“Total Quality Management and Quality Risk Management” By: Pratitha Naik Parsekar Quality Assurance VerGo Pharma Research laboratory Pvt Ltd. Date: 16-Mar-2016

Sequence of Presentation Part I- Total Quality Management Introduction Brief about TQM Objective Framework for excellence performance Stages of TQM Management tools Benefits of TQM Problems of TQM

Sequence of Presentation Part II- Quality Risk Management Principle of QRM Brief about QRM Flow chart Flow chart explanation in detail

PART- I

Introduction Competition is getting harder in Pharma companies. Companies now have to be more responsive, offer better product and keep improving. TQM.... Customer Satisfaction Motivating the workforce Improving the way the company operates

What is Quality? “ Meeting customer ’ s requirements, formal and informal, at the lowest cost through doing the things right the first time ”.

What is TQM is the integration of all functions and processes within an organization in order to achieve continuous improvement of the quality of goods and services. TQM is approach to improving the effectiveness and flexibility of business as a whole. The goal is customer satisfaction.

Objective of TQM Meeting Customer requirement Continuous improvement of quality Developing the relationship of openness and trust among employees at all level in the organization

Framework for excellent performance of TQM Planning Performance PEOPLE PROCESS CULTURE COMMUNICATION COMMITMENT

STAGES OF TQM TQM Building a Quality Framework Measuring & Analyzing the performance Building a Quality policy Deployment Communicating the quality Strategy Evaluating and controlling Launching the changes

STAGES OF TQM TQM 1. Building a Quality Framework b. Creating and Changing the Culture c. Leadership a. Commitment to Total Quality

STAGES OF TQM 3. Communicating the quality Strategy a. Creating Awareness about the Change Use of communication techniques -creating awareness  Team briefings and presentations  Quality newsletters, magazines and manuals  Updates in the annual report regarding quality  Quality review meetings  Internet and Intranet  Suggestion boxes  Discussion forums  Lobby displays and DVD presentations  Inclusion of the TQM idea in new employee induction programs b. Creating Consensus Support and motivation of the higher management is a chief factor to remove mistrust and doubts among the employees Training and education of the employees

STAGES OF TQM 4. Measuring & Analyzing the performance Performance measurement is vital in:  Managing business processes by identifying and pinpointing processes for improvement  Evaluating if organizational goals are being achieved  Ensuring that customer requirements are being met  Telling if processes are in statistical control  Comparing performance against internal standards  Comparing performance against the external market  Providing feedback for steering the improvement efforts.

STAGES OF TQM 5. Launching the changes  most crucial steps because at this point the business processes have to be brought under control.  Procedures and work instructions have to be clearly issued by the higher management.  Designing of products and services and reworking the processes according to raised improvements & customer needs takes place at this step

STAGES OF TQM  The culture change has taken place in the organization and efforts are being made to maintain ths position.  Processes, systems and employees - work towards defects and problem preventing rather than taking corrective action.  Can be done by:  Quality Auidts  Reviews  Self Assessment 6. Evaluating and controlling

MANAGEMENT TOOLS FOR PROCESS ANALYSIS, PLANNING AND DECISION MAKING

Benefits of Total Quality Management System  Helps to sustain the level of customer satisfaction.  Enables senior management to make all levels of management in the organization responsible for quality.  Helps reduce costs of the organization through the management of cost of quality.  Results in decreased costs, increased productivity.  Cross departmental barriers are removed as a total quality system believes in effective communication on a daily basis among different departments.

Faster problem solving because of usage of measurement tools Reduction of time involved from product conception to delivery time. Development in the workforce -employees are well-trained and motivated to produce consistent results TQM systems promote employee participation, and there are reward and recognition systems, ongoing education and training. Employees are taught effective communication and they are encouraged to innovate. A TQM culture promotes better supplier communication. Benefits of Total Quality Management System

Reason for Failure of TQM Lack of management commitment to TQM programme Improper planning Lack of employee commitment Lack of effective communication Lack of interest Non Application of proper tools and techniques Processes are not analyzed, systems are weak and procedures are not written down.

PART- II QUALITY RISK MANGEMENT

Principles of QRM The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk

What is QRM? Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.

