Didn't really know how to word the title but here is my delima.

First of all, my company is still trying to grasp GMP and most don't have the years of experience in GMPs. Also, there addage is, "if it's not in our documents, then we don't do it" Technically they are right but if the QSR's dictate it then we are in the wrong regardless.

Okay, here is my issue: Per 21 CFR 820.40 - Document Control: (b) Approved changes shall be communicated to the appropriate personnel in a timely manner.

We have devices that are staged to manufacturing for debugging/rework/testing. At the time they are staged (ie: 2004) the traveler was a rev A. The device had been sitting on the rework shelf for the past 2½ yrs until yesterday. The process traveler had since been updated to a rev C. I performed a Final Inspection and noted that the document was out-dated and to use the most current form, even if to reference the old form for data and then complete any sections in the rev C form that was not in the rev A form. The supervisor refused and said that it wasn't in any procedure and that some verbal conversation happened between my boss and her boss and they wouldn't have to do that.

The QSR of course is at best, MINIMAL requirements. Does manufacturing have a leg to stand on?

Please respond is you have the correct definite answer. Assumptions will not work in this case.

Thanks in advance.

I'm not that sharp on FDA interpretations, but my assumption is that this is a case of both parties being right :confused:

If this is an issue that can and will occur it should IMO be adressed in your QMS. Operators etc. should normally always use the most recent form. However, the argument being that this process can last 2-3 years would, still IMO, call for the establishment of a baseline for which WO and procedures to use. It is really annoying to keep updating files [U]just /U]for the papersystem.....

:(

Anybody with good insight on these requirements who can participate?

In this case, the rev C form had additional information required, which was lacking on the rev A form 2½ yrs ago.

Yes, our procedures need to be updated and of course were never noted in the internal audits for Document Control, which were performed by the manufacturing department. :tunnel:

In this case, the rev C form had additional information required, which was lacking on the rev A form 2½ yrs ago.

Yes, our procedures need to be updated and of course were never noted in the internal audits for Document Control, which were performed by the manufacturing department. :tunnel:What prompted this change to the traveler? A design change or process change? If so WIP should have been addressed then.

What prompted this change to the traveler? A design change or process change? If so WIP should have been addressed then.

Exactly. Went through the proper ECO channels. All affected parties (mfg) were notified of the change to the traveler.

There are hundreds upon hundreds of units sitting throughout many shelves/workstations for the past 3 yrs.

Since I don't have the manhours to sift through each and every document, I suggested that when those units with the out-dated travelers come around, notify their supervisor for the correct version. The supervisor stated since our procedure doesn't call out any instances such as this, she will not comply. :mad:

I decided to reject one of those units today even though our procedure doesn't spell it out but referencing 820.40 for proper notification upon release. The corrective action will state to correct the current procedure to address this issue in the future.

Will hold a meeting tomorrow with the Director of Mfg, who stated that "we have always done it this way" (that's their motto) but she will need to justify why she would allow her department to dismiss common sense and GMP.

Wish me luck. :cfingers:

Exactly. Went through the proper ECO channels. All affected parties (mfg) were notified of the change to the traveler.

There are hundreds upon hundreds of units sitting throughout many shelves/workstations for the past 3 yrs.

Since I don't have the manhours to sift through each and every document, I suggested that when those units with the out-dated travelers come around, notify their supervisor for the correct version. The supervisor stated since our procedure doesn't call out any instances such as this, she will not comply. :mad:

I decided to reject one of those units today even though our procedure doesn't spell it out but referencing 820.40 for proper notification upon release. The corrective action will state to correct the current procedure to address this issue in the future.

Will hold a meeting tomorrow with the Director of Mfg, who stated that "we have always done it this way" (that's their motto) but she will need to justify why she would allow her department to dismiss common sense and GMP.

Wish me luck. :cfingers:Why do you have 3 year old WIP?

These units have been deactivated because alot of troubleshooting. When they run low on activated units, they will start activating those and work on them.

These units have been deactivated because alot of troubleshooting. When they run low on activated units, they will start activating those and work on them.I hope they're not pacemakers.

No they are not.

What is a "traveler"? :confused:

Let me try and explain this correctly. It's an old term used in the manufacturing process.

The document (traveler) will travel with the lot, batch, device at each stage of the process. Information/data will be recorded, the person who performed that step of the process and the date performed.

Our travelers are one page and each step will state to peform a certain operation per procedure number xxxxx. At the end of the traveler, the QA inspector will review all documents associated with that traveler as well as the traveler and sign off at the end of it, whether to accept or reject the device.

That's about the easiest way I can explain it. There are other terminologies used such as ticket, batch record, etc.