A new business analyst at PlastiPharm|The process design

A new business analyst at PlastiPharm, a company that produces medical device plastic bags for safe storage, handling, and transportation of scientific products, was tasked with developing a process design document for a company that needed a new bag for their cell culture process for a new vaccine.

The business analyst, being new, looked at the inputs, the outputs, the process flow, the resources, and the structure of the process. Why was it important for the business analyst to thoroughly understand each aspect of the process?

  • Understanding the process and documenting it accurately created a foundation for the process and made it more likely to be successful.
  • The business analyst learned how all the process pieces worked together and helped her better understand why steps were taken in a certain order.
  • It was important for the business analyst to understand each aspect of the process to make sure that nothing was omitted inadvertently.
  • The process design document allowed the new business analyst to connect with different company divisions and get to know the employees better.


During a production audit at PlastiPharm, a client noted that the number of medical device bags produced during his hour of observation was higher than what was reported for the eight-hour shift (multiplying the hourly output by eight). Which of these explanations best explains why there is a difference?

  • Differing conditions in the clean room can create variances in the process, which results in lost production and reduces overall shift outputs.
  • The goal for the eight-hour shift is always lower than the hourly output to allow employees to take breaks and eat a meal.
  • The clean room employees were aware a client was observing them and made sure everything ran smoothly for the audit.
  • What the client saw during the hour of observation might not have been a typical production hour and should not be used as a measurement of output.


When assessing whether product release deadlines were met during the first three months of the year, the quality assurance (QA) team noted that they were late 23 percent of the time. During that time, the team had hired two new specialists.

The team immediately assessed their processes, including that of approving lot records, a required step to ensure that each lot met product requirements, which then triggered a product release. They found that the new QA reviewers were slow to make decisions because of lack of experience and knowledge. Which statement best explains why analyzing the lot record process and identifying the major constraint for product release was helpful to the QA director so she could take action to improve?

  • Analyzing the root cause of the delays helped the QA director alert the new specialists that their work was not acceptable.
  • Understanding what went wrong helped the QA director rethink her hiring policy and process so she could identify stronger candidates.
  • Identifying the constraint informed the QA director of the need for increased training for the new specialists.
  • Knowing what the constraint was helped the QA director to watch deadlines more closely as she is the one responsible for meeting them.


In the PlastiPharm clean room, where production of the medical device bags occurs, one of the floor technicians questioned a step in the process and suggested another approach that she said would shave off some production time. The shift supervisor organized a process review with all personnel involved and reviewed the process map. Which of the following statements best explains why expending so much effort was worthwhile?

  • Reviewing the process gave everyone a chance to understand the process better, ask questions, and share ideas for improvement.
  • Spending time together allows people to get to know one another and improved the work culture, an important aspect of continuous improvement.
  • Working together to review the process was an expensive venture, but the employees were able to identify problems with the equipment and operators
  • Taking time to review the process map allowed the shift supervisor to observe which employees were most engaged and identify those with the most potential for advancement.


A client ordered 1,000 2D medical device bags from PlastiPharm. Unfortunately, delivery was delayed by two days, and the client was not pleased. A bottleneck analysis was conducted to determine where the problems were in the process. Target times in all steps of the process were compared to actual times. Interestingly, the analysis showed that the client did not respond to questions for two days (someone was out sick, and no one covered for them). While the two-day delay was explained, PlastiPharm determined that improvements could be made to avoid such a delay in the future and took steps to ensure there would be multiple people in the client organization with whom they could ask questions. The client was satisfied with the analysis results and appreciated the effort. Why was it important for the company to perform a bottleneck analysis and then take action?

  • Keeping a client happy is always of highest priority, and the bottleneck analysis helped the company to do that.
  • The bottleneck analysis allowed for the collection of relevant qualitative data that they could show the client and explain the delay.
  • Analyzing where the problem occurred made it possible for the company to demonstrate that it was not to blame.
  • The bottleneck analysis allowed the company to identify the problem, determine a solution so it would not happen in the future, and maintain client satisfaction.


