Failure Mode Setup

Please select the object link below for more information on how to configure the object

Object	Shared with other SmartSolve© Applications	Required for SmartCAPATM
Failure Modes	Yes	Yes
Failure Mode Category	Yes	Yes
Severity	Yes	Yes
Cause	Yes	No
Cause Category	Yes	No
Failure Mode Update	Yes	No

Failure Modes

What are failure modes? Failure modes are sometimes described as categories of failure on design (product) or on operations (process). 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 yet 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.

DFMEA (Design FMEA)

Design = Products (Product Lines and Parts)

PFMEA (Process FMEA)

Process = (Standard Operations and Operations)

Failure Analysis

The criteria used to evaluate severity, occurrence and detection can vary by industry.

Criteria	Description
Severity	An assessment of how serious the effect of the potential failure mode is. Ranking numbers can be identified to track severity from more severe (10) to less severe (1).
Occurrence	An assessment of the likelihood that a particular cause will happen and result in the failure mode during the intended life and use of the product. Ranking numbers can be identified to track probability of failure rates from higher failure rates (10) to lower failure rates (1).
Detection	An assessment of the likelihood that the current controls (design and process) will detect the cause of the failure mode or the failure mode itself. Detection ranking numbers can be identified to track detection from less certain rates (10) to higher certainty rates (1).

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 than require additional quality planning.

SmartCAPA 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 SmartCAPATM through failure mode tables which track existing and new failures recorded in exception records.

Failure modes can be specific to exception type as well as specific parts and product lines:

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:

· Failure status and severity

· Estimated cost to the company if the failure occurs

· Tolerance triggers to trigger notification of high volume or number failure occurrence

· Root causes which have caused the failure in past investigations

· All exceptions submitted thus far for this failure

Tracking Failure with SmartCAPATM

The SmartCAPATM system tracks failure modes on the design of products (product or customer exceptions). It can also track process failures if you wish to incorporate process failures into your SmartCAPATM system.

Facilitation of quality disciplines such as FMEA can greatly reduce the overall time to capture information necessary to assess the risk of each design feature failure mode and/or process step failure mode. Once risk has been determined, an action may be necessary to reduce risk by preventing, or reducing its occurrence. This is where SmartCAPATM comes into the picture.

Product Failure Occurrence

Tracked through Product, and/or Customer Exceptions in SmartCAPATM

Process Failure Occurrence

Tracked through Process Exceptions in SmartCAPATM

Root Cause Analysis

Tracked through an Issue record in SmartCAPATM

Root Cause can be against a product and/or process (operation).

Example Product Failure Occurrence

Product failures are recorded through the Product or Customer Exception. The example below illustrates how a product failure is submitted in a product exception:

Step 1: A part number is selected in the product exception

Step 2: After zooming into the Short Description field above, the failures that are specific to that part number display. See an example below.

User Rights

The following rights must be assigned to a user to manage or view Failure Modes:

Rights	Description
PFM_MANAGE	Allows administrator to Add new Product Failure Modes, modify existing Failure Modes, or delete Failure Modes.
PFM_VIEW	Allows user to access the Product Failure Modes list to View and select.
RFM_MANAGE	Allows administrator to Add new Process Failure Modes, modify existing Failure Modes, or delete Failure Modes.
RFM_VIEW	Allows user to access the Process Failure Modes list to View and select.

Please see Rights Group to assign Rights Groups to users.

Global vs. Local

· Global Failure Modes will be inherited by all local organizations.

· Local Failure Modes will only be viewed and used within that local organization.

Product Failure Mode Setup

There are three Setup tables in SmartCAPATM where Product Failure Modes can be configured. Before setting up Failure Modes, it is important to first understand how each table works.

Setup	Description
Product Failure Modes	Setup any failures that could occur for any products (internal/external) under this setup table (i.e., Delivery, Quantity Failures).
Product Line Failure Modes	Setup any failures that could occur for any parts attached to the associated product line (product line specific failures).
Part Failure Modes	Setup any failures that could occur only for the specified part number.