Flow chart for QRM Risk Review Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process Risk Communication Risk management Tools

Responsibilities Decision makers: Person(s) with competence and authority to make a decision Ensuring that ongoing Quality Risk Management processes operate Coordinating quality risk management process across various functions and departments Supporting the team approach

Team approach Experts from appropriate areas to the risk being considered e.g. Quality unit Development Engineering / Statistics Regulatory affairs Production operations Business, Sales and Marketing Legal Medical / Clinical &… Individuals knowledgeable of the QRM processes Responsibilities

General QRM Process science-based decision making Systematic processes designed to coordinate, facilitate and improve science-based decision making with respect to risk to quality

When to initiate and plan a QRM Process ?  First define the question which should be answered (e.g. a problem and/or risk question) including pertinent assumptions identifying the potential for risk  Then assemble background information and/ or data on the potential hazard, harm or human health impact relevant to the risk Identify a leader and necessary resources Specify a timeline, deliverables and appropriate level of decision making for the QRM process

RISK ASSESSMENT  Identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards 3 fundamental questions: What might go wrong? Risk Identification What is the likelihood (probability) it will go wrong? …… Risk Analysis What are the consequences (severity)? Risk Evaluation

Risk Assessment: Risk Identification “What might go wrong?” A systematic use of information to identify hazards referring to the risk question or problem description. Information include:  historical data  theoretical analysis  informed opinions  concerns of stakeholders

Risk Assessment: Risk Analysis “What is the likelihood it will go wrong?” The estimation of the risk associated with the identified hazards. A qualitative or quantitative process of linking the likelihood of occurrence and severity of harm.

Risk Assessment: Risk Evaluation RISK EVALUATION Compare the identified and analyzed risk against given risk criteria. Consider the strength of evidence for all three of the fundamental questions  What might go wrong?  What is the likelihood (probability) it will go wrong?  What are the consequences (severity)?

Risk Control: Decision-making activity The purpose of risk control is to reduce the risk to an acceptable level. Focus on following questions: Is the risk above an acceptable level? What can be done to reduce or eliminate risks? What is the appropriate balance between benefits, risks and resources? Are new risks introduced as a result of the identified risks being controlled?

Mitigation or avoidance of quality risk Elimination of risks, where appropriate Focus actions on severity and/or probability of harm; It might be appropriate to revisit the risk assessment during the life cycle for new risks or increased significance of existing risks Risk Control: Risk Reduction

Decision to  Accept the residual risk  Passively accept non specified residual risks May require support by (senior) management Will always be made on a case-by-case basis Risk Control: Risk Acceptance

Who has to accept risk?  Decision Maker(s) Person(s) with the competence and authority to make appropriate and timely quality risk management decisions  Stakeholder Any individual, group or organization that can …be affected by a risk Decision makers might also be stakeholders The primary stakeholders are the patient, healthcare professional, regulatory authority, and industry The secondary stakeholders are patient associations, public opinions, politicians Risk Control: Risk Acceptance

Risk Communication Bi-directional sharing of information about risk and risk management between the decision makers and others Parties can communicate at any stage of the QRM process Communicate and document the output/result of the QRM process appropriately Communication need not be carried out for each and every individual risk acceptance

Risk review: Review Events Review the output / results of the QRM process Take into account new knowledge and experience The frequency of review shd be based upon the level of risk

Risk Management Methodology QRM Supports a scientific and practical approach to decision-making QRM process  Provides documented, transparent and reproducible methods  Assessing current knowledge  Assessing probability, severity and sometimes detectability

Risk Management Methodology Overview: some Tools and their key word Failure Mode Effects Analysis (FMEA)  Break down large complex processes into manageable steps Failure Mode, Effects and Criticality Analysis (FMECA)  FMEA & links severity, probability & detectability to criticality Fault Tree Analysis (FTA)  Tree of failure modes combinations with logical operators Hazard Analysis and Critical Control Points (HACCP)  Systematic, proactive, and preventive method on criticality Hazard Operability Analysis (HAZOP)  Brainstorming technique Preliminary Hazard Analysis (PHA)  Possibilities that the risk event happens Risk ranking and filtering  Compare and prioritize risks with factors for each risk

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