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189 Cards in this Set
- Front
- Back
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Acceptable Quality Level (AQL)
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The maximum percentage of noncoforming units in a lot or batch that, for the purpose of acceptance sampling, can be considered satisfactory as a process average.
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Acceptance Number
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The maximum number of defective units of defects in a sample that will permit acceptance of the inspection lot.
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Accreditation
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Formal recognition of a an organization's technical competancy to perform specific tests, types of tests, or calibrations.
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ANAB
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The ANSI-ASQ National Accreditation Board (ANAB) is a review board which approves and accredits registrars in the U.S.
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Where is the ANAB currently located?
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Milwaukee, WI
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Appraisal
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A form of the quality system audit, normally conducted to examine the total quality program effectiveness and implementation. An appraisal is usually conducted by a third party and reported to highest management.
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Assessment
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An estimate or determination of the significance, importance, or value of something.
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Attribute
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A characteristic or property that is appraised in terms of whether it does or does not exist, with respect to a given requirement.
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Attributes Inspection
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Inspection whereby either the product or product characteristics are classified as defective or non-defective, or the number of defects in the unit of product is counted.
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Audit
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A planned, independent and documented assessment to determine whether agreed upon requirements are met.
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Audit Program
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The ogranizational structure, commitment, and documented methods used to plan and perform audits.
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Audit Program Management
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Organization, or function within an organization, given the responsibility to plan and carry out a programmed series of quality system audits.
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Audit Standard
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The authentic description of essential characteristics of audits that reflects current thought and practice.
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Audit Team
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The group of individuals conducting an audit under the direction of a team leader.
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Audit Team Leader
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The individudual who supervises auditors during an audit.
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Auditee
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An organization to be (being) audited.
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Auditing Organization
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A unit or function that carries out audits through its employees. This organization may be a department of the auditee, a client, or an independent third party.
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Auditor
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The individual who carries out the audit.
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Auditor (Quality)
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A person who has the qualifications to perform quality audits.
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Average Outgoing Quality (AOQ)
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The expected quality of outgoing product following the use of an acceptance sampling plan for a given value of incoming products.
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Batch
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A definite quantity of some product or material produced under conditions that are considered uniform.
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Calibration
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A comparison of two instruments or measuring devices one of which is a standard of known accuracy traceable to national standards - to detect, correlate, report, or eliminate by adjustment any discrepancy in accuracy of the instrument measuring device being compared to the standard.
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Certification
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The procedure or action, by a duly authorized body, of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with applicable requirements.
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Characteristic
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A property that helps to identify or to differentiate between entities and that can be described or measured to determine conformance or nonconformance to requirements.
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Client
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The person or organization that has the authority to initiate an audit. Depending on the circumstances, the client may be the auditing organization, the auditee, or a third party.
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Compliance
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An affirmative indication or judgement that the supplier (of a product or service) has met the requirements of the relevant specifications, contract, or regulation; also the state of meeting the requirements.
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Confirmation
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The concurrence of data or information obtained from two or more different sources.
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Conformance
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An affirmative indication or judgement that a product or service has met the requirements of the relevant specifications, contract, or regulation; also the state of meeting the requirements.
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Contractor
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Any organization under contract to furnish items or services: a vendor, supplier, subcontractor, fabricator, and sub-tier levels of these where appropriate.
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Convention
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A customary practice, rule, or method.
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Corrective Action
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Action taken to eliminate the root cause(s) and symptom(s) of an existing undesireable deviation or nonconformity to prevent recurrence.
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Corrective Action Request
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A formal document noting audit findings and requesting resolution.
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Defect
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A departure of a quality characteristic from its intended level that occurs with a severity sufficient to cause an associate product or service not to satisfy intended normal, or reasonably foreseeable, usage requirements.
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Defective
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A unit of product or service containing at least one defect, or having several imperfections that in combination cause the unit to not satisfy intended normal, or reasonably foreseeable, usage requirements.
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Deviation
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A nonconformance of product or a departure of a characteristic from specified product, process, or system requirements.
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Element
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Any component of a quality system standard.
