Modern Quality Systems in Pharmaceutical Education and Industries

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Information about Modern Quality Systems in Pharmaceutical Education and Industries
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Published on February 24, 2018

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Modern Quality Systems in Pharmaceutical Education and Industries: By: Dr.K.B.Gabhane Assistant Professor, Vidyabharti College of Pharmacy, Amravati Modern Quality Systems in Pharmaceutical Education and Industries Contents: Contents Quality Quality system Modern Quality system Six Sigma What is six sigma Why Six sigma How applied Case study : Pharmaceutical Industry Education System Slide 3: Quality means meeting the specifications that are summarized keeping in mind the demand of today’s fast changing world. In manufacturing, a measure of excellence or a state of being free from defects, deficiencies and significant variations is often referred as Quality In Pharmaceutical Industry, quality becomes an unavoidable thing because the drugs / or pharmaceutical products are directly delivered to the customers body system, thus identity, purity safety and ultimately appropriate quality of product are strongly essential Slide 4: Quality is conformance to internal requirements which is expressed as Potential quality (PQ) : Maximum value added per unit of input Actual Quality (AQ) : Current value added per unit of input PQ – AQ = Waste This waste segment is the target area for Quality system bcoz waste means loss and defects With Quality System we r trying to raise the quality and decrease the difference between PQ and AQ Source: 1998 GE Annual report Jack Welch Letter to share owners and Employees. Quality System / Quality Management system: Quality System / Quality Management system “quality system” alternatively referred as “Quality Management System” (QMS) According to the ASQ glossary online, Quality management system can be considered a mechanism for managing and continuously improving core processes to “achieve maximum customer satisfaction at the lowest overall cost to the organization”. Slide 6: A quality system applies and synthesizes philosophies, standards, methodologies and tools to achieve quality-related goals. Quality system thus represents a specific implementation of quality philosophies/concepts, standards, methodologies and tools, for the purpose of achieving quality-related goals. Upon implementation, a quality system will be unique to an organization. When we talk about quality systems we are taking about a standard. Evaluation of Quality management: Evaluation of Quality management 2000 : Six Sigma INSPECTION : INSPECTION During 1930 this time duration was major quality tool but can be carried out only when production is of one type and production scale is low . Done by either who is maker of the product or checker (buyer) of the product Statistical Process Control : * Done by production people * Not only inspects the process but also tells us ways how to control it.: Statistical Process Control : * Done by production people * Not only inspects the process but also tells us ways how to control it. A,B,C : Controlable factors affecting the process n1 and n2 : Noise factors which are uncontrollable Y: Output as required by the customer Because of noise factors we get distribution of products which are not required by the customer Anything out of this limit is referred as Waste / Defect Slide 10: How to control the process to bring desirable product in spec limit Which factor to be controlled, which will have maximum impact on the output : Hence DOE (Design of Experiments)was launched Design of Experiments: Design of Experiments Which factor from statistical process need to be controleed is studied under this by Rand D. They study relation between causes and their effects and conferes which factor to be controlled so that we can maximum output Most important tool Cause and Effect diagram or FISH bone diagram or Ishikawa diagram Taguchi Robust design: Taguchi Robust design Utilized DOE (design of experiments) Taguchi found that 2/3 of problem of any process or product were due to its design, if we could control design of product or process we would be controlling output which is better and we would be designing better product Using DOE important discovery was made called ROBUST designs It means to hold on the performance and do not get affected by any of the parameters Slide 13: Managing the entire organization so that it excels on all dimensions of products and services that are important to customer TOTAL QULAITY MANAGMENT Total means every component of concerned organization Quality means degree of excellence i.e. “Performance over Expectations” Management means act,art,or the manner of handling , controlling , directing etc Disadvantages These are supposed to be suggestive system and are not considered to be practical system 2. They are not able to tell the exact benefit on the output 3. Benefits may not be seen for several years 4. Workers which are resistant to change may fell les secure in jobs Modern Quality management tools: Modern Quality management tools Slide 15: Six sigma is a management technique developed by Motorola in 1986 Six sigma