Audits of Process Effectiveness

Unfortunately, most audits focus on the conformity of a process, not its true performance. This emphasis on meeting requirements is important, but evaluating how well a process is achieving its planned results is critical.

ISO 9001:2000 requires internal audits to determine not only if the quality management system conforms to planned arrangements, but also if it has been “effectively” implemented. ISO 9000:2005 defines effectiveness as the “extent to which planned activities are realized and planned results achieved”.

So, how do we audit the effectiveness of a process?

Start with the definition of a process. It is a set of interrelated or interacting activities which transform inputs into outputs. So, the purpose of a process, its reason for existing, is to use inputs provided by the prior process (its supplier) to produce the deliverables needed by the next process (its internal customer).

ISO 9001:2000 promotes the use of the “process approach” to systematically identify and manage the processes of a quality management system, particularly their interactions. As auditors, we need to do the same and view the system as a set of integrated processes.

To assess process results (effectiveness), we need to:

  • Adopt the process approach for our audits
  • Understand process interfaces and interactions
  • Add value by looking at more than conformity
  • Evaluate linked processes for “effectiveness”
  • Verify the controls and identify process risks
  • Compare performance to quality objectives
  • Determine any opportunities for improvement
  • Promote process view through audit methods

To assess the effectiveness of a process, we can’t rely solely on an audit of that process. We need to go downstream to see what the next process (internal customer) has to say about how well the process under audit is meeting their needs.