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 Failure Mode and Effects Analysis (FMEA) is a systematic, proactive method for identifying and evaluating the potential causes and impacts of failures in a process, product, or service1. It aims to anticipate and prevent failures by assessing the relative effect and risk of different failure modes1.

The use of FMEA would be most appropriate prior to a new product introduction (NPI). During the NPI phase, FMEA can be used to identify potential failure modes in the design of the product and assess their potential effects on the product’s performance and reliability. This allows for proactive measures to be taken to mitigate or eliminate these risks before the product is launched. FMEA is particularly useful in the early stages of design, as it helps in making informed decisions that can improve the quality and safety of the product1.

In contrast, using FMEA after a one-time quality incident investigation (A) or during evaluation of a new market opportunity © may not be as effective, as these situations do not involve the design or development of a product or process. While FMEA can be used during the define phase of a Six Sigma project (B), its most impactful application is during the design phase of a new product, where it can significantly influence the final outcome.

Sales and operations planning (S&OP) in a make-to-stock (MTS) environment is concerned with projecting inventory. S&OP is an integrated planning process that aligns demand, supply, and financial planning and is managed as part of a company’s master planning1. MTS is a traditional production strategy that is used by businesses to match inventory with anticipated consumer demand2. Inventory is the quantity and value of materials and products that are available in stock or in transit3.

S&OP in an MTS environment is concerned with projecting inventory because inventory is the key link between demand and supply. Inventory can be classified into three types: raw materials, work-in-process, and finished goods3. S&OP aims to balance the inventory levels of these types with the expected demand and supply plans, as well as the financial objectives of the company. S&OP can help optimize inventory management by:

• Reducing inventory costs, such as holding, ordering, and shortage costs3.
• Improving inventory turnover, which is the ratio of sales to average inventory3.
• Increasing inventory availability, which is the percentage of orders that can be fulfilled from stock3.
• Enhancing inventory quality, which is the degree of conformance to specifications and standards3.

The other options are not as relevant for S&OP in an MTS environment as inventory. Item forecasts are estimates of future demand for specific products or services based on historical data, market trends, or customer inputs4. Item forecasts are an input to S&OP, not an output. S&OP uses item forecasts to generate aggregate demand plans for product families or categories, which are then matched with aggregate supply plans for production capacity or resources1. Backlog is the quantity of customer orders that have been received but not yet fulfilled3. Backlog is not applicable for S&OP in an MTS environment, because MTS products are produced before customer orders are received. MTS products are delivered from stock, not from backlog. Bookings are the quantity of customer orders that have been received and confirmed3. Bookings are also not applicable for S&OP in an MTS environment, because MTS products are not dependent on customer orders. MTS products are based on forecasted demand, not actual demand.

References: Make To Stock (MTS): Definition, Example, and How It Works - Investopedia; Forecasting - Definition & Examples - ASQ; What is Sales and Operations Planning (S&OP) | Oracle; Inventory Management - Definition, Types, Objectives and Examples.

To successfully empower individuals to drive change, an organization should ensure everyone can clearly articulate the business’s vision and strategy. According to various sources, such as Forbes, Mercuri Urval, and LSA Global, one of the key factors for effective change leadership is to communicate a powerful and compelling change vision that inspires and motivates employees to support the change. A change vision is a statement that describes the desired future state of the organization after the change is implemented, and how it aligns with the overall business vision and strategy1. A clear and consistent change vision can help employees understand the purpose and benefits of the change, as well as their roles and responsibilities in the change process2. A change vision can also help create a sense of urgency, direction, and alignment among employees, as well as foster a culture of empowerment and participation3.

The other options are not sufficient or necessary to successfully empower individuals to drive change. Conducting thorough training programs for all levels of employees is important, but not enough to empower them to drive change. Training can help employees acquire the skills and knowledge needed to perform their tasks in the new situation, but it does not necessarily influence their attitudes, beliefs, or behaviors toward the change1. Aligning performance appraisals with the business’s vision is also helpful, but not essential to empower individuals to drive change. Performance appraisals can provide feedback, recognition, and incentives for employees who demonstrate the desired behaviors and outcomes related to the change, but they do not address the underlying motivations, emotions, or barriers that may affect employees’ willingness or ability to change4. Establishing and tracking broad change metrics on a quarterly basis is also useful, but not critical to empower individuals to drive change. Change metrics can help measure the progress and impact of the change initiatives, but they do not necessarily engage or involve employees in the change process or give them a sense of ownership or autonomy over the change5.

References: CPIM Part 2 Exam Content Manual, Domain 8: Manage Quality, Continuous Improvement, and Technology, Section 8.2: Continuous Improvement Concepts and Tools, p. 61-62; 5 Ways To Empower And Engage Employees To Lead Change - Forbes; How to successfully drive change in your organisation - Mercuri Urval; Empower Employees to Effect Change - 4 Ways | LSA Global; Empowering Teams to Drive Change Sustainably; Change Management Metrics: How To Measure Your Change Management Project.

A process capability study is a method of evaluating how well a process can produce outputs that meet the specifications or requirements. A process capability study involves collecting data from a sample of the process output, calculating the process mean and standard deviation, and comparing them with the specification limits1. A process capability study can help identify the sources and causes of variation, measure the performance and quality of the process, and determine the potential for improvement2.

A process capability study would be necessary in a laboratory when frequent failures are occurring. Frequent failures indicate that the process is not capable of producing reliable and consistent results, and that there may be some problems or defects in the process. A process capability study can help diagnose the issues and suggest corrective actions to reduce or eliminate the failures. For example, a laboratory that performs blood tests may conduct a process capability study to find out why some of the test results are inaccurate or invalid, and what factors affect the accuracy and validity of the test results.

The other options are not situations that would require a process capability study, because they are either unrelated or irrelevant to the process performance or quality. A test results are consistently late (A) is a problem of timeliness, not capability. A new technician is hired © is a change of personnel, not process. Hours of operation are to be extended (D) is a change of schedule, not process.

References:

• Process Capability Analysis Cp, Cpk, Pp, Ppk - A Guide - 1factory
• What is Process Capability? Capability Estimates & Studies | ASQ