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Complaint and grievance management incl. Failure Mode and Effects Analysis#

Introduction#

Complaint and Grievance Management (RuB) makes it possible to map the entire complaint and grievance process. Errors and measures are stored with codes and thus enable an evaluation. The module is based on DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016, deliberately distinguishing between the terms complaint and reclamation as follows:

Complaints are
generally directly related to a product or service and include a legal claim for remedy if the product does not meet the specifications.

ComplaintExpression of
a customer's displeasure or unfulfilled requirements about a product or service.

When a complaint or claim is accepted, the persons, goods and services involved are recorded. In the process, it is also possible to access documents from purchasing, sales, service or production that already exist in the system. Each complaint and/or reclamation can be evaluated and processed by means of corrective and preventive measures. In the process, risk analysis, evaluation and effectiveness testing of the measures implemented can be carried out using FMEA procedures.

Note

The complaint and grievance management as well as FMEA are activation modules, which can only be used with additional licensing and activation.

Establishment#

Necessary facilities for RuB#

Complaint & Grievance Management Facility#

In the RuB facility, the basic setup for complaint and grievance management is made. It is divided into different info registers:

Inforegister General#

Settings for contacts and for the digital signature are stored in the General info tab:

Field Meaning
Contact plant If a complaint or claim is created for a contact that does not yet exist in the system, this can be used to control whether the contact should be created automatically. The following options are available:

NeverNo
new contact will be created in any case.

QuestionIf the
contact used has not yet been created in the system, the user is asked whether a new contact should be created.

Whenever
a contact is used that has not yet been created in the system, it is created automatically.
Contact update If an existing contact is used in a complaint or claim with data that does not match that in the system, this setting can be used to control whether the existing contact should be updated. The following options are available:

NeverThe
already existing contact data will not be updated in any case.

QuestionThe
user is asked whether the existing contact should be updated with the contact data used here.

AlwaysIf
contact details are used in the process that differ from those already in the system, the existing contact is automatically updated with the contact details of the complaint/complaint.
Check digital signature If the switch is activated, the user must authenticate with his digital signature when releasing, archiving, deleting and resetting the status of a complaint, reclamation or FMEA card.

Note

If you have KUMAVISION MedTech365 in use, you have at this point the further possibility to make specifications about the booking code. Further information on this topic can be found here.

Complaint information register#

In the Complaint tab, the number series for creating complaints is managed in the Complaint Call Numbers field.

In all other fields, the authorization codes are assigned via the "Generate authorizations" function to the individual functions at which an authorization check is to take place as part of a complaint.

Information register complaint#

In the Complaint tab, in the Complaint Call Numbers field, the number series to be transferred to the complaints is stored.

In all other fields, the authorization codes are assigned via the "Generate authorizations" function to the individual functions at which an authorization check is to take place as part of a complaint.

Ribbon Function#

With the help of the "Generate Authorizations" button, the authorization codes are automatically initialized during the system configuration and written to the RuB authorizations.

Note

After the authorization codes have been initialized automatically, please do not run the function again.

RuB authorizations#

The RuB authorizations were initialized by the Generate authorizations function in the RuB setup and automatically generated for the claim and complaint -see RuB setup. In order for a user to be able to open complaints and/or reclamations (without further processing), this user must have at least the individual authorization to display in one of his assigned authorization groups. Otherwise, a corresponding error message appears.

RuB Authorization groups#

In the "RuB authorization groups", the individual RuB authorizations are combined via the RuB authorization lines.

The RuB authorization groups can then be assigned to users.

Note

The authorization group "Super" for complaint or complaint must contain each individual authorization for complaint or complaint.

RuB User Setup#

The RuB users are created in the RuB user setup. Only the users entered here can work in the RuB module according to their authorization. The setup also includes the management of the digital signature.

Field Meaning
User ID Specification of the user
Digital signature Entering the user's digital signature
Digital signature locked If the checkbox is activated, the user's digital signature is locked. This happens automatically if it is entered incorrectly 3 times, or can be set manually
In the case of an automatic lock due to repeated incorrect password entry, the Digital signature lock reason field will store password entered incorrectly 3 times.
Digital signature Number of incorrect entries Displays how many times the user entered the digital signature incorrectly the last time it was used.
If the user has entered his digital signature incorrectly 3 times, the checkbox Digital signature locked is automatically activated and stored in the field Digital signature lock reason Password entered incorrectly 3 times.
If the user enters the password correctly after all, the indicator in Digital signature locked is removed, as well as the number of incorrect entries is reset.
Digital signature blocking reason Specification of the reason for locking the digital signature. In case of automatic blocking due to repeated incorrect password entry, password is automatically stored incorrectly entered 3 times.
Reset digital signature If the checkbox is activated, the user must update his digital signature before the next use.
This can also be set when the RuB module is used for the first time, so that the user can assign his own password before the first action.

To assign an authorization group to a user, first select the corresponding user line. Any number of RuB authorization groups can be assigned to a user via the "RuB authorization groups" button. For more information, see the "RuB authorization groups" section. The authorizations of a user are made up of the sum of the individual authorizations in the assigned authorization groups. If, for example, a specific authorization is required for a complaint, the RuB user must have this authorization in at least one of his assigned authorization groups.

Call error#

This table is used to manage the error codes that can be selected in complaints or reclamations in the Analysis info tab, Assigned errors area. These should be designed in such a way that as many errors as possible can be recorded in the system and thus the most complete and meaningful evaluations of complaints and calls can be created. The call errors can be assigned to a call type and call subtype and are thus displayed in the selection filtered accordingly.

Field Meaning
Code Clear naming of the error
Type Control for which document the error code can be selected. The following options are available for selection:

EMPTYErrors of
this type are available for selection in both complaints and reclamations.

ComplaintErrors
of this type are only available for selection in complaints.

ComplaintErrors
of this type are only available for selection in complaints.
Description Field for more detailed description of the error
Description 2 Field for more detailed description of the error
Callart Determination for which call type the RuB / call error is available for selection in the call.
Call subtype Definition for which call subtype (depending on the call type) the RuB / call error is available for selection.

Depending on the call type and call subtype defined in the complaint in the General info tab, the call errors in the Analysis info tab are available as filtered error codes in the complaint. If no call type/subtype is selected in the complaint, all error codes can be selected, including those that have not been assigned.

Note

A validation check is not performed when an error code with a different call type / call subtype is selected.

Authorities#

The authorities to which an incident must be reported can be created in the "Authorities". The authorities will be specified in the later process in a complaint or claim on the "Analysis" info tab.

Call Reasons for rejection#

In the "Call Rejection Reasons" global codes can be defined for the rejection reasons of a complaint or claim.

Field Meaning
Code Unique code for a reason for rejection
Description Description of the reason for rejection
Statistics relevant Specifies whether this code should later be included in statistical evaluations.

Initially, this field has no integrated function, but it can be evaluated via a BI.
Standard for This field defines a code as "default code" for certain system processes.

blank:
No automatic.

Closure by call classification change:
If the classification of a complaint or appeal is changed, the original complaint/appeal document is automatically archived. Within this system process, the first rejection reason with this option is automatically entered as a "rejection reason code" in the complaint/appeal to be archived.

The rejection reason code is applied in the General info tab of a complaint or claim and can only be applied if the entry="no" is made in the "Justified" field.

The field must be filled when the claim or complaint is closed, as soon as the call is declared as not justified.

In the overviews of complaints and claims, as well as their archives, the reason for rejection is also displayed.

Call species and subspecies#

Call types and call subtypes are defined for complaints and grievances. These can be used, for example, to differentiate complaints within their document type.

