Forum

Notifications
Clear all

Risk management methods

33 Posts
33 Users
0 Likes
2,709 Views
(@jp582)
Posts: 51
Trusted Member
Topic starter
 

As Dr. Simon has mentioned in this week video lecture, method to analyze risks and one of the method he talked about is Failure Mode, Effects, and Criticality Analysis (FMECA). FMECA is potentially utilized for failure and risks associated with manufacturing processes. It is used to analyze the probability of failure against the severity of their consequences. I would like to discuss some other methods such as
Quality risk management methods and tools
•Basic Risk Management Facilitation Method- organizing data and facilitating decision making such as flowchart, check sheets, process mapping, and cause and effect diagram.
•Fault Tree Analysis (FTA) - a pathway to evaluate system failures one at a time. It is a function as a diagnostic tool to identify and fully solve the issue so it would not cause other issues later on.
•Hazard Analysis and Critical Control Points (HACCP)-a tool for assuring product quality, reliability, and safety. It applies scientific principles to analyze, evaluate, prevent, and control the risk. It is use to identify and manage risks associated with physical, chemical, and biological hazards.
•Risk Ranking and Filtering- evaluate qualitative and quantitative factors for each risk. The potential use is to prioritize manufacturing sites for inspection/audit by regulators or industry.
•Supporting Statistical Tools- support and facilitate quality risk management. They can enable effective data assessment, aid in determining the significance of the data set, and facilitate more reliable decision making.
What are the other risk management methods?

 
Posted : 14/11/2016 7:27 pm
 cef3
(@cef3)
Posts: 18
Active Member
 

Two other methods are:

Hazard Operability Analysis (HAZOP) - Based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called guide words. Guide words (e.g., No, More, Other Than, Part of) are applied to relevant parameters (e.g., contamination, temperature) to help identify potential deviations from normal use or design intentions. HAZOP often uses a team of people with expertise covering the design of the process or product and its application.

Preliminary Hazard Analysis (PHA) - a tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product, or system. The tool consists of: (1) the identification of the possibilities that the risk event happens, (2) the qualitative evaluation of the extent of possible injury or damage to health that could result, (3) a relative ranking of the hazard using a combination of severity and likelihood of occurrence, and (4) the identification of possible remedial measures

See: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073511.pdf

 
Posted : 15/11/2016 8:20 am
 nda4
(@nda4)
Posts: 19
Active Member
 

Great post. Just to add onto what has been stated.

Risk ranking and filtering is also particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using a single tool. Risk ranking can also be useful for management to evaluate both quantitatively-assessed and qualitatively-assessed risks within the same organizational framework.

http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073511.pdf

 
Posted : 15/11/2016 11:30 am
(@aowalker)
Posts: 15
Active Member
 

Another method: Event Tree Analysis (ETA)
It is an inductive failure analysis performed to determine the consequences of a single failure for the overall system risk or reliability. Event Tree Analysis uses similar logic and mathematics as Fault Tree Analysis, but the approach is different - FTA uses deductive approach (from a system failure to its causes), while ETA uses the inductive approach (from basic failure to its consequences).
An event tree itself is a visual representation of single failure sequences, its influence on other events and on the whole system.

 
Posted : 15/11/2016 12:08 pm
(@vnd4)
Posts: 54
Trusted Member
 

Some other tools that I have seen used in risk management is root cause analysis. This allows us to pinpoint the factor or cause of the failure to help resolve and analyze how to stop it, how to prevent it from occuring, and what to learn from it. There are several methods to this including:
- Pareto Analysis
- Fault Tree Analysis
- Current Reality Tree (CRT)
- Fishbone or Ishikawa or Cause-and-Effect Diagrams
- Kepner-Tregoe Technique
- RPR Problem Diagnosis

 
Posted : 16/11/2016 6:44 am
(@rgp29)
Posts: 53
Trusted Member
 

Another good technique that is used in the Industry is: Failure Mode Effects Analysis (FMEA)

This technique analyses the outcomes of a failing project. First you establish the failure modes, then risk reduction is used in order to increase the possibility of the product's success. So pretty much you delete any failure possibility in the product. This technique let's you summarize what are the most important features of the product, from that point the researchers can cut/add whatever is needed to increment the quality of the product. My uncle works in the computer Engineering Industry and he has mentioned to me that they have used this technique multiple times.

Let me know what you think

-Roberto Pineda.

 
Posted : 16/11/2016 11:39 am
 kdg4
(@kdg4)
Posts: 16
Active Member
 

FMEA does sound interesting Roberto. By being able to make sure you device fails and then fixing those failures could be a way to have a stronger more reliable product. On the flip side, if you are unable to fix those failures that could be a great indication that this project should be on the market. This seems like something could be useful in risk management. This type of modeling could be helpful in a go or no go meeting.

