XYZ Laboratory
Master Copy
1.0 TABLE OF CONTENTS
Page
1.0 Table of Contents …………………………………..………………………...2
1.1 List of Appendices…………………………………….……..3
2.0 Document Structure …………………………………..…………………..….4
3.0 Quality Policy……………………………………………………………....….6
4.0 MANAGEMENT REQUIREMENTS
4.1 Organization………………………………………..….….….6
4.2 Quality System……………………………………………...10
4.3 Document Control……………………………………..……11
4.4 Contract Review…………………………………………….13
4.5 Subcontracting of Tests and Forwarding
4.6 of Test Specimens …………………………………….……13
4.7 Purchasing Supplies and Services ………………………..13
4.8 Client Service……………………………………………..….14
4.9 Corrective Actions…………………………………………...14
4.10 Preventive Actions…………………………………………..15
4.11 Records Management…………………………………..…..16
4.12 Internal Audits………………………………………………..17
4.13 Management Reviews………………………………..……..17
5.0 TECHNICAL REQUIREMENTS
5.1 General……………………………………………………….17
5.2 Personnel…………………………………………………….17
5.3 Accommodation and Environmental Conditions……..….18
5.4 Test Methods………………………………………….…….19
5.5 Equipment……………………………………………….…..20
5.6 Measurement Traceability…………………………..……..21
5.7 Sampling……………………………………………………..21
5.8 Handling of Samples………………………………….…....22
5.9 Assuring the Quality of Test Results………………….….22
5.10 Reporting the Results………………………………………23
1.1 LIST OF APPENDICES
Appendix 1: XYZ Laboratory Section Head List
Appendix 2:XYZ LAB Organizational Chart
Appendix 3: State of XYZ RCW Title 42, Chapter 42.52, Section 45.52.020: Activities incompatible with public duties.
Appendix 4: XYZ State University Business Policies and Procedures Manual: Summary of Ethics Laws and Policies
2.0 DOCUMENT STRUCTURE
2.1 Quality Manual
2.2 System procedures
SOP 101 Document Control
SOP 102.1 Information Systems
SOP 102.2 XYZ LAB Case Log-In
SOP 102.3 Vetstar Animal Disease Diagnostic System Look-Ups
SOP 102.4 Opening and Evaluating Packages Prior to Case Log-In
SOP 102.6 XYZ LAB Case Log-In, Ordering and Routing in XYZ BRANCH
SOP 103 Case Accession
SOP 103.1 Policies and Procedures for Non-Human Primate Accessions
SOP 103.2 Guidance for Proper Use of Chain-of-Custody Forms
SOP 104 Test Specimen Forwarding
SOP 104.1 Sample Handling and Routing for Toxicology Testing of Necropsy Samples
SOP 104.2 Use and Routing of Additional Test Request Forms
SOP 106 Purchasing Supplies and Services
SOP 107 Client Services
SOP 108 Corrective Action
SOP 109 Preventive Action
SOP 110 Records Management
SOP 111 Internal Audits
SOP 112 Management Review
SOP 113.1 Training of Laboratory Personnel
SOP 113.2 Anatomic Pathology Training
SOP 115 Facility Monitoring
SOP 116 Trend Analysis Using Control Charts or Other Statistical Methods
SOP 117 Data Review and Approval
SOP 118 Laboratory Equipment
SOP 119 Reference Standards and Materials
SOP 120 Report Generation
SOP 121 Creating Standard Operating Procedures (SOPs)
SOP 122 Monthly Security System Review (confidential)
SOP 123 Case Status Review
SOP 124 Procedure for Handling a Non-Conformance
SOP 125 Updating Procedures from Standards-Setting Bodies
SOP 126 Method Validation
SOP 127 XYZ LAB Reportable Disease Notification Policy
SOP 131 Policy for Cancelling Tests and Cases in VADDS
SOP 190 XYZ LAB Biosafety Manual
SOP 190.1 Exposure Control Policy – Bloodborne Pathogens
SOP 190.2 Orientation in Biosafety for XYZ LAB Anatomic Pathology Residents
SOP 190.5 XYZ LAB Medical Waste Disposal Procedures
SOP 191 XYZ LAB Exposure Control and Personal Protective Equipment Guidelines
SOP 192 XYZ LAB Safety Program and Chemical Hygiene Plan
SOP 193 Accident Prevention Program
SOP 194 XYZ LAB Emergency Plan
SOP 196 Producing and Issuing Corrected Reports
2.3 Technical Procedures (See Master List for Details of Procedures in Each Department)
SOP 1-99 XYZ LAB Business Office Procedures
SOP 100’s General System Procedures
SOP 199’s Shared Equipment Procedures
SOP 200s Serology Procedures
SOP 300s Bacteriology Procedures
SOP 400s Virology Procedures
SOP 500s Molecular Diagnostics Procedures
SOP 600s Histopathology Procedures
SOP 700s Pathology Procedures
SOP 800’s Immunohistochemistry Procedures
SOP 900’s Aquaculture Procedures
SOP 1100’s Central Processing Procedures
SOP 1200’s Avian Health and Food Safety Procedures
SOP 1300’s Parasitology
SOP 1400’s TSE Laboratory
3.0 QUALITY POLICY AND OBJECTIVES
Mission and Values Statements
Mission: Our mission is to provide accurate, state-of-the-art, timely, and cost-effective diagnostic services, consultation, disease surveillance and outreach in order to safeguard animal health, the food supply and public health and to contribute to the University and College of Veterinary Medicine through discovery, scholarly activity, and education.
Values: As a combined service and educational unit within a land grant University, the XYZ Laboratory (XYZ LAB) occupies a unique position that links the University to public and private stakeholders. We recognize and value the importance of our role in providing a positive, responsive interface between XYZ State University and the animal and public health community, and between our stakeholders and the academic community.
We value service and outreach to our constituents, which include the practicing veterinary community, the agricultural animal industry, animal and public health regulatory agencies, companion animal owners, and the general public. We also place a high value on quality, both in service to and communication with our clientele.
