Failure Modes
Failure modes are categories of failure on design (product failure modes) or on operations (process failure modes). Product failure modes may be determined by design engineers; whereas process failure modes may be determined by process engineers within an organization that manufactures products.
FMEA
Failure Mode and Effects Analysis (FMEA) is an easy to use and powerful pro-active engineering quality method that helps you identify and counter weak points in the early conception phase of products and processes.
FMEA is a systematic approach that identifies potential failure modes in a system, product, or manufacturing/assembly operation caused either by design or manufacturing/assembly process deficiencies. It also identifies critical or significant design or process characteristics that require special controls to prevent or detect failure modes.
In addition, the Food and Drug Administration (FDA) has recognized FMEA as a design verification method for drugs and medical devices.
| Failure Mode | Description |
|---|---|
|
DFMEA (Design FMEA) |
Design = Products (Product Lines and Parts) |
|
PFMEA (ProcessFMEA) |
Process = (Standard Operations and Operations) |
Failure Analysis
The criteria used to evaluate severity, occurrence and detection can vary by industry.
| Criteria | Description |
|---|---|
|
DFMEA (Design FMEA) |
Design = Products (Product Lines and Parts) |
|
PFMEA (ProcessFMEA) |
Process = (Standard Operations and Operations) |
Risk Priority Number (RPN)
RPN is a mathematical product of the numerical severity, occurrence, and detection ratings. RPN = S x O x D. This number is used to place priority on items that require additional quality planning.
Management Failure Modes
How good are the products a company manufactures, purchases, or maintains? How good is a company’s process for manufacturing these products? How can designated users be notified when too many of the same failures are occurring for the same product? Failures can be tracked in the application through failure mode tables which track existing and new failures recorded in the records.
Failure modes can be tied specifically to product and process tables in SmartSolve. Each failure mode record contains important information about the failure which may later need to be analyzed by product managers and/or engineers, etc. Some information that is pertinent to the failure includes:
Root Cause Analysis
Step 1: A product is selected during root cause analysis of the record.
Step 2: When zooming into the Failure Mode field, the active failures that are specific to the product selected in Step 1 will now display for the user to select from (known failures).
Step 3: When zooming into the Root Cause field, any known causes that were found in past investigations for this product failure will now display for the user to select from (known causes).
User Rights
The following rights must be assigned to a user to manage or view failure modes:
| Rights | Description |
|---|---|
|
PFM_MANAGE |
Allows the administrator to add new product failure modes, modify existing failure modes, or delete failure modes. |
|
PFM_VIEW |
Allows the user to access and view product failure modes. |
|
RFM_MANAGE |
Allows the administrator to add new process failure modes, modify existing failure modes, or delete failure modes. |
|
RFM_VIEW |
Allows the user to access and view process failure modes. |
Failure Mode Setup is comprised of the following:
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