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Warranty claims, complaints, and FMEA#

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 medtec365:

Claim
Refers to a specific product or service and grants legal remedies should the product or service not be up to standard.

Complaint
States 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 Claims and Complaints Management and FMEA functions.

Note

For general information about the functionality, see Warranty Claims, Complaints, and FMEA. This article only describes the additional pages, functions, and fields available for it in medtec365.

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.

  1. Choose the Search icon, enter Warranty Claims & Complaints Setup, and then choose the related link.
  2. Fill in the field as described in the following table.
General#
Field Description
Default Transaction Code Specify the code that will be assigned to issues named in a warranty claim or complaint if the system cannot determine, for example, the ownership of equipment or the allocation of services (to internal and external resources) from posted entries.

Note

For general information about the functionality, see Warranty Claims, Complaints, and FMEA. This article only describes the additional pages, functions, and fields available for it in medtec365.

Case types and subtypes#

Both are used on warranty claims and complaints for classification purposes.

Note

For general information about the functionality, see Warranty Claims, Complaints, and FMEA. This article only describes the additional pages, functions, and fields available for it in medtec365.

You can set the types as filters when you want to assign a workflow template to a case.

Note

A Workflow and Notification manager license is required for this feature.

However, you can enter them only for main claim or complaint workflows and they must match the type and subtype stored on the relevant workflow card. If no type is available, you’ll see every template stored in the system. Be aware that the system will not run a check to validate the chosen template.

The case type and subtype codes are also included on all archived claims and complaints, although they cannot be edited there.

Action setup#

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.

Note

For general information about the functionality, see Warranty Claims, Complaints, and FMEA. This article only describes the additional pages, functions, and fields available for it in medtec365.

Field checks#

Table 5488142 (Action) can be included in checks for mandatory field values.

  1. Choose the Search icon, enter Action Setup, and then choose the related link.
  2. On the General FastTab, turn the Action Data Check toggle on or off.

This will activate or deactivate the check throughout the app.

Complaints#

Complaints are recorded on cards that contain every bit of information (such as contact details and item specifications) entered for a certain case.

To see a list of all ongoing and completed complaints, choose the Search icon, enter Complaints, and then choose the related link.

Note

For general information about the functionality, see Warranty Claims, Complaints, and FMEA. This article only describes the additional pages, functions, and fields available for it in medtec365.

General#

Field Description
Workflow Templ. Code If you’re working with the Workflow and Notification Manager, shows the code of the template that will be used to automate processes.
Workflow Templ. Version Code If you’re working with the Workflow and Notification Manager, shows the version code of the template that will be used to automate processes.

Workflow#

Warranty claims are recorded on cards that contain every bit of information (such as contact details and item specifications) entered for a certain case.

To see a list of all ongoing and completed claims, choose the Search icon, enter Warranty Claims, and then choose the related link.

Warranty Claims#

Warranty claims are recorded on cards that contain every bit of information (such as contact details and item specifications) entered for a certain case.

To see a list of all ongoing and completed claims, choose the Search icon, enter Warranty Claims, and then choose the related link.

Note

For general information about the functionality, see Warranty Claims, Complaints, and FMEA. This article only describes the additional pages, functions, and fields available for it in medtec365.

General#

Field Description
Workflow Templ. Code If you’re working with the Workflow and Notification Manager, shows the code of the template that will be used to automate processes.
Workflow Templ.
Version Code
If you’re working with the Workflow and Notification Manager, shows the version code of the template that will be used to automate processes.

Workflow#

This FastTab lists the processes tied to the claim. To see this tab, you need a Workflow and Notification Manager license. As it is an integral part of WNM, it will be explained in more detail in the relevant article.

To run the main processes that link a claim to the WNM app, choose Pick Workflow on the ribbon.

Actions#

Actions are recorded on cards that contain every bit of information (such as contact details and item specifications) entered for a certain 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.

To see a list of all ongoing and completed actions, choose the Search icon, enter Actions, and then choose the related link. You can also create an action from this list or can do so later from a card.

Note

For general information about the functionality, see Warranty Claims, Complaints, and FMEA. This article only describes the additional pages, functions, and fields available for it in medtec365.

Action card#

Actions#

Function Description
Create Follow-up Creates a follow-up document for the current action card.

Register claims and complaints#

Registration via contact, customer, or vendor is the only way to add a warranty claim or complaint. You cannot choose New on the ribbon of a list for this.

Note

For general information about the functionality, see Warranty Claims, Complaints, and FMEA. This article only describes the additional pages, functions, and fields available for it in medtec365.

Serial number information#

These cards show each device, machine, or industrial equipment identified by a serial number. You can also register a complaint or claim from the Serial No. List or a card.

  1. Choose the Search icon, enter Serial No. Information List, and then choose the related link.
  2. Select a line or open a card, and then choose New Case on the ribbon.
  3. Turn on the relevant toggle on the Select Case Classification page, and then choose OK.

Afterward, the system registers the document, and copies all serial number data to it for processing.

Registering a complaint or claim based on lot number information is currently not supported. If lot-tracked items should be included in a claim or complaint, you can open the marketing cockpit, or a vendor or customer card, and create a case there. After the case has been registered, the tracked items need to be entered manually on the Reported For FastTab on the card.