Information & Training. | Quality Assurance. Quality Management.
Quality Assurance and Quality Control.
Quality Assurance and Quality Control are frequently interchanged and in many businesses can be considered to have similar meaning, however there are quite considerable differences between the assurance of quality and the control of quality.
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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Quality Control would normally be considered to be a component of Quality Assurance. When implementing quality controls, we are looking at incoming inspections processes, in-process inspection and testing, finished goods or finished output testing and inspection. Control may extend back into the supplier processes where again controls may be applied in terms of process inspection and testing throughout the supplier process. In quality control, the objective is to identify any potential product or process failings, to identify non conforming product, to detect changes in process output. With the controls in-place, corrective actions can be taken to address any output failures. Quality control can therefore be considered to be a passive confirmation of quality where the focus is on checking and testing after the product has been produced or the process has been completed.
Quality Assurance has a different focus in that the objective is to assure quality via an active, up front approach to quality. Activities will be implemented which seek to ensure process controls are in place in advance of product completion which aim to guarantee or “assure” that the product is of the appropriate quality. For example under quality assurance, we may perform process capability analysis to ensure that a process can consistently output to the desired quality. Products will be validated in advance of release into routine production. Staff competence will be confirmed via education and training, in advance of such staff being allowed work on a production process. Suppliers will need to undergo rigorous audit, which will look at their support processes again in advance of being “approved” as a supplier. Under a quality assurance program, these advance qualification activities will then be continued into normal routine processing, i.e. the supplier will continue to be audited, re-validations will continue to be performed, process capability studies will continue to be completed. The objective under quality assurance, is that processes are continually maintained in a state, which ensures that their output will always be to the appropriate quality requirements. Once the quality assurance activities are implemented, the majority of organizations will also operate quality controls, to check or verify that the processes which have been “assured” as operating appropriately do indeed output product and processes of the correct quality.
The distinction between assurance and control can be difficult to distinguish under certain circumstances. Take the example of statistical process control process (SPC) implemented into a production line. Is this a quality assurance or a quality control activity? Quality assurance is about preventing failures. The SPC process will identify changes in a process before the process goes out of specification, thereby acts as an early warning system. Corrective action can be taken based on trends identified in the SPC charts, failures will be prevented, therefore SPC is an approach to quality assurance. However, SPC involves recording the output of a process. The SPC chart will also allow a process operator to see if a process is operating within required operating parameters. If a process starts to output non-conforming product, this will immediately become visible on the SPC chart and action can be taken to address the failures. In this instance the SPC recording is a quality control.
In summary:
There is no exact boundary between quality assurance and quality control. The best means of differentiating is to consider quality assurance to be those activities focused on preventing failures, quality control is focused on detecting potential failures. In most organizations, both assurance and control activities are implemented with the end objective of ensuring the customer receives a quality product or service.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. …
- Information & Training presentation >>>