Field Meaning
Code Unique code for the call type
Description Call type code description
Number Call subspecies Calculated field to display the corresponding call subtypes. Clicking on this field displays the call subtypes accordingly.

Via the field "Number of call subtypes" or the function "Call subtypes" (the call subtypes for a call type can be viewed and edited.

Field Meaning
Code Unique code for the call subtype
Description Call type code description

In the complaint and reclamation the call types and subtypes can be assigned:

Field Meaning
Type Selecting or entering a call type code from the "Call types" table
Subspecies Selecting or entering a call subtype code from the "Call subtypes" table for the selected call type

The call type and subtype fields are integrated in the archived complaints and reclamations, editing is not possible in them.

Necessary facilities for measures#

Actions can be managed in the system stand-alone, as well as within a complaint, reclamation and FMEA. Therefore, the necessary setups must be made independently of the RuB setups. When creating actions in an FMEA, it should be noted that this must then be called up via the action overview.

Measures facility#

The global facilities for the measures can be defined via the "Measures Setup" window.

In the Inforegister General, the number series for the measures, the data check of the measure and the check of the risk assessment texts are defined:

Field Meaning
Measure number This is where the assignment of the number series created for the action cards takes place
Data check measure map This field disables/enables the mandatory field checks for table 5488142 "Measure".
Review risk assessment texts This field can be used to set up whether or not risk assessment texts must be maintained when a measure card is closed.

Never:
It never checks for existing risk assessment text when completing a measure card.

With existing FMEA:
As soon as an FMEA or an archived FMEA is linked to the measure, risk assessment texts must also be maintained in the measure card.

Always:
With this option, the check for existing risk assessment texts for the measure is always executed.

In the authorization info tab, the authorization codes are assigned to the individual functions at which an authorization check is to take place as part of a measure.

Field Meaning
Create Authorized to create an action card from various program points (e.g. complaint, grievance, FMEA)
View Authorized to view a map of measures
Edit Authorized to edit/modify a task card
Delete Authorized to delete a task card
Care risk assessment Authorized to maintain a risk assessment text for a measure card
Care effectiveness test Authorized to maintain an effectiveness check text for a measure card
Lock Entitled to conclude an action card

With the help of the "Generate Authorizations" button in the Measures Setup ribbon, the authorization codes are automatically initialized during the system configuration.

In order for a user to be able to open tasks (without further processing), this user must have at least the individual authorization to display a document in one of his assigned authorization groups. Otherwise, a corresponding error message appears:

Note

After the authorization codes have been initialized automatically, the function must not be executed again.

Measures authorizations#

The table is automatically filled via the " Generate permissions" action in the "Actions setup" window.

Measures Authorization groups#

The individual task authorizations are summarized in the task authorization groups. These can then be assigned to users.

The individual authorizations that are to be combined into an authorization group are stored in the task authorization lines.

Measure User Setup#

The "Measures User Setup" window can be used to assign user authorizations for managing measure cards. The respective user is entered, selected and the corresponding groups are assigned via the "Authorization group code" field.

Note

This setup does not replace the setup in the roles and permissions of a users. These must continue to be made accordingly elsewhere.

Measures CAPA / Call CAPA#

The abbreviation CAPA stands for Corrective and Preventive Action. This procedure has its origins in quality management and thus represents GMP-compliant work. Every deviation or error that occurs is investigated and then corrective and preventive action is taken. CAPA is thus part of the continuous improvement process (CIP).

Note

Action / CAPA is taken to initiate immediate correction of a failure to avoid further impact.

In the system, these corrective and preventive actions are managed in the "Call CAPA" table.

Field Meaning
Code Unique designation of the CAPA code
Type Control for which type of measure he CAPA code can be selected. The following options are available for selection:
• EMPTY
• Correcting
• Preventive
Description Field for more detailed description of the CAPA
Description 2 Field for more detailed description of the CAPA

These CAPA codes are used in the measure, General info tab, Measure code field. The selection depends on the field Action type (Corrective, Preventive, Empty) in the Action card.

Necessary facilities FMEA#

The abbreviation FMEA stands for Failure Mode and Effective Analysis and is used for risk assessment. FMEA can be used in the system both standalone and as part of the measure, so the necessary facilities must be made independently of the RuB facilities.

FMEA setup#

In the FMEA facility, the basic setup for the risk assessment is made. It is divided into different information registers.

Inforegister General#

In the General information tab, the number series for the FEMA installation is managed in the "FMEA numbers" field.

Inforegister Authorization#

In the authorization info tab, the authorization codes are assigned to the individual functions at which an authorization check is to take place as part of an FMEA.

With the help of the "Generate Authorizations" button in the ribbon, the authorization codes are automatically initialized during the system configuration.

Note

After the authorization codes have been initialized automatically, the function must not be executed again.

Inforegister coloring FMEA lines#

The Coloring FMEA Lines info tab stores the colored indicators that are displayed in the FMEA line for the individual threshold values when calculating the risk priority number.

Field Meaning
Green traffic light By right-clicking on this field, an image file for the traffic light display of the initial color in the FMEA lines can be added/modified.
Yellow traffic light By right-clicking on this field, an image file for the traffic light display of the yellow color in the FMEA lines can be added/modified.
Red traffic light By right-clicking on this field, an image file for the traffic light representation of the red color in the FMEA lines can be added/modified.

Notes

If the fields "Green traffic light", "Yellow traffic light", "Red traffic light" are changed afterwards, there is no automated recalculation of the colors on the FMEA lines and archived FMEA lines.

However, when changing an FMEA line (excluding archive), the color would be recalculated.

FMEA authorizations#

The FMEA authorizations are initialized and automatically generated in the FMEA setup by the "Generate authorizations" function.

These can be viewed in the FMEA Authorization Overview and can be assigned to the authorization groups in the following section.

FMEA authorization groups#

The individual FMEA authorizations are summarized in the FMEA authorization groups. These can then be assigned to users. The FMEA authorization lines contain the individual authorizations that are to be combined into an FMEA authorization group. In order for a user to be able to open an FMEA (without further editing), this user must have at least the individual authorization to display a document in the authorization group. Otherwise, a corresponding message appears.

FMEA user setup#

In the FMEA User Setup the users are set up. Only the users entered here can view, create and edit FEMA, depending on the FMEA authorization group assignment.

The FMEA Authorization Groups button can be used to assign a user his FMEA authorization groups.

Thus, the authorizations of a user are composed of the sums of the individual authorizations from the assigned authorization groups. If, for example, a specific authorization is required for an FMEA, the user must be assigned in at least one of his assigned authorization groups.  

Facility for internal company complaints and reclamations#

Complaints and reclamations can be created not only for calls from debtors and creditors, but can also be used for internal processes (e.g. for manufacturing, internal processes, etc.). For this purpose, the own company must be created as an internal contact in the system (activated switch "Internal" on the contact card).

Further processing of internal company complaints and claims then works in the same way as those relating to external company contacts.

Complaint card#

A complaint is recorded via a separate card, which contains all the necessary information such as contact, article, etc., but also includes the further procedure for handling the complaint.

The call of open and archived complaints can be found through the search:

Inforegister General#

The General info tab contains general data about the complaint created:

Field Meaning
No. Document number of the complaint, is assigned automatically and cannot be changed.
Description Enter a brief description of the complaint
Type Selection of whether the complaint is internal, accounts payable or accounts receivable.
Accounts Payable No.
/ Accounts Receivable No.
/ Contact No.
Contact no.
Depending on the type of complaint, these fields are automatically filled with the corresponding data. The contact number is always filled in, the customer number only if it is a customer complaint, and the vendor number for a vendor complaint. If a wrong customer/vendor has been selected by mistake, this cannot be changed here, a new data record must be created and the wrong one must be closed.
Name/Name2 Specification of the contact or customer/vendor name
Note If sales price texts have been entered for a customer or purchase price texts for a vendor, they will be displayed here.
Justified Selection of whether the complaint is justified, the following information is available for selection:
EMPTY complaint
is not classified.

