The requirement is to show control over the outsorced processes. To show control you should have a written agreement/specification and a metric to prove that you are indeed in control. Lately FDA has been very interested on this subject see below:
Of particular interest is the last paragraph that clearly recognizes the existance of "internal suppliers."
FDA is stressing the importance of complying with supplier controls in an effort to stem the rising number of recalls associated with vendor-provided products.
“We as an industry have to start focusing in on this,” Kim Trautman, FDA GMP/quality systems expert, told “The Silver Sheet.” As industry has “become more globalized,” she says, “it has started to outsource a lot more things. In doing so, it has now started to stretch its controls of those suppliers thinner and thinner.”
Trautman and other FDA officials are speaking at industry conferences and workshops to highlight vendor issues and remind companies of their responsibility to abide by the purchasing controls section of the Quality System Regulation.
The agency’s interest in boosting manufacturers’ understanding of this issue was sparked in part by an observation it made when analyzing recall information provided by firms, Trautman says. The data often indicates that companies are reporting supplier troubles as the root cause of failure in their devices.
“When the recalls come in and they’re identifying some of the causes for the recall, it seems to be more prevalent within the past five or so years that they are supplier issues,” she says.
Although Trautman admits that there has not been a formal FDA analysis to determine whether poor supplier controls are leading to more recalls, she notes that “when we looked at ... some of the very specific examples we’ve had on the device side recently, there have been a lot of supplier issues.”
One of the more high-profile examples Trautman points to is the supplier trouble that plagued Guidant and forced the company to conduct numerous recalls of implantable cardioverter defibrillators (ICDs) and pacemakers. In a 2005 recall, the firm blamed a faulty supplied magnetic switch as the reason why some Contak Renewal devices were malfunctioning.
More recently, Boston Scientific – which purchased Guidant last year – initiated a recall April 5, warning users that batteries in 73,000 Contak Renewal and Vitality ICDs could run out faster than indicated on their label. In a letter to physicians, Boston Scientific said it identified low-voltage capacitors from a former supplier that may be subject to degradation and cause accelerated battery depletion.
The action was reminiscent of three Class II recalls carried out by the company last year in which devices also were malfunctioning due to the failure of capacitors from a component supplier.
When a company encounters supplier problems such as those faced by Boston Scientific, “what they’re not doing well is one of two things. Either they’re not controlling internal ... suppliers between different divisions or parts of the company, or they’re not controlling their external suppliers to the degree that may be necessary for the risk of that product or service,” Trautman says.