We have been searching for what we consider 'bandit' documents and records; i.e., those that are uncontrolled, have no number, version, approval, etc., and are just laying around or pinned up on a wall. When found, we either destroy them (usually not needed anyway), or we add the necessary notations and archive appropriately.

We have found a few, however, that are not so clear cut: Blank sheets of paper where operators jot down information so they can later enter said information in the appropriate computer screen (database) or perhaps write it down on a controlled form to become a bona fide record. The hand-written sheet is thrown away after the information is 'transferred', which normally is done within a few hours.

I thought about generating forms (properly annotated and controlled) for the operators to jot down the information. However, these filled forms (now records) would still not constitute an actual controlled record as they are discarded.

Could these temporary, uncontrolled records be a problem, or would it be OK to allow the practice to continue as is?

Thanks -

Alex

I would have thought that you are OK with what you are doing providing you have the following in place.

1) A document number assigned to the form the operators are completing, to provide a reference for the operator to request.

2) You have a procedure / flow in place covering the notation of records manually at lineside (refering to the document in point 1) through to updating records online.

If you feel and can demonstrate the effectiveness of the system you have, and convince the auditing body of this you'd be unlucky to be penalised on this one.

If it ain't broke don't fix it.

We actually have a little bit of both in our lab. We use a home made LIMS to enter/report/store all of the data we generate. Some of the tests we do require the techs to write raw data down on a sheet of paper, which is alway a form of some kind. The raw data is then entered to the LIMS and the paper form is discarded. Most of the paper forms we use are NOT controlled forms, but a few are. We are looking to get all of the data forms out of the QMS and make them uncontrolled, since we only temporarily use them and then toss them. We've never had an issue with this in our 3rd party audits, because we never wrote ourselves into a corner over it. Ifyou are not forcing yourself to control them in your own QMS, then the standard does not force you to either, in this particular instance.

...Blank sheets of paper where operators jot down information so they can later enter said information in the appropriate computer screen (database) or perhaps write it down on a controlled form to become a bona fide record. The hand-written sheet is thrown away after the information is 'transferred', which normally is done within a few hours...

I'd have a real problem around here if I told people they had to use a controlled document instead of a scratch pad.

I am in a calibaration environment, so this may not work for you the same way it does for me ...

If a calibration procedure requires the technician to record temporary values or intermediate calculations, then an appendix to the procedure contains forms for that purpose. When final measurement results are recorded, either directly by the automated procedure, or in the laboratory database, or on a form that is also part of the procedure (but in section 5, not an appendix).

If the work process has a written instruction, then it may also be possible to do the same thing - put a simple form for recording temporary values and calculations in the process instruction. Include a note that it can be reproduced as needed and destroyed after use. If it is part of the instructions for the work process then the issue of controlling a separate form vanishes.

We have found a few, however, that are not so clear cut: Blank sheets of paper where operators jot down information so they can later enter said information in the appropriate computer screen (database) or perhaps write it down on a controlled form to become a bona fide record. The hand-written sheet is thrown away after the information is 'transferred', which normally is done within a few hours.

I thought about generating forms (properly annotated and controlled) for the operators to jot down the information. However, these filled forms (now records) would still not constitute an actual controlled record as they are discarded.

Could these temporary, uncontrolled records be a problem, or would it be OK to allow the practice to continue as is?

Thanks -

Alex


Alex,

If you have not had problems with personnel making errors in this transfer process, why complicate the process with worthless "controlled" forms?

There are many times during a day that I (and most of the world around me) jot down a few notes, either to remind us of things to do, people to meet with, all of which may be directly related to my work - but I do not need, nor am I required to take these notes on "controlled" forms.

Don't make your quality system so cumbersome that it doesn't make sense, and is a setup for failure (people are always going to jot things down and in many cases that is a good thing, why force them into having to search for a specific controlled form in which to accomplish this - Afterall they may need a form to jot down where the controlled forms are being maintained. :rolleyes:

Cari -I'd have a real problem around here if I told people they had to use a controlled document instead of a scratch pad.You bet - ditto here!

