Anyone been asked by an auditor if software is certified?

Here is an update on my question concerning Datapage. I just think anyone who might need this info in the future will at least have some idea about it.

My name is Joseph Batts, Product Owner for Web Reporting applications, including DataPage+ and WebReporter. I received notification of a ticket you submitted asking about NIST 3rd party certification for DataPage+. The calculations used in DataPage+ were certified 25 years ago using recognized industry SPC standards then, which have not changed. However, no additional certification has been performed and documented since. That being said, your request is one of several for the same or similar certification. In May 2014, I started a project to gain this 3rd party certification for DataPage+ and WebReporter, and it is in the works. When the applications are certified, and publishable documentation is available, it will be made available on the PC-DMIS website for DataPage+ ( http://www.pcdmis.com/products/datapage-plus-spc).

If you have additional questions, please feel free to call me. I will be happy to help in any way I can.

Best regards,

Joseph Batts
Product Owner – Web Reporting
(MMS, DataPage+, WebReporter, DataGage+)
Wilcox Associates, Inc.

I then received this email from Hexagon.

From: Hexagon Metrology - Technical Support [mailto:Support@HexagonMetrology.us]
Sent: Wednesday, July 16, 2014 4:30 PM

Your ticket has been closed.
Please follow up on this issue with Joseph Batts directly as he emailed you earlier today.

My response to the closed ticket.

Why should this ticket be closed? My (Iroquois) support is through Hexagon, not Joseph Batts. I can only ask the software that was purchased through Hexagon be accredited to a recognized national standard. If Hexagon contracted with Joseph Batts for statistical software, would it not make sense that Hexagon expect the software to be certified to a recognized national standard when changes (upgrades or fixes) are made or a certain time period is reached, just like PCDMIS is? Please tell me how I would answer an auditor if they asked about the software? Show the email that the software was certified 25 years ago? This ticket should remain open until Mr. Batts finishes his statement “In May 2014, I started a project to gain this 3rd party certification for DataPage+ and WebReporter, and it is in the works. When the applications are certified, and publishable documentation is available, it will be made available on the PC-DMIS website for DataPage+”. I would respectfully ask that this ticket remain open so I can be notified when the 3rd party cert is available. If there are any concerns with this ticket being open, please send it to a higher authority to answer it with me.

First, let me preface this by saying I am not the only expert at Hexagon, nor a certifications expert either. But I will state what I know and ask a couple of questions, and I've checked and your ticket was reopened and attached to a problem report with our developers. The only reason it was closed was because you were in direct contact with a developer, they did not mean to offend.

Questions/statements:

1. I can find no NIST certification for SPC software. Are you sure one exists?
   
2. Do you know of any 3rd party testing for SPC software? I've got to believe one exists, but I can't find one myself in a quick check (again, I don't check these kinds of certifications every day).
   
3. Does your auditor require/accept a certain company's tests?
   

I am only familiar with NIST and PTB testing for PC-DMIS, I've never been asked for DataPage/SPC software certification as a customer or working for Hexagon (and I've been doing this over 20 years). For fun, I checked the Minitab website, and didn't find any meaningful certifications there for Minitab either.

Brian,
I was not offended, just making a point to the tech that I want the ticket open until a final answer is available. The ticket is traceability for me to get an answer. I know of no third party certification either, well, NIST. The TS standard and, I believe other lab certification standards (A2LA, NIST) require software performing measuring, inspection, testing, (all the code words) be reviewed. Statistics in my opinion, would fall under the code word criteria since decisions are made using statistical analysis to improve your final product. In my opinion, maybe an official third party titled organization / company is not needed. Maybe the math and other info can be certified by an educational institution approved by Hexagon? But this is just a guess from me. Hexagon would have to research what all, or at least the major certification bodies accept. I have not had an auditor ask about software since back in the late 90's, but while reviewing our lab scope, this subject was mentioned.
Another question that was mentioned during our review, how do we check our in use software to assure nothing changed over the coarse of time? We were thinking of a spreadsheet with the formulas from / in the AIAG MSA book, compare the results to the Datapage and see if there are any differences. Like you Brian, I am not an expert, just asking the masses if there is one or two that might have went through this process.

Odda

NIST, to our knowledge (checking everything we know so far) does not certify SPC software, only measurement software. I'm hoping to be corrected soon on that, we like getting certifications (I do), it's another form of testing.

DataPage does not "measure", "inspect", or "test". It simply summarizes data produced by measurement/testing software. Now I agree there are calculations that could be certified in there that are not trivial, but they are also not that hard to correlate either.

Educational institutes have no accreditation of their own (that I am aware of...) that would qualify them for this testing except maybe for marketing purposes, so that's not a valid route.


For your last question, an artifact, a checking gauge, a virtual measurement program are all variations on things I have seen used to verify software "not changing".

I will report more when we hear back from our contacts in this arena.

DataPageStats.exe is an external command inserted at the end of the part program. It pops up a window with a progress bar. Running this way produces a .XML file, that the importer grabs and tosses in the database. If you are doing this, you could open the importer and see where it is looking for the XML files, and the location of the database. If you didn't know where they were before May, you probably wouldn't know if they were wrong now though.

http://www.prolinksoftware.com/sales_validation.aspx

QC-Calc does validate their software. Check out this post as it is what is needed for this exact question by an auditor especially in the medical industry. QC-Calc is doing it and maybe it would be worth while for Hexagon to do the same. I am right now trying to work out whether or not we will even be able to use datapage+ since we cannot even get someone to write a letter saying that the software is made to industry standards. I am very interested in this topic and will continue to watch the thread.

http://www.prolinksoftware.com/sales_validation.aspx

Check out what QC-Calc does for this question by an auditor. I asked the same question to the sales rep and just got a link to show the part 11 compliance to data security that is on their website. I cannot even get them to write a letter saying that datapage+ was made to industry standards.

please let me know of any updates that you get on this subject. I would like to use datapage+ for our SPC needs but may have to go with QC-Calc if hexagon can't remedy the problem. Once a year a document on the website could be updated just like is done for PC-DMIS which would help us all out in this situation.

Where can I get a copy of this NIST certification for PC-DMIS, ver2012 MR1?????

Go to the hexagon website and it is posted on there. It is a PDF file in the software section. I can't remember the exact location but it is there I printed off a copy for my company.