Product Audits - Who should perform Product Audits?

[JuneFoo]

Re: product audit

Anyone you deem as competent to perform product audits...

It's entirely up to you who does them!

Hi, AndyN,

During TS2 audit, my CB issue me an observation because I only list down the job spec (competency requirement) for Internal Auditor, but not product & process auditor.

What is the extra requirement for product/ process audit? If no, I will just add Product/ process auditor in the job spec list. But I think there should be extra requirement because the auditor hint me -- what process effectiveness / functionality etc....

 

[AndyN]

Re: product audit

Hi, AndyN,

During TS2 audit, my CB issue me an observation because I only list down the job spec (competency requirement) for Internal Auditor, but not product & process auditor.

What is the extra requirement for product/ process audit? If no, I will just add Product/ process auditor in the job spec list. But I think there should be extra requirement because the auditor hint me -- what process effectiveness / functionality etc....

You have to define the competencies for your product and process auditors. There's no 'extra requirement' to consider. Anyone who performs this type of work must be competent, that's all.

 

[amanbhai]

Most of the product audits are performed by customer (specially in auto and pharma).
They do product audit and can also check your non conformance procedure since it is relevant.

 

[AndyN]

Most of the product audits are performed by customer (specially in auto and pharma).
They do product audit and can also check your non conformance procedure since it is relevant.

Not at all! In my experience of TS implementation, the organization had to do the audits, not the customer...

Customers MAY do audits, but that's nothing to do with TS 16949...

 

[Geoff Withnell]

Let us remember the question is about product audit. So we need someone who can evaluate the product against its requirements. Often, the best person for this is someone in final/shipping inspection. A product audit should imho, start with an item, packed and ready to ship, and have documents and packing evaluated, then the product removed and subjected to top level requirements evaluation. Is it the right size, color, undamaged, right inferfaces, does it turn on, etc. It's really an inspection job, and has very little to do with ISO9001 system requirements. Many internal auditors are not qualified to do product audits.

 

[qusys]

Let us remember the question is about product audit. So we need someone who can evaluate the product against its requirements. Often, the best person for this is someone in final/shipping inspection. A product audit should imho, start with an item, packed and ready to ship, and have documents and packing evaluated, then the product removed and subjected to top level requirements evaluation. Is it the right size, color, undamaged, right inferfaces, does it turn on, etc. It's really an inspection job, and has very little to do with ISO9001 system requirements. Many internal auditors are not qualified to do product audits.

As per ISO TS , the requirement is that the organization in adequare phases of the production and shipping to verify the conformity to all specified requirements, such as dimension of the product, functionality, packaging, labelling , with established frequency.

I agree with your methodogy, but, In my opinion, making only the product audit at the shipping phase is reductive and does not completely meet the requirement of the standard.
The statement of the requirement also mentions " in adequate phase of the production", based upon this, I think that the organization should define how to proceed, establishing for them what it means for them " adequate phases of the production".
Take also into account that in particular environment, such as electronic and semincon ones, it is impossible to open the package of the selected product to be audited due to contamination issues.
Besides, many controls are performed directly on the production line by the operators themselves, based upon the production flow ( i.e. measurements , control of particles, other defectiveness).
In these kind of organization I've seen that the product audit is focused on the verification of control plans control effectiveness in the production line ( I mean verification of the reaction mechanisms effectiveness, MSA available, FMEA etc.), availability of right PPAP, checking for quality record regarding to the audited product item as well as including the verification of the incoming raw material used for process.
Competences of the internal auditors are defined in the related documented procedure.
What about?

 

[Geoff Withnell]

As per ISO TS , the requirement is that the organization in adequare phases of the production and shipping to verify the conformity to all specified requirements, such as dimension of the product, functionality, packaging, labelling , with established frequency.

I agree with your methodogy, but, In my opinion, making only the product audit at the shipping phase is reductive and does not completely meet the requirement of the standard.
The statement of the requirement also mentions " in adequate phase of the production", based upon this, I think that the organization should define how to proceed, establishing for them what it means for them " adequate phases of the production".
Take also into account that in particular environment, such as electronic and semincon ones, it is impossible to open the package of the selected product to be audited due to contamination issues.
Besides, many controls are performed directly on the production line by the operators themselves, based upon the production flow ( i.e. measurements , control of particles, other defectiveness).
In these kind of organization I've seen that the product audit is focused on the verification of control plans control effectiveness in the production line ( I mean verification of the reaction mechanisms effectiveness, MSA available, FMEA etc.), availability of right PPAP, checking for quality record regarding to the audited product item as well as including the verification of the incoming raw material used for process.
Competences of the internal auditors are defined in the related documented procedure.
What about?

Ok, I agree that these things need to be audited, and I would say that checking the items' documentation that the right steps were followed (shop traveler, etc) would be part of the product audit. However, I would say that control plan effectiveness and so forth belongs in a process audit, a distinctly different creature. It all needs to be done.

Geoff Withnell

 

[qusys]

Ok, I agree that these things need to be audited, and I would say that checking the items' documentation that the right steps were followed (shop traveler, etc) would be part of the product audit. However, I would say that control plan effectiveness and so forth belongs in a process audit, a distinctly different creature. It all needs to be done.

Geoff Withnell

Hi Geoff,
thank for your response.
I agree with your point concerning with documentation. SOmetimes, for some envirionment like electronic, desk audit with data , records and documentation check is a part of the product audit focused on the specific item selected to the shipping and then backwards for the compliance.
In many training on this topic I was taught that the process audit verfies that the process is being followed, while the product audit verifies that the control plan is being followed. Gnerally spaeking, the product audit requires how the organization is sure if the product controls, included in the control plan, are performed as per specifications.
I think that the different organizations shall be find benefits from the product audit, based upon their environment and production characteristics, and have the aim to improve the product controls by means of the product audit too.