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How Quality Ensures Success
An Overview
GlaxoSmithKline (GSK) was formed from the December 2000 merger of Glaxo Welcome and SmithKline Beecham plc.
The $70 billion deal created the world's largest drug manufacturer and research-based pharmaceutical concern.
PRODUCTS
PRODUCTS
GlaxoSmithKline develops, manufacturers and markets:
pharmaceuticals, vaccines, over-the-counter medicines and health related consumer products
Our broad pharmaceutical product line includes:
antibiotic, antidepressant, gastrointestinal, dermatological, respiratory, cancer and cardiovascular medications
PRODUCTS
PRODUCTS
VISION
“We want to become the indisputable leader in our country, not simply in terms of size, but in how we use that size to achieve our mission and improve the quality of human life.”
MISSION
SPIRIT OF GSK
TOTAL QUALITY MANAGEMENT
SIX PILLARS
“Commitment” – the commitment from the top level to the operational level was observed during our visit as the lower staff and the strategic level gave the same answer for the quality that is to “follow the benchmark”.
“An unwavering focus on the both customers” – the organization believes that both internal and external customers are the key players in being profitable and so they never assist their stakeholders in every means to get the required output.
“Employee Involvement” – employee involvement acts as strong pillar in meeting the targets. The organization provides a linked database system through which every employee can contribute in terms of suggestions and ideas for growth and improvement.
SIX PILLARS
“Optimal use of resources” – they do understand the importance of the concept of scarce resources and thus tries to minimize the waste and get the optimal level of benefit from the raw material and other available resources.
“Treating suppliers as partners” – the output of the firm do depend on the quality of the raw material and differentiating on the basis of quality requires consistent and accurate level input with sustainable quality level and thus the organization has treated the supplier as their long term strategic alliance.
“Benchmarking” – GSK Pakistan over the period of time has developed its own standard, which includes ISO standards and their best practices.
QUALITY POLICY
QUALITY IMPROVEMENT STRATEGY
Reduce failure costs by problem solving methods and tools
Contributing in the selected prevention activities
Reduce appraisal costs in a statistically sound manner
Continuously monitoring and reinforce the prevention effort to gain desired quality improvement level.
QUALITY PLANNING
The overall planning can be summarize as the following steps
Customer needs
Forecast the future
Gap- analysis
Closing the loop holes
Alternatives Evaluation
Implementation
4. An Overview
•
•
GlaxoSmithKline (GSK) was formed from the December 2000
merger of Glaxo Welcome and SmithKline Beecham plc.
The $70 billion deal created the world's largest drug
manufacturer and research-based pharmaceutical concern.
6. PRODUCTS
GlaxoSmithKline develops, manufacturers and
markets:
pharmaceuticals, vaccines, over-the-counter medicines
and health related consumer products
Our broad pharmaceutical product line includes:
antibiotic, antidepressant, gastrointestinal, dermatologic
al, respiratory, cancer and cardiovascular medications
7. PRODUCTS
They supply products to 191 global markets
Produce over 1,200 different brands
Manufacture 4 billion packs per year
Produce over 28,000 different finished packs per
year
Supply 6,900 tonnes of bulk active each year
Manage 2,000 new product launches globally each
year
9. VISION
“We want to become the indisputable leader in
our country, not simply in terms of size, but in
how we use that size to achieve our mission
and improve the quality of human life.”
10. MISSION
“Our global quest is to improve the quality
human life by enabling people to do more, feel
better and live longer.”
12. TOTAL QUALITY MANAGEMENT
“TQM is an enhancement to the traditional way of
doing business. It is the art of managing the whole
to achieve excellence. It is defined both a
philosophy and a set of guiding principles that
represent the foundation of a continuously
improving organization. It is the application of
quantitative methods and human resources to
improve all the processes within an organization
and exceed customer needs now and in the future.
It
integrates
fundamental
management
techniques, existing improvement efforts, and
technical tools under a disciplined approach.”
James T. Levin
Book: “Ways of Quality e4”
13. SIX PILLARS
“Commitment” – the commitment from the top level to the
operational level was observed during our visit as the lower
staff and the strategic level gave the same answer for the
quality that is to “follow the benchmark”.
“An unwavering focus on the both customers” – the
organization believes that both internal and external
customers are the key players in being profitable and so they
never assist their stakeholders in every means to get the
required output.
“Employee Involvement” – employee involvement acts as
strong pillar in meeting the targets. The organization provides
a linked database system through which every employee can
contribute in terms of suggestions and ideas for growth and
improvement.
