Warranty Claims, Complaints, and FMEA#
Overview#
The Complaints Management functionality helps you handle warranty claims and customer complaints that concern products or services provided by your organization.
Based on ISO 9001:2015 and ISO 13485:2016, “claim” and “complaint” have the following meaning when used in KUMAVISION base (BOOSTER):
Claim
Refers to a specific product or service and grants legal remedies should the product or service not be up to standard.
Complaint
Voices displeasure with the quality of a product or service.
When you receive a claim or complaint, you can enter in the system the people and products or services written on the document and the staff members who will investigate or review the matter. Staff can also look at the purchase, sales, service, or production documents that might be relevant to the case.
The claim or complaint can then be reviewed, with the aim of taking preventive or corrective actions to remedy or mitigate failures. The effectiveness of these measures can later be evaluated as part of a failure mode and effects analysis (FMEA).
Note
You need separate licenses before you can use Complaints Management and FMEA functions.
Setup#
Claims and complaints#
Warranty Claims & Complaints Setup#
To be able to enter claims and complaints in the system, you must turn on the functionality first.
- Choose the Search icon, enter Warranty Claims & Complaints Setup, and then choose the related link.
- Fill in the fields as described in the following table.
General#
| Field | Description |
|---|---|
| Contact Creation | Specify whether you want a contact created automatically when you receive a claim or complaint by a person or organization not yet stored in the system. |
| Update Contact | Specify whether data for an existing contact who is involved in a claim or complaint should be updated if some of the information given on the document differs from what is stored in the system. |
| Check Digital Signature | Turn on this toggle if a user’s signature should be required when a complaint, claim, or FMEA card is released, reopened, archived, or deleted. |
Note
If you’re using KUMAVISION medtec365, you can see additional options for adjusting transaction codes on this page. For more information, click here.
Warranty Claims#
In the Warranty Claim Nos. field, specify a number series that will be used for warranty claims.
For all other fields, use the Create Permissions action on the ribbon to assign codes to functions for which permissions should be checked.
Complaints#
In the Complaint Nos. field, specify a number series that will be used to assign numbers to complaints.
For all other fields, use the Create Permissions action on the ribbon to assign codes to functions for which permissions should be checked.
Ribbon Function#
Choose Create Permissions to have permission codes initialized during setup of the functionality and copied to the Claim & Complaint Permissions page.
Note
Do not rerun this function after the permission codes have been initialized.
Claim & Complaint Permissions#
For more information on how to initialize the values shown on this page, see Warranty Claims & Complaints Setup.
For users to be able to view claims or complaints, they must have at least the Read permission assigned to an associated permission group.
Claim & Complaint Permission Groups#
On this page, claim and complaint permissions can be grouped on the lines.
Note
The Super permission group must contain each individual permission for a claim or complaint.
Warranty Claims & Complaints User Setup#
To specify who can use the functionality and store their digital signatures:
- Choose the Search icon, enter Warranty Claims & Complaints User Setup, and then choose the related link.
- On the ribbon, choose New.
- Fill in the fields as described in the following table.
| Field | Description |
|---|---|
| User ID | Select the ID of the user for whom you want to enter a digital signature. |
| Digital Signature | Specify the user’s digital signature. |
| Signature Blocked | Turn on the toggle if you want to block this signature from being used. |
| Signature Fail Count | Shows the number of times the wrong signature was entered. Following three failed attempts, the Signature Blocked toggle turns on automatically. The reason for blocking the sign-off is then shown in the Signature Blocking Reason field. |
| Signature Blocking Reason | Shows why the signature was blocked. |
| Reset Signature | With the toggle turned on, the signature needs to be updated before it can be used again. |
You can then assign permissions in groups to a user authorized to manage claims and complaints:
- Select the line on which to find the relevant user.
- On the ribbon, choose Claim & Complaint Permission Groups.
Any number of groups can be assigned to the user. If a specific permission is required for a complaint, the user must have this permission in at least one of the assigned groups.
Failures#
On the Analysis FastTab of claims and complaints, you can specify a code for every category of failures that you want to record. For a complete, meaningful evaluation of claims and complaints, each of these categories needs to cover as many defects and errors as possible. To set up a code:
- Choose the Search icon, enter Failure Categories, and then choose the related link.
- On the ribbon, choose New.
- Fill in the fields as described in the following table.
| Field | Description |
|---|---|
| Code | Specify a code that clearly identifies the failure. |
| Type | Specify for which document the code can be selected. (blank) You can select this category on claims and complaints. Complaint The category is only available for complaints. Warranty Claim The category is only available for claims. |
| Description | Here you can enter a more detailed description of the error. |
| Description 2 | Here you can enter even more details. |
| Case Type Code | Specify for which type of case the code can be selected. |
| Case Subtype Code | Specify for which subtype of a case the code can be selected. |
The type and subtype specified for a claim or complaint determine the codes available on the Analysis FastTab of the claim or complaint card. If no type or subtype has been specified, all codes will be available for selection, including those that haven’t been assigned anywhere.
Note
The system doesn’t check if the case type or subtype that you selected is valid.
Authorities#
To set up the authorities to which incidents must be reported:
- Choose the Search icon, enter Authorities, and then choose the related link.
- On the ribbon, choose New.
- Fill in the fields as described in the following table.
| Field | Description |
|---|---|
| Code | Specify a code for the agency to which incidents must be reported. |
| Description | Enter a brief description of the agency. |
Government authorities that must be notified of certain claims or complaints are later entered on the Analysis FastTab of a claim or complaint card.
Reasons for rejecting cases#
To specify reasons why a claim or complaint might have been rejected:
- Choose the Search icon, enter Case Rejection Reasons, and then choose the related link.
- On the ribbon, choose New.