is a purely scientific method used for process improvement and this method is known as “DMAIC” Main focus is on quality improvement and reduction of waste and defects and targets to bring down error rates to 3.4 error ppm If target of 3.4 is achieved by six sigma team than it can be said that products and services will be cost effective, faster, and much better Six sigma and Motorola: Six sigma and Motorola Motorola during 1986 was manufacturing Quasar television sets But within small duration of time lot of errors peeped out like poor picture quality, poor sound quality and many more As a result Motorola share felled by 10 % to 90 % due to increasing complaints and warranty claims for defective products . Motorola sold his television division to other Japanese firm Matushita Electric (Panasonic) firm take which further rectified all the problems associated with Quasar televisions by using same raw material and same machineries and same workforce. Conclusion : It was concluded that problem was with Motorola management and not with the televisions. Sigma and six sigma ( ): Sigma and six sigma ( ) Sigma Symbol in statistics denotes Standard Deviation 2. Characterizes the dispersion of set of data values with respect to mean Sigma Level ( Process Capability) Defects per Million Opportunities 2 308,537 3 66,807 4 6,210 5 233 6 3.4 Error rates to 3.4 error ppm: Error rates to 3.4 error ppm Objectives of six sigma is to reduce the error opportunities to3.4 errors per millions opportunities Error rates to 3.4 error ppm: Error rates to 3.4 error ppm Only organization in world who got Six sigma certification “FUKKAT” FORBES global magzine conducted quality assurance and gave 99.999999 rating i.e 1 error in 6 million transactions Process improvement method “DMAIC”: Process improvement method “DMAIC” Case Study 1: Medical Transcription Six Sigma Case Study: Case Study 1: Medical Transcription Six Sigma Case Study Medical Transcription Business crucial steps Receiving Dictation from Doctor Transcribing them according to set rules Editing output for errors Transmitting it back to the source of recording “The incoming load was heavy…that is good for revenues. But the deliveries were late again.” Slide 23: Got Distance call from client having query about Company’s performance in meeting their need “Need of Breakthrough Improvement in Buisness Performance” Committed itself to trying the Six Sigma quality approach and measuring the return for his business. The Journey Begins: The Journey Begins Step 1: Define the Problem : A  brainstorming session  produced a list of more than 20 problems. These were  categorised  into two categories: End result problems faced by external customers Internal problems that were causes of customer problems, rather than basic problems themselves. Problem 1 was targeted first and was defined : “ Consistency of Quality and Timeliness” Among quality and timeliness was targeted first Precise definition of the problem as per the equation : Problem = Customer desire – Current status Customer desire: dispatch by 5:30 p.m. every day Current Status : Average delay was of 89 minutes Slide 25: By applying the concept of variability, sigma and quality as a distribution. Calculations showed: sigma = 82 minutes Thus (average + 3 sigma) = 335 minutes. Target : For 99.7 percent on time delivery, we would need to reduce 335 minutes to zero.  Step 2: Analyze the Problem : Why? Why? Why? Why? Why? List of Variables: absenteeism, peaking of loads on some days, inefficient transcriptionists not delivering the expected outputs, drowsiness during the night shift, lack of supervision in the night shift, planning and allocation of files, too little capacity, doctors that were tough to understand, etc.  Slide 26: A check sheet was developed to record the following: start time of processing, input loads, transcriptionists allocated and present, capacity per transcriptionist, and the finishing time. data for the first week revealed one surprising fact – the bulk of the data collected between 7:30 a.m. on day X and 7:30 a.m. on day X+1, which was to be dispatched by 5:30 p.m. on day X+1 started processing by design only at 8:00 a.m. on day X+1.  The query “can processing begin earlier?” prompted the reply, “the data comes from U.S., and doctors tend to dictate at the end of the day and this corresponds to AM in terms of Indian time. Therefore, not much data is available for processing during the night.” To countercheck this: T he group was asked to collect the arrival pattern of data from the U.S. every hour for a week. Slide 27: Findings : The voice recordings were coming in a steady stream from 7:30 p.m. Indian time on day X-1 to 7:30 a.m. on day X, peaking typically between midnight and 2 a.m.   Suddenly the old mindsets were shattered and new ideas could begin forming Step 3: Generate Ideas  Based upon the average arrival pattern of data two alternatives were suggested: Bring two teams during the night shift and one during the day shift OR 2. Bring one team at night, one in for an early morning shift, and one in the day shift. The former idea was preferred. Step 4: Testing The Idea : Step 4: Testing The Idea detailed hour-to-hour data was collected. the senior management went into the night shift to ensure that operational issues with assignable causes were sorted out expeditiously and did not interfere with the results of the trial. The first two days of testing were so successful that dispatches were made up to  two hours before schedule.   