_ Answer Key QMS Questions - Series 2

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Quality Management Systems - By Maya S  www.qmstips.com

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Quality Management Systems - By Maya S    ANSWER KEY TO  QUALITY INTRODUCTION QUIZ-  SERIES 2 - ​ ​BY MAYA S.    Q1 ​ Which is the following Total Quality Management TQM strategies was developed by Motorola in 1986: Options - ​A ​ – Plan-Do-Check -Act ​B ​ – MBO C ​ – Six Sigma ​D ​– PERT Ans. ​ Six Sigma Six Sigma 6σ is a set of techniques and tools for process improvement. It was introduced by engineer Bill Smith while working at Motorola in 1986. Jack Welch made it central to his business strategy at General Electric in 1995. Six Sigma strategies seek to improve the quality of the output of a process by identifying and removing the causes of defects and minimizing variability in manufacturing and business processes. It uses a set of quality management methods mainly empirical statistical methods and creates a special infrastructure of people within the organization who are experts in these methods.Each Six Sigma project carried out within an organization follows a defined sequence of steps and has specific value targets for example: reduce process cycle time reduce pollution reduce costs increase customer satisfaction and increase profits. QUALITY SYSTEMS  www.qmstips.com  13-July-2018  www.qmstips.com

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Quality Management Systems - By Maya S  Q.2 ​Accreditation in QMS refers to which one option below Options - ​ ​A ​- Making assessment ​B ​- Meeting predetermined standards ​C ​- Making care cost effective ​D ​- Ensuring Quality Ans: ​ D- Ensuring Quality Quality Management System certification is provided by certification bodies CBs to organisations whose management system meets the requirements of the ISO 9000 series of standards. ISO 9001 is an international standard that sets out an organisation’s quality management system. Its objective is to provide a set of requirements that are effectively implemented to provide confidence that goods and services supplied by the organisation consistently meet customer needs and expectations and comply with applicable regulations. ISO 9001 requirements cover a wide range of business aspects including top management commitment to quality purchasing process control equipment calibration customer 1 for the products/services provided that is up to the customer. A Certification Body applying for ISO 9001 accreditation must conform to ISO/IEC 17021-1 and ISO 17021-3 and other additional International requirements as detailed in Specific Requirements for Accreditation for QMS Scheme. Q.3 ​ ​The right way to measure Reliability is Options - ​ ​A ​- ​ ​Inter-rater reliability ​B ​- Test-retest reliability ​C ​- Parallel-forms reliability D ​- All Above www.qmstips.com

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Quality Management Systems - By Maya S  Ans: ​ All Above There are several general classes of reliability estimates: Inter-rater reliability assesses the degree of agreement between two or more raters in their appraisals. Test-retest reliability assesses the degree to which test scores are consistent from one test administration to the next. Measurements are gathered from a single rater who uses the same methods or instruments and the same testing conditions. This includes intra-rater reliability. Inter-method reliability assesses the degree to which test scores are consistent when there is a variation in the methods or instruments used. This allows inter-rater reliability to be ruled out. When dealing with forms it may be termed ​parallel-forms reliability ​. Q.4 ​How to measure the Value of a Quality Management System Ans. ​ Measuring Reliability Reliability is customer satisfaction driven – the User was successful when they used the commodity Reliability is measured at end of life – it functioned www.qmstips.com

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Quality Management Systems - By Maya S  as required for the periods of time it was needed by the User Reliability is observable by number of past customers that return and service call-outs from users. Value of a ​Quality Management System: You need to purposely design business systems and processes that will deliver all the quality and reliability intentions your customers want. Service and product success is decided by its Users. That is why you need a Quality Management System so you have the organisation structure procedures processes and resources needed to implement the design creation and management of quality in your company. ISO 9001 gives you a framework to hold your business processes methods and solutions and helps you improve them. But that is all ISO 9001 can do for you. So when you decide to adopt a ISO 9001 quality management system be sure that FIRST you design and build the ideal quality-creation processes products and services that are sure to make your customers satisfied. ISO 9001 will only keep you making the same quality and reliability that you engineer into your business offers and customer solutions.   Q.5 ​Which quality system covers the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients diagnostics foods pharmaceutical products and medical devices: Options – ​A ​- ​ ​Good manufacturing practice GMP ​B ​- Good regulatory practice GRP ​C ​- Good Clinical Practice GCP D ​- Good laboratory practice GLP Ans: ​ Good manufacturing practice GMP Good manufacturing practices GMP are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and www.qmstips.com