- Fill in the fields as described in the following table.
| Field | Description |
|---|---|
| Code | Specify a code for the rejection reason. The code must be unique. |
| Description | Describe why the claim or complaint is being rejected. |
| Relevant to Statistics | Specify if the rejection reason should be included in statistical analyses. This checkbox can be used for informational purposes or as part of BI functionality. |
| Default | Select a procedure that the system needs to follow in certain situations. (blank) No default procedure to follow. Closed by Class Change If you reclassify a warranty claim or complaint, the system will archive the document with this option selected in the Rejection Reason Code field on the claim or complaint card. |
A rejection reason code must be filled in when the Justified field on a claim or complaint card that you want to close has been set to No. The codes can be found on both open and archived document lists.
Types and subtypes of cases#
To specify case types:
- Choose the Search icon, enter Case Types, and then choose the related link.
- On the ribbon, choose New.
- Fill in the fields as described in the following table.
| Field | Description |
|---|---|
| Code | Specify a code for the type. The code must be unique. |
| Description | Specify a description for the type. |
| No. of Case Subtypes | Indicates the number of subtypes assigned to this type. You can select this field to see the subtypes. |
To assign subtypes to a certain type:
- Select the highlighted No. of Case Subtypes field. Alternatively, select a line and choose Case Subtypes on the ribbon.
- Fill in the fields as described in the following table.
| Field | Description |
|---|---|
| Code | Specify a code for the subtype. The code must be unique. |
| Description | Specify a description for the subtype. |
Both types and subtypes might be linked to a claim or complaint, for example, to distinguish between complaints by document type. You assign them to documents in the fields described in the following table.
| Field | Description |
|---|---|
| Type | Select a case type from the Case Types page. |
| Subtype | Select a subtype from the Case Subtype page based on the type of case specified. |
Although archived claims and complaints also include these types, you cannot edit them there.
Actions#
Mitigation and remedial measures can be maintained in the system as stand-alone actions or in the context of specific claims, complaints, or FMEAs. For this reason, they cannot be specified in Warranty Claims & Complaints Setup.
Action Setup#
To set up actions for use throughout the system:
- Choose the Search icon, enter Action Setup, and then choose the related link.
- Fill in the fields as described in the following table.
General#
| Field | Description |
|---|---|
| Action Nos. | Specify the number series that will be used for actions. |
| Action Data Check | Turn on this toggle if you want to activate the mandatory field check feature for actions. |
| Check Risk Assessment Texts | Specify if risk assessment texts need to be available when an action card is closed or an FMEA (or an archived FMEA) has been linked to the action. |
Permissions#
On this FastTab, codes are assigned to functions for which permission checks should be performed. To initialize these codes, choose Create Permissions on the ribbon.
For users to be able to view actions, they must have at least the Read permission assigned to an associated permission group.
Note
Do not rerun this function after the permission codes have been initialized.
Action Permissions#
For more information on how to initialize the values shown on this page, see Actions Setup.
Action Permission Groups#
On this page, action permissions can be grouped on the lines.
Action User Setup#
Here you can assign permissions in groups to a user authorized to manage actions. To assign a group:
- Select the line on which to find the relevant user.
- On the ribbon, choose Action Permission Groups.
Any number of groups can be assigned to the user. If a specific permission is required for an action, the user must have this permission in at least one of the assigned groups.
Note
The setup on this page doesn’t replace the roles and permissions specified for a user elsewhere in the system.
Case CAPA#
CAPA stands for Corrective and Preventive Actions. This quality management subsystem is part of the continuous improvement process (CIP).
A CAPA process ensures GMP-compliant work through identifying deviations from a specified standard before corrective and preventive actions are taken.
Note
CAPA are used to immediately correct a failure and avoid further repercussions.
To set up a procedure:
- Choose the Search icon, enter Case CAPA, and then choose the related link.
- Fill in the fields as described in the following table.
| Field | Description |
|---|---|
| Code | Specify a code for the CAPA. |
| Type | Specify for which type of action the code can be selected: • (blank) • Corrective • Preventive |
| Description | Specify a description for the CAPA. |
| Description 2 | Enter a more detailed description of the CAPA if necessary. |
CAPA codes are used on action cards in the Action Code field on the General FastTab. What codes are available depends on what you choose in the Action Type field there.
FMEA#
FMEA, which is short for Failure Mode and Effects Analysis, is used to assess the risks associated with an error or a defect. Because FMEAs can be created from actions or as stand-alone solutions, you cannot specify them in Warranty Claims & Complaints Setup.
FMEA Risk Matrix Field Setup#
Before you can work with risk matrices, you must specify a color scheme for the graphs.
Based on a set of x and y coordinates [(1|1) – (4|4)], these colors can then help you visualize, for example, if the severity or effect probability associated with a certain failure has changed since the last time you printed a matrix for it. To initialize the colors:
- Choose the Search icon, enter FMEA Risk Matrix Setup, and then choose the related link.
- Select a line and fill in the fields as described in the following table.
- Repeat the process until a color has been specified for all coordinates.
| Field | Description |
|---|---|
| X Axis | Specify the X coordinate (1 – 4) that will be assigned to this line on the matrix. |
| Y Axis | Specify the X coordinate (1 – 4) that will be assigned to this line on the matrix. |
| Field No. | Select what field content should be shown at the coordinates entered in the X Axis and Y Axis fields. |
| Field Caption | Shows the caption of the matrix field that you selected a Field No. for. |
You can also choose New > Initialize on the ribbon to have the system set up a default color scheme or reset the current matrix to those default values.
FMEA Setup#
To set up FMEAs for use throughout the system:
- Choose the Search icon, enter FMEA Setup, and then choose the related link.
- Fill in the fields as described in the following.
General#
In the FMEA Nos. field, specify the number series that will be used for analyses.
Permissions#
On this FastTab, codes are assigned to functions for which permission checks should be performed. To initialize these codes, choose Create Permissions on the ribbon.
Note
Do not rerun this function after the permission codes have been initialized.