Example Product Failure Mode Matrix

Failure Mode	Severity	Failure Mode Category	Product	Exception Type
Late Delivery	Low	Service	All Products	Product
Short Quantity	Low	Service	All Products	Product
Shipping Damage	Low	Service	All Products	Product
Unknown	Low	New	All Products	All
All Failure Modes above would be setup under the Product Failure Mode Setup table. The first three Failure Modes would show up as applicable failures for any parts selected in a product exception as these are tied to Product Exception Types. The last Failure Mode listed above would show up as an applicable failure for any parts selected in ANY exception type which tracks product failures.
Battery Failure	Fatal	Malfunction	Any Sensors	Product
Short Circuit	High	Malfunction	Any Sensors	Product
Power Failure	Fatal	Malfunction	Any Sensors	Product
All three failure modes directly above would be setup under the Failure Mode Setup table under the Sensors Product Line. These failure modes would show up as applicable failures for any parts selected in a product exception that belong to the Sensor Product Line only.
Leak	Medium	Visual	Toxic Gas Sensors 1234	Product
The failure mode directly above (Leak) would be setup under the Failure Mode Setup table under Part Number Toxic Gas Sensors 1234. This failure mode would show up as an applicable failure only if this specific part number is selected in a product exception.
Crack	Medium	Visual	EKG Sensors 2235	Product
The failure mode directly above (Crack) would be setup under the Failure Mode Setup table under Part Number EKG Sensors 2235. This failure mode would show up as an applicable failure only if this specific part number is selected in a product exception.

How to Create Product Failure Modes

1. From the SmartSolve© tabs select Admin > Setup. Under Product select Product Failure Mode.

2. Right click and select Add.

3. Enter information in the failure fields.

See Failure Mode Definitions for more information.

4. Click the Save button.

Failure Mode Definitions

Field		Definition
Failure	Failure name.
Description	Description of the failure.
Status	Status can be selected from the drop down list.
Exception Type	An exception type can be selected from the drop down list.
Analysis Code	An additional field used to run analysis
Volume Tolerance	Volume Tolerance can be configured within each specific Failure Mode to trigger the Status of the failure to change to SUSPECT and notify affected parties that this tolerance has been met and further action needs to be taken on this exception. Volume Tolerance is based on number of defective parts (Quantity Affected or Serialized) entered under the Lot Section of the exception form.
Severity	This field usually matches your FMEA’s. How severe is the failure on this particular product/process)? Please see Severity
Within	Enter information if necessary.
Failure Category	This field is used for sorting exceptions and failures. Category is a way to group different failure modes for better reporting. Please see Failure Category
Count Tolerance	Count Tolerance can be configured within each specific Failure Mode to trigger the Status of the Failure to change to SUSPECT and notify affected parties that this tolerance has been met and further action needs to be taken on this Exception. Count Tolerance is based on number of Exception records are created in the system based on this Failure Mode.
Est. Cost	This field is used by the quality team to identify the cost of this failure. You can run pareto reports in the system to determine the cost and number of failures that are occurring.
Exception Type	Failure modes can be specific to an Exception Type (i.e., Product Failures, Complaints, Operation Failures, general failures, etc.). The system filters the failure modes by Exception Type. Please see Exception Type
Status	Failure Mode Status (may be managed by Product/Process Engineer). Active - Indicates the failure mode has occurred recently. Inactive - Indicates the failure mode has not occurred recently. Failures with this status will not be present in the exception created. New – Indicates the failure mode is being recorded for the first time. Suspect - Based on the failure mode tolerances. The Count Tolerance and Volume Tolerance of each failure mode are monitored as exceptions are recorded. When either the Count Tolerance or Volume Tolerance is reached, the application changes the failure mode's status to SUSPECT.
	NOTE: The system will send an email if SUSPECT status is reached in the failure mode.