David -If you have not had problems with personnel making errors in this transfer process, why complicate the process with worthless "controlled" forms?Amen to that!

I'll keep it simple, as it is now, and be done with this issue. (KISS principle rears its 'pretty' head again!)

Thanks,

Alex

I used to address these in a 'procedure' and called them 'Ad Hoc' documents. The procedure detailed how to put uncontrolled documents on the floor. In fact, I did this so long ago it was part of my original site in 1995-96. Back then a link to the gif picture of a mountain range below was on the header of every page (as it still is on http://Elsmar.com/iso9000.html - Click the Mountain range on that page).

http://Elsmar.com/gif/peakssmall.gif
http://Elsmar.com/gif/doc-pyramid.gif

Look at Level 5...

This also addresses bulletin boards and related - well, 'ad hoc' or 'rogue' documents.

Minimum requirements:
Date issued/posted
Signature/Initial or other way to track the owner (responsibility)
Date of expiration

I was 'born' into 'quality' in a military manufacturing environment. I long ago learned you can do what you want if you can explain it and have - at a minimum - basic guidelines.

We have found a few, however, that are not so clear cut: Blank sheets of paper where operators jot down information so they can later enter said information in the appropriate computer screen (database) or perhaps write it down on a controlled form to become a bona fide record. The hand-written sheet is thrown away after the information is 'transferred', which normally is done within a few hours.


Alex

Alex not sure if this applies to you but, if you are in the Medical/Pharmaceutical Industry you must retain these scraps/napkins/sticky notes, etc.. you are recording the original data on with the controlled form you copy them over to. Data must also be recorded at the time it is obtained (no going back at the end of the day and trying to remember what your results were).

Alex not sure if this applies to you but, if you are in the Medical/Pharmaceutical Industry you must retain these scraps/napkins/sticky notes, etc.. you are recording the original data on with the controlled form you copy them over to. Data must also be recorded at the time it is obtained (no going back at the end of the day and trying to remember what your results were).Let's be clear about the difference between

"special cases for control" of documents which have to do with the nature of the organization's business and its relationship with customers and regulators
and
general "shalls" under ISO9k2k.
The primary factor is "What makes sense for this particular business?" Therefore, if the special cases exist, by all means incorporate the controls into your system. If not, ignore them (bandit documents) as long as employees are clear they are "extraneous" and the only documents and records which should be relied on are the ones within the system.

Example - would you try to incorporate United Way posters in your workplace as Quality documents? What about the sign-up sheets for the softball team or bowling league? If those bandit docs don't have an effect on the quality of the product or process, ISO9k2k would say they don't matter.

Alex not sure if this applies to you but, if you are in the Medical/Pharmaceutical Industry you must retain these scraps/napkins/sticky notes, etc.. you are recording the original data on with the controlled form you copy them over to. Data must also be recorded at the time it is obtained (no going back at the end of the day and trying to remember what your results were).
Bottom line is you have to address the existence of these types of documents in your system wherein you define basic requirements. Whether United Way or product or process specific temporary 'test' or 'investigation' documents / data.

Example - would you try to incorporate United Way posters in your workplace as Quality documents? What about the sign-up sheets for the softball team or bowling league? If those bandit docs don't have an effect on the quality of the product or process, ISO9k2k would say they don't matter.
I agree. I've seen where the organization was told that "everything had to be controlled". They assigned a part number to just about everything including the performance review form and toilet paper.:lmao: Just kidding about the TP. If it doesen't affect the quality of the product, you don't need to control it.

They assigned a part number to just about everything including the performance review form and toilet paper.:lmao: Just kidding about the TP.
Then again, if the TP is rough single ply newsprint 'quality', the company may have a 'dissatisfied' workforce which could cause more problems than if they were supplied with 'soft' TP.... :rolleyes:

Then again, if the TP is rough single ply newsprint 'quality', the company may have a 'dissatisfied' workforce which could cause more problems than if they were supplied with 'soft' TP.... :rolleyes: :ca:That would be described in this controlled document:

If only the government had put this much thought and planning into the space shuttle!

