Issue date (Definition of) and Control of 'Rapid Forms' (store bought)

[michelle8075]

Doc & Data control.... everyone's favorite!

I am by no means a consultant, but I have helped to implement QS-9000 TE within our
organization. I Have been trying to help another colleague at a different company help set up
their ISO-9001:2000 system. I really need some clarification.

1) Documents have to have an issued date on them and a revision indicator. Currently, they
are using the following: "Issued date, revision date and revision date".

a) we have benchmarked other companies and they say that the issue date is the
"ORIGINAL" date the document was created. It never changes with any updates to the
form.
b) Their consultant says that the issue date is the date that they distribute it to the company
every time the document is updated and the revision date is the actual date that they
updated it in their "system"

So if anyone can tell us or lead us to know what the correct interpretation in, it would be
appreciated.

2) The next question: The company does not have any controlled document numbers, issued
dates, revision dates or revision levels on their forms such as purchase orders that they order
from a printer, or requisition forms that they purchase as a "stock item" like "Rapid Forms".
They had been previously been told that they don't require the controlled document numbers on these forms. I do know that this is very much untrue, as these are quality forms. The problem now is that they
had ordered at least a year supply of these forms. They are a VERY small Mom and Pop type
organization with 8 employees and they can't afford to purchase new ones. They were
stamping these forms or writing on the controlled doc number, revision level etc. But again, I
had told them that this was not acceptable, defeating the purpose of a controlled document. . The only thing we can think of is to write it in the procedure that these types of forms (ordered from the printer or are "Rapid Forms") do not have a controlled document number etc. on them that they are controlled at the
time that they are purchased via approval from the MR. The MR would then have on file a copy
of what they approved, and their Master Index of Controlled Documents would show the date
in which the forms were ordered and any revisions to them.

Are we going down the wrong path? Any help is truly appreciated.

[Tom W]

First let me welcome you to the cove.

I don't believe there are any fast and hard rules on how to control documents. The key is to pick a system that works for you and implement it. The requirement is that you need to ensure that obsolete documents are removed from use, so you have to have a way to know which are obsolete and which are current. The revision tracking is one common way to do this. The original issue date is not as important as the current revision level/date. JMHO.

On the forms side of it. Many printers will put there own refence number on the forms that the print, like a print / style number or something like that. You could use that number if it is available. The problem really comes into play if you change a form and now have two different versions out there. You would want to develop a system of control - be it by title or something else, and a method to ensure that the desired revision is the one being used. Again JMHO.

There are many gurus on this site that can give you tons of insite on control of documents and forms, these are just my humble opinions on your situation.

Thanks and again - welcome to the cove. A wealth of resources are at your fingertips here. Don't be shy to ask questions.

[D.Scott]

Welcome to the Cove.

I agree with Tom. The method you use to control your documents and forms is up to you. Decide what works for you and put it in your procedure. If you want to call the "Original" date the date somebody dreamed it up, that is your choice. If the revision date is also your revision level and you say so, that is fine. If you want to control a pre-printed document by using a stock number already on the document - say so in the procedure. Don't overkill document control. You decide what needs to be controlled, how you will control it and then document your procedure.

Dave

[Claes Gefvenberg]

Hi there michelle, and welcome to the Cove

First of all, I think Tom has provided you with a good reply. I also suggest that you have a look at the thread Version vs Revision . It should prove interesting. As a matter of fact, that goes for the entire Documentation and Forms forum.

Another thing: Considering the fact that we are talking about a mom & pop organzation with 8 people, you should pay close attention to note 2 in clause 4.2.1: (I have repeated this so often that the regulars here must be getting sick of it by now, but it is important):

4.2.1, note 2:

The extent of the quality management system documentation can differ from one organization to another due to

a) the size of organization and type of activities,

b) the complexityof processes and their interactions, and

c) the competence of personnel.

The essence of this is that it allows you to build a reasonable system acc. to the needs of your company. I.e: With only eight people, you probably don't need the same level of documentation as a large corporation would.

