供应商的风险管理培训课件.pptVIP

* The obvious places to look in a factory are where the products are made and tested. These tend to be where the regulars will look to assess GMP compliance and are very important. The audits should also consider the role that Management and Human Resources take in the overall operations (the importance of these is emphasised by the fact that the first two sections of the QMS are Management and Personnel). As auditors we are taught for focus on the system not the person, focus on the operation not the operator. The reality though is that when a system or operation fails, it is often as a result of human intervention, mistake, bad judgement, incompetence! * This section deals with these topics * Observe / Ask / Verify / Record These are Questioning and Listening Skills The purpose is for confirming facts: Linking confirmations: Outputs becoming Inputs (answers to a question become the basis to formulate the next question in the sequence) Use of Checklists Note-taking: Defining the ground covered Defining key facts: What to record and How to record Interactive session At this point conduct the following: “My skills as a listener” read this from the handout Listening skills: - Age of the pilot - Number of months with 28 days - Initials at the end of a line * Use this tool until you are satisfied you have reached the true answer to your questions. You seldom get all of the information you require with your first question. Remember the analogy earlier about peeling an onion through many layers before you reach the core of the subject. * This section deals with these topics * An audit finding is a core element of the final audit report. Writing good audit findings is crucial to how well the audit report is received. There are several challenges associated with this activity: To obtain a standard structure use recommended template design. Write the finding/observation in language that is easily understood by customers and stakeholders. Use proper grammar and s