Document Control - Simple definition of when to control a document

L

little__cee

#1
I've searched. And searched. There are endless threads and discussion about document control. What I am looking for is a simple definition of when to control a document.

My simple generic example is that if you have a list and you hand-write information on that list which is then in turn used to be entered into an Excel spreadsheet:
1) should the "form" be controlled?
2) should the printed spreadsheet be controlled?
3) should both be controlled?

I'm looking for some sort of test that I can apply to see what needs controlled and what doesn't.

I always thought if the form was going to turn into a record that it had to be controlled but if you were just going to enter the data off of the form and then discard the form since there was no need to retain it then it didn't have to be controlled. But I am really confused right now and really just don't know. Can anyone help, not just for this situation but for future ones as well?

Thanks in advance
 
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The Taz!

Quite Involved in Discussions
#2
1) I would say that the "worksheet" you physically WRITE the info on is nothing more than a "worksheet" and need not be controlled if you intend to use the spreadsheet as the actual evidence. BUT. . . IF you feel that there may be transposition errors, and decide to retain the "worksheet" as the original evidence. . . then you may want to consider control. I wouldn't.

2) As far as the spreadsheet goes, IF it is being used by a variety of people to provide the same input, control it. . .Protect the cells you don't want changed. If you are the ONLY person using the spreadsheet, then you do not need the level of control. The completeness of the information is the real record.

Hope this helps a bit
 

Wes Bucey

Quite Involved in Discussions
#3
To answer the direct question:
If an organization has a documented routine (Procedure or Work Instruction) which ensures the data on the worksheet is faithfully transferred to the spreadsheet, it is no different a method of transference than clicking the "save" button to save the entered data on the spreadsheet to the corporate network server. The question is simply one of protecting from error or misdeed in transferring data from one medium to another. The data hasn't changed, only the medium on which it is recorded. In the case of a computer - from RAM to Hard Disk (probably tape backup or to offsite hard disks.)

My test for whether a document should be controlled can probably be put into a flashy flowchart by our resident geniuses at the Cove:
  1. Is anyone going to want to see the document at a later date or is it temporary, to be discarded?
    If "see later," it should probably be controlled.
  2. Is document (to be controlled) subject to future change?
    If yes, it is a Process or Procedure document and gets handled accordingly.
    If no, it is a record and needs safeguard from change and damage PLUS storage for easy retrieval when needed.
  3. If it is a Process or Procedure Document, it needs a few steps (different at different organizations) to be "approved" for release (and to retire previous versions.)
  4. Once approved, Process or Procedure Document requires safeguards to assure it isn't changed without formal approval and that the most recent, approved version is the only one available at the point of use.
Gray areas:
"Forms" are just blank sheets or computer files (maybe with preprinted instructions) on which data from a process or activity is recorded. Sometimes, an operator continues to add data to a form over a period of time which may encompass hours or weeks. The gray area is whether the partially completed form is "controlled" while it still sits on an operator's desk or terminal. There is no question that once an operator has completed entering data, the form becomes a record subject to control.

Many organizations consider the partially complete form a "worksheet" and not subject to control until the operator signs off on it as "complete." A few, especially those in which the data is entered directly into a computer, consider the form a controlled "log" which can only have data added, not modified or deleted. The additions of new data do not change or modify the previous data, so the form or log is still considered a controlled document. By virtue of date or time stamps, the various entries in the log constitute the record, accurate and complete as of the last date of entry.

The primary question is one of traceability back to the original source of data. Are there safeguards along the way to assure accurate transfer of data from medium to medium (paper to computer back to paper)?

The layout of a form is a controlled Procedure or Process document, which is always subject to modification or revision according to the organization's established method for document revision. Changing the layout of a form does not invalidate previous versions of the form because ONLY the data within the form is controlled record, NOT the format or layout.

Some organizations create "uncontrolled reports" which summarize the data contained in records. Rarely are the reports controlled because they only refer to existing controlled records. Sample reports might include an executive summary of the records from all the turning centers for the previous week. Such a report could be discarded once read because the basic data used to compile it is still under control and the report could be duplicated at any time.

document retention
In other threads, we have previously explored the concept of data and document retention. It's always a good topic and may be raised again if a Search in the Cove doesn't get you the detail you need.
 
A

Al Dyer

#4
L.C.;


How about this;

Control any documents that pertain to your manufacturing/quality system.

If it is policy, control it!
If it is instruction/procedure/print, control it!
If it is evidence of some requirement, control it!

Don't control:

Worksheets that are transferred to electronic medium.
Time cards, you already have payroll.
Control charts that are transferred to electronic medium

The above assumes that a training program is in place and effective, that data needs some type of control.
More to come, I love this subject but have to go to a meeting!

Al...
 
A

Aaron Lupo

#5
This is what I tell people when they ask should this be a controlled document:


Should a document be controlled?

