Manufacturing Quality Control...
Information & Training. | Quality Assurance. Quality Management.
The key objectives for any quality control system are that appropriate controls are applied across all aspects of the organization where product or process quality can be affected.The controls applied need to be “effective”, i.e. result in both the internal and external customers receiving the quality of product and associated service that they expect. In fact, the objective in an “effective” quality control system is that the customer is delighted with the product offering, thereby communicating positively to work peers, line managers, etc., about the superior product they received.
All quality controls applied must be “efficient”. Feedback on deviations need to be promptly received. New test methods should be introduced without internal bureaucratic delay (i.e. the approval process needs to be fast). Feedback from customers needs to happen in real time, so that corrective actions responses can happen in real time. Efficiency also includes the cost of quality. The costs of the quality control effort, needs to provide real costs benefits to the organization.
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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Manufacturing Quality Control Options?
There are many options, which depend on the environment the organization operates within. For example, is the manufacturing subject to tight regulatory control? Or is the business capital intensive? What is the approach to risk within the business?The skills base, educational mix and culture of the employees in the organization will influence the optimum quality controls to be implemented. For example an SPC control system may be suitable where line employees are encouraged and keen to develop their personal process understanding and wish to input into manufacturing process improvement. Alternatively, in another manufacturing organization intensive pass/fail inspection points may be optimum.
“Prevention” versus “Appraisal”.
Prevention focuses on implementing quality controls which identify and root out failures before they get into the manufacturing process. For example, by placing quality control on suppliers, raw material quality can be improved and defective materials can be minimized in the manufacturing process. Similarly, introducing controls during the product or process design phases such as measuring product and process capability (Ppk’s, Cpk’s) will drive down on-going routine variation and failures. Similarly, strict training controls, with testing performed on line employees prior to them operating on live product can reduce routine defects.Alternatively, if an organization takes the approach to focus on “appraisal” methods of inspection, then the focus will be in implementing a range of in-process and final inspections. Here quality control may focus on implementing a statistical process control system, which can be implemented across critical processes and for key quality attributes. As product is produced, measures are recorded of outputs and adjustments can be made to maintain the process within desired control specifications.
Quality Management System process, such as CAPA, Validation, Document Control, are all supporting processes in any manufacturing quality control effort.
For example, failure investigation and corrective action will help in the understanding of the reasons for any failures and will help implement change to prevent recurrence.
Implementing Manufacturing Quality Control …
a) Define the current situation. What quality controls are currently in place? Where are the gaps between the quality levels we want to achieve and the quality levels being recorded.b) Define the desired situation. Where does the organization wish to reside in terms of future internal and external customer expectations? Where does the organization wish to focus their quality efforts along the “prevention” versus “appraisal” spectrum?
c) What are the various quality controls that currently suit the operating environment for the organization and what controls could be introduced via changing culture, environment, skills mix?
d) Outline a roadmap, with short, medium and long term changes to quality controls that may be necessary to achieve the desired quality objectives for the organization.
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 >>>