FMEA Software

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DataLyzer FMEA Software Guided Tour

The movie below gives you an introduction into Advanced Planning Quality Process and how DataLyzer’s FMEA software fits in your APQP process.

Understanding FMEA Structure

The movie below gives you a clear understanding of the FMEA document structure and the relationships.

DataLyzer FMEA software

For manufacturers worldwide, FMEA has become synonymous with Continuous Improvement programs. The Process Flow, FMEA, Control Plan and SPC have a logical connection. The FMEA process ensures that products, processes or detection techniques are constantly improved.

Continuous feedback is provided from the SPC results on the shop floor to the engineers responsible for the FMEA process. DataLyzer FMEA software is a module where all data is integrated within the DataLyzer database making it possible to exchange Process Flow/FMEA/Control Plan and SPC information between employees, thus ensuring that FMEAs and Control Plans are truly living documents. This is a very practical way of implementing reverse FMEA. Also see a more detailed approach in the whitepapers.

DataLyzer® FMEA  is one of the modules in the DataLyzer software suite. The program closely follows the methodology defined in IATF 16949 and RM13004. DataLyzer FMEA can operate as a stand-alone module or link to DataLyzer SPC software.

DataLyzer fully supports the harmonized AIAG-VDA FMEA system and the new AIAG Control Plan requirements released March 2024. Users can switch between different methods and templates. Some of the features in the AIAG VDA FMEA:

  • RPN is replaced by Action Priority. See how this is implemented in DataLyzer FMEA in this video.
  • A 7-step process is applied, implemented in DataLyzer in form C
  • The criteria tables have changed. In addition to the change you can add extra columns in DataLyzer FMEA for further clarification.
  • Some columns in old FMEA are changed, split or merged.

For automotive suppliers this means a big change if they are not yet using FMEA software that is capable of the new functionality. For new FMEAs the new method will be audited. If you want to know more about the changes you can read this article. For Food industry our FMEA software can be used to comply to HACCP  requirements. In the Aerospace industry it is used to comply to RM13004. Our FMEA software is also fully compliant with ITAR/EAR regulations. FMEA documents are technical documents which fall under ITAR/EAR regulation.


Typical results of the implementation of DataLyzer FMEA software:

  • Significant reduction of engineering time to prepare the Process Flow/FMEA/Control Plan.
  • Proper registration of engineering knowledge due to the structured setup of standard and specific FMEAs and Control Plans
  • Efficient action follow-up.
  • Fewer problems during customer or system audit.
  • More time on process improvement, rather than on running the FMEA system.
Customize to your Industry

FMEA criteria and classification symbols can be customized, even per group of documents. Standard texts for FMEA and Control Plan can be used. This set up guarantees consistency and saves time when completing FMEAs. Alarm levels for RPN or Action priority or severity are also defined. Additional setup preferences support exact configuration to your needs.

Granular Authorization

The FMEA software supports users, roles, and permission schemes. Obtain complete control access to specific documents through users, user groups, documents or document groups, making DataLyzer FMEA best-suited for use even in a multi-plant environment. User management can be linked to Active Directory.

Create and Generate Process Flows

Process flow must be created before creating the process FMEA. The software supports the development of a primary and secondary flow and offers standard symbols. Changes in the process flow are automatically updated in the process FMEA and vice-versa.

Reference FMEA and special filter columns

FMEAs can be maintained a lot easier if you work with reference FMEAs (also called Foundation FMEA or Generic FMEA). The Reference FMEAs can be made on multiple levels. Changes in Reference FMEAs will be updated automatically in all FMEAs  using these reference FMEAs.

In some situations adding filter columns will help to facilitate the development of FMEAs.  DataLyzer FMEA offers the  option to add multiple columns for example for different producttypes (Product families).

IATF 16949 / RM13004 Validation

Forget about formatting and just key in data. Validation rules can be applied to ensure relevant regulations and the prescribed IATF 16949, RM13004 or other formats are followed, leaving no room for error. This is specifically important for auditors. Linkage of process flow, FMEA and Control Plan prevents conflicts between the 3 documents. DataLyzer FMEA system complies with new harmonized AIAG-VDA FMEA methodology.

Root cause Analysis

Ascertain the root cause from “5 Why” problem-solving approach and the Ishikawa (Fishbone) analysis stored within the FMEA.

Action priority

The action priority method according to the harmonized AIAG-VDA FMEA method is  implemented. You can switch between RPN and Action priority or show them both. Rows can be filtered on Action Priority and/or RPN. See this video.

Open Actions

Report incomplete actions in any FMEA in an open action list and directly access the FMEA. Receive Email notifications in case actions are almost due.

