Size of QMS - QMS system that has over 6,200 files spread across 685 folders

Proud Liberal

Proud Liberal

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#1
#1
Looking for opinions / comments from an auditor's and user's viewpoint on a QMS system that has over 6,200 files spread across 685 folders.
 
Marc

Marc

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#2
#2
What type of files? What software for control, or do people just traverse directories to get to the one they want/need to access? Is there some type of "sitemap" that employees can use to find specific directories and/or files? Is there a document database of any kind?

The size of the QMS depends upon the size of the company, including how many documents there are.
 
John Broomfield

John Broomfield

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#4
#4
Proud Liberal said:
Looking for opinions / comments from an auditor's and user's viewpoint on a QMS system that has over 6,200 files spread across 685 folders.
Click to expand...
Proud Liberal,

You could ask the auditee's IT department to provide you with usage stats on the QMS docs during audit planning.

From this you'd have an objective basis for auditing the effectiveness of their archiving (also know as control of records).

You may also have a basis for auditing the upkeep of QMS documents.

You may also find users are unclear of where to find requirements relevant to their processes and products. You may find that certain process owners are allowing their documentation to grow like topsy.

Then you could have a discussion with the QMS Manager or equivalent and the relevant process owners. You may find the system has failed to impart clarity, authority, care or competence.

Or it may be working just fine.

John
 
Last edited:
Pancho

Pancho

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#8
#8
Proud Liberal said:
Looking for opinions / comments from an auditor's and user's viewpoint on a QMS system that has over 6,200 files spread across 685 folders.
Click to expand...
The number of files is not a good measure of the usefulness of the QMS. And that you even measure the number of folders that contain those files is worrying.

Regardless of how many files you have, can folks get to the information they need within a few seconds? If it takes anyone more than 3 clicks or one search, then they probably can't. This makes the system not useful.

The "accessible at points of use" requirement is easy to meet with the right technology, even if you have hundreds of thousands of files.

Hierarchical file directories alone are not the right technology for anything more than a few dozen documents. Unfortunately, many will opt for "lean" or "minimal" documentation to shoehorn a QMS into just such file directories and get through a certification audit. But this shortchanges the organization: it leaves no good place or structure to deal with the growth in documentation that should come from capturing knowledge through the continual improvement cycle.

Instead of using file folders or paper binders to store your documents, create a small world network with them. You can do this with dedicated software or a database, or best of all, a wiki. Then don't hold back from documenting every little detail of your business through your CI process. Accessible documented details are quality.
 
somashekar

somashekar

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#10
#10
Proud Liberal said:
1 company, 1 QM, 75 employees
Click to expand...
6,200 files spread across 685 folders
Click to expand...
Are all these documents and records under control ?
If so, find out if you can lighten your luggage.
Its like a Bank. The systems are same, the personnel and the resources must be adequate to operate and manage the size of Banking.
Then whether it is 500 various types of accounts or 50000. No big deal.....
 
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