YesComplaint
is justified.

NoComplaint
is not justified.

GoodwillComplaint
is accepted for goodwill reasons.

If a classification of the complaint is made, a text editor opens automatically, in which the user must enter the reasons for the classification made. Without this entry, the Justified field cannot be filled or changed.
Justification text As soon as the "Justified" field is changed to the "Yes", "No" or "Goodwill" option, a text must be entered. Only the first line entered in the editor is always displayed, regardless of whether this comes from the justification text or analysis text. This can be adjusted in the editor. All changes to the texts are recorded in versions in the analysis text.
Rejection reason code Select or enter a rejection reason code from the Call Rejection Reasons table.

The selection of a rejection reason is only possible with "Justified" = "No". Should the "Justified" field be changed afterwards, the rejection reason will be removed automatically if required.

The field must be filled when the claim or complaint is closed, as soon as the call is declared as not justified.
Reason for rejection Calculated field to display the description of the specified rejection reason code.
Status Indication of the status:

Open:
The complaint is in the Open status. In this status, the complaint can be processed.

Released:
The complaint has the status Released. In this status, the complaint is completely processed except for the final review that is still missing.

If a digital signature is activated, a changeover can only be made by specifying it.
Origin no. If the complaint was created by converting a complaint into a complaint, the document number of the related complaint is displayed here.
Type Selecting or entering a call subtype code from the "Call subtypes" table for the selected call type
Subspecies Selecting or entering a call subtype code from the "Call subtypes" table for the selected call type
Assigned user Select or enter an assigned user for the complaint.
Number FMEA Indicates the number of FMEA created for this complaint.
Number Archived FMEA Indicates the number of archived FMEA related to this complaint.
Number of FMEA performed Measure Indicates the number of FMEA actions performed related to this complaint.
Number Archive. FMEA performed Measure Indicates the number of performed, already archived actions related to this complaint.

Information register Reporting persons#

In the Reporting persons info tab, the person of the creditor or debtor or the contact who reports the complaint is recorded. If this person is already entered as a contact in the system, the corresponding information from the master data is automatically inserted. If there is a connection to a CTI system, the reporting person can be called directly from the system.

Furthermore, other contact persons can be entered in new lines below the line already entered. If the entry is done manually, the corresponding data must be entered in the individual fields. If automatic contact creation is activated in the RuB setup, the system automatically creates a new contact from this.

If a contact already in the system is to be added as the reporting person, all partner contacts assigned to the company can be accessed via the No. field.

Inforegister Disputed Positions#

In the Complained items tab all items of the complaint are recorded, they can be items, services (resources or G/L accounts) or other things.

The rows can also be filled using the documents already in the system with the function in the menu ribbon, for more information see section "Menu ribbon complaint".

In case of a manual entry of the positions, the lines are filled in field by field, starting with the Type field. Application for this is when the disputed item is not managed in the system, which is possible at the beginning of one of the system. Example: The position was still processed through the previous system.

Inforegister acceptance text#

In the "Acceptance text" info tab, the content of the complaint acceptance call is entered with the help of a simple text editor. The text entry is started by clicking the "Enter text" button in the menu ribbon; after completion, the text is displayed in the info tab. The text is versioned.

For more information on entering texts, see the section "Entering texts in a complaint, claim or action".

Inforegister analysis#

In the "Analysis" info tab, the error analysis of the complaint is documented. The "Error analysis on" and "Error analysis by" are filled in first. The fields "Analysis checked on" cannot be filled in by the same user as in "Error analysis by", in accordance with the 4-eyes principle. A corresponding message is displayed.

If a complaint is reportable, this can be marked with the "Reportable" indicator and the authority report can be documented via "Report to authorities". It is not possible to transmit the report(s) via the system.

An analysis text can be entered using the "Enter text" function in the menu bar, which is then displayed in the info tab. The text is versioned.

In addition, for a possible evaluation, the error codes (call errors) can be filled in the "Assigned errors" info tab.

Field Meaning
Analysis on/by Fields to record who performed the analysis and when.
Analysis checked on/by Fields for recording who checked the previously performed analysis and when. The user who checks the analysis must not be the same as the user who performed the analysis (illustration of the dual control principle); if this is the case, a corresponding error message is displayed.
Reportable Marking whether the complaint must be reported to an authority
Notification to authorities Documentation of the notification to the authority(ies) (no transfer)
Assigned errors Sub-tab to classify the errors found during the analysis via the error codes already present for a complaint in the system. These can be selected via the Error code field. It is mandatory to fill this field. The Description and Description 2 fields are automatically filled with the data stored in the RuB Error facility.
Analysis text Display of the already recorded analysis texts and the justification text

Inforegister Measures#

Open complaints can be assigned preventive and corrective action cards in the "Actions" info tab, or new action cards can be created from these, which can then be accessed by all other documents. The management of measures is thus centrally regulated via the measure cards. The tasks created or inserted in the complaint are carried over to the archived complaint. The complaint can only be closed if the tasks have the status "Closed". A corresponding message is issued.

Field Meaning
Measure card no. Input/selection of the assigned action card for the complaint or grievance.
Error code Assignment of the action to a concrete error code of the complaint/complaint.

When the measure is created from the Analysis section, then the error code from the analysis is carried along.
Description Calculated field to display the description from the measure map.
Description 2 Calculated field to display description 2 from the measures map.
Status Calculated field to display the status from the action map.
Measure type Calculated field to display the measure type from the measure map.
Measure code Calculated field to display the measure code from the measure map.
Successful Calculated field to display the "Successfully performed" field from the measures map.
Number FMEA Calculated field to display "Number of FMEA" from the action card.
Number of FMEA performed Measures Calculated field to display the "Number FMEA by. Measures" from the measures card
Number Archived FMEA Calculated field to display "Number of Archived FMEA" from the action card.
Number Archive. FMEA by. Measures Calculated field to display "Number of archiv. FMEA by. Measures" from the measures card.

Ribbon complaint#

Depending on whether the complaint is related to an internal contact, customer or vendor, the menu bands contain different buttons.

The "Process" tab of the menu ribbon can be used to call up the accounts payable or accounts receivable card or the Marketing Cockpit associated with the complaint.

Via the tab "Get position", the documents belonging to the vendor or customer can be called up using the various buttons, in order to insert positions for the complaint from them.

In the case of a complaint related to an internal contact, some entries of the ribbon are not active or are available to a reduced extent, since there are no outgoing documents for internal complaints.

Via the actions "Release", "Reset status" and "Close call", the status of the complaint is changed accordingly.

The different texts (acceptance text, analysis text, etc.) can also be entered using the "Enter text" button. Further information on entering tests can be found in the "Entering texts" chapter.

RuB sheet#

The Rub sheet button in the ribbon enables the document printing of the complaint.

Audit Trail#

The Belonging tab contains the Change log items button, here all changes to the complaint are logged as well (who inserted/changed/deleted what and when), if the activity log is enabled for the corresponding tables.

Complaint card#

A complaint, similar to a complaint, is recorded on a separate card, which contains all the necessary information such as contact, article, etc., but also contains the further procedure for processing the complaint. The call of open and archived complaints can be found via the search.  

Inforegister General#

The "General" info tab contains general data about the created complaint.

