Podcast
Questions and Answers
What is one of the benefits of equipment management?
What is one of the benefits of equipment management?
- Increases complexity
- Lowers repair costs (correct)
- Decreases customer satisfaction
- Increases interruption of services
What should you do if you come across equipment that does not function properly?
What should you do if you come across equipment that does not function properly?
- Ignore it and use it anyway
- Report it and do not use it (correct)
- Check the user manual
- Try to fix it yourself
What is a benefit of equipment management in terms of customer satisfaction?
What is a benefit of equipment management in terms of customer satisfaction?
- It increases customer satisfaction (correct)
- It does not affect customer satisfaction
- It decreases customer satisfaction
- It has no impact on business operations
What happens to the lifespan of equipment when it is properly managed?
What happens to the lifespan of equipment when it is properly managed?
Why is it important to have properly functioning equipment?
Why is it important to have properly functioning equipment?
What type of audit reviews one or more elements in the quality system?
What type of audit reviews one or more elements in the quality system?
Which of the following is an example of an element that may be reviewed in a horizontal audit?
Which of the following is an example of an element that may be reviewed in a horizontal audit?
What is the primary focus of a vertical audit?
What is the primary focus of a vertical audit?
Which of the following is NOT an example of an element that may be reviewed in a horizontal audit?
Which of the following is NOT an example of an element that may be reviewed in a horizontal audit?
What is the main difference between horizontal and vertical audits?
What is the main difference between horizontal and vertical audits?
What decade is associated with the contribution of Walter A. Shewhart in quality management?
What decade is associated with the contribution of Walter A. Shewhart in quality management?
Who is credited with a significant contribution to quality management in the 1920s?
Who is credited with a significant contribution to quality management in the 1920s?
Which decade is associated with the concept of Micro Scale Error Reduction?
Which decade is associated with the concept of Micro Scale Error Reduction?
What is the primary focus of Walter A. Shewhart's contribution to quality management?
What is the primary focus of Walter A. Shewhart's contribution to quality management?
Which standard is concerned with the competence of testing and calibration laboratories?
Which standard is concerned with the competence of testing and calibration laboratories?
What is the theme of the text that mentions Walter A. Shewhart's contribution?
What is the theme of the text that mentions Walter A. Shewhart's contribution?
What is the primary focus of ISO 15189:2007?
What is the primary focus of ISO 15189:2007?
What is the author of the text that mentions Walter A. Shewhart's contribution?
What is the author of the text that mentions Walter A. Shewhart's contribution?
Who is associated with the concept of Quality by Requirement?
Who is associated with the concept of Quality by Requirement?
What is the primary focus of ISO 9001:2015?
What is the primary focus of ISO 9001:2015?
What is the main purpose of Quality Control (QC) in quality management?
What is the main purpose of Quality Control (QC) in quality management?
What type of materials are examined in the Quality Control (QC) process?
What type of materials are examined in the Quality Control (QC) process?
What is the primary focus of the Quality Control (QC) process?
What is the primary focus of the Quality Control (QC) process?
What is the difference between documents and records?
What is the difference between documents and records?
What is the characteristic of records?
What is the characteristic of records?
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Study Notes
Brief History of Quality Management
- Quality Management is not new, with innovators contributing to its development throughout history
- Walter A. Shewhart introduced Statistical Process Control in the 1920s
- W. Crosby introduced Quality by Requirement in the 1970s
- Robert W. Galvin introduced Micro Scale Error Reduction in the 1980s
ISO Documents
- ISO 9001:2015 specifies requirements for a Quality Management System
- ISO/IEC 17025:2005 outlines general requirements for the competence of testing and calibration laboratories
- ISO 15189:2007 provides a Quality Management System for clinical laboratories
Accreditation
- Accreditation involves horizontal audits, reviewing specific elements in the quality system
- Horizontal audits may focus on training, equipment, quality control activities, test methods, complaints, and corrective actions
- Accreditation also involves vertical audits, reviewing a random selection of tests that have passed through the laboratory
Equipment Management
- Effective equipment management lowers repair costs and lengthens equipment lifespan
- Benefits include improved performance, increased safety, reduced service interruptions, and greater customer satisfaction
- Equipment that does not function properly should not be used
Documents and Records
- Documents communicate information on policies, processes, and procedures
- Records capture information on worksheets, forms, labels, and charts
- Documents need to be updated, while records are permanent and do not change
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