14. SIX PILLARS
“Optimal use of resources” – they do understand the
importance of the concept of scarce resources and thus tries to
minimize the waste and get the optimal level of benefit from
the raw material and other available resources.
“Treating suppliers as partners” – the output of the firm do
depend on the quality of the raw material and differentiating
on the basis of quality requires consistent and accurate level
input with sustainable quality level and thus the organization
has treated the supplier as their long term strategic alliance.
“Benchmarking” – GSK Pakistan over the period of time has
developed its own standard, which includes ISO standards
and their best practices.
20. QUALITY IMPROVEMENT
STRATEGY
The organization is working on its “Quality Improvement Strategy”
which would be focusing on the issues like
Reduce failure costs by problem solving methods and tools
Contributing in the selected prevention activities
Reduce appraisal costs in a statistically sound manner
Continuously monitoring and reinforce the prevention effort to gain
desired quality improvement level.
21. QUALITY PLANNING
The overall planning can be summarize as the following steps
Customer needs
Forecast the future
Gap- analysis
Closing the loop holes
Alternatives Evaluation
Implementation
These steps are used to identify the gaps and set SMART objectives to
measure it and eliminate it through PDCA-plan, do, check and act cycle.
22. QUALITY COUNCIL
The organization has formed a different quality department and circles
to assure the quality at every process.
Develop the quality based core values, vision statement and quality
policy statement.
Design the long-term strategic plan with annual goals for quality
improvement programs and objectives.
Establish total education and training plan and procedure.
Continually monitor and update with the help of best practices.
23. QUALITY COUNCIL
Determine the measures that are the performance
measures for organization with coordination with
different organizational functional areas.
Unwavering focus on the issues regarding external and
internal customers.
Develop a system to solve those problems.
Monitor and revise the benchmarks to remain updated.
Look for certifications and recognition for the best
practices followed in the organization.
24. QUALITY COST
“Comparison” – comparing themselves with the
companies in the industry that is evaluating the
alternatives for doing the same job with low cost.
“Optimizing the results at individual level” – focusing to
attain maximum results at individual level so that the
quality gets ensured from the beginning.
“Creating relationships among the cost categories” –
linking the cost drivers to minimize the cost.
25. SENIOR MANAGEMENT & LEADERSHIP
PLAYS A ROLE
Effective leader must have the clear concept of
• the providing security and independence,
• sensitive rewards and incentives for self-motivation,
• defined area of responsibilities
26. ENVIRONMENTAL MANAGEMENT SYSTEM
GlaxoSmithKline (GSK) have always shown strong commitment and
support for public health, awareness and many social causes.
GSK does not have a fixed budget for CSR because they believe in
funding as many deserving ,charities & NGOs as possible.
It focus on improving health and education
GSK’s program include:
Global: this focus on supporting major public health issues - LF, HIV
and AIDS, malaria and diarrheal disease
Regional: 4 regions make a Contributions Committee that does
funding for selected program that address relevant local needs
Local: All GSK sites have community support and employee
involvement.
27. ENVIRONMENTAL MANAGEMENT
SYSTEM
Encouraging prevention and prompt treatment of malaria.
PHASE (Personal Hygiene and Sanitation Education) A simple hand washing
education program run in schools
In 2008, GSK donated medicines for £5.3 million for humanitarian aid to 118
countries supporting relief efforts for natural disaster or war.
GSK supplies and deliver donations of medicines, vaccines and consumer
healthcare product for the earthquake-affected people. Rs.3million were donated
for the victims of the Baluchistan in October 08.
The initiative allows employees to take one day fully paid to volunteer for a chosen
community project, organization or cause
The storeroom, packaging, warehouse, and the boiler for the factory assistance are
highly protected, as it is dangerous if damaged.
Cafeteria is apart from the company so it is totally hygienic, and there is a medical
center for the employee facilitation.
Environmental health and safety council conducts meeting every month.
GSK is against animal testing.
28. FAILURE MODE AND EFFECT
ANALYSIS (FMEA)
At GSK most of the products or we can say 95% products are
established products ,therefore they carry out FMEA and
make QFD model at the time of launching new products.
The team who carry out FMEA at GSK is the same team who
launch new products, and who are able to
define (FMEA) Failure Mode and Effect Analysis
define the role (FMEA) in error reduction strategies
describe the (FMEA) requirements
describe the application of (FMEA) in product or process
evaluation
29. QFD AT GSK
Where as QFD model basically concerned with two
departments at GSK
Manufacturing Department and
Commercial Department.
