Axia of University of Phoenix
Riordan Manufacturing has completed the intense training from Waterloo Manufacturing Software and is pleased with the results. Samuel Adams has recently checked in with each business unit personally to ensure the satisfaction of his employees as well. Production has been running smoother and traveling for further training has ceased. Each product can be traced from start to finish and the scheduling is now on track. Riordan should see vast improvements in their financial future and company moral. Crisis
It has come to Mr. Adams attention that there might be a defect with some of the items that Riordan MFG assembles. Dr. Wallace from Duke University Medical Center in Durham North Carolina had just contacted Mr. Adams via email to inform him of a problem that he encountered from a coronary stent that recently was shipped to the hospital. While installing the device the balloon did not want to deploy. He is concerned that this may be an issue Mr. Adams should look into; for this is a potential health hazard to the public. At this stage of the crisis the public does not need to be informed. There are proper protocols that Riordan must follow prior to any broadcast of this issue. Riordan must first post a warning to all employees on the intranet of the suspected recall. This will ensure that there is no leakage before it is handled properly. Past Scenario
Previously on October 8, 1998 Boston Scientific had to recall their coronary stents for this specific reason. ( Wood, Shelly) This resulted in Boston Scientific to scramble to resolve the issue; much like Riordan will have to do. This problem for Boston had them recall “29,664 units in the United States, Puerto Rico, Trinidad, Tobago and the American Virgin Islands.” (Travis) The stent not working properly caused 26 injuries and 1 death that was recorded due to the breakdown of the catheters while inside the blood vessel; which can cause clots, heart attacks, stocks, or even death. (Travis) Riordan is very much aware of this past issue and will need to take a similar course of action in order to resolve this with the least amount of casualties. Public Affairs
The first line of defense in such a crisis is the Public Affair department. “Manufacturers and/or distributors many initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective.” (Regulatory Procedures Manual) Riordan has a prestige PA department and their first step to this crisis is to notify the Food and Drug Administration, much like Boston Scientific approach to the same crisis. The FDA is a powerful tool for all companies that may have to recall a product. A major malfunction as this one will need the assistance that the FDA can provide. The FDA will post the recall on their website to ensure that the public will know of the coronary stent recall. The FDA will also be able to post this information for all federal, state, government and foreign governments to view. (Regulatory Procedures Manual) The FDA also has a Recall Enterprise System that allows information of the recall to be updated to promote consistency through the entire recall process. This allows “field coordinators to input recall information via an on-line, Intranet system and reduces duplication of efforts between field Offices and the PA department.” (RPM) The PA department at Riordan must assist the FDA with the proper paper work in order to get the recall started. There will need to be official samples of the coronary stent that has malfunctioned. With the new TACTIC system that Riordan just purchased they were able to track down the product with the assigned lot number. What is at Stack?
Riordan has just revamped their entire company from moving a business unit overseas to doing a major...