4 Elements for Process Approach Audits

“Quality System Audit is your basic Compliance Assurance mechanism”

- Mayra I. Rosa-Pagán, Lead Consultant

An effective Quality Management System must have a solid Auditing Program that assures you the upmost compliance standing. However, good quality audits are obtained through a process approach methodology that could reveal the efficiency of your systems, processes and operational activities. 

What are the core 4 elements for process approach audits?

Process approach refers to the audit cycle and it is what I call: the “PERC” process.

Plan (P)

Planning the audit requires understanding the regulatory requirements, developing the auditing strategy, reviewing all required documentation and notifying the organization to begin the audit.

Execute (E)

Execution will start with an opening meeting, implementing auditing techniques to gather objective evidence and reporting progress according to audit plan.

Report (R)

Reporting consists on preparing the final document that details all findings during the process approach audit. This will be the report to Management that evidences the compliance standing of the organization against specific regulatory requirements.

Close (C)

Closing the audit can occur once all findings are addressed and corrected. But, in other instances the audit can be considered closed once all associated corrective and preventive actions (CAPAs) have been effectively closed.

The assessment of your quality system requirements must be performed with defined intervals during the operational cycle. Include these requirements in your standard operating procedures to guarantee the best outcome of your basic Compliance Assurance mechanism.

If your need additional information related to all the regulatory compliance requirements, you may review this course available for you: Audit Management

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