Like pretty much everyone else with a pulse I have watched the sad spectacle of Ebola marching into my living room on every news outlet. Much like an anvil hitting a cartoon character repeatedly, I am gob smacked by the cascading series of lousy decisions made at every level.Read More
Quality Management 2.0 Blog
Risk Management as a Career Tool
In the last blog I vented my most annoying compliance issue. This week I thought I would switch gears to my most amusing and embarrassing Quality moments.
A couple of blog posts ago I wrote about a warning I had once received to carefully distinguish between fads and fashion versus legitimate innovations and quality tools that stand the test of time. Risk Assessment is certainly not new but it seems to currently be the popular kid in the class. The idea of risk analysis as part of Design and Process FMEAs have been the standard within the Auto Industry for many years. Likewise, Risk Assessment is and has been an important element of Environmental Risk Management.
Statistical Analysis, Trending and Risk Assessment Pitfalls
One of the few gifts of being older is a sense of perspective. Interestingly it cuts both ways. For every situation where I am impressed by the immediate availability of Business Intelligence data I am equally perplexed by the seemingly conscious efforts of organizations to ignore or misread the data. There are all sorts of data collection systems that can keep a finger on the pulse of a process and the quality and risks associated with the outputs.
Topics: IBS America, QSYS, Mary McAtee, Corrective Actions and Preventive Actions, Document Management Systems, Corrective Action Software, Risk Management Software, Risk Assessment & Analysis, corrective and preventative actions
Everyone that participates in the Life Sciences industry that uses software anywhere in their processes has wrestled with the challenges of Software Validation. Companies spend a considerable amount of time, money, energy and expertise in ensuring that they address all of the requirements necessary as defined in in 21 CFR Part 11 to make sure that the software is going to both satisfy the FDA Regulatory Requirements and meet business expectations. The most challenging validation portion seems to uniformly be Process Qualification (PQ). The time and effort to determine and address where the software capability ends and the human process interaction begins can be very challenging. It is easy to miss some of the important supporting elements that are absolutely required and necessary to make Process Qualification successful. If we were to quantify those requirements at a very high level it would boil down to:
Topics: IBS America, Process Management Software, Mary McAtee, FDA Validation, Risk Management Software, Risk Assessment Software, FDA Validation Software, Life Science Software Validation, 21 CFR Part 11 FDA Validation Software
“Lies, Damned Lies and Statistics”
Andrew Zolli, coauthor of the book "Resilience: Why Things Bounce Back," in a recent Harvard Business Review interview relates a story from the auto industry that illustrates the importance of resilience to an organization. He also discusses the strategies for improving the resilience of an organization.
Topics: Automotive Quality Management, Process Control, Manufacturing Software, Supply Chain Management, Enterprise Quality Management, Process Management Software, Enterprise Risk Management, Risk Management Software, Risk Management, Manufacturing Productivity, Enterprise Manufacturing Software, Crisis Management, Resilience, Andrew Zolli
IBS values the expertise of individuals in the quality management space, and we're always seeking to educate our quality management readers on the latest research end knowledge in the industry. Here is a video of our keynote speaker at a recent User Forum event discussing crisis management, and what it can mean for enhancing your organization's business value. Don't have time to watch the video? Read the transcript, below!
Compliance management stretches far beyond the scope of industry and likely finds genesis in daily living. I find it of peculiar note when specific technical directives distill to fundamental kindergarten tenets. While presenting universal mandates in an arduous set of documents, compliance is a human endeavor. Every assertion that is more than a thought requires authority, and authoritative assertions about a project are stakeholder voices. Ultimately, value and quality within an effort are measured by business goals. Assumptions at iteration zero are vital but not relevant when stakeholders do not share context. A litmus test in a vacuum is a technique.
Savvy professionals take a strategic, company-wide approach to enterprise risk management, minimizing all risks that can significantly undermine business value. By performing Enterprise Risk Management (ERM), companies protect the safety of all their resources, including governance, business processes, operations, and network infrastructure.