In addition to general diagnostics, we endorse and highly value the critical role we play in surveillance and detection of emerging and exotic diseases, whether introduced accidentally or deliberately with intention to disrupt the nation’s food supply. We value our role as a reference laboratory, our role in helping to assure a safe food supply, the critical importance of our surveillance for early detection of disease agents impacting public health, our vital contribution to maintaining international trade of agricultural animal products, and our ability to contribute to the discipline of diagnostic medicine through training of professional veterinary diagnosticians and discovery of new knowledge.
The XYZ Laboratory is guided by a commitment to excellence, and endorses the core values of XYZ State University, including inquiry and knowledge, application, leadership, character, stewardship, and diversity.
The quality system of XYZ LAB is comprised of all of the policies in this Quality Manual and referenced procedures and documents. This system was established to guide the staff in the performance of good laboratory practices and the production of quality outputs. The requirements of the quality system apply to all technical work of the laboratory.
The laboratory intends to provide clients or other concerned parties with the highest quality services and data and is committed to meeting or exceeding the client's requirements.
The purpose of the quality system is to help fulfill the mission of XYZ LAB. All XYZ LAB personnel are to implement and follow the policies contained within this Quality Manual, the procedures referenced by this Manual, and to the principles and current standards of the American Association of Veterinary Laboratory Diagnosticians’ (AAVLD) Requirements, ISO/IEC 17025:1999 and OIE. Each employee has a role in the quality of the laboratory's work and has a responsibility for its implementation according to his/her technical and/or managerial responsibilities.
Each member of the XYZ LAB staff shall be alert to problems or sources of error that could compromise the quality of technical work performed throughout the laboratory. Problems or sources of error shall be reported to the Section Heads or the Director.
Note: The term “Director” refers to both the Executive Director and Director throughout the Quality Manual.
The objective of the quality control program is to assure the scientific reliability of laboratory data. Management, administrative, statistical, investigative, preventative and corrective techniques will be employed to maximize reliability of the data.
Quality Policy Authorized By: Date:
Director
4. 0 MANAGEMENT REQUIREMENTS
4.1 ORGANIZATION
4.1.1 XYZ Laboratory (XYZ LAB) was created by legislative mandate in 1974 with a mission to “provide appropriate and timely veterinary diagnostic services to safeguard the health of livestock, pets, and poultry in the State of XYZ and to protect the public from zoonotic diseases”. The state of XYZ also established a poultry diagnostic laboratory in EFG, and in July 1, 1994 this laboratory was renamed the XYZ Branch Laboratory and placed under the administrative and fiscal responsibility of XYZ LAB and the College of Veterinary Medicine. In 1995 a new state appropriation was provided to the laboratory with a legislative mandate to provide diagnostic and health certification services to the aquaculture industry. Samples, supplies, and mail for XYZ LAB are received at:
XYZ State University
College of Veterinary Medicine
PO Box XXX
ABC, ZR XXXXX-XXXX
OR
XYZ Branch Laboratory
XYZ Laboratory
2607 West Lane
EFG, ZR XXXXX-XXXX
The XYZ LAB is an integral part of the Agricultural Animal Health Program (AAHP) in the College of Veterinary Medicine. Allied units within the AAHP include the Field Disease Investigation Unit, the Animal Health Research Center, and the ARS Animal Disease Research Unit. The mission of the AAHP is to enhance the well being of agricultural animals and wholesomeness of food animal products through integrated disease diagnosis, field investigation, and research.
4.1.2 XYZ LAB intends to conform to all requirements of the AAVLD Requirements, ISO/IEC 17025:1999 / OIE, while satisfying the needs of its clients.
4.1.3 The XYZ LAB management system is described by the policies in this document as well as the documents referenced by this document, and is intended to cover all aspects of the analytical services provided.
4.1.4 XYZ LAB is an integral part of XYZ State University’s College of Veterinary Medicine, and the university and the college policies act to protect XYZ LAB from potential conflicts of interest. The laboratory is not formally affiliated with any companies or corporations that might be a source of potential conflicts of interest. Potential conflicts of interest are governed by the regulations of the state of XYZ (RCW 42.52.020, see Appendix 3).
4.1.5 Laboratory Resources
4.1.5.1 XYZ LAB management has the responsibility and authority for supervising and administering the quality system. Management provides both the necessary resources (people, equipment, supplies, etc.) and the environment in which quality work shall be safely produced. Management ensures that employees conduct themselves in an ethical manner at all times. Policies and procedures of the State of XYZ relevant to ethics are described in the QRS Policies and Procedures Manual (see Appendix 4).
4.1.5.2 The laboratory protects the confidential information and proprietary rights of its clients during the analysis period and when issuing hard copy or electronic reports. The XYZ Laboratory (“XYZ LAB”) treats all its consultations as fully confidential medical protocols. XYZ LAB will maintain all material and information it obtains in the course of its professional consultations in the strictest confidence, to the extent allowed by the laws of the State of XYZ. No material relating to any client consultation will be disclosed except as required under such laws, absent consent of the client to disclosure. To assist it in these efforts, XYZ LAB expects all its clients to cooperate fully and to provide XYZ LAB with assistance in any proceedings or other actions that may be necessary to maintain confidentiality.
4.1.5.3 XYZ LAB management and staff do not engage in any outside activities that would compromise their ability to generate quality and legally defensible data, as specified by the regulations of the State of XYZ (RCW 42.52.020, see Appendix 3).
4.1.5.4 The XYZ LAB technical staff members report to Laboratory Managers (if present) and Section Heads. The Section Heads report to the Director, who in turn reports to the Executive Director. The Quality Systems Manager, also reports to the Director. The XYZ LAB Administrative Manager maintains a complete and current organizational chart (see Appendix 2).
4.1.5.5 The job responsibilities and authorities for all personnel shall be found in their Job Descriptions, which are filed with the Administrative Manager and optionally in the staff member’s department.
4.1.5.6 The Laboratory Section Heads enforce the quality and safety policies within their sections. It is their responsibility that all requirements of the quality system and of the clients are strictly followed. The Section Heads have meetings with their staff, addressing quality assurance and safety topics relevant to the work performed in their respective areas.
