CQA flashcards

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

Audit

A systematic, independent, documented process for obtaining objective evidence and evaluating it objectively against audit criteria to determine the extent to which the criteria are fulfilled.

Objective Evidence

Records, statements of fact, or other information that are verifiable and based on observation, measurement, or testing; it forms the basis for audit findings and conclusions.

Third-Party Audit

An audit performed by an external, independent organization such as a certification body or registrar, typically to verify conformity to a standard for certification or registration purposes.

Second-Party Audit

An audit conducted by an organization on a supplier or on another organization with which it has a contractual relationship, often called a supplier or customer audit.

Audit Criteria

The set of policies, procedures, standards, contract requirements, or regulations used as the reference against which audit evidence is compared to determine conformity.

Major Nonconformity

A nonconformity that affects the capability of the management system to achieve intended results, or a significant failure to meet a requirement, requiring prompt corrective action.

Audit Scope

The extent and boundaries of an audit, including physical locations, organizational units, processes, and the time period covered, as stated in the audit plan.

Audit Plan

A description of the activities and arrangements for an audit, including objectives, criteria, scope, dates, locations, audit team, and the schedule of activities.

Opening Meeting

A meeting at the start of an audit to confirm the audit plan, introduce the team, explain methods, and confirm communication channels, confidentiality, and safety arrangements.

Closing Meeting

A meeting at the end of an audit where findings and conclusions are presented to the auditee and timeframes for corrective action responses are agreed.

Audit Report

A documented record of the audit that includes scope, criteria, objectives, dates, team, findings with supporting evidence, conclusions, and where appropriate recommendations.

Audit Sampling

Selecting less than one hundred percent of items from a population to obtain evidence; methods include random, systematic, and judgmental or risk-based selection.

Follow-Up Audit

Verification that corrective actions have been implemented and are effective; it may be done on site or by document review and results in closing out the finding.

Nonconformity Statement

A written finding stating the requirement, the objective evidence of the gap observed, and where and when it was seen, so the auditee can investigate root cause.

Lead Auditor

The auditor responsible for managing the audit, including planning, directing the audit team, conducting opening and closing meetings, and approving the audit report.

Auditor Independence

The principle that auditors must not audit their own work and must be free of bias or conflict of interest, preserving objectivity and impartiality of audit conclusions.

Technical Expert

A person who provides specific knowledge or expertise to the audit team but does not act as an auditor and does not audit independently, though they may accompany auditors.

Interviewing Technique

Using open-ended questions, active listening, and follow-up probing to gather objective evidence and understand how processes are actually performed by auditees.

Auditor Competence

The demonstrated ability to apply knowledge and skills, achieved through education, training, work experience, and audit experience, as described in ISO 19011.

Conflict of Interest

A situation where an auditor's personal, financial, or other interests could compromise impartiality; it must be declared and the auditor removed from that assignment.

Audit Program

A set of audits planned for a specific time frame and directed at a specific purpose, managed so that the program objectives are achieved effectively and efficiently.

Risk-Based Audit Scheduling

Assigning audit frequency and depth according to process risk, criticality, past performance, and changes, rather than cycling through all areas at equal intervals.

Audit Program Records

Documentation such as audit plans, reports, auditor qualification records, and corrective action status, retained to demonstrate program effectiveness and provide traceability.

Audit Program KPI

A metric used to monitor the audit program, such as completion against schedule, timeliness of finding closure, repeat nonconformity rate, or report turnaround time.

Process Approach

Managing activities as interrelated processes that function as a coherent system, with defined inputs, outputs, and interactions, to achieve intended results efficiently.

Management Review

Top management's periodic evaluation of the management system's continuing suitability, adequacy, and effectiveness, for which audit results are a required input.

Pareto Principle

The principle that roughly eighty percent of effects come from twenty percent of causes, used on a Pareto chart to prioritize the few vital causes for action.

Ishikawa Diagram

A cause-and-effect diagram that organizes potential causes into categories such as man, machine, material, method, measurement, and environment to identify root causes.

Cpk

A process capability index that accounts for centering, equal to the lesser of (USL minus mean) divided by three sigma or (mean minus LSL) divided by three sigma.

FMEA Risk Priority Number

The Risk Priority Number calculated as Severity multiplied by Occurrence multiplied by Detection, used to rank failure modes for corrective action priority.

5 Whys

A root cause analysis technique that repeatedly asks why a problem occurs, typically five times, until the fundamental cause rather than a symptom is identified.

Stratification

Separating data into groups or categories based on shared characteristics so that patterns hidden when the data are viewed as a single set become visible.