What is 'output of risk management' in ISO 13485, Cl 7.3.2(e).?

#1
hi every one
My question is what is the output of risk management output in the ISO 13485 :7.3.2.

7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs
shall include
a) functional, performance and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management (see 7.1).
These inputs shall be reviewed for adequacy and approved.
Requirements shall be complete, unambiguous and not in conflict with each other.
 
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H

HighRisk

#2
I recommend doing the risk analysis in two stages. In the first stage, you do a hazard analysis to identify key hazards and develop mitigation strategies. If the mitigation strategy includes a specific design feature, such as a safety mechanism, then this would become part of design input, e.g., in PRD or design requirements document. You can do a more detailed risk analysis (e.g., FMEA) once you have a basic design.

Another instance when output from risk management is improtant is if you are modifying or developing a next generation product. In this case, you need to consider previously identified high-risk issues and also results of production and post-production montioring in establishing design requirements.
 

somashekar

Staff member
Super Moderator
#4
hi every one
My question is what is the output of risk management output in the ISO 13485 :7.3.2.

7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs
shall include
a) functional, performance and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management (see 7.1).
These inputs shall be reviewed for adequacy and approved.
Requirements shall be complete, unambiguous and not in conflict with each other.
Broadly the outputs are "Controls established" and "Residual risks" .....
 
A

arios

#5
The previous to last step of the flowchart in Figure 1 and B.1 of the standard refer to the Risk Management Report. It is meant to be ready prior to putting a product into market and hence before to gaining the post production information. I therefore consider thet the RM Report the "output" which also includes what Somashekar has mentioned.

Here is a script from the ISO 14971 std:

"Risk management report
Prior to release for commercial distribution of the medical device, the manufacturer shall carry out a review of the risk management process. This review shall at least ensure that:
  • the risk management plan has been appropriately implemented;
  • the overall residual risk is acceptable;
  • appropriate methods are in place to obtain relevant production and post-production information."
:read:
 
D

ddunn

#6
Not sure of the requirements of ISO 13485 but the Risk evaluation outputs use are:
1. Impact: Effect of the Project/Product
2. Probability: How likely is the Risk
3. Risk Trigger [symptom/warning sign]: Indication that a risk has occurred
4. Best Case Scenario: What is the least impact if the risk occurs
5. Worse Case Scenario: What is the greatest impact is the risk occurs
6. Containment Description: What can be done to avoid the risk
7. Mitigation Description: What will be done if the risk occurs
 
B

brandomenon

#7
An example of an output from risk management that was presented to me (when I had the same question):

Risk analysis revealed that the prototype device had a tendency to turn on accidentally. The solution was suggested that a power-on safety mechanism should be used. The design input was that the device had to have a safety switch that prevented unintentional start-up of the device. It was verified that the final device had a safety switch, and validation tests confirmed that the safety switch worked as intended.
 

Ajit Basrur

Staff member
Admin
#8
The intent of this point is to -

Has the Manufacturer determined the design and development inputs related
to the regulatory safety and effectiveness requirements?

Refer to the attachment by Health Canada - GD210: ISO 13485:2003 Quality Management System Audits Performed by Health Canada Recognized Registrars, Page 36 / 56 or Page 27 in the document.
 

Attachments

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