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Conducting Risk Analysis for Business Processes for ISO 9001:2015

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Seminar Content

This two or three day workshop addresses, in a hands on workshop, the Process Review approach to analyzing and managing risk in business processes as part of a management system. The workshop will enable a process team to define, analyze, control and document key processes in a management system.

Part of the intent of this seminar is to enable an organization to effectively apply risk-based thinking and to analyze and control risks in business and service processes. This approach includes the effective use of Process Flows and Process FMEAs in business, service and support processes.

Who Should Attend

This seminar is designed for managers responsible for Quality, Environmental or Health &Safety Management Systems, process owners, implementation teams, and management systems auditors, both internal and 3rd party.

Recommended Training and/or Experience


Seminar Materials

Each participant will receive a course manual and related exercise materials.

Seminar Goals

  • Demonstrate an ability to properly and effectively employ process risk assessment and process control methods
    • Demonstrate an ability to properly construct a Process Flow Diagram.
    • Identify steps, requirements, failure modes, causes and controls and properly enter the information in a PFMEA.
    • Be able to document and implement a control strategy through process documentation or Technical Process Control Plans
  • Explain the relationship among a Process Flow Diagram, PFMEA and Control Plan/Process Documentation.
  • Explain how to prioritize continual improvements employing qualitative risk analysis.

Seminar Outline

  • Overview of Enterprise Risk Assessment
    • Risk and ISO 9001:2015
    • Risk Assessment
    • Planning and Control of Risk Responses
  • Overview of the Process Review Approach
    • Developing the Process Approach
    • Alignment of Objectives, KPIs and Processes
  • Conducting a Process Review
    • Developing a Process Definition
    • Characteristics and Requirements
    • C-O-P-I-S and Turtle Analysis
    • Defining a Process
    • Breakout Exercise 1: Developing Turtle Diagram
  • Developing a Process FMEA
    • Preparing for PFMEA: Process Flow Diagram
    • Breakout Exercise 2: Developing a Process Flow Diagram
    • Process FMEA for a Business or Service Process
    • Breakout Exercise 3: Developing a Process FMEA
  • Process Control Methods
    • Process Documentation & Standardization
    • Technical Process Control Plan
    • Breakout Exercise 4: Developing a Technical Process Control Plan
  • Summary


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