How to audit identical processes? TS 16949 Clause 8.2.2

D

darkafar

#1
How to audit identical processes?

TS clause 8.2.2 states:

The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangement(see 7.1)…….
b) is effectively implemented and maintained.

So I think for two identical manufacturing processes, the auditor need to check if they both are following the planned steps, and produce the desired result.

Then I read CQI-7, ISO/TS 16949:2002 IMPLEMENTATION GUIDE, which states, “All different types of processes must be audited. For example, if an identical process is repeated on three manufacturing lines, one process may be audited, provided measurement indicators show no difference among the three lines.”

So according to CQI-7, for two identical manufacturing processes, the auditor only needs to check one process to see if the planned steps are actually being followed, and he/she only needs to compare the performances of the two identical processes to see if they are the same.

Have I got the message wrong?

If I got the message right, how do you view this difference? Do you think the auditors should accept the method prescribed in CQI-7?

Another question:
TS 8.2.2.4 states, “Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan.”

Does this mean every manufacturing process has to be audited at least once every year?
 
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Stijloor

Staff member
Super Moderator
#2
How to audit identical processes?

TS clause 8.2.2 states:

The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangement(see 7.1)…….
b) is effectively implemented and maintained.

So I think for two identical manufacturing processes, the auditor need to check if they both are following the planned steps, and produce the desired result.
Yes, but that does not have to happen at the same time, unless there is a particular reason to do so. You decide.

Then I read CQI-7, ISO/TS 16949:2002 IMPLEMENTATION GUIDE, which states, “All different types of processes must be audited. For example, if an identical process is repeated on three manufacturing lines, one process may be audited, provided measurement indicators show no difference among the three lines.”
Yes, but you need to be sure that there is no significant variation between these three lines. My suggestion is to audit these lines, but at different times perhaps. You decide.

So according to CQI-7, for two identical manufacturing processes, the auditor only needs to check one process to see if the planned steps are actually being followed, and he/she only needs to compare the performances of the two identical processes to see if they are the same.
That could be an option as well. It depends on the performance of the process.

Have I got the message wrong?
If I got the message right, how do you view this difference? Do you think the auditors should accept the method prescribed in CQI-7?
CQI-7 is an implementation guide. Just guidelines and suggestions. ISO/TS spells out the requirements. The auditors will follow ISO/TS and any applicable customer-specific requirements.

Another question:
TS 8.2.2.4 states, “Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan.”

Does this mean every manufacturing process has to be audited at least once every year?
No, your audit schedule must cover a year's period. "Annual" does not mean the frequency of audits. You determine the audit frequency based on the requirements in 8.2.2 and any additional audit requirements.

Hope this helps.

Stijloor.
 
#3
I'm not sure where the CQI-7 guidelines came from, apart from that they're AIAG documents, but doesn't TS state that you have to perform audits on each manufacturing process to determine their effectiveness? So I don't understand what CQI-7 means, in that case. If you have three lines doing identical work, doesn't 'each' mean you have to audit all three (at some time)??

The idea in CQI -7 that as long as the results are the same from each of the processes, you only need audit 1 is a little strange, IMHO. How do you know if the other, unaudited processes, are in control? Just looking at the results is a huge assumption that they're being run the same.......
 
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