Scribd
Upload
548 views1 page

FMEA Example for Acupuncture Needles

The document describes a failure mode and effects analysis for acupuncture needle sterilization. It outlines the process steps of inspecting needles, loading them into autoclave bags, loading the autoclave, running the sterilization program, and unloading and packaging the autoclaved needles. Potential failures include defective needles being missed during inspection, loads not being balanced in the autoclave, and incomplete sterilization due to operator error or equipment issues. Controls and corrective actions are suggested such as training, load diagrams, equipment validation, and quality testing.

Uploaded by

David Sigalingging
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
548 views1 page

FMEA Example for Acupuncture Needles

The document describes a failure mode and effects analysis for acupuncture needle sterilization. It outlines the process steps of inspecting needles, loading them into autoclave bags, loading the autoclave, running the sterilization program, and unloading and packaging the autoclaved needles. Potential failures include defective needles being missed during inspection, loads not being balanced in the autoclave, and incomplete sterilization due to operator error or equipment issues. Controls and corrective actions are suggested such as training, load diagrams, equipment validation, and quality testing.

Uploaded by

David Sigalingging
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
  • FMEA Risk Analysis for Acupuncture Needles

Failure Mode and Effects Analysis (FMEA) Risk Analysis Example Acupuncture Needles Flow Charts

Inspect needles Load needles into autoclave bags Load autoclave Run program Unload autoclave Transfer bags to packaging

Process Step

Mode Kegagalan

Akibat Patient injury bruise Patient injury broken needle under skin

Sev 1-3

Penyebab Insufficient sampling plan Operator error (missed defect) Insufficient sampling plan Operator error (missed defect) Insufficient sampling plan

Controls

Prob 1-3

Risk Index

Saran Tindakan

Provide training and visual guidance on inspection techniques

Inspection

Defective needle is missed

Provide training and visual guidance on inspection techniques

Unusable needle

Operator error (missed defect) Document states to distribute load evenly Bioburden QC testing Document provides load/program matrix Bioburden QC testing Document provides load/program matrix Operator Error Visual inspection during packaging/ assembly operation Lot file review includes equipment printout review Bioburden QC testing

Provide training and visual guidance on inspection techniques Add load diagram to document Validate bioburden test method Validate load capacities Validate bioburden test method Validate load capacity

Load is not balanced

Incomplete sterilization

Operator Error

Load autoclave

Unit is overloaded

Incomplete sterilization

Operator Error

Unit is underloaded

Deformed needle housing unusable needle

Incorrect program is selected Run autoclave program

Incomplete sterilization

Fix batch sizes and use a single program Validate bioburden test method

Operator Error

Entire cycle is not run Cycle does not meet max temperature

Incomplete sterilization Incomplete sterilization

Equipment failure Power failure Equipment is out of calibration

Preventive maintenance Connect to emergency generator; allow repeat run

Annual calibration check

Run each cycle with biological indicators

You might also like