FG00084 V1 Risk Checklist

Therapeutics

Sr. No. IMPACT LIKELIHOOD RISK RATING

1 4 C E YES NO2 2 D L YES NO

2 C M YES NO4 C E YES NO

3 2 D L YES NO4 C E YES NO3 C H YES NO

4 2 D L YES NO4 C E YES NO3 C H YES NO

5 2 C M YES NO4 C E YES NO2 D L YES NO3 C H YES NO

6 2 C M YES NO4 C E YES NO2 D L YES NO3 C H YES NO

7 2 C M YES NO4 C E YES NO2 D L YES NO3 C 0 YES NO

NE00037_3 0 Gamma StabilityNE00037_4 0 Expiry Date

NE00037_1 Mixing Cannula SharpsNE00037_2 0 Compromised Sterility


NE00009_1 23G Needle Terumo SharpsNE00009_2 0 Compromised Sterility


NE00029_1 18G Drawing Up Needle SharpsNE00029_2 0 Compromised Sterility

NE00036_2 0 Compromised SterilityNE00036_3 0 Expiry Date

NE00026_3 0 Expiry DateNE00036_1 30mL Syringe Luer Slip Eccentric Gamma Stability

NE00026_1 10mL Syringe Luer Lock Terumo Gamma StabilityNE00026_2 0 Compromised Sterility

MS00068_1 Suction Tubing High BioburdenMS00103_1 Yankauer Suction Handle, non-sterile Incorrect Specifications

INDIVIDUAL COMPONENTSSPECIFIC

COMPONENT DESCRIPTION HAZARDS IDENTIFIED RISK REDUCTION REQUIRED

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

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

RISK RATING : L=Low, M=Moderate, H = High, E= Extreme

Role of Device (Tick more than one if required) Special Intervention

needed if Failure:NIL

Intended Environment of Use: Hospital/. Theatre Type of Device:

STEP 1

Intended Use of Device: Theatre Dental Intended User e.g. Nurse, professional: Nurse, Medical Practitioner

Medical Device Risk Management ChecklistName of Device or FG

(Finished Good): MR084- DR Reed Dental Pack, HV Private Product Code: FG00084 Date: 16-Jul-08

MS00103_2MS00103_3

0 Gamma Stability0 High Bioburden

Life Supporting Life Sustaining

Diagnosis Monitoring Alleviation of disease Control of Concept.Modification Of anatomyTreatment











FG00084_V1_Risk Checklist of 5 HTD 59 R0 11/06

Therapeutics

Sr. No. IMPACT LIKELIHOOD RISK RATING

8 4 C E YES NO9 4 C E YES NO10 4 C E YES NO

2 C M YES NO3 D M YES NO

11 3 D M YES NO12 2 D L YES NO

3 C H YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO#N/A #N/A #N/A YES NO

#N/A #N/A#N/A #N/A

#N/A #N/A#N/A #N/A

#N/A #N/A#N/A #N/A

#N/A #N/A#N/A #N/A

#N/A #N/A#N/A #N/A

#N/A #N/A#N/A #N/A

LB00061_1 Adhesive content label_10 per Page Incorrect Specs/ LabellingLB00061_2 0 Expiry Date

BG00067_3 0 Incorrect Specs/LabellingLB00005_1 Etigam Dot Incorrect Specs/Labelling

BG00067_1 Peel Pouch 250x500mm High BioburdenBG00067_2 0 Gamma Stability

GZ00008_1 X-Ray Gauze High BioburdenGZ00013_1 X-Ray Gauze with Tail High Bioburden

INDIVIDUAL COMPONENTSSPECIFIC

COMPONENT DESCRIPTION HAZARDS IDENTIFIED RISK REDUCTION REQUIRED

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

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

RISK RATING : L=Low, M=Moderate, H = High, E= Extreme


Therapeutics

1 Chemical Hazard2 Compromised Sterility

3 Expiry Date

4 Gamma stability

5 Gamma Validation6 High Bioburden

7 Improper sealing8 Incorrect Specs/Labelling9 Mechanical breakage10 Sharps11 Storage requirement12131415

1 YES NO2 YES NO3 YES NO4 YES NO5 YES NO6 YES NO7 YES NO8 YES NO9 YES NO

10 YES NO11 YES NO12 YES NO13 YES NO14 YES NO15 YES NO #N/A

#N/A#N/A#N/A#N/A#N/A#N/A#N/A

Quality Checks M YES NOHeat seal testing L YES NO

Gamma Validation M YES NOGamma stability testing L YES NO

Expiry date check L YES NOConfirming Specs/Labelling L YES NO

Is Further Risk Reduction Needed, Possible Or Impractical?

