Information & Training. | Quality Assurance. Quality Management.
Types of Audits.
There are a range of types of Audits which are based either on the area of audit focus or on the relationship between the activity being audited and those performing the audit.Based on audit activity, the audits could be considered to be product audits, process audits, system audits, risk audits, quality audits, competence audits, safety audits, environmental audits, regulatory compliance audits, supplier audits ….
Based on the relationship between the activity being audited and those performing the audit, then the audit can be considered to be internal, or external or third party audit. For example, audits performed within a business by the staff of the business are internal audits. Audits performed by a regulatory agency to assure compliance with legislative requirements would be considered an external audit. Audits performed on an organization when it requests 3rd party certification to a quality management system standard such as ISO 9000 would be considered 3rd party audits.
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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Internal Audits are focused on ensuring that the controls and practices applied within an organization are appropriate and meet the expectations of the organization. Internal auditors may be employees of the organization itself or may be external auditors hired by the organization to perform the internal audits.
External audits are often performed by regulators or by customers within the business to business environment. For example in the medical device, pharmaceutical, bio-technology industries, manufacturers must meet strict regulatory requirements. Regulatory bodies established by legislation perform audits to ensure compliance with such regulatory requirements.
Within the business to business sectors, purchasing organizations will regularly audit suppliers to ensure minimum quality systems have been established by suppliers. Such audits seek to ensure quality products and services are delivered on an on-going, consistent manner.
Many organizations seek certification to industry, national and international standards. For example for product safety, a manufacturer may seek approval to the UL (Underwriter Laboratories) standard for the components utilized within a product, or a business may seek ISO 14001 Environmental Management System certification. In both these instances, a 3rd party auditing body will perform the audit to ascertain if the required levels of compliance and practice are in place to permit certification to the relevant standard.
For internal, external and 3rd party audits the focus of the audit may be on a particular activity or functional area. For example, product audits will seek to determine if the product will consistently meet required standards or regulations. In such an audit, the design history of the product will be reviewed, clinical or functional prototype performance results will be checked, the methods of production will be reviewed, delivery and installation practices will be assessed. If there are DFU’s (directions for use) these will be subject to audit. Any non-conformances identified from the development through to the delivery and on-going use of the product will be reviewed. Associated corrective and preventative actions will be verified as having fully and permanently addressed any identified failings within the product.
Where a process audit is being performed the focus of the audit will be to ensure that the process as designed and implemented has the capability of consistently producing the required outputs. The outputs will be clearly defined by specifications, standards or regulations. Process history documentation will be reviewed during the audit to confirm process capability. Included within the scope of the audit will be all the inputs impacting on the process, for example, are raw materials appropriately controlled, are staff fully competent via either training, education or experience? Is the environment suitably controlled or stable so as to assure process stability and capability?
Whatever types of audits are being performed, the objective will be to determine current status versus expectations. Where deviations are identified, then the potential severity of any such deviations needs to be determined. Follow-up corrective and preventative actions will then be performed to align practice and requirements.
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 >>>