Actually, this was a very good example of a customer specification which had comfort of workers as an objective.:rolleyes:

I agree. I've seen where the organization was told that "everything had to be controlled". They assigned a part number to just about everything including the performance review form and toilet paper.:lmao: Just kidding about the TP. If it doesen't affect the quality of the product, you don't need to control it.
I think it's as much an issue of policies than formal document control. For example, as regards United Way - is there a policy regarding that type of 'document'? I doubt an auditor would address control of that type of 'document'. None the less, most companies have some type of policy about what can be posted and where. Some require an approval - moreso in larger companies than mom and pop shops.

Let's consider 'ad hoc' testing done. An engineer or whoever makes up some type of test to check for something. Do these have to be controlled? I would hope that there would be at least a policy on control of the test method and data if only at the departmental level. I see this a lot where each engineer is required to keep 'personal' files on that sort of test. It's technically document / data control, just not in the sense which typically first comes to mind - which is like having a procedure for everything and some big honkin' document and data control structure. People tend to think of a centralized, overbearing system.

The degree of the policies and requirements also vary by industry. In the aerospace and medical device industries there are more stringent requirements for document / data control and retention, for various reasons as we all know, as opposed to requirements in a lawn cutting business, for example.

I think it's as much an issue of policies than formal document control. For example, as regards United Way - is there a policy regarding that type of 'document'? I doubt an auditor would address control of that type of 'document'. None the less, most companies have some type of policy about what can be posted and where. Some require an approval - moreso in larger companies than mom and pop shops.
The point is: Control of postings (United Way or bowling league) would not be part of QMS unless the postings interfered with other postings pertinent to the QMS. Even then, only where and how the postings go, not the content or format, would affect the QMS.

So what constitutes control?
When I perform a dimensional layout my final reading of the dimensions are recorded on the blueprint (drawing). My computations are on blank paper and attached to the drawing. Everything is then kept in a file by either a job # or a drawing number.

When New Product Development is designing a new product all there data is kept in an Engineering Document "BOOK" and becomes part of the package that is handed to Application Engineering when design is released.

I am sure there are other examples that could be cited. My question is just how formal do we have to be. If every thing has to be "crossed and dotted" then I must say it could be one reason why certifications are not pursued as they should be. I read some of the post in other threads and absolutely shudder at the pains taking task companies heap on themselves. Reminds me of MIL- Q! :mad:

You are exercising document control at the personal level in accordance with company policy. You control their origin, their revisions, their distribution, etc. When you hand the documents off to the next function they inherit responsibility for their control, protection, etc.

But again - it depends upon the industry and needs on what has to be, for example, centrally controlled. Yet even 'central control' can be department specific. I have seen many companies, for example, which task sales with control of customer drawings. In other companies I've seen engineering responsible. In the 'bad Ol' Mil-Q days there was typically a central document control function. But also in those bad old days (prior to the 1990's - remember PCs didn't come on the scene in and great numbers prior to 1985) there weren't personal computers and 'instant publishing' or centralized servers everyone who needed to see a document could get to. Times have significantly changed as has the paradigm of 'document and data control'.

How many 'Old Mil-Q' folks are here that remember getting Mil_Specs on microfiche? Then there were film reels. Now days it's pdf files and CDs. Oh, the HORROR of it all!

You are exercising document control at the personal level in accordance with company policy. You control their origin, their revisions, their distribution, etc. When you hand the documents off to the next function they inherit responsibility for their control, protection, etc.

