Failure and Effect Mode Analysis

System Product
Process Team: INITIAL ANALYSIS C l a s s O c c u r D e t e c TAKEN ACTIONS RESULTS Product: CATGUT C FEMA number AMEF-CATGUT-01/2009 Elab. Date March 18, 2009 No. of Revision 0

Stage / Part of the Product

Function

Failure Potential Mode

Failure Potential Effect

S e v

Potential Cause(s) Potential/ Failure Mechanisms(s)

Current Controls (Detection)

R P N

Recommended Actions

Implementing Date and Reponsible

Taken Actions

S e v

O c c

D e t

R P N

SEROUS

SEROUS ACQUISITION

BSE CONTAMINATION

HUMAN INFECTION

10

CONTAMINATED COUNTRY OF ORIGIN CONTAMINATION WITH VERTEBRAS AND BOVINE SKULL

IMPORT WITH FREE COUNTRY BSE CERTIFICATE

10

300

INACTIVATION VALIDATION PROCESS ACQUISITION OF GELATIN BASED ON HIDE

GELATIN

GELATIN ACQUISITION

BSE CONTAMINATION

HUMAN INFECTION

NONE

10

240

Mar 31, 09

PRESERVATION

SEROUS WAREHOUSING

PUTREFACTION

INFECTION/TENSI ON DECREASE

PRESERVATION PROBLEMS

ACQUISITION OF SALTY SEROUS AND REFRIGERATOR WAREHOUSING WASHING WITH HOT WATER AND RINSING WITH CONCENTRATED DETERGENT Ph MEASUREMENT, TEMPERATURE AND PROCESSING TIME Ph MEASUREMENT, TEMPERATURE AND PROCESSING TIME CONTINUOUS CLEANING AND DISINFECTION PROCESS CONTROL BY COMPUTER

12

DESALTING

SALT EXTRACTION AND OBTAINING OF FLACCID STRIPS EXTRACTION OF ADHERED FAT AND VIRUS INACTIVATION

CONTAMINATION WITH FOREIGN SUBSTANCES

PROBLEMS WITH EXTRACTION OR CHROME

FAILURE IN DESALTING

EXTRACTION

FAT EXCESS

MATERIAL REJECTION

FAILURE IN H2O2 AND NAOH CONCENTRATION MEDIA ACIDITY FAILURE AND PROCESSING TIME DIRTY TABLES OR TWEEZERS NODULES FORMATION BY QUICK DEHYDRATION TOO CLOSED STONES

72

CHROME

COLOR AND SLIGHT COLOR INCREASE THREAD AND LOW THREAD STRENGTH STRENGTH THREADS PREPARATION FOR TWISTING CATGUT DEHYDRATION CONTAMINATION WITH FUNGUS AND BACTERIA STRENGTH REDUCTION

MATERIAL REJECTION

126

BUNDLING

MATERIAL REJECTION

144

ENVIRONMENTAL MONITORING

Mar 30 , 09

DRYING

MATERIAL REJECTION

12

POLISHING

THREAD POLISHING

LOW DIAMETER CONTAMINATION WITH FUNGUS AND BACTERIA

MATERIAL REJECTION MATERIAL REJECTION

PROCESS DIAMETER MEASUREMENT CONTINUOUS CLEANING AND DISINFECTION

12

FINAL INSPECTION

FP INSPECTON

DIRTY TABLES

144

ENVIRONMENTAL MONITORING

Mar 31st, 09