API Lead Auditor flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Audit program

A set of one or more audits planned for a specific time frame and directed toward a specific purpose, managed as a whole rather than as isolated events.

Audit criteria

The set of requirements used as a reference against which audit evidence is compared, such as API Q1, ISO 9001, contracts, or internal procedures.

Audit scope

The extent and boundaries of an audit, including which sites, processes, product lines, and organizational functions are covered by the audit activity.

Risk-based audit frequency

A planning rule in which processes with higher criticality, more past nonconformities, or greater change activity are audited more frequently.

Opening meeting purpose

To confirm scope, criteria, schedule, communication methods, confidentiality, sampling caveats, and safety arrangements with the auditee before evidence gathering begins.

Audit sampling rationale

The documented justification for how many and which items an auditor examines, based on risk, volume, and prior performance of the process.

Documented information

Information required to be controlled and maintained, comprising documents that describe how things are done and records that show what was actually done.

Risk-based thinking clause

ISO 9001 clause 6.1, requiring identification of risks and opportunities and actions proportionate to their potential impact on product conformity.

Control of nonconforming product

The requirement to identify, segregate, and disposition nonconforming output through rework, repair, regrade, scrap, or concession, with records retained.

Calibration requirement

Monitoring and measuring equipment must be calibrated or verified at specified intervals against traceable standards, with results recorded and status identified.

Competence evidence

Records of education, training, skills, and experience demonstrating that personnel meet defined competence requirements for the work they perform.

Management review

A planned top-management evaluation of quality management system performance using defined inputs, producing documented decisions and actions for improvement.

Outsourced process control

The requirement that externally provided processes, products, and services be controlled to the same extent as those performed internally, including monitoring and approval.

Objective evidence

Verifiable data, records, or observed facts traceable to a source that supports or refutes whether a requirement has been met.

Evidence hierarchy

A ranking in which records and direct observation outrank interview statements, requiring verbal claims to be corroborated before being cited as findings.

Traceability test

Selecting one order or unit and following it through receiving, production, inspection, and release to confirm records link correctly end to end.

Interview technique

Opening with broad questions, confirming with closed questions, avoiding leading phrasing, and interviewing the person who actually performs the activity.

Nonconformity confirmation

A finding is raised only when evidence shows a requirement was not met; an evidence gap is first pursued as a question before being classified as a nonconformity.

Closing meeting content

Presentation of findings, their classification, and the corrective action expectation, without negotiating away findings that are supported by valid evidence.

Audit time tracking

Monitoring planned versus actual minutes per process during execution to detect scope creep and reconcile deviations in the audit record.

Nonconformity statement structure

A three-part statement giving the requirement and clause, the objective evidence observed, and the specific gap between requirement and evidence.

Major nonconformity

A systemic failure or absence of a required process that affects the capability of the management system to deliver conforming product.

Minor nonconformity

An isolated lapse where the required process exists and generally functions, but a specific instance did not meet the stated requirement.

Correction versus corrective action

Correction fixes the specific nonconforming instance; corrective action eliminates the root cause so the nonconformity does not recur.

Root cause analysis

A structured method such as 5-Why, fishbone, or fault tree used to identify the systemic control failure that allowed a nonconformity to occur.

Effectiveness verification

Evidence gathered after corrective action implementation, at a defined interval, confirming that the nonconformity has not recurred.

Repeat nonconformity

The same nonconformity recurring on the same clause across audits, indicating prior corrective action was ineffective and possibly warranting escalation.

Finding closure evidence

Objective proof that corrective action was implemented and effective, rather than a statement of intent or a revised procedure alone.

Auditor competence pillars

The four elements of auditor competence: education, training, work experience, and audit experience, each evidenced by documented records.

Lead auditor responsibilities

Selecting the team, preparing the plan, conducting opening and closing meetings, adjudicating findings, issuing the report, and following up on corrective actions.

Independence and impartiality

The requirement that auditors not audit their own work or processes they managed within a defined look-back period, preserving objective judgment.

Confidentiality obligation

Information obtained during an audit is not disclosed to third parties without authorization, except where disclosure is legally required.