Quality Assurance Plan Basic Lab

Summary

Basic Laboratory, Inc

QAP, Revision 15.0, January 2012
QUALITY ASSURANCE PLAN
Revision 15.0
January 2012
(Initial Version Release: January 2001)
Prepared By: J. Nathan Hawley, QA Director
Basic Laboratory, Inc. Basic Laboratory, Inc

2218 Railroad Avenue 3860 Morrow Lane Ste F
Redding, California 96001 Chico, California 95928
Approved By:_____________________________________ 1/26/12
Date: ___________
Laboratory Director - Redding
Approved By:_____________________________________ 1/27/12
Date: ___________
Laboratory Director - Chico
Approved By:_____________________________________ 1/27/12
Date: ___________
Quality Assurance Director
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QAP, Revision 15.0, January 2012
Table of Contents
Title Page
Table of Contents
List of Appendices Page
1.0 Organization and Responsibility 6
1.1 Introduction 6
1.2 Code of Ethics 6
1.3 Organizational Structure 8
1.4 Duties and Responsibilities of Personnel 8
1.5 Personnel Qualifications 9
1.6 Personnel Training 9
1.7 Laboratory Capabilities 10
2.0 Quality Assurance Objectives 10
2.1 Precision 10
2.2 Accuracy 11
2.3 Representativeness 12
2.4 Completeness 12
2.5 Comparability 12
2.6 Detection Limits 12
3.0 Sample Collection Procedures 13
3.1 Sample Collection 13
3.2 Sampling Kit Preparation 13
4.0 Sample Custody 13
4.1 Sample Tracking 13
4.2 Sample Acceptance 14
4.3 Sample Receipt and Login 14
4.4 Sample Preservation 15
4.5 Sample Storage 15
4.6 Sample Disposal 15
5.0 Calibration Procedures and Frequency 15
5.1 Traceability 15
5.2 Reference Standards 15
5.3 General Requirements 16
5.4 Analytical Support Equipment 16
5.5 Instrument Calibration 16
5.6 FAA / GFAA / ICP Calibration Procedure 17
5.7 ICP/MS Calibration Procedure 18
5.8 UV-VIS Spectrophotometer Calibration Procedure 18
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5.9 GC and GC/MS Calibration Procedure 18
5.10 Radiation Instrument Calibration Procedure 18
5.11 Other Calibration Procedures (Support Equipment) 18
6.0 Analytical Methods and Standard Operating Procedures 19
6.1 SOP for Sample Custody 19
6.2 SOP for Reagent and Standard Preparation 19
6.3 SOPs for General Laboratory Techniques 20
6.4 SOPs for Analytical Test Methods 20
6.5 SOPs for Equipment Calibration and Maintenance 20
7.0 Internal Quality Control Checks 21
7.1 Laboratory Quality Control Samples 21
7.1.1 Method Blank (MB) Analysis 21
7.1.2 Laboratory Control Samples (LCS) Analysis 21
7.1.3 Matrix Spike / Matrix Spike Duplicate (MS/MSD) Analysis 22
7.1.4 Duplicate Sample Analysis 22
7.1.5 Check Standard Analysis (ICV, CCV) 23
7.1.6 Surrogate Analysis 23
7.1.7 Spike Components (Organic Chromatography) 23
7.2 Detection Limits 23
7.3 Selectivity 24
7.4 Demonstration of Method Capability 24
8.0 Data Reduction, Review, Reporting, and Records 24
8.1 Data Reduction and Review 24
8.2 Report Formats and Contents 25
8.3 Records 26
8.3.1 Standard Operating Procedures 27
8.3.2 Equipment Maintenance Documentation 27
8.3.3 Calibration Records & Traceability of Standards/Reagents 27
8.3.4 Sample Management 27
8.3.5 Original Data 27
8.3.6 QC Data 28
8.3.7 Correspondence 28
8.3.8 Deviations 28
8.3.9 Final Report 28
8.3.10 Administrative Records 28
8.3.11 Radiation Safety Plan Records 28
8.4 Document Control 28
8.5 Confidentiality 29
9.0 Performance and System Audits 29
9.1 Performance Evaluation Sample Program 29
9.2 Regulatory Laboratory Audits 29
9.3 Internal Laboratory Audits 29
9.4 Control Chart Monitoring 30
9.5 Managerial Review 30
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10.0 Facilities, Equipment, Reagents, and Preventative Maintenance 30
10.1 Facilities 30
10.2 Equipment and Reference Material 31
10.3 Documentation and Labeling of Standards and Reagents 31
10.4 Computers and Electronic Data Related Requirements 32
10.5 Preventative Maintenance 32
10.6 Inspection and Acceptance Requirements for Supplies 32
11.0 Routine Procedures for Evaluating Data Quality 33
11.1 Laboratory Control Samples 33
11.2 Matrix Spike / Matrix Spike Duplicates 33
11.3 Surrogate Recoveries 34
11.4 Method Blanks 34
12.0 Corrective Actions 34
13.0 Subcontracting and Support Services 35
13.1 Subcontracting Laboratory Services 35
13.2 Outside Support Services and Supplies 35
14.0 Laboratory Information Management System (LIMS) 35
14.1 General Information 35
14.2 Security 35
14.3 Updates 36
14.4 Backup 36
14.5 Audit Trail 36
15.0 References 37
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List of Appendices
A. Key Personnel Resumes
B. Laboratory Certification and Capabilities
C. Quality Assurance Objectives Summary for Water Samples
D. Quality Assurance Objectives Summary for Soil / Sediment Samples
E. Quality Assurance Objectives for Acute Toxicity Bioassay and Reporting Format
F. Sample Receiving Summary of Containers, Preservation, and Holding Times
G. Sample Receiving Forms
1) Sample Container Label
2) Chain of Custody Form
3) Bottle Order Form
H. Listing of Approved Standard Operating Procedures
I. Quality Assurance Forms
1) QA Audit Checklist (example)
2) Corrective Action Form
J. Instrumentation and Major Equipment
K. Flags and Data Qualifiers
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QAP, Revision 15.0, January 2012
1.0 Organization and Responsibility
1.1 Introduction
Basic Laboratory is committed to the production of analytical data of the highest
quality in all environmental analyses. Basic Laboratory recognizes that quality
data is a function of an effective and consistent quality assurance program. It is
in support of Basic Laboratory’s commitment to data integrity that this Quality
Assurance Plan was prepared. It is our goal to produce data that is scientifically
valid, legally defensible, and of known and documented quality in accordance
with nationally recognized standards

