uality is one of the most important management principles for any organization regardless of industry. This is particularly true for the pharmaceutical sector: maintaining quality product standards is essential for the prevention and treatment of numerous medical disorders.
Although the pharmaceutical industry has been around for centuries, in recent years we have experienced an increase in the number of drugs being launched in the market. As a result of this increase, the need for quality assurance and quality control measures has risen. For instance, drug manufacturers must follow strict guidelines to get their drugs approved by the FDA (Food and Drug Administration) in the United States. Such guidelines include requirements for testing, manufacturing, labelling, packaging, storing and distributing pharmaceuticals.
Quality Management
Quality management is a crucial component of any successful organization as it ensures that products and services are produced and distributed consistently and effectively.
Good Manufacturing Practice (GMP) is the element of quality management that ensures goods are produced and controlled according to the quality standards of their intended use and that they meet the requirements specified by the marketing authorization or product specification. Additionally, it ensures that manufactured goods are safe, of high quality, and effective. For pharmaceutical companies, GMP entails the monitoring of procedures, apparatuses, employees, and environments.
Quality planning, quality control, and quality assurance are all important aspects of quality management too. We’ll look at what quality management is, why it’s important, and the main components and principles of quality management in this article.
Quality planning
Quality planning refers to the process of defining the quality requirements and standards of a product or service and identifying the resources needed to meet such requirements and standards. The planning phase is the first stage in establishing a good quality management system. It is in this phase that companies define their baseline quality objectives. Once goals have been set, organizations must determine what is required to achieve these objectives and what procedures should be implemented to ensure their success. During this stage of the quality management process, it is important to keep in mind the following considerations:
The organization’s definition of success
How often procedures and processes will be evaluated for improvement
If the stakeholders have any quality-related priorities, goals, or ambitions
If there are any legal procedures or standards that must be followed in order to achieve the desired quality level
Quality Control
Quality control is the next step in the quality management process. At this stage, companies assess through physical inspection and testing whether their plan is achievable.
NMW-NHTP-DPH-FY17: Reduce Incidence of Delinquent IH Survey ReportsAmanda Marie
Lean Six Sigma Green Belt Process Improvement Project.
Industrial Hygiene Surveys were delinquent in meeting the 45 day policy requirement.
Baseline process had a mean of 42 days with a standard deviation of 30 Days. Improved process has a mean of 25 days with a standard deviation of 8 days.
Reduced DPMO by 375,813. Out of Specification was reduced by 98% from 38.51% to .93%.
uality is one of the most important management principles for any organization regardless of industry. This is particularly true for the pharmaceutical sector: maintaining quality product standards is essential for the prevention and treatment of numerous medical disorders.
Although the pharmaceutical industry has been around for centuries, in recent years we have experienced an increase in the number of drugs being launched in the market. As a result of this increase, the need for quality assurance and quality control measures has risen. For instance, drug manufacturers must follow strict guidelines to get their drugs approved by the FDA (Food and Drug Administration) in the United States. Such guidelines include requirements for testing, manufacturing, labelling, packaging, storing and distributing pharmaceuticals.
Quality Management
Quality management is a crucial component of any successful organization as it ensures that products and services are produced and distributed consistently and effectively.
Good Manufacturing Practice (GMP) is the element of quality management that ensures goods are produced and controlled according to the quality standards of their intended use and that they meet the requirements specified by the marketing authorization or product specification. Additionally, it ensures that manufactured goods are safe, of high quality, and effective. For pharmaceutical companies, GMP entails the monitoring of procedures, apparatuses, employees, and environments.
Quality planning, quality control, and quality assurance are all important aspects of quality management too. We’ll look at what quality management is, why it’s important, and the main components and principles of quality management in this article.
Quality planning
Quality planning refers to the process of defining the quality requirements and standards of a product or service and identifying the resources needed to meet such requirements and standards. The planning phase is the first stage in establishing a good quality management system. It is in this phase that companies define their baseline quality objectives. Once goals have been set, organizations must determine what is required to achieve these objectives and what procedures should be implemented to ensure their success. During this stage of the quality management process, it is important to keep in mind the following considerations:
The organization’s definition of success
How often procedures and processes will be evaluated for improvement
If the stakeholders have any quality-related priorities, goals, or ambitions
If there are any legal procedures or standards that must be followed in order to achieve the desired quality level
Quality Control
Quality control is the next step in the quality management process. At this stage, companies assess through physical inspection and testing whether their plan is achievable.
