HOW TO AUDIT AND TAKE AN AUDIT Welcome to: HOW TO AUDIT AND TAKE AN AUDIT Presented by: Somashekar for Internal auditors Modified from the original presentation of 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!

Common Processes across Control of documents Control of records Quality policy and objectives Responsibility and Authority Internal communication Internal audits Control of NC products Data analysis and CAPA …

Ownership processes Infrastructure and work environment Production and service provision Customer related processes Design and development Purchasing Customer property Control of MMD Monitoring and measurement of product

Look for the PDCA in audit Every process area you audit must be working within the PDCA cycle. PLAN Look for the plan, This can be from an other process. Audit for how process interaction is effectively happening Ex: Production schedule, Skill matrix, supplier selection, Competency and Training plan, Design plan, Out Sourced process determination…. etc

Look for the PDCA in audit DO This is the activity of the area. Look for the responsibility, authority, communication, Records, outputs meeting inputs or the plan Ex: Production records, PO generation, Records of training, Design i/p; o/p reviews, Outsourced process records,

Look for the PDCA in audit CHECK This is the activity of checking the DONE work. Look for responsibility, authority, How checking is done, evidences Etc. Ex: Testing records, Training effectiveness, PO approval process, Design verification, Validation, Outsourced process effectiveness ..etc.

Look for the PDCA in audit ACT This is when changes are taken up with CHECKing data. Look for complaints handling, Improvements, Objectives improvement, Audit CA, Internal and supplier CAPA. Supplier re-evaluation, Training plans, Design changes control, New outsourcing controls .. Etc

Thank you for your attention Are you ready for the audit ? Thank you for your attention … any discussions ??