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Siebel Life Sciences Guide > Recording Product Analysis for Adverse Events and Complaints Management > Scenario for Product Analysis Arising from a ComplaintThis scenario is an example process performed by the Siebel administrator, the manager of the product analysis team, a team member, and the quality manager. Your company might follow a different process according to its business requirements. This process is designed to illustrate the functionality of the Siebel AECM. IntroductionA customer had a problem with a new blood analyzer system. The analyzer's cartridge was determined to be faulty, and the customer returned it to the manufacturer for analysis. The quality manager has already opened a product complaint file (product issue record) for this problem. The Siebel AdministratorThe administrator sets up the activity templates that the product analysis team uses in the course of analyzing product issues. Before creating these templates, the administrator consults with the quality manager and reviews the company's S.O.P (standard operating procedure) for product analysis. The administrator checks that all the necessary codes for product analysis have been set up as appropriate for the company's business process and products. Quality ManagerThe initial review of the product complaint has been completed and the faulty cartridge has been sent by the customer. The quality manager creates a product analysis record in the complaint file. She assigns a member of the product analysis team to be the primary owner of the product analysis record. Member of the Product Analysis TeamThe decontamination unit initially receives and processes the faulty cartridge. After decontamination, the cartridge is sent to a member of the product analysis team. He records receipt of the faulty cartridge, reviews the product analysis record associated with this complaint, and begins analysis of cartridge. During the course of the analysis, the team member creates activities to keep track of the analysis steps. He records the results of the analysis. At the conclusion of the analysis, he records the root cause of the problem and proposes corrective action. When analysis of the cartridge is complete, the team member submits the product analysis information for approval. Quality Manager and Product Analysis ManagerBoth the manager of the product analysis team and the owner of the product complaint file are required to approve the product analysis. When they review their Inboxes, they learn that the product analysis is complete and ready for approval. Individually, they review and approve the product analysis. |
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