ISO 9001 Lead Auditor Training

Module 6 Conducting On-site Activities

6.1 Conducting On-Site Activities
Having made all the preparations with the auditee and confirmed all arrangements, it is proper etiquette for the team leader to contact the auditee a few days in advance of the audit to verify all the arrangements are in place. The audit team will then visit the organization’s facility on the scheduled date, to conduct the on-site audit activities.

ISO 9001 Auditor Training - If you recall from our earlier notes, the ISO 9001 audit is conducted in two stages. Please review these stages before continuing.

The on-site activities include a number of distinct activities:
  6.1.1 Conducting the opening meeting
  6.1.2 Communicating during the audit
  6.1.3 Defining roles and responsibilities of audit participants
  6.1.4 Collecting and verifying information
  6.1.5 Generating audit findings
  6.1.6 Preparing audit conclusions
  6.1.7 Conducting the closing meeting

6.1.1 Conducting The Opening Meeting
The opening meeting, sometimes called the entry meeting, pre-audit conference, or start up meeting, is typically held at the location of the audit. Good practice demands the auditors arrive together, neither early nor late, otherwise it can be embarrassing for both parties and, what is more, it is unprofessional.

This meeting, as any other, requires preparation by the team leader. The meeting is usually held in a manager's office or the company's conference room. It will usually begin with a welcome and introductions by a member of the auditee management. The audit team has prepared an agenda to ensure that all necessary points are covered quickly and efficiently.

ISO 9001 Training - It should be remembered that this meeting may be the first time the two parties (auditor and auditee) have met, therefore, it is an opportunity to make introductions and maybe “break the ice” since many of the auditees may be feeling tense. The way the opening meeting is carried out can set the style or tone for the remainder of the audit. The opening meeting is the place to establish the rules of conduct for the audit. Matters to be addressed include:

a) Introduction of personnel
The lead auditor should introduce the team and explain the way they are organized if there is more than one group, particular specialists in the group, etc. It is normally a requirement to record the attendees at this meeting. Passing around an attendance sheet and asking everyone present to record their name and position is a practical solution.

b) Audit purpose and scope
Just in case there is any doubt about why the audit is being carried out, and the extent to which the company is going to be examined, the team leader needs to restate these points. In certain situations, the auditee may require evidence or a statement about the team's authority, although matters such as these tend to be covered during the preparation stage. The team leader may also tell the auditee about the audit organization, e.g., the Registrar.

c) Review of the audit plan
The plan will have been discussed, developed, and agreed with the auditee. However, plans may have to be altered slightly and these possibilities should be covered at this stage. The plan should have enabled the company to ensure that someone represents them in each department and has been made aware of the audit and will therefore be available as defined by the plan. The team leader should confirm the intention to keep to the plan to the extent possible.

d) Guide(s) for the Auditor(s)
The team leader will determine, if they have not been advised already, who the guides are and whom they will accompany. The roles of the guide should be discussed. Is the guide to have the authority to agree to the facts surrounding audit findings? Is the guide there merely to provide the auditor an escort from one part of the facility to another?

e) Audit Methods
Describe briefly the methods that the auditors will use to gather objective evidence, such as interviews, observations, document and record reviews, and trend analysis.

f) Reporting methods
The method of recording nonconformities, and of presenting the audit report that will be left by the auditors at the end of the audit, will need to be explained by the team leader.

ISO 9000 Training - When facts are to be agreed with a company representative during the audit, will the guide or the departmental representative be required to sign for acknowledgment and understanding of the facts? If it is the auditor's procedure to gain a signature at this point, the team leader needs to explain the approach to the company representatives.

g) Audit is a Sample
The team leader should make it clear that the audit is a sampling activity and subject to those limitations. A good statement to make is “This assessment is based on representative samples and, therefore, nonconformities may exist that have not been identified”. Both conforming and nonconforming aspects will be seen and missed. The team leader should assure management, however, that they will make samples as representative as possible and draw only reasonable conclusions.

h) Confidentiality
The audit is confidential between the two parties, as well as, the information gained before, during, or after the audit. This confidentiality binds third party auditors. RAB registered auditors and lead auditors are bound by the Code of Conduct. The lead auditor should make a statement to this effect.

i) Logistics
Logistics covers all the other arrangements transport, protective clothing, lunch arrangements, and facilities for use by the auditors (office). Lunch arrangements need to be confirmed. Typically these take the form of a working lunch onsite or a short lunch off premises. Audit legend contains all the usual stories of huge three or four-hour banquets laid on for the auditors, usually at a considerable distance from the company. These are not practical and should be avoided. Again, many of these points would have been raised at the preliminary meeting and the arrangements are confirmed at this opening meeting.

j) Restrictions
Although any major restrictions to the auditors will tend to have been made clear during the planning stage, these may need confirmation or discussion during the opening meeting. Such restrictions include clean areas or hazardous areas where particular arrangements for protective clothing have to be made.

Lead Auditor Training - The restrictions may include sensitive union areas where there has in the past been conflict or layoffs. Usually there is no problem in such areas if the reasons for the audit are explained to the staff. There may be “no go” areas or secret areas. Sometimes companies maintain certain areas as restricted because the work going on there is concerned with development of considerable importance to their market position.

Companies involved in certain types of government work may have areas covered by the Official Secrets Act and appropriate (and lengthy) clearance is necessary for these areas. The various restrictions, if any, should be considered by the team leader and complied with, if legitimate.

Other points that can arise might unsettle an inexperienced team leader. Auditors find that each audit is different and a degree of flexibility is essential. For example, an audit carried out on an organization used to being audited by customers will not require a great deal of explanation about the audit, although they will want certain assurances. On the other hand, if the company is not used to being visited in this way, it may need extensive explanations and the auditors, therefore, need to be flexible.

ISO 9001 Auditor Training - Sometimes, the auditors might find that the auditee representatives are not particularly senior. While the team leader might have expected to find some top management at the opening meeting, they need not be concerned if all the correct preparations have been carried out beforehand. The auditors cannot insist on meeting anyone in particular or someone in a senior position. Some auditors consider that this shows interest and commitment by top management. This may be true. Other auditors are more guided by the evidence of action and involvement by top management in the working of the system.

k) Clarification
There may be questions or points the auditees wish to raise and the team leader should deal with these items during the opening meeting. The team leader also needs to confirm the current issue status of the key documents in the quality management system.

When all the above and any other matters have been dealt with, the team leader should bring the opening meeting to a close by thanking management and confirming the date, time, and location of the closing and any interim (end of day management briefings) meetings. 

"Understanding ISO 9001" provides a detailed explanation of each ISO 9001 clause (requirements).

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.