Receiving Incomplete Documents After Job Has Closed

[Quality_Goblin]

Hi All,
Part of my job as Doc Control Specialist is saving our DHR records. There are times when I get a work order packet where the in-process inspection sheet is incomplete - in that the required number of samples have not been recorded. I am at a loss on what to do at this point. Everyone has been trained on this several time, and we have also attached risk assessment memos to the records, but I am at a point where I am tired of seeing incomplete documents come to me when a job is closed. Has anyone experienced this and what were your solutions? Any and all help is appreciated. Thank you!

 

[japayson]

Why have you not started your corrective action process?

 

[Quality_Goblin]

Why have you not started your corrective action process?

We are starting one, but I guess what I am asking for is this - does anyone have any personal experience or examples like this where they can share what corrective actions they put in place and if they were effective.

 

[Golfman25]

Hi All,
Part of my job as Doc Control Specialist is saving our DHR records. There are times when I get a work order packet where the in-process inspection sheet is incomplete - in that the required number of samples have not been recorded. I am at a loss on what to do at this point. Everyone has been trained on this several time, and we have also attached risk assessment memos to the records, but I am at a point where I am tired of seeing incomplete documents come to me when a job is closed. Has anyone experienced this and what were your solutions? Any and all help is appreciated. Thank you!

How do you determine sample sizes? Could there be a timing/counting problem. I.E.; not enough time to check the required number of samples during the run.

 

[Quality_Goblin]

How do you determine sample sizes? Could there be a timing/counting problem. I.E.; not enough time to check the required number of samples during the run.

We use a software the predetermines our samples based on a 1.0 AQL so when we print the inspection sheets, it has the sample size and interval as well as the part number they should check off the machine, and even what kind of inspection method they should use to measure. I know a big problem is that the operators just forget to record it which drives us all bonkers. I am trying to figure out a more fool-proof way to get them to remember, but I am currently stumped.

What's frustrating the most is that when I look at logins I can see that they make the correct amount of parts for the job, they just don't record their inspection data.

 

[Golfman25]

We use a software the predetermines our samples based on a 1.0 AQL so when we print the inspection sheets, it has the sample size and interval as well as the part number they should check off the machine, and even what kind of inspection method they should use to measure. I know a big problem is that the operators just forget to record it which drives us all bonkers. I am trying to figure out a more fool-proof way to get them to remember, but I am currently stumped.

What's frustrating the most is that when I look at logins I can see that they make the correct amount of parts for the job, they just don't record their inspection data.

Sounds like they have too much to do and a lot is repetitive. Do you have a lot of in process rejections? Can they just record the high and low reading from the sample batch. So say you check 5 samples. Instead of recording all 5 samples, can they just record the high and low reading. Thus cutting down the amount of recordings.

 

[ChrisM]

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.

 

[Dazzur]

I've had this issue, have you ensured that the persons completing these forms have the resource & knowledge available to do so, you'll be surprised at how many 'basic' things people are not trained or basic resources they're missing.

We asked the management team to their face (& to be honest) if they knew what they were supposed to be accomplishing, their answer was 'no', which is completely fair.
We reviewed the way in which we communicate additional process requirement rollouts, so now every time we make a change, we sit with all/nominated management representatives and explain things in NON-QUALITY language. we saw massive improvement in engagement & interaction with quality functions. There are still slip ups & we're above to knock things up a level due to other regulatory requirements, but we've already prepared plenty of training material to supplement this.

tl;dr
effective communication

 

[Quality_Goblin]

Sounds like they have too much to do and a lot is repetitive. Do you have a lot of in process rejections? Can they just record the high and low reading from the sample batch. So say you check 5 samples. Instead of recording all 5 samples, can they just record the high and low reading. Thus cutting down the amount of recordings.

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.

 

[Quality_Goblin]

I've had this issue, have you ensured that the persons completing these forms have the resource & knowledge available to do so, you'll be surprised at how many 'basic' things people are not trained or basic resources they're missing.

We asked the management team to their face (& to be honest) if they knew what they were supposed to be accomplishing, their answer was 'no', which is completely fair.
We reviewed the way in which we communicate additional process requirement rollouts, so now every time we make a change, we sit with all/nominated management representatives and explain things in NON-QUALITY language. we saw massive improvement in engagement & interaction with quality functions. There are still slip ups & we're above to knock things up a level due to other regulatory requirements, but we've already prepared plenty of training material to supplement this.

tl;dr
effective communication

All of our machinists are at least a Level II so they know how to check their parts and how to use the tools to do so. They have been trained on proper recording procedures as well. It's not up to me to do any sort of reprimanding, and we are short on staff right now so we can't afford to lose any employees. Some of these employees have been with the company for years, so they should know better, but it's the complacency from them and not having a tighter checked system that's the issue.