Quality Assurance Guidelines for Laboratories Performing Microbial Forensic Work

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Quality Assurance Guidelines for Laboratories Performing Microbial Forensic Work"

Transcription

1 for Laboratories Performing Microbial Forensic Work Produced by the Members of the Scientific Working Group on Microbial Genetics and Forensics (SWGMGF) Contact: Bruce Budowle, Chair, FBI Laboratory, 2501 Investigation Parkway, Quantico, Virginia Preface The Scientific Working Group on Microbial Genetics and Forensics (SWGMGF) has developed the following quality assurance guidelines to provide laboratories engaged in microbial forensic analysis with a framework to implement a quality assurance program. This document provides guidance to laboratories that carry out microbial forensic analysis to support the judicial system. Consideration may be given to alternate methods of achieving the intent of these quality assurance practices as outlined in these guidelines. A quality program is always evolving, and likewise, this document should be considered a living document. It is the intent of SWGMGF to modify this document as quality assurance practices in microbial forensics advance. Introduction The for Laboratories Performing Microbial Forensic Work provides a base line from which laboratories may structure their quality assurance practices. Many of the recommendations outlined in this document will be familiar to laboratories already meeting International Standards Organization (ISO) and CLIA 88 (Clinical Laboratory Improvement Amendments 1988) requirements. It is the intent of SWGMGF to provide the community with a source document for quality practices in the microbial forensics field. References American Society of Crime Laboratory Directors Laboratory Accreditation Board (ASCLD/LAB), ASCLD/LAB Accreditation Manual (American Society of Crime Laboratory Directors, Garner, NC, April 2001). Federal Bureau of Investigation, Quality Assurance Standards for Forensic DNA Testing Laboratories (U.S. Government Printing Office, Washington, DC, 1998). International Standards Organization (ISO)/International Electrotechnical Commission (IEC), "General requirements for the competence of testing and calibration laboratories" (ISO/IEC 17025, American National Standards Institute, New York, 1999). U.S. Department of Health and Human Services, Biosafety in Microbiological and Biomedical Laboratories (U.S. Government Printing Office, Washington, DC, 4th ed., April 1999). CLIA 88, 57 C.F.R. 7139, pp (1988). Health Care Financing Administration, Health and Human Services, 42 C.F.R., chap. 4 (October 1995). The CDC (Centers for Disease Control and Prevention) "Possession, use, and transfer of select agents and toxins," interim final rule, 42 C.F.R., part 73; 67 Fed. Reg Page 1 of 12

2 The APHIS (Animal and Plant Health Inspection Service) interim final rule, Agricultural Bioterrorism Protection Act of 2002; Possession, use, and transfer of biological agents and toxins, 7 C.F.R. part 331, repeated at 9 C.F.R. part 121; interim final rule; 67 Fed. Reg Scope These guidelines describe quality assurance activities that a laboratory should follow to ensure the competency of the laboratory and the quality and integrity of scientific data. A laboratory, in the context of these guidelines, is defined as a facility in which microbial forensic testing is performed. These guidelines do not preclude the participation of a laboratory, by itself or in collaboration with others, from participating in research and development, or from using procedures that have not yet been validated by standard means for purposes other than forensic testing. 2. Definitions As used in these guidelines, the following terms have the meanings specified: Administrative review is an evaluation of examination documentation for consistency with laboratory policies and for editorial correctness. Analytical procedure is an orderly step-by-step procedure designed to ensure operational uniformity and to minimize analytical drift. Attribution is the information obtained regarding the identification or source of a material to the degree that it can be ascertained. Audit is an inspection used to evaluate, confirm, or verify activities related to quality. Biocrime or bioterrorism is the threat or use of microorganisms, toxins, pests, prions, or their associated ancillary products to commit acts of crime or terror. BMBL is Biosafety in Microbiological and Biomedical Laboratories (see References). Calibration is a set of operations that establish, under specified conditions, the relationship between values provided by a measuring instrument, measuring system, and a known material or known values. CDC is the Centers for Disease Control and Prevention. Chain of custody is the tracking and documentation of physical control of evidence. Contributing agency is identified as the organization that submitted the evidence to the laboratory for testing and which will receive the laboratory report. Control samples or known samples are test materials whose identity, type, or values have been established. (e.g., blind samples, negative and positive controls). Critical equipment or instruments are those requiring calibration prior to their initial use and on a regular basis thereafter. Critical reagents are determined by empirical studies or routine practice to require testing on known samples prior to use with evidentiary materials in order to prevent unnecessary consumption of forensic samples. Derivative evidence is material having originated from the original evidence (e.g., grown cultures, amplified DNA). Examination documentation encompasses any documentation generated as a result of the analysis of submitted evidence. This may include technical notes, worksheets, charts, Page 2 of 12

3 graphs, printouts, spectra, photographs, and other data or records used by examiners/analysts to support their reported conclusions. Examiner/analyst (or equivalent role, position, or title as designated by the laboratory director) is an individual who conducts and/or directs the analysis of samples, interprets data, and reaches conclusions, and may eventually testify to those findings or conclusions. Expert testimony is an opinion rendered by a qualified individual based on technical expertise or training. Investigative support is data that provide the contributing agency with basic information to assist an ongoing investigation. Laboratory is a facility in which microbial forensic testing is performed, a facility that contracts with another entity for such testing, or an entity contracted to perform analyses. Laboratory support personnel (or equivalent role, position, or title as designated by the laboratory director) is an individual(s) performing supportive laboratory duties, but not involved in the analysis or interpretation of evidence. Microbial forensics is a scientific discipline that examines microorganisms, toxins, pests, prions, or their associated ancillary products for source attribution. Proficiency test samples are materials whose identity, type, or values have been previously characterized and are used to assess the performance of a laboratory or an individual(s). Proficiency testing is a quality assurance measure used to monitor performance and identify areas where improvements may be needed. Proficiency tests may be classified as: Internal: A proficiency test that is prepared and administered within the laboratory being tested. External: A proficiency test that is prepared by an external agency. Qualifying test measures an individual s proficiency in both technical skills and knowledge and is administered prior to an individual assuming independent work responsibility. Quality assurance is the system of management activities designed to ensure that a process, item, or service is of the type and quality needed. This includes monitoring activities that are intended to verify whether practices and test results are providing reliable and relevant information. Quality control is a mechanism or laboratory activity intended to verify whether test conditions are functioning appropriately to yield reproducible results. Quality manual is a document stating the quality policy, quality system, and quality practices of an organization. Quality system is the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. Reference material (certified or standard) is a material for which identities, types, or values are certified by technically valid procedures and is accompanied by, or traceable to, a certificate or other documentation. Secure area is a locked space (e.g., cabinet, vault, room) with access restricted to authorized personnel. Subcontractor is an individual or entity having a transactional relationship with a laboratory. Page 3 of 12

