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    • Q52. Explain the use of Coefficient of Variation with examples.    This question is a part of the November Episode and can be answered by approved Excellence Ambassadors till 10 PM on November 24, 2017. There are many rewards amounting to 0.5 million INR or more. Just being regular here earns you a reward. Even a streak of 3 great answers can get you a reward. All rewards are mentioned here - https://www.benchmarksixsigma.com/forum/excellence-ambassador-rewards/   All questions so far can be seen here - https://www.benchmarksixsigma.com/forum/lean-six-sigma-business-excellence-questions/
    • FMEA:             FMEA is a Procedure that helps us to identify & understand the Potential Failure modes, their Causes & the effects of the Failure in the Process or the end User. It helps to analyse the Risks involved with the Failure Modes, Effects & Causes &  Categorize the issues for the Corrective Action. The Main goal of the FMEA is to align the Risks that are available within the resources. This helps to identify the Root causes of the Risks involved, allows to detect the occurrence of the Risks & to get a better solution to overcome the Risks.The Primary objective of the FMEA is to improve the Process & reduce the failures that would occur in the Process   Types of FMEA: - Design FMEA - System FMEA - Process FMEA [Which is being commonly used]   Risk, Risk Assessment & Risk analysis: - Risk can be said as the likelihood of Occurrence of an undesirable event. - Risk Assessment is the determination of quantitative / qualitative value of Risk related to a Concrete situation - Risk analysis included 1. Identification of Risks 2. Estimation of the likelihood of Occurrence 3. Estimation of the Causes & impact 4. Risk evaluation & development of risk    Limitations of FMEA in Risk Analysis: RPN - Risk Priority Number plays an important role in the FMEA, to determine the Risk factors involved. RPN = Severity X Occurrence X Detection  There are certain limitations in the FMEA during the Risk analysis. They are as follows - It needs an effective team to carryout the Risk analysis in an efficient manner. Small disputes between the Team members may lead to improper FMEA  - FMEA can describe the Risks involved in the Process to a certain extent only. Unknown hidden failures cannot be addressed completely. - Sometimes it doesn't directly capture the Failure mode & doesn't cover the Multiple failures involved in it - And another limitation is not covering the entire Failure modes involved. For example what happens if a Product fails at the End user will not be clearly explained in the FMEA   So FMEA when it is done correctly & effectively it will be an useful tool to Prevent Problems, reduce the Costs & develop the Process  
    • In my humble opinion, there are no distinct advantages or disadvantages of any tool or for that matter anything. Each tool has its unique features, which under some conditions act as advantages and under other conditions act as disadvantages. So is the case with Failure Modes and Effects Analysis (FMEA) also. The best way to identify the limitations and the conditions under which these limitations are experienced is to do an FMEA on FMEA, the results of which is depicted below. Sr. No. Limitation Counter-measures 1 Teams that use FMEA may not always be sufficiently trained on FMEA and also know the domain adequately Establish and institutionalize norms for participation in FMEA 2 Not all failure modes may be covered Appoint well experienced facilitators to compere the FMEA session and have the facilitators guide the team through multiple perspectives 3 Prioritization tends to draw attention to certain failure modes only and may not eliminate all failure modes Consolidate low priority failure modes, repositorize them and keep reviewing them periodically to ensure that they do not drop off the radar 4 Tendency for the FMEA team to misjudge scope, either bite off more than what they can chew or just keep nibbling without getting anything substantial Present the initial scope in manageable blocks and work on one block at a time 5 Yesterday’s FMEA can become obsolete today Build in a review frequency in the FMEA procedure and follow it. Include FMEAs and reviews in the scope of periodic process audits or Management Systems audits 6 Sometimes, certain factors will be rated the full 10 out of 10 and may not ever change When discussing actions to reduce the RPN, spend adequate time on reducing all three factors viz. Severity, Occurrence and Detectability 7 Chances of the FMEA, “running away” with uncontrollably and unmanageably too many failure modes As part of the FMEA process, whenever a failure mode is proposed for discussion, let the first step of the discussion be to review it for duplicacy and overlap and accordingly decide whether to record it as a separate failure mode or merge it with another failure mode 8 Templates are too cumbersome for filling and discussing No need to stick to the classical template. Review the template cell by cell and customize it according to requirements. Buy computerized templates or develop your own FMEA application.
