How to Write a Quality Management Audit Form

A comprehensive Quality Management Audit Form prepares you for internal and external audits of your system. The form also encourages employees to pay attention to documenting non-conforming issues that impact the company's regulatory compliance.

Instructions

1. Create a new document using a word processing program. Title the document, "Quality Management Audit Form." Add a heading title, "Audit Information: To Be Completed by the Auditor" directly under the main title. Insert a signature line for the auditor next to the main title.

2. Skip two line spaces. Insert a two-inch rectangular box with borders. Click inside the box and type "Non-Conformance - Include Section of QSR, ISO or SOP." Add one more signature line for the auditor's name.

3. Begin another rectangular box three inches in length and add outside borders. Outside the box, type "To Be Filled Out by Auditee." Beneath that line add: "Root Cause: This is the underlying factor that caused the non-conformity to occur." Insert a field for "Date" and "Root Cause Accepted."

4. Design one more box on the first page. Format the box to be 4-inches long and insert exterior borders. Position the cursor on the line above the box and type, "Corrective Action Plan: Steps to address the non-conformity." Include three fields on the inside end of the box for "Owner Name Signature," "Plant Submitted Date to Implement Corrective Action" and "Accepted By Quality Assurance/Regulatory Affairs."

5. Insert a page break and jump to the second page. Create two rectangular boxes, each 3-inches long. Title the first box, "Corrective Action Implemented." Add the following sentences in parentheses, "This is the action to eliminate the reason for the non-conformity."

6. Put in a title for the second box, "Preventive Action." Skip one line and add a sentence in parentheses that says, "This is the action to eliminate the cause of potential non-conformities or other undesirable situations."

7. Position the cursor beneath the second box. Type two fields for "Verification for Effectiveness" and "QA Representative or Auditor Signature After Verification." Insert one final signature line for company's supervisor of the Quality & Regulatory Affairs Department.