My Reading on ASQ CQA HB Part IV

Charlie Chong/ Fion Zhang
Part IVA8
Audit (Service) Risk (Conducting The Audit, Performance)
An audit is a service performed by auditors that may be internal or external to the organization being audited.
ISO 19011:2011 specifically lists audit performance risks that should be addressed.
The first risk to address is in preparing the audit plan (clause 6.3.2.1), the audit team leader should be aware of
the risks to the auditee organization created by the audit. For example, the presence of audit team members
could influence health, safety, environmental, or quality controls. Someone could be sick, get injured, cause
pollution, or interfere with an inspection. There may not be a specific audit objective that auditors should avoid
injury but it is a risk that should be considered depending on the auditee site and requirements. Here you are
being asked to analyze and evaluate risks associated with the audit. To manage the risk you may want to
consider the aspects related to the product or services as well as the causal factors such as people, equipment,
environment, materials, methods, and measures. For example: auditors could contaminate a clean room, ruin
a circuit board with a static spark, void a calibration due to equipment damage, and so on.
To identify potential risks, first consider the aspects that can create risks relative to the environment (nature of
the organization). Any methods that will be used to mitigate or treat risks should be discussed in the opening
meeting and included in the audit plan. You can include managed risks in the audit plan under managed risks
or another suitable title. Many auditors have done this in the past but they may have used titles such as special
requirements or special topics or issues.
One of the biggest risks in conducting an audit is the risk associated with sampling. Samples may not be
representative of the population from which they are selected and any conclusions based on the sample would
be wrong. Auditors conducting external audits are more likely to experience sampling error than internal
auditors. You should always be a vigilant and attentive listener to monitor any indication that the sample may be
skewed.