Indicators#
On this FastTab, specify the indicators that will be shown on FMEA lines when the analyzed values exceed certain risk priority thresholds.
| Field | Description |
|---|---|
| Green Light | Select this field to choose an image file that, as part of a traffic light system, should represent the green light on FMEA lines. |
| Yellow Light | Select this field to choose an image file that, as part of a traffic light system, should represent the yellow light on FMEA lines. |
| Red Light | Select this field to choose an image file that, as part of a traffic light system, should represent the red light on FMEA lines. |
Note
Changing the files will not update the images that have already been in use on open and archived FMEA lines unless you also change something else on these lines.
FMEA Permissions#
For more information on how to initialize the values shown on this page, see FMEA Setup.
FMEA Permission Groups#
On this page, FMEA permissions can be grouped on the lines.
For users to be able to view analyses, they must have at least the Read permission assigned to an associated permission group.
FMEA User Setup#
Here you can assign permissions in groups to a user authorized to perform analyses:
- Select the line on which to find the relevant user.
- On the ribbon, choose FMEA Permission Groups.
Any number of groups can be assigned to the user. If a specific permission is required for an analysis, the user must have this permission in at least one of the assigned groups.
Note
Only users entered on this page can view, create, or edit FMEAs.
Internal claims and complaints#
You can also register claims and complaints that arise within a company, for example, while a product is being manufactured. To set up a case that will be handled internally:
- Create a new contact card and fill in your company information.
- Select Internal on the card.
- Proceed as if the claim or complaint came from an external contact.
Register a warranty claim#
To register a claim in the system:
- Open the card of an existing contact, customer, or vendor for which you want to register a claim.
- Choose New Case on the ribbon.
- Choose Warranty Claim.
- The data stored for the contact, customer, or vendor is then copied to the claim automatically. The other fields must be filled in as described in the following table.
Note
This is the only way to register a claim in the system; you cannot choose New on the ribbon of a warranty claim list.
General#
| Field | Description |
|---|---|
| No. | Shows the number of the claim document. This number is assigned by the system and cannot be changed manually. |
| Description | Enter a brief text that describes the claim. |
| Type | Specify if the claim was received internally or from a vendor or customer. |
| Vendor No. Customer No. |
Based on the type of claim, one of these fields might be filled in automatically. If the wrong vendor or customer has been entered, you must create a new record and close the current case. |
| Contact No. | This field is always filled in and cannot be changed. |
| Name Name 2 |
Based on the type of claim, these fields show the name and additional name of a vendor, customer, or contact. |
| Note | Shows if notes have been entered for a customer or vendor. |
| Justified | Specify if the claim is justified. (blank) The claim has not been classified yet. Yes Is justified. No Is not justified. Goodwill Is accepted because of a goodwill policy. Classifying the claim will open an editor in which you must enter the reason for the classification. Without entering something there, the claim cannot be (re)classified. |
| Justification Text | Selecting Yes in the Justified field will open an editor in which you must enter a text to explain why the claim is considered justified. Only the first line of text entered in the editor will later be shown in this field, regardless of whether the line comes from a justification or analysis. You can adjust this in the editor. Changes to the text will be added as new versions to the description of the analysis. |
| Rejection Reason Code | Select a code for why the claim was rejected. You can only select a code if the Justified field is set to No; you can then close the case if necessary. Changing the Justified field will remove the code in this field. |
| Rejection Reason Description | Shows a text that describes the rejection. |
| Status | Indicates the status of the claim. Open The document can be edited. Released The document requires only final review. If the signature feature has been turned on, the status will not change until the specified signature has been entered. |
| Source No. | If the claim was created by converting a complaint, this field is filled in with the number of the complaint document. |
| Case Type Code | Choose a code to specify the type of case being handled. |
| Case Subtype Code | Choose a code to specify the subtype of the case. |
| Assigned User ID | Select an ID in this field to assign a user to the claim. |
| No. of FMEAs | Shows the number of analyses linked to the claim. |
| No. of Archived FMEAs | Shows the number of archived analyses linked to the claim. |
| No. of FMEA Actions | Shows the number of FMEA actions implemented to resolve the claim. |
| No. of Archived FMEA Actions | Shows the number of archived FMEA actions implemented to resolve the claim. |
Reported By#
This FastTab shows the person who made the claim.
If the person has been entered as a contact, data from the contact master is entered automatically on this FastTab. With a CTI system connected to Microsoft Dynamics 365 Business Central1, you can also call the person from the app.
Other contacts can be entered on the following lines. For people already in the system, this means that each contact linked to the person who made the claim can be chosen in the No. field.
The details of these contacts are then filled in by the system if automatic contact creation has been turned on in Warranty Claims & Complaints Setup. Else, you need to fill in the line fields manually.
Reported For#
This FastTab is used to enter the items, services (resources or G/L accounts), and other things that were named in the claim and that the person who made the claim has reported issues with.
You can also have the lines filled in with data from documents available in the system. For more information, see Ribbon Actions.
If you fill in the lines manually, you should do so field by field, starting with the Type field. This ensures that, for example, you can enter things not maintained in the app—for example, because a warranty claim had not been resolved prior to switching to another software system.
Registration Text#
On this FastTab, you can use a plain text editor to note down the conversation that led to registering the case in the system. Choose New Text on the ribbon to make an entry. When you’re finished, the text will be displayed on the tab.
Texts are versioned. For more information on how to enter text here, see Enter Text.