NMW-NHTP-DPH-FY17: Reduce Incidence of Delinquent IH Survey ReportsAmanda Marie
Lean Six Sigma Green Belt Process Improvement Project.
Industrial Hygiene Surveys were delinquent in meeting the 45 day policy requirement.
Baseline process had a mean of 42 days with a standard deviation of 30 Days. Improved process has a mean of 25 days with a standard deviation of 8 days.
Reduced DPMO by 375,813. Out of Specification was reduced by 98% from 38.51% to .93%.
Overview of 3 day Lean & Kaizen Course ContentTimothy Wooi
Objectives of the course is to equip participants with tools
and knowledge on Lean Manufacturing in a competitive World Class Business requirements.
Upon completion of the 3 day course,participants will be equip with knowledge allowing them to lead Kaizen workshops.
COURSE
The training is an intensive 3 days course covering all aspects of Lean Manufacturing in a World Class (WCM) environment.
The training course covers understanding of world class
requirements and using tools associated with WCM to perform Kaizen events to eliminate waste so as to be competitive in the fast changing business world. The training includes a mix of workshop exercises, group
and simulations using tools to give participants a real understanding to apply concepts in real work place to eliminate Waste to be Competitive.
For details email timothywooi2@gmail.com.
On the occasion of CII 1000 Visionary SME Programme Launch on 17th July 2013 in New Delhi, Pravesh Srivastava, Group President for Excellence in Manufacturing and Education, Anand Automotive Limited shared the success story. With learnings from VSME we have started our own "SSI Sahastra SME Institute". Under the leadership of Mr Deep Anand we have dedicated team of more than 150 managers and 250 engineers to transform our tier 2 companies in 3 years. We will also help other companies through CII to develop their SME's to achieve the target of 1000 SME's in next 3 years.
For more information, please contact p.girish@cii.in
Provides an introduction to Lean Management and its application along with video links. The slide also details the improvement cycle with Value added, non-value added and waste in any activity or process. This slide focuses on the time and motion study and how to observe the process. This helps identify process time and determine if the process is value-added. Helps anyone who wants an idea on starting process analysis and continuous improvement in office and factory environments to reduce waste and get cost-effectiveness. Provides an overview of the lean tools and some videos to expand the basic knowledge. Provides a link for the file download for direct observation.
Links for the video & Files
https://www.youtube.com/watch?v=wfsRAZUnonI
https://www.youtube.com/watch?v=yZvsqm4Jok8
https://files.fm/f/2uhf7y8er
https://www.youtube.com/watch?v=PHOppLiEG0o
https://www.youtube.com/watch?v=jmTOuHxc4nE
https://www.youtube.com/watch?v=yOLfe37gq4g
Overview of 3 day Lean & Kaizen Course ContentTimothy Wooi
Objectives of the course is to equip participants with tools
and knowledge on Lean Manufacturing in a competitive World Class Business requirements.
Upon completion of the 3 day course,participants will be equip with knowledge allowing them to lead Kaizen workshops.
COURSE
The training is an intensive 3 days course covering all aspects of Lean Manufacturing in a World Class (WCM) environment.
The training course covers understanding of world class
requirements and using tools associated with WCM to perform Kaizen events to eliminate waste so as to be competitive in the fast changing business world. The training includes a mix of workshop exercises, group
and simulations using tools to give participants a real understanding to apply concepts in real work place to eliminate Waste to be Competitive.
For details email timothywooi2@gmail.com.
On the occasion of CII 1000 Visionary SME Programme Launch on 17th July 2013 in New Delhi, Pravesh Srivastava, Group President for Excellence in Manufacturing and Education, Anand Automotive Limited shared the success story. With learnings from VSME we have started our own "SSI Sahastra SME Institute". Under the leadership of Mr Deep Anand we have dedicated team of more than 150 managers and 250 engineers to transform our tier 2 companies in 3 years. We will also help other companies through CII to develop their SME's to achieve the target of 1000 SME's in next 3 years.
For more information, please contact p.girish@cii.in
Provides an introduction to Lean Management and its application along with video links. The slide also details the improvement cycle with Value added, non-value added and waste in any activity or process. This slide focuses on the time and motion study and how to observe the process. This helps identify process time and determine if the process is value-added. Helps anyone who wants an idea on starting process analysis and continuous improvement in office and factory environments to reduce waste and get cost-effectiveness. Provides an overview of the lean tools and some videos to expand the basic knowledge. Provides a link for the file download for direct observation.
