Common Issues When Implementing ISO 9001:2015 Risk Based Thinking in the Machine Tool Industry

The Machine Tool Industry has struggled for years trying to implement risk management tools.  The requirement for their proper implementation has received additional emphasis with the introduction of ISO 9001:2015 and its requirement for the implementation of risk-based thinking when managing the Machine Tool business.

The purpose of this paper is to describe the purpose of three different commonly misunderstood risk management tools used in the Machine Tool industry and also to define when they should be done.  The three risk management tools are:

• Machinery Failure Mode and Effects Analysis (“Machinery FMEA”).
• Application Failure Mode and Effects Analysis (“Application FMEA”).
• Process Failure Modes and Effects Analysis (Process FMEA).

Performed prior to the release of the Machine Tool Design Specifications to Machine Tool manufacturing, the Machinery FMEA is designed to reduce risk exposure due to improperly defined Machine Tool Design Specifications. The Machinery FMEA is also used to assist in the performance of additional activities including Machine Tool Design Verification, Machine Tool Design Specification change control and problem solving should a problem with the Machine Tool occur. The Machinery FMEA also drives the performance of the Application FMEA (aka Process FMEA on use of Machine Tool by customer and Process FMEA on the manufacturing process used to manufacture the Machine Tool.

Performed prior to the release of the installation, usage and maintenance instructions to the customer the Application FMEA is designed to reduce risk exposure due to improperly installed, used and maintained Machine Tools. The Application FMEA is sometime referred to as a Process FMEA on the use of the Machine Tool by the customer. Information provided by the Application FMEA is used to assist in Machine Tool installation, usage and maintenance instruction creation, instruction change control and problem solving.

Performed prior to the release of the manufacturing process for manufacture of the Machine Tool, the Process FMEA is designed to reduce risk exposure due to improperly manufactured and assembled Machine Tool.   The Process FMEA is also used to assist in Machine Tool manufacturing and assembly instruction creation, instruction change control and problem solving.

For more detailed information on each of these three risk management tools and other risk management tools used in an ISO 9001:2015 compliant risk-based Machine Tool company quality management system please click on the following and read “Risk Based PLM For Tooling and Machinery Design and Manufacturing”.