4.1.5.7 The Laboratory Manager, when present, is responsible to ensure the quality and safety policies are followed and utilized during the daily operation of the laboratory. This includes but is not limited to:
§ Ensuring required SOPs are available, current and utilized by laboratory staff
§ Ensuring laboratory staff is appropriately trained and competent to perform the assigned technical tasks and follow SOPs
§ Ensuring equipment SOPs are available, equipment is identified, monitored, maintained, calibrated or serviced as required
§ Ensuring test results are qualified by using appropriate controls, and verified before reporting in a clear and timely manner
§ Ensuring applicable quality practices are documented as required
§ Ensuring applicable biosafety equipment and practices are in place and utilized by laboratory staff
§ Ensuring applicable safety procedures are in place and utilized by laboratory staff
§ Initiating appropriate Nonconformances, Corrective and Preventive Actions and Client Complaints and investigating as appropriate to reveal the root cause
§ Performing periodic laboratory audits to assure compliance with the quality and safety requirements in their laboratory
4.1.5.8 The Director has overall responsibility for the technical operations within the laboratory and supervises the Section Heads, listed in Appendix 1. The XYZ LAB faculty meet periodically as a technical committee to evaluate current testing methods and to set priorities for future test development. Responsibilities for the Director include but are not limited to:
· Enforcing the quality and safety policies within the laboratory;
· Facilitating resolution of conflicting issues involving two or more sections within the laboratory;
· Approving departures from documented policies and procedures and;
· Ensuring compliance with the current version of the AAVLD Requirements, ISO/IEC 17025:current version, as applicable and OIE standards.
4.1.5.9 The Quality Systems Manager is appointed by and reports to the Director. The Quality Systems Manager has responsibility and authority for:
· Ensuring that the quality system is implemented and followed at all times;
· Ensuring compliance with the AAVLD Requirements: current version and ISO 17025: current version, as applicable and OIE Standards;
· Stopping work for reasons of doubtful quality;
· Working directly with Section Heads and other employees concerning quality assurance;
· Reviewing and approving quality policies and procedures, as well as technical and administrative procedures to ensure that quality assurance and safety principles are included;
· Issuing revisions of the Quality Manual and quality procedures as necessary; and
· Establishing the schedule for internal auditing, selecting the employees to perform the internal audits, and providing training and direction for each audit team member during the course of the audit process.
4.1.5.10 Deputies for key managerial personnel
4.1.5.10.1 In the absence of the Quality Systems Manager, the deputy is the Director or an employee designated by the Director.
4.1.5.10.2 In the absence of any laboratory Section Head, the deputy is the Lab Manager or other qualified staff member designated by the Section Head for that absence. In the event that the Section Head has not designated a deputy, the Laboratory Manager, the Director or an employee assigned by the Director is the deputy Section Head.
4.1.5.10.3 In the absence of the Director, the deputy is the Associate Director, Section Head assigned by the Director, or the Executive Director.
4.1.5.10.4 Deputies for technical staff are not specifically nominated since each position has at least one competent and authorized backup staff member.
4.2 QUALITY SYSTEM
4.2.1 The quality system of XYZ LAB has been established to formalize the quality practices employed to meet the scope, mission, and quality objectives of the laboratory. Documentation used in the quality system is controlled in accordance with SOP 101 Document Control.
4.2.2 The quality policy and objectives of XYZ LAB are stated in Section 3.0 of this manual.
4.2.3 All elements of the quality system, those developed by the laboratory and those taken from outside sources, are formally documented. The structure of the quality system documentation is outlined in Section 2.0 of this manual and the details are found in a Master List generated from the XYZ LAB web site and maintained by the Quality Systems Manager.
4.2.4 The roles and responsibilities of the Director and the Quality Systems Manager are provided in Sections 4.1.5.7 and 4.1.5.8 of this manual.
4.3 DOCUMENT CONTROL
4.3.1 Controlled copies of all quality system documents (this Quality Manual, system procedures referenced in this manual, and technical procedures) used in XYZ LAB are available to all laboratory personnel and are controlled as described in SOP 101 Document Control.
4.3.2 Document Approval and Issue
4.3.2.1 All documents issued to personnel are reviewed and approved by the appropriate Section Head, Lab Manager or other approved laboratory staff member (approved by the Section Head and/or Director). When approved, the documents, as pdfs, are placed in a web folder entitled ‘Standard Operating Procedures’ or ‘Forms’ that is accessible to all XYZ LAB personnel. The titles of the files in this folder constitute the Master List of XYZ LAB quality documents. The Quality Systems Manager has read / write access to this folder and is responsible for maintaining the Master List and posting new procedures to the XYZ LAB web site. The Director approves all Quality System procedures.
4.3.2.2 Authorized editions of all documents pertinent to XYZ LAB operations are available on-line to all XYZ LAB employees at https://w3.vetmed.qrs.edu/XYZ Lab/docs. Controlled hard copies of procedures are issued by the Quality Systems Manager and identified by the ”Controlled Document Mark” printed at the bottom or near the lower left corner of each page. Each department stamps the document with a red “Entered” stamp (with initials and date) when the document is placed into the SOP manual. Documents posted on the web page are marked “Uncontrolled Document” in the background of each page. Non-official printed copies of any XYZ LAB procedure (i.e., those lacking the Controlled Document Mark, red stamp, and differing in version number from the current on-line version) are invalid and must be immediately removed from the SOP manuals and recycled according to the policies in SOP 101: Document Control. Copies with a version number different from the current web version are obsolete and should be immediately recycled, unless approved to remain in use by the Quality Systems Manager and stamped “Obsolete” or otherwise indicated as not controlled.
4.3.2.3 Quality System documents are periodically reviewed by the Quality Systems Manager and/or Director or his designee.
