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Showing posts from October, 2019

ALCOA & ALCOA+ Data Integrity

DATA+INTEGRITY = DATA INTEGRITY ALCOA was a tool to implement the data integrity but ALCOA+ made this tool more powerful and sharp.ALCOA is stands for Attributable,  Legible, Contemporaneous, Original and Accurate but ALCOA+ is additional of a few more concepts which are Complete, Consistent, Enduring and Available. ALCOA+ has been implemented and is in use by various big bodies such as the FDA, WHO, GAMP (GAMP= Good automated manufacturing practice).    Data : Fact and statistics collected together for reference or analysis. Thinking known or assume as facts, making the basis of reasoning or calculation. Integrity : The quality of being honest and having strong moral principles. The state of being whole and undivided. E XAMPLE OF GDP CORRECTIONS Writing errors Grammatically mistake Typographical errors Transcription errors Calculation errors etc. EXAMPLE OF DATA INTEGRITY ISSUES Back/Forward dating/Timing Time and date manipulati

Seven quality tools OR Problem solving tools

Seven quality tools OR Problem solving tools 1-Process flow chart 2-check sheet 3-Histogram 4-Pareto diagram 5-Cause and effect diagram 6-Scatter diagram 7-Control chart THE 7 QUALITY TOOLS HELP TO: Improve managerial decision making skills. Collect, present and analyses the data. Implement six sigma. Control cost of poor quality. Reduce variation and improve quality. Reduce cycle time and improve efficiency. Can be used in different continuous improvement methodology such as 6SIGMA, KAIZEN, 5S, 8D, SPC, quality circle. 95% quality related problem at workplace could be solved with the help of seven QC TOOL . 1-Process flow chart Ø   Showcase the whole picture of the process Ø   Streamlines the process Ø   Understand how input convert into output Ø   Reduce waste Ø  I mprove efficiency Ø   Reduce cycle time Ø   Reduce idle time Ø   Find the trouble spots in the process Ø   Identifies the VA and NVA activity Ø     Train a new comer 

Root Cause Analysis

Root Cause Analysis  Image Source-Google | Image by - QC/QA Methodology Root cause analysis is used in almost all industries to find out the cause of the problems. It helps to improve the quality of product if it is used properly by the management because it gives the way to implement the corrective and preventive action. Root Cause Analysis is the most important factor in determining the quality of each organization. It is a methodology of knowing the first action that leads to the sequence which in turn leads to the problem and finds a way to solve this problem. The company auditors must observe the deviation and its relation with the past events, they   have to understand how could this  intervention cause the deviation. So, Root Cause Analysis is used to know the reason for each deviation or bad results.   Type of Root Cause Analysis Techniques. 1)       Group Thinking OR Brain Storming: A group of experts meets together to find the exact cause of t