4 Technical manager (or equivalent position or title as designated by the laboratory director) is the individual who is accountable for the technical operations of the laboratory. Technical review is an evaluation of reports, notes, data, and other documents to ensure that an appropriate and sufficient basis exists for the reported scientific conclusions. Technician (or equivalent role, position, or title as designated by the laboratory director) is an individual who performs analytical techniques on samples under the supervision of an examiner/analyst. Traceability is the property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons. USDA is the United States Department of Agriculture. Validation is a process by which a procedure is evaluated to determine its efficacy and reliability for analysis and includes the following: Developmental validation is the acquisition of test data and the determination of conditions and limitations of a newly developed methodology for use on samples. Preliminary validation is the acquisition of limited test data to enable an evaluation of a method used to assess materials derived from a biocrime or bioterrorism event. Internal validation is an accumulation of test data within the laboratory to demonstrate that established methods and procedures perform within determined limits in the laboratory. 3. Quality Assurance Program 3.1 The laboratory should establish and maintain a documented quality system that is appropriate to the testing activities The quality manual should address, at a minimum, the following: Goals and objectives Organization and management Personnel qualifications and training Facilities and security Sample control Validation Analytical procedures Calibration and maintenance Proficiency testing Corrective action Documentation and report writing Review of reports Safety Audits Monitoring subcontractor work, if a subcontractor is used 3.2 The laboratory should identify an individual as the quality manager. Page 4 of 12

5 4. Organization and Management 4.1 A laboratory should: have a managerial staff with the authority and resources needed to discharge their duties and meet the criteria of the guidelines in this document. have a technical manager who is accountable for the technical operations. specify and document the responsibility, authority, and interrelation of all personnel who manage, perform, or verify work affecting the validity of microbial forensic analysis. 4.2 A laboratory should have a procedure for document control. 5. Personnel 5.1 Laboratory personnel should have the education, training, and experience necessary to perform examinations and provide testimony. The laboratory should: have written job description(s) for personnel that include responsibilities, duties, and required skills have a documented training program for assuring the competence of all technical laboratory personnel have a documented program to ensure technical qualifications are maintained through continuing education Continuing education the technical manager and examiner/analyst(s) should stay abreast of developments within the field of microbial forensics by reading current scientific literature and by attending seminars, courses, professional meetings, or documented training sessions/classes in relevant subject areas at least once a year maintain records on the relevant qualifications (including college transcripts), training, skills, and experience of all technical personnel maintain records of security clearances, when appropriate, for laboratory personnel, when evidence/information must be secure and protected obtain a nondisclosure agreement from employee, if required. 5.2 The technical manager should have the following: Degree/experience requirements: The technical manager of a laboratory should have, at a minimum, one of the following combinations of education/experience: Master s degree in biology, microbiology, clinical laboratory science, or other relevant science. Within the last eight years: a minimum of four years of work experience in a laboratory with at least one year in the relevant field and one year of supervisory experience. Doctorate degree in medicine, biology, microbiology, clinical laboratory science, or other relevant science. Within the last four years: a minimum of two years work experience in a laboratory with at least one year in the relevant field and one year of supervisory experience. Page 5 of 12

6 5.2.2 Duty requirements: General: manages the technical operations of the laboratory Specific duties: Is responsible for evaluating and approving all methods used by the laboratory and for proposing new or modified analytical procedures to be used by examiners. Is responsible for technical problem solving of analytical methods and for the oversight of training, quality assurance, safety, and proficiency testing in the laboratory. Has the authority to suspend laboratory operations The technical manager should be accessible to the laboratory to provide on-site, telephonic, or electronic consultation, as needed. The technical manager should spend at least 50 percent of the work year at the laboratory facility. 5.3 Examiner/analyst should have the following: Degree requirements: An examiner/analyst should have, at a minimum, a bachelor s degree or its equivalent in biology, microbiology, clinical laboratory science, or other relevant science Experience requirements: An examiner/analyst should have a minimum of 12 months of laboratory experience Duty requirements: An examiner/analyst is responsible for the content of a laboratory report released under his/her name and provide expert courtroom testimony, if required Training requirements: An examiner/analyst should have successfully completed a documented training program and qualifying test before assuming independent work responsibilities. The training program should require a minimum of four months and include the successful analysis of a range of samples typically encountered in his/her area of microbial forensics and provide an understanding of forensic operations. 5.4 Technician should have: On-the-job training specific to the job function(s) performed Successfully completed a qualifying test before participating in forensic testing responsibilities. Documentation of testing should be retained. 5.5 Laboratory support personnel should have training, education, and experience commensurate with their responsibilities as outlined in their job description. 6. Facilities 6.1 The laboratory should have a facility that is designed to provide appropriate levels of security, safety, and minimize contamination. Laboratory management should ensure that: Access to the laboratory is controlled and limited Evidence is appropriately secured and stored when not under examination. Page 6 of 12

7 6.1.3 Preamplification materials and activities are separated by time or space from postamplification products and activities The laboratory follows written procedures for monitoring, cleaning, and decontaminating facilities and equipment When CDC (BMBL) and/or USDA guidelines for biolevel containment are employed, appropriate protocols and records should be maintained. 6.2 A laboratory should document waste management requirements to ensure that appropriate decontamination and disposal measures are in accordance with federal and/or state law. 6.3 A laboratory should consider measures to address the following: 7. Sample Control Backup power sources for power outages to protect evidence from temperature fluctuations, when appropriate. Twenty-four-hour emergency notification procedures are advisable. Computer security and backups for data and case documentation records. 7.1 The laboratory should have and follow a documented sample inventory control system. This system should ensure that: Samples are marked with unique identifiers Documentation of sample identity, receipt, storage, and disposition is maintained The laboratory follows documented procedures that minimize sample loss, contamination, and/or deleterious change The laboratory has secure areas for sample storage including environmental control consistent with the form or nature of the sample. 7.2 The laboratory should have available guidelines for sample collection and should request the following information from the submitter of samples: Sample collected from an individual: if available, type of sample (method of collection and anatomical site from which collected), age, gender, population affinity, weight, body temperature, current medications, who collected sample, time and date of collection, and post collection and transportation conditions. When multiple samples are collected from the same individual, appropriate delineation should be provided to distinguish samples. Additionally, for nonhuman samples, species, animal, or plant identification number should be recorded Sample collected from a location: if available, type of sample, sampling tool, date and time collected, and who collected the sample. When multiple samples are collected from the same site, appropriate delineation should be provided to distinguish samples. Sample location and condition of location at time of sample collection should be recorded. Conditions of storage and transport should be documented. 7.3 The laboratory should maintain a chain of custody for forensic samples from the time of receipt in the laboratory. Individual items should be tracked. Time and date of sample transfers should be documented. Derivative evidence should be tracked. Reformatted with minor modifications for Science Online Page 7 of 12

8 7.4 When the laboratory consumes tested samples, that fact should be documented in the case notes. 7.5 If tested samples, or derivative evidence thereof, are released to a database, this should be recorded in the case notes and the chain-of-custody. 7.6 A laboratory should document and provide appropriate guidelines for sample submission, packaging, and return. 7.7 A laboratory should document a policy of long-term sample storage, retention, disposal, and/or return. 8. Validation 8.1 The laboratory should use validated methods and procedures for analyses Developmental validation should be appropriately documented and should address specificity, sensitivity, reproducibility, bias, precision, false-positives, false-negatives, and determine appropriate controls. Any reference database used should be documented Preliminary validation is the acquisition of limited test data to enable an evaluation of a method used to provide investigative support to investigate a biocrime or bioterrorism event. If the results are to be used for other than investigative support, then a panel of peer experts, external to the laboratory, should be convened to assess the utility of the method and to define the limits of interpretation and conclusions drawn Internal validation should be performed and documented by the laboratory The procedure should be tested using known samples. The laboratory should monitor and document the reproducibility and precision and define reportable ranges of the procedure using control(s) Before the introduction of a new procedure into sample analysis, the analyst or examination team should successfully complete a qualifying test for that procedure Material modifications made to analytical procedures should be documented and subjected to validation testing commensurate with the modification and have documented approval. 9. Analytical Procedures 9.1 The laboratory should have and follow written analytical procedures reviewed and approved by the laboratory management/technical manager The laboratory should have a documented procedure for each analytical technique used The laboratory should have a documented approach for testing general unknowns The procedures should include a list of equipment and reagents, step-by-step instructions, quality controls, test calculations, limitations, interpretation criteria, and literature references. Reformatted with minor modifications for Science Online Page 8 of 12