Agile Control Plan interconnecting FMEA, SPC and drawing or 3D Model

Import characteristics directly from ballooning software like for example Elias, SolidWorks, Discus etc. With the integration between ballooning software and DataLyzer you can fill out the FMEA and Control Plan directly from a PDF, DWG, DXF, IGES, Catia, NX Models etc etc. Create the SPC control charts or inspection plans directly from the Control Plan to minimize redundant data entry.

Flexibility & Customer Specific Requirements

Various customer requirements demand flexible software to assist users with the FMEA/Control Plan process. DataLyzer offers a wealth of features to comply to these specific CSR. Like Reference or Foundation FMEAs, family FMEAs, specific classification symbol sets including linkage between all documents,  support of reverse FMEA, etc etc


Print Pareto reports of the top ‘X’ RPN numbers from a document or group of documents or print reports sorted on action priority. Filter, sort or group on any column.

Multi language

DataLyzer supports multiple languages. You can switch on the fly to another language. Languages currently supported are: English, Spanish, German, French, Chinese (Simplified), Portuguese, Turkish, Dutch, Danish, Hungarian, Malay, Finish and Thai. But is goes a step further. Not only the labels can be translated but also teh content of the document. So a document setup in Spanish can be completely printed in English or in any language you want.


DataLyzer FMEA software is so intuitive that not much training time is required. In addition to the manual, 14 tutorial videos explain how to setup FMEA using DataLyzer FMEA. To watch the tutorials, click on the View Tutorial link. If desired, we can provide additional User Training for DataLyzer FMEA.

For more information please download the brochure.

Introduction to Risk Analysis

In the concept version of ISO 9000:2015 risk analysis will be a requirement. This white paper describes an introduction to risk analysis and FMEA, the history of FMEA, how to get started with FMEA and the layout for IATF 16949.

Managing FMEA’s

What is required to make your FMEA program a success? What do you need to prepare before starting with FMEAs and what do you need to do per individual FMEA.

FMEA Classification

How are is priority for improvement established and how are classification symbols and special characteristics used in FMEA? Different methods will be discussed for prioritizing: Risk Priority Matrix, RPN, Action Priority, Classification Symbols.

Is Excel the right tool for FMEA?

It seems at first but there are so many specific requirements which are very complicated to implement in Excel, that Excel is hardly the right tool.

FMEA and HACCP: A comparison

In industries, FMEA is used. In Food industry HACCP is used. What are the similarities and differences and what would be the advantages for the Food industries to apply FMEA.

FMEA and Cost Effectiveness

What problems do we fix, how much do they cost us? What are the current costs of customer returns? Does the FMEA affect the bottom line or the top line? How can FMEA generate new business?

Capturing Process Knowledge using Standard FMEAs

How can knowledge be stored in FMEAs and re-used with new product and process development.

Improve Reference FMEAs

To get the maximum result applying reference FMEAs you need an change the method normally used.


The new FMEA manual has restructured the FMEA process.  In this article we will summarize the major changes.

DataLyzer FMEA in different industries

This whitepaper shows how DataLyzer FMEA can be used throughout numerous different industries. It also highlights several features that have been added to improve the functionality of DataLyzer FMEA.

Reverse FMEA, a practical approach

This whitepaper shows how reverse FMEA can be implemented in a practical way using the DataLyzer software suite.

Linking of FMEA, Control Plan and Inspection Plan

In APQP, the relation between PFMEA and Control Plan is fairly clear. The Control Plan should be implemented on the shop floor. This is typically done by creating inspection plans and work instructions. In this whitepaper we show how this is implemented in the DataLyzer software suite.

Why Choose DataLyzer FMEA over Excel?

