Process fmea breakfast
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Failure Mode and
Effects Analysis
Lawrence Hallett!
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OriginFailure mode and effect analysis (FMEA) was one of the first systematic techniques for failure analysis. It was developed by reliability engineers in the 1950s to study problems that might arise from malfunctions of military systems
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Most COMMON Types of FMEA's
Design (Potential) Failure Modes and Effects Analysis-DFMEA • Focus is on potential design- related failures
and their causes. !
Process (Potential) Failures Modes and Effects Analysis-PFMEA • Focuses is on potential process failures and
their causes.
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PFMEA's!
● Focus is on potential process –related failures and their causes. ▪Main drive is to understand the process through the identification of as many potential failures as possible.
o e.g. Incorrect material used
● PFMEA typically assumes that the design is sound.
● Development of Recommended Actions is targeted at eliminating the Root Cause of the potential failures.
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PFMEA's benefits•Identifies Process Functions and Req’s!•Identifies potential failure modes!•Assesses effect of failure!•Identifies causes of failures!•Identifies process controls!•Identifies confirmed Critical Characteristics!•Provides an objective base for action
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PFMEA's - who prepares it
•A team effort - including!•Manufacturing/production!•Engineering!•Design !•Quality!•Test!!
•However it is a moving feast
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PFMEA
Three Parts: ●Process Flow Diagram (PFD) ●Process Failure Mode and Effects
Analysis (PFMEA) ●Process Control Plan (PCP)
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DFMEA/PFMEA Information Interrelationships
DFMEA Design FMEA
Process Flow Diagram
PFMEA Process FMEA
Boundary (Block) Diagram, P- Diagram,
Etc.
Design Verification Plan & Report
(DVP&R)
Process Control Plan
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Pencil Assembly
Using a simple mechanical pencil -conduct a Process FMEA
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Process Function/Requirements
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Process Flow Diagrams● The Process Flow
Diagram provides a logical (visual) depiction of the process that is being analyzed.
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PFD Example
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PFD Feeds PFMEAIdentify the Function(s)
● Function is a description of what the Process does to meet the requirements ➢Related to process specification and product
characteristics ➢Comes from the PFD operation description column
● Functions can be described as: ➢Do this operation… ➢To this part or material… ➢With this tooling or equipment…
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Potential Failure Mode
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Potential Failure Modes
Often missed
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Potential Effect of Failure
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Example
Failure Modes
Effect of Failure
Case assembled but not to the correct height
Fails height check causing rework(3) if not detected Connector corrosion leading to intermittence premature part failure(8)
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Potential Effects
of Failure
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Severity Ranking
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Severity
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Potential Cause of Failure
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Cause of Failure
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Developing CausesAlways assume a direct correlation between cause and failure i.e if the cause occurs then the failure mode occurs
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Occurrence
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Occurrence Evaluation Criteria
Probability of Likely Failure Rates Over Design Life Ranking Failure
SUGGESTED OCCURRENCE EVALUATION CRITERIA
Very High: Persistent failures
High: Frequent failures
Moderate: Occasional failures
Low: Relatively few failures
Remote: Failure is unlikely
≥ 100 per thousand vehicles/items
50 per thousand vehicles/items
20 per thousand vehicles/items
10 per thousand vehicles/items
5 per thousand vehicles/items
2 per thousand vehicles/items
1 per thousand vehicles/items
0.5 per thousand vehicles/items
0.1 per thousand vehicles/items
≤ 0.01 per thousand vehicles/items
10
9
8
7
6
5
4
3
2
1
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Current controls
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Current Controls
2 types of controls Prevention Prevent the Cause/mechanism or failure mode/effect from occurring or reduce their rate of occurrence !Detection Detect the cause/mechanism and lead to corrective action
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How to identify process controls
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Current Controls
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Detection ranking
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Detection Rankings
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Risk Priority Number
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Analysis Of Risk
▪ RPN / RISK PRIORITY NUMBER ▪ What Is Risk? ▪ Probability of danger ▪ Severity/Occurrence/Cause
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Evaluation by RPN Only
▪ Case 1 o S=5 O=5 D=2 RPN = 50
▪ Case 2 o S=3 O=3 D=6 RPN = 54
▪ Case 3 o S=2 O=10, D=10 = 200
▪ Case 4 o S=9 O=2 D=3 = 54
WHICH ONE IS WORSE?
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Example
▪ Extreme Safety/Regulatory Risk o =9 & 10 Severity
▪ High Risk to Customer Satisfaction o Sev. > or = to 5 and Occ > or = 4
▪ Consider Detection only as a measure of Test Capability.
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Actions taken
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Actions
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Re-rating RPN After Actions Have Occurred
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Re-rating RPN After Actions Have Occurred▪ Severity typically stays the same. ▪ Occurrence is the primary item to reduce / focus on. ▪ Detection is reduced only as a last resort. ▪ Do not plan to REDUCE RPN with detection actions!!!
o 100% inspection is only 80% effective! o Reducing RPN with detection does not eliminate failure mode,
or reduce probability of causes o Detection of 10 is not bad if occurrence is 1
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Outputs