9 9.1.4 The laboratory should have a policy whereby a deviation from an analytical procedure is documented and approved. 9.2 The laboratory should use reagents that are suitable for the methods employed The laboratory should have written procedures for documenting dates of receipt and expiration of commercial supplies and for the formulation of reagents. Lot numbers should be recorded Reagents should be labeled with the identity of the reagent, the date of preparation and expiration, the identity of the individual preparing the reagent, and storage instructions The laboratory should identify critical reagents, if any, and evaluate them prior to use. (e.g., restriction enzymes, primers, antibodies, growth media prepared in the laboratory) 10. Equipment Calibration and Maintenance 10.1 The laboratory should use equipment suitable for the methods employed The laboratory should identify critical equipment and should have a documented program for calibration and, when appropriate, monitoring of instruments and equipment When available and appropriate, standards traceable to national or international standards should be used for calibration. When traceability to national standards of measurement is not applicable, the laboratory should provide satisfactory evidence of correlation of results The frequency of the calibration should be documented for each instrument requiring calibration. Such documentation should be retained in accordance with appropriate federal and state law The laboratory should have and follow a documented program to ensure that instruments and equipment are properly maintained New critical instruments and equipment, or critical instruments and equipment that have undergone repair or maintenance, should be calibrated before use Written records or logs should be kept for maintenance service performed on instruments and equipment. Such documentation should be retained in accordance with federal and state law. 11. Reports 11.1 The laboratory should have and follow written procedures for generating and maintaining documentation for tested samples The laboratory should have written procedures for the release of tested sample information A laboratory report should include the following: Name of submitting agency Date the sample(s) was received in the laboratory Reformatted with minor modifications for Science Online Page 9 of 12

10 Brief description of all evidence submitted, including the indicated source of the sample, when available (e.g., lungs, circulatory, water source, debris) Statement to address the specific request made of the laboratory General statement of analytical method used Analytical results and interpretive statement to provide clarity of result Statement of negative results, when appropriate Statement of recommended additional testing, when appropriate (e.g., additional testing after 6 and 12 days is suggested so as to determine exact exposure date) Laboratory location (city, state) Identity of the person responsible for the technical conclusions of the laboratory report Identification of all components of the analysis completed using subcontractors 11.2 The laboratory should maintain, at a minimum, the following examination documentation: 12. Review of Reports Analyst- and technician-generated notes, to include identity of person generating notes List of instrumentation used (by specific identifier, if appropriate) All charts, graphs, photographs, and other examination-related records Chain of custody Description of evidence Dates of analysis Any deviations from examination protocol Statement regarding any consumption/disposition of evidence The identity of individuals performing technical and administrative reviews of the report 12.1 The laboratory should have and follow written procedures for technically reviewing all tested sample information and results. The technical review is conducted by a technically qualified individual other than the preparer of the report, notes, data, and other documents under review. All reports should be administratively reviewed The laboratory should have a documented mechanism in place to address discrepant interpretations and/or conclusions between analyst(s) and reviewer(s) and a mechanism to address unresolved conclusions/interpretations The laboratory should have a practice in place to review and address reports of noncompliance (e.g. findings resulting from audit reports, contamination logs, controls not functioning properly). 13. Proficiency Testing 13.1 Examiners and other personnel designated by the technical manager who are actively engaged in analysis should undergo annual proficiency testing. The test samples should be processed and analyzed in the same manner as casework. Successful completion of annual testing is required to continue casework. Reformatted with minor modifications for Science Online Page 10 of 12

11 The laboratory should maintain the following proficiency test documentation: Test set identifier Identity of the test participant Distribution date and due date Date of analysis and completion All data and notes supporting the conclusions Proficiency test results Any discrepancies noted Corrective actions taken Retention, if possible, of a portion of each proficiency test for reanalysis and comparison, if circumstances dictate Such documentation should be retained in accordance with appropriate federal and state law Records for each individual tested should be maintained, including all notes, records, reports, and evaluations The following proficiency test information should be documented for tests prepared within the laboratory: 14. Corrective Action 15. Audits Identity of person(s) who prepared the test samples Date test samples were prepared Test identifier Sufficient information to duplicate test preparation Expected results, including acceptable limits (if appropriate) 14.1 The laboratory should establish and follow procedures for corrective action whenever analytical errors and/or proficiency testing discrepancies are detected. The laboratory should maintain documentation for the corrective action. Such documentation should be retained in accordance with appropriate federal or state law The laboratory should conduct audits annually in accordance with the guidelines outlined herein Audit procedures should address, at a minimum, the following: Quality assurance program Organization and management Personnel Facilities and security Sample control Validation Analytical procedures Calibration and maintenance Proficiency testing Corrective action Documentation and report writing Reformatted with minor modifications for Science Online Page 11 of 12

12 Review of reports Safety Previous audits The laboratory should retain all documentation pertaining to audits in accordance with applicable federal and state laws A second agency should conduct an external audit once every two years. 16. Safety 16.1 The laboratory should have and follow a documented environmental health and safety program. This program should include a documented ongoing safety training program for laboratory personnel and should be in accordance with applicable federal and state laws The laboratory should identify an individual as the safety officer Laboratories employing biosafety level 2 or higher should meet applicable current CDC (BMBL) and/or USDA guidelines. 17. Subcontractor of Analytical Testing 17.1 The submitting agency should be notified and approve if its samples will be tested by a subcontracted laboratory. The laboratory will be notified and approve the use of a subcontractor by the subcontractor laboratory for testing of samples A laboratory operating under the scope of these guidelines should require certification of compliance with those portions of these guidelines appropriate to the analysis when a subcontractor performs analyses for the laboratory. A contracting laboratory may choose to require documentation of a laboratory following these guidelines before submitting samples for analysis The laboratory should establish and use appropriate review procedures based on the type of work being provided by the subcontracting laboratory. This is to verify the integrity of the data received from the subcontractor. The review includes, but is not limited to: Visual or expert system inspection and evaluation of all results and/or data Inclusion of quality control samples Annual on-site visits 17.3 Laboratories that use specialty contractors to fulfill narrowly focused analytical methods (e.g., genomic sequencing) should require the contractor to provide a minimum of the following documentation: Copy of the step-by-step analytical procedure used by the laboratory Identity of the person responsible for analysis results Analytical controls used during analysis Identity of all persons involved in the testing of the samples Chain of custody 17.4 The contracting laboratory should define a policy for notification of applicable personnel changes by the subcontracting laboratory. Reformatted with minor modifications for Science Online Page 12 of 12

NC SBI QUALITY ASSURANCE PROGRAM

NC SBI QUALITY ASSURANCE PROGRAM NC SBI QUALITY ASSURANCE PROGRAM for the SBI Reviewed by: Deputy Assistant Director Bill Weis Date: Approved by: Assistant Director Jerry Richardson Date: Originating Unit: SBI Effective Date: July 25,

