Information & Training. | Quality Assurance. Quality Management.
The Quality System Audit.
Organizations focused on the delivery of quality products and services require an effective Quality Management System suited to their needs. The quality management system will encompass all activities which can impact quality, the system will ensure customer needs are fully understood and will ensure that controls are in place to deliver customer requirements. The quality system will set controls over product development, service delivery, methods of feedback collection, will identify change yields and trends across all quality impacting activities. With the realization that every product and process can be improved, there will be continuous improvement processes established. One method of identifying opportunities for improvement and verifying the effectivity of prior continuous improvement initiatives is the quality management system audit.The Quality System Audit needs to be:
i) Seen as a method of assessing current practice to requirements,
ii) Utilized as a method of identifying opportunities for further improvement.
iii) Used as an opportunity to communicate and explain quality requirements.
iv) Applied as a method of verification that change is been effectively implemented.
v) A method of ensuring that customer expectations are being delivered upon.
vi) A medium utilized by management for reporting practice status across the organization versus management requirements.
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 >>>
In many organizations the quality management system is aligned or certified to the ISO 9001 Quality Management System standard. This standard establishes requirements across all activities that can impact quality, however the requirements are generic so that every organization needs to understand the expectations of the ISO standard, then detail how they will implement and meet those requirements via their own specific standard operating procedures. The ISO standard is only a good quality system baseline, the true effectivity of the ISO standard is totally dependent upon the enthusiasm, commitment, resources applied by each individual organization.
Internal Quality System Audits.
Internal quality management system audits are critical in the realization of a truly effective quality management system.The first step is normally the creation of a quality audit schedule. The schedule will list out all audits to be performed, the frequency of audit and timelines for audit performance.
As audits are performed, reports will be generated and distributed. Where non-conformances to standard are identified, corrective and preventative actions will be raised and followed-up to closure via the CAPA process. Where opportunities for improvement are identified, these will be detailed in the report and should generate discussion with relevant personnel with a view to investigating and implementing improvement opportunities.
The ISO 9001 standard details a range of generic operational activities that can impact quality, for example, setting quality objectives, controlling documentation, controlling processes, implementing continual improvement, performing management reviews, customer feedback, etc.. Each of these activities needs to be subject to audit. The frequency and extent of audit will be determined by the relative importance of each activity towards delivering customer expectations. Where an activity is critical to delivering customer quality expectations and there is a high risk to the organization associated with any failure within that process, then the frequency of audit will be higher versus an activity with an lower potential risk. Internal audits will be planned and performed based on relative risk, however, when performing audits, the auditors need to promote audit positives such as improvement opportunity identification and opportunity for communicating quality standard expectations.
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 >>>