The Purpose of Risk and Quality Management It's no secret that risk is prevalent in the healthcare industry. Healthcare organizations carry a great deal of risk just in their day-to-day operations. Healthcare organizations not only have to worry about risks to their patients, but also to their staff, financial stability or even a natural disaster. A healthcare organization must have a risk management department with trained and qualified people who know how to manage various issues within the organization. At Janssen they take a lot of risks when it comes to their product. They have compliance laws that must be followed meticulously to avoid severe punishments such as multimillion-dollar lawsuits or prison time for criminal convictions. They must promote their products legally and keep them regulated by the FDA, and keep medical decision-making free from improper industry influence. In addition to risk management, quality management also plays a vital role within a healthcare organization. Quality management oversees the quality of the services the organization provides and the products it can sell. In the case of pharmaceutical products, the quality must be consistent and how Janssen maintains this quality must be supervised. For them, quality control is an important factor. Control of all the various elements within the production and also consumer satisfaction plays a vital role for continued success. Key Concepts At Janssen Pharmaceuticals, managing numerous risks is mandatory because drug manufacturing and development carries the potential risk of adverse reactions along with many other risks, and even the possibility of death. Understand that medical science is rapidly evolving and they want to deal with development and manufacturing (Quality Risk Management, 2006). The population largely depends on medications to manage several life-threatening conditions, and the risk comes with the medication and should not be overlooked. There are several laws and regulations adopted for specific reasons, such as the FDA Amendments Act, which establishes risk identification, assessment and mitigation objectives related to post-market drugs. This helps the general population by making pharmaceutical companies more compliant with drug safety and incorporating safety into their pre-marketing processes and also once the drug has been released to the public. Janssen Pharmaceuticals has had a great journey with its company with only a few bumps along the way. They have learned through experience that putting profit before people can and does have consequences.