Audit Agendas

If you’ve been asked to audit an ISO 9001-based quality management system, how do you develop an efficient and effective audit agenda?

After confirming the audit dates, hours, and location, identify the functional areas that are included in the audit scope. Start by requesting a copy of the quality manual and organization chart. Review the description of the interaction between the processes that is a required part of the quality manual.

List the functional areas from the quality manual and organization chart. You want to know all the processes within the scope and how they interact with one another. Then, list the work hours for the areas so their audits are scheduled during normal hours of operation.

Ask your auditee contact to give you the employee and contractor totals for each of the functional areas. This information will help you determine the audit time to allocate to each area based on size. Other considerations in establishing the audit sample should be recent process changes, risk factors, new technology, process complexity, and new management.

In addition to auditing the applicable requirements for functional areas, you also want to assess the related clauses of the ISO 9001 standard. Therefore, see if the organization has a responsibility matrix that identifies the applicable clauses for each area. If not, talk to your auditee contact and gather the needed information.

You’re now ready to create the audit agenda. Using a document template, list times in the first column in 30 minute blocks from the start time to the end time. Block out the events that are independent of the audited areas, such as meetings.

For example, if the work day is 8:00 to 5:00, schedule the Opening Meeting at 8:00, lunch at 12:00, auditor preparation at 12:30, report preparation at 4:00, and the Closing Meeting at 4:30. For a two day audit, Day 1 will end with auditor preparation at 4:00 and a Management Briefing at 4:30. Day 2 will end with report preparation at 3:30 and the Closing meeting at 4:30.

Count the open time slots on the agenda that remain for auditing the areas. Allocate the number of time periods needed for the functional areas to be audited. Some areas may only need one time period (30 minutes), but others may be allocated multiple times periods, e.g., Engineering and Production.

Then, knowing the needed durations, plug the areas into the second column of the agenda in a logical sequence. A typical flow might start with the Quality department for a review of the quality manual and to understand the document control and record control procedures. This overview should help you assess the remaining areas and their linkages.

The next logical area to audit might be top management and their requirements from clause 5 of the standard. Afterwards, you could move to Sales and assess their applicable requirements, including clause 7.2. The audit flow might continue with Engineering (7.3), Purchasing (7.4), Receiving (7.4.3), Planning (7.1), Production (7.5), Test (8.2.4), Warehouse (7.5.3, 7.5.5), and Shipping (7.5.3, 7.5.5). The audit could finish with the Quality department to assess Internal Audit (8.2.2) and Corrective and Preventive Actions ( 8.5.2, 8.5.3).

Verify that all the areas are on the agenda and all the applicable ISO 9001 clauses will be addressed. List the key clauses with each area on the agenda as reminders. Ensure you and any other auditors on the team are independent of the areas to be audited. And, ensure all of you have the necessary competencies for the assignment.

If any of the areas on the agenda are far apart, take these distances into account and show the travel times on the agenda. Also, determine the number of shifts and arrange to sample some from each shift. For example, stay late one day for second shift and arrive early the next morning for third shift. Or, schedule separate audits for each of the shifts.

Send a copy of the draft agenda to the other auditors on the team, to the audit client (the person requesting the audit), and eventually the auditee (the organization to be audited). Ask for their review comments and make the appropriate changes.

Refer to the agenda at the opening meeting and use it during the audit to satisfy the audit objectives. Remember, it is a plan and may need to be adjusted during the audit. Include a copy of the final agenda in the audit report.

I hope this approach to creating an audit agenda proves useful. If you have any comments or tips to share, please send them to me.