TOTAL QUALITY MANAGEMENT BP 606T (VI Sem)

TOTAL QUALITY MANAGEMENTBP 606T (VI sem)Dr. Abhishek PandeyAssistant ProfessorSchool of Studies in Pharmaceutical Sciences, JiwajiUniversity, Gwalior

Contents Introduction.Concepts of tqm.Benefits of tqm.Characteristics of tqm.Key elements of tqm.Tqm in pharma ences.TOTAL QUALITY MANAGEMENT2

IntroductionTotal - made up of the wholeQuality - degree of excellence a product or service providesManagement - act, art or manner of planning, controlling,directing,.Therefore, TQM is the art of managing the whole to achieveexcellence.TOTAL QUALITY MANAGEMENT3

The concept of TQM Produce quality work the first time. Focus on the customer. Have a strategic approach to improvement. Improve continuously. Encourage mutual respect and teamwork.TOTAL QUALITY MANAGEMENT4

Various Definitions Total quality management (TQM) has been defined as anintegrated organizational effort designed to improve quality atevery level. The process to produce a perfect product by a series ofmeasures require an organized effort by the entire company toprevent or eliminate errors at every stage in production is calledtotal quality management. According to international organization for standards definedtqm as, “TQM is a management approach for an organization,centered on quality, based on the participation of all its membersand aiming at long-term success through customer satisfactionand benefits to all members of the organization andto the society.TOTAL QUALITY MANAGEMENT5

Characteristics of TQM Committed management. Adopting and communicating about total qualitymanagement. Closer customer relations. Closer provider relations. Benchmarking. Increased training. Open organization Employee empowerment. Flexible production. Process improvements. Process measuringTOTAL QUALITY MANAGEMENT6

Traditional approach and TQMQuality elementDefinitionPrevious sSecond to service andcostFirst among equals ofservice and ty ControlEveryoneProblem solvingManager’s roleManagersPlan, assign, control,and enforceTeamsDelegate, coach,facilitate, and mentorTOTAL QUALITY MANAGEMENT7

The three aspects of TQMCountingCustomersCultureTools, techniques, and training intheiruseforanalyzing,understanding, and solving qualityproblemsQuality for the customer as adriving force and central concern.Sharedvaluesandbeliefs,expressed by leaders, that defineand support quality.TOTAL QUALITY MANAGEMENT8

Principles of tqm1. Produce quality work the first time and every time.2. Focus on the customer.3. Have a strategic approach to improvement.4. Improve continuously.5. Encourage mutual respect and teamworkTOTAL QUALITY MANAGEMENT9

The key elements of the TQM Focus on the customer. Employee involvement Continuous improvementTOTAL QUALITY MANAGEMENT10

Focus on the customer It is important to identify the organization’s customers. External customers consume the organization’s productor service. Internal customers are employees who receive the outputof other employees.TOTAL QUALITY MANAGEMENT11

Employee Involvement Since the quality is considered the job of all employees, employeesshould be involved in quality initiatives. Front line employees are likely to have the closest contact withexternal customers and thus can make the most valuablecontribution to quality. Therefore, employees must have the authority to innovate andimprove quality.TOTAL QUALITY MANAGEMENT12

ContinuousContinuous improvementimP«ONE *fcNTCONTiMUOU*TOTAL QUALITY MANAGEMENT13

Continuous improvementTOTAL QUALITY MANAGEMENT14

CONTINUOUS IMPROVEMENT The quest for quality is a never-ending process in which people arecontinuously working to improve the performance, speed andnumber of features of the product or service. Continuous improvement means that small, incrementalimprovement that occurs on a regular basis will eventually add upto vast improvement in quality. TQM is the management process used to make continuousimprovements to all functions. TQM represents an ongoing, continuous commitment toimprovement.TOTAL QUALITY MANAGEMENT15

Continuous Process Improvement. View all work as process - production and business. Process - purchasing, design, invoicing, etc. Inputs - process - outputs. Process improvement - increased customer satisfaction. Improvement - 5 ways: Reduce resources, reduce errors, meet expectations ofdownstream customers, make process safer, make processmore satisfying to the person doingTOTAL QUALITY MANAGEMENT16

THE TQM tTotalInvolvementFocusElementsLeadershipEducation and Training SupportivestructureCommunications Reward andrecognitionMeasurementTOTAL QUALITY MANAGEMENT17

BENEFITS OF TQM: Improved quality.Employee participation.Team work.Working relationships.Customer satisfaction.Employee ity.Market share.TOTAL QUALITY MANAGEMENT18

