How much improvement is enough for quality systems?
It should be emphasised that the requirement in ISO 9001:2000 is for continual improvement of the effectiveness of the quality management system (QMS). There is no explicit requirement for the improvement of processes, though clearly this would be an important factor in achieving continual improvement of the effectiveness of the QMS.
Continual improvement emanates from the objectives set by top management, which should address (at least):
- the improvement of internal efficiency (for the organisation to remain competitive);
- customer needs; and
- the level of performance the market normally expects.
For example, in the aeronautical sector, the “acceptable rate” of non-conforming delivered product is zero per cent, so it would not be useful for the organisation to set objectives for an “improvement” in this rate. However, it would be useful for the organisation to have objectives aimed at improving its internal efficiency and its competitiveness (for example, through innovation).
The auditor should seek to determine if the auditee has attempted to set objectives that establish the relationship between three factors: corporate objectives, customer needs, and market expectations. Thereafter, it is up to the organisation to balance the need for improving internal efficiency and the need to progress with external performance (although the two are very often closely related). No one improvement in isolation can ever be considered as being “enough” or “not enough”.
One area that can be problematic for the auditor is to know what is a reasonable market benchmark. Continuing with the aeronautical example, if the organisation announced it had improved from a level of 50% non-conforming product delivered to 40%, this would demonstrate continual improvement, but would hardly be acceptable, given the industry sector’s zero per cent normal rate.
However, if it announced that it had set an objective to improve its performance from 0.5% to 0.4%, this would be much nearer the market norm. The only real solution for the auditor is to verify how the organisation has determined this 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 almost impossible to issue a non-conformance report that stated, “There was not enough continual improvement”.
What information is relevant ?
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 organisation is analysing data from process monitoring and then taking the results forward for evaluating process efficiency and/or improving process output.
One point that should be specifically examined, is the consistency of the way in which the improvement of any one process contributes to meeting the overall objectives, so as to ensure this will not cause 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 QMS objectives.
For example, an organisation could set an objective to reduce customer complaints by 30%. The top management analysis shows 50% of the complaints concern overdue deliveries. The auditor should then look for evidence that the organisation is monitoring and analysing key aspects of its scheduling and planning activities, throughout its processes, and the process interfaces, to reduce delays.
Improvement of the process or improvement of the QMS?
An auditor should remember that it would be unrealistic to expect an organisation to make progress on all potential improvements simultaneously. Each improvement will require the commitment of resources, which may need prioritisation by top management, especially where investment is needed.
Instead, the auditor should seek to ensure that the improvement objectives are consistent overall, and are coherent with the trilogy of factors mentioned above. However, the absence of a policy and/or objectives relating to continual improvement is clearly a non-compliance 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 organisation’s quality policy is not in line with ISO 9001:2000.
One word of warning: There is no requirement that the organisation should set objectives for improvement of all its processes at any one time. As in the above example on reducing customer complaints, some processes may not be deemed by top management to contribute significantly to reduction of delays, and it is only normal therefore, that the organisation would not concentrate on these areas.
If the top management has set a (realistic) objective for a process, and there is no evidence of improvement, this information must be fed back into the management review so 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.
In summary, when auditing ‘improvement’
- Improvement objectives should be set by top management and depend on industry norms, customer needs and market expectations.
- Improvement objectives need to balance internal efficiency and business performance.
- The auditor needs to verify how corporate objectives have been translated into internal requirements.
- Improvement in one objective should not conflict with progress in another objective.