1. Chapter 3 – The Process Approach 1 Process Approach Auditing 14-April-2009 QUESTIONS FOR USE DURING YOUR PROCESS AUDITS

2. Chapter 3 – The Process Approach 2 Process Approach Auditing 14-April-2009 Critical elements of all processes Process owner is identified Outputs are completely and accurately defined and understood by all employees Inputs are defined and prioritized based on risk Process is monitored, measured, analyzed & improved / An effective PDCA cycle exists

3. Chapter 3 – The Process Approach 3 Process Approach Auditing 14-April-2009 Critical elements of all processes Management commitment, involvement and allocation of resources is evident Relevant customer feedback is available (internal and external) Employees are aware of process performance, improvement goals, plans, incentives, etc. Competency & Training requirements Process is documented as necessary to ensure effective training & control

4. Chapter 3 – The Process Approach 4 Process Approach Auditing 14-April-2009 AUDIT QUESTIONS: Are all processes being measured for effectiveness and efficiency? Are process owners being held accountable for the performance and compliance of their processes? Are process improvement objectives aligned with organizational objectives, specifically the business plan? Are there adequate plans in place to achieve the objectives? Is the performance of all organizational processes being reviewed at some appropriate frequency by top management? When a process is not performing to goal ask to see the analysis of data showing why, and the plan showing what is being done about it. THIS INCLUDES SOPS AND MOPS!

5. Chapter 3 – The Process Approach 5 Process Approach Auditing 14-April-2009 AUDIT QUESTIONS: Are all employees aware of the organizational objectives and the current status of these measurements? Are all employees aware of who their customers are and whether they are satisfied? Are employees aware of the process metrics that they can affect? Are they aware of the current analysis of data related to these metrics and the plans in place to achieve them? Can they demonstrate areas of past or planned continual improvement? Ask them to show you the objectives and explain how they contribute to the achievement of them

6. Chapter 3 – The Process Approach 6 Process Approach Auditing 14-April-2009 While interviewing personnel in all areas/processes – what are they saying? Are they satisfied with their: Work area / Cleanliness/Safety Equipment / tooling / IT support Internal / External Suppliers Management and supervisor attitude What is their biggest problem? What would they like to change about their process? Are they motivated to make improvements? ASK – the answers tell you a lot about the Management style and culture. The answers could become audit trails

7. Chapter 3 – The Process Approach 7 Process Approach Auditing 14-April-2009 Advanced process elements Dominant process variables (Man, Machine, Method, Material, Environment.) Effective analysis and use of any process and/or product data that is recorded Reduction in RISK factors Reduction in measurement system and process variation Reduction of waste