FMEA Software for DFMEA, PFMEA and Control Plan management
We deliver and implement web based quality software for APQP, SPC, FMEA, Gage management and more — helping manufacturing teams improve quality, meet audit demands and reduce costs. Proven for 40+ years, live within days.
ISO 27001
Certified
SOC2
Certified
Trusted by
Industry leaders
Much faster audits
Due to aligned documents
500+ Manufacturers
Using Datalyzer FMEA globally
Substantial Cost Reduction
Achieved on average per client
Weeks
From demo to live
Why FMEA matters
Quality issues cost time and money. With FMEA, you can prevent problems before they occur. Our FMEA module helps manufacturers to facilitate the creation of FMEA documents, align them with Process Flows and Control Plans.
Alignment of documents
DFMEA, PFMEA, Process Flow, Control Plan are linked. This guarantees alignment and improves the efficiency of the FMEA process.
Standardization and flexibility
FMEAs can be created based on usage of reference FMEAs and FMEAs can be shared between all locations. This way standardization of processes can be established.
Audit-ready always
Aligning all documents and assuring FMEA rules are following will save much time preparing for audits and will improve audit results.
Bring control to your quality, and confidence to your FMEA process
Start small, grow as needed. More users and more locations can be added easily while preserving access to documents based on advanced authorization.
You can start quickly by importing current FMEA and Control Plan documents from Excel.
Based on hundreds of customers functionality is extensive. Different templates, embedded action reporting and notification, enforcing FMEA structured processes etc etc
FMEA can be integrated with SPC. Measurement configuration can be created directly from Control Plan and feedback from SPC can be provided to FMEA owner.
Works across teams, sites and languages. Ideal for scaling standardization globally. Documents can be translated from any language to any language.
All quality modules in one platform
FMEA links to MSA, APQP and SPC. Everything you need for quality management is combined in one clear, connected system. No more scattered tools or messy spreadsheets. Just one reliable source of truth that grows with your process.
Share documents across sites
Get one shared database of all FMEA and Control Plan documents across multiple sites — no matter where or how your teams operate.
Why it matters:
Efficient FMEA/Control Plan process
Characteristics can be imported directly from ballooning software. In addition the fields not being part of ballooning can be added automatically. This can reduce required engineering time to establish control plans with more than 50%.
Suited for all Industries
Qualis FMEA offers templates for all industries including AIAG&VDA (Automotive), RM13004 (Aerospace) and Medical Industry.
“Datalyzer is a key partner for Philips Healthcare. Datalyzer has implemented an SPC solution which is used to monitor the complete plant. The SPC solution collect data automatically from machines which saves a huge amount of time to monitor the plant within Manufacturing and analyze the data for Product and Process Development and to comply to FDA regulations.“
“We use DataLyzer Qualis to maintain a growing number of SPC charts for our semiconductor wafer fab. Some charts are monitored daily, some are used only for troubleshooting; whilst others exist more-or-less to “see if we can find anything”. Recently, we added the FMEA module. I’d say that Datalyzer is helping us most by providing a glimpse into how our troubleshooting and product/process development might eventually work.“
“Using Datalyzer SPC makes it easy for the manufacturing side to control their processes and to review Cpk data. We release our processes to the next process by reviewing the Cpk. Additionally, we use the historical data for certain analytical engineering studies for continuous improvement. We know that we are not fully utilizing this software, but what we use is really helpful.“
“Neways Electronics is investing heavily in continuous improvement of their processes. Part of the continuous improvement process is the development of an efficient data architecture where data will be collected automatically from all production processes and testers. Datalyzer is supporting this process with training, consultancy and software components.“
“Callaway Golf closely monitors continuous improvement in all processes in our own plants as well as with suppliers. Callaway Golf works with Datalyzer to implement SPC worldwide where we have the option to follow all processes real time in every location world wide.“
“TF-AMD has worked closely with Datalyzer over the past years to continuously improve our process control solutions in our global operations. Datalyzer is now completely integrated in our manufacturing environment. Over the years Datalyzer has proven to be a very trustworthy partner.“
“We are using Datalyzer SPC to control and monitor all input of all daily production quality data into all satellites workstations by shop floor users. It provides us the required charts and reports for trouble shooting and process improvement to ensure that we have efficient quality control to our product. We have received dedicated support from the Datalyzer team before, during and after completion of the implementation project”
“Heineken Nederland uses Datalyzer solutions to import the quality data of European suppliers into the central SPC database in our head office which offers the opportunity to link external quality to internal quality and productivity.“
“We use Datalyzer FMEA to control our PFMEAs for all products. The support of the AIAG/VDA FMEA format is an excellent feature. The Open Actions Report is extremely useful as we can easily see all the open actions across all FMEAs in just a couple of clicks. A wise investment for any organization aiming to better the way they manage their FMEAs vs Excel and to support industry accreditations!“
9%
Cost Reduction Achieved by customers
What customers say
“Datalyzer helped us automatically link quality data from all processes for advanced analysis”
Dave Beeren
Yield Engineer, Philips
Industries we serve
ISO Certified
ISO 27001 & SOC2
FMEA software which brings your FMEA process to the next level
For manufacturers worldwide, FMEA has become synonymous with Continuous Improvement programs. The DFMEA, Process Flow, PFMEA, Control Plan and SPC have a logical connection. The FMEA process ensures that products, processes or detection techniques are improved during the design phase based on a structured risk assessment.
Extended functionality
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 product types (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 (AIAG&VDA), 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. For RM13004 ITAR and EAR regulations are fully supported.
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
Reports
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 the content of the document. So a document setup in Spanish can be completely printed in English or in any language you want.
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. If desired, we can provide additional User Training for Datalyzer FMEA.
For more information please download the brochure.
The outcome
What is FMEA?
Failure Mode and Effects Analysis (FMEA) is a structured method used to identify potential failure points in a design, manufacturing process, or service before they occur. It analyzes how systems might fail (modes) and the consequences of those failures (effects) to prioritize risk reduction. For more extension explanation please see What is FMEA?
Does Datalyzer FMEA support AIAG&VDA methods?
Yes our FMEA software is fully IATF16949 compliant, including Action Priority (AP) scoring, structured severity/occurrence/detection tables and AIAG-VDA form compliance.
Why use FMEA software instead of Excel?
Datalyzer FMEA provides amongst others structured templates which are aligned, multi-user collaboration, approval workflows, action tracking, audit-ready outputs and integration with SPC and APQP — impossible in Excel. Ford doesn’t even accept suppliers using Excel for FMEA.
Can you import Excel sheets into Datalyzer FMEA?
Yes Excel documents (FMEA or Control Plan) can be imported from any format and can even be linked after importing.
Is DFMEA, PFMEA, Process Flow and Control Plan aligned in your software?
Yes you can link DFMEA to PFMEA. PFMEA and Process Flow are completely aligned and PFMEA is linked to the Control Plan again.