Analysis#
On this FastTab, you can document the analysis of the issues named on the claim document.
| Field | Description |
|---|---|
| Analyzed On Analyzed By |
These fields specify who analyzed the claim and when. |
| Analysis Reviewed On Analysis Reviewed By |
These fields specify who checked the analysis and when. Note The user who checks the analysis cannot also be the user who performed it (dual control principle). |
| Notification Required | Turn on this toggle if the warranty claim must be reported to the authorities. |
| Notifications to Authorities | Indicates how many notifications are related to the case. You can select the blue hyperlink to view or enter notifications. Note You cannot transmit notifications from Microsoft Dynamics 365 Business Central1. |
| Assigned Failures | On this FastTab, you can categorize the errors or defects that were found during analysis by using the failure codes set up in the system. You must fill in the Failure Code field here. The Description and Description 2 fields are filled in from Warranty Claims & Complaints Setup. |
| Analysis Text | Shows the analysis and justification texts that have already been entered in the system. |
Assigned Actions#
On this tab, you can link preventive and corrective actions to open claims or create new action cards based on the claims for use on other documents.
All actions are managed on cards. Actions created or entered for a claim are transferred along when you archive the document.
Note
You can only close claims for which all actions have been set to Implemented.
| Field | Description |
|---|---|
| Action Card No. | Specify the action card that you want to assign to the claim. |
| Failure Code | Assign a failure code to the claim. If an action is created from the Analysis FastTab, the failure code used for analysis will be copied to the card created for this action. |
| Description | Shows the description of the action as specified on the related action card. |
| Description 2 | Shows the additional description of the action as specified on the related action card. |
| Status | Shows the status of the action as specified on the related action card. |
| Action Type | Shows the type of the action as specified on the related action card. |
| Action Code | Shows the code of the action as specified on the related action card. |
| Successful | Shows the content of the field from the related action card. |
| No. of FMEAs | Shows the number of FMEAs entered on the action card. |
| No. of FMEA Actions | Shows the number of FMEA actions entered on the action card. |
| No. of Archived FMEAs | Shows the number of archived FMEAs specified on the action card. |
| No. of Archived FMEA Actions | Shows the number of archived FMEA actions specified on the action card. |
Ribbon actions#
Based on whether the claim you registered came from a customer, a vendor, or an internal source, the ribbon found on the warranty claim card will display different functions.
To open a customer or vendor card or the contact list, choose Home and the corresponding option.
To retrieve data from a vendor or customer document, choose Get Document and the relevant document.
If a complaint comes from an internal source, some of the functions might be grayed out or might only be available to a limited extent, considering there are no outbound documents to manage.
To change the status of a complaint, choose Status and the relevant option.
To enter text for registration, analysis, or in other situations, choose Actions > Functions > New Text. For more information, see Enter Text.
To print a claim, choose Print > C & C Sheet. You can then fill in the No. of Copies field to specify how many copies of the document you want printed and choose what to include on each by turning toggles on or off.
To create a new action for a claim, choose Create Action on the ribbon. To create a new FMEA, choose Create FMEA.
To reclassify a claim, choose Actions > Functions > Change Classification.
For a list of who created, edited, or deleted entries on a complaint, choose Related > Change Log on the ribbon.
Edit a claim#
To change information on a warranty claim:
- Choose the Search icon, enter Warranty Claims, and then choose the related link.
- Select a claim and choose Edit on the ribbon.
- You can now add details to the document, such as the items named on the document (by filling in the relevant fields on the Issues Reported For FastTab).
If you also want to perform an FMEA (only possible from a claim or an action), choose Create FMEA on the ribbon. For more details on how errors or defects can be analyzed, see Perform an analysis.
When all required data has been entered, the claim can be released by choosing Release on the ribbon.
Note
If the release of the claim requires your signature, you need to sign in the Digital Signature field on the query that appears and choose OK.
The claim is then released. It’s not closed yet.
Register a complaint#
To set up a complaint in the system:
- Open the card of an existing contact, customer, or vendor for which you want to register a complaint.
- Choose New Case on the ribbon.
- Choose Complaint.
- The data stored for the contact, customer, or vendor is then copied to the complaint automatically. The other fields must be filled in as described in the following table.
Note
This is the only way to register a complaint in the system; you cannot choose New on the ribbon of a complaint list.
General#
| Field | Description |
|---|---|
| No. | Shows the number of the complaint document. This number is assigned by the system and cannot be changed manually. |
| Description | Enter a brief text that describes the complaint. |
| Type | Specify if the complaint was received internally or from a vendor or customer. |
| Vendor No. Customer No. |
Based on the type of complaint, one of these fields might be filled in automatically. If the wrong vendor or customer has been entered, you must create a new record and close the current case. |
| Contact No. | This field is always filled in and cannot be changed. |
| Name Name 2 |
Based on the type of complaint, these fields show the name and additional name of a vendor, customer, or contact. |
| Note | Shows if notes have been entered for a customer or vendor. |
| Justified | Specify if the complaint is justified. (blank) The complaint has not been classified yet. Yes Is justified. No Is not justified. Goodwill Is accepted because of a goodwill policy. Classifying the complaint will open an editor where you must enter the reason for the classification. Without entering something there, the complaint cannot be (re)classified. |
| Justification Text | Filling in the Justified field will open an editor in which you must enter a text to describe why the complaint is justified. Only the first line of text entered in the editor will later be shown in this field, regardless of whether the line comes from a justification or analysis. You can adjust this in the editor. Changes to the text will be added as new versions to the description of the analysis. |
| Rejection Reason Code | Select a code for why the complaint was rejected. You can only select a code if the Justified field is set to No; you can then close the case if necessary. Changing the Justified field will remove the code in this field. |
| Rejection Reason Description | Shows a text that describes the rejection. |
| Status | Indicates the status of the complaint. Open The document can be edited. Released The document requires only final review. If the signature feature has been turned on, the status will not change until the specified signature has been entered. |
| Source No. | If the complaint was created by converting a warranty claim, this field is filled in with the number of the claim document. |
| Case Type Code | Choose a code to specify the type of case being handled. |
| Case Subtype Code | Choose a code to specify the subtype of the case. |
| Assigned User ID | Select an ID in this field to assign a user to the complaint. |
| No. of FMEAs | Shows the number of analyses linked to the complaint. |
| No. of Archived FMEAs | Shows the number of archived analyses linked to the complaint. |
| No. of FMEA Actions | Shows the number of FMEA actions implemented to resolve the complaint. |
| No. of Archived FMEA Actions | Shows the number of archived FMEA actions implemented to resolve the complaint. |
Reported By#
This FastTab shows the person who made the complaint.
