Quality Management System

QUALITY MANAGEMENT SYSTEM

If you are out of Quality, are out of business

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Kuldeep YagikQuality Assurance Professional

WHAT IS QUALITY?

According to the American Society for Quality, “quality” can be defined in the following ways:✔ Based on customer’s perceptions of a product/service’s

design and how well the design matches the original specifications.

✔ The ability of a product/service to satisfy stated or impliedneeds.

✔ Achieved by conforming to established requirements within an organization.

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WHY IS QUALITY IMPORTANT?

Ò Business success may simply be the extent to which your organization can produce a higher-quality product or service than your competitors are able to do at a competitive price.

Ò When quality is the key to a company’s success, quality management systems allow organizations to keep up with and meet current quality levels, meet the consumer’s requirement for quality, retain employees through competitive compensationprograms, and keep up with the latest technology.

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WHAT IS A QUALITY MANAGEMENT SYSTEM?

Ò A quality management system is a management technique used to communicate to employees what is required to produce the desired quality of products and services and to influence employee actions to complete tasks according to the quality specifications.

Ò “A set of co-ordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance.”

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WHAT PURPOSE DOES A QUALITYMANAGEMENT SYSTEM SERVE?

Management systems are needed in all areas of activity, whether large or small businesses, manufacturing, service or public sector. A good QMS will:

• Set direction and meet customers’ expectations• Improve process control• Reduce wastage• Lower costs• Increase market share/ values• Facilitate training• Involve staff• Raise morale

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HISTORY OF THE QUALITY MOVEMENTÒ In 1911, Fredrick W. Taylor, suggested need of inspection

to assess quality in his publication ‘The principles of Scientific Management’

Ò Quality Control & Statistical Theory: Quality Control was introduced to detect & fix problems along the production line to prevent production of faulty products. Statistical theory played a important role in this area. In 1920s Dr. W Shewart developed the application of statistical methods to the management of quality.

Quality In JapanÒ As early as the 1950s, Japanese companies began to see

the benefits of emphasizing quality throughout their organizations and enlisted the help of an American, W. Edwards Deming, who is credited with giving Japanese companies a massive head start in the quality movement.

Ò Deming believed that 85 percent of all quality problems were the fault of management. In order to improve, management had to take the lead and put in place the necessary resources and systems.

Ò According to Deming, there were two different concepts of process improvement that quality systems needed to address: (1) common (systematic) causes of error, and (2) special causes of error.

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HISTORY OF THE QUALITY MOVEMENTÒ Another influential individual in the development

of quality control was Joseph M. Juran, who, like Deming, made a name for himself working in Japanese organizations focusing on improving quality. Juran also established the JuranInstitute in 1979; its goals and objectives were centered on helping organizations improve the quality of their products and services.

Ò Juran defined quality as “fitness for use,” meaning that the users of products or services should be able to rely on that product or service 100 percent of the time without any worry of defects. If this was true, the product could be classified as fit for use.

Ò Juran also developed a comprehensive approach to quality as Quality by Design (QbD).

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HISTORY OF THE QUALITY MOVEMENT

The Quality Revolution Comes to the United StatesÒ In the 1980s, the Ford Motor Company was the first to

invite Deming to help the company transform itself into a quality-oriented organization. As a result, Ford was able to achieve higher quality standards than any other American automotive manufacturer and substantial sales growth in the late 1980s even when the rest of the U.S. automotive market was declining. Ford attributes the ability of its Taurus to overtake the Honda Accord in annual sales to the high quality standards set by the company.

Ò Since the early 1980s and on into the twenty-first century, quality issues have surfaced in every industry and almost every organization in the United States.

Ò The quality movement started in manufacturing and then moved to service industries.

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Ò Total Quality: The term total quality was used ofr first time in 1969 in Tokyo by Feigenbaum at first international conference of Quality Control.

Ò Total Quality Management (TQM): In 1980s to 1990s, a new phrase of Quality Control & Management coined in Japan as Total Quality Management. TQM is a management approach in which quality is emphasized in every aspect of the business and organization. Its goals are aimed at long-term development of quality products and services.

Ò Standardized Systems : In 1987, International Organization for Standardization take lead and launched ISO 9000 is a series of quality management systems (QMS) standards based on BS 5750 series of standard of BSI.

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Continuous Quality Improvement (CQI)It focus on the process of quality improvement. CQI allows individuals involved in the day-to-day operations to change and improve processes and work flows as they see fit.

