Information & Training. | Quality Assurance. Quality Management.
The Lead Auditor.
The role of the lead auditor is often interchangeable with that of an audit team leader. The designation really depends of the organization and industry within which audits are being performed.In the majority of organizations, the lead auditor is effectively the audit team leader, who has developed competences based on experience within that or previous organizations.
The Lead Auditor will need a set of competences which generally exceed those required as an auditor.
However, before detailing those additional competences, it may be appropriate to summarily review what is expected from all auditors:All auditors require a level of competence (technical knowledge, experience, or training) to ensure they have ability to audit the process and practices under review.
They need to have an ability to communicate effectively, both written and orally.
Will need to be able to clearly document observations “on the go” (as they arise) and transcribe into an understandable report.
Will need to look and act professionally (conscientious, business like, courteous). In dealing with others they will be expected to be diplomatic, open-minded, observant and perceptive, non-argumentative.
As a person progresses from being an auditor, to being a lead auditor, in addition to having the characteristics previously listed, will need to be able to demonstrate that they are well organized, decisive, approachable, independent of mind and portray competence and natural leadership.
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 >>>
Responsibilities of the Lead Auditor.
Development of a plan for audit performance, which details the scope of the audit. Identifying applicable reference standards, guidelines, regulations. Determining resource requirements and timelines for preparation, performance and reporting on the audit. Where resource constraints apply, then adjusting the audit schedule, to align with available resources.The lead auditor will need to set the “tone” of the audit, i.e. through his/her professionalism will need to project and deliver “professionalism” upon an audit team which is itself staffed by competent professionals, who are seen as impartial observers of actual practice versus expected practice and who can distinguish true issues from the trivial.
The lead auditor, needs to instill in the audit team, an approach to auditing where the auditor builds a relationship with the auditee(s), where informal suggestions for improvement can be made, if the auditors sees such opportunities. Clearly, such suggestions would not form part of any non-conformances as detailed in the audit report, but may be recorded as opportunities for improvement, where there are no specific actions addressed against the auditee, but just advisory suggestions. Clearly, the original objective behind the audit and the authority of the auditors will influence how audits can be used for improvement.
The outcome of an audit will be detailed in the audit report. The lead auditor will need an ability to ensure that the audit report captures the extent of the audit, and clearly identifies positives associated with the process audited in addition to documenting those aspects of performances which did not meet requirements.
In summary.
The lead auditor needs an ability to plan, organize, re-organize audits, to clearly communicate with the audit team and those being audited, to project a level of professionalism that permeates the audit team and receives a respect from those being audited.Utilizing technical knowledge and experience has an ability to distinguish between the trivial many and the critical few issues that may arise.
Is able to hold the confidence of senior management within an organization or key personnel within third party organizations.
In summary he/she is a strong, competent leader.
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 >>>