And hey... Good luck with your quest.

/Claes

Added later: Aha...Dave beat me to it, and his advice is good too.

[michelle8075]

Thank you everyone for your posts. I never did think of the fact that some printers have their own number on these forms.

Also, I did forget about claus 4.2.1. I think that sometimes we do try to overkill what needs to be done. Personally, I try to cover all the bases, but it can get very tangled the more information you put into it.

Thanks again Tom, Dave and Claes your responses are truly appreciated and have provided me with some great advice.

I think I am going to like the Elmar Coves Forums!!!! What a great tool to this newbie!

Happy Holidays!
Michelle

[Mike S.]

Welcome aboard, Michelle.

The advice given so far is good, as usual here at the Cove.

However, let me add my own opinion regarding the forms. Nowhere does ISO 9001 say that forms must necessarily be controlled. If you want to or need to, do it. However, IMO, unless the form is also serving as a WI (work instruction) control via document number and revision number, etc. is not required.

I look at it this way: If training and/or WI's tell you to enter certain data somewhere, and it really doesn't matter if this data is written on a blank piece of paper or on a pre-printed form used for neatness/efficiency then the presence or absence of the form will not cause problems, therefore no doc. and rev. number is needed for the form. But, if the form is required for the user to know what to record, or if it gives other instructions or formulas or what-have-you, then I'd say it needs to be get a doc. and rev. number.

JMO.

Originally Posted by Mike S.

Welcome aboard, Michelle.

I look at it this way: If training and/or WI's tell you to enter certain data somewhere, and it really doesn't matter if this data is written on a blank piece of paper or on a pre-printed form used for neatness/efficiency then the presence or absence of the form will not cause problems, therefore no doc. and rev. number is needed for the form. JMO.

I keep reading this and it doesn't change! If a WI tells me to enter data, I can write it on a blank piece of paper? Why's that? Do I keep it? Is it a note? I'm for simplicity, but pieces of paper laying around with info on them makes me nervous. You? Of course, I'm from the old school, but doesn't that invite scrutiny? Hi Michelle!

[Mike S.]

Originally Posted by energy

I keep reading this and it doesn't change! If a WI tells me to enter data, I can write it on a blank piece of paper? Why's that? Do I keep it? Is it a note? I'm for simplicity, but pieces of paper laying around with info on them makes me nervous. You? Of course, I'm from the old school, but doesn't that invite scrutiny? Hi Michelle!

l'm all for KISS, that's all. Almost everyone here agrees on 2 things -- do what works for you, and don't make things harder than they need to be and/or read things into ISO that aren't there.

Let's say you're in the final test lab. The test you need to do is density on some material you produce. You are trained and authorized/certified to do the test and have a basic WI to support the training. The WI says the following data must be recorded for every test: Lot or serial number; material type; date of test; name of test operator; sample dimensions (L, W, T); weight; and calculated density. The WI says this data is to be kept as a Q record for 18 months.

Scenerio 1: The WI gives you the formula (formulae ) for density. You record the required data on a blank piece of paper and file it as a quality record as required. IMO you meet all ISO and internal requirements.

Scenerio 2: The WI gives you the formula for density. You record the required data on a pre-printed form (the form has the required parameter and a space to write it -- like LOT # ________ MATERIAL TYPE __________ but it has no document and revision number on it) and file it as a quality record as required. IMO you meet all ISO and internal requirements.

Scenerio 3: The WI does not give you the formula for density -- this formula is however located on the pre-printed form. You record the required data on the form and file it as a quality record as required. IMO, if the form is formally reviewed and controlled with a doc. and revision number you meet all ISO and internal requirements, as the presence or absence of the form, or unauthorized changes to the form, could affect the result of ther test.

IMO if the form is just a convienience, or a neatness thing, or an organization thing and nothing more there is no need for a doc. and revision number. So what if you change the font size or the size of the blanks or make room for 3 sets of data on one page instead of one set? No harm can come from it.

JMO.