Master List - Does anyone have an equivalent method that they would care to share?

[Sam]

QS states; "A master list or equivalent documentation control procedure identifying the current revision status of documents shall be established . . . ."
A master list seems to be the choice that most people pick, however; does anyone have an equivalent method that they would care to share? And how would it be made readily available to operators.

[Laura M]

An on-line look-up of the actual document. In other words, if a print is out in a tool shop, the employees don't go to a master list, but to a terminal, look up the rev level on the actual drawing - is one example.
No need for a master list.

We also had a documentation control area which held process specifications. The master document in the file was the "master list." If new ones were issued to the floor, the manufacturing area had to remove the old. If there was a question of a document on the floor, the master file in the documentation control area served as the "master list." There were thousands of part numbers, so to keep a master list would have been a redundant waste of time.
Further control on those documents was the engineering rev level which the doc center could look up on line if there was further question. The only list kept was a log of what was issued to the floor when. This was a record of change in addition to a quick look up.

I'd be interested in other schemes too. The creation of a master list is some cases seems like a big waste of time.

One of the schemes here is an electronic ECO tracking system. All parts are on the system, along with information about pending ECO effectivity dates for Engineering, Document Control, Materials and Production.
Type in a part #, get the associated drawing # and the last ECO's effectivity dates, along with the revision level.
Nice, since you also get a warning about prospective changes.
AJP

[pbojsen]

Well, this is a very old thread, but I have to reply anyway since Document Control is my primary job at this time.

"Document Control" is an FDA requirement, and makes good business sense as well. It is difficult to control a document if you don't know what the most current revision is. It is also difficult to control your documents if you don't really know "what" and "how many" you really have. This is especially true if you're going to migrate to an electronic system. How will you know when you're finished? Are you sure you got them all?

A Master Document Register can be as simple as an Excel spreadsheet, which is what we're currently using. The information is put in when an ECO is processed. Everyone can read it, but only Doc Control can write to it.

We have tabs for DMRs, drawings, components, forms, protocols, reports, customer supplied documents, etc. - all controlled documents, all in the same spreadsheet.

It is SO MUCH faster to look at a MDR that you know is correct and current than to have to try to find - either on the PC or physically - a document that can very well be misplaced, misfiled, at the wrong revision, or just missing. It's also very easy to search to see if there already exists a document that you need, or are thinking of creating because you don't know it's there, and everyone else forgot about it too. This is easy to do if you have enough documents.

Electronic systems make this easier as most of them will have an automatically created MDR.

So, what's in our MDR? We have the following fields:

Doc number, Doc title, revision, Customer's doc number if applicable, last author, date of last revision, customer name, and engineering project file number. Most of this doesn't change, so you put it in one time only. We also change the text to red if the document or component has been obsoleted. It's very easy to see what's been obsoleted, which has come in handy many times when engineers are researching documentation.

[qualitychic]

I would use a simple Excel spreadsheet that is accessible for everyone. However, the key is to only allow read-only access. The only one who will have a full access will be the document controller.

[vandenbar]

I'm at a relatively small facility so distribution and training are pretty easy to keep control of, but this is the document that I use. I have about 4 in an excel file, one for procedures, work instructions, lab wki, external documents.

[Russ]

Our system documentation is kept in a QM folder and floor documents are kept in our "Master Production Documents" folder. We control our QM documents with a database, the floor documents are controlled by Engineering and only the latest & greatest reside in the "MPD" folder. It's working very well and allows quick changes of QM documents with good tracking of: what, who, when, & why!

[pbojsen]

Vandenbar, that is a pretty decent MDR for a small company.

I noticed that you also have a distribution matrix. I remember those days, and not happily. When I first came to my current company, we too had paper copies of documents all over the place. The frustrating part was during audits when we found that some people had stashed old revisions of the documentation in their desks and were using them. That, of course, is a "no no" but they did it anyway. That happens in lots of companies. If it was an external audit, we got a finding. Mostly, we got them on internal audits. I have also spent a lot of time replacing those paper copies and once again telling people not to keep personal copies of specs. There had to be a better way without spending thousands of dollars on an electronic document management system (EDMS) to organize and control the distribution of documentation.

Having worked in a couple of larger medical device and pharma companies that had an EDMS, what I did was have our Doc Control procedures mimic an EDMS. We have each doctype (DMR, BOM, work instruction, SOP, component spec - all controlled documents) each in their own folder on a common drive on the computer. Everyone has access to read, but only Document Control can add, revise, or delete these documents. The native formats (Word, Excel, Pro-E, etc.) have been either scanned in or transformed to PDF so they are not alterable, and kept on a separate drive accessible only by Doc Control. Only Doc Control has full Adobe, so nobody else can revise the PDFs.

This has made the use of these specifications SO MUCH easier and user-friendly. Gone are the days of misfiled and lost specs, and having to go around finding and replacing documents and drawings. Everyone knows where they are and can bring them up fast. If a spec needs to be revised, then the engineer gets the native format to change. We also mimic the check in and check out functionality of an EDMS. We're just using Explorer as an EDMS, pretty much. We also now only have one paper original of the document that is vaulted for disaster recovery purposes.

This has also sped up the ECO process tremendously from around 3 weeks to less than a day from creation to implementation. Not too shabby.