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MANUFACTURING
PRESENTED BY-
MISS. VAISHALI V. DUDHABALE
M. PH. F. Y. SEM II (QAT)
GUIDED BY-
DR. SONALI MAHAPARLE
PROF., DR. D. Y. PATIL COLLEGE OF
PHARMACY, AKURDI PUNE.
MANUFACTURING
The process of converting raw materials, components, or parts into finished goods that meet a customer's
expectations or specifications. Manufacturing commonly employs a man-machine setup with division of
labor in a large scale production.
Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by
pharmaceutical companies. The process of drug manufacturing can be broken down into a series of unit
operations, such as milling, granulation, coating, tablet pressing, and others.
Today most firms are interested in a strategic approach for improving productivity and quality in their
organizations.
AUTOMATED MANUFACTURING
The march to automation proceeds unbated.
SOME IMP TERMS:
 Computer-integrated manufacturing(CIM)
 Computer-aided manufacturing(CAM)
 Computer-aided design(CAD)
This trio is producing huge increase in factory productivity. But automation, with proper planning has
large benefits-
BENEFITS OF AUTOMATION
 1. Elimination of fatigue tasks that result in human error.
 2. Reduction in process variation.
 3. Reduction in important process trouble, i.e., no. of machine setups.
 4. Automatic data record, feedback, thus reducing impending troubles.
 5.CAD provides approach of various changes without any efforts.
Thus, this advancement of computer based manufacturing is called as-
“ADVANCED MANUFACTURING SYSTEMS”
AMS SPECTRUM
 To achieve the benefits of automated manufacturing spectrum of concepts and techniques are
required, viz, are:
 Key functions of CIM
 Group technology
 Flexible manufacturing system
1. KEY FUNCTIONS OF CIM
 CIM integrates engineering and production with suppliers and customers to interactively design, plan and
conduct the manufacturing activities.
CIM
ACTIVITIES
MANUFACTUR
ING
PLANNING
COMPUTER
SIMULATION
MODELS
PREDICT
PROCESS
PREFORMANCE
PROVIDING DESIGN TOOL
2. GROUP TECHNOLOGY
 It is the process of examining all items, manufactured by a company to
identify those with sufficient similarity.
 The aim is to reduce the no. of new designs or new mfg plans.
 It can improve both the quality and conformance of proving new designs
and mfg plans.
 In many companies, strategy says that only 20% of plan requires new
design, 40% could be built from existing design and remaining 40%
could be created by modifying an existing design.
 Location from production machine can also be benefit from group
technology concept.
3.FLEXIBLE MANUFACTURING SYSTEM
 A FMS is a automated machine cell, consisting of a group of
processing workstations, interconnected with automated material
handling and storage system.
 FMS is most suited for mid-variety, mid-volume production range.
 The potential benefits of the automated factory require significant
time and resources for planning.
OVERALL REVIEW OF MANUFACTURING PLANNING
 Great risk is involved in going directly from proposed mfg process plan
into regular production.
 Review of proposed process should be done through preproduction trials
and runs effectively.
 “Preproduction”, is mostly avoided by many companies in practice or
otherwise it is limited to specific processes or products.
 Still, some companies strictly follow rules in which flexibility is a usual
approach, where preproduction depends on :-
CONT…
 The extent to which product embodies new or untested quality features.
 The extent to which design of mfg process embodies new or untried machines, tools, etc.
 The amount and value of product that will be out in the field before process, product, & use difficulties
fully known.
 These trials sometimes include “production validation tests” to ensure that full-scale process can meet
the design intent.
 Process qualification and process certification are also imp terms used in review of mfg process.
 Eg., The failure mode, effect, and criticality analysis is useful in analysing a proposed product design.
PROCESS QUALITYAUDITS
 A quality audit is an independent review to compare some aspect of quality performance with the
standard of that performance.
 Quality audit for manufacturing is extensive and includes both process and product audits.
PROCESS QUALITY AUDIT:-
 Done on any activity that can affect final product quality.
 Done usually by one or more persons and uses the process operating procedure.
 It is based on that report will help in determine and execute required corrective action.
.
PROCESS QUALITY AUDIT
ENGINEERING AUDIT
-conducted by QA engineer
-intense review of all process
steps
MONITOR AUDIT
-covers broad range of issues
-documentation is done in writing
-critical defects are corrected
immediately, majors & minors are
corrected within next 5 days
.