 
Posted : 17/11/2016 10:15 am
 neb2
(@neb2)
Posts: 49
Eminent Member
 

I would like to add that FMEA is subdivided into two types:
1) Design Failure Mode and Effects Analysis (DFMEA): is an application of FMEA especially for product design. It begins at the development stage. It is a procedure used basically in engineering to explore the possibility of a design failing in a real-world situation or use. It is a document which compiles the key functions in a design and analyzes the potential causes of failure modes.It deals with design inadequacies and their effect on manufacturing operations
2) Process Failure Mode and Effects Analysis (PFMEA): addresses the occurrence and the detectability. Meaning that any identified failure mode should be addressed by either improving the process to reduce the chance of occurrence or by having a proper way to detect flawed products before shipping it to the customer. The intention behind the PFMEA process is to make sure that flawed products will not get to the customer.

 
Posted : 19/11/2016 9:33 am
(@hmp42)
Posts: 15
Active Member
 

Good discussion so far! I would like to add more to HACCP-Hazard Analysis Critical Control Point. HACCP process could be divided as following.

• Conduct a Hazard Analysis.
• Identify Critical Control Points.
• Establish the critical limits of the control.
• Monitor your CCPs.
• Corrective Actions.
• Establish record keeping procedures.
• Verify - Ensure the HACCP System is Working as it's Supposed to.

Source: http://blog.etq.com/bid/52835/haccp-for-medical-device-and-pharmaceuticals

-Hetal

 
Posted : 20/11/2016 9:35 am
(@grzegorzgalka)
Posts: 15
Active Member
 

The CAR (corrective action) would be a good method to manage the risks. I had a chance to send few of them to the vendors when they send defected materials to my company. The corrective action gives the other company information that something is incorrect. By fixing their problems the risk that their material will be defective again will decrease. Also it’s good to do vendor evaluation. The vendor evaluation log show which vendors are better in delivering the right material in proper time period. Of course pricing also have to be taken into consideration. The risk of choosing worst vendor is often taken if he can supply the company with materials for lower price.

Thanks

 
Posted : 20/11/2016 5:21 pm
(@ds654)
Posts: 15
Active Member
 

Risk Management Methods start with Risk Screening. Starting from categorizing them from High Impact and High probability, risks are analyzed using a number of methods.

The PDRI(Project Definition Rating Index) is used in front-end project planning to help the project team assess project scope definition, identify risk elements, and subsequently develop mitigation plans. It includes detailed descriptions of issues and a weighted checklist of project scope definition elements to jog the memory of project team participants. It provides the means to assess risk at various stages during the front-end project planning process and to focus efforts on high-risk areas that need additional definition.

 
Posted : 20/11/2016 7:54 pm
(@me88)
Posts: 15
Active Member
 

Hey Grzegorz,

The CAR sounds like an interesting method to manage risks. They seem like an instructive way to provide feedback on products and improve them for the future. Using this method, the rate of failure will hopefully decrease. This seems to be under the critical analysis portion of FMECA, although it has its own unique points.

-Murad Elias

 
Posted : 20/11/2016 7:54 pm
(@merzkrashed)
Posts: 123
Estimable Member
 

As we have learned, Risk Management is done on multiple areas of a project, not just one:The product, The product design, and The manufacturing process.
A method to analyze risk
Looks at:
HOW something can fail
SEVERITY of the consequences
PROBABILITY that it will fail
you also can apply DFMEA – Design Failure Mode and Effect Analysis
Apply APQP= Advanced Product Quality Planning and Control

 
Posted : 13/11/2017 10:37 am
(@mark-abdelshahed)
Posts: 80
Trusted Member
 

Other risk management methods are:
- Risk indicator scales: Works as a support for subjective judgement when the content and commercial environment of your project is routine and the scales have been calibrated. Often misused by inexperienced personnel who try to convert scales into dollar or time values
- Probability modelling: Model development can be used as a framework for risk identification and tends to highlight any gaps in plans and optimistic assumptions. Provides a sound basis for understanding the uncertainty in cost and schedule estimates and setting realistic targets and contingencies, as well as clarifying the effects of alternative risk sharing strategies.
- Informal direct assessment of risks: Works well when the content and commercial environment of your project is routine and experienced people are available with time to consider each project in depth.

 
Posted : 13/11/2017 3:08 pm
(@akashranpura)
Posts: 39
Eminent Member
 

There are several ways of managing risk. Being part of a medical device company, it is integral to understand and predict certain risks and dangers the product might face. One form of risk management is risk mitigation. Risk Mitigation is when the consequences of certain actions can be reduced or limited. This is used in cases where risk is unavoidable but its effect can be limited. Another way to manage risk is by the transfer of risk. This is done by paying insurance companies to protect you incase of substantial financial loss or property loss. Risk acceptance is another form of managing risk and this is done by increasing anticipated profit to adjust for the risk associated.

 
Posted : 17/11/2017 10:46 am
Page 1 / 3
Share: