Temporary Bandit, Ad Hoc or Rogue Records, Forms, Data, Documents - How to Justify

[Ingeniero1]

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

 

[s-bell]

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.

 

[Joe Cruse]

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.

 

[Cari Spears]

...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.

 

[Graeme]

Make a form part of the work process description

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.

 

[David Hartman]

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.

 

[Ingeniero1]

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

 

[Marc]

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 https://Elsmar.com/iso9000.html - Click the Mountain range on that page).

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.

 

[Aaron Lupo]

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).

 

[Wes Bucey]

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.