4.3.2.4 Invalid and obsolete documents are promptly removed from the ‘Standard Operating Procedures’ and ‘Forms’ folders, and automatically placed into a folder entitled ‘Obsolete’ or ‘Snapshots’. Printed copies of obsolete procedures may be retrieved by or returned to the Quality Systems Manager to be recycled or destroyed, or the Section Head, Laboratory Manager or designee, may do this, with approval of the Quality Manager. The folders, Obsolete and Snapshots, are available only to the Director, the Quality Systems Manager, and to XYZ LAB Information Systems staff. Both authorized and archived document directories are copied and archived indefinitely as described in SOP 102 Information Systems.
4.3.3 Document Changes
4.3.3.1 Document changes are proposed by the laboratory Section Heads, Laboratory Managers, or other laboratory staff member, reviewed and approved by the Laboratory Manager (as designated by the Section Head) or Section Heads or other approved laboratory staff member, and optionally reviewed by the Director or his designee.
4.3.3.2 Standard Operating Procedures, instructions and other applicable documents shall be reviewed on a periodic basis and revised as appropriate. Reviews are documented by each department individually, and revisions shall not be more than every three years. Procedures that require no revision after a three year period shall be reissued with a new version number as indicated in SOP 121: Creating and Maintaining Standard Operating Procedures.
4.3.3.3 Technical revisions to Standard Operating Procedures that will affect the quality of a test shall be revised as soon as possible.
4.3.3.4 The specific changes that result in a new version are clearly identified in the electronic version by using Microsoft Word® Track Changes during the review. Revisions to procedures are listed in a SOP Changes section in the newly issued document and may be promulgated to the laboratory staff by the Section Head or Laboratory Manager.
4.3.3.5 Hand amendments to printed copies of XYZ LAB documents are strongly discouraged. Changes to SOPs indicated by hand-written notes should be revised and issued in a new SOP version as soon as possible after the change is accepted by the laboratory Section Head or Laboratory Manager and staff. Printed XYZ LAB documents amended by hand are invalid and should be destroyed or recycled as soon as possible. Highlighting or underlining is not considered a document amendment.
4.3.3.4 The procedures used to identify and revise documents in the laboratory's computer system are found in SOP 102 Information Systems.
4.4 CONTRACT REVIEW
4.4.1 Client requests for testing are received in the form of specimens accompanied by a XYZ LAB Accession Form containing a request for any tests listed in the XYZ LAB fee schedules (http://www.vetmed.qrs.edu/depts_XYZ Lab/fees.aspx) are considered a request to contract services. All client requests for testing are reviewed and addressed as in SOP 103 Case Accession. If the accession is acceptable for testing by this SOP, a contract for XYZ LAB services is established. If an accession is unacceptable for testing by this SOP, a contract is not established and XYZ LAB will attempt to contact the submitter to indicate this within 24 hours. An evaluation of the laboratory's capabilities, resources, and capacity are an essential part of the review process before work is accepted for testing.
4.5 SUBCONTRACTING TESTS and FORWARDING OF TEST SPECIMENS
4.5.1 No XYZ LAB testing other than toxicology testing is sub-contracted.
4.5.2 When testing is requested that is not included in the range of XYZ LAB procedures, XYZ LAB will make efforts to find another accredited laboratory willing and capable of performing the requested testing, as described in SOP 104 Test Specimen Forwarding.
4.5.3 XYZ LAB makes no certification of the accuracy or acceptability of the quality systems of laboratories used for test specimen forwarding. Results of testing done at other laboratories after forwarding will be attached to XYZ LAB reports along with clear indication of the laboratory that is the source of these results.
4.5.4 Costs of specimen forwarding and the costs of the laboratory testing of forwarded specimens will be added to the XYZ LAB invoice with a shipping and handling charge.
4.5.5 The Quality Systems Manager maintains a list of tests and laboratories used for testing (See Appendix 1 of SOP 104: Test Specimen Forwarding) not included in the range of XYZ LAB test procedures in the XYZ LAB User Guide.
(http://www.vetmed.qrs.edu/depts_XYZ Lab/userguide.aspx)
4.6 PURCHASING SUPPLIES AND SERVICES
4.6.1 Services and supplies are purchased as described in SOP 106 Purchasing Supplies and Services.
4.6.2 All items received are visually inspected to ensure compliance with the order specifications. Verifications of the quality of consumable materials are also required, and records of those evaluations are maintained. All supplies are stored as specified in the related procedures.
4.6.3 The Section Heads or authorized Laboratory Manager approve purchases for materials that affect the quality of the work performed and records are maintained of the approval if appropriate. The Director has final approval for purchases of new equipment or materials that are over a certain budget amount.
4.6.4 Evaluations of the vendors of critical supplies and services are kept for 5 years in laboratory sections where this is a requirement.
4.7 SERVICE TO THE CLIENT
4.7.1 The laboratory services provided to clients are listed in the XYZ LAB User Guides (http://www.vetmed.qrs.edu/depts_XYZ Lab/userguide.aspx).
4.7.2 The laboratory provides clients with assistance in determining the appropriate test methods to be used, as well as in explaining the results of the tests. Details are found in SOP 107 Client Services.
4.7.3 In order to monitor the laboratory activities, clients are permitted to visit the laboratory at any time during normal operation provided safety and confidentiality policies and procedures are followed.
4.7.4 Client complaint policies and procedures are included in SOP 107 Client Services.
4.8 CORRECTIVE ACTIONS
4.8.1 Corrective Action is a process used to understand, resolve, monitor and document a problem that has occurred with a test, procedure, or the quality system. Corrective Actions are handled in accordance with SOP 108 Corrective Action. Records of all corrective actions are kept on Corrective Action Request forms (CARs) and maintained on file in the Quality Office (and for specific XYZ BRANCH LAB CARS, in the main office of XYZ BRANCH LAB). Investigation of problems that occur that are not necessarily systematic problems, but should be documented, may be treated as a Non-Conformance (see Section 4.10).
4.8.2 The responsibility for the management of corrective actions is as follows:
4.8.2.1 XYZ LAB staff are expected to initiate CARs for any problem within their job responsibilities, including testing discrepancies and Quality Control problems;
4.8.2.2 Section Heads or Laboratory Managers are expected to initiate CARs (or NCs, PARs) for deviations from laboratory policies and procedures. If the deviation is planned, documentation of the deviation and the approval is accomplished using the SOP Planned Deviation Documentation form (QC 025).
