Transcript Quality Assurance & Quality Control

A planned set of activities necessary to provide adequate confidence
that requirements are properly established and products or service
conform to specified requirements.
Sets up measurement programs to evaluate processes.
Identifies weakness in process and improves them.
The process by which product quality is compared with applicable
standards; and the action taken when nonconformance detected.
An activity which verifies that the process meets pre-defined standards.
To document the procedures and methods of sample collection,
preparation and analysis.
To provide assurance as to reliability of analyses using
replicate samples, cross-laboratory checks and an
“known reference” standards.
To provide assurance as to the precision from
duplicate samples.
To provide assurance as to the accuracy from using recognized
reference standards.
To provide reliable information regarding the interpretation of
the data.
To provide a chain of custody of samples.
Bruce W. Downing, M.Sc., P.Geo. is Senior Geologist, Gamah International Ltd., Vancouver.
21 CFR PART 58 - Food and Drug Administration
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
40 CFR PART 160 – Environmental Protection Agency
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=68585f39e9accd101eb9a716f01fc95e&rgn=div5&view=text&node=40:23.0.1.1.11&idno=40
GLP Principles…
Management
1. Organization Personnel
Sponsor
Study Director
2. Quality Assurance Program
3. Facilities
4. Equipments, Reagents and Materials
GLP Principles
5. Test Systems
Physical/Chemical
Biological
6. Test & Reference Items
7. Protocol SOPs
8. Performance of Study
Study plan
Conduct of study
9. Reporting of Results
10. Storage of Records and Reports
(a) Must designate a study director.
(b) Must have a quality assurance unit.
“A testing facility shall permit an authorized employee of
the Food and Drug Administration to inspect the facility
and to inspect all records and specimens required to be
maintained regarding the study.”
• Each testing facility shall be of suitable size and construction
and shall be designed so that there is a degree of separation
that will prevent any function or activity from having an
adverse effect on the study.
• As necessary to prevent contamination or mixups, there shall
be separate areas for:
• (1) Receipt and storage of the test and control articles.
• (2) Mixing of the test and control articles with a carrier, e.g.,
feed.
• (3) Storage of the test and control article mixtures.
• Space shall be provided for archives, limited to access by
authorized personnel only, for the storage and retrieval of all
raw data and specimens from completed studies.
(a) Each individual shall have education, training, and experience,
or combination thereof, to enable that individual to perform the
assigned functions.
(b) Each testing facility shall maintain a current summary of training
and experience and job description for each individual engaged in
or supervising the conduct of the laboratory study.
• A scientist or other professional of appropriate education,
training, and experience, shall be identified as the study
director. The study director has overall responsibility for the
technical conduct of the study, and represents the single
point of study control.
• (a) Approves the protocol, including any changes.
• (b) All data, including observations of unanticipated
responses are accurately recorded and verified.
• (c) Unforeseen circumstances that may affect the quality and
integrity of the study are noted when they occur, and
corrective action is taken and documented.
• (e) All good laboratory practice regulations are followed.
• (f) All raw data, documentation, protocols, specimens, and
final reports are transferred to the archives during or at the
close of the study.
(1) A descriptive title and statement of the purpose
of the study.
(2) Identification of the test and control articles.
(3) The procedure for identification of the test system.
(6) A description of the experimental design, including
the methods for the control of bias.
(4) A description and/or identification of solvents,
emulsifiers, and/or other materials used to solubilize
or suspend the test or control articles before mixing
with the carrier.
(5) The type and frequency of tests, analyses, and
measurements to be made.
(6) The records to be maintained.
(7) A statement of the proposed statistical methods
to be used.
A testing facility shall have a quality assurance unit which
shall be responsible for monitoring each study to assure
management that the facilities, equipment, personnel,
methods, practices, records, and controls are in conformance
with regulations.
For any given study, the quality assurance unit shall be
entirely separate from and independent of the personnel
engaged in the direction and conduct of that study.
• (1) Maintain a copy of a master schedule sheet containing the
test system, nature of study, date study was initiated, current
status of each study.
• (2) Maintain copies of all protocols pertaining to all laboratory
studies for which the unit is responsible.
• (3) Inspect each laboratory study and maintain written and
properly signed records of each periodic inspection. Any
problems found during the course of an inspection which are
likely to affect study integrity shall be brought to the attention
of the study director and management immediately.
• (5) Determine that no deviations from standard operating
procedures were made without proper authorization and
documentation.
• (6) Review the final study report and assure that the reported
results accurately reflect the raw data of the laboratory study.