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Evaluation
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The act of examining a process or group to some standard and forming certain conclusions as a result.
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Evidence
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Something that furnishes proof. An outward sign or indication. Facts that are verifiable.
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Examination
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A measurement of goods or services to determine conformances to some specified requirement.
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Exit Meeting
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The meeting at the end of the audit between the auditors and the representative auditees, at which time a rough draft of audit findings and observations is presented.
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Finding
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A conclusion of importance based on observation(s). An evaluation of audit evidence against audit criteria.
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Follow-up Audit
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An audit whose purpose and scope are limited to verifying that corrective action has been accomplished as scheduled and determining that the action prevented recurrence effectively.
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Guidelines
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Documented instructions that are considered good practice but that are not mandatory.
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Independence
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Freedom from bias and external influences.
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Inspection
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Activities - such as measuring, examining, and testing - that guage one or more characteristics of a product or service and the comparison of these with specified requirements to determine conformity. Inspection is a planned activity in the production process.
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Inspection Lot
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A specific quantity of similar units, offered for inspection and subject to an acceptance decision.
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Inspection, Normal
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An inspection, sampling plan, used when there is no evidence that the quality of the product being submitted is better or poorer than the specified quality level.
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Inspection Record
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Recorded data concerning inspection results.
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Inspection, Reduced
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A feature of a sampling scheme permitting smaller sample sizes than are used in normal inspection, when experience with the level of submitted quality is sufficiently good.
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Inspection, Tightened
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A feature of a sampling scheme using stricter acceptance criteria than those used in normal inspection.
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Lead Auditor
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An individual who supervises auditors as a team leader.
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Lot
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A definite quantity of a product or material accumulated under conditions that are considered uniform for sampling purposes.
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Lot Size (N)
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The number of units in the lot.
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Measuring and Test Equipment
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All devices used to measure, gage, test, inspect, diagnose, or otherwise examine materials, supplies, and equipment to determine compliance with technical requirements.
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Noncompliance
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A departure from minimum requirements specified in a contract, specification, drawing, etc.
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Nonconformance
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A parameter which does not meet its specification. A departure of quality characteristics from its intended level, sever enough to create a departure from specification requirements.
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Nonconforming unit
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A unit of product or service containing at least one nonconformity.
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Nonconformity
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The nonfulfillment of specified requirements
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Objective Evidence
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Qualitative or quantitative information, records, or statements of fact pertaining to the quality of an item or service or to the existence and implementation of a quality system element, which is based on observation, measurement, or test and which can be verified.
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Observation
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A statement of fact made during an audit and substantiated by objective evidence. Also called audit evidence.
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Pre-Audit Meeting
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The introductory meeting between the auditors and the representative auditees, at which time the overview of the planned audit is presented.
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Pre-award Survey
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An activity conducted prior to a contract award and used to evaluate the overall quality capability and capacity of a prospective supplier or contractor.
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Procedure
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A document that specifies the way to perform an activity.
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Process
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The particular method of producing a product or service, generally involving a number of steps or operations.
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Process Average
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The average percent of defective or average number or defects per hundred units of product submitted by the supplier for original inspection.
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Process Quality Audit
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An analysis of elements of a process and appraisal of completeness, correctness of conditions, and probable effectiveness.
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Product
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A piece of goods manufactured for a customer or service delievered to a customer.
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Product Quality Audit
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A quantitative assessment of conformance to required product characteristics.
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Qualification
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The status given to an entity or person when the fulfillment of specified requirements has been demonstrated; the process of obtaining status.
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Qualitative Audit Methods
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The audit verfication activities used to obtain objective information essential to provide evidence of merit to quality the audit conclusions.
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Quality
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The degree to which a set of inherent characteristics fulfil requirements. Also, the totality of features and characteristics of a product, activity, or system that bears on its ability to satisfy stated or implied needs.
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Quality Assurance
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All those planned and systemic actions necessary to provide adequate confidence that a product or service will satisfy given quality requirements.
