JAN ROOVERS ASSOCIATES, INC. Charlotte, North Carolina Welcome to: HOW TO SURVIVE AN AUDIT Presented by: JAN (“Yon”) ROOVERS JAN ROOVERS ASSOCIATES, INC. Charlotte, North Carolina

What is the purpose of an audit?: The purpose of an audit is to find out how effective the Quality Management System (QMS) and its Processes are working. The Auditors “Test the System.” You are the process expert and you can help the Auditors understand how your process works.

What do the Auditors verify?: Are the processes documented? Are the processes implemented? - Do you know and understand the process? Do you comply with process requirements? Are the processes effective? Are the processes continually improving?

What is expected of the Employees?: Know your process and product requirements Know exactly what to do and how Understand your role in the QMS Help correct process and product problems Help improve the process and the product Know and understand the Quality Policy and Objectives Ask, if you’re not sure……….

How do you prepare for an Audit?: Know and follow all your process and product requirements Be able to show the appropriate documents that apply to your job Check your process and work area - Clean, well-organized, all product identified, calibrations up-to-date, all checks/inspections completed, all “paperwork” correctly filled-out Anything you don’t know? ASK!!!! Be prepared to answer the Auditor’s questions

Auditor questions……… When you start a new job, what do you do? How do you check your work? How often do you check your work? Do you record the inspection results? Where is this process written down? Can you show me? What do you do when you find something wrong? Can you explain your company’s quality policy? Do you know the objectives for your process? Are these objectives measured? Can you show me? What happens if you find something wrong? How do you know that your measuring tool is calibrated? What happens if you’re not here? (One person process) Are you involved with correcting problems? Are you involved with improving your process? Etc…………

How to answer the Auditor’s questions……… Be polite and honest. Answer only the questions that are asked. Do not volunteer information. Never lie!! Answer directly and with confidence. It’s OK to ask for clarification. It’s OK to say: “I don’t know.” It’s OK to say: “That’s not my responsibility” but be prepared to say who is. Remember, the Auditors are not out “to get you.” They are only TESTING the quality system and its processes. You help the Auditor understand how your process works. That’s all!

Thank you for your attention Are you ready for the audit? Thank you for your attention