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  ISO 9001/4:2000
  Control of Monitoring and Measuring Devices - Software

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Author Topic:   Control of Monitoring and Measuring Devices - Software
emgall
Lurker (<10 Posts)

Posts: 2
From:Butler, PA, USA
Registered: Apr 2001

posted 06 July 2001 11:04 AM     Click Here to See the Profile for emgall   Click Here to Email emgall     Edit/Delete Message   Reply w/Quote
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 Smith
Cheech Wizard

Posts: 4367
From:West Chester, OH, USA
Registered:

posted 07 July 2001 03:25 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
-> 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.

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Al Dyer
Forum Wizard

Posts: 814
From:Lapeer, MI USA
Registered: Oct 2000

posted 08 July 2001 03:45 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
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...

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