Eliminating 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
Human Error Prevention In Manufacturing Ppt
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Human Error Reduction Ppt
Calculating ROI IT 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 human error reduction training COMPLIANCE Stay On Top 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 how to reduce human error in the workplace TS 16949 CLIA Canadian Standards 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 e
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
Corrective Action Response For Human Error
time in simulated emergency situations. Scary, isn't it? You can see many more human error prevention techniques such examples by clicking here. So the solution is to get rid of human operators and to automate the
Human Error Pharmaceutical Industry
whole process, right? I don't agree. And 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. http://www.mastercontrol.com/newsletter/pharmaceutical/reducing_human_error_manufacturing_floor_0310.html The general philosophy As Jon Miller points out, 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 https://qualityinspection.org/human-mistakes-lean/ there is a problem! I have found that, if the pay structure 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
for 18 years. In 1993 Jon was fortunate to start his career working in lean, kaizen and continuous improvement. He traveled learned while visiting many gembas with engineers who were students of http://gembapantarei.com/2009/03/how_do_lean_processes_prevent_human_error.html Taiichi Ohno. HOME Publications ARCHIVES ALL ARCHIVES BOOK REVIEWS TAIICHI OHNO KAIZEN KAIZEN SONGS 101 KAIZEN TEMPLATES LEAN MANUFACTURING LEAN OFFICE THE 5S THE DARK SIDE OF LEAN TIPS FOR LEAN MANAGERS TPS BENCHMARKING LEAN HEALTHCARE How Do Lean Processes Prevent Human Error? By Jon Miller in Ask Gemba, Lean Manufacturing, TPS Benchmarking March 24, 2009 6 Comments Scott asked an important question on how lean processes can be used to prevent human error human errors. The good news is that lean processes not only support quality but they lean cannot function without a strong quality culture and organizational commitment to quality improvement. Scott asked: As part of the Nuclear support industry our customer base is committed to Human Performance, the elimination of error as it is a natural part of being human but also ensuring that the organization itself is not the cause of creating human error reduction an environment that contributes to the potential for human error by allowing "Error Precursors" to go unmitigated. I am trying to marry the commitment to lean with the focus on Human Performance. The focus of lean to break down a process to its simplest components to eliminate error and Human Performance to eliminate the precursors of error, the work environment, individual capabilities, task demands, and human nature. Any suggestions? We are looking both as tools to support our overall initiative of ISQO, excellence in Integrity, Safety, Quality and Output.
This is an extremely important considering the industry Scott supports. To review briefly, lean is based on the Toyota Production System model in which the quality culture is one of the two pillars. The other pillar focuses on flexibility and speed through the focus on continuous flow, pull and the balancing of work to takt time (customer demand pace). These two pillars hold up the headstone that is the elimination of waste. The result is performance excellence. Human factors as well as organizational factors are the foundation on which a lean structure is built. We need to be very careful not to equate lean with eliminating waste, kaizen events, a group of tools such as 5S, kanban, cells and so forth, but as a whole op