Audit Procedure

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1.0 PURPOSE

The purpose of this procedure is to assess the conformity of our quality management system to specified requirements and its effectiveness in meeting quality objectives.

2.0 SCOPE

This procedure covers scheduling, initiating, planning, conducting, recording, and reporting internal audits. It also addresses qualifying auditors, performing follow-up audits, and managing the overall audit program.

This procedure applies to internal audits for all functional areas involved in performing, verifying, supporting, and managing our quality-related activities.

3.0 REFERENCES

3.1 Internal Audit Schedule, file PLAN.XLS
3.2 Corrective Action Procedure, QA-P-014
3.3 Prior internal and external audit reports
3.4 Documents for the areas to be audited:

  • Quality Manual policies
  • Department procedures
  • Plans and specifications
  • Work instructions and forms

3.5 Customer contracts
3.6 Statutes and regulations
3.7 Applicable standards

4.0 RESPONSIBILITIES

4.1 Quality Manager

Performs the duties of the audit program manager. Maintains the audit schedule, initiates audits, assigns qualified auditors, and manages the overall audit program.

4.2 Internal Auditor

Reviews the applicable documents, considers prior audit results, prepares an audit checklist, conducts the audit, and reports the results.

4.3 Lead Internal Auditor

Carries out the duties of an auditor, prepares the audit agenda, briefs the auditor team, conducts the opening and closing meetings, and issues the audit report.

4.4 Manager of Audited Area

Provides access to information, encourages employee cooperation, acknowledges any findings, proposes corrective actions, and notifies the audit program manager when actions are complete, effective, and ready for a follow-up audit.

5.0 PROCEDURE

5.1 Scheduling

The audit program manager creates and maintains the internal audit schedule. Each functional area within the quality management system is audited at least annually. Audits are conducted such that all activities corresponding to the requirements of the Standard are assessed throughout the year.

Departments may be scheduled for more frequent audits based on the importance of the area, the status of product quality, and the results of prior audits. Planned audits are identified on the internal audit schedule, along with tracking information regarding audit completion and closure.

The audit program manager presents the annual schedule for approval at the Management Review meeting. Supplemental audits can be added to the schedule during the year if warranted by changes to the quality management system.

5.2 Initiating

The audit program manager refers to the schedule to identify the audits planned for the next month. A reminder notice is sent to the assigned auditors, and the manager of the area to be audited, at least two weeks prior to the audit.

5.3 Planning

The audit program manager communicates the audit objective and scope in the audit notice sent to the assigned auditors and the managers of the areas to be audited. The lead auditor is appointed by the audit program manager and prepares the agenda for the audit. The agenda defines the auditor assignments and identifies the times and duration for each audited area.

Auditors prepare by reviewing the applicable parts of the Standard and quality manual, as well as, applicable plans, procedures, and instructions for the areas to be audited. Using this information, the auditors create checklists identifying the key requirements, representative samples, expected evidence, and suggested questions.

5.4 Conducting

The lead auditor briefs the team on the audit objective, scope, assignments, procedure, and forms. An opening meeting is held with the manager of the area to be audited to review the audit plan and initiate the assessment.

Auditors review documents, interview employees, examine records, and observe operations to search for evidence of conformity to requirements.

If a nonconformity is found, the auditor discusses it with the person being interviewed to confirm the facts and seek agreement with the finding.

5.5 Recording

Objective evidence of conformity with requirements is captured on the audit checklist. Any nonconformities are documented on nonconformity reports and reviewed with the lead auditor.

The auditor completes the first section of the nonconformity report (QA-P-17.01) to describe the requirement and evidence of nonconformity. The responsible manager for the identified process completes the next section by proposing the immediate correction, as well as, the corrective action to prevent recurrence of the nonconformity.

The manager of the process completes the third part of the form when the action has completed and its effectiveness has been verified. An auditor completes the final section during the follow-up audit to close the finding, as appropriate.

5.6 Reporting

The lead auditor prepares the audit summary report (QA-P-17.01) with assistance from the audit team. A closing meeting is held to share the audit results with the manager of audited area and seek acknowledgement of the report.

The lead auditor reminds the auditee that a representative sample was taken during a brief time period and nonconformities may still exist.

Appeals of findings are sent to the audit program manager for arbitration.

A copy of the audit report is given to the manager of the audited area. The original report goes to the audit program manager for record retention.

5.7 Correcting

The manager of the audited area submits an action plan within two weeks of the closing meeting. If the action plan is acceptable, the audit program manager approves the plan and notifies the manager to proceed with the proposed corrective action.

Actions are to be completed within sixty days of the plan approval, unless a new due date is negotiated with the audit program manager.

5.8 Verifying

An auditor is assigned to conduct a follow-up audit and verify the effective implementation of corrective actions for previously reported nonconformities.

Follow-up audits are scheduled within two weeks after receiving notice that the actions have completed. If the audit program manager has not received the notice by the due date, a reminder note is sent to the manager of the audited area.

If after one additional week the action has not completed, an overdue note will be sent, with a copy going to the manager’s manager. If more work is still needed to complete the corrective action, a new due date must be negotiated with the audit program manager.

5.9 Training

The audit program manager selects auditors that are open-minded, impartial, objective, and possess sound judgment. These personal traits, along with company experience, are considered important auditor attributes for conducting effective audits.

Auditors receive classroom training in auditing techniques and Standard requirements, observe an audit conducted by a qualified auditor, and then participate as members of an audit team. The audit program manager maintains records of the auditor training and the list of qualified auditors.

5.10 Managing

The audit program manager maintains the audit schedule and assigns qualified auditors that are independent of the areas to be audited.

The audit program manager tracks the status of audits and summarizes the results for presentation at the Management Review meetings.

6.0 RECORDS

6.1 Audit Notice (sent via e-mail)
6.2 Audit Summary Report, form QA-P-17.01
6.3 Audit Nonconformity Report, form QA-P-17.02
6.4 Audit Checklist, form QA-P-17.03
6.5 Internal Audit Schedule, file PLAN.XLS
6.6 Auditor Training Records
6.7 Qualified Auditor List

7.0 ATTACHMENTS

7.1 Sample Audit Summary Report
7.2 Sample Nonconformity Report
7.3 Sample Audit Checklist Section

8.0 REVISION HISTORY

(Include revision level, change description, changed by, and effective date).