供应商的风险管理--王彦忠讲义.ppt

* 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 spelling Report the impact of issues and deficiencies on the product, process or system Ensure that the finding as worded reflects the significance of the issue and is aligned with classification Ensure it is fully supported by examples, observations and evidence avoiding redundant and judgemental statements Include context. Be specific-include reference numbers, SOPs, validation protocols, room numbers Clearly identify and separate recommendations from observations The CAPA should be clearly self-evident If someone reads the report in 10 years, will they understand it? From “guide to writing audit findings” ex Peter J Turner dated 15 01 07 * As the auditor/investigator, you have the benefit of “f