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HISTORY OF THE QUALITY MOVEMENTContinuous Quality Improvement (CQI)Ò CQI implementation attempts to develop a quality system that is never

satisfied; it strives for constant innovation to improve work processes and systems by reducing time-consuming, low value-added activities.

Ò CQI has been adapted in several different industries. For example, in health care and other service sectors, it has taken on the acronym FOCUS-PDCA work:

Find a process to improve.Organize to improve a process.Clarify what is known.Understand variation.Select a process improvement.

Then move through the process improvement plan:Plan—create a time line, including all resources, activities, dates, and personnel training.Do—implement the plan and collect data.Check—analyze the results of the plan.Act—act on what was learned and determine the next steps.

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Six SigmaSix sigma was developed at Motorola in the 1980s as a method to measure and improve high-volume production processes.The term six sigma refers to a statistical measure with no more than 3.4 defects per million.Six sigma is a statistically oriented approach to process improvement that uses a variety of tools, including statistical process control (SPC), total quality management (TQM), and design of experiments (DOE). It can be coordinated with other major initiatives and systems, such as new product development, materials requirement planning (MRP), and just-in-time (JIT) inventory control.

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Six SigmaThe following is a brief description of the steps involved in the six sigma process:1. Break down business process flow into individual steps.2. Define what defects there are.3. Measure the number of defects.4. Probe for the root cause.5. Implement changes to improve.6. Re-measure.7. Take a long-term view of goals.

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QUALITY MANAGEMENT PRINCIPLES

The eight quality management principles are defined in ISO 9000:2005Principle 1 – Customer focusPrinciple 2 – LeadershipPrinciple 3 – Involvement of peoplePrinciple 4 – Process approachPrinciple 5 – System approach to managementPrinciple 6 – Continual improvementPrinciple 7 – Factual approach to decision makingPrinciple 8 – Mutually beneficial supplier relationships

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PQS : PHARMACEUTICAL QUALITY SYSTEM

Why do we need a “modern effective PQS”? Ò Good business practice! Ò Pharmaceutical industry is still way behind other industries in

Quality Management philosophies/practicesÒ GMPs do not provide a “full modern” Quality System

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Where are we Currently?

Ò Evolution of regional GMPs 1970s -Ò Evolution of ISO 9000 approaches 1980s -Ò FDA 21st Century initiative 2002 -Ò ICH Quality Vision / Q8, Q9, Q10 2003 -Ò FDA Quality Systems guide 2006 -Ò ICH Q10 Pharmaceutical Quality System 2008 Ò Q10 Implementation journey…………………………….

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What is the Purpose of Q10?Ò ICH Q10 aims to promote a paradigm shift from discrete GMP

compliance procedures at each stage of the product lifecycle to a comprehensive quality systems approach over the lifecycle of the product

Ò The objective is to:üAchieve product realizationüEstablish and maintain a state of controlüFacilitate continual improvement

Development

Technology Transfer

Commercial Manufacturing

Discontinuation

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Q10 - Scope Ò Applies to systems supporting the development and manufacture

of pharmaceutical drug substances (API) and drug products, including biotechnology and biological products, throughout the product lifecycle

Ò Both newly developed and existing products fall within the scopeÒ Apply in a manner appropriate and proportionate to the stage of

lifecycle

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Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7Ò Augment existing GMPs with specific PQS elements and

management responsibilities Ò Encourage science and risk based approaches Ò Be used together with existing GMPs Ò Cover all stages of the product lifecycle as defined (beyond GMPs)

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Relationship of ICH Q10 to Regulatory Approaches Ò Regulatory approaches for a specific product or manufacturing

facility should be commensurate with: É The level of product and process understanding É The results of quality risk management É The effectiveness of the PQS

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Q10 - Enablers Ò The enablers provide the means for science and risk based

decisions related to product quality through the lifecycle

Ò Knowledge ManagementÉ Manage knowledge from development through

commercialization to discontinuation Ò Quality Risk Management (Q9)

É Proactive approach to managing risks to quality

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Design and Content considerations are: Ò PQS should be well structured and clear / consider

complexity of organization Ò The elements of ICH Q10 should be applied in a manner

that is proportionate to each of the product lifecycle stages Ò Outsourced activities / purchased materials should be

within the scope of the PQS Ò Management responsibilities should be identified Ò The PQS should include process performance and product

quality monitoring, corrective and preventive action, change management and management review