4.8.2.3 Technical and quality management are expected to initiate CARs for all other issues;
4.8.2.4 The Quality Systems Manager (or Director, Section Head or Laboratory Manager) has the authority to stop any nonconforming testing work. The Director or Quality Manager reinitiate work following appropriate corrective actions; and
4.8.2.5 The Director or designated Section Head will notify in writing any clients who have received nonconforming work and will recall such work.
4.8.3 After evaluating the situation initiated by the CAR, the Quality Systems Manager is authorized to conduct a detailed internal audit in the appropriate area, if there are indications the problem could recur.
4.8.4 All corrective actions require an investigation to determine the root cause of problems detailed in the CAR. This root cause analysis is done according to SOP 108 Corrective Action.
4.8.5 Selection of the required corrective action takes into account the impact of the problems and non-conformances and the probability of their reoccurrence.
4.8.6 Usually the XYZ LAB staff conducts the monitoring of corrective actions. Final disposition of a CAR requires the approval of the Quality Systems Manager.
4.9 PREVENTIVE ACTIONS
4.9.1 Procedures for the improvement of the laboratory's quality system and identification of actions to prevent potential problems are addressed in SOP 109 Preventive Action.
4.9.2 Examples of preventive action include monitoring trends in control charts and actions taken to preclude out-of-control situations, applying corrective actions to new situations, and responding to employee suggestions for quality improvements.
4.9.3 Control charts and proficiency testing results are used to demonstrate that preventive actions taken are effective.
4.10 NON-CONFORMING WORK
4.10.1 Non-Conformances are handled according to SOP 124: Procedure for Handling a Non-Conformance.
4.11 RECORDS MANAGEMENT
4.11.1 It is the responsibility of all laboratory personnel to keep records of all work or operations performed in the format prescribed by the various policies and procedures of the quality system. All records shall contain the date of creation and identification of the person responsible for their creation. All records shall be made in a permanent and legible manner.
4.11.2 The Quality Systems Manager is the custodian of quality records, including internal and external audits, management reviews, corrective actions, preventive actions, proficiency test results, and other related records.
4.11.3 The Section Head and Laboratory Manager of each laboratory section are responsible for the completed technical records (laboratory notebooks, worksheets, reports, electronic data stored on computers, etc.) generated by the staff in their section.
4.11.4 The identification, collection, indexing, access, filing, storage, maintenance and disposal of records generated in the laboratory are defined in SOP 110 Records Management.
4.11.5 All records of the laboratory are maintained in the respective access-controlled XYZ LAB laboratory sections, XYZ LAB Business Office or XYZ BRANCH LAB main office for one year or longer, depending on the space available. After that the records shall be archived in the appropriate access-controlled storage areas. . Refer to SOP 110: Records Management for details. In addition, all records available in electronic form will be maintained and archived as described in SOP 102 Information Systems. The record retention time of XYZ LAB is defined by the QRS Policies and Procedures Manual.
4.11.6 Computer records are protected and backed-up according to SOP 110 Records Management.
4.11.7 All records shall be recorded contemporaneously with their creation.
4.11.7.1 Hand-written Corrections: Corrections to hard copy (paper) record errors are made using a single-line strike through, writing the correct information alongside, specifying the reason for the change (if needed), and initialing and dating each correction.
4.11.7.2 Electronic Corrections: Corrections to record errors in the LIMS are done through an audit trail providing date/time stamping and identification of the person making the change.
4.12 INTERNAL AUDITS
4.12.1 Internal audits of all policies and procedures in the laboratory's quality system are conducted to ensure compliance with the quality system according to the schedule published by the Quality Systems Manager and according to the procedures described in SOP 111 Internal Audits.
4.12.2 The Quality Systems Manager or other qualified staff approved by the Director conduct internal audits. When an audit casts doubt on the effectiveness of operations or correctness of laboratory results timely corrective action shall be taken. Should the audits show that client results have been compromised the Director should immediately notify the affected clients in writing of the situation.
4.12.3 All audit findings are recorded on Internal Audit forms and related corrective actions are recorded on CAR forms.
4.12.4 Follow-up monitoring and other activities are taken to ensure corrective actions have been effective.
4.13 MANAGEMENT REVIEWS
4.13.1 The Director and the Executive Director, along with the Quality Manger review all aspects of the quality system according to the schedule and procedure defined in SOP 112 Management Review. This procedure outlines all the topics that are to be addressed. The goal of the management review is to determine if the laboratory's quality system is suitable and effective in meeting the quality objectives of the laboratory.
4.13.2 All findings from management reviews are recorded.
5.0 TECHNICAL REQUIREMENTS
5.1 GENERAL
5.1.1 Management has developed the technical requirements of its quality system recognizing that the factors in the following sections are critical in determining the correctness and reliability of tests and it has addressed these factors with policies and procedures to reduce the uncertainty of the tests performed.
5.2 PERSONNEL
5.2.1 The Section Heads are responsible for ensuring that all laboratory staff in their section are competent and have received all required training prior to allowing them to work on client samples.
5.2.2 The Section Heads ensure that the training records of all members are current and on file in their laboratory section or in the XYZ BRANCH LAB main office.
5.2.3 The process of defining individual training needs and providing that training is described in SOP 113 Training of Personnel. The demonstration of competence of the staff is an ongoing activity and is monitored through the use of QC control samples, proficiency testing, and observation by the Section Head or Laboratory Manager, and documented annually. The data used to demonstrate analyst competency is kept in that person's training records. The analyst's Section Head shall authorize the analyst to conduct the tasks and tests and to operate specific equipment.
5.2.4 The laboratory uses personnel who are permanently employed or under contract. When part-time employees are used their work shall be compliant with the laboratory's quality system, and shall be subject to all policies and procedures on training and demonstration of competency.
5.2.5 For each position appearing on the organizational chart, the laboratory has a Job Description. The job responsibilities and authorities for all personnel shall be found in their Job Descriptions, which are filed in the office of the Administrative Manager, the XYZ BRANCH LAB main office and optionally the staff member’s laboratory section.
