Do you use software and/or database for FMEAs rather than Excel?

G

Gert Sorensen

#21
Thanks for the recommendation. If there is anyone looking for information about this product, PM me. I'd be happy to help you personally.

Hi Karen,

Nice to have you here. We look forward to your input. We appreciate your offer to help in PM's, however please try to keep the conversation in the threads. We do like knowledge to be spread, not kept to the lucky few.

:bigwave:
 
Elsmar Forum Sponsor
P

pgr22

#22
We still use Excel, but our parent company is requesting us to begin use "SCIO FMEA System“ from the company PLATO AG next year ... does anyone have any experience/knowledge with that software?
 
R

Richard Pike

#24
Hey everybody, :bigwave:

I am interested in finding a way to convert our FMEAs in Excel form to a database.

Does anyone have an Access based FMEA system?

Does anyone use software for FMEAs, and if so, what is it and is it performing well for you?

Thank you in advance!
Have a look at www.hoquality.com On their Members Lounge (it's free) follow the Core Tools - FMEA Link. You will find a Tutorial and a Trial Download. In my opinion it combines the best of Excel and Access with VB & Java. But I have to admit I am biased as I was the concept author.
 
B

Bischof

#25
I use IQ-RM v.5.1 from Apis. It's very complete and we can elaborate COntrol Plan and Process flow from same file. It's based on VDA volume 4 guidelines and it's also aligned with AIAG manual.
 

Ron Rompen

Trusted Information Resource
#26
I have used both FMEA-Pro and IQ-RM and I personally would prefer to still be working in Excel. Although both programs allow you to create the PFMEA, Process Flow and Control Plan all at the same time, I find them to be very restrictive and difficult to use for a new employee. Yes, they are capable of doing a lot, but the amount of experience and training required to use them to their maximum effectiveness is, unfortunately, something that the majority of us don't have.
 
J

jeilers

#27
If nothing else helps:

Produce nice printouts (paper or PDF) and a standard OCR (optical character recognition) software for creation of Excel input.
 
2

20131011a

#28
I use IQ-RM v.5.1 from Apis. It's very complete and we can elaborate COntrol Plan and Process flow from same file. It's based on VDA volume 4 guidelines and it's also aligned with AIAG manual.
Do you find it easy to work with this software? Is it fast? Does it require a lot of work before you can derive those document from out of the same file?

Greetings!
 
T

teodora

#29
Hi, I was using IQRM when working in an automotive company; It's very good software and it has the advantage it will generate the control plan based on the FMEA, so any procedure or special notes you put in the FMEA will show up in the control plan. We were using Excel but then we had everything transferred to the software; way easier to control changes..
 
Last edited by a moderator:
2

20131011a

#30
Does it require that a lot of people need to know how this works?

We are an international company with production locations in several countries. Is it necessary that all those people get trained?

Also: how do you link work instructions, inspection plans and special characteristics to the FMEA / Control plans?

And what about specific maintenance or operator instructions? Is that easy to fill in into IQRM?
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
D Microsoft Excel database to Stand-alone software Calibration and Metrology Software and Hardware 3
K Ideas for an Open Source Calibration Database Software Calibration and Metrology Software and Hardware 3
B Do I need to validate my database software? Calibration and Metrology Software and Hardware 1
E Open Sourced Surgical Tray Sterilization Database and Software wanted Medical Information Technology, Medical Software and Health Informatics 2
C Comprehensive Quality Management Software (database) Recommendations wanted Quality Tools, Improvement and Analysis 13
K Question about referencing software - Database Records Document Control Systems, Procedures, Forms and Templates 11
W NCR (Nonconformance Report System) Home Made Database or Software Recommendation Quality Assurance and Compliance Software Tools and Solutions 7
J Software for tracking QMS training - Database to track training requirements Quality Tools, Improvement and Analysis 2
J PONC Database Software - Seeking database software to track Price of Nonconformance Quality Assurance and Compliance Software Tools and Solutions 1
S Quality System Database Validation - FDA's General Principles of Software Validation Qualification and Validation (including 21 CFR Part 11) 20
Govind Training Administration Software - EZ tracker training database software? Quality Assurance and Compliance Software Tools and Solutions 1
G 8D - Corrective Action Database Software - Seeking Recommendations Quality Assurance and Compliance Software Tools and Solutions 9
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 2
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
L Micro-Vu InSpec Software Program Qualification and Validation (including 21 CFR Part 11) 6
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 4
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C SharePoint Contract Management Software General Information Resources 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
D Safety data sheets software REACH and RoHS Conversations 2
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
S Asterisk in DOE minitab software Using Minitab Software 23
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
bruceian Software Quality Metrics Software Quality Assurance 11
optomist1 How Secure Are Our Software Systems Software Quality Assurance 7
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
O Software for comparing text of PDF files Contract Review Process 2

Similar threads

Top Bottom