Protocol Number

Engineering
1

Hi All, we have generated two protocols with same number however each protcol should have unique number, we reliazed after one month, now the protocols are approved and closed, what to do to ensure the issue is addressed properly

2

Hello and welcome!

You Quality System should have procedures to handle changes to docuemntation, it varies between companies. In my experience, most copmanies deal with these events in two ways:

  • Since the protocol number is the ID of the document, most companies opt to cancel de document or change its status as obsolete (or something equivalent to render the document not applicable anymore), and issue a new document with the protocol ID correct.

  • If your documentation system allows it, you can issue an addendum/erratum/amendemnt/ to the original protocol, to fix the ID number. This has a higher risk in terms of mantaining document tracebility, since the same document had two differnet IDs in its lifetime, but if your documentation system is robust enough, you can can handle it properly.

It should always be in compliance with your documentation system and SOPs, as part of the quality system of your copmany.

I hope this helps!