AS9100D PEAR - Examples for organization's method for determining process results?

[Sarah in NoCo]

I am working on AS9100D Certification; we already have ISO 9001 and 13485. I've searched other threads but haven't found this; if it's a repeat just point me in the right direction please.

I'm having trouble coming up with process results and KPI's for two of our key processes - "Receiving and Inspection" and "Packaging and Shipping". My company is a small contract manufacturer (65 employees). The fact that I can't think of any KPI's makes me think maybe they shouldn't be stand alone key processes? It doesn't seem quite right to combine them with Assembly though. Any insights?

 

[Techster]

Receiving and inspection is that incoming parts and/or raw material from external suppliers?
If so I would have On Time Delivery and some sort of rejected PO/total Amount of PO.
Packaging and shipping could be number of claims because of packaging/total numbers of delivery lines and also on time delivery at your customer.

 

[Sidney Vianna]

Any insights?

Critical to remember that the 3 standards you are referencing, ISO 9001, ISO 13485 and AS9100 are QUALITY system standards, so the key aspect is to measure these processes from the perspective of PRODUCT CONFORMITY and CUSTOMER SATISFACTION.

As for receiving and (assume receiving) inspection, a KEY indicator related to quality would be these processes ability to effectively screen good from bad parts. Do you ever have instances where components are being assembled and production discovers that the wrong or defective components were received? If that ever happens in your assembly line, it is a sign that receiving/incoming inspection FAILED to screen that parts. If you come up with an indicator of this yield, that would be a good KPI for these processes.

As for packaging and shipping, does it ever occur that customers complain receiving damaged and/or incorrect parts? Wrong quantity? Missing parts? Late arrivals? Wrong shipping method? Those would be typical (quality) indicators of problems in those processes.

Good luck.

 

[Sarah in NoCo]

Critical to remember that the 3 standards you are referencing, ISO 9001, ISO 13485 and AS9100 are QUALITY system standards, so the key aspect is to measure these processes from the perspective of PRODUCT CONFORMITY and CUSTOMER SATISFACTION.

Thanks for that. It's a good reminder.

For "Receiving and Receiving Inspection" that was what I came up with as well. It would be something like "# errors" with a goal of zero, to be measured by what gets put on non-conforming hold that the Material Review Board determines was received incorrectly or missed at receiving inspection. The concern I have with that is those errors are really rare. In the past two years, it's happened once. Would the auditor be okay with a long string of zeros with very little variation in the data? If I saw data like that, I would probably be suspicious of how real it is just because that's not how data behaves. Or does that just show our process is working well and planned results are achieved?

The same thing with shipping - we seldom have errors and none in the last year. It would be another long string of zeroes.

My background is much more statistics focused than regulatory, so maybe I'm making too much out of what the data will look like. ( I would also far rather have a positive metric than a negative one (% correct instead of # errors) but it's much more difficult to keep track of. And, there would still be the problem of the lack of variation in the data.)

 

[Big Jim]

If you pay attention to topics that you need to perform analysis and evaluation to look at 9.1.2, 9.1.3 and 5.1.2. From that you should come up with customer satisfaction, product quality, on-time delivery, and supplier performance. Even if you don't choose to use these topics as KPI, you still need to be doing it, so why not also use them as KPI to fulfill the requirement to monitor and measure your processes as shown in 4.4.

From these topics, receiving and inspection could be measured by tracking supplier performance. They are in integral part of keeping the suppliers honest. Packaging and shipping could be measured by tracking on-time delivery. If they are not paying attention to getting things out in time on-time delivery could be hurt.

Since you brought it up, receiving and inspection can easily be rolled into purchasing where it addressed in the standard and packaging and shipping could easily be part of production (assembly) (or even rearrange with production as the process and include the activities of assembly and packaging and shipping included within).

It is up to the organization to determine what their core processes are and their can be many ways to accomplish it. Just letting you know there is room for you to roll them into others if you so desire.

 

[Sarah in NoCo]

Thank you for the insights! That helps.