    • Given the many benefits of FMEA in assessing posaible risks in a process and predicting any possible failures that may be there in a process, there are certain limitations that FMEA has...  -FMEA by itself, in isolation is only a tool for assessment and has to be supplemented with another error eliminating strategies or tools to actually see the benefit of the exercise.  - The effectiveness or Impact of FMEA is proportional to the knowledge, experience, awareness, attitude and wisdom of the people behind it.  - It is not a one time process and needs to be updated and reviewed as the new elements of risks keep occurring or coming up in a given process.  - FMEA as a process needs to be balanced... It cannot have too much of detail or too less of detail for analysis as too much can cause a lot of effort and time consumption and too little will not give enough o relevant output.  Apart from the above the most conspicuous limitation that most of the practitioners attribute to the FMEA is the more than due bias towards severity during the calculation of RPN.  It is a must that FMEA is done by an able team with expertise in subject matter.  
    • What is Failure Mode Effect Analysis (FMEA)?  The FMEA is an team oriented analytical methodology which aims for identifying and correcting potential failures in a systematic and structured manner   The FMEA is already implemented in an early phase of the product engineering process and tries to identify imaginable/possible failures and implements corresponding corrective actions.  The FMEA aims for reducing the risk of possible failures in the best possible way. The method records the generated knowledge to the advantage of the organization and integrates the lessons learned into future tasks and scopes.   The FMEA is living documents that must be reviewed and updated whenever the process has been modified  There are three basic cases for which FMEA process is to be applied….   New designs, New Technology or New Process   Modification to existing design or process Use of an existing design or process in a new environment, location or application usage on the existing design or process.  In Six sigma DMAIC methodology, Initially, FMEA is done in Measure phase and provides recommended actions for the team to minimize risk to the customer. Its revision continues up to the Analyze and Improve Phase to ensure that the evaluation criteria and cause/effect relationships are updated with data-driven conclusions. During the Control phase, the FMEA needs to be updated to reflect the final state of improved project. The information from FMEA is then summarized in the control plan documents   Process of Carrying out FMEA   Review the process and list the Process steps and key Process inputs  – can be derived from process maps, cause and effect diagram, brainstorming sessions or existing process data. Brainstorm all the expected potential failure modes for each key process input – can be described in physical/technical terms ,not as a symptoms noted by the customer List the potential cause for this failure mode – May be several causes for such failure, here consider the operating conditions, usage or in-service, and possible combinations as potential causes. List the controls that are existing in place to detect the cause of the failure mode. Rate the severity of the failure effect  the customer experiences  in a Scale of 1 to 10 (1 being no effect and 10 being the Hazardous without warning) Determine how often the cause of the failure mode occurs and rate the occurrence in a scale 1 to 10 (1 being unlikely to 10 being almost inevitable) Determine the effectiveness of the current controls to detect the cause of the failure and rate the detection criteria in a scale of 1 to 10 (1 being very effective detection and 10 being no detection.) Calculate the risk priority number(RPN)by multiplying Severity, Occurrence and detection together. Note : Risk priority number (RPN) = (probability of occurrence) x (severity ranking) x (detection ranking).Highest RPN would be 1000 and lowest would be 1 , lowest RPN is lower risk. However if the severity rating is 9 or 10 ,efforts should first focus on these key process inputs to ensure detection is at least 1 or 2 and occurrence is also low. Establish the action plan which can help to minimize the risk to customer by using the RPN value –recommended action can only impact the detections or Occurrence. Severity will remain same until and unless the product/service or information is used for a different intent.  Identify the person responsible to complete the recommended action with target date Once the action taken, list the specific actions taken, along with the actual completion date Calculate or reevaluate the resulting RPN, based on the completed action. After finishing the above-mentioned steps, sort the RPN numbers and identify most critical issues and where to focus first  For understanding clarity, tried to describe the rating scale elaborately as below, which can be used as reference for FMEA RPN calculation  …     Severity Rating Occurrence Rating Detection Rating No effect -None (Unable to realize a failure has occurred.) 1 Very Low <1 /1500000 (Failure is unlikely) 1 Almost certain (Defect is obvious and can be kept from affecting the customer) 1 Annoyance- Very Minor (Very Minor on product or system performance. Minor defects noticed by discriminating customers. No disruption to product line. No effect to performances. Inconvenience to administration of customer) 2 Low- 1/150000 (Relatively low failures) 2 Very high (Very high chance of detection. All units are automatically inspected.) 2 Annoyance - Minor (Minor on product or system performance. Minor defects noticed by some customers) 3 Low- 1/15000 (Relatively low failures. Isolated failure associated with similar process,) 3 High (High Chance of detection. SPC is 100% inspection surrounding out of conditions) 3 Annoyance - Very Low (Small impact on product performance. The product does not require repair. Minor defects noticed by most customers.                               