 PRODUCT QUALITY AUDIT
It involves reinspection of product to verify the adequacy of acceptance and rejection decisions.
Such audit have little importance in theory, but in practice it should be carried out at each station pf
production.
Its criticality depends upon field complaints.
Sometimes the audit is required, before the product may be moved to the next operation.
QUALITYAND PRODUCTION FLOOR CULTURE
 Culture is manifested in collective behaviours and is the set of shared
beliefs, attitudes, values, goals, and practices that characterizes an
institution or organization.
 A Quality Culture is one in which employees “live” Quality in all their
actions. No defects are passed to the next person.
 A Quality Culture is the organizational capabilities, its habits and beliefs,
that enable it to design and deliver products and services that can meet
customer needs and be successful in the market place over the long term.
DIFFERENCE IN OLD AND NEW CULTURE
PROBLEMS IN TRADITIONAL
CULTURE
• Not working across functions
• Management abdicating quality
• Customer focus
• Conflicting strategies
• Growth strategies
• Alignment
• Cost reduction vs. quality improvement
• Poor planning Source
IMPROVEMENTS IN NEW QUALITY CULTURE
• Moving from cost based to value based quality
• Process efficiency and effectiveness
• Integrate Six Sigma-like programs
• Process
• Regular check
• Bi-lingual employees
• Multi-tasking employees
• performance improvement
CHANGE TRADITIONAL CULTURE INTO QUALITY
CULTURE- HOW?
 .
FOUNDATIONAL ELEMENTS OF QUALITY CULTURE
 Leadership commitment
 Quality Infrastructure
 Employee empowerment
 Customer focus
 Teamwork and collaboration
 Continuous Process Improvement
BENEFITS OF QUALITY CULTURE
CLIENTS EMPLOYEES ORGANIZATION
Improved services Pride in services delivered Improved/expanded services
Improved choices Job satisfaction Client oriented employees
and improved client relations
Expectations met or
exceeded
Improved
communications
Improved community
relations = better political
relations
Client oriented employees Streamlined work
processes
Lower costs/cost contained
Friendlier
atmosphere
Strong client relationships Improved funding
REFERNCES
 Juran’s Quality Planning and Analysis for Enterprise Quality, 5TH edditition, Forward
by Joseph M. Jurans, et. Al, pg. no. 394-426.
Manufacturing

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Manufacturing

  • 1. MANUFACTURING PRESENTED BY- MISS. VAISHALI V. DUDHABALE M. PH. F. Y. SEM II (QAT) GUIDED BY- DR. SONALI MAHAPARLE PROF., DR. D. Y. PATIL COLLEGE OF PHARMACY, AKURDI PUNE.
  • 2. MANUFACTURING The process of converting raw materials, components, or parts into finished goods that meet a customer's expectations or specifications. Manufacturing commonly employs a man-machine setup with division of labor in a large scale production. Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others. Today most firms are interested in a strategic approach for improving productivity and quality in their organizations.
  • 3. AUTOMATED MANUFACTURING The march to automation proceeds unbated. SOME IMP TERMS:  Computer-integrated manufacturing(CIM)  Computer-aided manufacturing(CAM)  Computer-aided design(CAD) This trio is producing huge increase in factory productivity. But automation, with proper planning has large benefits-
  • 4. BENEFITS OF AUTOMATION  1. Elimination of fatigue tasks that result in human error.  2. Reduction in process variation.  3. Reduction in important process trouble, i.e., no. of machine setups.  4. Automatic data record, feedback, thus reducing impending troubles.  5.CAD provides approach of various changes without any efforts. Thus, this advancement of computer based manufacturing is called as- “ADVANCED MANUFACTURING SYSTEMS”
  • 5. AMS SPECTRUM  To achieve the benefits of automated manufacturing spectrum of concepts and techniques are required, viz, are:  Key functions of CIM  Group technology  Flexible manufacturing system
  • 6. 1. KEY FUNCTIONS OF CIM  CIM integrates engineering and production with suppliers and customers to interactively design, plan and conduct the manufacturing activities. CIM ACTIVITIES MANUFACTUR ING PLANNING COMPUTER SIMULATION MODELS PREDICT PROCESS PREFORMANCE PROVIDING DESIGN TOOL
  • 7. 2. GROUP TECHNOLOGY  It is the process of examining all items, manufactured by a company to identify those with sufficient similarity.  The aim is to reduce the no. of new designs or new mfg plans.  It can improve both the quality and conformance of proving new designs and mfg plans.  In many companies, strategy says that only 20% of plan requires new design, 40% could be built from existing design and remaining 40% could be created by modifying an existing design.  Location from production machine can also be benefit from group technology concept.
