What is an audit?
Make no mistake about it, an eQMS system is your first line of defense in an audit.
The FDA has announced that it is drastically increasing the auditing of companies, small or large, foreign and domestic.
“You get what you inspect, not what you expect!”
An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step.
In a simple word, it means checking to ensure you are actually doing what you say you are doing.
As it is mentioned in the first paragraph, an audit can be applied to different parts, and as such, there are three types of audits (depending on its scope):
- Product audit applies to a particular product or service. It is the assessment of the final product/service and its qualification for use evaluated versus the intent of the purpose of the product/service.
- Process audit to verify that processes are working properly.
- System audit which is conducted over a management system. It evaluates an existing QMS to determine conformance to company policies and regulatory requirements.
System audits are one of the key management tools for accomplishing the aims set out in the policy of the organization. A system audit is a disciplined method to evaluate and improve the efficiency of a system. Audits are carried out in order to confirm that the individual elements within the system are effective and suitable in achieving the stated objectives.
The system audit also delivers objective evidence concerning the need for the reduction, elimination and most importantly, prevention of nonconformities. The outcomes of these audits can be used by the management for improving the performance of the organization. They are conducted by the trained auditors who can be organization own staff or staff of an external auditing agency or independent professional auditors. They are conducted by looking for objective evidence.
In nearly every industry, audits are increasingly used as important management, compliance, quality and process improvement tool.