Receiving Incomplete Documents After Job Has Closed

[Quality_Goblin]

Where I have worked in the past (at least 4 companies manufacturing to ISO13485) a final QA/QC check ensured that all necessary records were complete before product could be released for sale/shipment. Seems like there is an issue in your product release procedure, or it is being blatantly ignored. See japayson's remark above. Someone needs to act now.

This actually isn't a bad idea. My concern is - say QC is required to check the work order paperwork that traveled around the shop with the parts before it goes to Shipping. If they notice that the in-process inspection sheets haven't been completed, but the job is done, how can we fix it? They can't take them back to the machinists and say "fill in this data that you don't have" that would be pencil-whipping. This is where the risk assessment memos came into place that I was sending out recently. When I came across a DHR that had incomplete samples, I would send the memo to the supervisor of that department and ask them to provide a response on why that was acceptable. Then I would attach it to the document packet. But the problem is that it's not fixing the issue. I do like your idea of a final document check, and I am going to bring it up to my boss. Thanks!!

 

[Golfman25]

We have two facilities. One of them is nearly perfect at recording their data and making sure all documentation is complete, granted this facility is only a year old, so we've been able to instill good behavior and proper conduct. The other, which is the one I mentioned, has had a history of poor habits and despite our best efforts, can't seem to get through to the shop floor personnel.

In regards to cutting the number of samples recorded, I will have to ask. We manufacture both aerospace and medical parts, so I think the 1.0 AQL is the minimum that can do, but I am not sure.

Here is the problem you have. These guys have been doing it one way for years before you went “all ISO” on them. Suddenly they have to record a bunch more stuff, even though they have been making good parts for years before. So the question for you, is do you really need all this “crap.” One of the things we did was try to strip everything down to the bare minimum — what works for us.

 

[Golfman25]

This actually isn't a bad idea. My concern is - say QC is required to check the work order paperwork that traveled around the shop with the parts before it goes to Shipping. If they notice that the in-process inspection sheets haven't been completed, but the job is done, how can we fix it? They can't take them back to the machinists and say "fill in this data that you don't have" that would be pencil-whipping. This is where the risk assessment memos came into place that I was sending out recently. When I came across a DHR that had incomplete samples, I would send the memo to the supervisor of that department and ask them to provide a response on why that was acceptable. Then I would attach it to the document packet. But the problem is that it's not fixing the issue. I do like your idea of a final document check, and I am going to bring it up to my boss. Thanks!!

Actually you can, no? There is nothing that says you can’t do in process inspection after the fact, is there? Obviously you can’t stop the process if you have a bad part, but that’s a different issue.

 

[Quality_Goblin]

Actually you can, no? There is nothing that says you can’t do in process inspection after the fact, is there? Obviously you can’t stop the process if you have a bad part, but that’s a different issue.

That's a fair point! I can't imagine how frustrating it would be for the operator to have to go back and measure all the parts they just completed because they failed to do it the first time. This might be a good exercise to get them to follow their process correctly. But my other question is what happens when it stops production for a job that they are currently on? Time constraints are always a concern especially when on-time delivery is one of our quality objectives. So I am concerned about the impact that might have on production. I do like this idea though.

 

[Golfman25]

That's a fair point! I can't imagine how frustrating it would be for the operator to have to go back and measure all the parts they just completed because they failed to do it the first time. This might be a good exercise to get them to follow their process correctly. But my other question is what happens when it stops production for a job that they are currently on? Time constraints are always a concern especially when on-time delivery is one of our quality objectives. So I am concerned about the impact that might have on production. I do like this idea though.

IF the recording is that important to your company, then you have to sacrifice one goal for another. A lot will depend what level of managerial support you have, which will also give you an indication of how important the records are. But my first focus would be, why is this record, and all of these recorded samples, important?

 

[hogheavenfarm]

I handled that a bit differently. I tracked the departments that missed the paperwork, and every department that accepted the product with the missing paperwork on a monthly basis. Then, in the Quality Newsletter that went out to all supervisors on up, I scored the misses and listed the departments. A bit of a stick approach, but it worked because I got all the departments to stop accepting the product with missing paperwork until it was completed. So a quick line stoppage while the previous dept would reinspect and sign off on the product before the next operation was completed. This led to a "competition" between depts to have no listings in the newsletter for missing paperwork, which made the line supervisors get involved since they didnt want their depts listed either. If you have a tough crowd you could also give a carrot for perfect paperwork for the month as well, I didnt have to do that as they were very happy to be listed on the good side and making the supervisors happy.

 

[Quality_Goblin]

Where I have worked in the past (at least 4 companies manufacturing to ISO13485) a final QA/QC check ensured that all necessary records were complete before product could be released for sale/shipment. Seems like there is an issue in your product release procedure, or it is being blatantly ignored. See japayson's remark above. Someone needs to act now.

What do you do in the case where you ship partials? We often do partial shipments which means the work order packet is out on the shop floor with the rest of the parts. I like the final QA/QC check before a job is closed, but I am stuck on what to do when you do multiple shipments for a job. Would you suggest that QA/QC find the work order packet and check that it is complete to the current date while still in production? My concern is that we have tight deadlines to ship product out so this might get skipped.

 

[ChrisM]

^
Exactly as suggested. You ensure that the records are up-to-date even if the job is not complete, and make a note on the Release Paperwork/electronic record to that effect with summary information