GUIDE TO OUTSOURCING
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Suppose, for example, that an outsourcing partner in Mexico assembles, packages, and labels a Colorado-based company’s product, which is then shipped back the to the United States for sterilization. During the course of a routine poststerilization review of the device history record by the organization, it is discovered that the sealing operation was not working within the parameters specified in the validation. How should this situation be handled? This is a serious breach of procedure that may have a perfectly reasonable explanation. Perhaps the partner has a local validation that verifies the current equipment set points.
One response would be to send out an e-mail to the plant manager with a detailed list of shortcomings requesting explanation. Although e-mails are a common way to communicate, it is important to consider the content and tone of the e-mail carefully. Because of a possible miscommunication, a much better response would be a personal phone call to the plant manager explaining the problem and asking for resolution. If company representatives have never met, a visit might be a better choice. It is best to have met with the critical people in the offshore operation before any such problems occur.
The best solution is soft-skills training specific to cultural and language differences for all key individuals. Furthermore, training should be ongoing as people rotate out of the project and new people rotate in. It is imperative for management to routinely revisit cultural issues to ensure effective communication.



