We are an ISO9001 certified organization. One of my colleague misplaced all his project documents including records of review and authorization. He has softcopies of all project documents, but the records of review and authorization which were in hardcopy forms are lost forever. The project was implemented sometime back and is a potential candidate for audit. Any idea what concerns would the auditors have and what would be the immediate corrective action.

Thanks

As an (Internal) auditor I would be concerned that this could happen to other records (i.e., system breakdown). You would have to convince me that the root cause has been eliminated, and that it will not happen again.

Without knowing the root cause or causes, I don't want to venture a guess as to corrective action.

One measure you can take to reduce the severity of the NC would be to have all persons involved in the project sign off (e.g. a memo) to say that all requirements related to the project were met, and an endorsement by the highest-ranking full-time person in the organization (e.g. CEO) AND a commitment to prevent it happening AGAIN.

the records of review and authorization which were in hardcopy forms are lost forever

If it happened again and I found it during a subsequent audit, it would suggest to me that both your Record control (ref. ISO 9001 4.2.4) and Corrective Action (ref. ISO 9001 8.5.2) are not effective.

Your screwed!! Only kidding :D

How long has it been since you lost the documentation and what have you done in the meanwhile?

I would suggest starting again, explaining the situation in advance of the Surveillance Visit to your Certification Body as they will usually be quite understanding (these things happen!). As you already have the documentation you will just be missing some change control history. Ideally if you could have the new system in place some months in advance you might also be able to show them some document change control which should keep them happy! Also you may need to demonstrate how you will prevent the same thing from happening again.


You may just have to take the loss of these documents on the chin but you should still get through the audit.

We are an ISO9001 certified organization. One of my colleague misplaced all his project documents including records of review and authorization. He has softcopies of all project documents, but the records of review and authorization which were in hardcopy forms are lost forever. The project was implemented sometime back and is a potential candidate for audit. Any idea what concerns would the auditors have and what would be the immediate corrective action.

Thanks

If this is a one-time event, it's not a too much of a deal. Just be able to explain this to the Auditor as my Fellow Covers have stated.

Now, if this has happened a number of times, that's more serious because that indicates a systems issue.

Devote an internal audit to verify that this is not a systems issue.

Good Luck!

Stijloor.

I had the same thing happen to me. The hardcopies that had the approval signatures were thrown away and all I was left with were the electronic copies. This was caught during a survenliance audit and a nonconformance was sited. The root cause was due to oversight by the QS manager at the time who decided to clean up. We had subsequently implemented an electronic approval system so that was our corrective action.

I would just document what you found in a CAR. This way if it comes up during the audit you can reference your CAR and all should be good.

I think it might be good to mention that corrections and corrective actions could be two different things. As several have pointed out, if this is a systemic issue, a corrective action should be undertaken to identify the root cause such that a change can be made to the process to ensure it doesn't recur.

The correction, as some have pointed out, is how to recover and/or explain to the auditor what happened.

Please remember that there is no requirement in the standard that there be hard copies.
If there is a requirement then it is in your procedures.

Why do you want hard copies?
Think and then

Take this as an opportunity to change and then you have totally prevented re occurrence
:biglaugh:

Hi,

Thanks for your inputs.

I am looking at electronic approval system as a possible corrective action and to prevent this from happening again.

Terrisandrew : May I know what electronic approval system did you implement?

Regds.