5.2.6 Participation in inter-laboratory proficiency testing programs serves as a tool for qualifying laboratory personnel and aids management in authorizing personnel to perform particular laboratory tasks. Where inter-laboratory proficiency tests do not exist Section Heads have the option to implement intra-laboratory proficiency tests as a substitute. Results of proficiency tests are maintained by the Section Heads (and Quality Manager) to document the performance of employees in such tests. Any corrective action taken as a consequence of the results is included in the training records.
5.3 ACCOMODATION AND ENVIRONMENTAL CONDITIONS
5.3.1 The XYZ LAB has two laboratory locations. The main laboratory is located in Eastern XYZ and housed in 123 Hall on the ABC campus of XYZ State University, is accommodated in rooms and laboratories totaling approximately 14,500 square feet. The XYZ LAB Branch Laboratory is located in western XYZ and housed in a 5,620 square feet facility located on the XYZ Research and Extension Center campus of XYZ State University. Both laboratories have designated areas for centralized functions, e.g. office functions, sample receiving and processing, glassware washing and media preparation, chemical and reagent storage, autoclaving, and shared instrumentation. General safety rules and chemical handling processes are described in SOP 192 Chemical Hygiene and Safety Plan. Fume hoods and biosafety cabinets are located throughout the laboratories to facilitate quality and safety requirements.
5.3.2 Environmental temperatures in the laboratory, including the temperature in rooms, on lab benches (when applicable), refrigerators, freezers, ovens, and incubators, are monitored, as described in SOP 115 Facility Monitoring.
5.3.3 Access to most areas of the main laboratory is controlled by a security card access system. The branch laboratory has access by key to the main building with an alarm system. SOP 115 Facility Monitoring addresses access control.
5.3.4 Section Heads and Laboratory Managers are responsible fora clean work area. This helps to facilitate the laboratory operations and serves to protect the health and safety of the staff. Safe collection, storage, and disposal practices are followed as described in SOP 190.5 XYZ LAB Medical Waste Disposal Procedures and SOP 192 Chemical Hygiene and Safety Plan. Requirements forhandling and storing compressed gas cylinders are also found in the same procedure.
5.4 TEST METHODS
5.4.1 Testing is conducted following the requirements of the Technical Procedures in the 200, 300, 400, 500, 600, 700, 800, 900, 100, 1100, 1200, 1300 and 1400 Series SOPs. These procedures address sample preparation, analysis, and quality control, general work instructions, as well as data recording and reporting. These same or separate procedures address the use of laboratory equipment and instrumentation. Copies of technical procedures are kept up to date and are distributed to the staff as specified in SOP 101 Document Control.
5.4.2 Analytical work is accomplished using methodology appropriate forthe specific purpose. The methodology to be used is available to the client by request. The methods include standard methods, methods having peer recognition, and methods mandated by legal requirements. If a client requests use of methodology other than that described in laboratory Technical Procedures, this request will be considered in light of the Section Heads’ or Pathologists’ judgment regarding the methodology as described in SOP 103 Case Accession.
5.4.3 Any deviations fromtest methods are specifically recorded, technically justified, and approved by management and the client prior to implementation.
5.4.4 The laboratory develops test methods, takes test methods fromauthoritative sources, and adapts or modifies test methods from the refereed scientific literature or from other AAVLD accredited laboratories. The laboratory ensures that the latest version of each test method is utilized, except as approved by the Section Head. New test methods are validated according to SOP 126: Method Validation. No methods are used to obtain data forroutine samples until their applicability has been established and the competence of each technical staff member to use those methods has been demonstrated and documented as described in SOP 113 Training of Personnel. Once the test has been approved for routine testing, its performance is monitored by the routine use of control samples or reference standards to assure the ongoing validity of the test.
5.4.5 Control charts for each applicable quantitative method are developed to establish quality control acceptance criteria. The development of control charts is described in SOP 116 Trend Analysis Using Control Charts or Other Statistical Methods.
5.4.6 The data taken from the control charts may be utilized to estimate the measurement uncertainty of the test method. When available and as appropriate, records of the measurement uncertainty, sensitivity, specificity, etc., for each test method are filed in the applicable laboratory section.
5.4.7 Control data from qualitative testing is logged to allow ongoing evaluation and trend tracking over time.
5.4.8 All manual data calculations and data transfers are reviewed and approved by a second reviewer (normally another analyst) in accordance with the requirements SOP 117 Data Review and Approval.
5.4.9 The protection and security of data that is recorded, processed, stored, reported, or retrieved via computers is addressed in SOP 110 Records Management.
5.4.10 All computers and automated equipment are maintained as specified in SOP 118 Laboratory Equipment.
5.5 EQUIPMENT
5.5.1 The requirements for the acceptance, use, and maintenance of laboratory equipment, instrumentation and computers are found in SOP 118 Laboratory Equipment and the Technical Procedures (SOP 200s, 300s, 400s, etc.).
5.5.2 Equipment SOPs for each piece of equipment are readily available to the equipment operators. These documents are maintained according to SOP 101 Document Control. It is the responsibility of each employee to read and understand the procedures for all equipment they use.
5.5.3 The Section Heads ensure the competence level all of their staff members in the operation of any laboratory equipment via proficiency testing as described in SOP 113 Training of Personnel.
5.5.4 No equipment is used until it is in a safe and reliable operational state, and then only by personnel who have been trained and qualified as operators. Equipment and its associated reference materials are identified and labeled, marked, or qualified by calibration data to indicate their calibration status as required by SOP 118 Laboratory Equipment.
5.5.5 Maintenance Records of all equipment are kept as specified by SOP 118 Laboratory Equipment.
5.5.6 Equipment that gives suspect results or is not functioning is removed from service and labeled “out of service”. If defective equipment is suspected to have a detrimental effect on test results, a Non-Conformance or Corrective Action should be initiated to determine the scope of the problem. The Director or Section Head will inform the applicable clients of the problem, if needed.
5.5.7 Equipment sent outside the control of the laboratory for repair is checked for function and calibration status before being placed back into service.