Bioburden testing of FG M YES NO

Risk Control Measures Implemented?

Are the control measures effective and were implemented effectively?

Risk Rating AFTER Risk Control Measures Implemented

Is Residual Risk within Acceptable

Limits?

#N/A #N/A

STEP 3 RISK RATING : L=Low, M=Moderate, H = High, E= Extreme RESIDUAL RISK ACCEPTANCE GUIDELINE: L & M = ACCEPTABLE; H & E = UNACCEPTABLE

#N/A #N/A#N/A #N/A

N/A N/A#N/A #N/A

N/A N/AN/A N/A

Validated sealing machine & daily dye testingSealer Validation report; In-process Insp. check sheet for every production

batch Checking each item when received and before packaging

g yNon-conforming product + HT12: Purchasing

Gamma dose validation and regular dose audits Gamma Validation & Dose audit reportsFinished goods Bioburden analysis; Under 4500 cfu/component Bioburden testing report for individual batches as per WI 13

Checking each item when received and before packagingWI 6: Incoming Goods Inspection + WI 8: Quality Checks + Expiry date claim

report

Testing stability at 30 & 60 kGy Gamma irradiation Gamma stability testing report

N/A N/AChecking each item when received and before packaging WI 6: Incoming Goods Inspection & WI 8: Quality Checks

STEP 2

COMPLETE KIT / MEDICAL DEVICE (FG)

HAZARDS IDENTIFIED RISK CONTROL OPTIONS SUPPORTING EVIDENCE ATTACHED OR REFERENCED


Therapeutics

1234567

1 Does the Medical Benefit Outweigh the Residual Risk? YES NO

2 Is Supporting Evidence Attached? YES NO

1 Are further hazards Identified? YES NO

2 If YES, recomplete Steps 2 to 4.

3 Do the Overall Benefits outweigh the Remaining Residual Risk? YES NO

DEVICE ACCEPTED DEVICE UNACCEPTED

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

POSITION: QA MANAGERNAME: DEEPAK SHAH

STEP 5

STEP 6

APPROVED BY (SIGN): DATE: 16-Jul-08

STEP 5 TO BE COMPLETED ONLY IF FURTHER RISK REDUCTION IS IMPRACTICAL

STEP 4 TO BE COMPLETED ONLY IF FURTHER RISK REDUCTION IS REQUIRED. IF NOT, MOVE TO STEP 6

STEP 4

Remaining Risks / Hazards Identified REVISED RISK CONTROL OPTIONS SUPPORTING EVIDENCE ATTACHED OR

REFERRED


Therapeutics

REPORT DATE

CODENAME

YES NO YES NO

YES NO

1 6

2 7

3 8

4 9

5 10

YES NO YES NO YES NO

YES NO

E YES NOFG

POSITION: QA MANAGER Not to be used without Authorisation

SCHEDULED REVIEW DATE FOR THE RISK MANAGEMENT PLAN FOR THE DEVICE Jul-09 This worksheet is IP of HWNS, Hunter Region

Prepared By Dr. Deepak ShahDATE: 16-Jul-08

H FINAL REPORT COMPLETED BY:

SIGN:

NAME: DEEPAK SHAH

IS DEVICE APPROVED FOR MANUFACTURE?SCHEDULED REVIEW DATE FOR THE DEVICE Jul-09

DOCUMENTED

BEVIDENCE OF RISK

ANALYSIS AND EVALUATION ATTACHED

DIF C = YES, ARE

CONTROL MEASURES EFFECTIVE?

ADD COMMENTS BELOW IF REQUIRED

C STATUS OF ALL RISK CONTROL MEASURES

IDENTIFIED ACTIONED

WI 6: Incoming Goods Inspection & WI 8: Quality Checks Sealer Validation report; In-process Insp. check sheet for every production batch

N/A

Gamma Validation & Dose audit reports N/A

WI 6: Incoming Goods Inspection + WI 8: Quality Checks + Expiry date claim report

WI 6: Incoming Goods Inspection & WI 8: Quality Checks + HT4: Control of Non-conforming product + HT12: Purchasing

Gamma stability testing report

A STATUS OF ALL HAZARDSIDENTIFIED ACTIONED

DETAILS OF ATTACHMENTS

N/A Bioburden testing report for individual batches as per WI 13

DEVICE DETAILS 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.FG00084

MR084- DR Reed Dental Pack, HV Private

FINAL REPORT16-Jul-08 REPORT VERSION V1


FG00084 V1 Risk Checklist

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