B
B4Quality
I've recently been asked (as an external internal audit resource) to weigh in on the more "specific" wording in regards to Nonconformance Handling. My sense is that the intent of the Standard has not changed from Rev A to Rev B, although the changes in wording may imply a stricter requirement. I spend more time in statistical process capability assessment than FAI, so bearing with the ludicrous premise that 1 "representative" part can be a valid way to establish whether a process is capable, here is the question on which I'd very much appreciate some Forum member opinions:
[FONT="]AS9102 Rev B Requirement Excerpt[/FONT][FONT="]: 4.4 Nonconformance Handling[/FONT]
[FONT="]a. The FAI with design characteristic nonconformance(s) is ?not complete?. An FAI with noted nonconforming design characteristics may have Form 1, ?Part Number Accountability?, (see field 19) signed and shall be noted as ?FAI Not Complete?.[/FONT]
[FONT="]?[/FONT]
[FONT="]c. The organization shall implement corrective action(s) and perform a partial FAI for all affected characteristics on the next production run, after implementation of the associated corrective action(s). If the partial FAI does not clear all identified nonconformances, the FAI is still ?not complete? and the requirement to complete the FAI is still in effect.[/FONT]
[FONT="]?[/FONT]
[FONT="]Context[/FONT][FONT="]: In an AS9100 Revision C QMS, the nonconforming design characteristic(s) would be dispositioned per 8.3 Control of Nonconforming Product. A possible disposition per 8.3 is ?Use As Is (UAI)? if authorized by the organization responsible for design, and if required by contract, by the customer.[/FONT]
[FONT="]The next consideration, per 8.5 Corrective Action, would be to determine if corrective action is warranted. Corrective actions are to be ?appropriate to the effects of the nonconformities encountered? and the requirement includes ?evaluating the need for action to ensure the nonconformities do not recur.?[/FONT]
[FONT="]Question[/FONT][FONT="]: What if, in the UAI scenario above, the nonconformance investigation performed by the organization responsible for design (and approved as required by the customer) determines that the associated product realization processes do not need corrective actions and that there is sufficient confidence (based on investigation/analysis of the NC) that the product realization processes are capable of producing conforming parts. Would the FAI then be considered complete, without the need for an additional production run?[/FONT]
In a pure sense, of course "corrective action" should always be pursued. In a pragmatic sense, if a customer orders a handful of parts, all are built at once in the pre-production run and there won't be another order for many months or even a year or two, should the FAI (and potentially shipment) be held up for a minor dimensional NC that will not affect form, fit or function? And further, let's say the customer agrees to open up the tolerance band and allow a drawing change, does the supplier still have to wait for a "next production run" to complete the FAI?
[FONT="]AS9102 Rev B Requirement Excerpt[/FONT][FONT="]: 4.4 Nonconformance Handling[/FONT]
[FONT="]a. The FAI with design characteristic nonconformance(s) is ?not complete?. An FAI with noted nonconforming design characteristics may have Form 1, ?Part Number Accountability?, (see field 19) signed and shall be noted as ?FAI Not Complete?.[/FONT]
[FONT="]?[/FONT]
[FONT="]c. The organization shall implement corrective action(s) and perform a partial FAI for all affected characteristics on the next production run, after implementation of the associated corrective action(s). If the partial FAI does not clear all identified nonconformances, the FAI is still ?not complete? and the requirement to complete the FAI is still in effect.[/FONT]
[FONT="]?[/FONT]
[FONT="]Context[/FONT][FONT="]: In an AS9100 Revision C QMS, the nonconforming design characteristic(s) would be dispositioned per 8.3 Control of Nonconforming Product. A possible disposition per 8.3 is ?Use As Is (UAI)? if authorized by the organization responsible for design, and if required by contract, by the customer.[/FONT]
[FONT="]The next consideration, per 8.5 Corrective Action, would be to determine if corrective action is warranted. Corrective actions are to be ?appropriate to the effects of the nonconformities encountered? and the requirement includes ?evaluating the need for action to ensure the nonconformities do not recur.?[/FONT]
[FONT="]Question[/FONT][FONT="]: What if, in the UAI scenario above, the nonconformance investigation performed by the organization responsible for design (and approved as required by the customer) determines that the associated product realization processes do not need corrective actions and that there is sufficient confidence (based on investigation/analysis of the NC) that the product realization processes are capable of producing conforming parts. Would the FAI then be considered complete, without the need for an additional production run?[/FONT]
In a pure sense, of course "corrective action" should always be pursued. In a pragmatic sense, if a customer orders a handful of parts, all are built at once in the pre-production run and there won't be another order for many months or even a year or two, should the FAI (and potentially shipment) be held up for a minor dimensional NC that will not affect form, fit or function? And further, let's say the customer agrees to open up the tolerance band and allow a drawing change, does the supplier still have to wait for a "next production run" to complete the FAI?