There are three questions you can ask yourself to help determine if a document should be controlled they are as follows:

1.) Is it important that the information on the forms is accurate?
2.) Is the document referenced in a procedure?
3.) If the document is changed, if not everyone who is using it knows that it was changed, could the wrong information, incomplete information, or a non-conformance occur from using the old revision?

Controlled Document: is a document that needs to be accurate; will it get to the right people at the right time and are all obsolete copies removed.
 
#6
Another consideration is:

Is the information being gathered subject to change? I'm not talking about the data, but the types of information. For example take any form. It typically lists the information you are seeking. It tells you what information to collect (the fields: ie Name, Parts per hour, Thickness, etc.)

We control the blank form because we want to make sure we are capturing the necessary information. If it is important to capture certain things, then we need to control the device used to capture the information to ensure we get all of the required info. If, however, the information required (the field name) is everchanging, then there might not be a valid standard vehicle to contol.

The answer to your question might be how the form is used. I would tend to think that if the fields are constant, and it is important to ensure all of the fields are recorded, then the form should be controlled.
 
M

momoalx

#7
to controll a form, without a procedure

Hi everybody,
I was reading, your messagges and I have a question, ¿it is a requirement to have a procedure in order to register a form?. In our company it is possible to register and control a form (p.e. a Maintainence Programa Form) that is not related with any SOP or other document. ¿Is that possible according with ISO9001:2000?. I'm think not, but it happends here. Please help me to support it.

Alejandro Molina.
 
#8
momoalx said:
Hi everybody,
I was reading, your messagges and I have a question, ¿it is a requirement to have a procedure in order to register a form?. In our company it is possible to register and control a form (p.e. a Maintainence Programa Form) that is not related with any SOP or other document. ¿Is that possible according with ISO9001:2000?. I'm think not, but it happends here. Please help me to support it.

Alejandro Molina.
First of all, Welcome to the Cove, Alejandro! :bigwave:

ISO does not require anything to be tied to a procedure. What you have to do is to meet 4.2.3 a) - g). Think of it this way. It is the information you want to control. So, how do you control it? Who approves it? How is its revision status made known? Local control of documents is okay, provided that your system works.

Also, if it is not tied to a procedure, then how do folks know they have to use it?
 

RoxaneB

Super Moderator
Super Moderator
#9
momoalx said:
Hi everybody,
I was reading, your messagges and I have a question, ¿it is a requirement to have a procedure in order to register a form?. In our company it is possible to register and control a form (p.e. a Maintainence Programa Form) that is not related with any SOP or other document. ¿Is that possible according with ISO9001:2000?. I'm think not, but it happends here. Please help me to support it.
Welcome to the Cove, Alejandro! :bigwave:

In my opinion, which slightly varies from db's (wow!...this is a first, eh, Dave?), there are a few cases where there is a link between an established procedure and a form (assuming that once the form is completed, however, it becomes a record):

  • 8.2.2 Internal audit - "The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining results (see 4.2.4) shall be defined in a documented procedure."
  • 8.3 Control of nonconforming product - "The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure." Follwed with "Records of the nature of nonconformities....shall be maintained."
  • 8.5.2 Corrective action - "A documented procedure shall be established to define requirements for....e) records of the results of action taken (see 4.2.4)..."
  • 8.5.3 Preventive action - "A documented procedure shall be established to define requirements for....d) records of results of action taken (see 4.2.4)..."

4.2.3 Document control also requires a documented procedure that requires records be considered a special type of document and controlled as per 4.2.4.

4.2.4 Record control requires a procedure on how records are controlled but does not indicate any records are generated.

So of the 6 required documented procedures by ISO 9001:2000, 4 appear to have ties to forms/records. (by my interpretation)

db said:
Also, if it is not tied to a procedure, then how do folks know they have to use it?
Because it is part of the process. We have forms that are in use with no corresponding documentation on how to use them, who fills in what, etc. However, they are linked into documentation like process maps or referred to in Work Instructions where a possible output may result in the form being used. If the form is deemed a Quality Record, it is captured in our Records List database where the requirements of 4.2.4 are met.

I guess our process allows for people to know they have to use the form...but not always how to use the form. However, my organization's system is mature enough now that we are starting to streamline our documentation and rendering unnecessary/unused documentation as obsolete ("5S the BMS!"). Training and routine practices ensure that the necessary forms are used properly....and that documentation on how to use the forms in not needed.
 
#10
RCBeyette said:
I guess our process allows for people to know they have to use the form...but not always how to use the form. However, my organization's system is mature enough now that we are starting to streamline our documentation and rendering unnecessary/unused documentation as obsolete ("5S the BMS!"). Training and routine practices ensure that the necessary forms are used properly....and that documentation on how to use the forms in not needed.
This shouldn't be overlooked. We seem to think that ISO requires us to document everything. Which is not the case. I think your answer to the question is acceptable. Even the how can be included in the training and normal management oversight can ensure that the forms are being used correctly.

BTW, It wouldn't matter if your opinion varied from me greatly. I am gracious enough to allow you to think you are right! :yes:
 
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