You are production manager for a company that manufactures toy stuffed animals.
ID: 423005 • Letter: Y
Question
You are production manager for a company that manufactures toy stuffed animals. The current stuffing in the manufacturing process has become prohibitively expensive and you have been tasked with finding an alternative stuffing. You have found a new stuffing that is compatible with your assembly line and within the price range set by the company. This new stuffing contains a fiber that may be linked to lung disease if it is inhaled after becoming airborne. You believe that risk can be effectively controlled by using a rayon cloth "second skin" to enclose the stuffing before attaching the outer covering of the animal The cost of the stuffing and enclosing it in a "second skin" is still within the price range set by the company. Discuss the regulatory issues your company faces if it should choose to use this new stuffing with the "second skin." What federal regulatory agencies would regulate use of this stuffing, what requirements must your company comply with if it uses the stuffing?Explanation / Answer
Answer:
In the given case the company is going to use the alternate stuffing process which will help the company to manage the cost, but it will have some health related significant issue. The health issue is that if it is inhaled then it will lead to lung disease. Thus it has a complex health impact on the users of the toys.
Regulatory issue: As per regulatory rules and guidelines, company cannot manufacturer products and sale in the market if they have health related impacts to consumers. The company needs to certify their products for free from any health issues. In worst case company needs to mention the warning that the product is injurious to health.
The company will face the health issues by the agencies so the company needs to provide the suitable solution for prevention of the health issue to consumers by the product.
Company may be audited by the agencies for confirmation of health issues, so company needs to develop and implement the suitable solutions with compliances as per regulatory requirements and legal laws.
The company needs to comply with following regulatory requirements if it going to use the new health affecting stuffing process as below
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