How Quality Ensures Success

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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 productsOur broad pharmaceutical product line includes:

antibiotic, antidepressant, gastrointestinal, dermatological, respiratory, cancer and cardiovascular medications

PRODUCTS

They supply products to 191 global marketsProduce over 1,200 different brandsManufacture 4 billion packs per yearProduce over 28,000 different finished packs per yearSupply 6,900 tonnes of bulk active each yearManage 2,000 new product launches globally each

year

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

“Our global quest is to improve the quality human life by enabling people to do more, feel better and live longer.”

SPIRIT OF GSK

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. LevinBook: “Ways of Quality e4”

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

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.

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.

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.

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.

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.

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

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.

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.

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 Analysisdefine the role (FMEA) in error reduction strategiesdescribe the (FMEA) requirementsdescribe the application of (FMEA) in product or process

evaluation

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.

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

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

KM-FOR CREDITS DEFAULT @ SILK BANK LTD.

WHAT WE KNOW

HOW TO REDUCE

REASONS FOR CUSTOMER DEFAULT

• DECLINING ECO.GROWTH

• RECESSION• UNFORESEEN

EVENTS• INC INTEREST

RATES• LAW&ORDER

• STABLE POLITICAL GOVT

• FRIENDLY ECONOMIC& COMMERCE POLICY

• GOOD GOVERNANCE

• NEW AVENUES FOR FOREIGN INV.

HOW WE OPERATE

OUR STRATEGIES

• 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

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

QUALITY MANAGEMENT SYSTEM

The Quality Management System (QMS) is designed to support the commitment in the GSK Quality Statement. It provides a framework that ensure Quality Regulatory compliance Assure product safety Efficacy and support continuous improvement at GSK.

The whole system is centrally managed which is published on GSK intranet and also implemented at sites through local SOP (standard operating procedures) systems.

At GSK (standard operating procedures) SOPS implements QMS locally and comply with the Global Quality Policy requirements.

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.

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

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.

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.

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

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.

“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.

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.

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.

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.

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

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.

RECOMMENDATIONS/CONCLUSIONS

RFERENCES Sites: www.goolge.com www.wikipedia.com www.qualitymanualchat.com/ general-quality-system/ quality-policy-statement-and-quality-objectives/ 34/ http:/ / www.answers.com/ topic/ quality-circle http:/ / www.answers.com/ topic/ quality-policy Books: TQM by Dale H Besterfield Visits: GSK-GMS (Miss RUBY SHEIKH Head of Quality)

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