Overview and Benefits

FMEA software

 

For manufacturers worldwide, FMEA has become synonymous with continuous improvement programs. Process Flows, 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 SPC results on the shop floor to engineers responsible for the FMEA process. DataLyzer FMEA software is a module where all data is integrated with the DataLyzer database making it possible to exchange SPC and Process Flow/FMEA/Control Plan information between employees, and ensuring that FMEAs and Control Plans are truly living documents.

DataLyzer® FMEA  is one of the modules in the DataLyzer software suite. The program closely follows the methodology defined in IATF 16949 and AS13004. DataLyzer FMEA will operate as a stand-alone or it will link to the DataLyzer Spectrum SPC software.

DataLyzer will fully support the new harmonized AIAG VDA FMEA system, which is planned to be released September 2018. The new FMEA system will have many changes.

For example:

  • RPN will disappear and will be replaced by Action Priority. See how this is implemented in DataLyzer FMEA in this video
  • A 6-step process needs to be implemented
  • The criteria tables will change
  • Some columns in old FMEA will be changed, splitted or merged

For automotive suppliers this means a big change in 2018 if they are not using FMEA software yet which is capable of the new functionality. For new FMEAs the new method will be audited from  2019. The new manual indicates that this is hardly possible to realize with Excel, meaning that if you are an automotive supplier and still use Excel for your FMEAs you should consider switching to FMEA software in 2018.

For Food industry our FMEA software can be used to comply to HACCP  requirements.

In Aerospace industry it is used to comply to AS13004. 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.

Features

  • 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.

  • IATF 16949 Validation

    Forget about formatting and just key in data. Validation rules can be applied to ensure relevant regulations and the prescribed IATF 16949 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 will be adopted to comply 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 new harmonized AIAG VDA FMEA method is already implemented. You can switch between RPN and Action priority. See video

  • Open Actions

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

  • Agile Control Plan interconnecting FMEA, SPC and drawing

    Import characteristics directly from the ballooning software. Create the SPC control charts directly from the Control Plan to minimize redundant data entry.

  • Flexibility & User-Specific requirements

    Diverse customer requirements demand flexible software to assist users with the FMEA/Control Plan process. Adding columns as per customer requirements or adding a classification column for Pass Through Characteristics (PTC) is easy. Six specific user defined fields per document allows customization as per your needs. Translate the FMEA or Control Plan contents while printing, enabling you to create the CP in the customer-specified language and print the Control Plan in another language for shop floor operators.

  • Reports

    Print Pareto reports of the top X RPN numbers from a document or group of documents or print reports sorted on new action priority

  • Training

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.

For more information please download the brochure

Video Tour

DataLyzer FMEA SOFTWARE Guided Tour

The movie below gives you an introduction to 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.

Whitepapers

Whitepapers

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 classification symbols and special characteristics used in FMEA? Different methods will be discussed for rating: SxOxD, OxD, SxO, Failure modes with Severity 9 and 10. Safety and Critical failure modes.

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 reused with new product and process development.

Why not Excel?

Why Choose DataLyzer FMEA over Excel?

  • The IATF16949 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 format. For more details, click on view tutorial below.
  • 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.
  • 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 FMEAs for standard processes and adopting these in customer FMEAs. Although this can be setup in Excel, it is a tedious task.
  • Open actions in FMEAs are managed in an action list, which can be printed by a manager/ engineer and sorted by due date.
  • 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
  • FMEA might require extended user configuration and authorization which is not supported in Excel.
  • The new 6 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 whitepaper for more details.

To facilitate the start-up of DataLyzer FMEA, the Excel FMEAs can be imported.

Ballooning

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.
  • 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.

Read this whitepaper for further information and examples.

Whitepapers

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 classification symbols and special characteristics used in FMEA? Different methods will be discussed for rating: SxOxD, OxD, SxO, Failure modes with Severity 9 and 10. Safety and Critical failure modes.

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 reused with new product and process development.

Why not Excel?

Why Choose DataLyzer FMEA over Excel?

  • The IATF16949 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 format. For more details, click on view tutorial below.
  • 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.
  • 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 FMEAs for standard processes and adopting these in customer FMEAs. Although this can be setup in Excel, it is a tedious task.
  • Open actions in FMEAs are managed in an action list, which can be printed by a manager/ engineer and sorted by due date.
  • 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
  • FMEA might require extended user configuration and authorization which is not supported in Excel.
  • The new 6 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 whitepaper for more details.

To facilitate the start-up of DataLyzer FMEA, the Excel FMEAs can be imported.

Ballooning

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.
  • 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.

Read this whitepaper for further information and examples.

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