Information & Training. | Quality Assurance. Quality Management.
Audit Schedule
It is important that compliance requirements within an organization are subject to effective and systematic auditing on an on-going basis. The frequency of audit should be based on risk. Risk needs to be related to the potential for poor quality products, or risk of an un-reliable service, employee safety risks, risks to the consumer associated with using a product, financial risk to the organization, etc., etc.. The greater the potential risk to the organization, then the frequency of audit focused on those activities generating the risk needs to be greatest. Audits need to be planned or scheduled to take account of the risk to the organization, to ensure all aspects of applicable standard or regulation are subject to audit and to identify opportunities for improvement across 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. …
Information & Training presentation >>>
Basis for the Audit Schedule
i) Frequency of audit needs to reflect the potential risks to the organization.
ii) The need to perform an audit should take into account the maturity of the quality management system and previous audit history.
iii) Experience from customer feedback, process deviations, yield trends should all feed into the determination of audit frequency.
iv) In the case of external audits, significant changes in management, organization, policies, techniques or technologies, products may prompt an audit.
v) Internally, audits are organized on a regular basis to verify the implementation and effectiveness of the organization’s quality management system and to review the results of any significant changes to the system.
Building an Audit Schedule
Identify all activities that need to be subject to audit. This will normally cover any activity that has the potential to impact product or process quality. The scope of the audit program will need to take account of all relevant standards, regulations, customers and all stakeholder expectations.Once the range of activities to be audited has been identified, then the potential risk to the organization from any failure associated with the area of activity will need to be estimated. This will normally require some from of risk assessment and risk management process to be performed.
With the risk levels determined, then a frequency of audit can be defined for each activity. The frequency of audit will need to take account of the resource requirements and impacts on the organization. Resources will be required to perform the audits, equally, resources will be impacted in facilitating the audits and addressing issues which may arise from the audits.
Once the above is defined then a schedule of activities, versus proposed audit timelines can be created. The schedule should seek to create a balanced level of audit activity so that there are not a glut of audits in one time period followed by an absence of audits in a subsequent time period.
As audits are performed, the schedule will be reviewed and updated. Additional audits may be requested, some audits may be re-scheduled etc..
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 >>>