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Quality Audit
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A systematic and independent examination and evaluation to dermine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
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Quality Control
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The operational techniques and activities that are used to fulfil requirements for quality.
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Quality Management
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The totality of functions involved in the determination and achievement of quality.
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Quality Manual
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A document stating the quality policy, quality system, and quality practices of an organization.
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Quality Plan
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A document setting out the specific quality practices, resources, and activities relevant to a particular product, process, service, contract, or project.
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Quality Policy
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The overall intentions and direction of an organization regarding quality, as formally expressed by top management.
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Quality Surveillance
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The continual monitoring and verification of the status of procedures, methods, conditions, products, processes, and services and teh analysis of records in relation to state references to ensure that requirements for quality are being met.
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Quality System
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The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.
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Quality System Audit
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A documented activity performed to verify, by examination and evaluation of objective evidence, that applicable elements of the quality system are suitable and have been developed, documented, and effectively implemented in accordance with specified requirements.
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Quality System Review
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A formal evaluation by management of the status and adequacy of the quality system in relation to a quality policy and/or new objectives resulting from changing circumstances.
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Quantitative Audit Methods
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Methods used to obtain variable or attribute data or information which supports, gives evidence, or qualifies audit conclusions.
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Random Sampling
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The selection of units for a sample size (n) in such a manner that all combinations of (n) units under consideration have an equal chance of being selected.
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Rejection Number
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The minumum number of variant units in the sample that will cause the lot or batch to be unacceptable.
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Registration
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When an accredited 3rd party assesses the management system and issues a certificate to show that the organization abides by the principles set out in a quality system standard such as ISO 9001.
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Root Cause
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A fundamental deficiency that results in a nonconformance and must be corrected to prevent recurrence of the same or similar nonconformance.
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Sample
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A group of units or observations taken from a larger collection of units or observations that servces to provide an information basis for making a decision concerning the larger quantity.
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Sample Size (n)
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The number of units in a sample
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Sampling Plan
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A statement of the sample size or sizes to be used and the associated acceptance and rejection criteria.
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Specification
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The document that prescribes teh requirements with which the product or service must conform.
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Specification Limits
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Limits that define the conformance boundaries for an individual manufacturing unit or service operation.
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Standard
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The documented result of a particular standardization effort approved by a recognized authority
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Standardization
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The act of documenting, formalizing, and implementing efforts which result in an improvement, (for the purpose of conformity), to similar or applicable processes or systems.
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Survey
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An examination for some specific purpose; to inspect or consider carefully; to review in detail.
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Testing
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A means of determining an item's capability to meet specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating actions and conditions.
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Traceability
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The ability to trace the history, application, or location of an item or activity and like items or activities by means of recorded identification.
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Unit
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A quantity of product, material, or service forming a cohesive entity on which a measurement or observation may be made
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Universe
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A group of populations, often reflecting different charactertistics of the items or material under consideration.
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Variable Inspection
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Inspection wherein certain quality characteristics of samples are evaluated with respect to a measurement.
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Variant
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An item or event that is classified differently from others of its type.
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Verification
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The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
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What are the three types of audits?
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1. The System Audit
2. The Process Audit 3. The Product Audit |
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Which type of audit focuses on the overall quality system?
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System Audit
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Which type of audit is the largest and most extensive?
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System Audit
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How long does a system audit typically last?
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2-6 days
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Why are system audits conducted?
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To verify whether or not the quality management system and organizational plans are carried out to adequately and effectively meet identified requirements.
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How many auditors are considered effective for a full system audit?
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2-3
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What is the audit schedule?
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Documented plan of the upcoming audits to be performed
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What type of audit is the most performed and most convenient?
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Process Audit
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What are process audits useful in verifying?
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Standards, methods, and procedures
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How long does a typical process audit take?
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1 Hour to a couple of days
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What does a product audit investigate?
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The final product or service
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When are product audits performed?
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After final investigation of the product
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How many auditors are often involved in product audits?
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1
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What are some examples of consumer product audits?
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Door-to-door surveys, product mailing response forms, telephone surveys, location surveys, and published/televised investigative surveys
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What are Management Audits?