5.5.8 Intermediate checks used to maintain confidence in the calibration status of equipment are described in the Technical Procedures. These checks serve to safe guard the equipment to ensure the acceptance of data.
5.5.9 Equipment and software are to be protected from adjustments or changes that could invalidate test results.
5.6 MEASUREMENT TRACEABILITY
5.6.1 All equipment and instrumentation employed whose performance shall have a bearing on any results supplied to clients is calibrated and/or verified before it is used in accordance with requirements in SOP 118 Laboratory Equipment and the applicable Technical Procedures.
5.6.2 Reference Standards and Reference Materials
5.6.2.1 Where relevant, XYZ LAB uses Reference Standards traceable to NIST wherever possible (weights/masses, thermometers, metal analysis standards, etc.) or ISO 17025 accredited vendors who provide traceability via Calibration Certificates or Certificates of Analysis containing appropriate measurement uncertainty estimates. These standards and materials are calibrated and/or verified according to the procedures in SOP 119 Reference Standards and Materials.
5.6.2.2 Where traceability to standard reference materials is not possible and/or not relevant, other methods are used to establish confidence in the results, e.g. participation in proficiency testing programs, interlaboratory comparisons, use of reference materials (certified if available), testing by another technical procedure, or ratio-type measurements.
5.6.2.3 Intermediate checks are performed on reference standards and materials as appropriate, and are described in SOP 119 Reference Standards and Materials and in the applicable laboratory section procedures.
5.6.3 The laboratory handles and stores reference standards and materials according SOP 119 Reference Standards and Materials.
5.7 SAMPLING
5.7.1 Sampling is a critical step in the analytical process, but is the responsibility of the laboratory's clients rather than XYZ LAB technical staff, with the exceptions below. Therefore, acceptance/rejection criteria are established for samples that are directed at minimum acceptable requirements to accomplish quality service as described in SOP 103 Case Accession.
5.7.2 Sampling is performed by XYZ LAB pathologists during necropsies and may be performed by the Aquaculture laboratory section.
5.7.3 Sampling for Aquaculture and during Necropsy is performed according to Standard Operating Procedures for sampling that includes sample collection, processing (when applicable) and preservation. The procedures are available where the sampling is performed. Relevant data pertaining to sampling is recorded during the sampling event, including the collection procedure used, the sampler identity, environmental conditions (where relevant), and diagrams or other means to identify the collection location, and when applicable, the statistics the sampling procedures are based on.
5.8 HANDLING OF SAMPLES
5.8.1 Samples submitted by clients are handled in accordance with the requirements of SOP 103 Case Accession.
5.8.2 The scope of sample handling includes receipt and login, chain of custody, storage and disposal.
5.8.3 Abnormalities and departures are recorded as described in the referenced SOP.
5.9 ASSURING THE QUALITY OF TEST RESULTS
5.9.1 The laboratory monitors the quality (accuracy and precision) of test results by the inclusion of appropriate quality control measures on all tests done in XYZ LAB (See the Technical Procedures). The establishment of acceptance criteria is based on these historical quality measurements and trend analysis is employed for routine quantitative tests as described in SOP 116 Control Charts.
5.9.2 XYZ LAB participates in proficiency testing exercises as detailed below.
· African Swine Fever Virus Real Time PCR
· Anaplasmosis cELISA
· Avian Influenza AGID
· Avian Influenza Real Time PCR
· Avian Paramyxovirus PCR
· Bacteriology Interlaboratory Survey
· Bluetongue (BT)
· Bovine Leukosis (BLV)
· Bovine Spongiform Encephalopathy (BSE) ELISA
· Bovine Viral Diarrhea Virus, Antigen, Virus Isolation, IHC Ring Test
· Brucellosis Serologic Tests
· Chronic Wasting Disease, ELISA, IHC
· Classical Swine Fever Virus, PCR
· Equine Infectious Anemia (EIA)
· Equine Viral Arteritis (EVA)
· Foot and Mouth Disease Virus, PCR
· IBR Virus IHC Ring Test
· Johne’s Disease, Liquid culture, ELISAS, fecal Real Time PCR
· Koi Herpes Virus PCR International Ring Trial
· Leptospira, MAT
· Newcastle Disease Real Time PCR
· Porcine Reproductive and Respiratory Syndrome (PRRS)
· Pseudorabies (PRV) Serology, LA, gB ELISA, gl ELISA
· Rinderpest Virus Real Time PCR
· Salmonella in Liquid Egg
· Scrapie, IHC
· Vesicular Stomatitis Serum Viral Neutralization (SVN), PCR
· West Nile Virus ELISA
· Yersinia pestis Real Time PCR
5.10 REPORTING THE RESULTS
5.10.1 Test results are provided to clients via test reports as specified in SOP 120 Report Generation. Each test report contains all information required by the client to whom the report is sent, and is intended to meet the requirements of Sections 5.10.2 through 5.10.3 of the ISO/IEC 17025: Standard, current version. If the client does not want all the required information, it is readily available in the laboratory with the exception of those items pertaining to sampling.
5.10.2 The laboratory provides opinions and interpretations of reported data by faculty qualified based on experience and training (e.g. Ph.D., D.V.M., and diplomates of the ACVP, ACPV, ACLAM and ACVM) or other appropriately qualified and authorized Section Heads or Laboratory Managers.
5.10.3 Results of tests performed on the specimens forwarded to other laboratories are clearly identified on test reports.
5.10.4 The issuance of electronic reports is addressed in SOP 120 Report Generation and the confidentiality policy described in 4.1.5.2 of this document.
5.10.5 The format for test reports and the requirements for submitting amendments or supplements to test reports are also addressed in SOP 120 Report Generation.