The different elements of the Quality Assurance Plan are discussed in the
remainder of this manual. The detailed procedures for how each element of the
plan is carried out can be found in the Standard Operating Procedures (SOP). All
analyses are performed using promulgated reference methods for which the
laboratory has demonstrated competency prior to its use

Basic Laboratory provides microbiological, bioassay, general chemical, organic
chemical, and metals analysis for water and soil. Radiological, electron
microscopy, and other testing services are provided through state certified
subcontractor laboratories with established quality assurance plans. Basic
Laboratory analyzes blind Performance Testing samples annually for all methods
and analyses for which we are certified

The implementation of the Quality Assurance Plan is achieved through a
laboratory-wide effort of the entire staff. The laboratory organization and
personnel are geared toward carrying out the objectives of the Quality Assurance
Plan. This may be seen in the organization chart in section 1.3 and in the
descriptions of the staff duties, responsibilities, and qualifications provided in the
remainder of this section and in Appendix A. As the lab grows, additional staff
will be added to the organizational structure

To strengthen its commitment to the production of quality data, Basic Laboratory
has established high qualification standards for employment and provides a
comprehensive training program for all its employees. The result is a laboratory
staff who offer a unique blend of scientific and technical expertise, highly capable
of serving a wide range of analytical needs in the environmental arena

1.2 Code of Ethics
All employees are to adhere to the following code of ethical business practices

Any ethical infraction by an employee is grounds for immediate termination of
employment, and also for legal action against the offending employee

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I. Basic Laboratory and employees thereof will perform all work in a manner
that merits full confidence and trust

II. Basic Laboratory and employees thereof, will not engage in illegal
practices, or cooperate with anyone so engaged

III. Basic Laboratory and employees thereof, will ensure the integrity of their
data by complete adherence to the laboratory QA/QC Manual and
Standard Operating Procedures, and will be diligent to expose and
correct any errors that may be brought to light

IV. Basic Laboratory and employees thereof, will maintain as their first priority
the common needs of the community, and will at all times contribute as
responsible and profitable members of our society

V. Basic Laboratory and employees thereof, will work and act in a strict spirit
of honesty and fairness to clients, and in a spirit of personal helpfulness
and fraternity toward fellow employees

VI. Basic Laboratory and employees thereof, will not accept any of the
following practices:
 Fabrication of data
 Misrepresentation of QC samples
 Non-acceptable instrument calibration procedures
 Unapproved modification of samples to alter their characteristics
 Improper and unethical manual integrations
 Manipulation or misrepresentation of analytical results
 Substitution of samples, files, or data
 Falsification of records or instrument readings
 Any other form of fraud or intentional misrepresentation
VII. Basic Laboratory and employees thereof, will advise clients of the
probability of success before undertaking a project, and will not accept
work that would constitute a conflict of interest

VIII. Basic Laboratory and employees thereof will ensure the confidentiality of
all data and information provided by their clients

IX. Basic Laboratory and employees thereof will only perform testing services for
which they have consistently demonstrated full compliance with high quality,
legally defensible performance standards

