Product Development - When to start calculating Process Capability

v9991

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product development goes through stages of strategy - prototype - scale - validation/verification;

my question is, at what stage should we start calculating process capability index; and how to interpret them at each of the stages!.
 
Q

QAMTY

Could You explain What Your product is? I Have seen that process capability doesnt apply completely to all products. I work in a print shop, we print, and in this phase of the process, i dont know how to apply it, if limits are not so Easy to establish them, after printing, we fold the labels,and same thing happens, could some of You share your experiences in print shops? When measuring process capability?
 

v9991

Trusted Information Resource
Could You explain What Your product is? I Have seen that process capability doesnt apply completely to all products.

ours is an manufacturing process of drug device product. devices certainly come with process capability; now the question is for activity we do at our end, for assembly/manufacturing process.
its definitely relevant for us.
 

Ronen E

Problem Solver
Moderator
product development goes through stages of strategy - prototype - scale - validation/verification;

my question is, at what stage should we start calculating process capability index; and how to interpret them at each of the stages!.

Hi,

In a product like that you actually develop to entities in parallel - (1) the device/drug and (2) the manufacturing process - whether this is done as two distinct projects or integrated. I will assume that in your case it's integrated because this is what I see more often.

Introduction of process capability monitoring is more related to the maturity of the manufacturing process than to the device design's maturity. Naturally the manufacturing process matures later, so I wouldn't expect it in the early R&D stages unless it is an explicit, high-priority requirement in your Design Input (I wouldn't commonly expect that, only where planned unit volumes are very big, unit costs are critical and production has to be very efficient).

You could start looking into process capability at the design verification or pilot production stages (again depending on your Design Input), but to me it would make the greatest sense when you scale up and do your process validation. Would be interesting to get other perspectives from (mass) production statisticians and SPC experts (I come from a stronger D&D background).

Cheers,
Ronen.
 
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