To prepare your organization for an external audit:
- Communicate the audit scope and schedule
- Ensure key contacts are available for interview
- Verify process owners can clearly describe
- inputs and outputs
- resources and methods
- controls and measures
- Arrange for auditor access to documentation
- Plan the logistics for the audit team visit
Managers of the areas to be audited should:
- Become familiar with the documents in their area
- Walk through the area for a spot check on operations
- Verify that only valid documents are being used
- Identify records that prove requirements are met
- Be prepared to share performance results for area
- Ensure that the work areas are clean and orderly
- Confirm that past nonconformities have been fixed
- Brief employees on how to interact with auditors
- Communicate a positive, learning view of the audit
- Participate in the audit briefings and meetings
Auditors will need escorts, so their guides should:
- Know the quality system and how it operates
- Understand the audit plan and functional areas
- Be available by staying with the audit team
- Clarify, not answer, for the person interviewed
- Act as witnesses for any audit nonconformities
- Help keep the auditors on the planned schedule
- Take good notes for possible follow-up actions
Of course, employees in the areas to be audited should:
- Understand the quality policy and their role
- Prepare by participating in internal audits
- Know where their documents are located
- Be able to quickly retrieve their records
- Know how to respond to auditor questions
- Be prepared to demonstrate their activities
- Be aware of quality objectives for their area
Employees should be ready to answer audit questions such as:
- What is the overall purpose of this process?
- Please describe your job and responsibilities.
- What are the process inputs and who supplies them?
- What resources are needed for this process?
- What are the process outputs and who receives them?
- How do you know what to do?
- What training, skill, and experience are needed?
- Show me, or tell me, how you do the job.
- How do you know if it is done right?
- When it is not right, what do you do?
- What records are kept of this activity?
- How is the process controlled?
- What are the process objectives?
- How is the performance measured?
- How could this process be improved?
When being interviewed, employees should:
- Listen carefully to the auditor questions
- Provide brief, accurate, honest answers
- Answer specific questions, not volunteer
- Avoid steering auditor to other discussions
- Be cooperative, not misleading or defensive
- Avoid digressing, speculating, or embellishing
- Ask for clarification if they don’t understand
- Admit if they don’t know the answer to question
- Refer auditor to right person for an answer
After the audit, be sure to:
- Thank everyone for their participation
- Summarize audit results to organization
- Request corrective actions, as needed
- Monitor actions for timely completion
- Verify corrective actions are effective
- Inform the audit body, as appropriate
- Analyze results and identify any trends
- Initiate preventive actions, as needed