Scope: This document is intended to define the requirements of the internal audit program at Prime Machine Inc. The elements of the program that will be discussed are: the basis or audit criteria, audit schedule, frequency of audits, qualifications of personnel performing the audits, the format for reporting the results, and corrective action policy.

Purpose: The purpose of this document is to assure conformance to existing procedures and policies and to determine the effectiveness of those procedures and policies.

The majority of audits within the scope of this document shall be Process Audits. The criteria or basis material for the audit will, in most cases, be the Prime Machine Procedures (PMP- documents) Process Flows PMF-Documents and the associated forms. Compliance to these documents shall be the baseline for identifying audit findings.

The audits will be scheduled on an annual basis. The planning process for the audit schedule will take into account past audit findings, as well as processes that have a greater affect on delivered product. An audit schedule will be created for each calendar year as noted in the example in Table (1)

Deviations form this schedule may occur based upon needs as defined in section (1) above.

Any individual conducting internal audits shall posses the adequate skills and training needed to perform the audits in a competent and professional manner. This training may be in-house training provided by the Quality Administrator or be obtained at third party outside sources

All audits will be performed in a professional manner. Notification of the audit will be made to the to a affected area personnel. These personnel will be informed of the date and time of the audit and what specific procedures will be uses as the basis. Upon execution of the audit, all issues will be noted on the audit report form Qform-203.

Audit issues will be characterized as follows:

Comments: Comments are areas noted for possible improvements that could save time or increase effectiveness of a system. These comments are issues that if not addressed will have no impact on desired results of the Quality Management System.(QMS)

Observations: Observations are potential non-conformities that may lead to a failure of the QMS. These observations are also areas of improvement intended to prevent non-conformities in the QMS or delivery product.

Finding: A finding is an observed violation of the QMS process and procedures that will create or has created non conformities in the products if not corrected.

All Audit comments observations and finding will be documented on the Audit report Qform-203. This report will be discussed with area personnel to clarify and assure understanding of the nature of the report. Only finding will require a written statement of corrective action form the audited area. After a reasonable implementation time verification shall be made that the finding has been corrected.

Audit results will be summarized for each management review. Observed trends will be identified as well as significant chronic failures of the QMS. The management team will develop preventive action plans as an output of the management review.

 

Table (1) Example of audit schedule

 

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