IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes"

[vailmij]

Just like any audit, you would only need to do a random sample.

An audit is almost always going to sample occurrences in a process

Ah, that seems obvious to me now, thank you for clarifying.

Attached is the form we are considering using when conducting the review of our Internal Audit Schedule.

What we would do is list out the Corrective Actions and Process Changes (Engineering Change Request #s) that have occurred since the last audit and make a determination as to whether or not the current audit schedule should be revised. We would do this for each of our main QMS processes bi-annually.

Is this similar to what is being done at other organizations or are we missing the mark?

 

[shobha popalghat]

Hello everyone,

I know the Internal Audit Program section of the standard has been discussed dozens of times before on this forum, but what I think could be still useful is clarification of the term "process change" that is used in section 9.2.2.1.

Specifically, the sentence I am referring to states that "The frequency of audits shall be reviewed and, where appropriate, adjusted based on occurrence of process changes, internal and external nonconformities, and/or customer complaints."

Our quality team was discussing ways we can improve our internal audit program, and we came upon some different interpretations as to what exactly the standard is considering a "process change" in the context of this section. Throughout our procedures and several quality documents, we mention "process changes", but they are referring to a change in the way a part is processed through product realization, for example adding an additional cleaning step for a particular part before packing. So, a definition of process change in that context would be "any changes that impact product realization" [or perhaps something more specific]

Using this definition, it would then mean that any "process changes," such as the example above, would have to be an input during the internal audit reviews. It doesn't seem logical to me, however, that these types of changes have any bearing on the internal audit program. These changes are already controlled and verified using our Control of Changes procedures (see Sec 8.5.6).

What I would propose, in the context of the internal audit program, "process change" be defined as "any changes to the equipment, procedures, controls, or outputs of a QMS process." This definition is more appropriate, in my opinion, to the internal audit program because it is logical that if there have been any of these types of changes to a QMS process, then those changes should be reviewed when planning the internal audit schedule.

I hope I have made my distinction clear enough to spur a discussion. I would be very interested to know if your organization uses either of these interpretations of "process changes."

tl;dr In the context of reviewing the internal audit program, what is your organizations definition of a "process change"? How is the review of "process changes" incorporated into your organization's internal audit program?

Hello Everyone ,

I am shobha ,

Sharing you department wise internal audit checklist prepared for my organisation ,i tried ,hope it will be useful for others..