Quality Control, Quality Assurance, Quality Management....
Information & Training. | Quality Control. Quality Management.Every organization can improve the processes it utilizes to provide products and services. Such improvement will result in more satisfied customers, lower operating costs, faster product delivery, etc..
The question is how best to implement an effective, efficient, compliant quality improvement system.
“Quality” has many definitions, one that is widely accepted is “fitness for intended purpose”. In thinking of fitness for purpose you must consider Quality, Cost and timely Delivery. If provided correctly – All add up to customer satisfaction.
In order for an organization to compete you need satisfied customers. Better still you want: delighted customers, or customers who say “WOW”.
With delighted customers, your organization will successfully compete and grow.
Without delighted customers, you organization will stagnate and decline.
If you “delight your customers”, they will tell their friends & business associates and they will all seek to buy from your organization.
If you and your colleagues perform your daily business in a quality manner, your work environment will improve, staff will be motivated, new ideas will spring-up on how to improve, etc, etc. Therefore you and your organization will prosper.
An organization that has an effective Quality Management System in every aspect of its business, will grow, will retain its staff, will increase its customer base and will become more profitable.
The fundamental components of a Quality Management System are Quality Control and Quality Assurance.
Quality Control tends to 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 confirms that there is no contamination in the product. QC may also perform the following tasks, but this varies from organization to organization, namely, create, test and continually update specifications for testing and sampling, maintain documentation on all aspects of the team’s work, retain samples of all materials tested, investigate complaints and initiate suitable action. Etc.. etc.
The role of Quality Assurance may cover aspects such as the design and monitoring of documentation systems, approval and monitoring of written procedures to produce the product, approval of written records of the processing operations, approval and monitoring of cleaning systems, regulatory control, batch or lot review, release of product. Etc, ..etc.
One of the primary documents in a quality system is the Quality Manual.The Quality Manual is a means to communicate the vision, values, mission, policies and objectives of the organization. The manual documents the structure of the quality management system, i.e. who does what. The manual is an aid to training new members of staff. The manual can be used as a means of demonstrating compliance with external standards and regulations, etc. An organization must ensure that the quality policy is understood, implemented and maintained at all levels. The policy will normally be defined within the QA Manual. The Quality Manual will also outline the organization’s top level approach to the following:
International Quality Standards Requirements, Quality Management Systems & Quality Practices, Good Manufacturing Practice (GMP) and GMP Principles, Quality Costs, Quality and Competitiveness, Documentation, Validation, Change Control, Deviation Reporting, Auditing, Complaints & Recalls, Training.
Quality Culture.While the documentation implemented by an organization is a basic requirement for improving product and service quality, the culture within that organization is critical to the effective implementation of the documentation.
A quality culture is an organizational value system that results in an environment that is conducive to the establishment and continual improvement of quality. It consists of values, traditions, procedures and expectations that promote quality.
Continuous Improvement.Quality Assurance is an on-going learning and implementation process. Deming (Edward) stated very nicely with his Plan-Do-Check-Act model presented in a continuous circle. “Plan your activities to improve a process, implement, check to see the effectiveness of the actions you’ve implemented, if effective move onto the next improvement activity, if not effective, revisit the root causes of any problems, identify new actions, implement, ……..etc….etc.”
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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