More information

NABL NATIONAL ACCREDITATION

NABL NATIONAL ACCREDITATION NABL 160 NABL NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES GUIDE for PREPARING A QUALITY MANUAL ISSUE NO. : 05 AMENDMENT NO : 00 ISSUE DATE: 27.06.2012 AMENDMENT DATE: -- Amendment

More information

ILLINOIS DEPARTMENT OF CENTRAL MANAGEMENT SERVICES CLASS SPECIFICATION STATE POLICE EVIDENCE TECHNICIAN SERIES

ILLINOIS DEPARTMENT OF CENTRAL MANAGEMENT SERVICES CLASS SPECIFICATION STATE POLICE EVIDENCE TECHNICIAN SERIES ILLINOIS DEPARTMENT OF CENTRAL MANAGEMENT SERVICES CLASS SPECIFICATION STATE POLICE EVIDENCE TECHNICIAN SERIES CLASS TITLE POSITION CODE STATE POLICE EVIDENCE TECHNICIAN I 41901 STATE POLICE EVIDENCE TECHNICIAN

More information

ILLINOIS DEPARTMENT OF CENTRAL MANAGEMENT SERVICES CLASS SPECIFICATION FORENSIC SCIENTIST SERIES

ILLINOIS DEPARTMENT OF CENTRAL MANAGEMENT SERVICES CLASS SPECIFICATION FORENSIC SCIENTIST SERIES ILLINOIS DEPARTMENT OF CENTRAL MANAGEMENT SERVICES CLASS SPECIFICATION FORENSIC SCIENTIST SERIES CLASS TITLE POSITION CODE EFFECTIVE FORENSIC SCIENTIST TRAINEE 15897 5/1/10 FORENSIC SCIENTIST I 15891 5/1/10

More information

Scientific Working Group on DNA Analysis Methods. Validation Guidelines for DNA Analysis Methods. Table of Contents

Scientific Working Group on DNA Analysis Methods. Validation Guidelines for DNA Analysis Methods. Table of Contents Scientific Working Group on DNA Analysis Methods Validation Guidelines for DNA Analysis Methods Table of Contents Introduction.2 1. Definitions. 2 2. General Considerations 3 3. Developmental Validation..5

More information

SWGDE Minimum Requirements for Quality Assurance in the Processing of Digital and Multimedia Evidence

SWGDE Minimum Requirements for Quality Assurance in the Processing of Digital and Multimedia Evidence SWGDE Minimum Requirements for Quality Assurance in the Processing of Digital and Multimedia Disclaimer: As a condition to the use of this document and the information contained therein, the SWGDE requests

More information

State Meat and Poultry Inspection (MPI) Program Laboratory Quality Management System Checklist

State Meat and Poultry Inspection (MPI) Program Laboratory Quality Management System Checklist This checklist is intended to help laboratories improve the quality of their testing programs with regard to meat and poultry testing samples, in order to ensure those laboratories are at least equal to

More information

CAPABILITY 12: Public Health Laboratory Testing

CAPABILITY 12: Public Health Laboratory Testing Public health laboratory testing is the ability to conduct rapid and conventional detection, characterization, confirmatory testing, data reporting, investigative support, and laboratory networking to

More information

Section VI Principles of Laboratory Biosecurity

Section VI Principles of Laboratory Biosecurity Section VI Principles of Laboratory Biosecurity Since the publication of the 4th edition of BMBL in 1999, significant events have brought national and international scrutiny to the area of laboratory security.

More information

Standard Practice for Quality Control Systems for Nondestructive Testing Agencies 1

Standard Practice for Quality Control Systems for Nondestructive Testing Agencies 1 Designation: E 1212 99 AMERICAN SOCIETY FOR TESTING AND MATERIALS 100 Barr Harbor Dr., West Conshohocken, PA 19428 Reprinted from the Annual Book of ASTM Standards. Copyright ASTM Standard Practice for

More information

This article discusses the challenges that can be

This article discusses the challenges that can be Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science Volume 10, Number 4, 2012 ª Mary Ann Liebert, Inc. DOI: 10.1089/bsp.2012.0054 Establishing a National Biological Laboratory Safety

More information

North Carolina State Crime Laboratory Quality Manual

North Carolina State Crime Laboratory Quality Manual North Carolina State Crime Laboratory Quality Manual TABLE OF CONTENTS Topic Page 1.0 Introduction 3 2.0 Controlled Distribution of the Quality Manual 3 3.0 Quality Policy Statement 4 4.0 Management Requirements

More information

DC Office of the Chief Medical Examiner Standard Operating Procedures

DC Office of the Chief Medical Examiner Standard Operating Procedures TITLE: QUALITY ASSURANCE AND CONTROL PROGRAM Policy: Purpose: Scope: OCME QUALITY ASSURANCE AND CONTROL PROGRAM Each OCME Divisional Unit is to establish a QA/QC program specific to their professional

More information

M E M O R A N D U M. Austin Police Department Field Support Services Forensic Science Division

M E M O R A N D U M. Austin Police Department Field Support Services Forensic Science Division M E M O R A N D U M Austin Police Department Field Support Services Forensic Science Division TO: Bill Gibbens, Division Manager FROM: Tony Arnold, Quality Assurance Manager DATE: July 20, 2011 SUBJECT:

More information

QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC.

QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC. QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC. Hattiesburg, MS Revision E 01/19/11 Revised to ISO 9001:2008 on July 9, 2009 JPM OF MISSISSIPPI, INC. MANAGEMENT QUALITY POLICY It is the goal of JPM of

More information

ISO/IEC 17025 QUALITY MANUAL

ISO/IEC 17025 QUALITY MANUAL 1800 NW 169 th Pl, Beaverton, OR 97006 Revision F Date: 9/18/06 PAGE 1 OF 18 TABLE OF CONTENTS Quality Manual Section Applicable ISO/IEC 17025:2005 clause(s) Page Quality Policy 4.2.2 3 Introduction 4

More information

ARKANSAS STATE CRIME LABORATORY. Evidence Receiving Quality Manual. Executive Director: Kermit B. Channell, II

ARKANSAS STATE CRIME LABORATORY. Evidence Receiving Quality Manual. Executive Director: Kermit B. Channell, II ARKANSAS STATE CRIME LABORATORY Evidence Receiving Quality Manual Executive Director: Kermit B. Channell, II Page 1 of 34 SECTION 4 MANAGEMENT REQUIREMENTS... 3 4.1 ORGANIZATION... 3 4.2 MANAGEMENT SYSTEM...

More information

OPERATIONAL STANDARD

OPERATIONAL STANDARD 1 of 11 1. Introduction The International Safe Transit Association (ISTA), a non-profit association whose objective is to prevent product damage and excess packaging usage within the distribution environment.

