MERMED Inc. is a medical device manufacturer.

The company’s headquarters is located in Houston, Texas. It is a global leader in developing, manufacturing, selling and servicing diagnostic imaging and therapeutic medical devices used to diagnose and treat cardiovascular and other diseases. MERMED earned $300 million of revenue in 2015, while employing more than 10,000 people worldwide. One of it’s manufacturing plants is located in Dingle, Co. Kerry, Ireland. Tom Jones is the plant manager at the Dingle facility.

The Dingle site runs 12 hour shifts, 7 days a week. It has 1000 employees. It manufactures a variety of of medical devices (including Class III devices). A number of it's products are sold in the US and European markets. The facility has a Quality Management System in place. Their Quality Management System is in compliance with ISO 13485:2016 and 21 CFR 820. Their facility is frequently audited by Notified Bodies and the FDA.
The site was recently audited by corporate. The corporate auditing team were checking the site's compliance with ISO 13485:2016 and 21 CFR 820. The auditors found a number of potential non-conformances to ISO 13485:2016 and 21 CFR 820.

You must complete 4 tasks (for each of the 5 incidents/questions):

1.   Review each of these potential non-conformances (5 incidents in total)

2.   Determine if they are non-conformances against the requirements of the ISO13485:2016 AND 21 CFR 820.

3.   If they are non-compliances, write down the specific clause numbers in ISO 13485:2016 AND specific section number of 21 CFR 820 which is applicable (write down the main clause/section in each regulation that the non-compliance is against).

4.   Briefly EXPLAIN your decision.

The design file for the medical Device Alpha 04 was reviewed. The company has not analyzed the service log, problem reports, or other quality sources to verify the effectiveness of each design change and documented the results of the company's analysis.

1. What are the downsides of litigation?

2. What are the benefits of the various forms of alternative dispute resolution? Provide 2-3 reasons why you as a business owner or manager would choose to use an alternative dispute resolution format (and name what type of ADR you would choose).

3. What are the downsides of the various forms of alternative dispute resolution?

4. Choose one business dispute from the news or the world around us and explain whether, if you were the owner of the business and had the option, you would choose to move forward with litigation or an alternative dispute resolution method. And why.

What is your view of race relations in general, and of color blindness in particular especially, but not only, at work?

While the legal doctrine of reasonable accommodation (you read about that concept during our employment law chapters related to disabilities and religion) is not applicable in a contract dispute case, how might the application of that doctrine result in a solution for both parties? Sometimes, creative problem solving can result in a win-win rather than a win/lose situation. How might this be turned into a win-win?

Public Personnel Administration Which of the employee-friendly initiatives do you think is most important to those just entering the workforce? Explain why. 250-word minimum.

5. Much of traditional advertising now incorporates some form of online promotion or information, even if it is as simple as including a website URL on a magazine, newspaper, or television advertisement. Each of the web addresses below leads to the online component of a traditional media ad campaign. Review each site and then answer these questions: What added value does the online component bring to the campaign? What other ways could the advertiser incorporate digital media in the campaign? Why would a consumer go the website, and why would he or she stay?

In Nike’s sweatshop case what’s the first thing a CEO of nike should do as a business leader?

Why do you think production and operations managers often are not directly involved in strategy-formulation ac-tivities? Why can this be a major organizational weakness?

• Using the Internet, research acquisitions that are currently underway and choose one of these acquisitions to discuss. Based on the firms' characteristics and experiences and the reasons cited to support the acquisition, do you feel it will result in increased strategic competitiveness for the acquiring firm? Why or why not?
• Of the problems that affect the success of an acquisition, which one do you believe is the most critical in the global economy? Why? What should firms do to make certain that they do not experience such a problem when they use an acquisition strategy?

1. What is the benefit of separating Period and Variable costs on the Income Statement?
2. What does a Contribution Margin represent?

4-9. Describe two ways how a firm can determine from a list of 50 to 100 internal factors the 20 most important factors to include in an IFE Matrix

Discuss the strategic, tactical and operational roles of the procurement / ( in logistic management )

Problem 9-11

Assume that Product Z is made of two units of A and three units of B. A is made of three units of C and four of D. D is made of two units of E

     Lead times for purchase or fabrication of each unit to final assembly are: Z takes two weeks; A, B, C, and D take one week each; and E takes three weeks.

     Sixty eight units of Product Z are required in Period 10. (Assume that there is currently no inventory on hand of any of these items.)

b. Develop an MRP planning schedule showing gross and net requirements and order release and order receipt dates. (Leave no cells blank - be certain to enter "0" wherever required.)

Problem 9-17

Each unit of A is composed of one unit of B, two units of C, and one unit of D. C is composed of two units of D and three units of E. Items A, C, D, and E have on-hand inventories of 25, 20, 40, and 40 units, respectively. Item B has a scheduled receipt of 15 units in Period 1, and C has a scheduled receipt of 50 units in Period 1. Lot-for-lot (L4L) is used for Items A and B. Item C requires a minimum lot size of 60 units. D and E are required to be purchased in multiples of 110 and 60, respectively. Lead times are one period for Items A, B, and C, and two periods for Items D and E. The gross requirements for A are 40 in Period 2, 30 in Period 5, and 45 in Period 8.

Find the planned order releases for all items. (Leave no cells blank - be certain to enter "0" wherever required.)