS
INCREASED QUALITY-CONSCIOUSNESS AND PROBLEM-CONSCIOUSNESS MORE CONFIDENCE IN NEW PRODUCT DEVELOPMENT IMPROVED STANDARDIZATION IMPROVED QUALITY OF WORK

IMPROVED INFORMATION FEEDBACK

2.7

FMEA PROJECT IMPLEMENTATION

QUANTITATIVE METHODS
SEVERITY RANKING OCCURRENCE RANKING DETECTION RANKING

RISK PRIORITY NUMBER (RPN)

2.8

FMEA PROJECT IMPLEMENTATION

QUALITATIVE METHODS
SIMILAR PAST EXPERIENCES BRAINSTORMING ANALYSIS CUSTOMER(S) INPUT

FINANCIAL IMPACT

2.9

FAILURE MODE ERRORS DESCRIPTIONS

DESIGN
POTENTIAL FAILURE MODE CAN BE DESCRIBED AS THE MANNER IN WHICH A COMPONENT, SYSTEM, OR SUBSYSTEM COULD FAIL TO MEET THE DESIGN INTENT. THESE FAILURE MODES SHOULD BE

DESCRIBED IN PHYSICAL OR TECHNICAL TERMS.

2.10

FAILURE MODE ERRORS DESCRIPTIONS PROCESS

POTENTIAL FAILURE MODE IS DEFINED AS THE MANNER IN WHICH THE PROCESS COULD FAIL TO MEET THE REQUIREMENTS OF THE DESIGN INTENT. THE FMEA TEAM SHOULD BE ABLE TO POSE AND ANSWER THE FOLLOWING QUESTIONS:

HOW CAN THE PROCESS/PART FAIL TO MEET SPECIFICATIONS? REGARDLESS OF ENGINEERING SPECIFICATIONS, WHAT WOULD A CUSTOMER (END USER, SUBSEQUENT OPERATIONS, OR SERVICE) CONSIDER OBJECTIONABLE?

2.11

FAILURE MODE ERRORS EXAMPLES

GROUNDED SHORT CIRCUITED OPEN CIRCUITED CRACKED HANDLING DAMAGE DEFORMED BENT IMPROPER SET-UP FRACTURED OXIDIZED STICKING BURRED LEAKING LOOSENED TOOL WORN DIRTY

THESE ARE SOME TYPICAL FAILURE MODES. IT IS RECOMMENDED THAT A COMPARISON OF SIMILAR PROCESSES AND A REVIEW OF CUSTOMER (SUBSEQUENT OPERATION AND END USER) CONSIDERATIONS BE CONDUCTED.

2.12

FAILURE MODE ERRORS PROBABILISTIC ERRORS

DEFINITION: A PROBABILISTIC ERROR IS ONE THAT CANNOT BE PREDICTED WITH CERTAINTY. SAMPLE PROBLEM THE VOLTAGES OF 50 BATTERIES OF THE SAME TYPE HAVE A MEAN OF 1.52 VOLTS AND A STANDARD DEVIATION OF 0.04 VOLT.

FIND THE PROBABLE ERROR OF THE MEAN AND THE 50% CONFIDENCE LIMITS. SOLUTION: PROBABLE ERROR OF THE MEAN = 0.6745 x = 0.6745 N = 0.6745s N-1 = 0.6745(0.04 49) = 0.00385 VOLTS THEN, 50% CONFIDENCE LIMITS ARE 1.52 0.00385 VOLTS
2.13
Comment [VJ1]:

FAILURE MODE TECHNICAL ANALYSIS

FAILURE MODE ANALYSIS AND CONTROL MUST BE ASSIGNED TO AN INDIVIDUAL WHO POSSESSES THE BACKGROUND EXPERIENCE AND NECESSARY SKILLS TO SUCCESSFULLY MANAGE THE FMEA. THIS

INDIVIDUAL MAY BE AN EMPLOYEE OF THE COMPANY OR A SPECIALIST THAT IS ENGAGED BY THE COMPANY.

