s**********8
发帖数: 25265 | 1 The bar for risk management has suddenly moved higher for medical device
companies. After numerous product-safety-related recalls and field actions
over the past few years, FDA has dramatically increased its scrutiny of the
product risk management practices, demanding adherence to the current
standard, ISO 14971:2007. With the agency now examining risks in terms of
the worst possible outcome, practices that had been presumed acceptable are
subject to heightened scrutiny. The rate at which FDA issues warning letters
citing risk management deficiencies has more than doubled since 2007.
Recent warning letters have highlighted inadequate links between risk
management practices and corrective and preventive actions (CAPA) that have
always been the focus of FDA inspections. This shift in risk management
regulatory expectations makes it imperative for medical device companies to
revamp their risk management practices.
Jim Prutrow
The change on the regulatory front is only one reason for companies to
reassess their practices. The use of risk management as a development tool
to drive product quality often falls short of its potential. Much of the
time, it is seen by development teams as a paper exercise to be completed
right before launch. Poorly implemented risk management programs further
fuel this misguided notion that the practice adds little value. To the
contrary, a well-executed risk management program that includes product
development and safety, process development, strategic planning, and project
execution can serve as a powerful tool for a firm to innovate and grow.
When initiated early and employed frequently throughout the product life
cycle, risk management can promote innovation, leading to a reduction in the
number of customer complaints, lowered service and support costs, fewer
disruptions from field actions, and improved execution against program
expectations. Resources once spent on such non-value-added activities can
instead be used to fuel growth and shareholder value.
To reap these benefits, the organization needs to apply risk management
practices across the product life cycle. This means eliminating silos and
aligning incentives between development and post-commercial organizations.
For maximum impact, risk management practices must be data driven, with
logical, consistent risk characterization that is well communicated across
the organization.
Companies should ensure robustness in the following fundamental areas:
•Integrated processes. Companies need to develop risk management
processes with integrated links to CAPA and management review processes,
systems, and procedures. Such integration allows companies to prioritize
continuous improvement activities, improve customer satisfaction, and
sustain long-run profitability—maximizing results while minimizing risk.
•Robust governance. Management must also play a strong role in
ensuring the proper governance of risk management processes. It’s critical
that an established governing body make executive-level decisions regarding
risk-benefit analyses and drive key company-wide risk control measures;
doing so provides single-point accountability. This body must also establish
and monitor sensible metrics to measure process effectiveness.
•Cross-functional involvement. Risk management is not limited to the
quality function. Success requires close collaboration with a variety of
groups, including regulatory, medical, manufacturing, R&D, and engineering.
Management must ensure that these different functions all play a part in
risk-management initiatives.
•Adequate resources and tools. Determining the right number and type
of resources is also crucial. Dedicated resources, fully engaged in
development and post-market risk management activities, are critical to the
effective and timely identification and resolution of product risks. To
ensure sustained excellence, ongoing investment in training and evolving
tools and techniques is key.
Given the current regulatory climate, there is no better time for companies
to revamp their risk management programs—and to realize the potential
business benefits.
http://www.mddionline.com/article/basics-medical-device-risk-ma | h********e
发帖数: 2823 | 2 It seems the FDA has been through a series reforms on the review
of medical devices? I saw another article on its review procedures,
will post too! | b***p
发帖数: 1398 | 3 any difference between
RPN (risk priority #: multiplication of severity *occurance*detection)
and
risk matrix (severity _ probability of hazard & Harm)
两个东西有什么不同？ 什么时候用什么？
the
are
letters
have
【在 s**********8 的大作中提到】
: The bar for risk management has suddenly moved higher for medical device
: companies. After numerous product-safety-related recalls and field actions
: over the past few years, FDA has dramatically increased its scrutiny of the
: product risk management practices, demanding adherence to the current
: standard, ISO 14971:2007. With the agency now examining risks in terms of
: the worst possible outcome, practices that had been presumed acceptable are
: subject to heightened scrutiny. The rate at which FDA issues warning letters
: citing risk management deficiencies has more than doubled since 2007.
: Recent warning letters have highlighted inadequate links between risk
: management practices and corrective and preventive actions (CAPA) that have
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