But again - it depends upon the industry and needs on what has to be, for example, centrally controlled. Yet even 'central control' can be department specific. I have seen many companies, for example, which task sales with control of customer drawings. In other companies I've seen engineering responsible. In the 'bad Ol' Mil-Q days there was typically a central document control function. But also in those bad old days (prior to the 1990's - remember PCs didn't come on the scene in and great numbers prior to 1985) there weren't personal computers and 'instant publishing' or centralized servers everyone who needed to see a document could get to. Times have significantly changed as has the paradigm of 'document and data control'.

How many 'Old Mil-Q' folks are here that remember getting Mil_Specs on microfiche? Then there were film reels. Now days it's pdf files and CDs. Oh, the HORROR of it all!

Oh Yes! Remember them quite well. Thanks Marc! I also remember my very first "AT" computer which was used mostly to tie in to the mainframes. We had some electronic bullitin boards but I do not think the internet was available. We have indeed progressed haven't we.
:thanx:

The point is: Control of postings (United Way or bowling league) would not be part of QMS unless the postings interfered with other postings pertinent to the QMS. Even then, only where and how the postings go, not the content or format, would affect the QMS.
Yes, but the QMS is a part of the whole. It may not affect the QMS - Is that the only aspect which should be considered?

Oh Yes! Remember them quite well. Thanks Marc! I also remember my very first "AT" computer which was used mostly to tie in to the mainframes. We had some electronic bullitin boards but I do not think the internet was available. We have indeed progressed haven't we.
:thanx:
I was at a company recently which distributed signed, serialized copies of the quality manual initial, too. The overhead to do that is unbelieveable. I sorta freaked out when I saw that. I thought I was in a time warp.

I was at a company recently which distributed signed, serialized copies of the quality manual initial, too. The overhead to do that is unbelieveable. I sorta freaked out when I saw that. I thought I was in a time warp.Sorry to report - since each FAA inspector is a god unto himself (no appeal from a ruling when trying to get FAA-PMA certification), there are many FAA inspectors who require exactly that - signed, serialized copies of QManual PLUS a continuously updated Master list of who has a copy. Systems which have "push" method of distributing revisions to Qmanual and other documents find greater favor with FAA folk than "pull" systems.

Push - document "owner" sends new revisions to master list of holders and takes obsolete versions back for destruction (keeping records of transactions)

Pull - document "holder" is responsible for ensuring he has most recent version to use and must constantly inquire of "owner" and "pull" new version when available.

This all gibes with FAA holding certificate holder for everything upstream and downstream in the supply chain.

In a weird way, it makes sense when life, health, safety issues may be involved.

Note - this only holds for "controlled copies" of documents. Uncontrolled copies are usually stamped with a disclaimer saying they are in the "pull" category.

None the less, I doubt that even an FAA inspector requires 92 controlled copies of the quality manual. I am surprised that it is only 'required' by 'some' FAA inspectors and not others.In a weird way, it makes sense when life, health, safety issues may be involved.Yes, weird if some inspectors require it and others don't. Sounds dangerous to me if the inspectors have so much latitude that they can make up rules on the fly.

None the less, I doubt that even an FAA inspector requires 92 controlled copies of the quality manual. I am surprised that it is only 'required' by 'some' FAA inspectors and not others.Yes, weird if some inspectors require it and others don't. Sounds dangerous to me if the inspectors have so much latitude that they can make up rules on the fly. They do, and aren't afraid to let you know. One just flat out said to me: I have the power to shut you down.

I don't doubt it's true. Doesn't make it any less scarry to me.

I don't doubt it's true. Doesn't make it any less scarry to me.In defense of the FAA inspector, I have never met one that wan't absolutely, positively dedicated to safety - all the ones I dealt with were multi-engine rated pilots who had to fly the prototype craft for testing - they were definitely not "desk jockeys."

None of the interpretations of requirements were intended to make the operation less safe.

Two reasons for this attitude spring to mind:

Inspectors were sincere about ensuring the manufacturing operation would produce safe products
Inspectors had to pass recommendations up the line to someone else - the "someone else" would never countermand an order by the field inspector which called for more documentation (saying less documentation was necessary), but could, himself or herself, demand even more documentation than the field inspector required. (Ergo, field inspector never wanted to look "not vigilant" to his superior.)

