This document discusses principles of continuous manufacturing improvement. It begins by explaining why continuous improvement is important due to continuous changes in customer demands, technology, and competition. It then outlines key stakeholders in improvement and drivers of improvement such as waste reduction, cycle time reduction, yield improvement, and people involvement. Specific types of waste are defined and examples are provided. The importance of cycle time reduction is explained, and concepts of horizontal and vertical cycle times are introduced. Finally, approaches to cycle time improvement are discussed, including clarifying supply chain structure, process mapping, benchmarking, and implementing an action plan.
Corrective Actions and Preventive Actions.Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. Corrective vs. Preventive Action. Quality professionals frequently express confusion as to the difference between corrective and preventive action. A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur.
In Industry there are lots failures related to the routine process, Equipment and System by one or other means.
So one must analyze control such failures in manner that it will not affect your ultimate output and obviously that is your Product and its Quality.
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
The ultimate guide on constructing a FMEA process for Manufacturing, Maintenance, Services and Design.
The presentation include step by step on how to determine the failure modes, failure effects, assign severity, assign occurrence, assign detection, calculate risk priority numbers and prioritize the RPNs for action. With some examples and illustrations.
Presentation contents:
1. Determing failure modes, effects and causes.
2. FMEA team & team leader.
3. Brainstorming.
4. The basic steps of FMEA.
5. Examples.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
Find the way to prevent the human error in industries as well as 16 types of human errors for better identification and generating solution for given identified errors
Introduction to Understanding Human errors in Pharmaceutical IndustriesKarishmaRK
Human errors are inevitable part of our day-to-day activities. However, in highly regulated work environments, such errors can lead to huge losses. The presentation aims at introducing the concept of Human errors in regulated GMP work-space and its widely accepted classification for better evaluation & prevention.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Sense of urgency, lessons learned, organizational alignment, team approach, training and an increasing engineering and statistical capability at CDER FDA can be expected to facilitate a move by industry towards continues manufacturing, FDA’s current emphasis on ‘statistical confidence’, Process Validation Guidance 2011, is likely to highlight certain issues (e.g., special causes) within current batch processing; these observation will need to be addressed in an appropriate risk-based manner
Ensuring that pragmatic consideration for specifications & control (intended use) is essential and importance of pragmatic decisions should not be forgotten (e.g., as in case of Design Space Vs. SUPAC), Effective regulatory communication (considering the engineering and statistical emphasis) will be crucial for ensuring regulatory uncertainty is managed in a timely manner,
Prof Alastair Florence
Presentation at EIPG - Royal Pharmaceutical Society Scientific Symposium "Advances in Technology Impacting the Pharmaceutical Industry" at the University of Strathclyde, Glasgow 2015.
Corrective Actions and Preventive Actions.Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. Corrective vs. Preventive Action. Quality professionals frequently express confusion as to the difference between corrective and preventive action. A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur.
In Industry there are lots failures related to the routine process, Equipment and System by one or other means.
So one must analyze control such failures in manner that it will not affect your ultimate output and obviously that is your Product and its Quality.
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
The ultimate guide on constructing a FMEA process for Manufacturing, Maintenance, Services and Design.
The presentation include step by step on how to determine the failure modes, failure effects, assign severity, assign occurrence, assign detection, calculate risk priority numbers and prioritize the RPNs for action. With some examples and illustrations.
Presentation contents:
