Which version is on the bench?
The quality manager revises a method. The new version goes on the shared drive. The old one is renamed, or not. Printed copies of the old one are still in the plastic wallet at the bench. Staff are told by email to read the new one. Some do. Six months later, an assessor finds the old version being followed at one bench.
Why document control slips
- Shared drives allow several versions to exist side by side.
- Review and approval happen by email.
- Printed copies are not tracked.
- Reading the new version is not recorded.
- Review dates are not reminded.
Forms and worksheets are often forgotten. The SOP is revised, but the bench worksheet that goes with it still carries the old layout, or a spreadsheet template used in the method still has old limits. Document control that covers only the procedures leaves the tools that staff actually use uncontrolled.
Review dates are the other weak point. Most procedures require periodic review even when nothing has changed, and on a shared drive those dates live in a spreadsheet or in the document footer, where nobody sees them until an audit.
What it costs
Work may be carried out to an old method. Assessors raise findings. The quality manager spends time chasing reviews and read confirmations. Nobody is confident about which version is current.
| Aspect | Shared drive | Document control |
|---|---|---|
| Current version | Several files | One controlled version |
| Approval | Recorded review and approval | |
| Printed copies | Untracked | Controlled, with retrieval on revision |
| Read records | None | Per person, per version |
| Review dates | Missed | Reminders to owners |
Uncontrolled copies also travel. A method printed for a trainee ends up in a drawer, a PDF is emailed to a client who asked how a test is done, a worksheet is saved to someone's desktop. When the method changes, none of those copies know. The more copies exist outside the system, the more likely an old one is used on a busy day.
How we build it
- Documents are held in a controlled library, often in Microsoft 365 or SharePoint with a custom front end, with one current version and full history.
- Revisions go through drafting, review and approval steps your procedures define, with each step recorded.
- On approval, affected staff are asked to read and confirm, and their confirmation is recorded.
- Printed copies are issued with a copy number, and the holders are told to return or destroy them when a new version is issued.
- Owners are reminded of review dates.
- Links from the LIMS or competence records go to the current version.
Forms, worksheets and calculation templates are controlled alongside the procedures they support, so a revision to a method can include its worksheet and template, approved together and released together.
Access is set by role. Analysts see the current released version and nothing else, reviewers see drafts they are asked to review, and the quality manager sees the full history. Anyone printing a document gets a copy marked as uncontrolled unless it is issued as a numbered controlled copy, so a stray printout is obviously not the master.
What changes
Everyone sees one current version. Approvals and read confirmations are on record. Printed copies are controlled. Review dates are not missed.
Assessors can be shown the history of any document, with who approved each version and who has read it. New starters get a reading list of the current versions they need, and their confirmations feed their training record.
Does your document control need work?
- SOPs exist in several versions on the shared drive.
- Printed copies at benches go out of date.
- Read confirmations are not recorded.
- Review dates are missed.
- Approvals happen by email.