Temporary Change of Process Controls - IATF 16949 Clause 8.5.5.1.1

[tongxiaozhi]

What's the purpose of 8.5.5.1.1: temporary change of process controls? What shall I do to meet the requirements?

What if our process is quite stable and there is no alternate process?

thanks in advance

 

[QualitySpirit]

If you don't have any alternative methods, no history of use/ no plan to use ones in the future, you do not need to make the list.

 

[hiepyeuh]

Hi there,

I think that it like a contingency plan for control plan because you can't sure whether your equipment is suddenly broken down in the future or not.
For us, we included it into 4M change procedure.

 

[Blaest]

That must be clause 8.5.6.1.1

As I see it the procedure for 'alterntive control methods' shall be activated based on the risk analysis (such as FMEA) - from the FMEA you have the Control Plan which is the outcome of the risk analysis.

The logic (as I see it) here would be that from every line/check in the Control plan there shall be an alternative control method.

This was also the clear message I got from the SMMT Industry Forum trainer.
No, I do not like the sound of this message either.

 

[Ajay Akole]

What's the purpose of 8.5.5.1.1: temporary change of process controls? What shall I do to meet the requirements?

What if our process is quite stable and there is no alternate process?

thanks in advance

I think that clause no 8.5.6.1.1 gives requirement about process control means inspection, measuring, test, and error-proofing devices, that includes the primary process control. And not about the process.

 

[Pieht]

Ok, I hope someone sees and reads this...and can help.

I am dealing with an auditing-company (in Germany) that believes that "process controls" includes all machinery.
So...CNC milling cutters, drills, grinding machines.
I, on the other hand, understood "Process controls" to be things, that make me see if my process is "ok". So as listet here numerous times: inspection, measuring, tests, error-proofing devices.

So...what is it?
Measuring-Devices of all possible sorts?
Or the above AND "Everything" that can influence the process??

I would really really appreciate an answer to this, because as it is, we do not know what to do.
Thanks in Advance,

Peter

 

[Golfman25]

I would take a narrow view and state that it means what is in that particular column of your control plan. So if you use inspection as a control, then all the gagues that makes that up. If you use a machine setting/CNC etc. as control, then that control/software, etc. Good luck.

 

[morteza]

Ok, I hope someone sees and reads this...and can help.

I am dealing with an auditing-company (in Germany) that believes that "process controls" includes all machinery.
So...CNC milling cutters, drills, grinding machines.
I, on the other hand, understood "Process controls" to be things, that make me see if my process is "ok". So as listet here numerous times: inspection, measuring, tests, error-proofing devices.

So...what is it?
Measuring-Devices of all possible sorts?
Or the above AND "Everything" that can influence the process??

I would really really appreciate an answer to this, because as it is, we do not know what to do.
Thanks in Advance,

Peter

Hi,

Based on my understanding, process controls are any equipment/systems used to inspect/measure/test product and process characteristics. equipment can also be a machine. For example, in automotive gearbox assembly line, gearbox screws are tightened a controlled (for torque value) by an automated equipment. the alternative control method is usually manual torque meter.
So, drilling machines are not control equipment. they usually only drill.

 

[morteza]

Hi all,

In clause 8.5.6.1.1, IATF 16949 also requires:

The organization shall include in this process, based on risk analysis (such as FMEA), severity, and the internal approvals to be obtained prior to production implementation of the alternate control method.

I can not understand the structure of the above sentence. My understanding is that:
based on risk analysis (such as FMEA) and severity, the organization shall defined any internal approvals to be obtained prior to production implementation of the alternate control method.

But as you see in the original text, there is no "and" between risk analysis (such as FMEA) and severity, so I think that my understanding could not be true.

May someone explain me the structure and intent of the above requirement?

Thanks

 

[jack770214]

What's the purpose of 8.5.5.1.1: temporary change of process controls? What shall I do to meet the requirements?

What if our process is quite stable and there is no alternate process?

thanks in advance

The key word is controls. Say your automated inspection tool goes down and you need to go to 100% visual inspection or use a backup inspection tool. You need to have a change management process that includes updating your control plan and pfmea SOD calculations. Dude you would have to hire me as your quality manager for me to assess everything that needed to be done. Your IATF training should have covered this bro. Also there are many threads in the forum on this. We impress the hell out of customers and auditors with our global change mangement system. Its critical to our biz and handling changes such as alternate process control methods is a tiny piece of it.