The Quality Compliance AuditThe compliance audit is focused on ensuring regulatory requirements are effectively implemented within a business. The intent of the compliance audit can be quite different to that of the quality management system audit. With the quality management system audit, the audit has a much broader scope. It not only seeks to confirm compliance with standard requirements, but also seeks to identify improvement opportunities, to use the audit as a tool to relate quality expectations to front line staff and as an opportunity to facility open communication. The compliance audit tends to have a much narrower focus on ensuring the requirements of the relevant regulations are fully implemented.
When performing compliance audits within highly regulated industries, for example the pharmaceutical, bio-technology, medical device industries, etc., staff will frequently be trained on how to answer auditor questions. Staff will be required to only specifically answer the question asked, to offer no opinions or suggestions for improved methods of operating. During a strict compliance audit, when an auditor asks about how a process is performed, he/she will be provided with the relevant standard operating procedure and the auditee will step through the procedure, quoting lines or sections. The objective is to strictly control the flow of information from the auditee to the auditor. The objective is not to improve auditee knowledge or understanding on regulatory requirements nor to identify any potential opportunities for improvement. The objective is to solely demonstrate adherence by the organization to regulatory requirements.
The reason for the different approach with the regulatory compliance audit is the potential penalties associated with the identification of non-conformance to requirements. Where regulations have legislative backing, for example the US FDA (Food and Drug Administration) Code of Federal Regulations, or the European Medical Device Directives, failure to meet regulations can stop product access into markets. The result is that a business required to comply with statutory regulations will seek to minimize the potential for an auditor to identify non-compliance to regulatory requirements. Once the compliance audit is completed, the business can then continue to focus on continuous improvement, development of staff, etc..
With the quality management system audit, or any form of audit performed against a voluntary standard, the approach by both auditor and auditee can be more informal and facilitates discussion and communication flows. Many organizations subject to regulatory requirements that have statutory backing, will seek to use voluntary certifications and quality management system audits as a means of preparing and optimizing their processes in order to ensure successful compliance audits.
Information & Training Presentation on 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)
- 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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