Question

A) How is ‘risk self assessment’ performed for a business?

B) Describe the ‘brain storming’ process. What is the importance of this procedure in risk identification?

Answer 1

A) Process of Risk Assessment in a business:

Failure Modes and Effects Analysis (FMEA) What is Risk? Risk can be defined as the likelihood of occurrence of an undesi rable event combined with the magnitude of its impact What is Risk Assessment? Risk assessment is the determination of quantitative and qualitative value of risk related to a concrete situation and recognized threat (also called hazard). What does Risk Analysis include? Risk analysis includes Identification of risks Estimation of their likelihood of occurrence Estimation of their causes and the magnitude of their potential impact risk mitigation plan Risk ev Development on Failure modes and effect analysis is a structured method to identify failure modes, determine the severity of the failure, cause of the failure, frequency of the failure, current controls in place and efficiency of the controls. This enables us to evaluate current risks in the process and thereafter developing an action plan to mitigate risks. FMEA Operating Definition Failure Mode and Effects Analysis is a structured and systematic process to identify potential design and process failures before they have a chance to occur with the ultimate objective of eliminating these failures or at least minimizing their occurrence or severity. FMEA helps in Identifying the areas and ways in which a process or system can fail (failure mode) Estimating risk associated with specific causes Identifying and prioritizing the actions that should be taken to reduce those risks Evaluating and documenting proposed process plans or current control plans What is Failure Mode? A Failure Mode is: The way in which the product, service, input, or process could: Fail to meet requirements of the end user

Cause downstream operations to fail Things that could go wrong: Total failure C Partial failure (too much, too little, too fast, or too slow) C Unintended result C Best to be stated in terms of failing to perform a function Combination of Failure Modes Often, catastrophes are the result of more than one failure mechanism which occur in tandem Each individual failure mechanism, if it had occurred by itself, would probably have resulted in a far less "deadly outcome" Cause and Effect Effects are usually events that occur downstream that affect internal or external customers. Root causes are the most basic causes within the process owner's control. Causes, and root causes, are in the background; they are an input resulting in an effect Failures are what transform a cause to an effect; they are often unobservable. PFMEA (Process Failure Modes and Effect Analysis How does PFMEA help? The process FMEA supports processes in reducing risk of failures by: Identifying and evaluating process functions and requirements Identifying and evaluating potential product and process related failure modes, and the effects of the potential failures on the process and the customers Identifying potential manufacturing, assembly or service process causes Identifying process variables on which to focus process controls for occurrence reduction or increased detection of the failure conditions Enabling the establishment of a priority system for preventive/corrective actions and controls Process FMEA doesn't rely on design changes to overcome limitations in the process. PFMEA assumes the product/service as designed will meet the design intent. Potential failure modes that can occur because of design weakness may be included in PFMEA. Their effect and avoidance is covered by Design FMEA.

What about the Design issues? During the development of a PFMEA, a team may identify design opportunities which if implemented, would either eliminate or reduce the occurrence of a failure mode. Such information should be provided to Process Improvement/ Design expert for consideration and possible implementation. Who should develop PFMEA? PFMEA is deve loped and maintained by multi-disciplinary (or cross functional) team typically led by the Green Belt/ Black Belt/Process Owner. Developing PFMEA The PFMEA begins by developing a list of what the process is expected to do and not do.lt is also known as the process intent Identification of the product/service effects from the DFMEA should be included A flow chart of the general process should be developed. It should ident ify the product/process characteristics associated with each operation. The process flow diagram is a primary input for development of PFMEA. It helps establish the scope of the analysis. The initial flow diagram is generally considered a high level process map A more detailed process map is needed for identification of potential failure modes The PFMEA should be consistent with the information in the process flow diagram Requirement(s) should be identified for each process/ function. Requirements are the outputs of each operation/step and related to the requirements of the product/service. The Requirement provides a description of what should be achieved at each operation/step. The Requirements provide the team with a basis to identify potential failure modes Other sources of information may include but not limited to Cause and Effect Matrix C Lesson learned from previous product or similar process C Known failure modes based on historical data Performance indicators (Cp, Cpk, Sigma level, FTY, RTY) data of similar process Once we have most of the required information, we can fill out the Process FMEA form PFMEA Template

Process Prepared by: Page of or Product Name: FMEA Date (Orig) (Rev) Responsib le: Action Results Current Process Potential Recommende Responsibility and Potential Potential Cause(s)/ Mechanis Controls m(s) of Preventio Process Requireme Action Controls Step Failure Effects Completion nt Detectio S Function Mode of Failure Action(s) Taken Date Failure k nnnn a1 a2 b f h d e m C Clas

B) Brainstorming:

the Importance of this brainstorming procedure in risk identification includes:

Brainstorming Brainstorming is used at the initial steps and during the Analyze phase of a Project to identify potential factors that affect the output. It is a group discussion session that consists of encouraging a voluntary generation of a large volume of creative, new, and not necessarily traditional ideas by all the participants. It is very beneficial because it helps prevent narrowing the scope of the issue being addressed to the limited vision of a small dominant group of managers. Since the participants come from different disciplines, the ideas that they bring forth are very unlikely to be uniform in structure. They can be organized for the purpose of finding root causes of a problem and suggest palliatives. If the brainstorming session is unstructured, the participants can give any idea that comes to their minds, but this might lead the session to stray from its objectives.

• Here, Participants from various discipline join the session, and help to generate the applicable or possible risk for the project, here, many stakeholder engagement happened, so the session is not limited to just Top Management,
• with this brainstorming session many idea and risk, issues could be caught, people get flexibility to think on their project and tasks, knowing the risk from stakeholders, project , department, Internal and external environment, organization further analyze them and set better response strategy for them, so project could achieve their milestone successfully,