They decided to extend the trial into routine operation. Step 6: Results Review : Step 6: Results Review Once the operation had settled down data was collected. The third week after the changes (blue line) were compared to the week before the project began (red line) and revealed a dramatic improvement in dispatch timings, as shown below: The system handled: 22 percent higher load 33 percent higher peak load with average dispatch 134 minutes early compared to 89 minutes late 99.7 percent (average + 3 sigma) delivery on time compared to 335 minutes late Other reported case study involves:: Other reported case study involves: Six Sigma Catapults Hospitals to Next Level of Quality Reducing Avoidable Cancellations on the Day of Surgery Using Six Sigma to Improve Clinical Quality and Outcomes Leveraging Six Sigma to Improve Hospital Bed Availability “Education Industry” : “Education Industry” Traditionally : “Education” was considered as a ‘Social Work’ for the masses, and literacy a gift to the mankind. Today : Considered as professionalism where the students are treated as a product and a customer, which has an expectation of total satisfaction through the school, the once known temple of learning “Education Industry”: “Education Industry” With approximately 28.1 per cent of India’s population in the age group of 0-14 years, as of 2015, educational industry in India provides great growth opportunity. The country has more than 1.5 million schools with over 260 million students enrolled. In 2015, with 34.2 million students enrolled in approximately 48,116 colleges & institutions for pursuing higher education. India’s higher education segment is the largest in the world. Government target of Gross Enrolment Ratio (GER) of 30 per cent for higher education by 2020 to drive investments. The education industry in India is estimated to reach US$ 144 billion by 2020 from US$ 97.8 billion in 2016. Source :  UGC Annual Report 2014-15, Technopak , Centre for Budget and Governance Accountability Slide 33: With 762 universities, India has the world’s largest higher education system in the world & it ranks 2nd in terms of student enrolment in higher education Gross Enrolment Ratio (GER) in higher education reached 24.5 per cent in 2016. Government has a target Gross Enrolment Ratio of 30 per cent to be achieved by 2020. Indian literacy rate is estimated to be at 75 per cent in 2016 as compared to 63 per cent in 2011. According to the Economic Survey of Delhi 2016-17, the city has observed an increase in expenditure on education. The national capital’s total expenditure (plan and non-plan) on education, including sports, art & culture, increased from US$ 713.8 million in 2011-12 to US$ 1.59 billion in 2016-17. Source :  Census 2011, Ministry of HRD, UGC , AICTE, NCTE, MHRD and INC . , UGC Annual Report 2013-14 A Shift from Industry to Schools: : A Shift from Industry to Schools: Moving the Theory from Industry to Education, it is important to keep in mind certain differences between education and business: The school is not a factory. The student is not a “product”. The education of the student is the product. Successful completion of the product requires the student to participate as a worker, co-managing the learning process. According to the Kothari Commission report, of all the factors which influence the quality of education and its contribution to national development, the quality, competence and character of teachers are undoubtedly the most significant. THE ESSENTIAL ELEMENTS OF TQM IN EDUCATION :: THE ESSENTIAL ELEMENTS OF TQM IN EDUCATION : Awareness and Commitment for Everyone A Clear Mission A Systems Planning Approach Teaming Replacing Hierarchy Enablement and Empowerment Replacing Fear Focus on Mastery Learning Development of Student TQM Skills APPLICATION OF SIX SIGMA IN EDUCATIONAL INSTITUTIONS: : APPLICATION OF SIX SIGMA IN EDUCATIONAL INSTITUTIONS: The following are some of the common processes in the educational institutions which can be significantly improved by applying the Six Sigma methodology: Academic achievement College Admission process Teaching and Academic programs Study program and process Institutional effectiveness Student learning performance Evaluation of the instructional delivery Accreditation process IMPORTANT POINTS: IMPORTANT POINTS Six sigma is a rigorous, focused, highly effective implementation of proven principles and techniques which aims at virtually error free buisness performance Six sigma is a management tool which was pioneered by Motorola in 1986 and Bob Galwin become the quality leader. Six sigma is a Buisness improvement approach which focuses on customer requirement, defect prevention, cycle time reduction and cost saving . Seeks to find, elimiate causes of defects, errors in manufacturing and service procesess . Aims at producing defects no more than 3.6 ppm error opportunities . Focuses on output that are critical to customer and clear financial gain to organisation .

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