1. Determing failure modes, effects and causes.
2. FMEA team & team leader.
3. Brainstorming.
4. The basic steps of FMEA.
5. Examples.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
Find the way to prevent the human error in industries as well as 16 types of human errors for better identification and generating solution for given identified errors
Introduction to Understanding Human errors in Pharmaceutical IndustriesKarishmaRK
Human errors are inevitable part of our day-to-day activities. However, in highly regulated work environments, such errors can lead to huge losses. The presentation aims at introducing the concept of Human errors in regulated GMP work-space and its widely accepted classification for better evaluation & prevention.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Sense of urgency, lessons learned, organizational alignment, team approach, training and an increasing engineering and statistical capability at CDER FDA can be expected to facilitate a move by industry towards continues manufacturing, FDA’s current emphasis on ‘statistical confidence’, Process Validation Guidance 2011, is likely to highlight certain issues (e.g., special causes) within current batch processing; these observation will need to be addressed in an appropriate risk-based manner
Ensuring that pragmatic consideration for specifications & control (intended use) is essential and importance of pragmatic decisions should not be forgotten (e.g., as in case of Design Space Vs. SUPAC), Effective regulatory communication (considering the engineering and statistical emphasis) will be crucial for ensuring regulatory uncertainty is managed in a timely manner,
Prof Alastair Florence
Presentation at EIPG - Royal Pharmaceutical Society Scientific Symposium "Advances in Technology Impacting the Pharmaceutical Industry" at the University of Strathclyde, Glasgow 2015.
glendimplex manufacturing improvement changeNigel Charles
Rework Trend Improvement
Relocation of testing Area
T Card Torque Control System
Kamishibal Job Instruction Sheet
T Card Process Parts Hourly Delivery Status
Rebalance of Range Line 12.
This slide set is a work in progress and is embedded in my Principles of Finance course, which is also a work in progress, that I teach to computer scientists and engineers
http://awesomefinance.weebly.com/
Beyond financing, your syndicate can be a boon to scaling and overcoming obstacles in your startup. Streamline keeping them in the loop by using this compact deck.
Details
~In 6 slides covers all the essential details your syndicate cares about
~Contains tips and step-by-guide to walk you through best practices (see the "Notes" area)
~PPT format for easy modification
Periodic Reassessment, Continuous Improvement of Finance OperationsCognizant
A well-considered and executed transformation roadmap can help finance keep pace with emerging technologies and service delivery models, as well as advance key business objectives.
A Manufacturer’s Perspective on Innovations in BiomanufacturingKBI Biopharma
A presentation by Abhinav A. Shukla, Ph.D., KBI's Vice President of Process Development & Manufacturing delivered at the IBC’s Biopharmaceutical Development & Production Week, Huntington Beach, CA (2013)
While there are several approaches - all of which you should explore to find the best fit - this template captures our thoughts on a well put-together board deck.
Details
~20+ slides covering department updates, cash projections, roadmaps, and a whole lot more
~Contains tips and step-by-guide to walk you through best practices (see the "Notes" area in PPT)
~PPT format for easy modification
This presentation gives an overview of the proposed activities, recommendations and success factors for a software organization that wishes to implement a process improvement initiative
Improving continuous process operation using data analytics delta v applicati...Emerson Exchange
Quality parameters are available through lab measurements and the final product quality changes may go undetected until a lab sample is taken. Continuous data analytics tool provided on-line prediction of quality parameters and fault detection. Field trial results from a carbon dioxide absorption/stripping process at the UT/Austin Separations Research Program will be presented in this workshop.
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12. Performance: Customer (2/2) Innovation time to market / time to volume market price; market share learning curve; rate of improvement Service product support at the customer customer satisfaction; =loyalty !
44. “Waste related with time” waiting on material watching the machine run production of defect products (scrap) looking for tools repairing the machine producing needless products ..............etc.
45.
46. “Waste related with time” Where are the losses? What is the available time? How much of this time is really used? ‘Total Productive Maintenance’ (TPM): ‘Overall Equipment Effectiveness’(OEE)
47. “Waste related with time” dimension = [time] closed Company (open) Time available No production
48. “Effective use of time” AT = Available Time OT = Operational Time Standstill Speed PT = Production Time ET = Effective Time Quality Dimension = [time]
49. “The six big losses” Standstill losses caused by: adjustments machine defects Speed losses caused by: many little stops lower set point speed Quality losses caused by: producing defect products (‘yield’) start up PARETO !
50. “Overall Equipment Effectiveness” Definition of ‘Overall Equipment Effectiveness’: O.E.E. = Availability x Performance x Quality (deviation: low = 0,4 | high = 0,8)
59. House keeping a place for everything & everything in its place the first step to improve the factory a ‘must’ for ‘manufacturing excellence’
60. 2. Cycle time (reduction) 1. Concept Why cycle time reduction What is cycle time How to measure cycle time 2. Approach General conceptfor management ofcycle time improvement What? Why? How?