Ò Performance indicators should be identified and used to monitor the effectiveness of the PQS

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Q10 - Quality Manual Ò A Quality Manual (or equivalent) should be established and

should contain the description of the pharmaceutical quality system; including:

Ò The quality policy Ò The scope of the pharmaceutical quality system Ò Identification of the processes within the PQS, as well as their

sequences, linkages and interdependencies Ò Management responsibilities within the PQS

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So What are the Key Elements? Ò GMPs Ò Management Responsibility Ò Continual Improvement

É Products and Processes É PQS itself

Ò Quality Risk Management Ò Knowledge Management Ò Lifecycle approach Ò Opportunities for science-based and risk-based

regulatory approaches

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Ò So what are the Key Elements?

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Lifecycle Approach Ò A Modern PQS needs to be holistic and cover the product lifecycle

É Design and Development É Manufacturing É Withdrawal

Ò Challenges and removes some traditional organizational silos É Within Industry É Within Regulatory Agencies É With outsourcing partners

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ICH Q10 Pharmaceutical Quality System

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Management Responsibilities Ò Essential component Ò Not just about compliance

É Visible leadership to establish and maintain a company wide culture and commitment to Quality and improvement

É Monitor performance of the PQS and act É Internal and Outsourced activities

Ò Quality cannot be owned by the Q Unit É Management is accountable É But independent assessments / audits are key

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Management Responsibilities

Ò Clear roles, responsibilities and governance processes are essential É Quality Policy – standards and direction of organisationÉ Quality Planning – convert into objectives / plans É Resources - allocations and competence É Communication – Q items to appropriate audiences É Management Reviews

Ð Product and Process performance Ð PQS performance

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Management ResponsibilitiesÒ Management of Outsourced Activities and Purchased

Materials É PQS must extend to the control and review of these activities É Pharmaceutical firm (Management) is ultimately responsible

to assure processes are in place

Ò Processes must be in place to: É Assess suitability of contractors / suppliers before use É Ensure use of approved suppliers and a defined supply chain É Define responsibilities and communication processes for

quality related activities É Review performance and make improvements

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Continual Improvement Ò Monitoring of product quality and process

performance Ò CAPA Ò Change Management Ò PQS itself

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Product Quality and Process Performance Monitoring System Ò Use knowledge, QbD, Product and Process

understanding and QRM to set Control Strategy É What and when to monitor / measure / test É Based on critical product quality attributes and critical

process parameters to deliver them Ò Confirm and maintain a state of control

É Feed-back and Feed-forward loops Ò Reduce and control variation to appropriate levels Ò Drive continual improvement Ò Continual verification

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CAPA System Ò Investigation of non-conformances

e.g. deviations, rejections, complaints, recalls, observations from audits and inspections = reactive e.g. feedback from trends = proactive

Ò Structured investigations to seek root cause Ò Use QRM to ensure degree and formality is commensurate

with level of risk Ò Should result in enhanced knowledge and improvement Ò Not just reacting to non-conformances Ò Focus on preventative actions Ò Need effective tracking/follow up

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Change Management System Ò Change can be good! Ò Proactively driven by outputs from

monitoring / trending / improvement/innovation É Not just by reacting to problems

Ò Use expert teams and knowledge to evaluate and set success criteria

Ò Use QRM commensurate with level of risk Ò Consider impact on regulatory filings Ò Undertake in timely and effective way and track Ò Assure no unintended consequences Ò Self management by competent manufacturers

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Ò PQS itself i.e. Continual improvement of the pharmaceutical quality system

Ò Management Review of the PQS É Measurement of achievement É Assessment of performance indicators i.e. incidents,

deviation, CAPA, market complaint, OOS, Change Management

É Self-assessment processes including risk assessments, trending, and audits;

É Feedback on outsourced activities É External assessments such as regulatory inspections and

findings and customer audits. Ò Monitoring of Internal and External Factors Impacting the PQS

É Emerging regulations, guidance and quality issues that can impact the Pharmaceutical Quality System;

É Innovations, Change in business environment,

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Ò PQS itself i.e. Continual improvement of the pharmaceutical quality system

Ò Outcomes of Management Review and Monitoring É Improvements to the pharmaceutical quality system and

related processes É Allocation or reallocation of resources and/or personnel

training É Revisions to quality policy and quality objectives É Documentation and timely and effective communication

including escalation of appropriate issues to senior management.

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Any more Questions ??

THANK YOUKuldeep Yagik

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Documents

Quality Management System