J
If a company subcontracts an activity such as Design Control, is this a permissible exclusion?
My opinion is that it is not an exclusion, as it would be if the company were not responsible for design (if we build-to-print, for example -- customer provides the design). The standard clearly states that it cannot be excluded if it affects the organization's ability or responsibility to provide conforming product.
In my opinion, even if you don't have the capability to do design but the customer holds you responsible for it, it cannot be excluded. Furthermore, if the activity is subcontracted, the subbed processes must be identified and controlled (per clause 4.1).
This seems fairly obvious to me, but an instructor in an RAB-approved Transition Course I took stated that this subcontracted design activity would be a permissible exclusion. I wholeheartedly disagree, in this case, but am curious how others would address this in their quality manual? Would you include section 7.3, but state that the activity is subcontracted (and therefore controlled)?
It's very interesting to observe these initial (and varied) interpretations of the new standard.
Any feedback would be appreciated. Thanks. This site is very useful...
ps) Anyone else have the new standard on their Palm Pilot? It's cool.
------------------
Julie Drysdale
BSA
408-395-1928
My opinion is that it is not an exclusion, as it would be if the company were not responsible for design (if we build-to-print, for example -- customer provides the design). The standard clearly states that it cannot be excluded if it affects the organization's ability or responsibility to provide conforming product.
In my opinion, even if you don't have the capability to do design but the customer holds you responsible for it, it cannot be excluded. Furthermore, if the activity is subcontracted, the subbed processes must be identified and controlled (per clause 4.1).
This seems fairly obvious to me, but an instructor in an RAB-approved Transition Course I took stated that this subcontracted design activity would be a permissible exclusion. I wholeheartedly disagree, in this case, but am curious how others would address this in their quality manual? Would you include section 7.3, but state that the activity is subcontracted (and therefore controlled)?
It's very interesting to observe these initial (and varied) interpretations of the new standard.
Any feedback would be appreciated. Thanks. This site is very useful...
ps) Anyone else have the new standard on their Palm Pilot? It's cool.
------------------
Julie Drysdale
BSA
408-395-1928