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.
After releasing the draft version of the FMEA Handbook, thousands of comments/responses were received from FMEA practitioners around the world. AIAG states that the stakeholder review of the draft version of the FMEA Handbook, 1st Edition, has been completed. The new AIAG-VDA FMEA Handbook is scheduled for release in June 2019.
After the release, DataLyzer will offer training to explain the new manual and how this can be implemented with the help of DataLyzer
DataLyzer will fully support the new harmonized AIAG VDA FMEA system
It is not exactly clear what the new FMEA system will have but we know some of the changes:
For example:
For automotive suppliers this means a big change in 2019 if they are not using FMEA software yet which is capable of the new functionality. For new FMEAs the new method will be audited. 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. 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 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.
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.
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.
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.
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.
Ascertain the root cause from “5 Why” problem-solving approach and the Ishikawa (Fishbone) analysis stored within the FMEA.
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
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.
Import characteristics directly from ballooning software like for example Elias, SolidWorks etc. Create the SPC control charts directly from the Control Plan to minimize redundant data entry.
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.
Print Pareto reports of the top X RPN numbers from a document or group of documents or print reports sorted on new action priority
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
The movie below gives you an introduction to Advanced Planning Quality Process and how DataLyzer’s FMEA software fits in your APQP process.
The movie below gives you a clear understanding of the FMEA document structure and the relationships.
Introduction to Risk AnalysisIn 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’sWhat 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 ClassificationHow 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 comparisonIn 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 EffectivenessWhat 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 FMEAsHow can knowledge be stored in FMEAs and re-used with new product and process development. |
New Harmonized FMEA, to be released in June 2019The final draft of the new handbook was approved by AIAG QSC on April 2nd, and is expected to be approved by VDA QMA on May 8th. The new FMEA manual will restructure the FMEA process. The manual is not yet released, but we know some of the proposed changes. In this article we will summarise the major changes and highlight those changes which are already available in DataLyzer FMEA software. |
See whitepaper for more details.
To facilitate the start-up of DataLyzer FMEA, the Excel FMEAs can be imported.
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:
Read this whitepaper for further information and examples.
Introduction to Risk AnalysisIn 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’sWhat 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 ClassificationHow 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 comparisonIn 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 EffectivenessWhat 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 FMEAsHow can knowledge be stored in FMEAs and re-used with new product and process development. |
New Harmonized FMEA, to be released in June 2019The final draft of the new handbook was approved by AIAG QSC on April 2nd, and is expected to be approved by VDA QMA on May 8th. The new FMEA manual will restructure the FMEA process. The manual is not yet released, but we know some of the proposed changes. In this article we will summarise the major changes and highlight those changes which are already available in DataLyzer FMEA software. |
See whitepaper for more details.
To facilitate the start-up of DataLyzer FMEA, the Excel FMEAs can be imported.
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:
Read this whitepaper for further information and examples.
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