Managing Quality Flashcards by Cathrina Chavez

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

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A

QC

Q

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

Product-focused

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A

QC

Q

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

Process-focused

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A

QA

Q

Documents defining requirements that must be met by an organization.

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A

Quality System Standards

Confimation that the QMS is fully implemented and in compliance with the requirements. | QMS = Quality Management System

Certification

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

Accreditation

# What Quality System Standards? Standard employed by testing and calibration laboratories

ISO/IEC 17025:2005

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

ISO 9000 Quality Management System

Standard prepared specifically to cover **medical laboratories**

ISO 15189

Standard protocol required for all analytical laboratories

Good Laboratory Practices (GLP)

Protocol that requires all organizations **manufacturing products** for **human consumption**

Good Manufacturing Practice (GMP)

Standard employed specifically in **pathology labs**

Clinical Pathology Accreditation (CPA)

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

Quality Controls

Composition to the samples but without the analyte present

Blank

# What type of Blank Sample? Taken **through all steps** of the analytical procedure

Method blank

# What type of Blank Sample? It has not been subjected to all sample preparation procedures.

Reagent blank

# What type of Blank Sample? Exposed to the site of sampling and to all possible sources of contamination

Field blank

Characteristics of good QA sample

1. fully characterized in-house or by a third-party 2. similar in composition to the types of samples normally examined 3. stable; homogeneous; available in large quantities

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

Quality Control (QC) samples | aka *Check sample*

Provide a **less formal check** than conventional QC samples

Repeat samples

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

Blind samples

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.

Spike or Fortification

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

Chemical Standards

# What type of Chemical standards? Highest metrological qualities and whose value is accepted without reference

Primary Standard

# What type of Chemical standards? Assigned by comparison with a primary standard

Secondary Standard

# What type of Chemical standards? Known concentration used to calibrate an instrument.

Calibration Standard

# What type of Chemical standards? Solution or matrix containing a known amount of analyte used to check the performance of a method/instrument.

Analytical Standard

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

Reference materials (RM)

# What type of RM?

# What type of RM? Establishes its traceability to an accurate realization of the unit in which the property values are expressed.

Certified reference material (CRM)

# What type of RM? Prepared by an organization solely for its own internal purposes and for which values are obtained against a CRM.

In-house reference material

**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**.

Quality Control Chart