Field Meaning
No. Document number of the complaint, is assigned automatically and cannot be changed.
Description Enter a brief description of the complaint
Type Selection of whether the complaint is an internal, vendor or customer complaint.
Accounts Payable No.
/ Accounts Receivable No.
/ Contact No.
Contact no.
Depending on the type of complaint, these fields are automatically filled with the corresponding data. The contact number is always filled, the customer number only if it is a customer complaint, analogously the vendor number for a vendor complaint. If a wrong customer/vendor has been selected by mistake, this cannot be changed here, a new data record must be created and the wrong one must be completed.
Name/Name2 Specification of the contact or customer/vendor name
Note If sales price texts have been entered for a customer or purchase price texts for a vendor, they will be displayed here.
Justified Selection of whether the complaint is justified, the following information is available for selection:

EMPTY:
Complaint is not classified.

Yes:
Complaint is justified

No:
Complaint is not justified.

GoodwillReclamation
is accepted for goodwill reasons.

If a classification of the complaint is made, a text editor opens automatically, in which the user must enter the reasons for the classification made. Without this entry, the field cannot be filled or changed.

If a classification of the complaint is made, a text editor opens automatically, in which the user must enter the reasons for the classification made. Without this entry, the Justified field cannot be filled or changed.
The text stored in the text editor is partially displayed in the "Justification text" field and is included in the analysis text in versions.
Justification text As soon as the "Justified" field is changed to the "Yes", "No" or "Goodwill" option, a text must be entered. Only the first line entered in the editor is always displayed, regardless of whether this comes from the justification text or analysis text. This can be adjusted in the editor. All changes to the texts are recorded in versions in the analysis text.
Rejection reason code Select or enter a rejection reason code from the Call Rejection Reasons table.

The selection of a rejection reason is only possible with "Justified" = "No". Should the "Justified" field be changed afterwards, the rejection reason will be removed automatically if required.

The field must be filled when the claim or complaint is closed, as soon as the call is declared as not justified.
Reason for rejection Calculated field to display the description of the specified rejection reason code.
Status Indication of the status:

Open:
The complaint is in the Open status. The complaint can be processed in this status.

Released:
The complaint has the status Released. In this status, the complaint is completely processed except for the final check that is still missing.
If a digital signature is activated, a changeover can only be made by specifying it.
Origin no. If the complaint was created by converting a complaint into a reclamation, the document number of the related complaint is displayed here.
Type Selecting or entering a call subtype code from the "Call subtypes" table for the selected call type
Subspecies Selecting or entering a call subtype code from the "Call subtypes" table for the selected call type
Assigned user Select or enter an assigned user for the complaint.
Number FMEA Displays the number of FMEA created in the complaint still open
Number Archived FMEA Displays the number of archived FMEA created in the complaint
Number of FMEA performed Measure Indicates the number of actions created in the complaint still open, but with already performed action in FMEA
Number Archive. FMEA performed Measure Displays the number of archived in the complaint created with performed action in FMEA

Information register Reporting persons#

In the Reporting persons info tab, the person of the creditor or debtor or the contact who reports the complaint is entered. If this person is already entered as a contact in the system, the corresponding information from the master data is automatically inserted. If there is a connection to a CTI system, the reporting person can be called directly from the system.

Furthermore, other contact persons can be entered in new lines below the line already entered. If the entry is made manually, the corresponding data must be entered in the individual fields. If automatic contact creation is activated, the system automatically creates a new contact from it.

If a contact already in the system is to be added as the reporting person, all partner contacts assigned to the company can be accessed via the No. field.

Inforegister Disputed position#

In the "Complained items" info tab all items of the complaint are recorded, they can be items, services (resources or G/L accounts) or other things. The lines can be filled from the documents using the function in the ribbon, for further information see section "Ribbon Complaint". In case of a manual entry of the positions, the lines are filled in field by field, starting with the Type field. Application for this is when the disputed item is not managed in the system, which is possible at the beginning of one of the system. Example: The position was still processed through the previous system.

Inforegister acceptance text#

In the "Acceptance text" info tab, the content of the acceptance conversation of the complaint is entered with the help of a simple text editor. The text capture is started by pressing the "Capture text" button in the menu ribbon, after completion the text is displayed in the info tab. The text is versioned. For more information on capturing texts, see the section "Capturing texts".

Inforegister analysis#

In the "Analysis" info tab, the error analysis of the complaint is documented. The "Error analysis on" and "Error analysis by" fields are filled in first. The "Analysis checked on" fields cannot be filled in by the same user as in "Error analysis by", in accordance with the dual control principle. A corresponding message is displayed.

If a complaint is reportable, this can be marked with the "Reportable" indicator and the authority report can be documented via "Report to authorities". Transmission of the notification(s) is not possible via the system.

An analysis text can be entered using the "Enter text" function in the menu bar, which is then displayed in the info tab. The text is versioned.

In addition, for a possible evaluation, the error codes (call errors) can be filled in the "Assigned errors" info tab.

Field Meaning
Analysis on/by Fields to record who performed the analysis and when.
Analysis checked on/by Fields for recording who checked the previously performed analysis and when. The user who checks the analysis must not be the same as the user who performed the analysis (illustration of the dual control principle); if this is the case, a corresponding error message is displayed.
Reportable Marking whether the complaint must be reported to an authority
Notification to authorities Documentation of the notification to the authority(ies) (no transfer)
Assigned errors Sub-tab to classify the errors found during the analysis via the error codes already present for a complaint in the system. These can be selected via the "Error code" field. This field should be filled. The "Description" and "Description 2" fields are automatically filled with the data stored in the RuB error facility.
Analysis text Display of the already recorded analysis texts and the justification text

Inforegister Measures#

Open complaints can be assigned to preventive and corrective action cards on the "Actions" information tab, or new action cards can be created from these, which can then be accessed by all other documents. The management of measures is thus centrally controlled via the measure cards. The tasks created or inserted in the complaint are included in the archived complaint. The complaint can only be closed if the tasks have the status "Closed". A corresponding message is displayed.

Field Meaning
Measure card no. Input/selection of the assigned action card for the complaint or grievance.
Error code Assignment of the action to a concrete error code of the complaint/complaint.

When the measure is created from the Analysis section,then the error code from the analysis is carried along.
Description Calculated field for displaying the description from the measure map
Description 2 Calculated field for displaying description 2 from the measure map
Status Calculated field for displaying the status from the measure map
Measure type Calculated field for displaying the measure type from the measure map
Measure code Calculated field to display the measure code from the measure map.
Successful Calculated field for displaying the "Successfully executed" field from the measures map
Number FMEA Calculated field for displaying "Number of FMEA" from the action card
Number of FMEA performed Measures Calculated field to display the "Number FMEA by. Measures" from the measures card
Number Archived FMEA Calculated field for displaying "Number of archived FMEA" from the action card
Number Archive. FMEA by. Measures Calculated field to display "Number of archiv. FMEA by. Measures" from the measures card

Complaint ribbon#

Depending on whether the complaint refers to an internal contact, customer or vendor, the menu bands contain different buttons.

The "Process" tab of the menu bar can be used to call up the accounts payable or accounts receivable card or the Marketing Cockpit associated with the complaint.

On the "Get item" tab, you can use the various buttons to call up the documents belonging to the vendor or customer in order to insert items for the complaint.

In the case of a complaint that relates to an internal contact, some entries of the ribbon are not active or are available to a reduced extent, since there are no outgoing documents in the case of an internal complaint.

Via the actions "Release", "Reset status" and "Close call", the status of the complaint is changed accordingly.