2.14

PROCESS REVIEW IN PRACTICE

FAILURE MODE ERRORS INTRODUCE A RISK INTO A PROCESS (OR PROCESSES). A CONTROL SYSTEM PROVIDES A MEANS OF CATCHING AN ERROR BEFORE ANY DAMAGE IS INCURRED.

EXAMPLE:
TYPE OF ERROR DESCRIPTION Information Validation There are no checks to Omission catch incorrect or

incomplete information items. An administrative example could be the processing of purchase orders that could occasionally result in incorrect orders being sent to the supplier(s). This could be the case if there are no checks on orders before they are submitted. Such an error could result in an incorrect shipment of goods, and payment for undesired items. In this example, the preferable control system would be one that would more readily assure correct preparation of purchase orders. Training of staff and simplifying process steps are areas to support this goal.
2.15

FLOW CHART PROCESS DIAGRAMMING

FLOW CHART FOR PURCHASING PROCEDURE

2.16

FMEA PLAN
ONGOING EVALUATORY PROCEDURES
THE INDIVIDUAL RESPONSIBLE FOR DESIGN AND/OR PROCESS IS ACCOUNTABLE FOR ASSURING THAT ALL DFMEA AND/OR PFMEA ACTIONS RECOMMENDED HAVE BEEN IMPLEMENTED OR ADEQUATELY ADDRESSED.

THE FMEA IS A LIVING DOCUMENT AND SHOULD ALWAYS REFLECT THE LATEST DESIGN LEVEL, AS WELL AS THE LATEST RELEVANT ACTIONS, INCLUDING THOSE OCCURRING AFTER THE START OF PRODUCTION OPERATIONS.

2.17

SECTION THREE

Implementing

FMEA

3.0

IDENTIFYING POTENTIAL FAILURES

PRODUCT CONSIDERATIONS & PRODUCTION OPERATIONS FAILURE MODES DEFINITION

ALL WAYS IN WHICH A PRODUCT (INCLUDING EACH OF ITS SPECIFIC PARTS) OR PROCESS CAN FAIL TO PERFORM ITS INTENDED FUNCTION. MORE THAN ONE FAILURE MODE CAN EXIST FOR A GIVEN PART OR PROCESS. ALSO, SOME FAILURES MAY BE GRADUAL AND/OR PARTIAL, WHEREAS OTHERS MAY OCCUR IMMEDIATELY AND COMPLETELY.

3.1

IDENTIFYING POTENTIAL FAILURES

USE of STATISTICAL TOOLS TYPES/DEFINITIONS

1. PARETO Diagrams. Classify failures according to cause. The failures are diagrammed according to priority, using a

bar-graph format, with 100% indicating the total amount of failures. 2. Cause-and-Effect Diagrams. Also, known as fishbone diagrams. Used to analyze the characteristics of a product or process and the factors that contribute to them, and to prospective failures. Histograms. Frequency data obtained from measurements display a peak around a certain value. This can be used to determine potential failures by checking dispersion shape, center value, and the nature of dispersement.
3.2

3.

IDENTIFYING POTENTIAL FAILURES

USE of STATISTICAL TOOLS TYPES/DEFINITIONS

4. Control Charts. Serve to detect abnormal variations. Sample data (defining potential failures) are plotted to evaluate situations and trends in a process. Comparisons can be made against required control limits.

5.

Scatter Diagrams. Corresponding data are plotted and the relation between the data (and impact on prospective failures) can be analyzed.

BESIDES THESE ANALYTICAL (STATISTICAL) TOOLS, THERE CAN OFTEN BE MANAGEMENT SITUATIONS WHERE THE DATA NEEDED FOR PROBLEM SOLVING ARE NOT AVAILABLE. NEW PRODUCT DEVELOPMENT IS AN EXAMPLE. ANOTHER MAY BE DEVELOPING A NEW MANUFACTURING METHOD TO IMPROVE PRODUCTIVITY. THESE SITUATIONS REQUIRE COLLABORATION AMONG PEOPLE FROM DIFFERENT DEPARTMENTS.
3.3

IDENTIFYING POTENTIAL FAILURES

PROSPECTIVE QUESTIONS
FOLLOWING ARE REPRESENTATIVE QUESTIONS TO CONSIDER IN SOME BASIC AREAS THAT MAY REQUIRE FMEA. THIS IS NOT ALL INCLUSIVE, BUT EXAMPLES TO EVALUATE. A. MATERIAL 1. Are there any mistakes in volume? 2. Are there any mistakes in grade?