  • 8. 3.FLEXIBLE MANUFACTURING SYSTEM  A FMS is a automated machine cell, consisting of a group of processing workstations, interconnected with automated material handling and storage system.  FMS is most suited for mid-variety, mid-volume production range.  The potential benefits of the automated factory require significant time and resources for planning.
  • 9. OVERALL REVIEW OF MANUFACTURING PLANNING  Great risk is involved in going directly from proposed mfg process plan into regular production.  Review of proposed process should be done through preproduction trials and runs effectively.  “Preproduction”, is mostly avoided by many companies in practice or otherwise it is limited to specific processes or products.  Still, some companies strictly follow rules in which flexibility is a usual approach, where preproduction depends on :-
  • 10. CONT…  The extent to which product embodies new or untested quality features.  The extent to which design of mfg process embodies new or untried machines, tools, etc.  The amount and value of product that will be out in the field before process, product, & use difficulties fully known.  These trials sometimes include “production validation tests” to ensure that full-scale process can meet the design intent.  Process qualification and process certification are also imp terms used in review of mfg process.  Eg., The failure mode, effect, and criticality analysis is useful in analysing a proposed product design.
  • 11. PROCESS QUALITYAUDITS  A quality audit is an independent review to compare some aspect of quality performance with the standard of that performance.  Quality audit for manufacturing is extensive and includes both process and product audits. PROCESS QUALITY AUDIT:-  Done on any activity that can affect final product quality.  Done usually by one or more persons and uses the process operating procedure.  It is based on that report will help in determine and execute required corrective action.
  • 12. . PROCESS QUALITY AUDIT ENGINEERING AUDIT -conducted by QA engineer -intense review of all process steps MONITOR AUDIT -covers broad range of issues -documentation is done in writing -critical defects are corrected immediately, majors & minors are corrected within next 5 days
  • 13.
  • 14. .  PRODUCT QUALITY AUDIT It involves reinspection of product to verify the adequacy of acceptance and rejection decisions. Such audit have little importance in theory, but in practice it should be carried out at each station pf production. Its criticality depends upon field complaints. Sometimes the audit is required, before the product may be moved to the next operation.
  • 15. QUALITYAND PRODUCTION FLOOR CULTURE  Culture is manifested in collective behaviours and is the set of shared beliefs, attitudes, values, goals, and practices that characterizes an institution or organization.  A Quality Culture is one in which employees “live” Quality in all their actions. No defects are passed to the next person.  A Quality Culture is the organizational capabilities, its habits and beliefs, that enable it to design and deliver products and services that can meet customer needs and be successful in the market place over the long term.
  • 16. DIFFERENCE IN OLD AND NEW CULTURE PROBLEMS IN TRADITIONAL CULTURE • Not working across functions • Management abdicating quality • Customer focus • Conflicting strategies • Growth strategies • Alignment • Cost reduction vs. quality improvement • Poor planning Source IMPROVEMENTS IN NEW QUALITY CULTURE • Moving from cost based to value based quality • Process efficiency and effectiveness • Integrate Six Sigma-like programs • Process • Regular check • Bi-lingual employees • Multi-tasking employees • performance improvement
  • 17. CHANGE TRADITIONAL CULTURE INTO QUALITY CULTURE- HOW?  .
  • 18. FOUNDATIONAL ELEMENTS OF QUALITY CULTURE  Leadership commitment  Quality Infrastructure  Employee empowerment  Customer focus  Teamwork and collaboration  Continuous Process Improvement
  • 19. BENEFITS OF QUALITY CULTURE CLIENTS EMPLOYEES ORGANIZATION Improved services Pride in services delivered Improved/expanded services Improved choices Job satisfaction Client oriented employees and improved client relations Expectations met or exceeded Improved communications Improved community relations = better political relations Client oriented employees Streamlined work processes Lower costs/cost contained Friendlier atmosphere Strong client relationships Improved funding
  • 20. REFERNCES  Juran’s Quality Planning and Analysis for Enterprise Quality, 5TH edditition, Forward by Joseph M. Jurans, et. Al, pg. no. 394-426.