Document Handling during an Audit

[sniderdi]

The last question I asked went so well, that leads me to my next question. I have been asked to create a Deviation and Customer Complaint procedure, which I have in process right now. The hold up for the powers that be is my tracking spreadsheets I have created. They have been asked in previous client audits of our quality systems to provide and show the client our server and files on the server. I would like to create only one numbering system for both Deviations and Customer Complaints, my office manager is worried if we do that and have gaps in our numbers because we have filtered the spreadsheet by client name, the client will call into question of the numbering gaps. I have tried to assure her that can be explained with client confidentiality and they don't have a right to see those items. Our client specific documents begin with a 2 digit numbering system to indicate which client documents they are. She has suggested I keep a tab for each client that the number begins with their special 2 digit number so their specific Deviations and Customer Complaints remain in chronological order vs having numbering gaps. Any suggestions, opinions, guidance is very much appreciated. I want to make my company happy, my work life as simplified as it can possibly be in the QA/Compliance world and stay within the regulatory guidelines and protecting each client's product/process specific documents. Thank you in advance for your time and assistance.

 

[Ninja]

There is no right answer here, and it looks like you've already considered the pertinent factors (management, client, standard).

FWIW, we would filter by client, and explain the numbering gaps as "we are only showing you those pertaining to you...see what a great job we do for you!"

There will be numbering gaps no matter what you do...search this forum for "numbering gaps" and you'll see a number of threads...all of which end in "what's the big deal...move on".

The CA started by an idiot, and cancelled by you when you saw how idiotic it was....numbering gap.
The PA for janitorial service started by the facility chemist as justification for buying a Rhesus monkey as an 'at work' pet...numbering gap (yes, this happened where I used to work).

Numbering gaps are unavoidable in real life...they just happen.

 

[Golfman25]

I think you're on the right track. Make is simple for you. Forget about the customer auditor. Sounds like you're dealing with a doozy. Good luck.

Client confidentiality is a huge deal. We have competitors walk thru our facility and it's a "problem" -- Except for the fact that they have worked for each other. It's kind of funny to see a guy's name on his "competitor's" print.

 

[sniderdi]

That is exactly what has happened in this company. The quality auditor for one plasma center that was harsh with the company I recently gained employment at, is now the quality auditor for another plasma center and is playing the I know you have that document, yeah it is because it was client specific to the previous company. My current employers just created this position that I am in; I am employed because I was QA & Compliance at the pharmaceutical level, so I have worked in strict ISO/FDA/European regulatory. My thing that is different is we are manufacturing, and the only reason they have this kind of regulations and audits is because they are a critical supplier for these plasma centers. I appreciate your insight.

 

[Randy]

OK I'll chime it as a person that does nothing but 3rd party audits.... Do whatever works best for you, keep it as simple as possible, but you and only you matter in this (You includes your organization and clients...maintain their confidence/privacy etc.)

As a 3rd party I don't care what you do or how you do it, I really don't. All that matters is that you have a process/method, you use it consistently, it provides the control that's necessary and it fulfills what's set forth in 7.5 for Documentation, anything beyond that is fluff, gravy, icing or maybe wasted effort.

 

[sniderdi]

This is what I have been trying to convey. The procedures I have written are straight forward, so is the tracking system. I am highly organized, once we get out next audit, this company will see this and hopefully be more at ease. They have my manager all kinds of running in circles.

 

[dsanabria]

OK I'll chime it as a person that does nothing but 3rd party audits.... Do whatever works best for you, keep it as simple as possible, but you and only you matter in this (You includes your organization and clients...maintain their confidence/privacy etc.)

As a 3rd party I don't care what you do or how you do it, I really don't. All that matters is that you have a process/method, you use it consistently, it provides the control that's necessary and it fulfills what's set forth in 7.5 for Documentation, anything beyond that is fluff, gravy, icing or maybe wasted effort.

AMEN - Totally agree - as a third party auditor. We are more interested in the process. it's your process to skip numbering or change your numbering sequence all that matters is that you meet the requirements of the standard. and most of them don't tell you how.