1.0 Purpose
The purpose of this procedure is to provide a tool that can be used to analyze the process, to help identify potential failure modes, according to the priority order to distinguish the potential failure modes, a clear action plan to eliminate or reduce the possibility of potential failure modes occur, reduce the risk of manufacturing.
2.0 Scope
N/A
3.0 Responsibility
3.1 The Cross-function team: is composed of the department relevant personnel, responsible the implement of FMEA.
3.2 Relevant departments cooperate implementation of FMEA analysis and corrective action.
4.0 Form & Appendix
4.1 FMEA FORM
4.2 FMEA Follow Chart
5.0 Reference
N/A
6.0 Procedure
6.1 When a new product development, product change and raw materials or equipment changes, and so on and so forth, FMEA team should conduct FMEA related activities.
6.2 Collecting information: about brainstorming method is used to collect information. Each member of the FMEA team from the company's various departments and team members from the Angle of their respective departments, providing relevant information. The information collected by the FMEA team cope with sorting as input of the event.
6.3 Information analysis and evaluation: FMEA team according to the difficulty of detection, the consequences severity and frequency to analyze, to evaluate after
finishing the information of various failure modes are calculated respectively under the RPN values. The Risk Priority Number is a mathematical product of the numerical Severity, Probability, and Detection ratings:
RPN = (Severity) x (Probability) x (Detection)
The RPN is used to prioritize items than require additional quality planning or action.
6.4 Determine Recommended Action(s) to address potential failures that have a high RPN. These actions could include specific inspection, testing or quality procedures; selection of different components or material;redesign of the item to avoid the failure mode; monitoring mechanisms; performing preventative maintenance.
6.4 Assign Responsibility and a Target Completion Date for these actions. This makes responsibility clear-cut and facilitates tracking.
6.5 Indicate Actions Taken. After these actions have been taken, re-assess the severity, probability and detection and review the revised RPN's.
6.6 Update the FMEA as the design or process changes, the assessment changes or new information becomes known.
7.0 Application
7.1 Refer to FMEA Form
8.0 Working Steps
8.1 Refer to FMEA Follow Chart
9.0 Acceptance / Reject Criteria
ACTION PRIORITY (Action required)
Action priority will be ranked in order of the all item that RPN score > 100
Once the RPN score > 100 is solved, the FMEA will be revised.