The Process Approach applies systematic definition and management of processes and their interactions so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using a “Plan-Do-Check-Act” (PDCA) methodology with an overall focus on “Risk based thinking” aimed at preventing undesirable outcomes. (*) DRAFT INTERNATIONAL STANDARD ISO/DIS 9001, ISO/TC 176/SC 2 /WG24/N111, 2014, p10.
The expectations for this course are that students will:
- Understand the “Process Approach” and how to apply it to an organization’s quality and business management systems
- Understand the Concept of Risk Based Thinking and the use of Risk Tools to quantify risk and implement preventative actions
- Understand how the P-D-C-A (Plan-Do-Check-Act) model integrates the Process Approach and Risk Based Thinking into a Continual Improvement Process
Syllabus – Process Approach
What is the Process Approach?
- The inputs required and the outputs expected from these processes
- The sequence and interaction of these processes
- The criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of these processes
How to integrate Processes into Business/Quality Management Systems
Class Room Exercises demonstrating the approach
Risk Based Thinking
What is Risk Based Thinking?
Why is Risk Based Thinking important?
Risk Processes (Based of ISO 31000)
- Identify Risk
- Analyze Risk
- Evaluate Risk
- Residual Risk
- Treat Risk
Risk Based Tools (Based on ISO 14971)
- PHA, FTA, FMEA, HAZOP, HACCP
Class Room Exercises using Tools
Integrate the Process Approach with Risk Based Thinking to:
- Determine the resources needed to manage processes
- Determine the responsibilities and authorities for these processes
- Plan and implement the appropriate actions to address risks and opportunities
- Discuss methods for monitoring, measuring, and evaluation of processes
Class Room Exercises