More information

Flow Cytometry. CLIA Compliance Manual*

Flow Cytometry. CLIA Compliance Manual* Flow Cytometry CLIA Compliance Manual* Revised for the International Society for Advancement of Cytometry (ISAC) and Clinical Cytometry Society (CCS) By Michael Keeney ART, FIMLS Teri Oldaker B.A., CLS(NCA)QCYM

More information

ALACC Frequently Asked Questions (FAQs)

ALACC Frequently Asked Questions (FAQs) Updated October 17, 2012 ALACC Contents Web Introduction to FAQ... 2 FAQ #6... 3 ALACC Section: How to Meet ISO 17025 Requirements for Method Verification (Page 9)... 3 FAQ #13... 4 ALACC Section ALACC

More information

South Coast Air Quality Management District

South Coast Air Quality Management District South Coast Air Quality Management District Laboratory Approval Program Administrative, Operational and Technical Requirements November 2015 Direct Inquiries to: Laboratory Approval Program Coordinator

More information

COMMISSION DIRECTIVE 2003/94/EC

COMMISSION DIRECTIVE 2003/94/EC L 262/22 COMMISSION DIRECTIVE 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal

More information

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,

More information

Laboratory Director Responsibilities

Laboratory Director Responsibilities Clinical Laboratory Improvement Amendments (CLIA) Laboratory Director Responsibilities What Are My Responsibilities As A Laboratory Director NOTE: Congress passed the Clinical Laboratory Improvement Amendments

More information

Procedure for Equipment Calibration and Maintenance

Procedure for Equipment Calibration and Maintenance Procedure for Equipment Calibration and Maintenance 1.0 Purpose This procedure specifies the schedule and requirements for calibration, performance verification, and maintenance of State Crime Laboratory

More information

Great Lakes National Program Office and Office of Water Quality Management Training Modules

Great Lakes National Program Office and Office of Water Quality Management Training Modules GLOSSARY Assessment - the evaluation process used to measure the performance or effectiveness of a system and its elements. As used here, assessment is an all-inclusive term used to denote any of the following:

More information

Investigational Drugs: Investigational Drugs and Biologics

Investigational Drugs: Investigational Drugs and Biologics : I. PURPOSE The purpose of this policy is to establish procedures for the proper control, storage, use and handling of investigational drugs and biologics to ensure that adequate safeguards are in place

More information

Quality Procedures and Work Instructions Manual

Quality Procedures and Work Instructions Manual Quality Procedures and Work Instructions Manual Revision Number: (1) ISSUED TO: MANUAL NO: REVISION NO: ISSUE DATE: President Date 1 ii. Table of Contents 1 of 4 0 Section Number Name Revision Date i.

More information

JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR. 2nd Edition

JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR. 2nd Edition JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CliniCAl laboratories 2nd Edition Effective 1 April 2010 International Patient Safety Goals (IPSG) Goals The following is a list of all goals.

More information

Content Sheet 3-1: Equipment Management Overview

Content Sheet 3-1: Equipment Management Overview Content Sheet 3-1: Equipment Management Overview Role in quality management system Equipment management is one of the essential elements of a quality management system. Proper management of the equipment

More information

EPA NATIONAL LEAD LABORATORY ACCREDITATION PROGRAM. LABORATORY QUALITY SYSTEM REQUIREMENTS (LQSR) REVISION 3.0 (November 05, 2007)

EPA NATIONAL LEAD LABORATORY ACCREDITATION PROGRAM. LABORATORY QUALITY SYSTEM REQUIREMENTS (LQSR) REVISION 3.0 (November 05, 2007) EPA NATIONAL LEAD LABORATORY ACCREDITATION PROGRAM LABORATORY QUALITY SYSTEM REQUIREMENTS (LQSR) REVISION 3.0 (November 05, 2007) The requirements in this document apply to all lead testing laboratories

More information

GUIDELINES FOR FORENSIC LABORATORY MANAGEMENT PRACTICES INTRODUCTION

GUIDELINES FOR FORENSIC LABORATORY MANAGEMENT PRACTICES INTRODUCTION GUIDELINES FOR FORENSIC LABORATORY MANAGEMENT PRACTICES INTRODUCTION The American Society of Crime Laboratory Directors is a professional organization of managers and supervisors employed in forensic laboratories.

More information

Clinical Laboratory Standards of Practice

Clinical Laboratory Standards of Practice Wadsworth Center Clinical Laboratory Evaluation Program Part 1 General Systems TABLE OF CONTENTS Quality Management System 3 Human Resources 9 Facility Design and Resource Management 23 General Facilities...

More information

Final. National Health Care Billing Audit Guidelines. as amended by. The American Association of Medical Audit Specialists (AAMAS)

Final. National Health Care Billing Audit Guidelines. as amended by. The American Association of Medical Audit Specialists (AAMAS) Final National Health Care Billing Audit Guidelines as amended by The American Association of Medical Audit Specialists (AAMAS) May 1, 2009 Preface Billing audits serve as a check and balance to help ensure

More information

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP Document issued on: June 2004 U.S. Department of Health and Human Services Food and Drug Administration

More information

STANDARD OPERATING GUIDELINES: EVIDENTIAL BREATH ALCOHOL INSTRUMENT CALIBRATION

STANDARD OPERATING GUIDELINES: EVIDENTIAL BREATH ALCOHOL INSTRUMENT CALIBRATION Directive from the Scientific Director Page 1 of 16 STANDARD OPERATING GUIDELINES: EVIDENTIAL BREATH ALCOHOL INSTRUMENT CALIBRATION 1 Scope To describe the procedure for breath alcohol instrument calibration

More information

2. Neither the name of SWGIT, nor the names of its contributors, may be used to endorse or promote products derived from its documents.

2. Neither the name of SWGIT, nor the names of its contributors, may be used to endorse or promote products derived from its documents. Disclaimer: As a condition to the use of this document and the information contained herein, the SWGIT requests notification by e-mail before or contemporaneously to the introduction of this document,

More information

LAW ENFORCEMENT PROGRAM ACCREDITATION MANAGER (PROGRAM SPECIALIST 4)

LAW ENFORCEMENT PROGRAM ACCREDITATION MANAGER (PROGRAM SPECIALIST 4) From: To: Subject: Date: Galvan, Jodie Galvan, Jodie Emailing: Job Bulletin Tuesday, June 30, 2015 10:15:40 AM State of Washington Dept. of Fish and Wildlife invites applications for the position of: Accreditation

More information

MODULE 2D ENVIRONMENTAL MICROBIOLOGICAL LABORATORY ACCREDITATION PROGRAM (EMLAP) ADDITIONAL REQUIREMENTS

MODULE 2D ENVIRONMENTAL MICROBIOLOGICAL LABORATORY ACCREDITATION PROGRAM (EMLAP) ADDITIONAL REQUIREMENTS MODULE 2D ENVIRONMENTAL MICROBIOLOGICAL LABORATORY ACCREDITATION PROGRAM (EMLAP) ADDITIONAL REQUIREMENTS 2D.1 SCOPE The AIHA- Laboratory Accreditation Programs (AIHA-LAP), LLC s Environmental Microbiological

More information

STATE POLICE FORENSIC TECHNICAL LEADER

STATE POLICE FORENSIC TECHNICAL LEADER JOB DESCRIPTION MICHIGAN CIVIL SERVICE COMMISSION JOB SPECIFICATION STATE POLICE FORENSIC TECHNICAL LEADER Employees in this job function as statewide technical leaders within the Michigan State Police,

More information

FINAL DOCUMENT. Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 1: General Requirements

FINAL DOCUMENT. Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 1: General Requirements GHTF/SG4/N28R4:2008 FINAL DOCUMENT Title: Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Authoring Group: GHTF Study Group 4 Endorsed by: The Global Harmonization

More information

MEAT GRADING AND CERTIFICATION BRANCH QUALITY MANUAL

MEAT GRADING AND CERTIFICATION BRANCH QUALITY MANUAL United States Department of Agriculture Marketing and Regulatory Programs Agricultural Marketing Service Livestock and Seed Program Meat Grading & Certification Branch MGC Instruction 800 May 9, 2005 Page

More information

Standards for Laboratory Accreditation

Standards for Laboratory Accreditation Standards for Laboratory Accreditation 2013 Edition cap.org Laboratory Accreditation Program Standards for Accreditation 2013 Edition Preamble Pathology is a medical specialty essential to patient care

More information

R221 - Specific Requirements: Forensic

R221 - Specific Requirements: Forensic R221 - Specific Requirements: Forensic Page 1 of 6 R221 - Specific Requirements: Forensic (October 2015) 2015 by A2LA. All rights reserved. No part of this document may be reproduced in any form or by

More information

Calibration & Preventative Maintenance. Sally Wolfgang Manager, Quality Operations Merck & Co., Inc.

