Therapeutics

Medical Device Risk Management Checklist

Name of Device or FG (Finished Good): MR084- DR Reed Dental Pack, HV Private Product Code: STEP 1 Intended Use of Device: Intended Environment of Use: Theatre Dental Hospital/. Theatre Intended User e.g. Nurse, professional: Type of Device: Nurse, Medical Practitioner
Life Supporting Life Sustaining

FG00084

Date:

16-Jul-08

Role of Device (Tick more than one if required)

Diagnosis Monitoring Alleviation of disease Treatment Modification Of anatomy Control of Concept.

Special Intervention needed if Failure:

NIL

KEY IMPACT: 1= Insignificant, 2 = Minor, 3 = Moderate, 4 LIKELIHOOD: = Major, 5 = Catastrophic

SPECIFIC COMPONENT MS00068_1 MS00103_1 MS00103_2 MS00103_3 NE00026_1 NE00026_2 NE00026_3 NE00036_1 NE00036_2 NE00036_3 NE00029_1 NE00029_2 NE00029_3 NE00029_4 NE00009_1 NE00009_2 NE00009_3 NE00009_4 NE00037_1 NE00037_2 NE00037_3 NE00037_4

A= Almost Certain, B= Likely, C=Moderate, D = Unlikely, E = Rare

RISK RATING :

L=Low, M=Moderate, H = High, E= Extreme

RISK RATING E L M E L E H L E H M E L H M E L H M E L 0 RISK REDUCTION REQUIRED YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO

INDIVIDUAL COMPONENTS
Sr. No. 1 2 DESCRIPTION Suction Tubing Yankauer Suction Handle, non-sterile 0 0 10mL Syringe Luer Lock Terumo 0 0 30mL Syringe Luer Slip Eccentric 0 0 18G Drawing Up Needle 0 0 0 23G Needle Terumo 0 0 0 Mixing Cannula 0 0 0 HAZARDS IDENTIFIED High Bioburden Incorrect Specifications Gamma Stability High Bioburden Gamma Stability Compromised Sterility Expiry Date Gamma Stability Compromised Sterility Expiry Date Sharps Compromised Sterility Gamma Stability Expiry Date Sharps Compromised Sterility Gamma Stability Expiry Date Sharps Compromised Sterility Gamma Stability Expiry Date IMPACT 4 2 2 4 2 4 3 2 4 3 2 4 2 3 2 4 2 3 2 4 2 3 LIKELIHOOD C D C C D C C D C C C C D C C C D C C C D C

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KEY

IMPACT: 1= Insignificant, 2 = Minor, 3 = Moderate, 4 LIKELIHOOD: = Major, 5 = Catastrophic

SPECIFIC COMPONENT GZ00008_1 GZ00013_1 BG00067_1 BG00067_2 BG00067_3 LB00005_1 LB00061_1 LB00061_2

A= Almost Certain, B= Likely, C=Moderate, D = Unlikely, E = Rare

RISK RATING :

L=Low, M=Moderate, H = High, E= Extreme

RISK RATING E E E M M M L H #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A RISK REDUCTION REQUIRED YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO

INDIVIDUAL COMPONENTS
Sr. No. 8 9 10 DESCRIPTION X-Ray Gauze X-Ray Gauze with Tail Peel Pouch 250x500mm 0 0 Etigam Dot Adhesive content label_10 per Page 0 #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A HAZARDS IDENTIFIED High Bioburden High Bioburden High Bioburden Gamma Stability Incorrect Specs/Labelling Incorrect Specs/Labelling Incorrect Specs/ Labelling Expiry Date #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A IMPACT 4 4 4 2 3 3 2 3 #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A LIKELIHOOD C C C C D D D C #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A

11 12

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STEP 2

COMPLETE KIT / MEDICAL DEVICE (FG)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 HAZARDS IDENTIFIED Chemical Hazard Compromised Sterility Expiry Date Gamma stability Gamma Validation High Bioburden Improper sealing Incorrect Specs/Labelling Mechanical breakage Sharps Storage requirement RISK CONTROL OPTIONS N/A Checking each item when received and before packaging Checking each item when received and before packaging Testing stability at 30 & 60 kGy Gamma irradiation Gamma dose validation and regular dose audits Finished goods Bioburden analysis; Under 4500 cfu/component Validated sealing machine & daily dye testing Checking each item when received and before packaging N/A N/A N/A #N/A #N/A #N/A #N/A

