Managing Quality Flashcards by Cathrina Chavez | Brainscape

Q

Incorporation of standard protocols to all the laboratory activities

A

Quality Management

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Q

What is/are under the Quality management

subsets

A

Quality Assurance and Quality Control

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Q

Describing the product/service to meet the minimum specifications set in a timely manner

A

Quality

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Q

Procedures and responsibilities that all individuals and facilities involved are capable of performing based on the standard protocols.

A

Quality Systems

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Q

Combination of Quality Managment, Assurance, and Control

A

Quality Systems

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Q

Planned and systematic control giving assurance to the customer based on the good quality of the product standardized by protocols and accredited by different regulatory bodies.

A

Quality Assurance

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Q

What type of Quality Assurance (QA)?

Ensures quality to the management

A

Internal QA

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Q

Programs ensuring the practiced quality control in every aspect of the system.

A

Internal and External Quality Assurance (QA)

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Q

What type of Quality Assurance (QA)?

Ensures quality to the client

A

External QA

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Q

Provides guidelines and procedures in managing quality systems

A

Quality Manual

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Q

Inspection to determine the compliance of the laboratory with arranged quality management plans.

A

Quality Audit

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Q

What type of Quality Audit?

Inspection is conducted by the member

A

Internal Audit

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Q

What type of Quality Audit?

Inspection is made by indirectly-related organization

by clients, customer, representative, etc.

A

External Audit

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Q

Is it Quality Control (QC) or Quality Assurance (QA)

Focuses on the products quality

A

QC

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Q

Is it Quality Control (QC) or Quality Assurance (QA)

Defining standards of the products

A

QA

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Q

Is it Quality Control (QC) or Quality Assurance (QA)

Proactive

A

QA

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Q

Is it Quality Control (QC) or Quality Assurance (QA)

Focuses on the identification of the defects

A

QC

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Q

Is it Quality Control (QC) or Quality Assurance (QA)

Focuses on the processes to produce quality products

A

QA

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Q

Is it Quality Control (QC) or Quality Assurance (QA)

Reactive

A

QC

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Q

Is it Quality Control (QC) or Quality Assurance (QA)

Focuses on the prevention of the defects

A

QA

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Q

Is it Quality Control (QC) or Quality Assurance (QA)

Verification of products before release to clients

A

QC

Q

Is it Quality Control (QC) or Quality Assurance (QA)

Product-focused

A

QC

Q

Is it Quality Control (QC) or Quality Assurance (QA)

Process-focused

A

QA

Q

Documents defining requirements that must be met by an organization.

A

Quality System Standards

Q

Confimation that the QMS is fully implemented and in compliance with the requirements.

QMS = Quality Management System

A

Certification

Q

Adds further element and involves peer review carried out by the relevant authority which confers the recognition of the laboratory’s compentence.

A

Accreditation

Q

What Quality System Standards?

Standard employed by
testing and calibration laboratories

A

ISO/IEC 17025:2005

Q

Adoption of a process approach for improving the effectiveness of a quality management svstem

A

ISO 9000 Quality Management System

Q

Standard prepared specifically to cover medical
laboratories

A

ISO 15189

Q

Standard protocol required for all analytical laboratories

A

Good Laboratory Practices (GLP)

Q

Protocol that requires all organizations manufacturing products for human consumption

A

Good Manufacturing Practice (GMP)

Q

Standard employed specifically in pathology labs

A

Clinical Pathology Accreditation (CPA)

Q

Parameters used to ensure the quality
of individual or batch results of the laboratory activities

A

Quality Controls

Q

Composition to the samples but
without the analyte present

A

Blank

Q

What type of Blank Sample?

Taken through all
steps of the analytical procedure

A

Method blank

Q

What type of Blank Sample?

It has not been subjected to all sample
preparation procedures.

A

Reagent blank

Q

What type of Blank Sample?

Exposed to the site of sampling and to all possible sources of contamination

A

Field blank

Q

Characteristics of good QA sample

A

fully characterized in-house or by a third-party
similar in composition to the types of samples normally examined
stable; homogeneous; available in large quantities

Q

Samples of very similar matrix and
analyte concentration to the samples to be analyzed

A

Quality Control (QC) samples

aka Check sample

Q

Provide a less formal check than conventional QC samples

A

Repeat samples

Q

Samples inserted into the analytical batch without the knowledge of the analyst

A

Blind samples

Q

Known quantity of analyte is added to a sample to test whether the response to a sample is the same as that expected from a calibration curve.

A

Spike or Fortification

Q

Exceptional purity material that is used to check the quality and metrological traceability of products.

A

Chemical Standards

Q

What type of Chemical standards?

Highest metrological qualities and
whose value is accepted without reference

A

Primary Standard

Q

What type of Chemical standards?

Assigned by comparison with a primary standard

A

Secondary Standard

Q

What type of Chemical standards?

Known concentration used to calibrate an instrument.

A

Calibration Standard

Q

What type of Chemical standards?

Solution or matrix containing a known amount of analyte used to check the performance of a method/instrument.

A

Analytical Standard

Q

Substances which property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus

A

Reference materials (RM)

Q

What type of RM?

A

Q

What type of RM?

Establishes its traceability to an accurate
realization of the unit in which the property values are expressed.

A

Certified reference material (CRM)

Q

What type of RM?

Prepared by an organization solely for its own internal purposes and for which values are obtained against a CRM.

A

In-house reference material

Q

Graph showing the time-dependent change in the results of an analysis that is used to monitor whether an analysis is in a state of statistical control.

A

Quality Control Chart