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CQA
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"
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 Tasks of Management correct answer identify possible sources of problems, to plan preventive action in order to forestall the problems, and to solve them should they arise. Vast majority of problems correct answer quality of work being performed quality of items received quality of work that has been performed quality of info being communicated quality of available equipment quality of decisions made second party supplier audits correct answer may be needed to help eliminate the shipping of nonconforming products and reduce costs and waste. promote partnerships that ensure better understanding of customer expectations or provide a means of tech transfer between customer and supplier. Audit Purpose correct answer clients responsibility to determine purpose first-party audit purpose correct answer ensure continued compliance of management system, evaluate effectiveness of system be determining it meets states goals and objectives, identify opportunities for improvement review mechanical assembly areas's compliance with procedures & evaluate procedures for opportunities for improvement
confirm that project engineering, doc control,& procurement activities are being performed in support of basic design are being accomplished in accordance with the quality manual assess the progress of the management system toward meeting all ISO requirements identify opportunities for improved system/process effectiveness to achieve objectives report organization risks to management for evaluation identify process efficiencies for the delivery of products or services Purpose of a second party audit correct answer assess capability of XYZ company to meet contract requirements by a review of the available resources and by obtaining objective evidence of managements commitment to quality reqs of the product verify materials, eqiup, work is being performed under contract are in accordance with the procurement docs, section 6 of this contract, that the work is being executed by qualified personnel. identify the possible cause of recent cause of nonconformities by conducting a comprehensive assessment of he tasks, procedures, records and system docs related to production of the wireless widget verify that the supplier has an active environmental abatement and safety improvement program that meets customer reqs. Purpose of third party audits correct answer determine degree of conformity to reqs of the standard (ISO 9001, ISO 14001)
Key to a successful audit correct answer auditors temperament Professionalism correct answer the aims and qualities that characterize a profession or professional person independence correct answer internal auditors should be independent of the activities they audit professional proficiency correct answer internal audits should be performed with proficiency and due professional care scope of work correct answer scope of the internal audit should encompass the examination and evaluation of the adequacy and effectiveness of the organizations system of internal control and the quality of performance in carrying out assigned responsibilities performance of audit work correct answer audit work should include planning the audit, examining and evaluation info, conducting interviews communicating results, and following up management of the internal audit dept correct answer director of internal auditing should properly manage the internal auditing department ISO 19001 contains 6 principles correct answer 1. integrity: the foundation of professionalism
- fair presentation: obligation to report truthfully and accurately
- due professional care: the application of diligence and judgement in auditing. important factor is carrying out their work and making reasoned judgements in all audit situations
- confidentiality: security of information
- independence: the basis for the impartiality of the audit and objectivity of the audit conclusions
- Evidence based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process audit plan identifies correct answer the purpose (objectives) and scope (boundaries) of the audit the auditee and the organizational units to be audited audit team members the criteria being audited against (standard, contract procedure) logistical info such as the audit dates, place of audit, the expected duration of the audit, interview schedule, meetings with auditee ISO 19011 6.3.2.2 correct answer roles/responsibilities of audit team, and accompanying persons such as guides and observers the allocation of appropriate resources to critical areas of the audit the audit methods to be used, including the extent to which audit sampling is needed to obtain sufficient audit evidence and the design of the sampling plan as appropriate: the id of the auditees rep of the audit ISO 19011 6.3.2.2 contin. correct answer the working & reporting language of the audit when this is different from the language of the auditor and/or the auditee the audit report topics logistics an communication arrangements specific measures to be taken to address the effect of uncertainty on achieving the audit objectives matters related to confidentiality/ info security follow up action items from previous audit, follow up activities for the next audit coordination with other audit activities in case of a joint audit
acting as observer for management, provide overview of auditors observations, findings, conclusion to the auditee management acting as a guide for the auditor confirming/denying that a discrepancy has been found from moving on to the next area to audit ensuring auditors comply with the company rules, including safely rules completed audited checklist should include correct answer objective evid that an audit was performed order and organization record that all applicable aspects of the program were examined historical info on program, systems, supplier problems essence for the exit meeting/audit report info base for planning future audits vehicle for time management sampling plans and strategies 6 process forces correct answer material, methods, manpower, machinery, measurements, and environment tracing correct answer following chronological progress of something as it is processed, common and effective means of collecting objective evidence during an audit-
