SPEAK TO THE PROBLEMS 2.4: Spotting Problems

(SHORT NOTES FROM PROBLEM SOLVING SKILLS:

General Problem-Solving Tools at http://www.mindtools.com; http://asq.org/learn-about-quality )

FMEA was originally known as Failure Mode, Effects, and Criticality Analysis (FMECA), and was first published in 1949 by the U.S. Department of Defence.  FMEA is a widely-used tool for quality control.  It builds on tools like:

o   Risk Analysis

o   Cause and Effect

FMEA is a step-by-step approach for identifying all possible failures in:

o   a design,

o   a manufacturing or assembly process, or

o   a product or service.

“Failure modes” means the ways, or modes, in which something might fail.   “Effects analysis” refers to studying the consequences of those failures.   Failures are prioritized according to:

o   how serious their consequences are,

o   how frequently they occur and

o   how easily they can be detected

The purpose of the FMEA is to

1.    take actions to eliminate or reduce failures, starting with the highest-priority ones

2.    documents current knowledge and actions about the risks of failures, for use in continuous improvement

3.    be used during design to prevent failures

4.    be used for control, before and during ongoing operation of the process

When to Use FMEA

·         When a process, product or service is being designed or redesigned, after quality function deployment.

·         When an existing process, product or service is being applied in a new way.

·         Before developing control plans for a new or modified process.

·         When improvement goals are planned for an existing process, product or service.

·         When analyzing failures of an existing process, product or service.

·         Periodically throughout the life of the process, product or service

 

How to use FMEA

1.    Assemble a cross-functional team of people with diverse knowledge about the process, product or service and customer needs.  Functions usually includes design, manufacturing, quality, testing, reliability, maintenance, purchasing (and suppliers), sales, marketing (and customers) and customer service.

2.    Identify

1.    the scope of the FMEA (Is it for concept, system, design, process or service?)

2.    the boundaries? How detailed should we be?

3.    Make sure every team member understands the scope and boundaries in detail.

4.    Identify the functions of the scope:

1.    the purpose of this system, design, process or service

2.    customers’ expectation

5.    Break the scope into separate subsystems, items, parts, assemblies or process steps and identify the function of each.

6.    Identify potential failure modes for each function.

7.    If necessary, rewrite the function with more detail to be sure the failure modes show a loss of that function.

8.    For each failure mode, identify all the consequences on the system, related systems, process, related processes, product, service, customer or regulations.

9.    Determine the seriousness of each effect.

10. Determine all the potential root causes for each failure mode.

11. List all possible causes for each failure mode.

12. Determine the occurrence rating for each cause.

13. Identify current process controls for each cause.

14. Determine the detection rating for each control.

15. Identify measurements or indicators of critical characteristics that reflect safety or compliance with government regulations and need special controls.

16. Calculate the risk priority number.

17. Identify recommended actions.

18. Note results and the date on the FMEA form.