Control plan IATF non-conformity

[Bev D]

Again: what evidence was sited? Saying that you violated some requirement is not enough. The auditor must state how they know you violated the requirement.

Then what are teh operators supposed to do? How are they supposed to do it? eg is there a form for them to fill out with the measured data?
Then ask THEM about the finding. eg why they didn’t fill out the form?

 

[Johnnymo62]

Please search at the "Attachment List" for HERCA, that has been posted here before. It's a worksheet for Human Error Root Cause Analysis. It can be helpful determining why an Operator made an error.

 

[qusys]

We recently had our IATF audit completed. We had major finding on the control plan because the process characteristics were not recorded into the system as instructed in the work instruction. I am fairly new to this company and I have task with responding to this audit. So far, my root cause analysis have been pointing to the operators and I want to avoid this path. Please do any have a document I can reference to appropriately respond to our CB? Thank you.

Hi Aralek,
could you please share the nonconformity and evidence? Do you know that with a major ncn the certificate can be jeopardize?
Consider to make a root cause analysis in multidisciplinary approach to have a corrective action that is effective. Use for instance 5 Why's method.
Do you have problem solving method?

 

[Emerald]

What are the operators supposed to do vs what are they doing?

They are supposed to document measurement data in the log sheet.

 

[Emerald]

Again: what evidence was sited? Saying that you violated some requirement is not enough. The auditor must state how they know you violated the requirement.

Then what are teh operators supposed to do? How are they supposed to do it? eg is there a form for them to fill out with the measured data?
Then ask THEM about the finding. eg why they didn’t fill out the form?

Yes, there is log sheet for them to document measurement data. They forgot to fill out the form.

 

[Emerald]

What are the operators supposed to do vs what are they doing?

They supposed to fill out measurement data in the log sheet. They weren't doing that.

 

[Bev D]

Yes, there is log sheet for them to document measurement data. They forgot to fill out the form.

Is that what they said? Why did they forget? What do they say will make it obvious that they have to fill it out? Is there a supervisor or culture of go-go-go? (An ERP system makes it near impossible to ‘forget’).

 

[Emerald]

Is that what they said? Why did they forget? What do they say will make it obvious that they have to fill it out? Is there a supervisor or culture of go-go-go? (An ERP system makes it near impossible to ‘forget’).

Thanks @Bev D for the swift response. Majority of this data are documented in an ERP system while we use log sheet for others. 5 operators were audited on their processes. We had an instance where an operator didn't enter data into the ERP system at all. There is also an instance where an operator didn't enter data at the required frequency as instructed in the work instructions. There is another operator who didn't complete the log sheet at all during audit.

 

[optomist1]

full disclosure, I have not read all the above posts, yet from the most recent one there should be or is a need to prevent incomplete data entry...of require data. Whose ERP or what ERP system is in use?

Hope this helps
Optomist1

 

[Golfman25]

Thanks @Bev D for the swift response. Majority of this data are documented in an ERP system while we use log sheet for others. 5 operators were audited on their processes. We had an instance where an operator didn't enter data into the ERP system at all. There is also an instance where an operator didn't enter data at the required frequency as instructed in the work instructions. There is another operator who didn't complete the log sheet at all during audit.

So ERP or not, the operators aren't doing what is required of their job. Now the question is why not? Lazy, no time, not trained, don't care, etc. If they haven't been doing it, and the world hasn't ended, is it even necessary? Is there any check to verify that they are doing it? Not caught in previous internal audits? Seems like you have some digging to do.