The different texts (acceptance text, analysis text, etc.) can also be entered using the "Enter text" button. Further information on entering tests can be found in the "Entering texts" chapter.

The "Create action" button allows you to create a new action for the complaint.

The "Perform FMEA" button allows you to create a new FMEA for the complaint.

RuB sheet#

The "Rub sheet" button allows to print the receipt of the claim.

Audit trail#

The Related tab contains the Change log items button, here all changes to the reclamation are logged as well (who inserted/changed/deleted what and when), if the activity log is activated for the corresponding tables. Infoboxes

Measures#

An action is recorded via its own card, which contains all the necessary information such as contact, article, etc., but also includes the further procedure for processing the complaint.

An FMEA can be created in the action map. Within the FMEA, a risk graph can be created - see further in the section "FMEA Risk Graph".

The open and closed measures are called up via the user search by the term "Measures". A new creation can already be created from the overview or from a measure card - see also section "Create measure".

Overview of measures#

All open and closed measures are displayed in the measure overview.

Measures map#

Inforegister General#

The "Measures Map" window can be opened from the Measures Overview to edit existing measures.

Field Meaning
No. Unique number of the measure from the number series set up (see "Measures setup").
Measure type Selection from the "Corrective" and "Preventive" options depending on the type of action required.
Measure code Selecting a measure code from the CAPA measures.

Depending on the selected "Measure type", the allowed measure CAPA codes are displayed in the selection.
Description In the Description field, you can enter a free text about the measure.
Description 2 In the Description 2 field, you can enter a free text about the measure.
Type of origin "Empty":
The measure has no origin.

Measures Map:
The current measure map was created as a follow-up to the measure no. in the "Origin no." field.

Complaint:
The current action card is created from the complaint no. noted in the
Origin no." field.

Complaint:
The current measure card is created from the complaint no. noted in the "Origin no." field.

FMEA:
The current action map has been created from the FMEA noted in the "Origin No." field.
Origin no. Displays the document no. in relation to the "Origin type" field.
Status Open:
It is possible to edit the action map.

Completed:
The action card is closed - editing as well as resetting the status is no longer possible.
Successfully performed The field determines whether the action card was successfully performed. "Successfully performed" is set automatically, for example, as soon as the "Effectiveness test successfully performed" field is changed.
If this field is set to "No" when a measure card is completed, a follow-up measure is automatically created if required.
Successfully performed on The field is automatically filled with the timestamp of the change when the "Successfully done" field is changed.
Successfully carried out by The field is automatically filled with the user ID of the change when the "Successfully performed" field is changed.
Follow-up no. This field is automatically filled with the follow-up action card no. as soon as the "Successfully completed" field = "No" when the current action card is closed.
Completed on/about The field is automatically filled with the timestamp of completion when the action card is closed.
Completed from The field is automatically filled with the user ID of the closing user when closing the action card.

Inforegister Risk Assessment#

The "Risk assessment text" information tab in the measures map displays the risk assessment texts entered via the "Enter text" button in the menu ribbon (analog in the archive). The texts are versioned. The texts can only be added in the "Open" status. Further information on text entry can be found in the "Entering texts" section.

Field Meaning
Number FMEA Calculated field to display the number of FMEA lines for the current action card.
For this, the FMEA must have been created from the action map
Number Archived FMEA Calculated field to display the number of FMEA lines with the "Action performed" field filled in for the current action card.
For this, the FMEA must have been created from the action map

Inforegister effectiveness test#

Field Meaning
Number of FMEA performed Measure Calculated field to display the number of FMEA lines with the "Action performed" field filled in for the current action card.

For this, the FMEA must have been created from the action map.
Number Archive. FMEA performed Measure Calculated field to display the number of archived FMEA lines with the "Performed action" field filled in for the current action card.

For this, the FMEA must have been created from the action map.
Effectiveness test successfully performed Set manually by the user once the effectiveness check has been successfully performed. This field cannot be set to Yes as long as an FMEA of the action is still open.
Effectiveness test Comment A free text for the effectiveness check can be entered here.
Effectiveness test successfully performed on Filled with the timestamp of the change when the "Effectiveness check successfully performed" field is changed.
Effectiveness test successfully performed by Is filled with the user ID of the change when the "Effectiveness check successfully performed" field is changed.

Inforegister additional information#

Field Meaning
Created on/about Filled with the timestamp of creation when the action card is created.
Created by Filled with the user ID of the creation when the action card is created.
Corrected on/about Filled with the timestamp of the change when the action card is changed.
Corrected from Filled with the user ID of the change when the measure card is changed.

Ribbon Measure#

Function Meaning
Edit Switches the measures map to edit mode

Notes:
Only "open" action cards can be edited
Delete Deletes the current action card.

Notes:
Only "open" task cards can be deleted
Enter text Generates a risk assessment text
Create FMEA Creates an FMEA for the current action map. The FMEA and action map are linked by data. For more information on FMEA, see the FMEA Map section.
Archive Completes the current action card.

Notes:
If the "Perform successfully" field in the measure card is set to "No", a follow-up measure is automatically created, otherwise completion is not possible
Change log Displays the change log items for the action card

Note

If you have KUMAVISION MedTech365 in use, you have the further possibility to set up resubmissions and to view possibly existing document characteristics on the measures map. Further information can be found here .

FMEA card#

An FMEA can be created either stand-alone or from an action. The call of the open and archived FMEA can be found via the call "FMEA Overview" via the user search.

FMEA Basics#

FMEA is a procedure for the investigation of (possible) errors and for error prevention. There are different normative definitions, the FMEA implementation in KUMAVISION base365 (BC BOOSTER) is analogous to DIN EN 60812:2015-08. Accordingly, four different FMEA types can be distinguished:

Process FMEA
A process FMEA is based on the results of the design FMEA and investigates possible weaknesses in the production or performance process.

Product FMEA
A product FMEA examines possible defects and weaknesses in a specific product.

System FMEA
A system FMEA examines the interaction of several components in a complex system (e.g. machine, plant) with the aim of identifying potential weak points that arise from the interaction of the individual components or from the interaction of the system with the environment.

Design FMEA
A design FMEA is used to assess the manufacturability and assemblability of a product with respect to systematic errors in the design phase.

The goal of every FMEA is the consistent, permanent elimination of defects by identifying the causes of defects and introducing demonstrably effective measures (CAPA), as well as the avoidance of defect repetition in new products and processes by using experience gained. The individual errors are described and evaluated with regard to the following criteria:

Probability of occurrence A
of the cause, a high probability is rated as 4, an extremely low probability as 1.

Probability of detection E
of the defect before the product is passed on to the customer or passed on to the next process step, a high probability of detection is rated 1, a low probability of detection is rated 4.

Error meaning/error sequence B
is evaluated from the customer's point of view, a high impact of the error at the customer or for the subsequent process is evaluated as 4, a low impact as 1.

The product of these criteria forms the damage priority signal of the FMEA, which is mapped via the settings of the risk graph.

After the corresponding CAPA has been carried out, an FMEA must be carried out again, taking these measures into account, in order to determine the corresponding RPN and, via its reduction, to prove the effectiveness of the CAPA taken.

The FMEA card can be used to record and document the data required to carry out the FMEA. An FMEA can be created from a complaint and a task and thus receives a corresponding reference to the respective document. Stand-alone FMEA can be started via the FMEA overview and have no reference to a complaint or action.  

Inforegister General#

The General information tab contains general data about the created FMEA.