Calibration & Preventative Maintenance. Sally Wolfgang Manager, Quality Operations Merck & Co., Inc. Calibration & Preventative Maintenance Sally Wolfgang Manager, Quality Operations Merck & Co., Inc. Calibration: A comparison of two instruments or measuring devices one of which is a standard of known

More information

Guidance for Selecting a Commercial or Private Laboratory

Guidance for Selecting a Commercial or Private Laboratory Guidance for Selecting a Commercial or Private Laboratory Prepared by: Rachel L. Murphy, Brittney R. Scott, M.S., Lynn R. Delmore, Ph.D., Jennifer N. Martin, Ph.D., Dale R. Woerner, Ph.D., Keith E. Belk,

More information

CHAPTER VII CONSTRUCTION QUALITY CONTROL INSPECTION PROGRAM 1

CHAPTER VII CONSTRUCTION QUALITY CONTROL INSPECTION PROGRAM 1 CHAPTER VII CONSTRUCTION QUALITY CONTROL INSPECTION PROGRAM 1 1 This Chapter of the FERC Engineering Guidelines has been prepared under contract with R & H Thomas, Inc. JANUARY 1993 Chapter VII Construction

More information

Procedure for Personnel Training

Procedure for Personnel Training Procedure for Personnel Training 1.0 Purpose To establish, define and document a training program to ensure the competency of State Crime Laboratory (Laboratory) personnel. 2.0 Scope The procedure is applicable

More information

MINISTRY OF THE ENVIRONMENT DRINKING WATER QUALITY MANAGEMENT STANDARD

MINISTRY OF THE ENVIRONMENT DRINKING WATER QUALITY MANAGEMENT STANDARD MINISTRY OF THE ENVIRONMENT DRINKING WATER QUALITY MANAGEMENT STANDARD October 2006 Introduction The Safe Drinking Water Act, 2002 (SDWA) requires Owners and Operating Authorities of municipal residential

More information

Procedure for Procurement and Receipt

Procedure for Procurement and Receipt Procedure for Procurement and Receipt 1.0 Purpose - To ensure that all supplies, equipment and services purchased by the State Crime Laboratory (Laboratory) are properly procured and received. 2.0 Scope

More information

Standards for Laboratory Facilities

Standards for Laboratory Facilities Standards for Laboratory Facilities Version 2.1 APPROVED 24 FEBRUARY 2014 Article I. General Provisions Section 1.01 The facility shall be of suitable size and construction to facilitate the proper conduct

More information

REQUIREMENTS FOR CERTIFICATION BODIES TO DETERMINE COMPLIANCE OF APPLICANT ORGANIZATIONS TO THE MAGEN TZEDEK SERVICE MARK STANDARD

REQUIREMENTS FOR CERTIFICATION BODIES TO DETERMINE COMPLIANCE OF APPLICANT ORGANIZATIONS TO THE MAGEN TZEDEK SERVICE MARK STANDARD REQUIREMENTS FOR CERTIFICATION BODIES TO DETERMINE COMPLIANCE OF APPLICANT ORGANIZATIONS TO THE MAGEN TZEDEK SERVICE MARK STANDARD Foreword The Magen Tzedek Commission has established a standards and certification

More information

Competency Profile/Training Document RESEARCH TECHNICIAN

Competency Profile/Training Document RESEARCH TECHNICIAN RESEARCH TECHNICIAN Description of Work: Positions in this banded class support experimental processes in a laboratory, clinic, field and /or teaching environment (hereafter referred to as laboratory ).

More information

Procedure for the Use of Forensic Advantage (FA)

Procedure for the Use of Forensic Advantage (FA) Procedure for the Use of Forensic Advantage (FA) 1.0 Purpose To establish procedures for the use of the Forensic Advantage (FA) electronic information management system. 2.0 Scope This procedure applies

More information

Content Sheet 10-1: Overview of External Quality Assessment (EQA)

Content Sheet 10-1: Overview of External Quality Assessment (EQA) Content Sheet 10-1: Overview of External Quality Assessment (EQA) Role in quality management system Assessment is a critical aspect of laboratory quality management, and it can be conducted in several

More information

Annex 7 Guidelines for the preparation of a contract research organization master file

Annex 7 Guidelines for the preparation of a contract research organization master file World Health Organization WHO Technical Report Series, No. 957, 2010 Annex 7 Guidelines for the preparation of a contract research organization master file Background 1. General information 2. Quality

More information

CONCEPTS OF FOOD SAFETY QUALITY MANAGEMENT SYSTEMS. Mrs. Malini Rajendran

CONCEPTS OF FOOD SAFETY QUALITY MANAGEMENT SYSTEMS. Mrs. Malini Rajendran CONCEPTS OF FOOD SAFETY AND QUALITY MANAGEMENT SYSTEMS Mrs. Malini Rajendran Brief background 1963 - The Codex Alimentarius Commission was created by FAO and WHO to develop food standards, guidelines and

More information

DRY CLEANING PROGRAM QUALITY ASSURANCE MANAGEMENT PLAN

DRY CLEANING PROGRAM QUALITY ASSURANCE MANAGEMENT PLAN DIVISION OF ENVIRONMENT QUALITY MANAGEMENT PLAN PART III: DRY CLEANING PROGRAM QUALITY ASSURANCE MANAGEMENT PLAN Revision 3 January 8, 2013 Kansas Department of Health and Environment Division of Environment

More information

Luminus Devices, Inc Luminus Testing Laboratory Quality Management Systems Manual

Luminus Devices, Inc Luminus Testing Laboratory Quality Management Systems Manual Luminus Devices, Inc Luminus Testing Laboratory Quality Management Systems Manual ISO/IEC 17025 NVLAP, NIST HANDBOOKS 150,150-1 This document belongs to Luminus Devices, Inc. It cannot be reproduced without

More information

ASCLD/LAB-International

ASCLD/LAB-International ASCLD/LAB-International Program Overview 2015 Edition An ISO/IEC 17025 Program of Accreditation Applicable to both testing and breath alcohol calibration laboratories ASCLD/LAB-International is a program

More information

NIST HANDBOOK 150-5 CHECKLIST CONSTRUCTION MATERIALS TESTING

NIST HANDBOOK 150-5 CHECKLIST CONSTRUCTION MATERIALS TESTING NIST HANDBOOK 150-5 CHECKLIST CONSTRUCTION MATERIALS TESTING Instructions to the Assessor: This checklist addresses specific accreditation criteria prescribed in NIST Handbook 150-5, Construction Materials