X. Basic Laboratory and employees thereof will seek to consistently
demonstrate the positive qualities of enthusiasm, diligence, responsibility,
initiative, integrity, honesty, kindness, and patience in dealing with both
clients and fellow employees

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QAP, Revision 15.0, January 2012
1.3 Organizational Structure
1.4 Duties and Responsibilities of Personnel
 The Laboratory Director has the responsibility for the overall
management and supervision of the laboratory and its personnel. He will
interface with clients on all aspects of their projects including progress,
problems, and recommended solutions. He will also work with the Owner
and Quality Assurance Officer and laboratory personnel in reviewing
progress reports, analytical reports, financial reports, and QC reports. He
is primarily responsible to ensure that all employees have received the
necessary level of training to make them capable of properly executing
their duties

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QAP, Revision 15.0, January 2012
 The Quality Assurance Director/Officer (QAO) assists the Laboratory
Director in assuring the production of accurate, valid, and reliable data by
continuously monitoring the implementation of the laboratory quality
assurance program. The QAO administers all inter-laboratory QA efforts,
schedules and reviews performance evaluation results, takes corrective
actions, and prepares quality assurance reports for management. He also
conducts annual audits of the overall laboratory operation, and is
responsible for the management and annual review of this QA manual

 The Department Managers and/or Supervisors are responsible for
each task identified in their scope of work. They are responsible for
organizing and directing the technical activities within their assigned
sections(s). They are involved in daily laboratory operations and are
responsible for verifying that laboratory QC and analytical procedures are
being followed as specified for each project. They are responsible for
organizing, assembling, disseminating, and filing all documents pertinent
to the analysis for each set of samples. They may be responsible for the
review of data generated in their departments for accuracy. They also
advise the Laboratory Director of progress, needs, and potential problems
of their assigned section(s)

 The Analysts or Technical Staff are responsible for sample analysis, data
processing and recording in accordance with this laboratory QAP and
established SOPs. They are responsible for calibration and preventive
maintenance of instrumentation, data reduction, data review, and
reporting of all out-of-control situations, as well as for initial corrective
actions whenever necessary. Well documented training records are kept
on file for each Analyst in order to provide proof of proper training for
each method they perform

 The Sample Custodians are responsible for the proper preparation,
shipment and receipt of sampling kits. When the samples are received
into the laboratory, the sample custodian is responsible for checking and
documenting the chain-of-custody by checking sample descriptions,
labels, and parameters requested against the chain of custody record. If
any discrepancies are noted, the sample custodian informs the
Laboratory Director who coordinates corrections with clients. This
information is recorded into a sample logbook and into the Laboratory
Information Management System (LIMS). All samples are logged into the
LIMS and are tracked within the LIMS for the remainder of their journey
through the laboratory. Audit trails are available for each sample

1.5 Personnel Qualifications
See Appendix A – Key Personnel Resumes

1.6 Personnel Training
To ensure that all personnel involved in analytical activities are able to carry out
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QAP, Revision 15.0, January 2012
their duties, they are required to undergo a training program. Training is
administered by trainers designated by the Laboratory Director or by the QA
Officer, and is normally a senior analyst

The program is presented to new employees upon employment and must be
completed prior to assumption of assigned duties. It includes orientation, review
of the job description and how the position integrates with the overall
organization, overview of the QA program, overview of the safety program, and
initial on-the-job training on the employee’s initial job assignment. Each
employee has read, understood, and is using the latest version of the
laboratory’s QAP and the SOPs that relate to their job responsibilities

The readiness of the new employee to assume initial job assignment is assessed
by the area supervisor. Acceptable performance is determined by conducting an
Initial Demonstration of Capability (IDC). Each acceptable performance of
analysis is noted on the employee’s training record. After final approval by the
QAO, the employee is allowed to begin initial assignments. All completed
documentation is kept in the employees permanent training records

1.7 Laboratory Capabilities
Basic Laboratory is capable of testing water and soil samples for a wide variety
of parameters. See Appendix B for a complete listing of all certified methods

2.0 Quality Assurance Objectives
The overall QA objectives for Basic Laboratory are to develop and implement
procedures for laboratory analysis, chain-of-custody, and reporting that will provide
results which are of known and documented quality. Data Quality Indicators (DQIs) are
used as qualitative and quantitative descriptors in interpreting the degree of acceptability
or utility of data. The principal DQIs are precision, bias (accuracy), representativeness,
comparability, completeness and detection limits. DQIs are used as quantitative goals
for the quality of data generated in the analytical measurement process. This section
summarizes how specific QA objectives are achieved. The specific application of these
various activities are contained in the method SOPs