3. 4. 5. 6. 7.

Are there impurities mixed in? Is the inventory level adequate? Is there any waste in material? Is the handling adequate? Is the quality standard adequate?

B. OPERATION METHOD 1. Are the work standards adequate? 2. Is it a safe method? 3. Is it a method that ensures a good product? 4. Is it an efficient method? 5. Are the temperature and humidity adequate? 6. Is the lighting adequate? 7. Is there adequate contact with the previous and next processes?
3.4

IDENTIFYING POTENTIAL FAILURES

PROSPECTIVE QUESTIONS
C. MACHINE 1. Does it meet production requirements? 2. Does it meet process capabilities? 3. Does it meet precision requirements? 4. Is the layout adequate? 5. Are there enough machines/facilities?

6. Is everything in good working order? 7. Is operation stopped often because of mechanical trouble? D. MANPOWER (OPERATOR) 1. Does s/he follow standards? 2. Is his/her work efficiency acceptable? 3. Is he/she responsible (accountable)? 4. Is he/she qualified? 5. Is he/she experienced? 6. Is he/she assigned to the right job? 7. Does he/she maintain good human relations?
3.5

EFFECT AND ANALYSIS METHODOLOGIES

Failure Mode

Effect Severity: 1-10 Causes Occurrence: 1-10

Controls Detection: 1-10

RPN = Severity X Occurrence X Detection 1-1,000

3.6

EFFECT AND ANALYSIS METHODOLOGIES DEFINING FMEA TERMS RISK PRIORITY NUMBER (RPN)
The RISK PRIORITY NUMBER (RPN) is the product of the SEVERITY (S), OCCURRENCE (O), and DETECTION (D) ranking:

RPN = (S) x (O) x (D) The RPN is a measure of design risk. The RPN is also used to rank order the concerns in processes (e.g., in Pareto fashion). The RPN will be between 1 and 1,000. For higher RPNs the team must undertake efforts to reduce this calculated risk through corrective action(s).

3.7

EFFECT AND ANALYSIS METHODOLOGIES DEFINING FMEA TERMS SEVERITY (S)

SEVERITY (S) is an assessment of the seriousness of the effect of the potential failure mode. SEVERITY applies to the effect only. A reduction in SEVERITY ranking index can be effected only through a design change. SEVERITY is estimated on a 1 to 10 scale.
3.8

EFFECT AND ANALYSIS METHODOLOGIES SEVERITY (S) Evaluation Criteria

Effect
Hazardouswithout warning Hazardouswith warning

Criteria: SEVERITY of Effect

Very high severity ranking when a potential failure mode affects safe operation and/or involves noncompliance with regulations without warning. Very high severity ranking when a potential failure mode affects safe operation and/or involves noncompliance with regulations with warning.

Ranking
10

Very high High Moderate Low Very Low

Product/item inoperable, with loss of primary function. Product/item operable, but at reduced level of performance. Customer dissatisfied. Product/item operable, but may cause rework/repair and/or damage to equipment. Product/item operable, but may cause slight inconvenience to related operations. Product/item operable, but possesses some defects (aesthetic and otherwise) noticeable to most customers. Product/item operable, but may possess some defects noticeable by discriminating customers. Product/item operable, but is in noncompliance with company policy. No effect.

8 7 6 5 4

Minor Very Minor None NOTE:

3 2 1

Make sure team members agree on the criteria for ranking severity and apply them consistently. 3.9

EFFECT AND ANALYSIS METHODOLOGIES

DEFINING FMEA TERMS

OCCURRENCE (O) OCCURRENCE (O) is the likelihood that a specific cause/mechanism will occur. OCCURRENCE is estimated on a 1 to 10 scale.