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Audits sanctioned by management
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What type of audit is the most typical management audit?
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System Audit
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What to function audits relate to?
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Departmental or procedural areas
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What to Element audits relate to?
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Specific portions of ISO or other standards.
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What do department audits concentrate on?
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One distinct area or department
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What is a desk audit?
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Lower tier quality audits such as procedures, work instructions, and forms
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How are desk audits performed?
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The audit begins with high level documents and works their way downward
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When is a desk audit performed?
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Prior to field work
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What are the two purposes of a desk audit?
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To determine if low-level documents respond to high-level performance standards & to acquaint the auditor with the auditee's quality system so the audit is performed more effectively
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When are Surprise audits acceptable?
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To verify safety requirements, and when dishonest activity is suspected
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What may an unscheduled audit include?
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Housekeeping
Security Timekeeping Emergency Drills Personal Behavior |
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When can system audits be performed?
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Evaluation of potential new suppliers, when product quality declines, or when there are critical changes in management
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What is an extrinsic audit?
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Any company that is the subject of a customer audit
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What is a vendor survey?
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When the supplier is the subject
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What is a pre-award survey?
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When a potential supplier is the subject
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What is a system audit, management survey, or operation survey?
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An in-depth quality management systems and compliance audit
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What is an assessment audit?
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It is more limited in depth than the system audit
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What is an appraisal?
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Total quality program effectiveness
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What is a compliance review or quality review?
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Verification of effectiveness of quality management system (on a smaller scale)
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What is a full audit (cradle to grave)?
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An entire company or product is audited from design development to end of product life
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What type of audit is the most expensive and extensive to conduct?
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Full audit (cradle to grave)
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What is an internal audit?
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An audit performed within an organization to measure its own performance, strengths, and weaknesses against its own established procedures
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Who most often performs internal audits?
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In-house personnel (generally trained in auditing principles)
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What is an external audit?
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An audit performed by a company directive on an outside source, such as a supplier.
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What is a first party audit?
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When the audit is authorized and conducted by the company on itself.
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What is a second party audit?
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When the customer performs an audit on a supplier.
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What is a third party audit?
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When an outside source is used to conduct the audit.
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Why is a third party audit used?
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To obtain a more independent and objective assessment or achieve certification to a recognized standard.
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How is a third party audit different from first and second party audits?
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Both first and second party audits have direct business interests.
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What is another term used for "quality audit"?
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Assessment
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When may assessments be performed?
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During a contracting phase or execution phase
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What are registration audits?
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Audits performed by third party auditors to certify that a company or organization meets the requirements of a standard, such as ISO 9001.
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What is a for-cause audit?
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An audit performed for a specific reason.
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When are for-cause audits usually inititated?
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When a supplier's product or service disappoints a customer
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What is a compliance audit?
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An audit that verifies whether or not the systems, processes, or products satisfy the requirements as set forth in the contractual agreements or agreed upon standards.
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What is a pre-award survey?
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An audit conducted as a condition for acceptance of a new supplier, prior to awarding the contract.
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What is the purpose of a pre-award survey?
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To evaluate the ability of the potential supplier to provide products or services which meet requirements.
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What is a procedural audit?
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A form of the compliance audit which is focused on the verification and adequacy of documented and formal procedures.
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What is a risk audit?
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Audits that focus on areas that are perceived company risks.
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What is a follow-up audit?
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Audits typically conducted to verify what corrective action has been taken to promptly address previous audit findings and that the corrective action is effective in preventing recurrence.
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What is a new supplier audit?
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A system audit that may be conducted as a condition of accepting a new supplier.
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What is a surveillance audit?
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An audit performed internally or externally on a continuing basis to evaluate whether records, methods, procedures, products, or services meet requirements.
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What are routine or maintenance audits?
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Subsequent audits that are preformed on the supplier to assure that the supplier achieves and maintains compliance to established requirements.
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What are nonroutine audits?
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Audits that may be necessary as a result of significant changes which affect, or could potentially affect, product quality
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What is the purpose of a quality audit?