I don't have a problem with what you're saying. I am sure all the inspectors are hard working, dedicated and interested in safety.

But we are (were?) talking about a requirement (or no requirement?) to distribute hard copies of the company quality manual, signed, dated, etc. to multiple people. This speaks to actual, documented FAA requirements for such vs. an inspector's opinion as to whether this is required. If it all comes down to opinion on the part of an inspector and there are no documented requirements, you're in a no win position which is - to me - scarry. One inspector today says none required and next one says one is.

I might add I do understand as my 'earlier life' was in military manufacturing of electronic assemblies and parts for aerospace applications. I went through several loosing challanges while in the field vs. what was DCAS. In one appeal situation I requested, and amazingly got, a different DCAS fellow because of our 'differences'. I thought some of the stuff was stupid then and still do. Either document it as a requirement or leave well enough alone.

I'd ask what other requirements are left up to inspectors to determine.

I don't have a problem with what you're saying. I am sure all the inspectors are hard working, dedicated and interested in safety.

But we are (were?) talking about a requirement (or no requirement?) to distribute hard copies of the company quality manual, signed, dated, etc. to multiple people. This speaks to actual, documented FAA requirements for such vs. an inspector's opinion as to whether this is required. If it all comes down to opinion on the part of an inspector and there are no documented requirements, you're in a no win position which is - to me - scarry. One inspector today says none required and next one says one is.

I might add I do understand as my 'earlier life' was in military manufacturing of electronic assemblies and parts for aerospace applications. I went through several loosing challanges while in the field vs. what was DCAS. In one appeal situation I requested, and amazingly got, a different DCAS fellow because of our 'differences'. I thought some of the stuff was stupid then and still do. Either document it as a requirement or leave well enough alone.I'd ask what other requirements are left up to inspectors to determine.

Marc,
It is amazing sometimes what a little resistance can bring. When I was an Electronic Inspection Supervisor I challenged the DCAS inspectors right to zoom the microscopes to 10X when the solder spec called for all inspections to be performed at 4X, with referee at 10X. This guy was rejecting every PCB he looked at for solder problems. To my surprize, two days later, a contingent of DCAS and NUSC arrived to review the problem. I thought I was doomed but when it was all over the man from NUSC shook his finger in the poor guys face and flat out told him 4X! Never had a problem with any DCAS inspector after that.

We had an automotive customer perform an audit of us last year (on a day I wasn't here, so I couldn't defend it!!) who observed this very practice at the slitter - operators writing down numbers for arbor setups to remind themselves of the proper arbor settings. Customer wrote it up as a finding, and when I got back I fought it - successfully. I agree with earlier post that says it would be like requiring me to write notes to myself as I work in the TS system and making them "controlled." I agree with post that said if it ain't broke don't fix it, and don't write your document control procedure in such a way that paints you into this kind of corner. We defended ourselves against the customer by saying what someone else earlier in this post said - let me show you my failure rates or error rates that were traced to the notes on this piece of paper - they don't EXIST. We'd never had a single claim or complaint whose root cause was those "uncontrolled" bits of paper.

It's that same customer, that same audit, by the way that also cited us because some of our controlled documents, depending on the formatting and the document itself, had a controlled document number at the top of the page, while another document might have it at the bottom of the form. Needless to say we successfully fought off that one, too.

Moral to the story - Quality people can NEVER take a vacation day - **** like that happens when you do!! :bonk:

Perhaps we need to also keep in mind how difficult it was to convince the operators to take notes and write things down in the first place. :rolleyes:

Now that they are doing it - and rather well, thank you - albeit using a paper pad (of their choice) as a temporary medium, I believe I will just let it be and be thankful. :) For as long as the information gets transferred to the proper form/record on a timely basis, as has been the case, I will not raise a fuss - "it ain't broke, so don't attempt to fix it and risk it".

Thanks!
Alex