  • The  layout of the FMEA is very strict and creating the prescribed format in Excel is time-consuming. DataLyzer FMEA not only automatically adjusts the layout while typing, but also ensures adherence to the prescribed structure. For more details, click on video on the left explaining the structure.
  • Since Excel doesn’t support the underlying FMEA structure and only allows you to copy or move rows, copying or moving parts of the structure is impossible.
  • If you want to analyze FMEAs by sorting, grouping or filtering that is not possible in Excel and certainly not across multiple FMEAs. In DataLyzer FMEA that is possible.
  • In Excel, FMEAs and CPs must be issued and older versions must be maintained. Moreover, issuing and creating new documents requires immense effort and stringent procedures. DataLyzer’s validation rules ensure that the FMEA is correct even before it is released.
  • Saves time by using reference (Foundation) FMEAs for standard processes and adopting these in part specific FMEAs. Ford requires for example automatic updates of both Foundation FMEAs as well as part specific FMEAs. This is possible in dataLyzer FMEA but impossible in Excel.
  • Open actions in FMEAs are managed in an action list, which can be printed by a manager/ engineer and sorted by due date. It is also possible to send reminder mails if an action is almost due. That is not possible in Excel.
  • FMEAs and CPs are standardized and can be translated automatically before printing.
  • Changing the language of the FMEA is simple and enables you to view the information in your local language.
  • Automatically importing the characteristics into the FMEA or CP from drawings using ballooning software saves time and effort.
  • Using Action Priority requires programming in Excel to implement. This means you need to implement macros in every FMEA Excel sheet
  • Switching between templates (old AIAG format to new VDA AIG format) needs to be done manually in Excel and can be done fully automatically in DataLyzer FMEA.
  • FMEA might require extended user configuration and authorization which is not supported in Excel.
  • The new 7 step process used in automotive results in approx 30 columns instead of 20 and requires a relation between FMEAs. This is very hard to implement in Excel. In the new FMEA manual it is recommended to switch to dedicated FMEA software.

See this whitepaper for more details. To facilitate the start-up of DataLyzer FMEA, the Excel FMEAs can be imported.

Integrated APQP: Drawing – Ballooning – CMM – Control Plan – SPC

During APQP, establishing critical characteristics in the control plan is a key step, but a time consuming and laborious process.  Characteristics are established during the design process and then they need to be entered in the CMM program, the control plan and the SPC program.  Furthermore suppliers need to balloon the drawing received from the customer.

DataLyzer’s solution along with third party software allows:

  • Adding of balloons to a drawing makes the characteristics’ list accessible.
  • DataLyzer offers a flexible tool to import characteristics from any ballooning software
  • This list can be imported into a CMM program.
  • Create a control plan based on the FMEA.
  • Map the characteristics to the appropriate machine/device/jig/tool field. Also add other fields such as (a fixed subgroup size, OCAP) that are not available in the balloon data.
  • Export the characteristics’ to the DataLyzer SPC software.
  • Report results in DataLyzer’s FAIR (COA) solution

Read this whitepaper for further information and examples.

How does DataLyzer comply with Ford Customer Specific Requirements?


    FMEA Software
    Suppliers shall use FMEA software which ensures the alignment of the Foundation FMEA, Part FMEA, control plan and other applicable documents.

    Implementation For Foundation and FMEA Software
    For forward model programs, which have not yet completed Job 1 by July 1, 2022, Foundation and Part FMEAs must be available in the FMEA software starting July 1, 2022.
    All Foundation PFMEAs for all manufacturing processes (current and forward model) and subsequent updates to all FMEAs must be available in the FMEA software starting December 31, 2022.


    DataLyzer FMEA offers linkage between DFMEA, PFD, PFMEA, Control Plan and real-time SPC. Data automatically flows from one document to the other.

    DataLyzer FMEA offers complete functionality for Foundation FMEA and family FMEA. Excel sheets can be automatically imported to facilitate the process to implement Foundation FMEAs.



    FMEA Information Flow and Linkage

    The Part and Foundation FMEAs shall be living documents that are always aligned. An update to the Foundation FMEA shall result in a review of the applicable information for the Part FMEA. This process also shall work backwards from the part FMEAs to the Foundation FMEA in that any updates to the part FMEAs result in updates of the applicable information in the Foundation FMEAs. In addition, FMEAs shall be aligned to the control plans and work instructions/visual aids.

    When an update is made in a Foundation FMEA or a part specific FMEA automatically owners of related documents can be informed by Email to review the related document.


    Reverse FMEA Process (RFMEA)

    Organizations are required to have a process in place that ensures all new launches complete an RFMEA event once the equipment is installed and running. This process should be first completed at the equipment manufacturer and then after final installation on the organization’s plant floor. The reverse FMEA involves design and process engineers working with operators and attempting to make bad parts, beat the error proofing and find new failure modes, causes, and develop controls. The goal is to discover opportunities and implement improvements in the FMEA that were not previously discovered. Evidence of Reverse FMEA events must be available starting July 1, 2022 for forward model programs which have not yet completed Job 1.

    DataLyzer offers linkage between FMEA and SPC. During RFMEA you need to analyze potential new failure modes, verify occurence and detection rating, verify effectivity of controls and document this all.

    In SPC all information is recorded so duirng a reverse FMEA process you can easily detect new potential failure modes, verify effectivity and establish correct occurrence values.

    For more information please contact or request a demo by clciking the button below.