Field Meaning
No. Document number of the FMEA, is assigned automatically and cannot be changed.
Origin no. If the FMEA is created from a complaint or task, the document number of the associated complaint/task is created here; for a stand-alone FMEA, the field remains empty.
Type Indication of the type of FMEA, are available for selection:
• Process
• Product
• System
• Construction
Department Input of the department/area, which is examined in the context of the FMEA (free text).
created on/about Indication of the date when the FMEA was created.
created by Indication of which user created the FMEA.
corrected on/about Indication of the date when the FMEA was last edited.
corrected from Indication of which user last edited the FMEA.

Information register FMEA lines#

The results of the FMEA are documented in the FMEA lines. Each defect is recorded in a separate line. The front part of the lines refers to the defect recording and analysis, as well as its risk assessment.

Field Meaning
Error location Indication of the place where the error occurred (in the process, department, etc.)
Potential error Description of the error/defect that can occur or has occurred.
Error sequence Description of the consequence that occurs due to the potential error.
Error cause Description of the possible cause of the error
Control measure Description of the measure that can be used to check whether the potential error is actually present.
Severity of the damage Selection of the severity of the damage, for further information see chapter "FMEA Basics", selection 1 - 4.
Probability of the damage Selection of the probability of damage, for further information see chapter "FMEA Basics", selection 1-4
Damage priority signal Color representation of the damage priority signal is calculated according to the setup of the risk graph - see chapter FMEA Risk Graph

The following part of the lines documents the effectiveness test of the implemented measure:

Field Meaning
Recommended measure Input of the measure to be carried out for risk minimization or error elimination.
Responsible Selection of the person responsible for the measure
Date Date on which the measure is completed. When entering the date, a resubmission is opened, which can be used to inform the responsible person about the action.
Implemented measure Enter the measure that was carried out to minimize the risk or eliminate the error.
New severity of the damage Selection of the severity of the damage after implementation of the measure, for further information see chapter "FMEA Basics", selection 1 - 4.
New probability of damage Selection of the probability of damage after implementation of the measure, for further information see chapter "FMEA Basics", selection 1-4
New damage priority signal Color representation of the damage priority signal is calculated according to the setup of the risk graph - see chapter FMEA Risk Graph

FMEA ribbon#

Function Meaning
Enter text Via "Enter text" the different texts (remarks, measure texts and performed measure texts.) can be entered.
Create measure With this call you can create a new action for the FMEA.
Lock The FMEA can be closed and archived via the "Close" button.
Riskograph Opens the FMEA Risk Graph overview for the current FMEA number.
Risk graph Prints the FMEA risk graph or this can be displayed in the preview.
Audit Trail If the activity log is activated for the corresponding tables, all changes to the FMEA are logged via the "Audit Trail" (who inserted/changed/deleted what and when).

Creation of complaints and claims#

Complaints and reclamations cannot be created standalone, their starting point must always be a master record such as a contact, customer or vendor.

Contacts#

The contact overview or the Marketing Cockpit is the central processing area based on the contacts, and therefore the starting point of many processes that can be started from the overview as well as from the respective contact card via the "New Call" button in the menu ribbon.

Prerequisite: A corresponding contact already exists for which a complaint or reclamation is to be created. Otherwise, this should be created.

The call classification opens.

Selection of the corresponding call classification. For a complaint, the "Complaint" button must be activated, for a reclamation the "Reclamation" button.

The system automatically creates a new complaint / claim (call) according to the pre-selected call classification. The data stored for the contact is automatically transferred to the complaint / reclamation (call). This can then be processed further or closed by clicking on "OK".

Debtor#

A complaint or claim can be created for a customer both from the customer overview and from a customer card via the "New Call" button in the menu ribbon.

Prerequisite: A corresponding customer already exists for which a complaint or reclamation is to be created. Otherwise, this should be created.

The call classification opens.

Selection of the corresponding call classification. For a complaint, the "Complaint" switch must be activated, for a complaint the "Complaint" switch. Then confirm the selection with "OK".

The system automatically creates a new complaint / reclamation (call) according to the pre-selected call classification. The data stored for the customer is automatically transferred to the complaint / reclamation (call). This can then be processed further or closed by clicking on "OK".

Vendor#

A complaint or claim can be created for a vendor both from the vendor overview and from a vendor card via the "New Call" button in the ribbon.

Prerequisite: A corresponding vendor already exists for which a complaint or reclamation is to be created. Otherwise, this should be created.

The call classification opens.

Selection of the corresponding call classification. For a complaint, the "Complaint" button must be activated, for a reclamation the "Reclamation" button. Then confirm the selection with "OK".

The system automatically creates a new complaint / claim (call) according to the pre-selected call classification. The data stored for the vendor is automatically transferred to the complaint / reclamation (call). This can then be processed further or closed by clicking on "OK".

Note

If you are using KUMAVISION MedTech365, you have the further possibility to create resubmissions and to view possibly existing document characteristics on the action card. Further information can be found here.

In addition to the creation and execution integrated in a complaint or reclamation, a task can also be created or executed stand-alone. If a measure was created from an FMEA, then this combination is called from the measure.

Create measure#

A measure can be created either as a stand-alone measure, via the corresponding "New" button in the measures overview, in the measures map, or from a complaint or complaint. In the following, the stand-alone creation is described in more detail. The creation of a measure from the complaint, reclamation and FMEA is described in the respective sections.

Click on "New" e.g. in the measures overview. A new measure will be opened.

After entering the "No." by return - click on selection button "Measure type" and select the desired for this measure.

After the entry in the "Measure type" field, click on the "Measure code" selection button and select the code that depends on the selected "Measure type".

In the fields "Description" and "Description 2" a free text can be entered for the measure.

So far, all data have been entered in the General information tab, the measure has been created and can be closed by clicking on "OK".

Edit measure#

Via the "Measures", the overview of all measures that can be processed is displayed. Both stand-alone actions and actions that have been generated from a complaint or reclamation are displayed.

Select the measure to be edited. In the ribbon click on the "Edit" button (alternatively Ctrl+Shift+E). The selected measure opens in edit mode.

Now, in the task, e.g. texts can be added and an FMEA can be created or fields necessary for later completion, such as the effectiveness test, can be set.

Creating an FMEA in the measure#

In a task, an FMEA can be created via the "Create FMEA" button in the ribbon. For more information on FMEA, see the FMEA section.  

Creation of a follow-up#

If the "Successfully completed" field is not set in a measure when it is closed, the "Successfully completed" and "Successfully completed by" fields are not filled and a follow-up measure is automatically created.

In the previously unsuccessfully completed measure, the newly created measure number is automatically entered in the "Follow-up measure no." field and you can use this field to branch to the new follow-up measure for further processing. The new follow-up measure is also displayed in the Measures overview.

In the follow-up task, the previous task is displayed as "origin type" and "origin no.".

If a task has been created within the complaint or claim and a follow-up task is created, this "new" follow-up task must be added manually in the Actions info tab of the complaint or claim.

Close measure#

Analogous to processing, a task can be completed and archived regardless of its origin (stand-alone or from complaint, reclamation, FMEA).

Prerequisites: A fully processed measure already exists that is to be completed.

Selection of the measures to be edited. Click on the "Edit" button in the ribbon (alternatively Ctrl+Shift+E), since the measure cannot be completed in the Measures overview.

The selected measure opens in edit mode. In the ribbon click on the "Complete" button (alternatively Ctrl+F9). Other requirements to complete a measure: The "Effectiveness check successfully performed" field in the Effectiveness check info tab of the measure must be set to "YES". By setting this value, the documentation fields are automatically filled with the date and user identifier. If these conditions are met, the measure will be closed after clicking the "Close" button mentioned above. The completed measures can be found in the measures. These can be filtered in the Measures overview according to their "Completed" status.