3.10

EFFECT AND ANALYSIS METHODOLOGIES

OCCURRENCE (O) Evaluation Criteria
Probability of Failure Possible Failure Rates Ranking

Very High: Failure is almost inevitable High: Repeated Failures

1 in 2 1 in 3 1 in 8 1 in 20

10 9 8 7 6 5 4 3 2 1

Moderate: Occasional Failures

1 in 80 1 in 400 1 in 2,000

Low: Relatively Few Failures

1 in 15,000 1 in 150,000 1 in 1,500,000

Remote: Failure is Unlikely

NOTE:

The team should agree on an evaluation criteria and ranking system, which is consistent, even if modified for individual product/process analysis.

3.11

EFFECT AND ANALYSIS METHODOLOGIES

DEFINING FMEA TERMS DETECTION (D)

DETECTION (D) is an assessment of the ability of proposed *type (2) current design controls to detect a potential cause/mechanism (design weakness), or the ability of the proposed #type (3) current design controls to detect the subsequent failure mode, before the component, subsystem, or system is released for production. In order to achieve a lower ranking, generally the planned design control (e.g., preventative, validation, and/or verification activities) has to be improved. DETECTION is estimated on a 1 to 10 scale. *Type (2) Design Controls: Detect the cause/mechanism or failure mode/effect from occurring, or reduce their rate of occurrence. #Type (3) Design Controls: Detect the failure mode.
3.12

EFFECT AND ANALYSIS METHODOLOGIES DETECTION (D) Evaluation Criteria

Detection
Absolute Uncertainty Very Remote

Criteria: Likelihood of DETECTION by Design Control

Design Control will not and/or can not detect a potential cause/mechanism and subsequent failure mode; or there is no Design Control. Very remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.

Ranking
10

Remote

Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Very low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Moderate chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Moderately high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Very high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Design Control will almost certainly detect a potential cause/mechanism and subsequent failure mode.

Very Low

Low Moderate

6 5

Moderately High High Very High

3 2

Almost Certain NOTE:

Make sure team members agree on the evaluation criteria and ranking system, which is consistent, even if modified for individual product analysis 3.13

IDENTIFYING AND ESTABLISHING APPROPRIATE FMEA TEAM(S) BASE CONSIDERATIONS SELECT A QUALIFIED TEAM

LEADER COMMITTED TO SPECIFIC FMEA PROJECT

SELECT QUALIFIED TEAM

MEMBERS THAT ARE MULTIFUNCTIONAL AND RELATED TO SPECIFIC FMEA PROJECT GIVE PROJECT LEADER AND TEAM MEMBERS COMPLETE AUTONOMY TO MANAGE SPECIFIC FMEA PROJECT
3.14

IDENTIFYING AND ESTABLISHING APPROPRIATE FMEA TEAM(S) ADDITIONAL CONSIDERATIONS

 WHEN POSSIBLE, SELECT AT

LEAST ONE, OR MORE, TEAM MEMBERS WITH PREVIOUS FMEA EXPERIENCE PROVIDE NECESSARY TRAINING TO FURTHER STRENGTHEN TEAM MEMBERS SKILLS INCORPORATE STANDARDIZATION METHODS TO OBTAIN OVERALL BENEFIT OF GIVING CONTROL OF EACH FMEA PROJECT TO THE PEOPLE WHO KNOW IT BEST

3.15

SECTION FOUR

FMEA Documentation

4.0

KEY DOCUMENTATION METHODS FOR FMEA

TECHNIQUES
1. Document and Understand existing Products and

Processes Review current DOCUMENTATION methods for existing Products and Processes, where applicable Evaluate successes, failures, and relevance of existing DOCUMENTS

2. Visualize how existing Products and Processes can be improved (or how these should be changed) utilizing FMEA methods DOCUMENT: Reference Control Plan form in Appendix

3. Consider Benchmarking (understanding best practice in the relevant industry or sector) and obtain information which could be useful for Product and/or Process improvement(s), including DOCUMENTATION Procedures.........understand the causes and magnitude of problems with existing products and/or processes, so effort is focused where it is most required

4. Implement plant-wide standardized forms and methods to assure consistency for FMEA DOCUMENTATION

5.