If the person has been entered as a contact, data from the contact master is entered automatically on this FastTab. With a CTI system connected to Microsoft Dynamics 365 Business Central1, you can also call the person from the app.
Other contacts can be entered on the following lines. For people already in the system, this means that each contact linked to the person who made the complaint can be chosen in the No. field.
The details of these contacts are then filled in by the system if automatic contact creation has been turned on in Warranty Claims & Complaints Setup. Else, you need to fill in the line fields manually.
Reported For#
This FastTab is used to enter the items, services (resources or G/L accounts), and other things that were named in the complaint and that the person who made the complaint has reported issues with.
You can also have the lines filled in with data from documents available in the system. For more information, see Ribbon Actions.
If you fill in the lines manually, you should do so field by field, starting with the Type field. This ensures that, for example, you can enter things not maintained in the app—for example, because a complaint had not been resolved prior to switching to another software system.
Registration Text#
On this FastTab, you can use a plain text editor to note down the conversation that led to registering the case in the system. Choose New Text on the ribbon to make an entry. When you’re finished, the text will be displayed on the tab.
Texts are versioned. For more information on how to enter text here, see Enter Text.
Analysis#
On this FastTab, you can document the analysis of the issues named on the complaint document.
| Field | Description |
|---|---|
| Analyzed On Analyzed By |
These fields specify who analyzed the complaint and when. |
| Analysis Reviewed On Analysis Reviewed By |
These fields specify who checked the analysis and when. Note The user who checks the analysis cannot also be the user who performed it (dual control principle). |
| Notification Required | Turn on this toggle if the complaint must be reported to the authorities. |
| Notifications to Authorities | Indicates how many notifications are related to the case. You can select the blue hyperlink to view or enter notifications. Note You cannot transmit notifications from Microsoft Dynamics 365 Business Central1. |
| Assigned Failures | On this FastTab, you can categorize the errors or defects that were found during analysis by using the failure codes set up in the system. You must fill in the Failure Code field here. The Description and Description 2 fields are filled in from Warranty Claims & Complaints Setup. |
| Analysis text | Shows the analysis and justification texts that have already been entered in the system. |
Assigned Actions#
On this tab, you can link preventive and corrective actions to open complaints or create new action cards based on the complaints for use on other documents.
All actions are managed on cards. Actions created or entered for a complaint are transferred along when you archive the document.
Note
You can only close complaints for which all actions have been set to Implemented.
| Field | Description |
|---|---|
| Action Card No. | Specify the action card that you want to assign to the complaint. |
| Failure Code | Assign a failure code to the complaint. If an action is created from the Analysis FastTab, the failure code used for analysis will be copied to the card created for this action. |
| Description | Shows the description of the action as specified on the related action card. |
| Description 2 | Shows the additional description of the action as specified on the related action card. |
| Status | Shows the status of the action as specified on the related action card. |
| Action Type | Shows the type of the action as specified on the related action card. |
| Action Code | Shows the code of the action as specified on the related action card. |
| Successful | Shows the content of the field from the related action card. |
| No. of FMEAs | Shows the number of FMEAs entered on the action card. |
| No. of FMEA Actions | Shows the number of FMEA actions entered on the action card. |
| No. of Archived FMEAs | Shows the number of archived FMEAs specified on the action card. |
| No. of Archived FMEA Actions | Shows the number of archived FMEA actions specified on the action card. |
Ribbon actions#
Based on whether the complaint you registered came from a customer, a vendor, or an internal source, the ribbon found on the complaint card will display different functions.
To open a customer or vendor card or the contact list, choose Home and the corresponding option.
To retrieve data from a vendor or customer document, choose Get Document and the relevant document.
If a complaint comes from an internal source, some of the functions might be grayed out or might only be available to a limited extent, considering there are no outbound documents to manage.
To change the status of a complaint, choose Status and the relevant option. To enter text for registration, analysis, or in other situations, choose Actions > Functions > New Text. For more information, see Enter Text.
To print a complaint, choose Print > C & C Sheet. You can then fill in the No. of Copies field to specify how many copies of the document you want printed and choose what to include on each by turning toggles on or off.
For a list of who created, edited, or deleted entries on a complaint, choose Related > Change Log on the ribbon.
Edit a complaint#
To change information on a complaint:
- Choose the Search icon, enter Complaints, and then choose the related link.
- Select a complaint and choose Edit on the ribbon.
- You can now add details to the document, such as the name and ID of the second person who will be participating in dual-control procedures (by filling in the relevant fields on the Analysis FastTab).
For more information, see Analysis. When all required data has been entered, the complaint can be released by choosing Release on the ribbon.
Note
If the release of the complaint requires your signature, you need to sign in the Digital Signature field on the query that appears and choose OK.
The complaint is then released. It’s not closed yet.
Convert a claim to a complaint#
If, when you process a warranty claim, you determine that what you’re working on reads more like a complaint than a claim with a legal basis, you can create a complaint from the document that you originally registered in the system as a claim while keeping the information you’ve already recorded.
To convert a claim:
- Choose the Search icon, enter Warranty Claims, and then choose the related link.
- Open the claim that you want to convert into a complaint. The status of a released claim will be reset during this process.
- On the ribbon, choose Change Classification and choose OK.
The claim is then converted, and all available information is transferred to the complaint. Afterward, the original claim will be closed and archived.
Reclassification is indicated on a claim in the Rejection Reason Code and the Rejection Reason Text fields. For the fields to be filled in, you must have set them up as described under Reasons for Rejecting Cases.
