NAME OF THE MANUFACTURER: - ABC
RISK ANALYSIS REPORT
(RELEVANT STANDARD – ISO 14971)
PRODUCT: - STERILE SINGLE USE INTRA VENOUS CANNULA
BRAND: -
PERFORMED BY: -
REVIEWED BY: -
APPROVED BY: -
RISK ASSESSMENT
RISK LEVEL
1. Nil
2. Very low (Negligible)
3. Low
4. High
DEGREE OF ACCEPTABILITY
Level 1 - Acceptable with monitoring to maintain.
Level 2 - Acceptable with monitoring & scope for improvements.
Level 3 & 4 – Not acceptable.
RISK ANALYSIS REPORT
PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA PRODUCT FAMILY:
|
Potential Hazard |
Description of specific hazards which may arise |
Initial Risk Estimate |
Mitigation Steps |
Residuals risk After Mitigation |
Comments, Test reports or References |
|
|
|
1 |
2 |
3 |
4 |
Risk Status |
|
1 |
2 |
3 |
4 |
Risk Status |
|
|
1. Integrity of connection
a. Hub and introducer needle
b. Wing and catheter
c. Filter and Luer lock cap
d. Blood stopper / Luer lock cap and hub. |
1. Separation from mating components during use.
2. Leakage
|
|
|
|
√ |
Not acceptable |
1.Design of the components
2. Process control
3. Product verification |
|
√ |
|
|
Acceptable |
Technical specification
Doc. #
Product measurement procedure Doc. #
|
|
2.Incompatibility |
1. Reaction with medicaments
2. Reaction with subject
|
|
|
|
√ |
Not acceptable |
1. Material selection
2. Material evaluation before use
3. Certification by the material manufacturer |
√ |
|
|
|
Acceptable |
Material specification
Material evaluation procedure
Doc. #
|
Risk Level: - 1. Nil 2. Very Low (Negligible) 3. Low 4. High
RISK ANALYSIS REPORT
PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA PRODUCT FAMILY:
|
Potential Hazard |
Description of specific hazards which may arise |
Initial Risk Estimate |
Mitigation Steps |
Residuals risk After Mitigation |
Comments, Test reports or References |
|
|
|
1 |
2 |
3 |
4 |
Risk Status |
|
1 |
2 |
3 |
4 |
Risk Status |
|
|
3. Blockage |
- No flow of blood in the needle at the time of veni puncture & failure to acertain access. |
|
|
|
√ |
Not acceptable |
1. In built system on assembly machine to detect blockage
2. Control & monitoring of silicon solution concentration
3. Product verification |
|
√ |
|
|
|
- Process validation reports
- Product measurement procedure Doc. #
|
|
4. Corrosion of needle tube |
Infection / Reaction
|
|
|
|
√ |
Not acceptable |
1. Material selection
2. Testing
3. Storage instructions |
|
√ |
|
|
Acceptable
|
- Material specification
- Material test procedure Doc. #
- Storage instruction on the shelf pack |
Risk Level: - 1. Nil 2. Very Low (Negligible) 3. Low 4. High
RISK ANALYSIS REPORT
PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA PRODUCT FAMILY:
|
Potential Hazard |
Description of specific hazards which may arise |
Initial Risk Estimate |
Mitigation Steps |
Residuals risk After Mitigation |
Comments, Test reports or References |
|
|
|
1 |
2 |
3 |
4 |
Risk Status |
|
1 |
2 |
3 |
4 |
Risk Status |
|
|
5. Catheter tip formation
a. Wall thickness
b. Tip not smooth
c. Overlapping of bevel by catheter |
1. Peel back effect
2. Thrombophlebitis
|
|
|
|
√ |
Not acceptable |
1. Tip design
Specification
2. Process control
3. Inspection |
|
√ |
|
|
Acceptable
|
- Related design drawing
- Process measurement procedure Doc. #
- Product measurement procedure Doc. #
ISO 10555 - 5 |
|
6. Valve fitment of injection port
|
Leakage |
|
|
|
√ |
Not acceptable |
1. Design of valve & port
2. Process control
3. Inspection |
|
√ |
|
|
Acceptable |
- Related design drawing
- Process measurement procedure Doc. #
- Product measurement procedure Doc. #
|
Risk Level: - 1. Nil 2. Very Low (Negligible) 3. Low 4. High
RISK ANALYSIS REPORT
PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA PRODUCT FAMILY:
|
Potential Hazard |
Description of specific hazards which may arise |
Initial Risk Estimate |
Mitigation Steps |
Residuals risk After Mitigation |
Comments, Test reports or References |
|
|
|
1 |
2 |
3 |
4 |
Risk Status |
|
1 |
2 |
3 |
4 |
Risk Status |
|
|
7. Components damaged
|
Not usable |
|
|
|
√ |
Not acceptable |
1. Component & process design
2. Process control
3. Inspection
4. Material handling |
|
√ |
|
|
Acceptable |
- Related design drawing
- Process measurement procedure Doc. #
- Product measurement procedure Doc. #
- Material handling procedure |
|
8. Manufacturing environment & personal hygiene |
Product contamination |
|
|
|
√ |
Not acceptable |
1. Design of manufacturing area
2. Validation of clean room
3. Routine maintenance & monitoring of clean room
4. Personal hygiene procedure
5. Monitoring of product bioburden |
|
√ |
|
|
Acceptable
|
- Clean room validation procedure Doc. #