Major disruption to production line. Significant delays in delivery to end customer. No effect on performance) 4 Moderate -1/2000 (Occasional failures. Generally associated with processes similar to previous processes which have experienced occasional failure, but not in major proportions) 4 Moderate high (SPC is used with an immediate reaction to out of) 4 Loss or degradation of secondary function -Low (Moderate impact on product performance - The product requires repair. Reduced secondary function performance.) 5 Moderate -1/400 (Occasional failures. Occasional failures. Generally associated with processes similar to previous processes which have experienced occasional failure, but not in major proportions) 5 Moderate (Process is monitored and manually inspected) 5 Loss or degradation of secondary function -Moderate (Product performance is degraded. Comfort or convenience function may not operate. Loss of secondary function performance. Major disruption to prod line. Customer product may have to be reworked. Customer product operable. End use experiences some dissatisfaction.) 6 Moderate - 1/80 (Occasional failures. Occasional failures. Generally associated with processes similar to previous processes which have experienced occasional failure, but not in major proportions.) 6 Low (Manual inspection with mistake proofing modification) 6 Loss or degradation of Primary function -High (Product performance is severely affected but functions. Reduced primary function performance. A portion (<100%) of customer product may have to be scrapped. Customer product operable but at a reduced level of performance. End user dissatisfied.) 7 High- 1/20 (Repeated Failures. Generally associated with processes similar to previous processes that have often failed) 7 Very Low (All units are manually inspected) 7 Loss or degradation of Primary function - Very High (Product is inoperable with loss of primary function. The system is inoperable./ Loss of primary function. 100% of customer product may have to be scrapped. Customer product inoperable, loss of primary function. End user very dissatisfied.) 8 High- 1/8 (Repeated Failures. Repeated Failures. Generally associated with processes similar to previous processes that have often failed.) 8 Remote (Units are systematically sampled and inspected) 8 Failure to meet safety/regulation - Hazardous with warning (Failure involves hazardous outcomes and/or noncompliance with govt. regulations or standards) 9 Very high -1/3 (Failure is almost inevitable) 9 Very Remote (Occasional units are checked for defects) 9 Failure to meet safety/regulation - Hazardous without warning (Failure is hazardous, and occurs without warning. It suspends operation of the system and/or involves noncompliance with govt regulations) 10 Very high >1/2 (Failure is almost inevitable) 10 Almost impossible (Defects caused by failure is not detectable) 10     As we know, the latter the failure is detected, the higher will be the corrective cost and customer dissatisfaction. If FMEA is done in the early stage with right way it will help in reducing the risk of possible failures in the best possible way. While FMEA as a preventive tool is highly beneficial for the organization, but it has certain limitations too.   Limitations:  Team Formation: Depends on how the interdisciplinary team is formed and what is their expertise on subject knowledge (product, process) and FMEA methods – If team is good, output will be good. Team members Involvement: Whatever the subject matter expert team may be, If the team is not actively involved, a superficial look at the process will miss many failure modes. FMEA Moderator: if the moderator is not expert, competent, target orientated and biased towards certain opinion, it may derail from its objectives. Prioritization: The initial output of an FMEA is the prioritizing of failure modes based on their risk priority numbers. Mostly Severity and occurrence ratings are often difficult for individuals or teams to estimate.   Time factor: This process takes time for discussion/brainstorming session Rating Scale Customization: Generic rating scale may create confusion; creation of meaningful rating scale plays a vital role in rating. Unknown Failure mode: Certain failures which is outside of the team experience, may be left in discussion and documentation. FMEA Timing: FMEA not initiated on early stage or design stage, may miss certain design /process verification Target Customer: Customer is both internal and external, but if the FMEA is targeted considering only external customers, internal process failure impacts may be missed from consideration. Product/Process: Every product /process is not similar and different from others and FMEA should be carried individually not coping & pasting from one to another. Detection Control: Assuming detection controls are more effective while in real they are not Action on Recommended failure mode: FMEA is a prioritization tool. It doesn’t eliminate failure modes or effects by itself. Organization need to apply mistake-proofing tools to eliminate the root causes of failure modes, especially true with failure modes that have very severe effects. FMEA/Control Plan Update: It is a live document, needs regular review and update if a new potential failure mode is identified, that should be added to the FMEA and control plans developed for that. The control plan tells people how to react when a failure mode occurs, if FMEA is not tied to control plan, people would not be aware how to react in case of failure. Note : FMEA Worksheet template is attached for better understanding FMEA-template.xls Rating Template.docx
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