You can open an archived claim that is the source of a complaint by clicking the highlighted portion of the Source No. field on the complaint card. After you’ve finished filling in the new complaint document, choose OK to exit.
Convert a complaint to a claim#
If, when you process a complaint, you determine that the case you’re working on reads more like a warranty claim, you can create a warranty claim from the complaint while keeping the information you’ve already recorded. To convert a complaint:
- Choose the Search icon, enter Complaints, and then choose the related link.
- Open the complaint that you want to convert into a claim. The status of a released complaint will be reset during this process.
- On the ribbon, choose Change Classification and choose OK.
The complaint is then converted, and all available information is copied to the claim. Afterward, the original complaint will be closed and archived.
Reclassification is indicated on a complaint in the Rejection Reason Code and the Rejection Reason Text fields. For the fields to be filled in, you must have set them up as described under Reasons for Rejecting Cases.
You can open an archived complaint that is the source of a warranty claim by clicking the highlighted portion of the Source No. field on the claim card.
After you’ve finished filling in the new claim document, choose OK to exit.
Close a claim or complaint#
Claims and complaints that have been processed and set to Released can be closed and archived by using a ribbon function.
Close a warranty claim#
All warranty claims can be closed and archived after processing. To close a claim:
- Choose the Search icon, enter Warranty Claims, and then choose the related link.
- Select the claim that you want to close.
- On the ribbon, choose Close Case and choose Yes to confirm.
If the Justified field on the complaint was set to No, a rejection reason code must be entered before you can close the document. You also might need to enter your digital signature if closing the case requires it.
Archived claims can be viewed on the Warranty Claims Archive page.
Close a complaint#
All complaints can be closed and archived after being processed. To close a complaint:
- Choose the Search icon, enter Complaints, and then choose the related link.
- Select the complaint that you want to close.
- On the ribbon, choose Close Case and choose Yes to confirm.
If the Justified field on the complaint was set to No, a rejection reason code must be entered before you can close the document. You also might need to enter your digital signature if closing the case requires it.
Archived complaints can be viewed on the Complaints Archive page.
Implement actions#
Actions are recorded on cards, which contain all necessary information, such as contact details and item specifications linked to a case. A Failure Modes and Effects Analysis and a risk matrix can be created based on them as well. For more information about the latter, see FMEA Risk Matrices.
Besides creating and implementing actions because of a claim or complaint, actions can also be created and implemented on their own.
Create an action#
To create an action on its own:
- Choose the Search icon, enter Actions, and then choose the related link.
- On the ribbon, choose New.
- Fill in the fields as described in the following tables.
General#
| Field | Description |
|---|---|
| No. | Shows the action number assigned from the series set up for this purpose (see Action Setup). |
| Action Type | Specify whether the action is corrective or preventive. |
| Action Code | Choose the code of an action entered on the Case CAPA page. The codes that are available depend on what option has been selected in the Action Type field. |
| Description | Specify a description for the action. |
| Description 2 | Here you can enter an additional description of the action. |
| Source Type | Indicates from where the action originates. (empty) The action has no source. Action Card The action was created as a follow-up to another action. Complaint The action was created from a complaint document. Claim The action was created from a claim document. FMEA The action was created during an analysis. |
| Source No. | Specify the number of an action card, a complaint or claim document, or an FMEA based on the option you selected in the Source Type field. |
| Status | Indicates the status of the action card. Open The card is ready for editing. Closed The action is completed. You can no longer edit or reopen the card. |
| Successfully Implemented | Shows if the action was successfully implemented. The toggle turns on automatically, for example, when the Success Evaluated toggle is turned on. If the field is set to No when a card is completed, a follow-up action is created automatically if necessary. |
| Successfully Implemented On | Shows when the Successfully Implemented toggle was turned on. |
| Successfully Implemented By | Shows who was logged on to the system when the Successfully Implemented toggle was turned on. |
| Follow-Up Action No. | Specify a follow-up action that you want to implement if the Successfully Implemented field is not turned on when the action card is closed. |
| Closed On | Specifies when the action card was closed. |
| Closed By | Specifies who closed the action card. |
Risk Assessment#
This tab shows the risk assessment texts that were entered by using the New Text function on the ribbon.
Texts are versioned and can only be entered if a card is in the Open status. For more information, see Enter Texts.
| Field | Description |
|---|---|
| No. of FMEAs | Shows the number of FMEA lines that are assigned to the action because they were created from it. |
| No. of Arch. FMEAs | Shows the number of archived FMEA lines assigned to the action because they were created from it. |
Evaluate Success#
| Field | Description |
|---|---|
| No. of FMEA Actions | Shows on how many FMEA lines that have been assigned to the action the Successfully Implemented toggle is turned on. |
| No. of Arch. FMEA Actions | Shows on how many archived FMEA lines assigned to the action the Successfully Implemented toggle is turned on. |
| Success Evaluated | This toggle needs to be turned on manually when the success of the action has been evaluated. Note You cannot turn on this toggle if a related FMEA has not been completed. |
| Evaluation Comment | Here you can enter a text to describe the outcome of the effectiveness analysis. |
| Success Evaluated On | Indicates when the Success Evaluated toggle was turned on. |
| Success Evaluated By | Shows who turned on the Success Evaluated toggle. |
More Information#
| Field | Description |
|---|---|
| Created On | Indicates when the action card was created. |
| Created By | Shows who created the action card. |
| Modified On | Indicates when the action card was last changed. |
| Modified By | Shows who last changed the action card. |
Ribbon actions#
| Function | Description |
|---|---|
| Edit | Description to follow |
| Delete (Icon Recycle Bin) |
Description to follow. |
| New Text | Used to enter a text describing the risk assessment. |
| Create FMEA | Creates an FMEA for an action. The FMEA and action cards are then linked through shared data. For more information, see FMEAs. |
| Close | Case Closes an action card. Notes: If the Implemented Successfully field on the action card was set to No, a follow-up action is automatically created so that the card can be closed. |
| Change Log Entries | Shows the change log of an action card. |
Edit an action#
To change information about an action:
- Choose the Search icon, enter Actions, and then choose the related link.
