Can anyone share an Note to File for justifying postponement of Internal Audits ?

[kellascat]

My company is now a subsidary of another larger international company. We have postponed internal auditing until we have completed the integration of their quality system at our business office and manufacturing sites. This includes moving our documents from our electronic database to their database. We also need to retrain auditors to the new system and because most of our trained auditors were laid off.

I was told to write a "note to file" or similar document detailing our intention to delay internal audits.

(most of our single-use products are not medical devcies, however we do make a few Class 1 and Class II medical devices)

Does anyone here have experience with this? What would you recommend? Does anyone have an example of such a letter?

Thanks

 

[somashekar]

Welcome to the COVE kellascat ~~~
Who (in the top management position) requested you to make a "note to file"...
If this is a decision that is justified in your QMS functioning, and you have directions to schedule your next internal audit, simply record it in the management review and have the top management output about this also in record.

 

[Big Jim]

May I add that you need to check you internal audit procedure. It is a required procedure, so you have one (or need to have one).

Check to see if you have painted yourself into a corner from the wording of your procedure so such a "note to file" is needed. If you have, reword it so you can simply alter your schedule.

I also view one of the best places to comment on how you handle or change how you handle internal audits is in the management review notes, along with your comments about results of audits.

 

[maaquilino]

My company is now a subsidary of another larger international company. We have postponed internal auditing until we have completed the integration of their quality system at our business office and manufacturing sites. This includes moving our documents from our electronic database to their database. We also need to retrain auditors to the new system and because most of our trained auditors were laid off.
...

(most of our single-use products are not medical devcies, however we do make a few Class 1 and Class II medical devices)
...

Thanks

Just a question that came to mind while reading your post...is the parent company you're now a subsidiary of one that also makes medical devices? Just wondering, as if they're not then their database (or their backup/restore, control of records, etc. procedures) may not cover some itmes you need to have covered for compliance for your classII med devices. It's probably a non-issue, but I've found that it's better to check and make sure than to find out down the road that one of your computer systems doesn't meet something defined in your procedures for ensuring compliance.

 

[kellascat]

Director of Operations asked me to prepare the letter in answer to an observation by an outside auditor (customer) regarding the lack of audits for 2013. We have another external audit at the end of the month.

Our audit process is a flowcharted procedure that only indicates that a schedule is required and that it will be revised based on the importance of a process, results of previous aduits, and any CAPAs. Note to file is not addressed in the procedure.

The 2013 Management Review did not indicate that the audits would be halted, and the next review will not be scheduled until after our new Regulatory Affairs supervisor starts in February.

I am not sure how to word this note-to-file.

 

[maaquilino]

Director of Operations asked me to prepare the letter in answer to an observation by an outside auditor (customer) regarding the lack of audits for 2013. We have another external audit at the end of the month.

Our audit process is a flowcharted procedure that only indicates that a schedule is required and that it will be revised based on the importance of a process, results of previous aduits, and any CAPAs. Note to file is not addressed in the procedure.

The 2013 Management Review did not indicate that the audits would be halted, and the next review will not be scheduled until after our new Regulatory Affairs supervisor starts in February.

I am not sure how to word this note-to-file.

I would just word it to state that internal audits have been postponed until the completed integration of the quality system at your business office and manufacturing sites and retraining of auditors to the new system.

You could also include that either once a schedule has been drawn up for the integration OR once the integration is completed, you will then draw up an internal audit schedule...But it's not necessary to include this, imo.

Were there no audits at all in 2013 strictly because of the integration?

If you are regulated by the FDA and CFR Part 820, 820.22 states that procedures shall be established but doesn't state when or how often they should take place...that's supposed to be noted in your policy or procedure.

In the preamble to 820 there's a lot of info on internal audits that can help when drafting a procedure. You can find a text and a .pdf version of 820 with the preamble at the FDA website; do a search for Medical Device Quality System Regulation and Preamble (I can't post links yet as I haven't posted enough). I use the .pdf version and use Find to locate relevant topics I need info on. I read the whole preamble a long time ago and it has a lot of helpful information in it.