Certified Quality Auditor Study Guide 2023/2024

Product Audit -Correct Answer-an examination of a particular product or service (hardware, processed material, software) to evaluate whether it conforms to requirements that is specifications, performance standards and customer requirements. Audit -Correct Answer-a systematic independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled Process audit -Correct Answer-verification by evaluation of an operation or method against predetermined instructions or standards to measure conformance to thee standards and effectiveness of instructions. Sytem Audit -Correct Answer-an audit conducted on a management system Quality management system audit -Correct Answer-examines an environmental management system Desk audit or document review -Correct Answer-an audit of an organizations documents, it can be conducted at a desk since people are not interviewed and activities are not observed Internal audits -Correct Answer-first party audit: organization is audited by an employee of the organization external audit -Correct Answer-second party audit: external audit performed on a supplier by a customer or by a contracted organization on behalf of a customer. Third party audits: performed by an audit organization independent of the customer- supplier relationship and is free of any conflict of interest. Conformity Europeene Mark (CE Mark) -Correct Answer-companies in high risk categories (medical devices, electrical devices pressure vessels, etc.) wanting to do business in Eu need to comply with CE mark requirements. One way to comply is to have a third party audit organization certify their manager system. accreditation -Correct Answer-used when validating or verifying the conformance of a certification boy to the requirements of national and/or international criteria certification body -Correct Answer-also known as a registrar is a third party company contracted to evaluate the conformance of an organization's management systems to the requirements of the appropriate standard(s) and issue a certificate of conformance when warranted compliance/conformance audit vs. performance improvement audit -Correct Answer- key difference between compliance/conformance audits and audit designed to promote improvement is the collection of audit evidence related to organization performance verses evidence to verify conformance or compliance to a standard or procedure Follow Up audit -Correct Answer-product, process, or system audit may have findings that require correction and corrective action. since the corrective actions can't be performed at the time of the audit, some audit program managers may require a follow up audit to verify corrections were made and corrective actions taken Common elements with audits -Correct Answer-Scope of the audit can very but basically is an activity or status is a subject to planning or reporting it can be audited. audits can address almost any topic of interest where activities or outputs results from defined plans. Key Concept of audits -Correct Answer-audits, regardless of form or name, are processes. processes consist of a set of resources (materials, labor, finance, and so on) called inputs being transformed through interactions to create outputs. outputs of processes are topically not just the desired product or service but also the nonconforming product or service, waste, pollution and worn equipment or tooling. 6 common elements of audits -Correct Answer-purpose/scope: "why are we doing this" documentation review: documents are reviewed during the audit prep phase to determine they have a good set to satisfy all relevant goals and requirements preparation for review: details of who will be interviewed, what location, aspects of the operations should be scheduled. onsite or remote data collection (the audit): actual data collection activities may vary between internal and external audits due to familiarity of the organization. collection of data is the same though formal audit report: normally include intro, overall summary, findings and conclusion. audit follow-up: auditee is responsible for implementation of the corrective action and its verification. audit reason -Correct Answer-provide management with unbiased facts provide input to management so they can make decisions keep management informed of actual or potential risks identify areas of opportunity for improvement assess personnel training effectiveness and equip capability provide visible management support of the programs ensure ongoing compliance determine system and process effectiveness identify system and process efficiencies The need for process and system audits -Correct Answer-monitoring risk treatments identifying risks improving organization performance effective process = -Correct Answer-process that is meeting output objectives Management determines goals and objectives -Correct Answer-audit evidence should indicate where the process owners are measuring results against the stated objectives/ goals. internal audits are necessary to find any problems with the system to be able to find the root causes and take corrective action