ISO 9001:2015 - Is control possible with Excel adaptable measurement sheets?

#1
New User/New Post - Apologize in advance if too wordy. :)

I am currently working on our company's document control practices while implementing ISO 9001:2015 standards.

For most of our production processes, we use Excel spreadsheets to input measurements taken from the warehouse floor point of use as a control. These measurements are then sampled/inspected using similar Excel spreadsheets as evidence of product conformance [conditional formatting and controls added to the inspection sheets].

Given that our order (measurement lot quantity) and inspection amounts (ANSI 2008) change frequently, is it possible to have revision/document control using these Excel sheets and still have the ability to add rows in the sheet as inspection or measurement quantities change without having to add revision levels?

I guess I am a little fuzzy on the technical definition of a "revision" when using Excel forms or other office products. I've created these basic measurement and inspection form templates for multiple parts and thought it would be best to get this understood prior to moving forward.

The company and myself are relatively green when it comes to ISO 9001:2015 standards.

Thank you in advance!

GlossyMikeQC
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Welcome to the Cove!

You should be able to make a spreadsheet model that makes calculations based on inputs that change results. If your formulas are protected and you can show a history of changes, you can reasonably demonstrate control. People have been doing this with measurement system analysis (MSA) and control charts for years.

Such things are why the standard now refers to "documented information" - there can be various types, including spreadsheets.
 

Ninja

Looking for Reality
Trusted
#5
But don't ever forget the drag and drop fault in XL...

This causes a significant risk of misleading results...and (as far as I've been able to determine after much angst) has remained unaddressed.

Password protecting your formulae does NOT necessarily mean that users can't break them without a password...
 
#6
I agree completely! I've had to warn others in management about the XL cell drag error multiple times over the years. That and cell reference issues have caused a huge headache when I've allowed others to edit themselves.
 

Miner

Forum Moderator
Staff member
Super Moderator
#8
But don't ever forget the drag and drop fault in XL...

This causes a significant risk of misleading results...and (as far as I've been able to determine after much angst) has remained unaddressed.
I agree completely! I've had to warn others in management about the XL cell drag error multiple times over the years.
What are the specific on this drag error?
 

Ninja

Looking for Reality
Trusted
#9
Make yourself an XL spreadsheet with calculation cells, and referenced cells.

Protect everything except for the referenced cells (using the protection tab).

Password protect the sheet.

Then have someone else open the sheet, put data into the referenced cells (like you would doing data entry).

Then drag that entered data from one referenced cell to another...the formula will change, even though the calculation is supposedly behind the password protection...

If I can find this thread tomorrow, I'll post an example sheet...there's one on here from one of my posts a few years ago...
 

Ninja

Looking for Reality
Trusted
#10
Here is a simple demo sheet showing the drag and drop flaw.

Any questions (or especially any solutions), please post.

This was made in Excel 2016 on a Windows 10 platform. I've seen this issue as far back as Windows 98 (not sure which XL level back then).
 

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