Links for the video & Files
https://www.youtube.com/watch?v=wfsRAZUnonI
https://www.youtube.com/watch?v=yZvsqm4Jok8
https://files.fm/f/2uhf7y8er
https://www.youtube.com/watch?v=PHOppLiEG0o
https://www.youtube.com/watch?v=jmTOuHxc4nE
https://www.youtube.com/watch?v=yOLfe37gq4g
Things to remember while upgrading the brakes of your carjennifermiller8137
Upgrading the brakes of your car? Keep these things in mind before doing so. Additionally, start using an OBD 2 GPS tracker so that you never miss a vehicle maintenance appointment. On top of this, a car GPS tracker will also let you master good driving habits that will let you increase the operational life of your car’s brakes.
What Exactly Is The Common Rail Direct Injection System & How Does It WorkMotor Cars International
Learn about Common Rail Direct Injection (CRDi) - the revolutionary technology that has made diesel engines more efficient. Explore its workings, advantages like enhanced fuel efficiency and increased power output, along with drawbacks such as complexity and higher initial cost. Compare CRDi with traditional diesel engines and discover why it's the preferred choice for modern engines.
Ever been troubled by the blinking sign and didn’t know what to do?
Here’s a handy guide to dashboard symbols so that you’ll never be confused again!
Save them for later and save the trouble!
Fleet management these days is next to impossible without connected vehicle solutions. Why? Well, fleet trackers and accompanying connected vehicle management solutions tend to offer quite a few hard-to-ignore benefits to fleet managers and businesses alike. Let’s check them out!
Why Is Your BMW X3 Hood Not Responding To Release CommandsDart Auto
Experiencing difficulty opening your BMW X3's hood? This guide explores potential issues like mechanical obstruction, hood release mechanism failure, electrical problems, and emergency release malfunctions. Troubleshooting tips include basic checks, clearing obstructions, applying pressure, and using the emergency release.
What Does the PARKTRONIC Inoperative, See Owner's Manual Message Mean for You...Autohaus Service and Sales
Learn what "PARKTRONIC Inoperative, See Owner's Manual" means for your Mercedes-Benz. This message indicates a malfunction in the parking assistance system, potentially due to sensor issues or electrical faults. Prompt attention is crucial to ensure safety and functionality. Follow steps outlined for diagnosis and repair in the owner's manual.
Core technology of Hyundai Motor Group's EV platform 'E-GMP'Hyundai Motor Group
What’s the force behind Hyundai Motor Group's EV performance and quality?
Maximized driving performance and quick charging time through high-density battery pack and fast charging technology and applicable to various vehicle types!
Discover more about Hyundai Motor Group’s EV platform ‘E-GMP’!
"Trans Failsafe Prog" on your BMW X5 indicates potential transmission issues requiring immediate action. This safety feature activates in response to abnormalities like low fluid levels, leaks, faulty sensors, electrical or mechanical failures, and overheating.
Symptoms like intermittent starting and key recognition errors signal potential problems with your Mercedes’ EIS. Use diagnostic steps like error code checks and spare key tests. Professional diagnosis and solutions like EIS replacement ensure safe driving. Consult a qualified technician for accurate diagnosis and repair.
𝘼𝙣𝙩𝙞𝙦𝙪𝙚 𝙋𝙡𝙖𝙨𝙩𝙞𝙘 𝙏𝙧𝙖𝙙𝙚𝙧𝙨 𝙞𝙨 𝙫𝙚𝙧𝙮 𝙛𝙖𝙢𝙤𝙪𝙨 𝙛𝙤𝙧 𝙢𝙖𝙣𝙪𝙛𝙖𝙘𝙩𝙪𝙧𝙞𝙣𝙜 𝙩𝙝𝙚𝙞𝙧 𝙥𝙧𝙤𝙙𝙪𝙘𝙩𝙨. 𝙒𝙚 𝙝𝙖𝙫𝙚 𝙖𝙡𝙡 𝙩𝙝𝙚 𝙥𝙡𝙖𝙨𝙩𝙞𝙘 𝙜𝙧𝙖𝙣𝙪𝙡𝙚𝙨 𝙪𝙨𝙚𝙙 𝙞𝙣 𝙖𝙪𝙩𝙤𝙢𝙤𝙩𝙞𝙫𝙚 𝙖𝙣𝙙 𝙖𝙪𝙩𝙤 𝙥𝙖𝙧𝙩𝙨 𝙖𝙣𝙙 𝙖𝙡𝙡 𝙩𝙝𝙚 𝙛𝙖𝙢𝙤𝙪𝙨 𝙘𝙤𝙢𝙥𝙖𝙣𝙞𝙚𝙨 𝙗𝙪𝙮 𝙩𝙝𝙚 𝙜𝙧𝙖𝙣𝙪𝙡𝙚𝙨 𝙛𝙧𝙤𝙢 𝙪𝙨.
