Preventing Human Error Manufacturing
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Find Out How Quality Management System Solutions All Solutions Audit Management Batch Records Bill of Materials (BOM) Change Control Corrective Action (CAPA) Customer Complaints Deviations Management human error prevention in manufacturing ppt Document Control Food Safety Nonconformance Out of Specification Quality & Compliance Consulting human error reduction tools Quality Management Risk Management Supplier Management Training Management Pricing Pricing Options QMS for Every Business Size Calculating ROI IT human error reduction ppt Resource Considerations Medical Device Solutions Design Control Device History Records Medical Device Reporting (eMDR) Pharmaceutical Solutions Clinical Management Trial Master File (eTMF) Regulatory Management Submissions Management COMPLIANCE Stay On Top
Human Error Prevention Techniques
of Ever-Changing Regulations and Quality Standards Find Out How FDA 21 CFR 21 CFR Part 11 21 CFR Part 111 21 CFR Part 1270-1271 21 CFR Part 210-211 21 CFR Part 606 21 CFR Part 820 ISO ISO 9000 ISO 9001 ISO 13485 ISO 14000 ISO 14971 ISO 15189 ISO 17025 Other Regulations & Standards TS 16949 CLIA Canadian Standards human error reduction training EU Annex 11 Need Help With Compliance Quality & Compliance Consulting RESOURCES Get Best Practices, Industry Insights, Solution Demos and More Find Out How Resource Center White Papers Case Studies Testimonials Blog - GxP Lifeline ABOUT US The #1 Enterprise Quality Management Software (EQMS) since 1993 See What We Do Company Info Who are we? Contact Us Careers News & Events Our Team Executive Team Partners For Pharmaceuticals and Biotechnology Reducing Human Error on the Manufacturing FloorBy Ginette M. Collazo, PhD. Jun 15, 2010 | Free Downloads | | As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments. Sadly, little is known about the nature of these events mainly because quality event investigations end where human error investigations should begin. Human error is about explaining human behavior. Chemical engineers explain product behavior, mechanical engineers explain equipment behavior, industrial engineers explain process behavior, but who explains human behavior? When we investigate quality events, the focus of th
lean approach. As Shigeo Shingo wrote, "humans are animals that make mistakes". But how often do we make mistakes? For example, trained military technicians make mistakes 20% of the time in simulated emergency how to reduce human error in the workplace situations. Scary, isn't it? You can see many more such examples by clicking here.
Corrective Action Response For Human Error
So the solution is to get rid of human operators and to automate the whole process, right? I don't agree. And
Human Error Pharmaceutical Industry
that leaves us with "animals that make mistakes" at the heart of production. The Lean movement, following Toyota's example, offers effective solutions to reduce human errors. 1. The general philosophy As Jon Miller points out, http://www.mastercontrol.com/newsletter/pharmaceutical/reducing_human_error_manufacturing_floor_0310.html there must be a non-negotiable acceptance by everyone of the following: We do not accept bad work We do not do bad work We do not pass on bad work In Chinese factories I regularly see employees creating defects, or working on parts that are faulty, and not doing anything about it -- even though they know there is a problem! I have found that, if the pay structure https://qualityinspection.org/human-mistakes-lean/ doesn't create the right incentives, this general philosophy will be ignored. If workers are paid by the piece and if there is no way to trace bad products back to a certain person, quality is the last priority. But if the team gets a bonus based on the number of GOOD pieces produced, the mentality changes quickly. 2. Mistake-proofing Have you ever managed to insert the battery of your cell phone upside down? Or to spill gas at a station, while the pump is in your car's tank? Probably not, because the manufacturers implemented mistake-proofing devices. Once one starts watching processes with these examples in mind, one can come up with many ideas. You can see some examples in a factory setting by clicking here. 3. Self-inspection Counting on quality inspectors to look for defects has a huge downside: problems might be found hours (or days) after they appear. In the meantime, hundreds of bad pieces might have been produced. And finding the root cause of these problems might be very difficult (the trail got cold). So the best is to have operators self-inspect. However, does an operator have the objectivity necessary to check his own work? Probably not. Fortunately, solutions exist. Here is what Miche
Videos Webinars Print ArchiveBack Issues (newer) Back Issues (older) Subscribe to e-newsletter ResourcesKnowledge Guides Buyer's Guides State Quality Awards Product Demos About Us Training Events Calendar Subscribe to Quality Digest Advertise Contact http://www.qualitydigest.com/inside/quality-insider-article/human-error-causal-factors-work-place.html Login / Register Quality Insider Articles Columns News Videos TweetSUBSCRIBE TweetSUBSCRIBEBen Marguglio|06/24/2009 Bio http://www.nsf.org/training-education/training-pharma-biotech/human-error-prevention Human Error Causal Factors in the Work Place An understanding of human error causal factors is important for design and root cause analysis Login to Comment ( Login / Register ) Rss Send Article Print Author Archive Human error is behavior that is wholly expected to achieve a desired human error result (in accordance with some standard) but that does not. A causal factor is anything that yields an occurrence resulting in an undesired effect or anything that exacerbates the level of severity of the undesired effect.Why is it important to understand human error causal factors? The answer is twofold.First, a good design (either the design of a process or hardware item) human error reduction is created, in large part, with an understanding of:Any potential undesired effects in operating or maintaining the process or in manufacturing, transporting, storing or using the hardware itemThe human errors and their causal factors that can activate these undesired effects.With this understanding, the intent is to design such as to eliminate the potential for the undesired effects, or when that can’t be done, to establish appropriate barriers for the:Prevention of any error that could activate the undesired effectTimely detection of the errorMitigation of the undesired effect.Of course, the resources applied to any such barriers are appropriate to the level of significance of the undesired effect.Second, without an understanding of human error causal factors, there is a greater potential for root cause analyses to be truncated at the point at which only the things that need correction are identified, rather than analyzing further to the point of identifying the behaviors that need correction as well. For example, a correction may be made to a specific integrated maintenance and inspection plan (a thing) or corrections may be made to a set of such plans (thing
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