Perform FMEA - stand-alone and within the measure#

An FMEA can either be created as a stand-alone FMEA using the corresponding button in the Role Center, or from a complaint or rejection. In the following, the stand-alone creation is described in more detail, further information on the creation of an FMEA from a complaint in the corresponding chapter Complaint.

Create FMEA#

An FMEA can either be created as a stand-alone FMEA by clicking on the corresponding button in the FMEA overview, or from a complaint or rejection. In the following, the stand-alone creation is described in more detail, further information on the creation of an FMEA from a complaint can be found in the corresponding section Complaint.

Clicking on "New" in the menu ribbon opens a new FMEA card

Click on the Type selection button and select the appropriate FMEA type. Click on the Department text field and enter the department that processes the FMEA.

So far, all data have been entered in the General information tab, the FMEA has been created and can be closed by clicking on "OK".

If no further data has been recorded in the FMEA, a query appears asking whether the FMEA should be deleted; answer this with "No".

Thus, a new FMEA has been created and the necessary data has already been entered in the General info register.

Edit FMEA#

The FMEA overview displays all FMEAs that can be edited. Both stand-alone FMEAs and FMEAs that were generated from a complaint are displayed.

Prerequisite: An FMEA already exists that is to be processed further. The further processing is independent of whether the FMEA was started on its own or from a complaint.

Selection of the FMEA to be edited. In the ribbon click on the "Edit" button (alternatively Ctrl+Shift+E). The selected FMEA opens in edit mode.

Now the following text fields can be filled in the FMEA line(s). To do this, click in the Error location field and enter the error location.

Click in Potential Error field, and enter the potential error.

Click in Error sequence field, and enter the error sequence.

Click in the Troubleshooting field and enter the cause of the error.

Click on the Control action column and enter the control action.

Click on the radio button in the Damage severity field and select the appropriate value.

Click on the radio button in the Probability of damage field and select the appropriate value.

Automatically, the corresponding color is displayed in color in the Damage priority signal field based on the setup of the risk graph.

Click in Recommended action field, and enter the recommended action.

For the recommended measure, a text with additional information belonging to the field can be entered in the FMEA. The type of text is selected using the "Enter text" button on the menu bar and the supplementary text is entered in the text editor that then opens.

The text is entered in the Action text info tab after the text editor is closed. When you call up "Enter text" and the text editor again, this text is then created as the next version.

Click on the radio button in the Responsible person field and select the user who is responsible for performing the action.

Click on the Appointment column and enter the appointment.

After the "Recommended action" has been performed, the FMEA can be further processed. By clicking in the "Performed action" field and entering the action actually performed.  

Note

The "Action performed" field is the counter if the FMEA was created from the action, so that the "Number of FMEA performed actions" is displayed in the action. Action" is displayed.

A text with additional information belonging to this field can be entered in the FMEA for the action performed. The type of text is selected via the "Enter text" button in the menu bar and the supplementary text is entered in the text editor that then opens.

The text is entered in the Action text info tab after the text editor is closed. When you call up "Enter text" and the text editor again, this text is then created as the next version.

Click on the radio button in the "New damage severity" field and select the appropriate value.

Click on the radio button in the "New damage probability" field and select the appropriate value.

Automatically, the corresponding color is graphically displayed in the "Damage priority signal" field based on the setup of the risk graph.

Additional errors can now be recorded in additional lines.

If all defects are documented accordingly, a comment can be stored in the FMEA via the button "Enter text" in the menu bar. The type of text is selected and text is entered in the text editor that then opens. The remarks are versioned.

The text of the remark can be viewed under Remarks.

When all necessary information has been entered in the FMEA, the FMEA can be closed by clicking on "OK".

FMEA risk graph#

Within the FMEA, the risk graph represents the risk in the FMEA line in color as a traffic light symbol.

The detailed setup for evaluation per risk graph is done in the respective FMEA card.

The basic pre-fitting takes place in the FMEA facility - see section FMEA Facility.

The number of risk graphs for the current FMEA is displayed in the General tab of the FMEA card.

The current risk graph can be printed as a graphic directly from the FMEA card.

The traffic light color result is then controlled by the evaluation fields of the FMEA line. Risk graphs can only be created in open FMEA.

Field Meaning
Riskograph Opens the FMEA risk graph overview for the current FMEA number
Risk graph Prints the currently valid version of the FMEA risk graphs for the FMEA.
If the risk graph is displayed completely white, no values have been set up in the risk graph yet.
Number of risk graphs Calculated field to display the number of associated risk graphs.
Clicking on the displayed number also opens the FMEA Risk Graph overview

FMEA Risk Graphs Overview#

Initially, the FMEA is created without a risk graph, there is no line in the overview.

If risk graphs have already been created, they are all displayed in the overview with the current status.

Field Meaning
Create new version Opens a FMEA risk graph map for new creation.
View Switches the window to view mode.
Edit Switches the window to edit mode.
Print Prints the FMEA risk graph or this can be displayed in the preview.

Create new version" risk graph#

A first or a new risk graph is called up by means of "Create new version" and can be set up accordingly. The window is initially offered empty to build up a first version.

Inforegister General#
Field Meaning
FMEA No. FMEA No. for which the risk graph is created.
Version no. Version number of the risk graph
Status Status in which the risk graph is located
Description / Description 2 Offer the possibility to enter free texts for the FMEA risk graph
Justification Justification must be entered when a risk graph is changed or when a new version is created.
Inforegister Rating#

In the "Evaluation" tab, the corresponding colors are defined for the respective combination of "Severity of damage" and "Probability of damage" or "New severity of damage" and "New probability of damage".

You can choose between the values "empty", "yellow" and "red". The empty value uses the defined RDLC standard color from the "FMEA Setup", Risk graph info tab as the color value (green/green in the example).  

Inforegister additional information#

The Additional Information tab shows the creation or modification dates of the FMEA Risk Graph.

Edit risk graph#

As long as a risk graph has not been closed with the "Close" function, it is in the "In process" status.

Via the call "Edit" this can be called and edited from the overview risk graphs.

As soon as a risk graph is in the "Invalid" or "Valid" status, it can no longer be edited. In this case, a new version must be created using the "Create new version" function. There, the risk graph can be edited again.

A newly created version is in the "in progress" status until it is closed with the "Close" function in the risk graph map and thus becomes the valid risk graph. The entries of the "Assessment" info tab are transferred to a new version from the previous version.

Complete risk graph#

The risk graph that has the status "Valid" is the one that controls the traffic light signal and over the damage fields.

As soon as a newly created version of the risk graph is completed using the "Complete" function in the risk graph map, it is changed to the "Valid" status and the risk graph previously in the "Valid" status is changed to the "Invalid" status.

The change is transferred directly to the traffic light symbols of the FMEA lines.

Risk graph ribbon#

Field Meaning
View Switches the window to view mode.
Edit Switches the window to edit mode.
Delete Deletes the FMEA risk graph. This is only allowed for FMEA risk graphs in the status "In progress".
Lock Completes the capture of the current FMEA risk graph. The version thus completed is declared in the status as "Valid", all previous versions as "Invalid".
If the version to be closed is a subsequent version of a risk graph, a corresponding value must be entered in the "Reason" field so that the FMEA risk graph can be closed/released.

The damage priority signals in the associated FMEA lines are recalculated.
Print Prints the FMEA risk graph. Or it can be displayed in the preview.

Close / archive FMEA#

Analogous to editing, an FMEA can be completed and archived regardless of its origin (stand-alone or from measure).

Prerequisite: A fully processed FMEA already exists that is to be completed.

Selection of the FMEA to be completed. In the ribbon click on the "Edit" button (alternatively Ctrl+Shift+E).

