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
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:
Standards for quality systems
Quality systems are designed to control processes Organizational Management : Organizational Management Commitment, responsibility and authority
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
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
Documents that are instructive: e.g. standard operating procedures (SOPs)
Documents that allow traceability: e.g. HIV test results Types of Documentation : Types of Documentation Policies
Standard operating procedures
+ 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
Calibration and maintenance
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.
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
Management System Men (Personnel) : Men (Personnel) Adequacy & Quality
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.
Approval & Authorization
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
Flow of Work
Space, Light, Ventilation
Safety- General, Biological, Chemical, Radiation & proper Waste Mx (Biohazards)
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:
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
Overall intentions and direction of an organization related to quality, as expressed by senior management Slide 29: THANK YOU