SUPPORTING EVIDENCE ATTACHED OR REFERENCED

N/A WI 6: Incoming Goods Inspection & WI 8: Quality Checks WI 6: Incoming Goods Inspection + WI 8: Quality Checks + Expiry date claim report Gamma stability testing report Gamma Validation & Dose audit reports Bioburden testing report for individual batches as per WI 13 Sealer Validation report; In-process Insp. check sheet for every production batch g y Non-conforming product + HT12: Purchasing N/A N/A N/A #N/A #N/A #N/A #N/A

STEP 3 Risk Control Measures Implemented? Bioburden testing of FG

Confirming Specs/Labelling Expiry date check Gamma stability testing Gamma Validation Heat seal testing Quality Checks

RISK RATING :

L=Low, M=Moderate, H = High, E= Extreme

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Are the control measures effective and were implemented effectively? YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO

Risk Rating AFTER Risk Control Measures Implemented

RESIDUAL RISK ACCEPTANCE GUIDELINE: L & M = ACCEPTABLE; H & E = UNACCEPTABLE Is Residual Risk Is Further Risk Reduction Needed, within Acceptable Possible Or Impractical? Limits?
YES YES YES YES YES YES YES NO NO NO NO NO NO NO

M L L L M L M #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A

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STEP 4 TO BE COMPLETED ONLY IF FURTHER RISK REDUCTION IS REQUIRED. IF NOT, MOVE TO STEP 6 STEP 4 Remaining Risks / Hazards Identified
1 2 3 4 5 6 7 REVISED RISK CONTROL OPTIONS

SUPPORTING EVIDENCE ATTACHED OR REFERRED

STEP 5 TO BE COMPLETED ONLY IF FURTHER RISK REDUCTION IS IMPRACTICAL STEP 5 1 2 Does the Medical Benefit Outweigh the Residual Risk? Is Supporting Evidence Attached? YES YES STEP 6 1 2 3 Are further hazards Identified? If YES, recomplete Steps 2 to 4. Do the Overall Benefits outweigh the Remaining Residual Risk? YES NO YES NO NO NO

DEVICE ACCEPTED
APPROVED BY (SIGN): NAME: DEEPAK SHAH DATE: POSITION:

DEVICE UNACCEPTED
16-Jul-08 QA MANAGER

COMPLETE RISK MANAGEMENT REPORT AND ATTACH ALL CORROSPONDING DOCUMENTATION IF REQUIRED. TO BE FILED IN RISK MANAGEMENT FOLDER

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FINAL REPORT
REPORT DATE CODE NAME 16-Jul-08 DEVICE DETAILS FG00084 MR084- DR Reed Dental Pack, HV Private IDENTIFIED YES YES
1 N/A WI 6: Incoming Goods Inspection & WI 8: Quality Checks WI 6: Incoming Goods Inspection + WI 8: Quality Checks + Expiry date claim report Gamma stability testing report Gamma Validation & Dose audit reports

REPORT VERSION

V1

Note: Report version shall be labelled sequentially as V0, V1 etc. upon revision. Older versions to be archived as "SUPERSEDED" till 7 years after Report date. ACTIONED YES NO DETAILS OF ATTACHMENTS
6 7 8 9 10 Bioburden testing report for individual batches as per WI 13 Sealer Validation report; In-process Insp. check sheet for every production batch WI 6: Incoming Goods Inspection & WI 8: Quality Checks + HT4: Control of Non-conforming product + HT12: Purchasing N/A N/A

STATUS OF ALL HAZARDS

NO

NO

EVIDENCE OF RISK ANALYSIS AND EVALUATION ATTACHED

2 3 4 5

STATUS OF ALL RISK CONTROL MEASURES IF C = YES, ARE CONTROL MEASURES EFFECTIVE? YES

IDENTIFIED YES NO NO

ACTIONED YES NO

DOCUMENTED YES NO

ADD COMMENTS BELOW IF REQUIRED

E F G H

IS DEVICE APPROVED FOR MANUFACTURE? SCHEDULED REVIEW DATE FOR THE DEVICE SCHEDULED REVIEW DATE FOR THE RISK MANAGEMENT PLAN FOR THE DEVICE SIGN: NAME: DEEPAK SHAH DATE: POSITION:

YES Jul-09 Jul-09 16-Jul-08

NO
This worksheet is IP of HWNS, Hunter Region

FINAL REPORT COMPLETED BY:

Prepared By Dr. Deepak Shah

Not to be used without Authorisation

QA MANAGER

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