Over the 10 years, we have gained a strong foothold in the market due to our range's high quality, competitive prices, and time-lined delivery schedules.
5 Warning Signs Your BMW's Intelligent Battery Sensor Needs AttentionBertini's German Motors
IBS monitors and manages your BMW’s battery performance. If it malfunctions, you will have to deal with an array of electrical issues in your vehicle. Recognize warning signs like dimming headlights, frequent battery replacements, and electrical malfunctions to address potential IBS issues promptly.
In this presentation, we have discussed a very important feature of BMW X5 cars… the Comfort Access. Things that can significantly limit its functionality. And things that you can try to restore the functionality of such a convenient feature of your vehicle.
2. Introduction to the team
TEAM MEMBERS
B V Mahesh Vinay A.M. Suresh T V G Reddy Vasanth
36 40 55 3 Trainee
40 27 29 52 20
20 7 11 30 2
QC QC QA PD QC
TEAM Advisor: T V G Reddy
TEAM Leader : Ravi Rao
Plant : Suma Spring
Deptt. : Production
Sect. : Winding
Circle Name : Improvement of Productivity
Theme : Productivity Improve with Operator fatigue Reduce
Member 1 Member 2 Member 3 Member 4 Member 5 Observer Observer
Name
ECode
Age
Exp
Cycle : Winter / Summer
Date of Registration :
14.05.2016.
Section
3. Activity Plan
START OF NH ACTIVITIES : Jan- 2016 Month
COMPLETION OF NH ACTIVITIES : June-2016 Month
PLAN
ACTUAL
SR.
NO.
ACTIVITIES PDCA RESP. Jan-16 Feb-16 Mar-16 Apr-16 May-16
1. Selection of Theme A N
2. Study of current situation TVG R
3 Goal / Objective setting A M S
4 Identification of Causes Team
5 Planning of C.Measures &
assigning responsibilities
Team
6 Implementation of Counter
Measures
Team
7 Countermeasure
effectiveness check
Ravi Rao
8 Prevention and
Standardization
Ravi Rao
9 Presentation Preparation Suresh
P
P
P
D
D
D
C
C
A
4. Reason for Selection
Avoid Operator Fatigue
• Doing manual operation will create more pain
on operator hand will cause to frequent Leaves
from them.
Improve productivity
• Produced Quantity Less and rejection Quantity
more with current Manual process.
Reduce Manpower
• With Manual unable to balance with the
machine produced quantity which is causing to
extra manpower.
5. Flow Diagram- Before Improvement
Received Raw
material from
Supplier
Inspection of
Raw material
Winding
Rolling Bending
(Manual)
Heat treatment
Identification
mark
Final Inspection
Surface
treatment / oiling
Packing
Despatch
7. Manual Vs. Pneumatic
Manual Tool for Hook Bending Pneumatic Tool for Hook Bending
Pneumatic Run Rate = 22 Pcs/Min
Operator Run Rate = 6 Pcs/Min
with operator Fatigue / 2 operators
8. Manual Tool for Hook Bending Pneumatic Tool for Hook Bending
Pneumatic Run Rate = 22 Pcs/Min
Operator Run Rate = 6 Pcs/Min per
operator with Fatigue
Manual Vs. Pneumatic
Before Improvement After Improvement
9. Benefits / Learning
FI.NO Before Improvement After Improvement
1 More difficult to operate with
manual which will create Hand
elbow & shoulder pain
Pneumatic piston with gear operating
tool
2 2 Manpower to balance the M/c
quantity for the Hook bending
operation.
Machine operator itself handling the
hook bending process in Pneumatic
3 12 Pcs /Min with 2 operator 22 Pcs /Min with Single Machine
Operator.
4 Unable to meet the customer
schedule with all HMSI Units
Able to meet more then scheduled
quantity with all HMSI Units.
5 Difficult to Handle & setup the tool
every time.
Easy to handle & attached with the
Machine.
10. Received Raw
material from
Supplier
Inspection of
Raw material
Winding
Rolling Bending
(Pneumatic)
Heat treatment
Identification
mark
Final Inspection
Surface
treatment / oiling
Packing
Despatch
Flow Diagram- After Improvement