Major Nonconformance - We had a control in place that was not on the control plan

[U-DOG]

During my TS audit, the auditor visited a process and discovered we had a control in place that was not on the control plan.

He visited another process, he discovered we had a control in place that was not on the control plan.

He issued a Major Nonconformance stating it was "A number of minor nonconformities against one requirement."

:mg:

What can I say in my appeal?

Thanks

 

[Marc]

What was the specific finding? Please cite the TS 16949 requirement the auditor cited.

 

[U-DOG]

In the first process we select a program by part number from the display panel. The program tells the machine how long to run the part. We have a first pc verification sheet to inspect the part to see if it did run the proper amount of time. The fact that we do not have the program control on the control plan was a minor.

The second minor was for not having poke yoke verification parts on the control plan.

The write up states: "The process to makes sure that control plans list the process controls for manufacturing process control is not fully effective."

 

[somashekar]

In the first process we select a program by part number from the display panel. The program tells the machine how long to run the part. We have a first pc verification sheet to inspect the part to see if it did run the proper amount of time. The fact that we do not have the program control on the control plan was a minor.

The second minor was for not having poke yoke verification parts on the control plan.

The write up states: "The process to makes sure that control plans list the process controls for manufacturing process control is not fully effective."

Your intentions are good and your working documents are per good intentions. Your planning documents are poor. You do not revisit your control plans which is the identifier of your good intentions. Your QMS must begin to follow the proven PDCA in practice. You have to be aware how your documentation change process is built around the PDCA cycle and respect it by following same.
Say this in your appeal to have a normal NC...
Good luck.

 

[U-DOG]

I actually used some of that for my root cause statement.

How do I defend two minors do not necessarily = "A number of Minor Nonconformities against one requirement can represent a total breakdown of the system." ????

 

[somashekar]

I actually used some of that for my root cause statement.

How do I defend two minors do not necessarily = "A number of Minor Nonconformities against one requirement can represent a total breakdown of the system." ????

In fact I do not see two nonconformity here.
I see that the established controls are not mapped in the control plan and for this there are two examples.
What is a major here ?

 

[isoalchemist]

I see a non conformance with two supporting examples but not a major.

Now if the control plans were 3-5 years old and never reviewed in the interim I could see where the assessor might raise the level of the non conformances, but their should be more to support the major. Good luck with that discussion

 

[AndyN]

I actually used some of that for my root cause statement.

How do I defend two minors do not necessarily = "A number of Minor Nonconformities against one requirement can represent a total breakdown of the system." ????

You may wish to check in the small print of the registration agreement with the CB. I have know for some CBs to prescribe this type of thing - otherwise, it's a matter of judgement on the part of the auditor. For example, if these controls weren't in the control plan and there had been escapes to the customer, then it would be cause for a major.

 

[U-DOG]

The "major" was received for having two separate control plans from two separate processes with the same type of nonconformance - controls in the process not identified on the CP.

I do not agree these issues should be considered a "Major Nonconformance." His reasoning for declaring a Major was "A number of minor nonconformities against one requirement..."


thanks

 

[Jim Wynne]

With the release of the 4th Edition TS Rules on April 1, many CBs have taken the stance that all NCs are major unless the organization can convinve the auditor otherwise. This strategy is going to cause major (pardon the expression) heartburn all around the world, and this instance is a good example.

First, there is a significant difference between a control in place that's not cited on the control plan, and a control that is cited on the CP but missing in production. The former is minor in most cases, while the latter could reasonably be called major if it there were several instances. Without knowing more about the situation I can't give direct advice except to say that the approach in appealing the "major" categorization might be to point out that there is no risk to the customer(s).