The Business Case for taking EQMS beyond NC/CAPA
Quality Management 2.0 Blog
Topics: Quality Management Software, Enterprise Quality Management, CAPA, IBS Quality Whitepapers, Supply Management Software, Risk Management, ISO Quality Management System, EQMS, NC/CAPA, Enterprise Manufacturing Software, LNS Research, Matthew Littlefield
Since the inception of our Quality Management 2.0 Blog, we've written many informative, research-driven whitepapers on quality management. Topics have ranged from how-to steps involving your quality management system, to informative whitepapers on basic tools and philosophies of quality.
The newest go-to guide for every quality professional, the Ultimate Quality Management Glossary contains a comprehensive mix of 150 quality management basic definitions, as well as helpful graphics depicting some key visual terms. This is a perfect eBook for the new quality manager, or for experienced quality management professionals to utilize in new employee training!
Looking for a few samples? Here's just a brief selection of the 100+ terms that are available in the newest IBS quality management eBook download:
1) Document control: A system of managing, distributing, and controlling documents.
2) FDA 21 CFR Part 11 The FDA’s rule that defines the criteria under which electronic document management records and signatures are acceptable, i.e. equivalent to paper records.
3) HACCP Hazard Analysis Critical Control Point - A quality management system for effectively and efficiently ensuring food and beverage control safety in the United States. HACCP-related regulations for various sectors are established by the Department of Agriculture and the Food and Drug Administration.
4) ISO/TS 16949 The automotive quality system standard that harmonizes the supplier quality requirements of the U.S., French, German and Italian automakers. It applies to the design, development, production, installation and servicing of automotive products.
5) NCMR - Nonconforming Material Report A document describing a defective material, product, or part and how it is dispositioned
In this comprehensive handbook, we have compiled key terms and definitions of quality management systems facts, tools, and other information that you can use to help you take your quality management techniques to the next level. This handbook includes:
- Thorough breakdowns of standards that all quality managers should be aware of
How-To Process and Visual aids of basic quality improvement tools, including flow charts, cause-and-effect diagrams, control charts, etc.
Common Quality Acronyms and what they mean, such as FMEA, SPC and APQP
Key Quality Concepts from quality gurus including work by Deming and Crosby
Download the Ultimate Quality Management Glossary by clicking the button below. This IBS America quality management systems glossary is an excellent resource to keep in mind the basics of quality or to prepare for quality management certification exams.
A large number of Quality practitioners describe their #1 problem as “Getting Management to Buy In to Quality Programs.” I have seen this show up consistently during my career. I experienced it personally on numerous occasions when I was employed as a Quality manager, and later at many companies after I became a consultant.
We are all aware that the FDA is taking a much stronger position in the world of enforcement and inspection activity. While many of us have had good relationships with our District office over the years (and work hard to maintain those relationships) we should always make certain we are well prepared when the agents show up at our door. Maybe it’s time for a brief refresher with the latest whitepaper now available for download, "Key Strategies to Succeed at your Next FDA Inspection"
Whether you are a seasoned quality assurance management professional looking for a fresh start, or a young quality manager just starting your first position, it’s important to know and be aware of the basics of quality.
The parent company of IBS America, Inc. - IBS AG - has commissioned corporate consultants, Confluentes, with the compilation of an international comparative study on the theme of warranty management.
Change is hard. Even if it is change for the better, getting it done can be difficult. Yet in companies today, change is being forced upon people like never before – specifically in the area of sustainability. Sustainable businesses by definition produce less waste, and less waste means less costs for companies. In a struggling economy, every chance for cost-cutting must be seriously considered.
You understand what quality is, and you understand how important it is to the life of your organization. It’s your responsibility as a quality assurance management professional to assure quality in the goods and services provided by your company, as well as acting as an advocate for quality to upper management. As you may know, this isn’t always easy: convincing C-Level executives of quality value can be daunting, especially when you don’t know where to start.
Managing risk is no longer a vague and tertiary activity – in this increasingly standards-driven business environment, it is a vital part of an organization’s Governance, Risk Management and Compliance (GRC) program.