Quality Risk Management: Missing Link in the Product Lifecycle?

Tech-Clarity published a new report titled "Quality Risk Management in Life Sciences: Preventing Failures, Protecting Patient Health". The study reviews two manufacturers’ experiences using Quality Risk Management (QRM) to proactively reduce risk. My response to the article.
Jim – Thank you for the timely article, especially when we are seeing a number of Recalls, Market Withdrawals & Safety Alerts by the FDA (http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2010/default.htm)

Medical products are developed and used within an intricate system involving a number of crucial contributors: manufacturers who develop and test products; the FDA, which does pre-marketing review, authorization and post marketing surveillance; the organizations providing health care, governments, health care practitioners and patients. Such products are required to be fail-safe, but safety does not denote zero risk – rather is one that has reasonable risks, as judged against the amount of benefit/gain expected and alternatives accessible. All participants in the medical product development and delivery scheme have a role to play in maintaining this benefit-risk balance. As per FDA, most injuries and deaths associated with the utilization of medical products result from their known side effects – some are unavoidable, but others can be prevented or diminished by vigilant product selection and usage. Other sources of preventable adverse events are medication or device errors, and product defects. Another category of potential risk involves the remaining uncertainties about a product like unexpected side effects, unstudied uses and unstudied populations.

The FDA recognizes ISO 14971 as an acceptable risk management model. Even if the makers choose not to implement ISO 14971, they are still expected to conduct and document a risk management process. ISO 14971 specifies procedures for a manufacturer to use in order to be familiar with the hazards involved with medical devices. The process is used to estimate and appraise associated risks, manage these risks, and keep an eye on the effectiveness of the controls. The requirements of ISO 14971 are applicable to all stages of the lifecycle of a medical device. Implementation of ISO 14971, proactive quality risk management, making information retrieval and reuse easier, post marketing vigilance and reporting, and the implementation of Good manufacturing practice, Good Laboratory Practice, Good Clinical Practice etc results in better prevention of defects, higher quality, and reduces cost of poor quality including claims, complaints, and rework.

Superior risk management is an imperative part of the industry. The extent of business damage due to recalls, warning letters, seizures, criminal prosecution by FDA are exponentially higher than the quantum of investment needed for a first-rate knowledge capture/management solution.

More Details:

1. CFR - Code of Federal Regulations Title 21 PART 820 QUALITY SYSTEM REGULATION
2. "Managing the Risks from Medical Product Use: Creating a Risk Management Framework"
3. An Introduction To Risk Management Professional Societies
4. Drug recalls surge
5. The Medical Product Safety Network (MedSun) 
6. Tech-Clarity Insight: Quality Risk Management in Life Sciences