CQA practice question 11 of 25
While performing an internal audit, an auditor notices that an operator on one shift skips part of the documented procedure. In this situation, the auditor should do which of the following?
Full set: 103 questionsThe auditor's primary responsibility upon observing a potential deviation is to gather objective evidence to understand the situation fully. The most direct and appropriate first step is to question the operator. This allows the auditor to gather context, determine if the operator has a valid reason for their action (e.g., an approved deviation, outdated documentation, specific product requirements), and verify whether the observation constitutes an actual nonconformity. Escalating the issue or simply documenting it without investigation is premature and unprofessional.
A. Simply noting the observation is an incomplete action; the auditor must first investigate the context to verify the finding.
B. Reporting to a supervisor is premature as the observation has not been verified as a nonconformity.
D. Asking another operator to evaluate a coworker is inappropriate and does not constitute gathering objective evidence.
1. ISO 19011:2018, Guidelines for auditing management systems. Clause 6.4.5, "Collecting and verifying information," states that information should be verified and can be collected through methods including interviews and observation. Questioning the operator is a form of an interview to verify the observation.
2. Russell, J. P. (Ed.). (2021). The ASQ Certified Quality Auditor Handbook (6th ed.). ASQ Quality Press. Chapter 14, "Performing the Audit," in the section on "Interviewing," emphasizes that auditors should ask clarifying questions to understand processes and confirm observations before drawing conclusions. This supports directly engaging the operator.
3. Sayle, A. J. (1997). Management Audits: The Assessment of Quality Management Systems (3rd ed.). Allan J Sayle Associates. In Chapter 8, "The Audit," it is explained that an auditor's observation of a deviation should be followed by tactful questioning to understand the reasons, which may reveal issues with the documented procedure itself rather than operator error.
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