The manufacturing department helps in identifying
technical descriptors i.e. material and process required
for making a product, and commercial department helps
in identifying customer requirements
Commercial department also measure level of GSK`s
customer`s satisfaction by different means periodically.
30. BENCHMARKING
The process of identifying the best practice in relation to products and
processes, both within an industry and outside it, with the object of
using this as a guide and reference point for improving the practice of
one's own organization.
The quality department at GSK has established certain criteria for
benchmarking its performances which set at global level and
implemented in every country. They have set there own standards by
integrating ISO standards therefore they are benchmark against the
pre-set standards and levels by GSK.
They follow WHO,FDA,TGA standards align with GSK global standards
31. Integrating Knowledge Management
and Total Quality:
A Complementary Process
• Knowledge management is concerned with the exploitation and
development of the knowledge assets of an organization with a view to
furthering the organization's objectives. The knowledge to be managed
includes both explicit, documented knowledge, and tacit, subjective
knowledge
32. KM-FOR CREDITS DEFAULT @ SILK
BANK LTD.
HOW TO
REDUCE
WHAT WE
KNOW
REASONS FOR
CUSTOMER
DEFAULT
OUR STRATEGIES
•
•
•
•
•
•
•
DECLINING
ECO.GROWTH
RECESSION
UNFORESEEN
EVENTS
INC INTEREST
RATES
LAW&ORDER
HOW WE
OPERATE
•
•
STABLE POLITICAL
GOVT
FRIENDLY
ECONOMIC&
COMMERCE
POLICY
GOOD
GOVERNANCE
NEW AVENUES
FOR FOREIGN INV.
•
•
•
•
•
•
STRICT LENDING
POLICY
FRIENDLY
REGULATORY POLICY
DUE DILIGENCE OF
BUS.SECTOR
RISK MANGT.POLICIES
MONITOR A/C TO
INSURE TIMELY
RETURNS
KEEP CHECK ON
INDICATORS
33. NON-CONFORMITY REPORT
.
PROBLEM: Non payment of installments, customer likely to default in
future.
CORRECTIVE ACTION: Reduce interest rates, restructure customer credit
line
(
cash
flow analysis)
ROOT CAUSE: Decline in Eco. Growth, recession, inc interest
rates, law&order, political unstability
PREVENTIVE ACTION: Monitor the industry and put cap on the industry
CONTINOUS IMPROVEMENT: Customer friendly policies, improve service
quality
34.
35. QUALITY MANAGEMENT SYSTEM
The Quality Management System (QMS) is designed to support the
the GSK Quality Statement. It provides a framework
that ensure
Quality
Regulatory compliance
Assure product safety
Efficacy and support continuous improvement at GSK.
commitment in
The whole system is centrally managed which is published on GSK intranet and
implemented at sites through local SOP (standard operating procedures) systems.
also
At GSK (standard operating procedures) SOPS implements QMS locally and comply with the
Global Quality Policy requirements.
36. CUSTOMER COMPLAINTS
At GSK they have developed a system for handling customer complaints called `COMPLAINT
HANDLER`. The system works in following manner
First of all it investigate customer`s past experience and then act on it
Secondly analyze the customer complaint
Thirdly develop complaint resolution procedure accordingly.
And finally identify process and material variation and then work to eliminate the root
cause.
At GSK a department called COMMERCIAL DEPARTMENT is also established who deals and
identify customer expectations and their satisfaction and constantly monitor them.
Quality Council at GSK is also provided with a monthly complaint report by such team or
department who handles CC.
At GSK they tend to take action on customer complaints within 24 hours.
37. AUDITING AT GSK
GSK has a very strong internal audit system or committee and it has given most
important at GSK. The GSK`s internal auditing function consist of following people
internal auditor
internal consultant
compliance officer
quality assurance manager
operational analysts
The whole Audit system at GSK can be elaborated in four levels i.e. L1, L2, L3, and
L4 of a pyramid. This can be shown by a figure in my next slide
38. L-4
L-3
L-2
L-1
L-1 which is known as Self Inspection level , in which
each and every member of all departments carry out their
own inspection and check what are the standards
requirements and how they are performing
L-2 which is also known as internal auditing level, in which
each and every department of the GSK gets internally audited
by an internal auditing body which consists of certified
auditors.
