Quality Systems Training...
Information & Training. | Quality Assurance. Quality Management.
A comprehensive effective quality system is an essential pre-requisite for success is all organizations. Depending on the business segment and size of the organization in question, the quality system needs to be developed to suit the specific business requirements. Many organizations have perfectly good quality systems but do not have any formal certification stating compliance with specific standards (e.g. ISO 9001), however, in order to provide consistent, reliable, quality outputs, a quality management system needs to be applied, contributed to, continually developed by all organizational staff.The first step in achieving, maintaining and developing a quality system is to ensure that all relevant staff have a good understanding on the need for product and process quality and have a clear picture of how their day to day efforts can impact on quality. Everyone needs to understand how they can contribute to improving quality. How continually improved quality will result in satisfied customers who will return, thus securing jobs, pay and profits.
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 >>>
At a management level, there needs to be a single individual with the responsibility for driving quality improvement and who promotes a vision for quality across the organization. Equally, there needs to be a clear understanding by all management, that everyone is responsible for quality and everyone must dynamically pursue continual quality improvement.
Once there is a buy-in at senior management level to the above, then a focus can be placed on the mechanics of implementing a quality system. Without management buy-in, there is no point in progressing any further the idea of an effective quality system.
A quality management system can be developed in accordance with an international standard such as ISO 9000, or may need to comply with a specific regulatory requirement imposed on an industry. However, regardless of the approach taken, the key components of all quality systems are fundamentally similar.
Quality Policy and Quality Manual.
There needs to be a “Quality Policy” which compliments the Mission, Vision for the organization. A Quality Manual will then go into more detail on the various components of the quality system and how they are applied across the organization.The Manual will reference a range of operational procedures, which will detail how the quality system is implemented, examples being…
How the corrective and preventative action system in implemented.
What is the approach to staff competence and training.
The process for obtaining and addressing customer feedback.
How are new products and processes introduced and qualified.
How is new equipment confirmed as being capable of consistently operating to requirements?
Is there a routine calibration and preventative maintenance program in place?
How are the results of the calibration and preventative maintenance programs reviewed?
Is there a focus on quality cost?
If yes, is the overall cost of quality increasing or decreasing?
Are the relative proportion of preventative versus appraisal costs changing?
Is this in line with the organization’s strategic vision for quality?
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 >>>