Control of Monitoring and Measuring Device Software

E

emgall

#1
#1
The final requirement in this section includes "...the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary."

Several questions:

1) Test equipment whose operation is computer controlled (in our instance, a spectrometer for chemical analysis) using software developed and installed by the manufacturer. Are we expected to confirm it's acceptability or require some type of documentation from the manufacturer to prove this?
2) What about MS excel spreadsheets and MS access databases employed for logging data, creating SPC charts? Would the software itself require confirmation and/or would each individual spreadsheet created require confirmation?

Thanks for any guidance you can offer.

------------------
Ed Gall
 
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Marc

Marc

Fully vaccinated are you?
Leader
#2
#2
-> 1) Test equipment whose operation is computer controlled
-> (in our instance, a spectrometer for chemical analysis)
-> using software developed and installed by the
-> manufacturer. Are we expected to confirm it's
-> acceptability or require some type of documentation from
-> the manufacturer to prove this?

I don't think this is an issue. Is your spectrometer calibrated? Your 'standards' should prove the instrument as a whole (hardware and software) is OK.

-> 2) What about MS excel
-> spreadsheets and MS access databases employed for logging
-> data, creating SPC charts? Would the software itself
-> require confirmation and/or would each individual
-> spreadsheet created require confirmation?

I would think you would validate that the software 'system' (Excel plus Access) is doing what you expect by entering a 'known' data set and seeing if the output is what you expect.

I'm sure the other folks here will have some comments on this.
 
A

Al Dyer

#3
#3
1: Stat Software or Excel program-

Take some data out of the AIAG MSA or SPC manual and run it through your software and compare results and take action as needed.

Get with your customer with a common set of data and punch it into each system and take action as needed.

2: Access program:

Copy an Accesss database to another computer and run the same reports and compare results.

In any case, if you are you are using Microsoft software make sure you are working with the same release and upgrade level of software.

3: Word:

Many use MS Word for documentation. Remember that there are differences in the versions and that not all data will transfer between versions in the exact same manner, even if you open a Word 97 file with Word 2000.

The thing to remember is to validate your software as you would validate your gages.

Example:

I have two identical CNC machines set-up to run the same part. I have two programs, one in each machine. Are the programs inter-changeable? One would think so, but that is not the case. One has to take into consideration, machine life, PM requirements, tool wear, MTFB etc...

Bad analogy?

I think not! You can install MS Excel on three different machines and depending on the service pack level, version level, type of operating system..... there can be different results with the same data.

Long response for the day! :)

ASD...
 
R

RCW

Quite Involved in Discussions
#4
#4
Re: Control of Monitoring and Measuring Devices - Software

The software portion of 7.6 was recently brought up in my department during an internal audit. Here's what it was regarding:

I am using a continuity tester that is controlled by computer software. I enter in continuity node data (point a goes to point b, etc.) into the software. From what I can determine from this post....
1) I do not have to verify the ability of the application software (per the last paragraph of 7.6.
2) I should be validating that my data file (the node information) meets the requirements of the wiring diagram. (Or not?)
3) I am unsure if there should be any records of the above validation. Or any records in general regarding the software mentioned here.

Any comments or suggestions for the above? This matter has never surfaced during registrar audits.
 
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