Quality Assurance vs Quality Control
Information & Training. | Quality Assurance. Quality Management.
Quality Assurance vs Quality Control: The American Society of Mechanical Engineers.
Quality Assurance: “All those planned and systematic actions necessary to provide adequate confidence that an item or a facility will perform satisfactorily in service”.Quality Control: “Those quality assurance actions which provide a means to control and measure the characteristics of an item, process, or facility to established requirements”.
The College of Science and Technology, Temple University, Philadelphia.
Quality Assurance: “The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled”.Quality Control: “The observation techniques and activities used to fulfil requirements for quality”.
The American Society of Quality (ASQ).
Quality Assurance: “The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled.”Quality Control: That “part of quality management focused on fulfilling quality requirements.”
Quality Assurance. Quality Management.
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Reviewing the above definitions, there are clear similarities and it can be seen that Quality Control is a subset of Quality Assurance.
In Quality Control the focus is on testing, measuring, inspecting, checking the activities and outputs of a process to ensure compliance with quality requirements. In Quality Assurance the focus is on planning, implementing and reviewing the effectiveness of the entire range of activities which support the continual development of a process to repeatably deliver quality outputs, preventing deviations from quality requirements, ensuring capable processes and resources are in place to deliver to quality expectations.
Quality Assurance activities will include the Quality Control Activities such as testing, measuring, inspecting, checking. However, in addition, Quality Assurance activities will include auditing, corrective and preventive actions, management reviews, training, development of quality plans and objectives, developing operating procedures, implementation of standards, process validations, customer feedback analysis, identification of resource constraints, etc..
A Quality Assurance System will often be based on an internationally recognised quality standard and/or legal regulations. For example, many organizations will operate to the ISO 9000 series of Quality Management Standards. Similarly, in regulated industries such as Pharmaceutical, Medical Device, Food processing, there will be defined regulations imposed by bodies such as the FDA (Food and Drug Administration), requiring minimum standards for Quality Assurance and Quality Control.
In many organizations the Quality Assurance System will be based on a defined Quality Policy which details Management commitment to Quality. The Policy will then be supported by a Quality Manual describing how the Quality System operates within the organization. The Manual will reference the various quality improvement activities, defect prevention processes, test and inspection processes.
These test and inspection activities fall within the realm of the Quality Control activities, which can be seen as being a component of the Quality Assurance processes.
Further building on the Quality Policy and Quality Manual, the Quality Assurance System, will require an annual (in some organization bi-annual) Management Review of the performance of how effectively the Quality Assurance system is operating. From the Management Review, updated Quality Objectives will be agreed and become goals for staff across the organizations to strive to achieve over the coming year(s).
Information & Training. | Quality Assurance. Quality Management.
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
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