Provide training in DOCUMENTATION procedures

4.1

FMEA APPLICATIONS
EFFECTIVE DOCUMENTATION PROCEDURES

Reference Design FMEA form is Appendix Following is a description of the categories noted on the DFMEA form: 1. Part Name/No. Enter the name and number of the system, subsystem, or component being analyzed. 2. Design Responsibility Enter the original equipment manufacturer (OEM), department, and group. Also, include the supplier name if known. 3. Prepared by Enter the name, telephone number, company of the individual (engineer) responsible for preparing the DFMEA. 4. Customer/Application Enter the name of the customer (internal/external) who is the recipient of the DFMEA and the application (of the design intent).

4.2

FMEA APPLICATIONS
EFFECTIVE DOCUMENTATION PROCEDURES
5. Key Date

Enter the initial DFMEA due date, which should not exceed the scheduled production design release date. 6. FMEA Date (Orig.) (Rev.) Enter the date the original FMEA was compiled, and the latest revision date, when applicable. 7. Core Team List the names of the responsible individuals and departments which have the authority to identify and/or perform tasks. (It is recommended that all team members names, departments, telephone numbers, addresses, etc. be included on a distribution list.) 8. FMEA Number Enter the FMEA document number, which may be used for tracking. 9. Item/Number Enter the name and number of the item being analyzed. Use the nomenclature and show the design level as indicated on the engineering drawing.
4.3

FMEA APPLICATIONS
EFFECTIVE DOCUMENTATION PROCEDURES
10. Potential Failure Mode

Potential Failure Mode is defined as the manner in which a component, subsystem, or system could potentially fail to meet the design intent. The potential failure mode may also be the cause of a potential failure mode in a higher level subsystem, or system, or be the effect of one in a lower level component. Each potential failure mode for the particular item and item function should be listed. The assumption is made that the failure could occur, but may not necessarily occur. (Example: Corroded battery case) 11. Potential Effect(s) of Failure Potential Effect(s) of Failure are defined as the effects of the failure mode on functions, as perceived by the customer. Describe the effects of the failure in terms of what the customer might notice or experience, remembering that the customer may be an internal customer as well as the ultimate end user. State clearly if the function could impact safety or noncompliance to regulations. (Example: Deteriorated life of the battery -also, Impaired operation of the battery)
4.4

FMEA APPLICATIONS
EFFECTIVE DOCUMENTATION PROCEDURES
12. Severity (S)

Severity is an assessment of the seriousness of the effect of the potential failure mode to the next component, subsystem, system, or customer if it occurs. Severity applies to the effect only. Severity should be estimated on a 1 to 10 scale. 13. Classification This column is intended to be used to classify any special product characteristics (e.g., critical, key, major, significant) for components, subsystems, or systems that may require additional process controls. 14. Potential Cause(s)/Mechanism(s) of Failure Potential cause of failure is defined as an indication of a design weakness, the consequence of which is the failure mode. List, to the extent possible, every conceivable failure cause and/or failure mechanism for each failure mode. Typical failure causes may include, but are not limited to: Incorrect material specified; Inadequate design life assumption; Inadequate maintenance instructions, etc. Typical failure mechanisms may include, but are not limited to: Yield; Fatigue; Material instability; Wear; Corrosion, etc.
4.5

FMEA APPLICATIONS
EFFECTIVE DOCUMENTATION PROCEDURES
15. Occurrence (O)

Occurrence is the likelihood that a specific cause/mechanism will occur. The likelihood of occurrence ranking number has a meaning rather than a value. Removing or controlling one or more of the causes/mechanisms of the failure mode through a design change is the only way a reduction in the occurrence ranking can be effected. The likelihood of occurrence of potential failure cause/mechanism is estimated on a 1 to 10 scale. 16. Current Design Controls List the prevention, design validation/verification (DV), or other activities which will assure the design adequacy for the failure mode and/or cause/mechanism under consideration. Current controls, such as mathematical studies, laboratory testing, feasibility reviews, prototype tests, etc. are those that have been or are being used with the same or similar designs. There are three types of design controls/features to consider, those that: (1) prevent the cause/mechanism or failure mode/effect from occurring, or reduce their rate of occurrence, (2) detect the cause/mechanism and lead to corrective actions, and (3) detect the failure mode.
4.6

