Information & Training. | Quality Assurance. Quality Management.

Auditing.

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   >>>

Why Conduct Audits?

Benchmark of current performance.

An audit will show how activities and existing systems are being used at the time of the audit.  This can be a baseline against which future improvements are compared. 

Standardization.

Applying the same expectations at various sites or departments can help achieve consistent performance throughout an organization.

Avoiding problems.

Auditing potential suppliers helps minimize the chances of “if we had only known….”  Having a structured auditing program and carefully identifying what to look for will help to avoid or minimize problems that could occur later.

Means for improvement.

Identifying problems is the first step in solving them; audits can do this.  In addition, the audit may point out the root and contributing causes of the problems.

Training.

The auditee’s primary contact and all those working with the auditor have an opportunity to learn the auditor’s view of how quality principles and regulations apply.  A qualified auditor should be able to explain the rationale behind requirements and how the auditee can use them to add value to their operations.  From the auditor’s perspective, each audit is a chance to learn about an organization and its approach in meeting best quality practice expectations.

Compliance.

If the audit is done properly, compliance will be only one of the many benefits.  Management that makes compliance the primary focus of the audit shows a lack of understanding of an audit’s power.

Process and equipment capability.

Audits can be utilized to assess the capability of a process or items of equipment to meet expected quality, reliability, efficiency standards.

Common terms applied to the auditing process:

Sponsor (or client) – the organization that wants the audit conducted.

Auditors – those conducting the audit.

Auditee – the individual(s) being audited.

When the sponsor, auditor and auditee are all part of the same organization, it is considered an internal audit.

When the sponsor and auditor are part of one organization and the auditee is part of another organization, it is considered an external audit.

If there is limited connection between the sponsor and the auditor then it is considered a third party external audit.

Audits can arise due to internal or external requirements.