The selected FMEA opens in edit mode. In the ribbon click the Close button (alternatively Ctrl+F9).

Confirm the displayed query with "Yes".

The FMEA is now closed and archived and can be found in the archived FMEA.

Note

Archived FMEA incl. their risk graphs cannot be edited. However, the risk graphs can be printed out using the "Print risk graph" function.

Edit created complaint#

The complaint overview displays the open or released complaints.

For further processing, it is a prerequisite that an open complaint that is to be processed further has already been entered in the system.

Selection of the complaint to be edited. In the ribbon click on Edit button (alternatively Ctrl+Shift+E).

The selected complaint opens in edit mode. Further data on the complaint can be entered. For example, its review by a second user can be documented in the "Analysis" info tab.

In the "Analysis checked on" field, enter the date of the analysis check.

In the "Analysis checked by" field, the user who performed the analysis is entered. The user must differ from the user in the "Analysis by" field, otherwise a corresponding message will be issued.

Once all the necessary data for the complaint has been entered, it can be released. To do this, click on the "Release" button in the ribbon (alternatively Ctrl+F9).

Note

If it is set up that the release of a complaint requires the entry of a digital signature, this must be entered in the appearing query in the text field Digital signature and the entry must then be confirmed with OK.

The complaint is now in the status Released. The complaint is not closed with this.  

Edit created complaint#

The complaint overview displays the open or released complaints that can be processed.

The prerequisite for further processing is that an open complaint that is to be processed further has already been entered in the system.

Selection of the complaint to be edited. Then click on the "Edit" button in the ribbon (alternatively Ctrl+Shift+E).

The selected complaint opens in edit mode. Now you can enter further data for the complaint, for example, you can enter additional data in the "Complained items" information tab.

In the Rejected items tab, click in the Type field and select the item type.

To select an item click on column No. and select the desired item.

To enter the claimed quantity, click on the Quantity field and enter the quantity.

If an FMEA is also to be performed (only possible in a complaint or measure), click on the "Perform FMEA" button in the menu ribbon:

A new FMEA is opened. This can be created, edited and completed in the same way as described in "Perform FMEA".

Once all the necessary data for the complaint has been entered, it can be released. To do this, click on the Release button in the ribbon (alternatively Ctrl+F9).

Note

If it is set up that the release of a complaint requires the entry of a digital signature, this must be entered in the Digital signature text field in the query that appears and the entry must then be confirmed with OK.

The complaint is now in the status Released. The complaint is not closed.

Converting a complaint into a reclamation#

If, during further processing of a complaint, it is determined that the recorded case is a complaint, the complaint can be transferred to a reclamation. In this case, the data already recorded in the complaint is transferred to the reclamation, and the two processes are also linked.

Prerequisite: A released complaint already exists that is to be converted into a complaint.

Selection of the complaint to be converted into a complaint.

The selected complaint will be opened and in case the complaint has the status "Released", the status will be reset.

In the complaint, the button "Convert classification" is selected via the ribbon.

Confirm the following query with "Yes".

The complaint is converted into a reclamation by transferring the complaint data into a new reclamation. The complaint is closed with the "reclassification" and archived. The complaint is opened automatically.

In the complaint, the "Reclassification" is recorded in the "Rejection reason code" field and in the "Rejection reason" field. The prerequisite for this is the corresponding setup in the "Call rejection reasons".

From the complaint, the archived complaint can be opened via the "Origin no." field in the General info tab.

The newly created complaint can be further processed and closed by clicking OK.

Converting a complaint into a grievance#

If, during further processing of a complaint, it is determined that the recorded case is a complaint, the complaint can be transferred to a complaint. In this case, the data already recorded in the complaint is transferred to the complaint, and the two processes are also linked.

Prerequisite: A released complaint already exists that is to be converted into a complaint.

Selection of the complaint to be converted.

In the ribbon click on the "Edit" button (alternatively Ctrl+Shift+E).

The selected complaint will be opened and in case the complaint has the status "Released", the status will be reset.

In the complaint, the button "Convert classification" is selected via the ribbon.

Confirm the following query with "Yes".

The complaint is converted into a complaint by transferring the complaint data into a new complaint. The complaint is closed with the reclassification and archived. The complaint is opened automatically.

In the complaint, the "Reclassification" is recorded in the "Rejection reason code" field and in the "Rejection reason" field. The prerequisite for this is the corresponding setup in the "Call rejection reasons".

From the complaint, the archived complaint can be opened via the "Origin no." field in the "General" info tab.

The archived complaint is opened.

The newly created complaint can be further edited and closed by clicking "OK".  

Close complaints and claims#

Complaints and reclamations that have been fully processed and are in the "Released" status can be closed and thus archived. A corresponding button is available for this purpose in the respective menu ribbon.

Close complaint#

Prerequisite: A fully processed and released complaint already exists that is to be closed. All actions in the complaint have the status "Closed".

Selection of the complaint to be closed.

Without opening the selected complaint, it can already be closed in the overview. Click on the "Close" button in the ribbon.

Confirm the displayed query with "Yes".

If the complaint has an entry of "No" in the "Justified" field, the "Rejection reason code" field must have an entry, otherwise a corresponding message will be issued.

If the entry in the "Justified" field is "Yes", "Goodwill" or "Empty", no message is generated.

Note

If it is set up that the closure of a complaint requires the entry of a digital signature, this must be entered in the Digital signature text field in the query that appears and the entry must then be confirmed with OK.

Close complaint#

Prerequisite: A fully processed and released complaint already exists that is to be closed. All actions in the complaint have the status "Completed".

Selection of the complaint to be closed.

Without opening the selected complaint, it can already be closed in the overview. To do this, click on the "Close" button in the menu ribbon.

Confirm the displayed query with "Yes".

If the complaint has an entry "No" in the "Justified" field, the "Rejection reason code" field must have an entry, otherwise a corresponding message will be issued.

If the entry in the "Justified" field is "Yes", "Goodwill" or "Empty", no message is generated.

Note

If it is set up that the completion of a complaint requires the entry of a digital signature, this must be entered in the Digital signature text field in the query that appears and the entry must then be confirmed with OK.

The complaint is closed and archived. The archived complaint can now be viewed via the "Archived complaints" call.

Capture texts#

Texts can be entered at various points in a complaint, reclamation, action and FMEA in order to record further information on the corresponding areas. The texts entered in this way are subject to versioning.

Note

As the further procedure for all text types is identical for a complaint, rejection, action and FMEA except for the selection of which text type is to be entered (e.g. acceptance text or analysis text), the entry of one text type is shown below as an example; the procedure shown can be used analogously for the other text types, regardless of which card is involved.

Prerequisite: A complaint, reclamation, action or FMEA already exists for which a text is to be entered.

Click on the "Enter text" button in the Start menu ribbon of the currently opened map.

The query, which text type is to be entered, opens. The text type is selected by activating the corresponding button.

When text is entered again, the previously entered text is displayed and can be changed or supplemented.

The entered text can be seen in the corresponding info tab according to the text type.

The text for remarks can be found under Remarks.

All shown text types are versioned, that means every new text input and text change is shown as a new version in the corresponding windows.

The first entry of a text creates version 1 in the text display. Re-entering or changing a text creates another version.

You can scroll between versions using the "Previous version" and "Next version" buttons.

Also aborted text inputs, generate versions, which are then shown as empty lines in the text info registers.

In Complaint and Reclamation, when the "Justified" field is changed, the text editor is automatically opened and a text must be stored so that the field can be changed. This text is entered in the Analysis text info tab and versioned with the analysis text.