FMEA APPLICATIONS
EFFECTIVE DOCUMENTATION PROCEDURES

17. Detection (D) Detection is an assessment of the ability of the proposed type (2) current design controls to detect a potential cause/mechanism (design weakness), or the ability of the proposed type (3) current design controls to detect the subsequent failure mode, before the component, subsystem, or system is released for production. Ranking is on a scale of 1 to 10 dependent on the detection level. 18. Risk Priority Number (RPN) The Risk Priority Number is the product of the Severity (S), Occurrence (O), and Detection (D) ranking. The RPN is a measure of design risk and will compute between 1 and 1,000. 19. Recommended Action(s) When the failure modes have been rank ordered by RPN, corrective action should be first directed at the highest ranked concerns and critical items. The intent of any recommended action is to reduce any one or all of the occurrence, severity, and/or detection rankings.
4.7

FMEA APPLICATIONS

EFFECTIVE DOCUMENTATION PROCEDURES

20. Responsibility & Target Completion Date Enter the organization and individual responsible for the recommended action and the target completion date. 21. Actions Taken After an action has been implemented, enter a brief description of the actual action and effective date. 22. Resulting RPN After the corrective action(s) have been identified, estimate and record the resulting severity, occurrence, and detection rankings. Calculate and record the resulting RPN. If no action(s) are taken, leave the Resulting RPN and related ranking columns blank. All resulting RPNs should be reviewed and if further action is considered necessary, repeat steps 19 through 22.

4.8

FMEA APPLICATIONS

EFFECTIVE DOCUMENTATION PROCEDURES

Reference Process FMEA form is Appendix Following is a description of the categories noted on the PFMEA form: 1. Process Enter the name of the process being analyzed. 2. Process Responsibility Enter the original equipment manufacturer (OEM), department, and group. Also, include the supplier name if known. 3. Prepared by Enter the name, telephone number, company of the individual (engineer) responsible for preparing the PFMEA. 4. Part Name/No. Enter the name and number of the system, subsystem, or component being analyzed. 5. Key Date Enter the initial PFMEA due date, which should not exceed the scheduled start of production date.
4.9

FMEA APPLICATIONS

EFFECTIVE DOCUMENTATION PROCEDURES

6. FMEA Date (Orig.) (Rev.) Enter the date the original FMEA was compiled, and the latest revision date, when applicable. 7. Core Team List the names of the responsible individuals and departments which have the authority to identify and/or perform tasks. (It is recommended that all team members names, departments, telephone numbers, addresses, etc. be included on a distribution list.) 8. FMEA Number Enter the FMEA document number, which may be used for tracking. 9. Process Function/Requirements Enter a simple description of the process or operation being analyzed (e.g., turning, drilling, tapping, welding, assembling). Indicate as concisely as possible the purpose of the process or operation being analyzed. Where the process involves numerous operations (e.g. assembling) with different potential modes of failure, it may be desirable to list the operations as separate processes.
4.10

FMEA APPLICATIONS

EFFECTIVE DOCUMENTATION PROCEDURES

10. Potential Failure Mode Potential Failure Mode is defined as the manner in which the process could potentially fail to meet the process requirements and/or design intent. It is a description of the nonconformance at that specific operation. It can be a cause associated with a potential failure mode in a subsequent (downstream) operation or an effect associated with a potential failure in a previous (upstream) operation. However, in preparation of the FMEA, the assumption should be made that the incoming part(s)/material(s) are correct. List each potential failure mode for the particular operation in terms of a component, subsystem, system, or process characteristic. The assumption is made that the failure could occur, but may not necessarily occur. 11. Potential Effect(s) of Failure Potential Effect(s) of Failure are defined as the effects of the failure mode on customer(s). The customer(s) in this context could be the next operation, subsequent operations or locations, or the end user. Describe the effects of the failure in terms of what the customer might notice or experience. (Example: Erratic operation -- also, Poor appearance)
4.11

