Internal auditor qualifications for product audits - TS 16949

A

atlantisind

#1
I have viewed these discussion boards many times and gotten great information but this is my first time actually posting something.

We are working on our ISO/TS certification and have some differences of opinion regarding the product audits. Currently our Quality Control Manager performs them according to her own schedule. They are separate from all other internal audits and get audited by the auditors. She is not an internal auditor nor has she had any internal auditor training. Do the people who do the product audits need to be "qualified internal auditors" or since she is the QC Manager performing the audits and the qualified internal auditors audit those product audits, is that sufficient?

Any input would be a tremendous help.

Thanks,
Billie Jean
 
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J
#2
Off the cuff

Simple answer is no.
I am assuming:
The QM is performing a task governed by a procedure.
This procedure has an output that is documented.
The Auditors verify that the process was performed correctly.

James
 
A

atlantisind

#3
James-
Pardon my ignorance but did you mean no to our current process is not sufficient or no to our QM does not need to be a "qualified internal auditor"?

Our procedure states, "Dock audits are performed at a minimum of once per year for automotive parts that are produced during that year. These audits are performed to verify conformity to specified requirements, product dimensions, functionality, packaging, and labeling. Dock audits are separate from our internal quality audits as they are performed by Quality Control and records for these audits are maintained by Quality Control."

Thanks again,
BJ
 
A

Al Dyer

#4
Welcome,


Personnel that perform product/dock audits do not need to be trained internal auditors. If fact it is a good idea to have as many people perform product audits as possible to look for faults in the system, gain confidence, learn differing processes etc...

Good luck!!!

Al...
 
A

atlantisind

#5
I think my definition of product audit needs to be clarified.

I have received 2 interpretations on this requirement.

1. Qualified internal auditors must perform product audits. Parts must be reviewed per the control plan and dimensions re-checked.

2. Qualified internal auditors should perform product audits. Parts to be verified per the control plan, verifying sampling rate and frequency (among other things) not re-checking dimensions.

Are either of these correct or are we headed in the wrong direction?
 

Helmut Jilling

Auditor / Consultant
#6
I have read in official TS literature that product auditors performing product audits do not require the same level of training specified in the audit requirements (like ISO 19011). However, they would fall under the more generic "competency" reuirements spelled out in 6.2. (I can't put my finger on where I read this, but I think it was a Sanctioned Interpretation or FAQ. You might search on the IAOB or AIAG websites.)
 
S

SilverHawk

#7
It was written in the Ford Customer specific requirements that those peforming process & product audit not required to attend the qms internal audit training based on ISO 19011.
 

bpritts

Involved - Posts
#8
hjilling and silverhawk are correct. The product audits (and manufacturing process audits, for that matter) are distinct types of audits. Training and
qualifications can be different for each type of audit.

Certainly your company needs to establish what kind of qualifications are needed to do any audit. For a product audit, the person needs to be able to determine the requirements (product print or control plan), and then able to do the necessary measurements & tests. Make sure you check customer
specific requirements for quality systems auditor qualifications; many
of the CSR's call out specific expectations.

For any kind of audit, I would think that you need the auditor "personal
attributes" specified in ISO 19011. Things like: auditor cannot be unduly
pressured to change their report; will report fairly on facts; etc.

Going to atlantasind's other question on what a product audit is:

The original requirement here came from QS-9000, and was added in 1998.
The idea was to sample a part (originally specified as a "dock" audit, taking
the part from finished ready to ship goods) and conduct specified inspections & tests. This was intended to be different from "process" audits where you
verified that people were following directions & process parameters, etc.

If the product failed, you needed to do a CAR on how & why the control plan failed to either make the part right or detect it.

Some people (including some registration auditors, alas!) seem to take the
approach that this requirement means doing a control plan audit on a specific part #. I think that's not at all what the standard writers intended. Such an approach would constitute a manufacturing process audit, or could be a part of a systems audit; but it's not a dock/product audit.

This whole area is unfortunately confused by the use of the term "process"
in several different connotations.

Best regards,
Brad
 

Howard Atkins

Forum Administrator
Staff member
Admin
#9
bpritts said:
hjilling and silverhawk are correct. The product audits (and manufacturing process audits, for that matter) are distinct types of audits. Training and qualifications can be different for each type of audit.
There are 3 different audits defined in the standard:
8.2.2.1 Quality management system audit
The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.
8.2.2.2 Manufacturing process audit
The organization shall audit each manufacturing process to determine its effectiveness.
8.2.2.3 Product audit
The organization shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labelling, at a defined frequency.

My emphasis of the reasons for each audit.
To my mind the manufacturing process audit is to ensure that all separate stages of production are audited and not as it was possible to audit by clauses in the previous standards and not enter certain departments but still "audit" according to the requirements of the standard. I do not think that the Manufacturing process audit is so different from the Quality management system audit as if one is auditing in a process manner then the QMS is audited during the Manufacturing process audit


bpritts said:
Such an approach would constitute a manufacturing process audit, or could be a part of a systems audit; but it's not a dock/product audit.

This whole area is unfortunately confused by the use of the term "process"
in several different connotations.
This is very true- there is the process of auditing a manufacturing process in a process manner

See this thread for more on product audits. I think that the issue of product audit has not been closed at the cove. Product Audit - Explanation and samples of the report
 

Helmut Jilling

Auditor / Consultant
#10
Howard Atkins said:
There are 3 different audits defined in the standard:
8.2.2.1 Quality management system audit
The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.
8.2.2.2 Manufacturing process audit
The organization shall audit each manufacturing process to determine its effectiveness.
8.2.2.3 Product audit
The organization shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labelling, at a defined frequency.

My emphasis of the reasons for each audit.
To my mind the manufacturing process audit is to ensure that all separate stages of production are audited and not as it was possible to audit by clauses in the previous standards and not enter certain departments but still "audit" according to the requirements of the standard. I do not think that the Manufacturing process audit is so different from the Quality management system audit as if one is auditing in a process manner then the QMS is audited during the Manufacturing process audit




This is very true- there is the process of auditing a manufacturing process in a process manner

See this thread for more on product audits. I think that the issue of product audit has not been closed at the cove. Product Audit - Explanation and samples of the report

I agreed with all of this, but was a little concerned about the last sentence: "I do not think that the Manufacturing process audit is so different from the Quality management system audit as if one is auditing in a process manner then the QMS is audited during the Manufacturing process audit:"

I would want to be clear, that as a registrar auditor, I doubt I would accept a situation where the Manufacturing process audit was presented as fulfilling the Quality management system audit.

I agree that the use of the word "process" in different ways causes confusion.

The manufacturing process audit is a rather specialized narrow-view audit, frequently performed by competent floor inspector type folks, or non-auditors. It commonly does walk the control plan, flow chart or a single manufacturing process or line, but generally does not audit at the system "Process" level where auditors are expected to evaluate linkages and support processes.

The QMS level audit has to be performed by qualified trained Auditors, and is a higher level audit to verify each Process defined in the quality system (including support processes) is functioning as planned, and to seek improvements. They might also use a control plan in some cases, but this is the "official" internal audit that we would have perfromed in QS-9000. Only now we perform it along the Sytem Processes we defined, rather than the elements we had defined in QS.

The whole purpose is we are trying to improve our companies (not our elements) by improving each Process (and subprocess) in that system. We can't improve a whole big organization. It's too complex. We have to improve each component part and process of the system.

The standard writers could have done a better job clarifying this.
 
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