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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 95928Approved By:_____________________________________ 1/26/12 Date: ___________ Laboratory Director - ReddingApproved By:_____________________________________ 1/27/12 Date: ___________ Laboratory Director - ChicoApproved By:_____________________________________ 1/27/12 Date: ___________ Quality Assurance Director Page 1 of 99 Basic Laboratory, Inc
QAP, Revision 15.0, January 2012 Table of ContentsTitle PageTable of ContentsList of Appendices Page1.0 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 102.0 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 123.0 Sample Collection Procedures 13 3.1 Sample Collection 13 3.2 Sampling Kit Preparation 134.0 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 155.0 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 Page 2 of 99 Basic Laboratory, Inc
QAP, Revision 15.0, January 2012 5.9 GC and GC/MS Calibration Procedure 18 5.10 Radiation Instrument Calibration Procedure 18 5.11 Other Calibration Procedures (Support Equipment) 186.0 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 207.0 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 248.0 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 299.0 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 Page 3 of 99 Basic Laboratory, Inc
QAP, Revision 15.0, January 201210.0 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 3211.0 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 3412.0 Corrective Actions 3413.0 Subcontracting and Support Services 35 13.1 Subcontracting Laboratory Services 35 13.2 Outside Support Services and Supplies 3514.0 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 3615.0 References 37 Page 4 of 99 Basic Laboratory, Inc
QAP, Revision 15.0, January 2012 List of AppendicesA. Key Personnel ResumesB. Laboratory Certification and CapabilitiesC. Quality Assurance Objectives Summary for Water SamplesD. Quality Assurance Objectives Summary for Soil / Sediment SamplesE. Quality Assurance Objectives for Acute Toxicity Bioassay and Reporting FormatF. Sample Receiving Summary of Containers, Preservation, and Holding TimesG. Sample Receiving Forms 1) Sample Container Label 2) Chain of Custody Form 3) Bottle Order FormH. Listing of Approved Standard Operating ProceduresI. Quality Assurance Forms 1) QA Audit Checklist (example) 2) Corrective Action FormJ. Instrumentation and Major EquipmentK. Flags and Data Qualifiers Page 5 of 99 Basic Laboratory, Inc
QAP, Revision 15.0, January 20121.0 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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QAP, Revision 15.0, January 2012I. 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 misrepresentationVII. 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 20121.3 Organizational Structure1.4 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 Page 9 of 99 Basic Laboratory, Inc
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 Page 10 of 99 Basic Laboratory, Inc
QAP, Revision 15.0, January 2012 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 replicates2.2 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: Page 11 of 99 Basic Laboratory, Inc
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 SRM2.3 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 analyzed2.5 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 Page 12 of 99
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 …
Strategies to ensure good quality in the lab
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.
Responsibilities for Quality Assurance
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.