How to Create Product Line Specific Failure Modes

1. From the SmartSolve© tabs select Admin > Setup. Under Product select Product Line.

The Product Lines window displays.

Please see How to Create Product Lines

2. From the product lines list click over the product line and select Failure Mode.

3. Right click and select Add.

5. Enter information in the failure fields.

See Failure Mode Definitions for more information.

4. Click the Save button.

How to Create Part Specific Failure Modes

1. From the SmartSolve© tabs select Admin > Setup. Under Product select Part.

Please see How to Create Parts

2. From the Parts list left click over the Part and select Failure Mode.

3. Right click and select Add.

4. Enter information in the failure fields.

See Failure Mode Definitions for more information.

5. Click the Save button.

Process Failure Mode Setup

There are three setup tables in SmartCAPATM where Product Failure Modes can be configured. Before setting up Failure Modes, it is important to first understand how each table works.

Setup	Description
Process Failure Modes	Setup any failures that could occur for any operations (internal/external) under this setup table (i.e., Delivery, Quantity Failures).
Standard Operation Failure Modes	Setup any failures that could occur for any operations attached to the associated Standard Operation (Standard Operation specific Failures).
Operation Failure Modes	Setup any failures that could occur only for the specified operation.

Example Process Failure Mode Matrix

Failure Mode	Severity	Failure Mode Category	Operation	Exception Type
Unauthorized Activity	HIGH	Internal Fraud	All Operations	Process
Theft and Fraud	HIGH	Internal Fraud	All Operations	Process
Systems Security	HIGH	External Fraud	All Operations	Process
Injury	HIGH	Workplace Safety	All Operations	Process
Natural Disaster	HIGH	Asset Damage	All Operations	Process
All failure modes above would be setup under the Process Failure Mode Setup table. The first three failure modes would show up as applicable failures for any operations selected in a Process Exception as these are tied to Process Exception Types.
Equipment Failures	HIGH	Downtime	MFG Operations	Process
Setup and Adjustments	HIGH	Downtime	MFG Operations	Process
Idling and Minor Stoppages	HIGH	Speed Loss	MFG Operations	Process
Reduced Speed Operation	HIGH	Speed Loss	MFG Operations	Process
Scrap and Rework	HIGH	Defect Loss	MFG Operations	Process
Startup Loss	HIGH	Defect Loss	MFG Operations	Process
All six Failure Modes directly above would be setup under the Failure Mode Setup table under the MFG Operations Standard Operation. These Failure Modes would show up as applicable failures for any operations selected in a Process Exception that belong to the MFG Standard Operation only.
Wrong Temperature	HIGH	Electrical	Injection Moulding	Process
No Power	HIGH	Electrical	Injection Moulding	Process
The two Failure Modes directly above would be setup under the Failure Mode Setup table under the Operation for Injection Moulding. This Failure Mode would show up as an applicable failure only if this specific operation is selected in a Process Exception.
Wrong Label	HIGH	Visual	Labeling	Process
Missing Barcode	HIGH	Visual	Labeling	Process
The two Failure Modes directly above would be setup under the Failure Mode Setup table under the Operation for Labeling. This Failure Mode would show up as an applicable failure only if this specific operation is selected in a Process Exception.

How to Create Process Failure Modes

1. From the SmartSolve© tabs select Admin > Setup. Under Process select Process Failure Mode.

The Process Failure Modes list displays.

2. Right click and select Add.

3. Enter information in the failure fields.

See Failure Mode Definitions for more information.

4. Click the Save button.

How to Create Standard Operation Specific Failure Modes

Please see How to Create Standard Operations.

2. From the Standard Operations list click over the Standard Operation.

3. Select Failure Mode.

4. Right click and select Add.

5. Enter information in the failure fields.

See Failure Mode Definitions for more information.