More information

EVALUATION AND ACCREDITATION OF SUPPLIER TEST FACILITIES GP 10

EVALUATION AND ACCREDITATION OF SUPPLIER TEST FACILITIES GP 10 EVALUATION AND ACCREDITATION OF SUPPLIER TEST FACILITIES GP 10 EVALUATION AND ACCREDITATION OF TESTING FACILITIES USED BY SUPPLIER OF MATERIALS TO GENERAL MOTORS PREFACE TO GP-10 General Motors expects

More information

REGULATION (EEC) No 2309/93

REGULATION (EEC) No 2309/93 REGULATION (EEC) No 2309/93 Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use

More information

CHAPTER 13. Quality Control/Quality Assurance

CHAPTER 13. Quality Control/Quality Assurance CHAPTER 13 Quality Control/Quality Assurance Quality Control/Quality Assurance (QC/QA) can be defined as the set of planned and systematic activities focused on providing confidence that quality requirements

More information

INTERPOL STANDING COMMITTEE ON DISASTER VICTIM IDENTIFICATION

INTERPOL STANDING COMMITTEE ON DISASTER VICTIM IDENTIFICATION INTERPOL STANDING COMMITTEE ON DISASTER VICTIM IDENTIFICATION QUALITY MANAGEMENT GUIDELINES INTERPOL For official use only INTERPOL DVI STANDING COMMITTEE Page 1 of 15 QUALITY MANAGEMENT GUIDELINES 1.

More information

Content Sheet 16-1: Introduction to Documents & Records

Content Sheet 16-1: Introduction to Documents & Records Content Sheet 16-1: Introduction to Documents & Records Role in quality management system The management of documents and records is one of the 12 essential elements of the quality system. The management

More information

POLICY TITLE: Employee Drug and Alcohol Testing POLICY NO: 403.50 PAGE 1 of 7

POLICY TITLE: Employee Drug and Alcohol Testing POLICY NO: 403.50 PAGE 1 of 7 POLICY TITLE: Employee Drug and Alcohol Testing POLICY NO: 403.50 PAGE 1 of 7 It is the intent of the board of trustees of this district to promote an alcohol and drug-free workplace, thereby enhancing

More information

STANDING DISCOVERY ORDER ON COPYING AND PRODUCTION OF BLOOD TESTING RECORDS

STANDING DISCOVERY ORDER ON COPYING AND PRODUCTION OF BLOOD TESTING RECORDS CAUSE NO. THE STATE OF TEXAS IN THE COUNTY CRIMINAL V. COURT AT LAW NO. HARRIS COUNTY, TEXAS STANDING DISCOVERY ORDER ON COPYING AND PRODUCTION OF BLOOD TESTING RECORDS THE COURT ORDERS the District Attorney

More information

GENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2011 SESSION LAW 2011-19 HOUSE BILL 27

GENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2011 SESSION LAW 2011-19 HOUSE BILL 27 GENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2011 SESSION LAW 2011-19 HOUSE BILL 27 AN ACT TO (1) CREATE THE NORTH CAROLINA FORENSIC SCIENCE ADVISORY BOARD, (2) ENCOURAGE EFFORTS TO ELIMINATE SOURCES OF

More information

QA Procedure Page 1 Appendix A

QA Procedure Page 1 Appendix A *Changes from the previous QASE noted by "yellow" highlight of block Evaluation Summary Company: Prepared By: Section Element Manual Audit OK Objective Evidence 2.1 Objective of Quality Assurance Program

More information

EA IAF/ILAC Guidance. on the Application of ISO/IEC 17020:1998

EA IAF/ILAC Guidance. on the Application of ISO/IEC 17020:1998 Publication Reference EA IAF/ILAC-A4: 2004 EA IAF/ILAC Guidance on the Application of ISO/IEC 17020:1998 PURPOSE This guidance document is for ISO/IEC 17020: General Criteria for the operation of various

More information

Certification. Septic Tank Contractors

Certification. Septic Tank Contractors Certification I. Certification Required Chapter 290-5-26-.17 provides for certification and de-certification of septic tank contractors, inspection personnel, pumpers, soil scientists and maintenance personnel.

More information

Decommissioning of Nuclear Facilities. Management of Decommissioning Projects

Decommissioning of Nuclear Facilities. Management of Decommissioning Projects International Atomic Energy Agency Decommissioning of Nuclear Facilities Management of Decommissioning Projects Lawrence E. Boing Manila, Philippines, October 2006 1 Lesson Objectives Understand the management

More information

Good Research Practice

Good Research Practice Page 1 of 8 The Royal Veterinary College Introduction Preface Good Research Practice Funding bodies need to be assured of the quality and validity of research they fund and ensure their contractors are

More information

C H A P T E R C O N T E N T S

C H A P T E R C O N T E N T S C H A P T E R QUALITY ASSURANCE M. Leanne Gray C O N T E N T S 3 12.1 Introduction 11 12.5 Reviewers 4 12.2 Quality Assurance Program 11 12.6 References 9 12.3 Additional Quality Assurance Measures That

More information

Position Classification Flysheet for Inventory Management Series, GS-2010. Table of Contents

Position Classification Flysheet for Inventory Management Series, GS-2010. Table of Contents Position Classification Flysheet for Inventory Management Series, GS-2010 Table of Contents SERIES DEFINITION... 2 EXCLUSIONS... 2 OCCUPATIONAL INFORMATION... 2 TITLES... 6 GRADING POSITIONS... 6 U.S.

More information

Position Classification Standard for Industrial Property Management Series, GS-1103. Table of Contents

Position Classification Standard for Industrial Property Management Series, GS-1103. Table of Contents Position Classification Standard for Industrial Property Management Series, GS-1103 Table of Contents SERIES DEFINITION... 2 EXCLUSIONS... 2 OCCUPATIONAL INFORMATION... 3 TITLES... 4 PART I - INDUSTRIAL

More information

QUALITY STANDARDS FOR DIGITAL FORENSICS

QUALITY STANDARDS FOR DIGITAL FORENSICS QUALITY STANDARDS FOR DIGITAL FORENSICS November 20, 2012 TABLE OF CONTENTS PREFACE... ii MANAGEMENT STANDARDS... 1 A. DIGITAL FORENSIC CAPABILITY... 1 B. QUALITY MANAGEMENT... 2 PERSONNEL STANDARDS...

More information

R000. Revision Summary Revision Number Date Description of Revisions R000 Feb. 18, 2011 Initial issue of the document.

R000. Revision Summary Revision Number Date Description of Revisions R000 Feb. 18, 2011 Initial issue of the document. 2 of 34 Revision Summary Revision Number Date Description of Revisions Initial issue of the document. Table of Contents Item Description Page 1. Introduction and Purpose... 5 2. Project Management Approach...

More information

COPY. Revision History: Changes were made to reflect the current practice of only including the most recent changes in the revision history.

