Quality :Quality Quality Management Section National Blood Center.


Quality :Quality Quality of a Product or Service refers to its Fitness or Suitability for the intended purpose in conformity with required standards.


Quality — the Concept :Quality — the Concept Quality does not happen by chance Quality needs to be developed in an organization Quality needs to be systematic Quality systems are the basis on which the quality of the product or service is built Quality is an ongoing activity, not a Goal that has to be reached.


Slide 4:Total Quality Management Quality Assurance Quality Management Quality Control Evolution of the Concept of Quality


Quality Control (QC) :Quality Control (QC) Controlling mechanism that ensures the release of only good quality products. Quality Control testing is done to detect the quality of a product or services by checking their degree of conformity with the required standards.


Quality Assurance (QA) :Quality Assurance (QA) Ensuring quality of a product or services by making sure that all the critical points in the production process are in conformity with the required standards. Detect shifts in Quality- Allowing prompt Attention CCPs should be described per institution, since programs vary.


Quality system (QS) :Quality system (QS) The organizational structure, procedure, processes, and resources needed to implement quality management. Acceptable results defined during the validation process according to specified standards


Quality system (QS) :Quality system (QS) Vein To Vein


Key Elements of a Quality System :Key Elements of a Quality System Supplier Customer Outputs Organizational management Training Standards Assessment Processes Quality System Inputs


Key Elements of a Quality System :Key Elements of a Quality System There are five key elements in a quality system: Organizational management Standards for quality systems Documentation Training Assessment Quality systems are designed to control processes


Organizational Management :Organizational Management Commitment, responsibility and authority Quality policy Organizational structure: organogram Job descriptions


Standards for a Quality System :Standards for a Quality System Standards- Defined sets of minimum quality requirements for each critical step in a process to ensure it’s quality Ensure safety and consistency National Country-specific International: e.g. Good Manufacturing Practice (GMP) International Organization for Standardization (ISO) American Association of Blood Banks (AABB)


Documentation :Documentation Documentation is the proper maintenance of records & document control in every critical step in a quality process.


Documentation :Documentation Information Documents that are informative: e.g. quality policy Instruction Documents that are instructive: e.g. standard operating procedures (SOPs) Records Documents that allow traceability: e.g. HIV test results


Types of Documentation :Types of Documentation Policies Standards Manuals Standard operating procedures Specifications Datasheets Forms Records Labels + Others ………………


Standard Operating Procedure (SOP) :Standard Operating Procedure (SOP) Instructive Documents A documented describing “How to do it,” the stepwise actions to be taken to perform an activity. Work instructions used to define policy, control processes, describe procedures, meet regulatory requirements and function as the primary means of process control.


Policy :Policy Informative Documents A written high level, statement of intent describing “What will be done”. This statement is endorsed by Management.


Training :Training The quality system is only as good as the staff who actually implement it on a daily basis However good the quality system is on paper, quality cannot be achieved if the theory is not translated into practice Training must include an understanding of why quality is important


Assessment :Assessment Processes, procedures, resources are assessed through: Validation Calibration and maintenance Error management Audits Quality assessment schemes (QAS): Internal quality assessment schemes (IQAS) External quality assessment schemes (EQAS)


Critical Control Points (CCPs) :Critical Control Points (CCPs) Major processes that must function properly to ensure the quality of the finished product or service. Examples: Component processing Compatibility Testing Storage Blood Administration


Essential Factors in Quality Assurance :Essential Factors in Quality Assurance Quality System Essentials (QES) are the cross-functional elements that are applied to all the facilities functions Men Method Material Machine Main Infrastructure Monitoring Management System


Men (Personnel) :Men (Personnel) Adequacy & Quality Qualification Knowledge Skill Commitment Continuous Training, Re-training & Proficiency Testing Pleasant Working Environment Job Descriptions & Recruitments Accordingly


Method (Processes & Procedures) :Method (Processes & Procedures) A set of interrelated resources and activities which describe “How it happens” transforming inputs into outputs. Flow charts SOPs Validation Approval & Authorization Training Variations & Process control Records


Machine (Equipment) & Material :Machine (Equipment) & Material Selected & Validated to suit it’s intended purposes Maintenance, Cleaning , Calibration Regularly & Recorded SOPs- Correct use, Cleaning, Servicing & Trouble Shooting Prior to routine use – Through Evaluation Critical Material- Only from Approved/ Reliable Suppliers Proper Storage, Stock Mx


Main Infrastructure :Main Infrastructure Safe & Healthy Work Place to Employees & Visitors Cleaning Flow of Work Space, Light, Ventilation Hygiene Safety- General, Biological, Chemical, Radiation & proper Waste Mx (Biohazards) Storage Areas Entry, Conditions- Controlled & Monitored


Monitoring :Monitoring Effectiveness of the System &Level of Actual Compliance Formal Mx Review Senior Mx to review the activities of the Quality programme to ensure that the system is delivering useful information that is being productively used to improve the Quality Audits- Internal & External Competence Assessment- for Staff


Quality Management :Quality Management Coordinated activities to direct and control an organization with regard to quality, including: Quality control Quality assurance Planning Improvement


Quality Management System :Quality Management System Quality management system System to establish a quality policy and quality objectives and the processes in operation to achieve these objectives Quality policy Overall intentions and direction of an organization related to quality, as expressed by senior management


Slide 29: THANK YOU