- This opens a list that shows all actions—both those with and without a reference to a claim or complaint.
- On the ribbon, choose Edit. You can now add text or create an FMEA or fill in fields that are needed later, such as the fields that will be used to evaluate the effectiveness of a measure.
Create FMEA (action)#
Analyzes the current measure. For more information, see FMEAs.
Create a follow-up action#
If the Successfully Implemented toggle on an action card hasn’t been turned on, the fields Successfully Implemented On and By will not be filled when you close the card.
Instead, another action will be created automatically, and the number of the new measure is entered on the card of the previous, unsuccessful action in the Follow-Up Action No. field.
You can then use this field to get to the follow-up. The new measure is also shown on the actions list.
On the card of the follow-up action, the source action is shown in the Source Type and Source No. fields.
Note
If an action was created from a claim or complaint, the follow-up measure must be added manually to the Actions FastTab on the claim or complaint.
Close an action#
An action can be closed and archived regardless of origin (action list, claim, complaint, or FMEA). The only requirement is that the action is completed.
To close an action card:
- Choose the Search icon, enter Actions, and then choose the related link.
- Choose Edit to open an action card.
- On the ribbon, choose Close.
The Success Evaluated toggle needs to be turned on before you can close the card. The Success Evaluated On and By fields on the Assessment FastTab are then filled in automatically.
Closed actions can be found on the regular action list. To view only those that have been closed, you can filter the list for the Completed status.
FMEAs#
An FMEA, or Failure Mode and Effects Analysis, is a method for investigating and preventing potential errors and defects during day-to-day operations.
Multiple definitions exist; the FMEA procedures implemented in KUMAVISION base (BOOSTER) originate from DIN EN 60812:2015-08. According to this standard, there are four types of FMEA:
Process FMEA
Investigates potential weaknesses in production or performance based on the results of a design analysis.
Product FMEA
Examines potential errors and defects of a specific product.
System FMEA
Analyzes the interaction of components within a complex system, such as a machine or piece of industrial equipment, and the interaction of that system with the environment.
Design FMEA
Evaluates a product’s ease of manufacturing and assembly.
The aim is to identify the causes of errors and defects before implementing actions that are demonstrably effective (=CAPA) to eliminate them from the affected processes while using the lessons learned from those experiences for the creation of a knowledge base that can help a company avoid making the same mistakes again in the future.
Individual errors are described and evaluated based on the following criteria:
Effect Probability A
High likelihood of failures occurring is rated at 4, with low probability put at 1.
Failure Effect Severity B
Seen from the customer's point of view. High-priority errors that affect internal or external processes are rated at 4, low-impact errors at 1.
By multiplying A and B, you’ll get priority numbers, which can be mapped to a risk matrix.
After initiating CAPA, another FMEA must be performed to gauge their impact and calculate new risk priority numbers. The lower in priority errors are ranked this time, the more effective the implemented measures have been.
FMEA cards can be used to record and document the analysis process. A card can be created from a complaint or an action, in which case a reference to the original document will be included. However, you can also create FMEAs from the list view, without a reference.
Create an FMEA#
To create an analysis on its own:
- Choose the Search icon, enter FMEA Overview, and then choose the related link.
- On the ribbon, choose New.
- Fill in the fields as described in the following table.
General#
| Field | Description |
|---|---|
| No. | Shows the number of the analysis. This number is assigned automatically and cannot be changed. |
| Source No. | This field shows the number of a complaint or an action if the analysis was created from one. For standalone FMEAs, the field remains blank. |
| Type | Specify the type of analysis. Options are: • Process • Product • System • Design |
| Department | Specify the department or area examined in the context of the analysis. |
| No. of Risk Matrices | Shows the number of risk matrices created from the analysis. You can select the highlighted value to get to the FMEA Risk Matrix Overview, which will be filtered for entries related to this analysis. |
Afterward, choose OK to exit. As no other FastTabs have been filled in, you’re asked if you want to delete the analysis. Choose No.
Lines#
The results of the analysis are documented on the lines. Every error or defect needs to be recorded on a separate line as described in the following table.
| Field | Description |
|---|---|
| Failure Location | Specify where the error occurred, for example, as part of a process chain or within a certain department. |
| Potential Failure | Specify the error or defect that can occur or has occurred. |
| Failure Effect | Specify the impact of the error or defect. |
| Cause of Failure | Specify the potential cause of the error or defect. |
| Verification | Specify a method that can be used to check if the error or defect does, in fact, occur. |
| Severity | Specify the severity of the damage. For more information, see FMEA Basics. |
| Effect Probability | Specify how likely the damage will occur. For more information, see FMEA Basics. |
| Risk Priority | Indicates by color the risk priority. For more information, see FMEA Risk Matrix. |
The second part of each line indicates the effectiveness of actions taken:
| Field | Description |
|---|---|
| Recommended Action | Specify the action that should be implemented so that risks can be mitigated or eliminated altogether. |
| Person Responsible | Specify the person in charge of the measure. |
| Deadline | Specify when the action has been completed. Filling in this field will open a follow-up document so that you can notify the person responsible for the measure. |
| Action Taken | Specify the action that has been implemented to mitigate the risk or eliminate the error altogether. |
| New Severity | Specify the new damage severity if the failure reoccurs after implementing the action. For more information, see FMEA Basics. |
| New Effect Probability | Specify the new likelihood of failure after implementing the action. For more information, see FMEA Basics. |
| New Effect Priority | Indicates by color the new effect priority. For more information, see FMEA Risk Matrix. |
Ribbon actions#
| Function | Description |
|---|---|
| New Text | Used to enter various texts, such as comments and descriptions of (implemented) actions. |
| Create Action | Creates a new action as part of the FMEA. |
| Close Case | Closes and archives the analysis. |
| Risk Matrices | Opens the FMEA Risk Matrix for the current analysis. |
| Risk Matrix | Previews or prints the FMEA Risk Matrix. |
| Change Log | Shows tracked changes if the feature has been turned on for the relevant tables in Change Log Setup. |
Edit an FMEA#
To change information about an analysis:
- Choose the Search icon, enter FMEA Overview, and then choose the related link.
