Risk and Quality Management Assessment Summary
Risk and Quality management help a health care organization provide quality of care and assure the organization is following policies and procedures properly, while reducing or minimizing risks for its patients, stakeholders, shareholders, and itself (Carroll, 2009). As the consultant of Pfizer pharmaceutical company, I have been asked help assess their current status and define a future plan to help them provide quality health care.
Pfizer is a pharmaceutical company that was founded in 1849 by cousins Charles Pfizer and Charles Erhart (Pfizer, 2013). ...view middle of the document...
Pfizer integrates Risk and Quality management into one, calling it QRM or Quality Risk Management. According to Quality Risk Management- the Pharmaceutical Experience, “The purpose of QRM is to create a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle (2011, p.7). QRM is Pfizer’s process that supports science-based and practical decisions when it is integrated into quality systems, such as development, auditing and inspections, training, documentation, change management, etc. (O'Mahony, 2011).
Describe the key concepts of risk and quality management in Pfizer.
According to Quality Risk Management- the Pharmaceutical Experience, “The key concepts of the Quality Risk Management integration of Pfizer is to evaluate the risk to quality based on scientific knowledge and ultimately include patient protection and the level of effort, formality and documentation of the quality risk management process should correspond with the level of risk” (2011, p.7). Being able to evaluate the risk to the quality and being able to put forth effort, formulate and document the processes of the QRM as it relates to the level of risk are vital to the safety and protection of the patient, but also the success and longevity of Pfizer.
Explain steps Pfizer takes to identify and manage risks.
Pfizer has a 10 step process to identify and manage their risks. These steps are outlined and explained in detail in our Quality Risk Management- the Pharmaceutical Experience handbook, but I will briefly explain each step of the 10 step process (2011, p.13-18).
1. Collect and Organize the information: Gathering relevant information, while reviewing references or witnesses and carefully identifying assumptions
2. Formulate Risk Question: This statement outlines the issue and purpose of conducting a QRM and includes the risk factors, scope of the issue, and any limits or constraints in relation to the issue.
3. Choose Tool: (There are 9 tools to choose but I will only list 3 tools) Basic risk facilitation methods such as flowcharts or check sheets, Hazard Analysis and Critical Control Points, and Risk Ranking and Filtering.
4. Identify Risks Factors and Related Hazards: Which determines what the risk factors are (patient safety, compliance, and business arising from all potential hazards identified?
5. Define Risk Components and Scales: three components Severity, which determine the criticality of the product, Probability, which determine the complexity of the site (multi-product), Detection, reviewing audit history and findings.
6. Create the Matrix: States the Risk Evaluation Score (increasing probability from bottom to top and increasing severity from left to right) Final Risk Evaluation Score (Risk Evaluation Score from bottom to top and decreasing detection from left to right).
7. Determine Action Threshold: A level or value above or below which an...