64. “Messner” Conventional mountaineering strategy is based on massive amounts of support, including extra oxygen, thought essential for climbs over 25,000 feet. Men such as Sir Edmund Hillary and Chris Bonington relied on hundreds of guides who carried food, oxygen and other supplies; an American expedition to climb Everest in 1963 included 900 porters trudging up the mountain with 300 tons of equipment, Messner argues that under this strategy, the slowest man sets the pace. His goal is speed of execution. Although assisted by guides up the base of the mountain, Messner usually makes the final assault by himself, or with one other person, in a single day. He scaled the north face of Everest solo, without oxygen - one of the most severe mountaineering challenges ever attempted.
65. . Stage One: Baseline Material flow Customer service Material Control Sales Purchasing Production Distribution Stage Two: Functional Integration Material flow Customer service Materials Management Manufacturing Management Distribution Stage Three: Internal Integration Material flow Customer service Materials Management Manufacturing Management Distribution Stage Four: External Integration Material flow Customer service Internal Supply Chain Suppliers Customers
66. 10 9 Composite Performance Intermediary steps are transitional only 8 Extended Enterprise 7 6 STEP 7 5 Integrated Supply Chain 4 3 2 STEP 4 Functional 1 STEP 1 Informal Time Supply Chain management: progressing through four distinct stages of maturity
67.
68. Agile : “quick in movement : nimble”Hi “Lean” works best in high volume, low variety and predictable environments. “Agility” is needed in less predictable environments where the demand for variety is high. AGILE Variety / Complexity LEAN Lo Lo Hi Predictability
69. Total cycle time SUPPLIERS INTERNAL CUSTOMERS Attack non-value adding time & complexity. Apply flow concepts Partnership sourcing and synchronized supply Vendor managed inventory & continuous replenishment Total Cycle time (Days)
81. Horizontal & Vertical CT ‘Horizontal cycle time’: The time of activities, like production planning, procurement, production, order processing, transport, etc. ‘Vertical cycle time’: The time that an item spends on stock, keeping working capital and not generating income yet. This can be expressed in days of sales.
84. Total integral CT: 97 days48 time 21 18 Transport to customer transport to DC Order processing production: 20 1 3 4 distribution center time Raw materials Finished product warehouse Horizontal, vertical and total integral cycle time can be expressed graphically:
85.
86. Production is planned by discrete organizational units with batch feeds between discrete systems.
87.
88. Replenishment of all echelons is driven from actual sales/usage data collected at the customer interface.
89. Production is planned across functional boundaries from vendor to customer, through highly integrated systems, and minimum lead-times.
90.
91. Uses performance measures that are market-facing and process related, e.g. time-to-market, cost-to-serve, customer retention
95. General concept for cycle time improvement A. Clarifying supply chain structure B. Mapping of processes C. Benchmark study D. Logistic assessment, based upon structural evaluation of time aspects of all processes E. Action plan F. Measure and control
96.
97.
98. Cycle time reduction on the production floor /contents Setup time reduction Product oriented layout Flexible skills Leveled/mixed production KANBAN
133. efficiency of individual operations can be optimizedAlso a production line can be a clear area of responsibility Do we need them in the first place? Increasing diversity, shorter life cycles! Machines can be simplified; operators can broaden their skills Machines in a flowline urge to solve reasons of breakdowns Efficiency of the total process can be optimized!
140. flow of materials is hard to standardizeA production line for one product group can be easily planned Transportation eliminated Inventory in a production line is usually very low Short lead-times Tracing back errors is quite easy! Flow of materials is standardized automatically!
170. Infrequently ordered items (specialties), hardly fit within a Kan Ban systemFabrication Final-assembly Sub-assembly
171. Total Quality Control / Total Productive Maintenance Total Quality Control (Total Quality Management) Total Productive Maintenance (Total Productivity Management)