FMEA APPLICATIONS

EFFECTIVE DOCUMENTATION PROCEDURES

12. Severity (S) Severity is an assessment of the seriousness of the effect of the potential failure mode to the customer(s). Severity applies to the effect only. Severity should be estimated on a 1 to 10 scale. 13. Classification This column is intended to be used to classify any special process characteristics (e.g., critical, key, major, significant) for components, subsystems, or systems that may require additional process controls. If a classification is identified in the PFMEA, notify the design responsible engineer since this may affect the engineering documents concerning control item identification. 14. Potential Cause(s)/Mechanism(s) of Failure Potential cause of failure is defined as how the failure could occur, described in terms of something that can be corrected or can be controlled. List, to the extent possible, every conceivable failure cause assignable to each potential failure mode. Typical failure causes may include, but are not limited to: Inaccurate gauging; Improper heat treating - time, temperature; Part missing or mislocated.
4.12

FMEA APPLICATIONS

EFFECTIVE DOCUMENTATION PROCEDURES

15. Occurrence (O) Occurrence is how frequently the specific cause/mechanism is projected to occur. The occurrence ranking number has a meaning rather than a value. Only occurrences resulting in the failure mode should be considered for this ranking; failure detecting measures are not considered here. The likelihood of occurrence of potential failure cause/mechanism is estimated on a 1 to 10 scale. 16. Current Process Controls Current process controls are descriptions of the controls that either prevent to the extent possible the failure mode from occurring or detect the failure mode should it occur. These controls can be process controls such as fixture error-proofing or Statistical Process Control (SPC), or can be post-process evaluation. The evaluation may occur at the subject operation or at subsequent operations. There are three types of process controls/features to consider; those that: (1) prevent the cause/mechanism or failure mode/effect from occurring, or reduce their rate of occurrence, (2) detect the cause/mechanism and lead to corrective actions, and (3) detect the failure mode.
4.13

FMEA APPLICATIONS

EFFECTIVE DOCUMENTATION PROCEDURES

17. Detection (D) Detection is an assessment of the probability that the proposed type (2) current process controls will detect a potential cause/mechanism (process weakness), or the probability that the proposed type (3) process controls will detect the subsequent failure mode, before the part or component leaves the manufacturing operation or assembly location. Ranking is on a scale of 1 to 10 dependent on the detection level. 18. Risk Priority Number (RPN) The Risk Priority Number is the product of the Severity (S), Occurrence (O), and Detection (D) ranking. This value should be used to rank order the concerns in the process (e.g., in Pareto fashion. The RPN will compute between 1 and 1,000. 19. Recommended Action(s) When the failure modes have been rank ordered by RPN, corrective action should be first directed at the highest ranked concerns and critical items. The intent of any recommended action is to reduce any one or all of the occurrence, severity, and/or detection rankings.
4.14

FMEA APPLICATIONS

EFFECTIVE DOCUMENTATION PROCEDURES

20. Responsibility & Target Completion Date Enter the organization and individual responsible for the recommended action and the target completion date. 21. Actions Taken After an action has been implemented, enter a brief description of the actual action and effective date. 22. Resulting RPN After the corrective action(s) have been identified, estimate and record the resulting severity, occurrence, and detection rankings. Calculate and record the resulting RPN. If no action(s) are taken, leave the Resulting RPN and related ranking columns blank. All resulting RPNs should be reviewed and if further action is considered necessary, repeat steps 19 through 22. Follow-Up: The process responsible engineer is responsible for assuring that all actions recommended have been implemented or adequately addressed. The FMEA is a living document and should always reflect the latest design/process level, as well as the latest relevant actions, including those occurring after the start of production.
4.15

SECTION FIVE

Improve Design & FMEA Project Skills

Specific In-House Product or Production Operation

5.0

FMEA IN-HOUSE PROJECT

AN APPROACH TO BUSINESS MODELING

Mission and Values

Objectives

Critical Success Factors

Products, Processes, and Functions

5.1