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To examine the effectiveness of management directed control programs
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What is the philosophy of quality assurance programs?
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Prevention rather than detection of problems.
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What do quality problems result in?
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Customer dissatisfaction or loss of employee morale.
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Why does management implement control programs?
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To identify problems and prevent reoccurence of problems
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What are the 7 audit objectives?
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Management priorities
Commerical intentions Management system requirements Satutory, regulatory, or contractual requirements A need for supplier evaluation Needs of other interested parties Risks to the organization |
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What are four audit object programs designed to do?
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Evaluate and maintain confidence in a supplier
Verify conformance to contractual requirements Become certified to a management system Follow up on corrective action |
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When does the market or supplier have the most opportunity?
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Before their product reaches market
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What are 9 specific auditing purposes?
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Products are fit for use
Adequate written procedures exist and are utilized There is adherence to legal or regulatory requirements Deficiences in the product or the management system are identified There is conformance to specification Remedial action is taken and the result is effective Information is obtained to identify and reduce risks Effective and efficient use of company resources occurs Standardized organizational practices and improvements exist |
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What is the best current guidance found?
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ISO 19011-2008, Guideline for Quality and/or Environmental Management Systems Auditing
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Why are industry standards developed?
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To rationalize and simplify the design, manufacturing, service and use of that industry's output
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What 11 items may industry standards cover?
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Elements from international or national standards
International or national standards in their entirety Information and/or lists of products Information on technical or economic optimization Information about equipment and/or processes Calculations and design Transportation and storage Treatments and special processes Testing and qualifications Quality control and quality assurance Parts lists, numbering methods and traceability |
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What 8 things are auditors responsible for?
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Complying with the applicable audit requirements
Communicating and clarifying audit requirements Planning and carrying out assignments effectively and efficiently Documenting audit observations and reporting audit results Verifying the effectiveness of corrective actions Retaining and safeguarding documents pertaining to the audity Maintaining confidentiality of the audit Cooperating with and supporting the audit team leader |
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What 5 things should an auditor do?
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Remain within the audit scope and exercise objectively
Collect and analyze evidence Remain alert for indications that may require more extensive auditing Answer relevant questions Act in an ethical manner |
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What 4 things should the client do?
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Determine the audit need, scope, and purpose
Initiation the audit Determine the auditing organization Receive the audit report Determine follow-up actions |
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What is a conflict of interest defined as?
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Previous involvement with the subject of the audit (previous employer, personal friendship, financial relationship, etc.).
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What are 4 items that are considered unethical activities?
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Role Playing
Bribery Sympathy Illegal/Unsafe conditions |
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What is a current example of how an auditee may bribe an auditor?
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Exploit the vulernability of an auditor away from home
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What is the most beneficial action for the auditor when the auditee is unprepared for an audit, but is trying?
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Addressing and reporting findings in an impersonal manner
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What should be done if an illegal activity is encountered during an audit?
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Report the activity to the client and appropriate auditee management for immediate action, and federal/state authorities, if needed
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What should be done if there is an unsafe condition encountered during an audit?
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It should be reported immediately to auditee management for correction & record of the incident should be included in the audit report
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To omit or fail to do a thingn that should be done or is required to be done. It may mean a designed refusal, indifference, or unwillingness to perform one's duty.
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Neglect
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The failure to use such care that a reasonably prudent and careful person would use under similar circumstances.
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Negligence
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A standard that a reasonable man will observe, under all circumstances, to avoid liability for negligence.
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Reasonable man doctrine or standard
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An obligation of the auditor to conform to certain standards of conduct to protect others against unreasonable risks.
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Duty
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A violation or omission of a legal or moral duty.
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Breach of duty
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The failure to perform any promise which forms part or all of a contract
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Breach of contract
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The amount of attention, diligence, discretion, or caution needed or demanded, proportion to the apparent risk
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Care
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The degree of care that a reasonably prudent person would exhibit to avoid liability.
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Standard of care
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An intentional perversion of the truth for the purposes of inducing someone to part with something of value.
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Fraud
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