Importance of TQM in pharma industryHandling: Containers should be opened carefully and subsequentlyresealed in an approved manner. Highly sensitizing material such as penicillins andcephalosporins should be handled in separate productionareas. Highly active or toxic API (e.g. certain steroids, cytostaticsubstances) should be manufactured in a dedicated area andusing dedicated equipment. Pure and final API should be handled in an environmentgiving adequate protection against contamination.TOTAL QUALITY MANAGEMENT20

Storage: Secure storage facilities should be designated for use toprevent damage or deterioration of materials. These should be kept clean and tidy and subject to appropriatepest control measures. Environmental conditions should be recorded. The condition of stored material should be assessed atappropriate intervals. Storage conditions for api should be based upon stabilitystudies taking into account time, temperature, humidity,light etcTOTAL QUALITY MANAGEMENT21

Packaging: Labelling and packaging processes should be defined andcontrolled to ensure that correct packaging materials are usedcorrectly and other specified requirements are met. Printed labels should be securely stored to avoid mix-upsarising. Marking and labelling should be legible and durable,provide sufficient information, for accurate identification andindicate, if appropriate, required storage conditions, retestand/or expiry date.TOTAL QUALITY MANAGEMENT22

Facilities and equipment: The location, design, and construction of buildingsshould be suitable for the type and stage of manufactureinvolved, protecting the product from contamination(including cross-contamination) and protecting operatorsand the environment from the product. Equipment surfaces in contact with materials used in apimanufacture should be non-reactive.TOTAL QUALITY MANAGEMENT23

Sterile area Personnel suffering from an infectious disease or havingopen lesions on the exposed surface of the body shouldavoid activities which could compromise the quality ofAPI. Smoking, eating, drinking, chewing and storage of foodshould be restricted to designated areas separated fromproduction or control areas.TOTAL QUALITY MANAGEMENT24

Labelling Each container should be identified by an appropriate label,showing at least the product identification and theassigned batch code, or any other easily understandablecombination of both. Containers for external distribution may require additionallabels.TOTAL QUALITY MANAGEMENT25

Computerised systems . Computer systems should be designed and operated toprevent unauthorised entries or changes to theprogramme. In the case of manual entry of quality critical data thereshould be a second independent check to verify accuracyof the initial entry. A back-up system should be provided of all quality criticaldata.TOTAL QUALITY MANAGEMENT26

Advantages of tqm Improves reputation- faults and problems are spotted andsorted quicker. Higher employee morale- workers motivated by extraresponsibility ,team work and involvement indecisions oftqm. Lower cost. Decrease waste as fewer defective products and no needfor separate.TOTAL QUALITY MANAGEMENT27

Disadvantages of tqm Initial introduction cost. Benefits may not be seen for several years. Workers may be resistant to change.TOTAL QUALITY MANAGEMENT28

A model for organization management.TOTAL QUALITY MANAGEMENT29

Models of tqmTOTAL QUALITY MANAGEMENT30

BENEFITS OF TOTAL QUALITYMANAGEMENT Financial benefits include lower costs, higher returns on sales andinvestment, and the ability to charge higher rather thancompetitive prices.Improved access to global markets, higher customer retentionlevels, lessTime required to develop new innovations, and a reputation as aquality firm.Total quality management (tqm) is one such approach that seeksto improve quality andPerformance which will meet or exceed customer expectations.TOTAL QUALITY MANAGEMENT31

CONCLUSION: TQM encourages participation amongst employees, managers and organizationas whole. Using Quality management reduces rework nearly to zero in an achievable goal.The responsibilities either its professional, social, legal one that rest with thepharmaceutical manufacturer for the assurance of quality of product aretremendous and it can only be achieved by well organised. Work culture and complete engagement of the employees at the work place. Itshould be realized that national & international regulations must beimplemented systematically and process. Control should be practiced rigorously. Thus quality is critically important ingredient to organisational success todaywhich can be achieved by TQM, an organisational approach that focusses onquality as an over achieving goals, aimed at aimed at the prevention of defectsrather than detection of defects.TOTAL QUALITY MANAGEMENT32

Reference: Text book of Total Quality Management by L.Suganthiand Anand A.Samuel,2nd edition,2005,page no.49-61. Total Quality Management by R.S Nagarajan,A.A.Arivalangar,new age international publishers,1stedition,2009,page no.21. www.slideshare.com/tqm in pharma industry.TOTAL QUALITY MANAGEMENT33

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BP 606T (VI sem) Dr. Abhishek Pandey Assistant Professor School of Studies in Pharmaceutical Sciences, Jiwaji University, Gwalior. Contents Introduction. Concepts of tqm. Benefits of tqm. Characteristics of tqm. Key