COPY. Revision History: Changes were made to reflect the current practice of only including the most recent changes in the revision history. Revision History COPY The top row of this table shows the most recent changes to this controlled document. For previous revision history information, archived versions of this document are maintained by

More information

Quality Assurance (QA) & Quality Control (QC)

Quality Assurance (QA) & Quality Control (QC) Quality Assurance (QA) & Quality Control (QC) In the laboratory Georges Ruta Water Quality Scientist City West Water 1 City West Water Water Supply & Sewerage Authority Melbourne Pop. >800,000 Area 580

More information

INTERNATIONAL STANDARDS FOR THE PROFESSIONAL PRACTICE OF INTERNAL AUDITING (STANDARDS)

INTERNATIONAL STANDARDS FOR THE PROFESSIONAL PRACTICE OF INTERNAL AUDITING (STANDARDS) INTERNATIONAL STANDARDS FOR THE PROFESSIONAL PRACTICE OF INTERNAL AUDITING (STANDARDS) Revised: October 2012 i Table of contents Attribute Standards... 3 1000 Purpose, Authority, and Responsibility...

More information

CQR-1 CONTRACTOR QUALITY REQUIREMENTS for CONSTRUCTION SERVICES

CQR-1 CONTRACTOR QUALITY REQUIREMENTS for CONSTRUCTION SERVICES 1.0 SCOPE CQR-1 CONTRACTOR QUALITY REQUIREMENTS for CONSTRUCTION SERVICES This document establishes the minimum quality program requirements for a contractor providing equipment, material, and construction

More information

Minor/technical revision of existing policy Reaffirmation of existing policy

Minor/technical revision of existing policy Reaffirmation of existing policy Name of Policy: Use of biohazardous materials, recombinant DNA and select agents and toxin in research. Policy Number: 3364-70-06 Approving Officer: President Responsible Agent: Vice President for Research

More information

Summary of ISO additional requirements

Summary of ISO additional requirements ISO 15189:2012 Clause 4.1.1.3.d 4.1.1.4 4.1.2.1h 4.1.2.4 4.2.1 4.3 4.6 4.9 4.1 4.11 4.13 Summary of ISO 15189 additional requirements Ethical conduct Procedures to deal with disposal of human samples,

More information

Cocoa Practices Verification Organization Approval Procedure

Cocoa Practices Verification Organization Approval Procedure Verification Organization Approval Procedure Starbucks Coffee Company V1.0 English Version TABLE OF CONTENTS 1.0 INTRODUCTION... 3 2.0 OVERVIEW OF COCOA PRACTICES... 4 3.0 ORGANIZATION APPROVAL PROCEDURE...

More information

Ordinance on the GLP Standard for Conduct of Nonclinical Safety Studies of Drugs

Ordinance on the GLP Standard for Conduct of Nonclinical Safety Studies of Drugs This English translation of ordinance on GLP has been made by JSQA. JSQA translated them with particular care to accuracy, but does not guarantee that there are no differences in the delicate shades of

More information

Gap Analysis of ISO 15189:2012 and ISO 15189:2007 in the field of Medical Testing

Gap Analysis of ISO 15189:2012 and ISO 15189:2007 in the field of Medical Testing Gap Analysis May 2013 Issued: May 2013 Gap Analysis of and in the field of Medical Testing Copyright National Association of Testing Authorities, Australia 2013 This publication is protected by copyright

More information

Select Agent Program Workshop November 2012

Select Agent Program Workshop November 2012 Select Agent Program Workshop November 2012 Agricultural Select Agent Program (USDA/APHIS) CDC Select Agent Program (HHS/CDC) Bioterrorism Risk Assessment Group (FBI/CJIS) Information Systems Security

More information

Quality Management System Policy Manual

Quality Management System Policy Manual Quality Management System Burns Engineering, Inc. 10201 Bren Road East Minnetonka, MN 55343 4. 4.1 General Requirements The Quality Manual consists of the quality system policy documents and the quality

More information

INTERNATIONAL STANDARDS FOR THE PROFESSIONAL PRACTICE OF INTERNAL AUDITING (STANDARDS)

INTERNATIONAL STANDARDS FOR THE PROFESSIONAL PRACTICE OF INTERNAL AUDITING (STANDARDS) INTERNATIONAL STANDARDS FOR THE PROFESSIONAL PRACTICE OF INTERNAL AUDITING (STANDARDS) Introduction to the International Standards Internal auditing is conducted in diverse legal and cultural environments;

More information

FREQUENTLY ASKED QUESTIONS

FREQUENTLY ASKED QUESTIONS NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY FREQUENTLY ASKED QUESTIONS Establishment of the NSABB 1. What is the Administration s policy on biosecurity in life sciences research? 2. Why was the NSABB

More information

Haulsey Engineering, Inc. Quality Management System (QMS) Table of Contents

Haulsey Engineering, Inc. Quality Management System (QMS) Table of Contents Haulsey Engineering, Inc. Quality Management System (QMS) Table of Contents 1.0 Introduction 1.1 Quality Management Policy and Practices 2.0 Quality System Components 2.1 Quality Management Plans 2.2 Quality

More information

REQUIREMENTS FOR AN ACCREDITED VETERINARY MEDICAL DIAGNOSTIC LABORATORY

REQUIREMENTS FOR AN ACCREDITED VETERINARY MEDICAL DIAGNOSTIC LABORATORY REQUIREMENTS FOR AN ACCREDITED VETERINARY MEDICAL DIAGNOSTIC LABORATORY AMERICAN ASSOCIATION OF VETERINARY LABORATORY DIAGNOSTICIANS, INC. Version 6.1 AC-201, Version 6.1, 06-01-12 Page 1 of 27 Table of

More information

THERMAL INSULATION MATERIALS

THERMAL INSULATION MATERIALS NIST HANDBOOK 150-15 2006 Edition National Voluntary Laboratory Accreditation Program THERMAL INSULATION MATERIALS Lawrence I. Knab National Voluntary Laboratory Accreditation Program Standards Services

More information

RULES AND REGULATIONS FOR LICENSING APPLIED BEHAVIOR ANALYSTS AND APPLIED BEHAVIOR ASSISTANT ANALYSTS

RULES AND REGULATIONS FOR LICENSING APPLIED BEHAVIOR ANALYSTS AND APPLIED BEHAVIOR ASSISTANT ANALYSTS RULES AND REGULATIONS FOR LICENSING APPLIED BEHAVIOR ANALYSTS AND APPLIED BEHAVIOR ASSISTANT ANALYSTS [R5-86-ABA] STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS DEPARTMENT OF HEALTH October 2015 INTRODUCTION

More information

1 For more information T: +1.847.664.1499 / E: DAP@ul.com / W: ul.com/dap

1 For more information T: +1.847.664.1499 / E: DAP@ul.com / W: ul.com/dap DATA ACCEPTANCE PROGRAM UL Client Test Data Program Investigations of products by UL typically involve the testing of product samples. While UL maintains extensive facilities for these purposes, customers

More information

American Association for Laboratory Accreditation

American Association for Laboratory Accreditation Page 1 of 6 1.0 INTRODUCTION These accreditation requirements are applicable to the special competition animal drug testing laboratory accreditation program. This program is designed to meet the requirements

More information

Winthrop University. Institutional Biosafety Committee Policy and Procedures

Winthrop University. Institutional Biosafety Committee Policy and Procedures Winthrop University Institutional Biosafety Committee Policy and Procedures MISSION STATEMENT The Institutional Biosafety Committee (IBC) oversees the safety of research and classroom projects involving

More information

http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ai.htm Office of Health and Safety (OHS) BMBL Appendix I

http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ai.htm Office of Health and Safety (OHS) BMBL Appendix I Office of Health and Safety (OHS) References BMBL Appendix I Guidelines for Work With Toxins of Biological Origin Biosafety Documents BMBL Table of Contents In recognition of the growing number of microbiological

More information