Inspection and Testing

The 3rd Edition of QS in 4.10.4.2, indicates that "The supplier Shall conduct audits of packaged final Product to verify conformance to all specified requirements at an appropriate frequency." We do not do final audits at any frequency as we believe that we have a system that will prevent defective product from reaching the packaging stage. I would hate to add the extra expense of auditing what has already passed through our process. Do these audits HAVE to be conducted and if so where is the value added to the customer. The old saying that you can't inspect quality into the product is really true. Auditing a product after you have just handled it seems like a true non value added activity.

In answer to your question "do these audits have to be conducted?", the answer is YES. 4.10.4.2 states "The supplier shall...." which means you must. However, the requirement is for audits at an appropriate frequency. If your system prevents defects from reaching the packaging stage and nothing can effect the product during or after this operation, then you will be able to develop objective evidence that will allow you to reduce the frequency of the audits to an absolute minimum provided there are no customer complaints to the contrary.

These audits are more than just product checks. They are to verify that the packaging performs its intended task of protecting and preserving product when stored, stacked, moved, and handled. They also verify that all labeling, marking, and other required identifications are being properly completed.

You also asked "where is the value added to the customer?". Well, I don't think there is any if you have never had an issue in this area, but since it is a requirement, you will have to prove it to your customer if it is to be waived.

As you can tell by the revised requirement the Big Three (Dummies) never heard that you cant inspect quality into a product. The only out that I can see and our registrar agrees is that the frequency can be determined by you (us) so once a Lot will meet the requirement. What we have to do is to find a frequency and method that will not be a total waste just to satisfy the requirement.

Dick's comments are the most accurate on this issue. The intent of this requirement is to ensure that nothing has happened to your product between the time it was finished (and I presume inspected) to the time you are about to ship. At our facility, we call these audits "Shipping audits" because that is essentially what they are. We are not so much looking at the parts as we are looking at the packaging. How many things can go wrong? Look in your FMEA! If you don't think anything can go wrong, your FMEA needs work. In my experience, I have seen many things go wrong from the time the product is packaged to the time it is shipped, even if it is within minutes. Like: Packaging deterioration (torn/broken/bent/damaged/skewered by forks/collapsed....) Labelling (wrong part #, rev../barcode smeared/scratched/removed/label fell off/ two lables (one old one new) on opposite sides of the container....) Environmental (roof leaks/dust in mechanisms/parts rusting/heat deterioration) and human errors (someone takes a piece(s) and affects the count, someone has a part in their hand and tosses it into the bin, not realising it is the opposite hand....) Lastly take some of Bill Smith's advice and define your audit frequency based on probability of defect ocurrance. Use your past track record to justify your frequency; ie how many complaints have you gotten from the customer regarding mixed parts? Part shortages(especially for Kanban oriented customers)? Damaged containers? Wrong labels or revision? If you havn't got any, that should satify the auditors if you decide to do your audits infrequently.