6. Click the Save button.

How to Create Operation Specific Failure Modes

Please see How to Create Operations

2. From the Operations list left click over the Operation and select Failure Mode.

3. Right click and select Add.

4. Enter information in the failure fields.

See Failure Mode Definitions for more information.

5. Click the Save button.

Managing Failure Mode Data

The following options are available within Failure Mode objects and can be managed accordingly by an administrator:

· Failure Modes can be edited and deleted.

· Failure Modes can be deactivated if no longer used by changing their status at anytime to INACTIVE.

Failure Mode Definitions

Field	Definition
Analysis Code	An additional field used to run analysis.
Severity	This field usually matches your FMEA’s. How severe is the failure on this particular product/process)? Please see Severity
Failure Category	This field is used for sorting Exceptions and Failures. Category is a way to group different failure modes for better reporting. Please see Failure Category
Est. Cost	This field is used by the quality team to identify the cost of this failure. You can run Pareto reports in the system to determine the cost and number of failures that are occurring.
Exception Type	Failure modes can be specific to an Exception Type (i.e., Product Failures, Complaints, Operation Failures, general failures, etc.). The system filters the failure modes by Exception Type. Please see Exception Type
Status	Failure Mode Status (may be managed by Product/Process Engineer). Active - Indicates the failure mode has occurred recently. Inactive - Indicates the failure mode has not occurred recently. Failures with this Status will not be present in the Exception created). New - Indicates the failure mode is being recorded for the first time. Suspect - Based on the failure mode tolerances. The Count Tolerance and Volume Tolerance of each failure mode are monitored as Exceptions are recorded. When either the Count Tolerance or Volume Tolerance is reached, the application changes the failure mode's status to SUSPECT.
	NOTE: The system will send an email if SUSPECT Status is reached in the failure mode.
Volume Tolerance	Volume Tolerance can be configured within each specific Failure Mode to trigger the Status of the failure to change to SUSPECT and notify affected parties that this tolerance has been met and further action needs to be taken on this Exception. Volume tolerance is based on number of defective parts (Quantity Affected or Serialized) entered under the Lot Section of the Exception form. If volume tolerance is met before the "within" time frame, and email can be sent to a fixed user or group. Please see SmartCommTM Notification Services for more information on how to setup the failure mode notification message.
Count Tolerance	Volume Tolerance can be configured within each specific Failure Mode to trigger the Status of the Failure to change to SUSPECT and notify affected parties that this tolerance has been met and further action needs to be taken on this Exception. Volume tolerance is based on number of defective parts (Quantity Affected or Serialized) entered under the Lot Section of the Exception form. If count tolerance is met before the "within" time frame, and email can be sent to a fixed user or group. Please see SmartCommTM Notification Services for more information on how to setup the failure mode notification message.

How to Edit Failure Modes

1. From the SmartSolve© tabs select Admin > Setup. Under Product select Product Failure Mode. Or, under Process select Process Failure Mode.

The object list displays.

2. Select the check box of the Failure Mode to edit, then select Action > Edit from the main menu (or right click).

3. Edit any information for your Failure Mode.

4. Click the Save button.

All changes should now be reflected in the list.

How to Delete Failure Modes

Failure Modes can only be deleted from SmartSolve© if the Failure Modes have not been attached to any SmartSolve© records.

1. From the SmartSolve© tabs select Admin > Setup. Under Product select Product Failure Mode. Or, under Process select Process Failure Mode.

The object list displays.

2. Select the check box of the Failure Mode to delete, then select Action > Delete from the main menu (or right click).

3. Click the Save button.

The object has now been removed from the system.

Object

Shared with other SmartSolve© Applications

Required for SmartCAPATM

Criteria

Description

Tracking Failure with SmartCAPATM

Rights

Description

Setup

Description

Failure Mode

Severity

Failure Mode

Category

Product

Exception

Type

Field

Definition

Setup

Description

Failure Mode

Severity

Failure Mode

Category

Operation

Exception

Type

Failure Mode Definitions

Field

Definition