- Clean room entry procedure Doc. #
- Clean room cleaning procedure Doc. #
- Personal hygiene procedure Doc. #
- Bioburden test procedure
Doc. # |
Risk Level: - 1. Nil 2. Very Low (Negligible) 3. Low 4. High
RISK ANALYSIS REPORT
PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA PRODUCT FAMILY:
|
Potential Hazard |
Description of specific hazards which may arise |
Initial Risk Estimate |
Mitigation Steps |
Residuals risk After Mitigation |
Comments, Test reports or References |
|
|
|
1 |
2 |
3 |
4 |
Risk Status |
|
1 |
2 |
3 |
4 |
Risk Status |
|
|
9. Integrity of unit pack
|
Product rendered unsterile / contaminated
|
|
|
|
√ |
Not acceptable
|
1. Selection of packing material
2. Process validation
3. Product testing |
√ |
|
|
|
Acceptable |
- Packing material (EN 868)
- Process validated as per Doc #
- Product tested as per Doc #
|
|
10. Toxicity |
Toxicity |
|
|
|
√ |
Not acceptable |
1. Material selection
2. Material testing prior to use
3. Testing of finished product |
√ |
|
|
|
Acceptable
|
Related material specification
Material test procedure Doc. # |
Risk Level: - 1. Nil 2. Very Low (Negligible) 3. Low 4. High
RISK ANALYSIS REPORT
PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA PRODUCT FAMILY:
|
Potential Hazard |
Description of specific hazards which may arise |
Initial Risk Estimate |
Mitigation Steps |
Residuals risk After Mitigation |
Comments, Test reports or References |
|
|
|
1 |
2 |
3 |
4 |
Risk Status |
|
1 |
2 |
3 |
4 |
Risk Status |
|
|
11. Bio burden / Pre packing contamination
|
Pyrogenicity
|
|
|
|
√ |
Not acceptable
|
1. Process control
2. Testing |
√ |
|
|
|
Acceptable |
- Process control procedure
- Environment control & monitoring procedure Doc. #
- Pyrogenicity test procedure Doc. #
|
|
12. Sterilization process failure |
Unsterile product |
|
|
|
√ |
Not acceptable |
1. Sterilization process validation
2. Sterilization process monitoring
3. Sterility testing |
√ |
|
|
|
Acceptable |
- ISO 11135 -1: Requirements for development, validation and routine control of a sterilization process for medical devices
-Sterilization process validation protocol Doc. #
- Related process specification Doc. #
- Sterility test procedure Doc. #
|
Risk Level: - 1. Nil 2. Very Low (Negligible) 3. Low 4. High
RISK ANALYSIS REPORT
PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA PRODUCT FAMILY:
|
Potential Hazard |
Description of specific hazards which may arise |
Initial Risk Estimate |
Mitigation Steps |
Residuals risk After Mitigation |
Comments, Test reports or References |
|
|
|
1 |
2 |
3 |
4 |
Risk Status |
|
1 |
2 |
3 |
4 |
Risk Status |
|
|
13. MIXING OF DEFECTIVE MATERIAL WITH ACCEPTED MATERIAL |
- Defective material reaches to user
- Injury or loss |
|
|
|
√ |
Not acceptable |
1. Product identification & segregation
2. Disposition of non-conformed material
3. Verification |
|
√ |
|
|
Acceptable |
- Inspection & test status doc. #
- Control of non-conforming material doc. # |
|
14. Ethylene oxide residuals |
Toxic effects on the subject |
|
|
|
√ |
Not acceptable |
1. Sterilization cycle validation
2. Quarantine period
3. E.O. residuals tests
|
√ |
|
|
|
Acceptable |
- ISO 11135 -1: Requirements for development, validation and routine control of a sterilization process for medical devices validation process Doc. #
- E.O. residuals test procedure |
|
15. Incompatibility with the device used in combination |
1. Loose connection
2. Leakage
|
|
|
|
√ |
Not acceptable |
1. Standard Luer taper as per ISO 594-1
2. Verification of luer taper
3. Study with
combination
device |
√ |
|
|
|
Acceptable |
- ISO 594-1
- Compatibility study reports
|
Risk Level: - 1. Nil 2. Very Low (Negligible) 3. Low 4. High
RISK ANALYSIS REPORT
PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA PRODUCT FAMILY:
|
Potential Hazard |
Description of specific hazards which may arise |
Initial Risk Estimate |
Mitigation Steps |
Residuals risk After Mitigation |
Comments, Test reports or References |
|
|
|
1 |
2 |
3 |
4 |
Risk Status |
|
1 |
2 |
3 |
4 |
Risk Status |
|
|
16. Improper product handling & storage
|
Packing and product damage / deterioration |
|
|
√ |
|
Not acceptable |
1. Packaging design
2. Material handling & storage procedure
3. Material handling & storage instructions |
|
√ |
|
|
Acceptable |
Material preservation procedure Doc. # |
|
17. Improper use of device |
- Local infection
- Vein cross perforation
- Peel back effect |
|
|
√ |
|
Not acceptable |
1. Product design
2. Instruction for use |
|
√ |
|
|
Acceptable |
- Product design & development procedure Doc. #
- Instruction for use
|
Risk Level: - 1. Nil 2. Very Low (Negligible) 3. Low 4. High
UPDATED ON:
