Pharmaceutical Risk and Assurance Services
Need more information?Contact Us
Your organization maintains high standards. Your workforce, customers and stakeholders trust and respect you. They believe in your integrity and honest approach to business. Your reputation is fundamental to your commercial success. But have you considered that your organization’s current processes and supply chain could directly affect your reputation and brand? The threat may not be immediately apparent, but it is real.
Your processes and suppliers may well deliver the goods and services you need, on time, on budget and to the quality you require. However, if any of them falter, use unethical employment practices, have unhealthy or hazardous working conditions, produce unsafe products, operate environmentally-unsound production plants, your organization’s reputation could be seriously compromised.
Though not always financial, these risks can rapidly affect margin gains, brand and reputation. Proactively mitigating these risk factors is critical and feasible through a consistent and disciplined approach of identification, assessment and planning.
DNV is a leading organization in helping companies build strong foundations to manage their risks effectively and efficiently. DNV offers a three-step solution that enables organizations to identify their internal and external risks, assess the risks against the severity and likelihood of occurrence, and plan and schedule risk actions.
IDENTIFICATION OF RISK
DNV has a wealth of knowledge on risk management. Operating as a global company, we can provide research and information on the global issues concerning services and manufacturing in many countries and industry sectors. Risk identification is the first step in the proactive risk management process. It provides the opportunities, indicators, and information that allows an organization to raise major risks before they adversely affect operations and the business. At this initial stage of the solution, we will use the guidelines of ICH Q9, ISO 14971 and ISO 31000 to help you pinpoint and prioritize focus areas in relation to identified risks in quality, health & safety, business continuity, supply chain, etc. This approach allows you to categorize your priorities by geographical location, position in the supply chain or even by processes.
Impact versus the likelihood of occurrence. The output of this step will allow an organization to rank the risks, which in turn allows a company to direct the most energy into managing the highest level of risk. Assessment based upon the principals and methodologies of ISO, IPEC, and ICH in order to obtain the risk levels; a multiplication of impact x likelihood = risk level.
By this stage, we will have begun to build your solution through our global expertise and experience in risk management and compliance. Your brand and reputation will strengthen and your organization will have a solid base for improvement.
Planning and scheduling risk actions is the third step in the risk management process. The planning activities translate the prioritized risks into action plans. Planning involves developing detailed strategies and actions for each of the top risks, prioritizing risk actions, and creating an integrated risk management plan. Scheduling will involve a detailed Gantt chart depicting the integration of the tasks required to implement the risk action plans into day-to-day operations activities by assigning them to individuals or roles and actively tracking their status.
RISK ACTION PLANS WILL FOCUS ON KEY AREAS SUCH AS:
• High-exposure risks
• Conditions to reduce the probability or likelihood
• Root causes as opposed to symptoms
• Address the consequences to minimize the impact
ONGOING – RE-EVALUATE THE RISK
By re-evaluating your risks on an ongoing basis, you can continually refocus and improve your program and/or supply chain controls to enable ongoing improvement and compliance. New risks may be discovered due to inevitable changes and the flexibility of the DNV solution allows additional requirements to be absorbed into your evaluation criteria whenever necessary. Through the application of controls and the re-evaluation of risks, DNV provides a complete management solution for the risks you face from within your own locations and throughout your supply chain. This unique flexibility of our program allows us to review and improve our service continually, as part of our ongoing client relationships.
DNV solution can enhance visibility and support your risk management initiatives and programs. Our capabilities and expertise provide all of the information you need to proactively address unforeseen issues and make improvements. Benefits include more effective risk management, regular cost savings and a strengthened brand and reputation.
DNV provides the tools to help improve your business systems through our suite of certification, assessment and business assurance services.