S
senna
Hi Ya'll,
I was browsing through the Cove and came across the 8D technique associated with corrective action. Is this useable in the medical device community? If not, any recommendations?
Also, I am in a quandry about how to establish threshold limits associated with CAPAs for facets other that process control. I assume that at a certain level, when evaluating non SPC CAPA data there reaches a point when you say "that's it - we have to do something" How are these threshold points set? I am assuming that you have to have some statistical basis for it. What do you think?
Finally, I know that SPC is a good method of evaluating your process controls for established threshold levels where corrective/preventive action must be initiated. But how do you set your upper and lower control levels? Again, any stats involved? If so, where can I find info on how to set these?
Thanks,
Senna
I was browsing through the Cove and came across the 8D technique associated with corrective action. Is this useable in the medical device community? If not, any recommendations?
Also, I am in a quandry about how to establish threshold limits associated with CAPAs for facets other that process control. I assume that at a certain level, when evaluating non SPC CAPA data there reaches a point when you say "that's it - we have to do something" How are these threshold points set? I am assuming that you have to have some statistical basis for it. What do you think?
Finally, I know that SPC is a good method of evaluating your process controls for established threshold levels where corrective/preventive action must be initiated. But how do you set your upper and lower control levels? Again, any stats involved? If so, where can I find info on how to set these?
Thanks,
Senna