- This opens a list that shows all analyses—both those with and without a reference to a claim or complaint.
- On the ribbon, choose Edit.
The Action Taken field on FMEA cards is used as a counter if an FMEA was created from an action so that the No. of FMEA Actions field is displayed on the related action card.
You can now add a text on the Action Taken FastTab to describe any measure that was implemented. To add text:
- Choose New Text on the ribbon.
- Enter a text and close the editor.
The text is then filled in on the tab. When you choose New Text again, the new description that you enter will be specified as a follow-on version.
The same is true for remarks about the analysis. To enter a remark, choose Related > Comments on the ribbon.
When all necessary information has been filled in, choose OK to exit the card.
Risk matrix#
This matrix indicates based on a traffic light system on FMEA lines the risk associated with a certain error or defect. For more information about the general setup of matrices, see FMEA Setup.
Matrices can be printed directly from FMEA cards. What colors will be used on these graphs depends on the values specified in the risk assessment fields on the lines.
Note
Risk matrices can only be created for open FMEAs.
All matrix-related functions and fields found on FMEA cards are described in the following table.
| Function/Field | Description |
|---|---|
| Related > Risk Matrices | Opens the FMEA risk matrix overview assigned to the current analysis. |
| Reports > Risk Matrix | Prints the current version of the FMEA risk matrix. A white matrix means that no values have been set up yet. |
| No. of Risk Matrices | Indicates the number of related matrices. Clicking the hyperlink will open the FMEA Risk Matrix Overview page. |
FMEA Risk Matrix Overview#
This page shows the matrices added to an analysis (along with the status that the matrices are in). Initially, all analyses are created without a matrix.
Ribbon actions#
| Field | Description |
|---|---|
| Create New Version | Creates a new version of the risk matrix. |
| View | Opens the matrix for viewing. |
| Edit | Opens the matrix for editing. |
| Prints or previews the matrix. |
Create a new version#
To create a new matrix:
- Open the FMEA Risk Matrix Overview page.
- On the ribbon, choose Create New Version.
- Fill in the fields as described in the following table.
General#
| Field | Description |
|---|---|
| FMEA No. | Shows the number of the analysis for which a matrix is created. |
| Version No. | Shows the version of the matrix. |
| Status | Indicates the status of the matrix. |
| Description Description 2 |
These fields can be used to describe the matrix. |
| Reason | You must select a reason in this field when you create a new version of the matrix or change an existing graph. |
Evaluate Success#
On this tab, you can specify the colors used to indicate the severity of a failure and the likelihood of damage in the form of risk priority numbers. You can also specify colors to show changes in priority after implementing actions.
You can leave a field blank or select yellow or red. Leaving a field blank will result in the use of the RDLC color set up on the Risk Matrix FastTab in FMEA Setup.
More Information#
The fields found on this FastTab show when and by whom this matrix version was created or last changed.
Edit a matrix#
You can change a graph until the Close function is used. To change a matrix:
- Open the FMEA Risk Matrix Overview page.
- On the ribbon, choose Edit.
A matrix that is in the Invalid or Valid status cannot be edited, and you need to create a new version for editing.
A new version is Under Development until you choose close on the ribbon to turn the graph into a valid risk matrix. The contents of the Evaluation FastTab fields are always copied from one version to the next.
Complete a matrix#
The colors used to indicate risk are governed by the matrix that is in the Valid status. When a new version is completed and the close action is run from the ribbon, this version is set to valid, whereas the previous graph is set to Invalid.
The change in matrices then changes the indicators to how they are set up on the FMEA lines in the new version.
Ribbon actions#
| Field | Description |
|---|---|
| View | Opens a version for viewing. |
| Edit | Opens a version for editing. |
| Delete (Icon Recycle Bin) |
Deletes a matrix version. You can only delete matrices set to Under Development. |
| Finish | Sets a matrix version to Completed. The status of the version then changes to Valid, whereas all previous versions are set to Invalid. |
| Prints or previews the matrix. |
Close an analysis#
An analysis can be closed and archived regardless of origin (FMEA overview or action). The only requirement is that the analysis has been completed. To close an FMEA card:
- Choose the Search icon, enter FMEA Overview, and then choose the related link.
- Choose Edit to open an FMEA card.
- On the ribbon, choose Close, and then choose Yes.
The FMEA is then closed, archived, and moved to the FMEA Archive Overview.
Note
Archived analyses and matrices cannot be edited. However, you can print an analysis by choosing Risk Matrix on the ribbon of an archived card.
Enter text#
You can specify a wide variety of texts on complaint, claim, action, and FMEA cards. Each text you add is subject to versioning.
As the method for entering texts is identical for warranty claims, complaints, actions, and analyses, except for the type of text that you want to enter (that is, for registration or analysis), the example provided in the following applies to all text entry functions in Complaints Management.
- Open the card on which you want to enter text.
- Choose New Text on the ribbon.
- This opens a text editor. Select the type of text by using the relevant function and specify the text you want in the editor.
- Afterward, the text will be shown on the relevant FastTab, where the description can be changed or supplemented.
Every text is versioned, including new entries and text changes on the relevant pages but also cancelled entries, which will be shown as empty lines. You can see other versions by choosing Previous or Next on the ribbon.
When the Justified toggle is modified on claims and complaints, a text editor opens automatically so that you can enter a reason for the change. This text must be filled in and will be copied to the Analysis Text FastTab as a new text version.