Product audit assessment

[QualityImre]

Dear All,

By the last customer audit i got a question related to the product audit. The question was "What will you do if during the product audit it turneds out that the any of the dimension or funciton are not meet the customer requiremets? How do you assess the risk of the occured failure?" I did not answered clearly to this question therefore we got a non-confomity for it.

Would be a good corrective/prevenetive action is to update our internal audit procedure that in such cases the PFMEA shall be reviewed and updated related to the deviated point in it and define a more robust and/or effective control prevention method?
Also i would like to ask your thought in which cases shall the customer to be informed in case of a deviation found during the product audit and when it is enough only the internal action without information of the customer?

If somebody can share with me their procedure or risk assessment matrix without any confidential information or just drop me a link with a good example or which handbook can be use as a refenrece would be welcome. I checked the VDA 6.5 and found only an assessment for the planning of the product audit.

Thank you for your support.

 

[Jim Wynne]

This should be treated like any other form of discovery of NC product.

• Containment-- locate all of the possible NC product in your building and segregate it until it can be verified.
• What is the likelihood that NC product has been shipped? If you're not sure, you must assume that it has happened and act accordingly, including customer notification.

 

[QualityImre]

Hello Jim.

Thank you for the input. Do you have idea how do you assess the consequences as well of the deviation?
I am thinking on separate levels like deviation from:
- affect on legal, governmental, safety regulation(s)
- affect on SC function, SC dimension requirements
- affect on simple dimension
- affect on packaging
- affect on assembly line
- etc
Thanks,
Imre

 

[Ashland78]

We have a procedure for how we respond fast, it is fast response as well as procedure for protect the customer. It explains this all when and how to notify. I am new to this organization so I can't send them but hopefully it helps answer your questions.

 

[ElenR]

Dear All,

By the last customer audit i got a question related to the product audit. The question was "What will you do if during the product audit it turneds out that the any of the dimension or funciton are not meet the customer requiremets? How do you assess the risk of the occured failure?" I did not answered clearly to this question therefore we got a non-confomity for it.

Would be a good corrective/prevenetive action is to update our internal audit procedure that in such cases the PFMEA shall be reviewed and updated related to the deviated point in it and define a more robust and/or effective control prevention method?
Also i would like to ask your thought in which cases shall the customer to be informed in case of a deviation found during the product audit and when it is enough only the internal action without information of the customer?

If somebody can share with me their procedure or risk assessment matrix without any confidential information or just drop me a link with a good example or which handbook can be use as a refenrece would be welcome. I checked the VDA 6.5 and found only an assessment for the planning of the product audit.

Thank you for your support.

Clause 8.7 Control of Nonconforming outputs - I suggest you review this clause and align all your process control in handling nonconforming products. It should cover both internal and external NC products.

As for informing the customer I suggest you review the CSR (customer specific requirements) provided by your customer. If your product is a catalogue product - your organization needs to ensure all products that were already in the distribution centers are contained and hold any shipment until you have identified the scope of the NC products.