Controlled copy and document withdrawal – printouts you can verify

The problem with printouts

Even in the digital age, printed work instructions, inspection plans and safety notices hang in workshops, labs and warehouses. As soon as a new version is approved, these printouts become a risk: nobody can tell whether they are still valid. Outdated printouts are among the most frequent audit findings of all.

ISO 9001 clause 7.5.3 requires current documents to be available and unintended use of obsolete documents to be prevented. ISO 13485 requires this explicitly in 4.2.4. The classic approach – numbered copies, distribution lists and collecting old copies – is laborious and error-prone. Controlled copies with a QR code let anyone check validity in seconds.

How controlled copies work

1. 1

   Create a copy

   From an approved document you create a controlled copy. It contains a unique verification code and a QR code that points to the public verification page.

2. 2

   Limit validity

   Optionally, the copy gets an expiry date. After that, the check reports “expired”, even if the document is still valid.

3. 3

   Check on site

   Anyone scans the QR code with a smartphone – no login needed. The page shows document, number, version, status and the copy's creation date.

4. 4

   Invalid automatically

   When a new version becomes effective or the document is withdrawn, the check immediately shows the copy as invalid.

Besides controlled copies there are uncontrolled copies, for example for customers or training purposes. They are marked as such and are not tracked. For each document you define which kinds of copies are allowed.

Withdrawing documents with evidence

Sometimes a document has to be taken out of use immediately – because of an error, a compliance issue or because the process no longer exists. Withdrawal in docxpert records the reason (obsolete, error, compliance, other), sets the document to withdrawn and informs the people affected.

• Acknowledgement: the people affected confirm in their personal inbox that they have noted the withdrawal.
• Copies: all controlled copies become invalid; the QR code check shows the withdrawal.
• Evidence: time, reason, responsible person and acknowledgements are logged in the audit trail.
• No data loss: withdrawn documents are kept as evidence and cannot be hard-deleted.

Features at a glance

Standards reference

Introducing controlled copies: making the switch

Switching from numbered paper copies to verifiable copies takes only a few days. First, record which documents are printed at all – usually work instructions, inspection plans, operating instructions and emergency plans. Define that only controlled copies are allowed for these documents and replace existing postings once with new copies carrying a QR code.

After that, you no longer need distribution lists: the overview in docxpert shows which copies exist at any time. When a new version arrives, the people on site simply print again – the old copies are recognisably invalid anyway. For documents needed only for a short time, such as project materials, set an expiry date.

Example: inspection plan on the line

Every production line displays the inspection plan as a controlled copy with a QR code. After a customer complaint, the inspection plan is changed and approved. From that moment, checking the old copies shows “invalid”. The shift lead prints new copies, and operators confirm the new version via read and understood.

In the next audit, the auditor scans three postings at random – all valid. The overview in docxpert also shows when each copy was created and checked.