All organizations at some point face issues in their operational activities related to product complexity, organizational inefficiencies, supply chain management and outsourcing, as well as internal and external risk. A series of highly publicized blunders, from BP’s oil disaster and Toyota’s massive recalls, to the egg recall, along with regulatory mandates and more active involvement among shareholders, are prompting organizations to focus their efforts more closely than ever on identifying areas of potential risk across their enterprise.
Risk exists in everything that we do. It is only through the effective management of risk that we can be assured that we are doing our reasonable best to manage ourselves to protect consumers, staff, the public and other stakeholders against risks of all kinds. Sure, this is a challenge, but the results can also bring rewards, such as:
- Fewer surprises and more confidence in product and processes
- Better service delivery
- More efficient use of resources
- Better management at all levels through improved decision making
- Improved working environment
- End-user safety and satisfaction
Risk management is a proactive approach that aims to identify, assess, prioritize and treat risk, so as to minimize its negative consequences. Product quality risk management then is a process consisting of well-defined steps, which support better decision-making by contributing to a greater insight into risks and their impacts to the overall product.
According to The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), here are some guiding principles for product quality risk management, as defined in ICH Q9:
- The evaluation of the risk should ultimately link back to the potential risk to the end user.
- The extent of the risk management process should be commensurate with the level of risk associated with the decision.
- A more robust data set will lead to lower uncertainty.
- It is essential to have a clear delineation of the risk question.
- Risk management should be an iterative process.
- People who apply risk management should have the appropriate training, skills and experience.
- The risk management process should be appropriately documented and verifiable.
Product quality risk management supports a scientific and practical approach to decision-making. It provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity and sometimes detectability of the risk.
Effective quality risk management offers the opportunity to make better and more informed decisions, provide regulators with greater assurance of a company’s ability to deal with potential risks, and possibly influence the level of direct regulatory oversight. In addition, product quality risk management can facilitate better use of resources by all parties. Clearly, the opportunities far outweigh the challenges.
By implementing an integrated Risk Management solution enterprise-wide, organizations can reduce the potential inefficiencies that result from unanticipated operational disruptions and evolving regulations and restrictions. Such a solution ultimately promotes healthy operating margins, process efficiencies, quality and compliance, and overall profitability.