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Quality Management Systems - By Maya S  beverages cosmetics pharmaceutical products dietary supplements and medical devices.     These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality from batch to batch for their intended use.        Q.6 ​ Standard Operating Procedure SOP in a QMS refers to: Options - ​A ​- An optimal balance between possibilities realized and a framework of norms and values. ​B ​- Doing the right thing right right away the first time ​C ​- ​ ​Detailed written instructions to achieve uniformity of the performance of a specific function. D ​- A process of meeting the needs and expectations of the customersboth internal and external. Ans: Detailed written instructions to achieve uniformity of the performance of a specific function. The QA systems in place will be covered in general by ‘standard operating procedures’ SOP and will be made up of the following essential components: www.qmstips.com

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Quality Management Systems - By Maya S  Title – Each SOP should be given a unique name which captures the essence of the practice described. Number – Each SOP should be given a unique number that can be used for easy reference. The numbering system should include the revision number for the practice so that the most recent version can be easily identified. Date – The date the procedure was first introduced as well as the date of the most recent version. The date format should be based on the ddmmyyyy system where d represents day m represents month and y represents year. Protective Wear – Protective equipment that should be worn by staff when performing the procedure described. Equipment ​ – A list of the equipment needed to perform the procedure. Supplies ​ – All materials and supplies should be recorded. Step-by-Step Guidance – The procedure should be written in specific detail to ensure that the procedure can be repeated in a reproducible fashion to include the order of steps that should be followed the times allowed for each step as needed and the temperatures at which the steps are performed. www.qmstips.com

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Quality Management Systems - By Maya S  Q.7 ​ Which definition of quality of care represents the entire continuum from ​structure to process and to outcome ​ Options - ​ ​A ​- ​ ​Demings ​ ​B ​- WHO 1988 ​C ​- Donabedian D ​- Kurt Lewin Ans. ​ Donabedian The Donabedian model is a conceptual model that provides a framework for examining health services and evaluating quality of health care. According to the model information about quality of care can be drawn from three categories: ​ “structure” “process” and “outcomes." ​ Structure describes the context in which care is delivered including hospital buildings staff financing and equipment. www.qmstips.com

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Quality Management Systems - By Maya S  Process denotes the transactions between patients and providers throughout the delivery of healthcare. Finally outcomes refer to the effects of healthcare on the health status of patients and populations. Avedis Donabedian a physician and health services researcher at the University of Michigan developed the original model in 1966. While there are other quality of care frameworks including the World Health Organization WHO-Recommended Quality of Care Framework and the Bamako Initiative the Donabedian Model continues to be the dominant paradigm for assessing the quality of health care. Q.8 ​ Who is associated with the concept of Total Quality Management Options - ​ ​A ​- ​ ​Rensis Likert ​B ​- Kurt Lewin ​C ​- Max Weber D ​- W. Edwards Deming Ans. ​ ​W. Edwards Deming www.qmstips.com

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Quality Management Systems - By Maya S  William Edwards Deming 1900-1993 is widely acknowledged as the leading management thinker in the field of quality. He was a statistician and business consultant whose methods helped hasten Japan’s recovery after the Second World War and beyond. He derived the first philosophy and method that allowed individuals and organisations to plan and continually improve themselves their relationships processes products and services. His philosophy is one of cooperation and continual improvement it avoids blame and redefines mistakes as opportunities for improvement. Q.9 ​Which accreditation system for hospitals and health care providers is sponsored by the Quality Council of India: Options - ​ A ​- ​ ​NABH ​B ​- Joint Commission International ​C ​- ​ ​BIS D ​- NABET Ans. ​NABH NABH is an acronym for National Accreditation Board for Hospitals Healthcare Providers is a constituent board of Quality Council of India Certification set up to establish and operate accreditation programme for healthcare organizations. NABH was established in year 2006. Organisations like the Quality Council of India QCI and its National Accreditation Board for Hospitals and Healthcare providers have designed an exhaustive healthcare standard for hospitals and healthcare providers. This standard consists of stringent 600 plus objective elements for the hospital to achieve in order to get the NABH accreditation. Q.10 ​ Plan-Do-Check -Act cycle is related to: Options - ​ A ​- ​ ​Donabedian ​ ​B ​- ​Deming ​C ​- ​Henry Gantt www.qmstips.com

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Quality Management Systems - By Maya S  D ​- ​B.F. Skinner Ans. ​ Deming PDCA plan–do–check–act or plan–do–check–adjust is an iterative four-step management method used in business for the control and continual improvement of processes and products. It is also known as the Deming circle/cycle/wheel the Shewhart cycle the control circle/cycle or plan–do–study–act PDSA. Another version of this PDCA cycle is OPDCA. The added "O" stands for observation or as some versions say: "Observe the current condition." Maya S an independant Quality consultant based out of Pune in India provide independent objective advice to organizations on strategies to improve the quality of their products and services.     www.qmstips.com

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