Information & Training. | Quality Assurance. Quality Management.

The Audit Process.

There are four distinct phases associated with all audits, namely:

#1. Preparation and planning.

#2. Performance of the audit.

#3. The audit report.

#4. The follow-up and closure.

 

The Audit Process: #1. Preparation and planning.

The need for an audit will be driven by some source. This may come from the management within an organization, from customers, from regulatory bodies or from certification bodies. In some instances the audit may arise as a request for a self inspection by a group of individuals seeking to understand current status and seeking to identify opportunities for improvement. In every organization the original demand for audits will vary depending on the activities of the organization.

Once the need for the audit has been identified, the next step in the audit process will be to identify the standards of performance to be assessed during the audit. The audit may compare practice against international standards, or against government regulations, or against corporate procedures, or against specific performance requirements. The key requirement is that the expected standards of performance are clearly defined and understood. There should be no ambiguity, otherwise any identified performance gaps arising from the audit may themselves be ambiguous and therefore open to dispute and difficult to address.

Audit Process Training

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   >>>



Prior to audit performance, the auditees will be identified and notified. The purpose of the audit needs to be explained and the estimated time demands from auditees should be outlined. The objective needs to be to facilitate a smooth efficient audit.

 

The Audit Process: #2. Performance of the audit.

The first stage in the audit will be the initial meeting, where the auditors will outline the purpose, scope and timeline for the audit. The auditors will also outline any key areas of focus or concern which may have given rise to the audit.

As the audit is performed, the auditors need to establish a solid understanding of current practice versus the expected standard of performance. Where practice is un-clear, the auditors need to probe to ensure full understanding. The auditors will seek samples, reports, records, procedures, will ask questions, will observe, etc.. so as to ensure a clear accurate understanding is established. Where differences to expected standards are indicated, the auditors need to further investigate to see if the performance gap is real and if so, the extent of the gap.

 

The Audit Process: #3. The audit report.

Upon completion of the audit, the auditors will draft a report of their findings. This report will detail the audit trail and any non-conformance identified. The draft report then needs to be discussed with the auditees, who will have the opportunity to provide feedback and further explanation where necessary. Once the draft has been reviewed, then the final report will be issued and copied to the original requestors of the audit (plus copied to other individuals who may be impacted by the audit or have responsibility for the areas under audit).

 

The Audit Process: #4. The follow-up and closure.

Where non-conformances or recommendations for improvement have been identified, then corrective action requests may be created. The corrective and preventative action process will ensure that findings from the report are fully and effectively corrected.

The auditee(s) is responsible for determining and initiating the corrective action necessary to correct a deficiency and to correct the cause of the deficiency.  The auditor should be responsible only for identifying the deficiency.

Corrective actions should be completed within a time-scale determined by the auditee but which is acceptable to the audit team.

In some instances a follow-on audit may be demanded due to the extent of non-conformances identified during the audit. Alternatively, the audit may be part of a routine audit program and subsequent audits may be implemented per a planned audit schedule.

 

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   >>>