Chapter 3 – The Process Approach

1Process Approach Auditing14-April-2009

QUESTIONS FOR USE DURING YOUR

PROCESS AUDITS

Chapter 3 – The Process Approach

2Process Approach Auditing14-April-2009

Critical elements of all processes

Process owner is identifiedOutputs are completely and accurately defined

and understood by all employees Inputs are defined and prioritized based on riskProcess is monitored, measured, analyzed &

improved / An effective PDCA cycle exists

Chapter 3 – The Process Approach

3Process Approach Auditing14-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

Chapter 3 – The Process Approach

4Process Approach Auditing14-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!

Chapter 3 – The Process Approach

5Process Approach Auditing14-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

Chapter 3 – The Process Approach

6Process Approach Auditing14-April-2009

While interviewing personnel in all areas/processes – what are they saying?

Are they satisfied with their:Work area / Cleanliness/SafetyEquipment / tooling / IT supportInternal / External SuppliersManagement 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

Chapter 3 – The Process Approach

7Process Approach Auditing14-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