ACHEM Managing Quality Flashcards
These can be achieved by incorporating all the standard protocols to all lab activities and requires analyst to practice these protocols
Quality management
Type of audit where you examine a specific aspect only.
Horizontal Audit
_______ adds a further element and involves peer review for the purpose which they are being offered and caried out by an authority confers formal recognition that a laboratory is allowed to carry out that analysis.
Accreditation
This provide all the guidelines and procedures involved in managing QMS
Quality manual
If the product or services meets the minimin specification set by the customer in a timely manner
Quality
They are proactive
QA remember PA
It involves confirmation that the qms in place in the lab is fully implemented and complied with reqmts of the standards.
Certification
They work to verify products before relasing to clients
Qc
Type of audit there the tested sample are followed through each stage of analytical process
Vertical audit
Set of procedures and responsibilities which an organisation has in place to ensure that all individuals involve in every acticity are capable of performing stanrd protocol
Quality system
This is conducted by those who are not directly related to the organizations. They can be representatives, clients or customers
External audit
Programs that will ensure that the quality control activities are being practiced in every aspect of the systems
internal and external QA
An inspection made on different areas of the laboratory to determine whether the company complies with the arranged quality
Quality Audit
They define the standards of the products
QA
They focus on the prevention of defects
QA
They focus on the process to produce quality products
QA
They are also known to be reactive
QC
They focuses on identification of defects
QC
They focuses on the products quality
QC
____ ensures quality to the management while _______ focuses on umensuring the quality to the clients
Internal QA, External QA
The _____ requires the use of quality control procedures and stats data treatment to monitor validity of the chemical analyses performed in the laboratory
ISO 17025
If there is a dot within the upper action limit,
Stop process
This is a graph showing time dependent change in result of an analysis that is usef to monitor whether an analysis is in a state of stat control
Quality control chart
________ are interpreted by examining the location of individual data poinfs in relation to warning limits and the distribution of the points around the central line
Control chart
Are materials of highest purity that is used to check the quality and metrological traceability of products, validate analytical methods for calibration of analytical methods
Chemical standards
A reference materials frim an organizations solely for itsbown internal purposes and values obtained against certified reference materials.
In-house reference
Example of this is the buffer
Calibration standard
Primary standards should have a quality of
Low reactivity, toxicity, efflorescence, hygroscopicity
Stable
99.99% purity
High solubility
High eqv. wt.
This is accompanied by a certificate one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values arw expressed and for which each certified value in accompanied by an uncertainties at a stated level of confidence
Certified reference material
Substabces which property values are sufficiently homogenous and well established to be used for the calibration of an aparatus
Reference materials
A pure compinent of accurately known concentrations used to calibrate an instrument
Calibration standard
Widely acknowledged standard with highest metrological qualities
Primary standard
_______ values are assigned by compariso with primary standard
Secondary standard
Na2CO3 and KHP is an exampke of what standard
Primary standard
Na2CO3 js used to standardized 0.1N HCl and this is used to standardized 1.N NaOH solution is an example of what standard.
Secondary Standard
The seven consecutive points completely above or below means
Out of reagent or clogging
Consecutive 14 up and down
Out of reagent
If any obvious non random pattern
Offset reading