Why Monitor?
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Why Monitor?
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from "Supply Chain Outsourcing: Risks and Rewards" FDA News, October 2005.
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"It is also important to monitor and oversee your partners....It is your responsibility to make sure that your outsourcing partners are performing in compliance with those standards."
"...you may audit once a year for your own operations, but you may audit two or three times a year for an outsourced operation, especially a critical one."
"In an outsourced environment, you need to do audits more frequently because you have less control over exactly what's going on and less knowledge of it."
"The FDA has established requirements for conducting those kinds of audits so that the people who conduct them are not to be the same people for the issues audited. That can be a problem, especially in smaller companies where you have very limited resources and personnel."
"Do not outsource activities that you cannot monitor."
"You will need to monitor those things to make sure that your vendors are doing those properly."
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Questions? Call us at 317-408-0286.
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