The laboratory’s quality assurance objectives of precision, accuracy, and completeness
are listed in Appendix C and D. These objectives are based on the laboratory’s
capabilities as indicated by historical data or results of validation studies. Where
sufficient data is not available, EPA CLP control criteria are used. The fish toxicity
bioassay QA/QC objectives along with a report format are listed in Appendix E

2.1 Precision
Precision is a measure of the degree to which two or more measurements are in
agreement. Precision is assessed through the calculation of relative percent
differences (RPD) and/or relative standard deviations (RSD) for replicate
samples. For inorganic analyses, laboratory precision is usually assessed
through the analysis of a sample/sample duplicate pair, although some methods
require the use of matrix spike/matrix spike duplicate. For organic analyses,
precision is usually assessed through the analysis of matrix spike/matrix spike
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duplicate (MS/MSD) and field duplicate samples

Precision is a measurement of the mutual agreement among individual
measurements of the same parameters under prescribed similar conditions

If calculated from duplicate measurements:
(C1 - C2) x 100
RPD =
(C1 + C2) /2
where: RPD = relative percent difference
C1 = larger of the two observed values
C2 = smaller of the two observed values
If calculated from three or more replicates, use relative standard deviation (RSD)
rather than RPD:
RSD = (s/y) x 100%
where: s = standard deviation
y = mean of replicate analysis
Standard deviation(s) is defined as follows:
n
 (yi - y)2
s= i=1 n-1
where:
yi = measured value of the ith replicate
y = mean of replicate measurements
n = number of replicates
2.2 Accuracy
Accuracy is the degree of agreement between an observed value and an
accepted reference or true value. Accuracy is first assessed by the analysis of
blanks and through the adherence to all sample handling, preservation and
holding times. Laboratory accuracy is further assessed through the analysis of
MS/MSD, quality control check samples, laboratory control samples (LCS) and
surrogate compound spikes

For measurements where matrix spikes are used, the percent recovery (%R) is
calculated:
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QAP, Revision 15.0, January 2012
S-U
%R = 100 x
Csa
where: S = measured concentration in spiked aliquot
U = measured concentration in un-spiked aliquot
Csa = actual concentration of spike added
For situations where a standard reference material (SRM) is used instead of, or
in addition to, a matrix spike, the percent recovery (%R) is calculated:
Cm
%R = 100 x
Csrm
where: Cm = measured concentration of SRM
Csrm = actual concentration of SRM
2.3 Representativeness
Representativeness expresses the degree to which data accurately and precisely
represent a characteristic of a population, parameter variations at a sampling
point, a process condition, or an environmental condition within a defined spatial
and/or temporal boundary. Representativeness is ensured by using the proper
analytical procedures, appropriate methods, meeting sample holding times and
analyzing field duplicate samples

2.4 Completeness
Completeness is a measure of the amount of valid data obtained from a
measurement system compared to the amount that was expected to be obtained
under normal conditions. Laboratory completeness is a measure of the amount of
valid measurements obtained from all the measurements taken in the project

No. of Acceptable parameters
%C= x 100
Total number analyzed
2.5 Comparability
Comparability is an expression of the confidence with which one data set can be
compared to another. Comparability is achieved by the use of routine analytical
methods, achieving holding times, reporting results in common units, use of
consistent detection levels, and consistent rules for reporting data

2.6 Detection Limits
Method Detection Limits (MDLs) are determined for all analytes as specified by
recognized EPA standards. From these, a Reporting Limit (RL), normally around
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Prepared By: J. Nathan Hawley, QA Director Basic Laboratory, Inc. Basic Laboratory, Inc. 2218 Railroad Avenue 3860 Morrow Lane Ste F Redding, California 96001 Chico, California 95928 …

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Frequently Asked Questions

How to improve quality of your laboratory?

Strategies to ensure good quality in the lab

• Costs of good quality. Maintaining a GQ test system incurs costs associated with prevention of adverse effects and test system review.
• Costs of poor quality. ...
• Examples of poor quality practices. ...
• Making quality improvements. ...

What is quality assurance plan qap?

What Is A Quality Assurance Plan? A Quality Assurance Plan (QAP) is a document created by the project team, which if followed, will ensure the finished product meets all criteria making it the best possible quality product. The product should not only meet all customer requirements but also meet the business objectives and targets.

What are the duties of quality assurance?

Responsibilities for Quality Assurance

• Create quality measurements to track improvement in products
• Execute quality improvement testing and activities
• Develop quality assurance standards and company processes
• Adhere to industry quality and safety standards
• Ensure products meet customer expectations and demand
• Create reports documenting errors and issues for fixing

More items...

What should an internal quality assurance plan contain?

IQA arrangements must include as a minimum: 1. A planned structure for internal quality assurance activities including a sampling strategy and/or plan. 2. An agreed and published annual timetable for internal verification activities, including standardisation meetings, observations on centre staff members etc. 3.