Auditing for Continual Improvement

How does an auditor judge how much improvement is “enough”? The ISO 9001:2000 requirement is for continual improvement of the effectiveness (results) of the quality management system. Continual improvement will be assessed based on the quality objectives set by top management.

Quality Objectives

The auditor should determine if the organization has attempted to set objectives that establish the correlation between three factors:

  • corporate objectives
  • customer needs
  • market expectations

Thereafter, it is up to the organization to balance the need for increasing internal efficiency and the need to improve external performance, although the two are very often closely related. Neither one in isolation can ever be considered as being enough or not enough.

A problem for the auditor may be knowing what is a reasonable market benchmark. If an organization announced that it had improved from a level of 50% delivered nonconforming product to 40%, this would demonstrate continual improvement. However, this quality level would hardly be acceptable. If instead, the organization announced that it had set an objective to improve its performance from 0.50% to 0.40%, this would be likely be acceptable, depending on the industry sector.

The only real solution for the auditor is to verify how the organization has determined its proposed rate of improvement, how it has evaluated the associated risks, and how this relates to customer requirements and the monitoring of feedback on customer satisfaction. It would be difficult to issue a nonconformity report stating there was not enough continual improvement.

Evidence Evaluation

What sort of information is relevant for continual improvement and where can we find it? The auditor has to verify how the overall corporate objectives have been translated into internal requirements throughout the appropriate processes, and how these requirements are communicated and monitored.

So, the auditor should look for evidence that the organization is analyzing data from process monitoring and taking the results forward for evaluating process efficiency and/or improving process output. A point that should be specifically examined is the consistency in the way in which the improvement of any one process contributes to meeting the overall objectives (to ensure that this will not cause a conflict in the achievement of other objectives).

The type of information that an auditor needs to look for is evidence of how the corporate objectives are translated into specific quality objectives. For example, an organization could set an objective to reduce customer complaints by 30%. The top management analysis may show that 50% of the complaints are concerned with overdue deliveries. The auditor should then look for evidence that the organization is monitoring and analyzing key aspects of its scheduling and planning activities, throughout its processes and the process interfaces, to reduce the delays.

Process or System Improvement?

An auditor should remember that it is unrealistic to expect an organization to make progress in all potential improvements simultaneously. Each improvement will require the commitment of resources, which may need prioritization by top management, especially where investments are needed. Instead, the auditor should determine if the improvement objectives are consistent overall, and are coherent with the three factors (corporate objectives, market needs, and customer expectations).

However, an organization that does not have a policy and objectives relating to continual improvement is clearly not conforming with the standard. Similarly, the absence of any evidence of improvement on at least one of these aspects would have to be considered as indicating that an organization’s quality policy is not in line with ISO 9001.

A word of warning: there is no requirement that the organization set objectives for improving all its processes at any one time. As in the above example about reducing customer complaints, some processes may not be deemed by top management to contribute significantly to the reduction of delays, and it is normal, therefore, that the organization would not concentrate on these areas.

If top management has set a realistic objective for a process and there is no evidence of improvement, this information must be considered at the management review so that top management can decide what type of action is appropriate, for example, re-adjusting the objective or providing other means to impact on the process.

This article was based on the audit guidance provided by the the ISO 9001 Auditing Practices Group at:<http://www.iso.org/tc176/ISO9001AuditingPracticesGroup>. The ISO 9001 Auditing Practices Group is an informal group of quality management system experts, auditors, and practitioners, drawn from the ISO TC176 and the International Accreditation Forum (IAF).

The papers at their web site were developed on current best practice, and therefore, have not been formally endorsed as IAF guidance or ISO TC176 interpretations.