L-3 which is also known as Manufacturing Internal Auditing (MIA) which is done by a
group of independent auditors, who audits different sites of manufacturing…
L-4 which is also known as regulatory auditing which is done by a local regulatory body
who audits the entire GSK
At GSK the Audit Committee uses Software called CHARISMA-2, for entering
and recording of data of all level of audits from L-1 to L-4.
39. RISK MANAGEMENT
At GSK there is very big section for Risk Management Processes, who carry out the
risk management of all operational, financial and manufacturing activities
At GSK there is a board called (RMCB) Risk Management Compliance Board who
provides assistance, instructions and procedures to the risk management
committee for identifying problems related to the following
Machine Maintenance
Production
Volume
Product labeling
Working instruction and conditions etc
They also analyze the impact of each risk in short term and long term both ,and
after analyzing they rate each risk on the basis of their type ( minor or major ) and
on the basis of their impact in short and long term. The rating is done globally at
GSK.
40. QUALITY MONTH
•
•
•
At GSK they use to make QUALITY MONTH once in a year in order to promote a
culture towards total quality management.
During this month new tools or improved tools are considered to be used for
bringing in and assuring more and more quality every where within the
organization.
Several interactive sessions take place and all employees and senior management
share their findings and their solutions which ultimately promote a culture
towards quality
41. PERIODIC PRODUCT REVIEW
•It is their prior responsibility to review their products annually.
•The process of reviewing the products includes tools like STATISCA.
•They have software called LIMPS. This software is a LAB
INFORMATION MANAGEMENT PERFORMANCE SYSTEM in which all
the product reviews are saved.
•All the past data saved in it and thus they can easily compare that
where they were last year and where they stand today.
•This also helps GSK to know is their product robust or not.
42. “GEMBA” CONCEPT AT GSK
• AT GSK they strongly believe on Management By Walking Around
(MBWA).
• They do daily GEMBAS on labs and production areas to keep a
proper check and balance on the working of the organization.
• Whether any employee is facing any problem to do his work and
to maintain environmental health and safety to their employees
so that the quality of their products is not at stake. .
• Management by walking around is done by any senior level
person.
43. KNOWLEDGE MANAGEMENT
• Their KMS is known as KNOWLEDGE REPOSITORY.
• They conduct training of their employees.
• Occurred problem is shared with all the other departments
through video conferencing so that every employee comes to
know that which corrective action was taken to solve a particular
kind of problem.
• Through this they also know that what causes the problem to
occur and what should be done in future to avoid the same kind of
problem.
44. EMPLOYEE TRAINING & AWARD SYSTEM
Before an employee joins the organization he is fully trained about his work and
the culture of his organization.
After training an audit is done on his training and then he is allowed to join the
organization as an employee and do the job.
Instructions are always written & approved and authorized to use it.
GSK have a proper system of complaints. They have a target to investigate and
report their serious complaints within 24 hours. Employees are empowered in
decision-making.
every month they select one employee in every department who does exceptional
work.
Recognition is given to employees by attaching a statement “EMPLOYEE OF THE
MONTH”. Besides this monthly activity they also have ERA awards once in a year.
45. PRODUCT LIABILITY
GSK has a proper system for their return products but as far now their has
not been any issue with their any medicine or any home oral ointments.
The problem only occurs with GSK cosmetics and for that they have a
policy of money back guarantee.
GSK is working to develop new cosmetic line for people with different
types of skin keeping in mind the weather of the country.
46. MUDA – WASTAGE
MUDA is basically a Japanese word, which is used at GSK for waste.
This waste is unproductive so at GSK every necessary step is taken to avoid using
this MUDA.
Environmental Health and Safety Council (EHSC) conducts meetings every
month. This council also has a target every month to reduce their waste as much
as they can because MUDA reduction is an effective way for any organization to
increase profitability.
At GSK waste is insanities or dump……….its not used in any case. GSK is against
landfill
47. EMPLOYEE SUGGESTION SYSTEM
GSK involves employees from grassroots level also in evaluating and formulating
strategies. Because it believes the fact that they are in direct contact with the customers.
GSK is open to accept any recommendation and suggestion from their employees.
Annually appraisal is done at the beginning of the year. In which targets given to each
employee is matched with its performance.
It is done for:
Basis for Reward (Increment Bonus)
Basis for Promotion, Placement
Ascertain Training And Development Needs
It increases Employee motivation and that leads to increase in profit, sales, and reduce
turn over.
If an employee is under performing he is given a time limit of 6-9 months to improve his
performance.