Introduction to Quality Assurance.
Information & Training. | Quality Assurance. Quality Management.Quality Assurance is a step in the path towards understanding, anticipating, delivering present and future customer needs. Quality Assurance tends to be associated with satisfying the expectations of the end customer, as opposed to a Quality Management System or Total Quality Management, which may place a greater emphasis on the internal customer in addition to the external final customer. There are many definitions associated with quality assurance, for example the International Standards Organization (ISO) defines quality assurance as: “the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs”.
Many organizations define quality as fitness for intended purpose”. Any consideration of Quality Assurance needs inherently to include not only product and service element quality, but also on-time delivery at an appropriate cost. What is Quality Assurance? In summary, quality assurance can be seen as achieving “customer satisfaction”.
Approach to Quality Assurance.A very basic approach to quality will entail the implementation of inspection and testing processes within an organization. The objective of such inspection and testing will be to identify and screen out defective process outputs.
As an organization matures in terms of the approach to quality it will implement forms of “quality control”.
Quality control spans the entire processes involved in inspection and testing. Quality control may be responsible for the testing and evaluation of materials including incoming raw materials, components and final products as well as in-process testing. This testing is to ensure that the product meets the defined specifications i.e. the chemical / physical structure is as it should be and there is no contamination in the product. Quality control may also create, test and continually update specifications for testing and sampling, may design and validate test methods. May be involved in maintaining documentation on all aspects of the QC team’s work. May retain samples of all materials tested, may investigate complaints and initiate suitable actions.
Note: The word “may” is applied as all organizations delegate responsibility and structure authority in a manner unique and optimum to their particular circumstances.
As suggested previously, quality assurance is focused on achieving customer satisfaction. As the quality culture develops and matures within an organization, the perception of the customer will evolve from being solely the final or end customer to be seen as including all recipients of products and services outputted by an organization. This entails the concept of the internal customer. For example, consider a manufacturing organization where raw materials are transformed through a production process via a number of manufacturing process steps. At each step there exists internal suppliers and internal customers. As the quality culture matures within an organization, these internal customers will be seen as critically important, and only when the internal customers can be truly satisfied, will the end customer be equally satisfied. The concept of the internal customer is fully developed in the “total quality” stage of quality development.
“the total arrangements made within a organization to ensure that products and / or services are of the required quality”.The role of QA may include the design and monitoring of documentation systems. Approval and monitoring of written procedures to produce the required products or services. Approval of written records, the approval and monitoring of cleaning systems, batch review, the release of product. Quality assurance may have responsibilities that span into regulatory control. The submission of information to regulatory authorities for licensing and approval (in conjunction with Research and Development, Regulatory Affairs, etc.). Again , as per quality control, each organization will take a unique approach to the role and responsibility of the quality assurance function.
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)
- 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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