The Audit Report.
The audit report is the single most important component for an effective audit. The report will provide an accurate picture on the compliance of the activity audited to the expected standard of performance. The report will detail any deficiencies and the potential severity of such deficiencies. The report should also provide a clear picture as to where standards of performance are being achieved, thereby allowing the report reader to understand if the deficiencies are outliers from normal practice or indicate wider systematic process failings.Best practice is to have a standardized report format so that all reports are presented in a uniform manner, i.e. there should be a standard format for the report cover sheet, the report contents sheets and standard approaches to any subsequent corrective action requests.
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 >>>
Audit reports should contain, as a minimum:
Audit objective and scope.
Audit dates.
Audit plan.
Auditor(s) / Audit team members.
The standard(s) used as the basis for the audit.
The status of the organization’s quality system documentation.
A full audit trail i.e. information on all activities audited.
Details of observations made or non-conformances identified.
Summary and conclusions.
Distribution list.
The audit report will become a quality system record, therefore there can be no confusion over the contents of the report. Also the report will be required as reference material for subsequent audits, therefore, any deficiencies identified need to be clearly explained so that any corrective actions taken as a result of the audit fully meet the expectations of the auditors.
Agreement on the Audit Report findings.
Before the audit report is issued in final draft the proposed contents should be detailed and discussed with the auditee(s). This will ensure there is a full understanding by the auditee(s) on the opinions of the auditors in terms of meeting expected standards of performance. The discussion will also provide an opportunity to clarify any potential mis-understandings or allow further discussion on potential areas of disagreement. The report should positively acknowledge the support and contribution of all those who provided information during the audit.The follow-on steps and tentative timelines should also be agreed. Where a response is to be provided to the report, then the timeline of the response should be agreed. Where corrective and preventative actions need to be raised, if possible, CAPA numbers should be allocated to the planned corrective actions and these numbers detailed into the report. This will facilitate preparation for future audits by allowing immediate reference to related corrective and preventative actions.
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 >>>