Business was booming at PlastiPharm, and the swing shift supervisor needed to hire 60 new employees on his shift alone to meet production demands. His first hires were two trainers, a deviation from how the two other shift supervisors were hiring. Which statement best explains how hiring trainers might lead to an improvement in the process-management culture on the swing shift?

  • Hiring two trainers sends a signal to the new employees that they will always have someone on whom they can rely to ask questions.
  • Training new employees on customer needs and doing the job right the first time promotes an attitude of continuous improvement that leads to successful production processes.
  • The training of new employees becomes a focus when enough trainers are hired and allows employees time to learn what their jobs are, which reduces stress and improves morale.
  • Providing adequate training for the new employees indicates that they will be expected to learn their jobs well in order to succeed but that they will have the resources needed to do well.


PlastiPharm has several clients whose contracts require the company to store three to six months of raw materials for them just in case they require a quick turnaround for an order, something that rarely happens. As the contracts come up for renewal, PlastiPharm intends to renegotiate the contract terms to reduce or, ideally, eliminate the inventory clause. Why should PlastiPharm care about excess inventory?

  • Making changes to the contract by eliminating the inventory clause demonstrates to the client that PlastiPharm is serious about its lean management processes.
  • Reducing inventory will allow the company to eliminate, or greatly reduce, problems with materials that might become obsolete while sitting on the shelf, thus reducing waste.
  • Reducing inventory will provide needed storage space for other items that PlastiPharm needs to store in its warehouse.
  • Managing and reducing inventory will help the company be better organized and allow them to focus on other areas to improve.


PlastiPharm customizes medical device bags for 350-400 clients. Customer demand for bags, which range from eight inches to four feet in length, is excellent. The company has embraced lean manufacturing practices. What reason best explains why PlastiPharm would pursue a lean journey?

  • Following lean manufacturing practices helps the company hire the right people for the right job at the right time.
  • Starting on a lean journey signals to others that the company wants to reduce waste, maximize value, and contribute to society.
  • The lean journey helps the company stay current and compete with other companies that are also practicing lean.
  • Lean practices help the company do more with less, be more flexible, and meet their clients’ demands.


New product types are continually being introduced at PlastiPharm as new clients, with their diverse needs, are added to the company’s portfolio. The new products are designed by the R&D team and prototyped, often on one of the company’s 3D printers. However, when the products are first produced on the production line, a lot of product is scrapped. In a lean environment, which PlastiPharm espouses, why is it important to eliminate the waste?

  • Eliminating waste encourages the R&D team to consider production needs and processes instead of just the design process.
  • Eliminating waste increases the efficiency of the process and allows the equipment operators to meet customer demands.
  • Eliminating waste requires that quality improves, which increases the company’s ability to compete.
  • Eliminating waste reduces overprocessing and allows for simplification of the production process.


PlastiPharm produces a foundational product that sits on a shelf until it is needed and added to another product. In reviewing the process of combining the two products, the production staff realized that the foundational products are sometimes not tested, although the final product is always tested. They determined that all the foundational products will now undergo testing. The additional testing will add time and effort, which transhttps://highmarkpapers.com/2021/04/02/signature-assignment-reconstruct-the-compensation-and-benefits-design-process/lates to additional costs, so why would PlastiPharm want to perform the additional testing?

  • Testing all the parts addresses any questions that customers might have about quality or performance of materials.
  • The additional testing helps the company as it strives for perfection in its products and helps avoid future problems by reducing waste (defective parts).
  • The additional testing will help the company meet customer demands for certification that all their products have been tested 100 percent of the time.
  • Making sure that all parts are tested ensures that the company is ready to respond to last-minute orders.


PlastiPharm has been on its lean journey for five years, and senior management has fully embraced the lean business methodology. Management requires a minimum number of monthly kaizen bursts, which are to involve all personnel involved in the improvement process. Why is it necessary to have everyone participate in these continuous improvement efforts?

  • Having everyone involved in the monthly kaizen bursts allows people to get acquainted and understand what everyone does in the organization.
  • The continuous improvement efforts of the company signals to all employees the importance of the company’s lean journey.
  • Participating in continuous improvement efforts will help all employees understand the challenges management faces as they seek to improve.
  • Involving people from all levels of the company helps them to buy into the improvements and aids them in developing a lean mindset.

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