Product Audits must include raw material or incoming inspection process?

[wangxingde]

Who can answer to me that Products audit shall include raw material or incoming inspection process or not.

 

[JaySturgeon]

Material Included

The way I have always hadnled this is that the material used to maufacture the product is included in the audit as it appears on the control plan. Whatever steps you have for incoming should be included in that audit.

Hope this helps.

 

[Manoj Mathur]

NO , IT IS NOT REQUIRED, PLEASE SEE THE REQUIREMENT BELOW
8.2.2.3 Product audit

The organization shall audit products at appropriate stages of production and delivery to verify conformance to all specified requirements, such as product dimensions, functionality, packaging, labeling, at a defined frequency


MANOJ MATHUR

 

[Shaun Daly]

I think it might depend on how your (product) process flows and control plans are designed.

We have a simple little job where we buy in resin & brass pins, mould a plastic lever & then insert the brass pin during an assembly process.

All of this is included in 1 control plan.

So, walking the CP through from start to finish would include goods-inwards inspection.

 

[Sam]

wangxingde asks,

Who can answer to me that Products audit shall include raw material or incoming inspection process or not.

IMO yes, I would want to know if the product that I am producing is made from the correct material.

Manoj states,
"The organization shall audit products at appropriate stages of production and delivery to verify conformance to all specified requirements, such as product dimensions, functionality, packaging, labeling, at a defined frequency"

read, "all specified requirements"

"such as" refers to a small list of examples and infers there could be more.
My question is, if you don't verify that the correct material is used during a product audit, when do you do it?

 

[howste]

I agree that all specified requirements must be audited, but also note that it says "at appropriate stages of production and delivery." It doesn't mention at receipt. I believe the intent of the standard is to audit my own product - 7.4.3.1 covers the incoming product.

If I meet the requirements of 7.4.3.1, I would know that the product that I am producing is made from the correct material. The requirements of 7.4.3.1 can be met with product audits, or other methods listed. If product audit must be applied to incoming material, why would they give me other options?

 

[Shaun Daly]

For any manufacturing company reciept of raw materials/sub assy is going to be one of the realisation processes - which would be audited. Thus you would check the general process itself.

But when doing a Product Audit, if you dont include reciept/incoming inspection how do you know that you are using the correct materials/satisfying customer requirements for that particular product unless you include them in the audit?

What happens if you are supposed to use approved materials, but do not? Or the wrong material due to a specification error/mix up?

A fault passing through Goods-Recieving can cause far more damage than many other problems, especially if the raw materials have been processed, and sent to the customer, who have sent them to THEIR customer......

As you may have guessed, these are not hypothetical comments...........

 

[Bill Ryan - 2007]

My $.02 worth.

I've had at least 3 PPAPs rejected because there was no mention of verifying the incoming materials were within specification (whether a Purchasing spec - raw mat'l - or a component spec) in the PFMEA or CP. I also used to get caught up in "Where does it say I have to?". As I thought about it, we actually do perform receiving inspection and it actually is part of our process flow and we actually do have procedures for receiving inspection - so why wouldn't it be included in our process flow. All of a sudden my customers' demands made sense and receiving inspection has been a step in our process flow since.

Whether it is a "Product audit", Process audit", or any other kind of "audit", it's not part of our flow because of a "Shall , "Should ", or "Could . It's part of our flow because it makes sense for us.

Sorry for the mini-rambling (had to go through this very exersize with our MR today. She wanted the inspection steps (among some others) pulled out so they couldn't be audited ). Hope I haven't gotten too far off topic but I'm plenty tired of not using common sense because of the absence of a "shall " in some standard.

I better go tip a few. Have a great weekend all

Bill

 

[howste]

Shaun, it sounds like you're assuming that if there is no product audit, then nothing at all is being done to ensure incoming product quality. 7.4.3.1 that I referenced above requires that something be done, but product audit is not the only way to do it. using unapproved or wrong materials, and a fault passing through Goods-Receiving are violations of 7.4.3.1.

7.4.3.1 Incoming product quality
The organization shall have a process to assure the quality of purchased product (see 7.4.3) utilizing one or more of the following methods:
- receipt of, and evaluation of, statistical data by the organization;
- receiving inspection and/or testing such as sampling based on performance;
- second- or third-party assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality;
- part evaluation by a designated laboratory;
- another method agreed with the customer.

 

[Shaun Daly]

howste, I wasnt assuming that nothing was being done (which would not be acceptable I agree). Maybe I didnt explain my rambling thoughts too well

You have a goods-in process.
You audit that process & take a few samples - overall the process works.

If you only take a few samples in the process audit, how do you detect that one possible (serious) potential problem unless;

You work your way through ALL of your different incoming materials assocaited with end user products through your product audits?