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

3

4

5

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7

FG00084_V1_Risk Checklist

Page 1 of 5

HTD 59 R0 11/06

4 LIKELIHOOD: = Major. D = Unlikely. 5 = Catastrophic SPECIFIC COMPONENT GZ00008_1 GZ00013_1 BG00067_1 BG00067_2 BG00067_3 LB00005_1 LB00061_1 LB00061_2 A= Almost Certain. No. E = Rare RISK RATING : L=Low. 3 = Moderate. 2 = Minor. 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 FG00084_V1_Risk Checklist Page 2 of 5 HTD 59 R0 11/06 . 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. C=Moderate.Therapeutics KEY IMPACT: 1= Insignificant. H = High. B= Likely. M=Moderate.

H = High. 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. 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 & E = UNACCEPTABLE Is Residual Risk Is Further Risk Reduction Needed. 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. 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 FG00084_V1_Risk Checklist Page 3 of 5 HTD 59 R0 11/06 . In-process Insp.Therapeutics 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.

TO BE FILED IN RISK MANAGEMENT FOLDER FG00084_V1_Risk Checklist Page 4 of 5 HTD 59 R0 11/06 . 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. 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.Therapeutics STEP 4 TO BE COMPLETED ONLY IF FURTHER RISK REDUCTION IS REQUIRED. recomplete Steps 2 to 4.

upon revision. V1 etc. Deepak Shah Not to be used without Authorisation QA MANAGER FG00084_V1_Risk Checklist Page 5 of 5 HTD 59 R0 11/06 . 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 A STATUS OF ALL HAZARDS NO NO B EVIDENCE OF RISK ANALYSIS AND EVALUATION ATTACHED 2 3 4 5 C STATUS OF ALL RISK CONTROL MEASURES IF C = YES. ACTIONED YES NO DETAILS OF ATTACHMENTS 6 7 8 9 10 Bioburden testing report for individual batches as per WI 13 Sealer Validation report. Older versions to be archived as "SUPERSEDED" till 7 years after Report date. 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.DR Reed Dental Pack. In-process Insp. Hunter Region FINAL REPORT COMPLETED BY: Prepared By Dr. ARE CONTROL MEASURES EFFECTIVE? YES IDENTIFIED YES NO NO ACTIONED YES NO DOCUMENTED YES NO ADD COMMENTS BELOW IF REQUIRED D 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.Therapeutics FINAL REPORT REPORT DATE CODE NAME 16-Jul-08 DEVICE DETAILS FG00084 MR084.

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