Equipment shall be adequately inspected, cleaned, and
maintained, and shall be adequately tested, calibrated
and/or standardized according to the Standard Operating
Procedures, and the person responsible for the performance
of each operation shall be designated.
Shall specify action to be taken in the event of failure or
malfunction of equipment.
Written records shall be maintained of all inspection,
maintenance, testing, calibrating and/or standardizing
operations.
A testing facility shall have standard operating procedures
in writing setting forth study methods that insure the
quality and integrity of the data generated in the course
of a study.
All deviations in a study from standard operating procedures
shall be authorized by the study director and shall be
documented in the raw data. Significant changes in
established standard operating procedures shall be
properly authorized in writing by management.
(a)The identity, strength, purity, etc. which will appropriately
define the test or control article shall be determined.
(b) The stability of each test or control article shall be determined.
(c) Each storage container shall be labeled by name or code
number, batch number, expiration date-if any.
(d)Each container shall also be labeled with appropriate, storage
conditions necessary to maintain the identity, strength, purity,
and composition of the test or control article.
(e) There is proper storage.
(f) Distribution is made in a manner designed to preclude the
possibility of contamination, deterioration, or damage.
(g) Proper identification is maintained throughout the distribution
process.
(h) The receipt and distribution of each batch is documented with
the date and quantity of each batch distributed or returned.
Chain of Custody
An acceptable QA/QC program will require that the complete
history of every sample taken for evaluation be recorded.
Such a history will include:
1. The date, time and sampling protocol for the original sample.
2. The method, duration and location of any sample storage.
3. A detailed record of any physical or chemical treatment of
the sample, including drying, crushing, grinding, screening,
splitting, and washing.
4. A record of all personnel who have handled the sample,
including time and place.
5. Records of all disposals of sample parts, fractions and splits.
This "cradle to grave" record allows an investigator to follow the
chain of custody backwards in order to investigate unusual
or unexpected results.
University of California DANR Analytical Lab
Quality Control for Laboratory Analyses:
BLANKS – A reagent blank is analyzed with every set of samples
that are extracted or digested. This reagent blank includes any
and all reagents that are used in the analytical process and is
carried through the entire process, including extraction and
filtering or digestion.
DUPLICATES – At least ten percent of samples are analyzed
in duplicate. The first, last and every tenth sample are run in
duplicate. Duplicate values typically should fall within 8%
of each other for all samples unless sample homogeneity
is a problem. This information is included in the report.
University of California DANR Analytical Lab
STANDARD REFERENCE MATERIALS – At least one standard
reference material is analyzed with each set of samples.
The values for the standard reference materials are included
in the final report. Samples run with a standard reference
material that falls outside the acceptable range are reanalyzed,
including digestion or extraction if necessary.
SPIKE SAMPLES – Sample fortifications or spikes are used to
verify accuracy of tests requiring extensive sample manipulation
(such as acid digestion) or for non-standard sample types.
SAMPLE EXCHANGE AND CERTIFICATION PROGRAMS The ANR Analytical Laboratory participates in a number of
sample exchange and certification programs. The Laboratory
participates in the International Plant Exchange for plant
material and the North American Proficiency Testing Program
for soils, water and plant material and manure.
Virginia Institute of Marine Science
The following Quality Control Criteria are the basic
parameters monitored by the analyst at the bench.
An Investigator may specify absolute limits or additional
protocols as required for the project.
Correlation - Calibration curve coefficient must exceed 0.999.
Standard Reference Materials - Analyzed daily, matrix
matched, mid-range concentration, must meet statistical
control limit (internal) for lot.
Intercept Correction - Employed to eliminate any standard
matrix artifacts not applicable to samples.
Virginia Institute of Marine Science
Precision - 10% Duplication - Randomly chosen, not linked
to field duplication. Control limits derived from past data in
similar concentration range and matrix, or specified by investigator.
Accuracy - 10% Spiking - Recovery of known addition added
directly to sample to verify the control of matrix interferences.
Statistical control limited. Failure to meet criteria triggers
interference screening and method modification.
Baseline correction - Zero analyte response verified every
10 samples. Drift mathematically compensated.
Sensitivity Correction - Calibration verified every 10 samples.
10% deviation triggers re-calibration.
Drift below 10% mathematically corrected.
There shall be archives for orderly storage and expedient
retrieval of all raw data, documentation, protocols,
specimens, and interim and final reports.
Depending on the study or funding agency these records
must be retained for from 2-5 years.