Hello everyone,

I am implementing an ISO 9001:2000 system for a facility where 85% of the current work is prototype. Does anyone have any good ideas on how to define this in SOPs? Additionally, is it acceptable to mix these materials on the floor with production items or should there be a separate area?

I am assuming that as long as we identify the prototype materials correctly and define that they do not follow standard manufacturing practices, that I will still meet ISO compliance. Pototype and Production are two separate processes here, but both very significant!

Thanks everyone!

Hello everyone,

I am implementing an ISO 9001:2000 system for a facility where 85% of the current work is prototype. Does anyone have any good ideas on how to define this in SOPs? Additionally, is it acceptable to mix these materials on the floor with production items or should there be a separate area?

I am assuming that as long as we identify the prototype materials correctly and define that they do not follow standard manufacturing practices, that I will still meet ISO compliance. Pototype and Production are two separate processes here, but both very significant!

Thanks everyone!I would somehow identify the prototype work in the work order documentation, . You can describe the method of identification in your manual or SOPs.

Hello,
In previous companies I have kept the protoype work segregated within the workcell. The protoype bench(s) can be easily identified with signs (I used MS Word Laminated sheets). This technique was acceptable to all of the customers and FAA. The manuals were revised to reflect the process.

Good Luck,
Rob Carrillo

Create a traveler document that follows each batch of prototypes through its interrupted process cycle. At each stage of the process have the processor... whether in-house, out source, inspection, etc. sign off on the completion of that step. This sort of documentation helps to identify the batch as prototype and aids in assuring that all of the process steps are completed.

The travelers mentioned, can be printed on different color paper if desired for visual identification that the job is a prototype. As an example, we had used green for prototype and red to identify a expedited job.

Rob Carrillo