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:
- 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.
- 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.
- 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.)
- 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.