Eliminating Human Error Quality Manufacturing
Contents |
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 Document Control Food Safety Nonconformance Out of
Human Error Prevention In Manufacturing Ppt
Specification Quality & Compliance Consulting Quality Management Risk Management Supplier Management Training Management human error manufacturing Pricing Pricing Options QMS for Every Business Size Calculating ROI IT Resource Considerations Medical Device Solutions Design Control Device History Records human error reduction tools Medical Device Reporting (eMDR) Pharmaceutical Solutions Clinical Management Trial Master File (eTMF) Regulatory Management Submissions Management COMPLIANCE Stay On Top of Ever-Changing Regulations and Quality Standards Find Out How FDA 21 CFR 21
Human Error Reduction Ppt
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 EU Annex 11 Need Help With Compliance Quality & Compliance Consulting RESOURCES Get Best Practices, Industry Insights, Solution Demos and
Human Error Reduction Training
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 those investigations rely on explaining what happened in the process and how the product was affected. A human error usually explains the reason for the occurrence of the deviation; nevertheless, the reason for that error remains unexplained and consequently the
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 how to reduce human error in the workplace 20% of the time in simulated emergency situations. Scary, isn't it? You
Human Error Prevention Techniques
can see many more such examples by clicking here. So the solution is to get rid of human operators corrective action response for human error and to automate the 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 http://www.mastercontrol.com/newsletter/pharmaceutical/reducing_human_error_manufacturing_floor_0310.html solutions to reduce human errors. 1. 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 https://qualityinspection.org/human-mistakes-lean/ doing anything about it -- even though they know 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 r
2016 Apr 2016 Nov 2015 Sep 2015 Jun 2015 Apr 2015 Dec 2014 Sep 2014 Aug 2014 May 2014 Mar 2014 Nov 2013 http://www.qmtmag.com/display_eds.cfm?edno=1531980 Sep 2013 Jul 2013 May 2013 Apr 2013 Mar 2013 Feb 2013 Nov 2012 Oct 2012 Aug 2012 May 2012 Apr 2012 Mar 2012 Feb 2012 Nov 2011 Oct http://www.fdanews.com/products/46157-reduce-human-error-on-the-drug-and-device-manufacturing-floor 2011 Sep 2011 Jul 2011 May 2011 Apr 2011 Mar 2011 Jan 2011 Nov 2010 Oct 2010 Sep 2010 May 2010 Apr 2010 Mar 2010 Jan 2010 Dec 2009 Oct human error 2009 Sep 2009 Jun 2009 Apr 2009 Mar 2009 Jan 2009 Nov 2008 Oct 2008 Sep 2008 Jul 2008 May 2008 Apr 2008 Mar 2008 Jan 2008 Nov 2007 Sep 2007 Jul 2007 May 2007 Mar 2007 QMT Features: August 2012 Overcoming human error Defect containment strategies in operations - overcoming human error. Graham Cartwright outlines a new approach aligning human error reduction traditional and modern practices. Modern tools & techniques such as Lean and Six Sigma are well known to bring significant improvement in operations and to reduce costs, and there are many notable success stories across most industry sectors. However, frequently they fail to address serious quality problems caused by human error. Overcoming human frailty present within various operational processes continues to be a challenge and one that requires special consideration. This is particularly acute where products are largely hand-built or where there is a substantive manual input. The approach discussed is equally applicable in medical or safety critical environments such as aviation or oil & gas industries.Much has been discussed and debated on improving human behaviour, leadership and related topics to improve the way work is done, but what is often forgotten is the huge benefit that more traditional approaches to quality improvement and defect reduction can still bring. This is particularly relevant when used alongside Lean to harness additional gains and synergies to great effect. Strategies Good product design, technology, engineering excellence and Lean processes a
InstituteClinical Leaders InstituteConferences and WebinarsWhite PapersMedia KitStore My Account Logout Login Subscribe or Register Email Password Forgot your password? ABOUT USCONTACTADVERTISE View Cart Advanced Search recent_searchesshacat iso/drug approval policy/gemstar/ethicon/single irb Home » Store » Webinar CDs » Reduce Human Error on the Drug and Device Manufacturing Floor - Webinar CD/Transcript Reduce Human Error on the Drug and Device Manufacturing Floor - Webinar CD/Transcript Price: $347.00 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 Quantity Discounts1 - 2$347.003 - 4$312.005 - 6$295.007 - 9$278.0010 - 99$260.00 Description Who Will Benefit Instructor Reduce Human Error on the Drug and Device Manufacturing Floor: Framework and Tools to Assure Effective CAPAs Human error causes 80% of drug and device manufacturing failures, studies indicate. Want to discover secrets of reducing human error, improving your products and fending off the FDA? What causes drug and device manufacturing failures and recalls? Human error. Time after time, CAPA investigations single it out as the root cause of violations. If there were a magic formula for ending human error, we’d share it. But here’s the next best thing — systematic best practices and strategies that have been proven to cut human error and boost success on the factory floor. In many cases, firms have seen error reductions of 50% in less than one year. Learn them yourself — in half an afternoon. Your leader is Ginette Collazzo, Ph.D., an authority on industrial/organizational psychology boasting more than 15 years’ experience with major drug and device makers, including Bristol-Myers Squibb, J&J, Schering-Plough and Wyeth, Parexel, Perrigo, and Cephalon Pharma. She has recently developed new tools to measure, explain and predict human error from both process and cognitive load perspectives. And she demonstrates her newly created tools for improving systems and processes, staff training and reducing human error: Process-related prediction tool: This too