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Master Copy
1.0 TABLE OF CONTENTS
Page
1.0 Table of Contents …………………………………..………………………...2
1.1 List of Appendices…………………………………….……..3
2.0 Document Structure …………………………………..…………………..….4
3.0 Quality Policy……………………………………………………………....….6
4.0 MANAGEMENT REQUIREMENTS
4.1 Organization………………………………………..….….….6
4.2 Quality System……………………………………………...10
4.3 Document Control……………………………………..……11
4.4 Contract Review…………………………………………….13
4.5 Subcontracting of Tests and Forwarding
4.6 of Test Specimens …………………………………….……13
4.7 Purchasing Supplies and Services ………………………..13
4.8 Client Service……………………………………………..….14
4.9 Corrective Actions…………………………………………...14
4.10 Preventive Actions…………………………………………..15
4.11 Records Management…………………………………..…..16
4.12 Internal Audits………………………………………………..17
4.13 Management Reviews………………………………..……..17
5.0 TECHNICAL REQUIREMENTS
5.1 General……………………………………………………….17
5.2 Personnel…………………………………………………….17
5.3 Accommodation and Environmental Conditions……..….18
5.4 Test Methods………………………………………….…….19
5.5 Equipment……………………………………………….…..20
5.6 Measurement Traceability…………………………..……..21
5.7 Sampling……………………………………………………..21
5.8 Handling of Samples………………………………….…....22
5.9 Assuring the Quality of Test Results………………….….22
5.10 Reporting the Results………………………………………23
1.1 LIST OF APPENDICES
Appendix 1: XYZ Laboratory Section Head List
Appendix 2:XYZ LAB Organizational Chart
Appendix 3: State of XYZ RCW Title 42, Chapter 42.52, Section 45.52.020: Activities incompatible with public duties.
Appendix 4: XYZ State University Business Policies and Procedures Manual: Summary of Ethics Laws and Policies
2.0 DOCUMENT STRUCTURE
2.1 Quality Manual
2.2 System procedures
SOP 101 Document Control
SOP 102.1 Information Systems
SOP 102.2 XYZ LAB Case Log-In
SOP 102.3 Vetstar Animal Disease Diagnostic System Look-Ups
SOP 102.4 Opening and Evaluating Packages Prior to Case Log-In
SOP 102.6 XYZ LAB Case Log-In, Ordering and Routing in XYZ BRANCH
SOP 103 Case Accession
SOP 103.1 Policies and Procedures for Non-Human Primate Accessions
SOP 103.2 Guidance for Proper Use of Chain-of-Custody Forms
SOP 104 Test Specimen Forwarding
SOP 104.1 Sample Handling and Routing for Toxicology Testing of Necropsy Samples
SOP 104.2 Use and Routing of Additional Test Request Forms
SOP 106 Purchasing Supplies and Services
SOP 107 Client Services
SOP 108 Corrective Action
SOP 109 Preventive Action
SOP 110 Records Management
SOP 111 Internal Audits
SOP 112 Management Review
SOP 113.1 Training of Laboratory Personnel
SOP 113.2 Anatomic Pathology Training
SOP 115 Facility Monitoring
SOP 116 Trend Analysis Using Control Charts or Other Statistical Methods
SOP 117 Data Review and Approval
SOP 118 Laboratory Equipment
SOP 119 Reference Standards and Materials
SOP 120 Report Generation
SOP 121 Creating Standard Operating Procedures (SOPs)
SOP 122 Monthly Security System Review (confidential)
SOP 123 Case Status Review
SOP 124 Procedure for Handling a Non-Conformance
SOP 125 Updating Procedures from Standards-Setting Bodies
SOP 126 Method Validation
SOP 127 XYZ LAB Reportable Disease Notification Policy
SOP 131 Policy for Cancelling Tests and Cases in VADDS
SOP 190 XYZ LAB Biosafety Manual
SOP 190.1 Exposure Control Policy – Bloodborne Pathogens
SOP 190.2 Orientation in Biosafety for XYZ LAB Anatomic Pathology Residents
SOP 190.5 XYZ LAB Medical Waste Disposal Procedures
SOP 191 XYZ LAB Exposure Control and Personal Protective Equipment Guidelines
SOP 192 XYZ LAB Safety Program and Chemical Hygiene Plan
SOP 193 Accident Prevention Program
SOP 194 XYZ LAB Emergency Plan
SOP 196 Producing and Issuing Corrected Reports
2.3 Technical Procedures (See Master List for Details of Procedures in Each Department)
SOP 1-99 XYZ LAB Business Office Procedures
SOP 100’s General System Procedures
SOP 199’s Shared Equipment Procedures
SOP 200s Serology Procedures
SOP 300s Bacteriology Procedures
SOP 400s Virology Procedures
SOP 500s Molecular Diagnostics Procedures
SOP 600s Histopathology Procedures
SOP 700s Pathology Procedures
SOP 800’s Immunohistochemistry Procedures
SOP 900’s Aquaculture Procedures
SOP 1100’s Central Processing Procedures
SOP 1200’s Avian Health and Food Safety Procedures
SOP 1300’s Parasitology
SOP 1400’s TSE Laboratory
3.0 QUALITY POLICY AND OBJECTIVES
Mission and Values Statements
Mission: Our mission is to provide accurate, state-of-the-art, timely, and cost-effective diagnostic services, consultation, disease surveillance and outreach in order to safeguard animal health, the food supply and public health and to contribute to the University and College of Veterinary Medicine through discovery, scholarly activity, and education.
Values: As a combined service and educational unit within a land grant University, the XYZ Laboratory (XYZ LAB) occupies a unique position that links the University to public and private stakeholders. We recognize and value the importance of our role in providing a positive, responsive interface between XYZ State University and the animal and public health community, and between our stakeholders and the academic community.
We value service and outreach to our constituents, which include the practicing veterinary community, the agricultural animal industry, animal and public health regulatory agencies, companion animal owners, and the general public. We also place a high value on quality, both in service to and communication with our clientele.
In addition to general diagnostics, we endorse and highly value the critical role we play in surveillance and detection of emerging and exotic diseases, whether introduced accidentally or deliberately with intention to disrupt the nation’s food supply. We value our role as a reference laboratory, our role in helping to assure a safe food supply, the critical importance of our surveillance for early detection of disease agents impacting public health, our vital contribution to maintaining international trade of agricultural animal products, and our ability to contribute to the discipline of diagnostic medicine through training of professional veterinary diagnosticians and discovery of new knowledge.
The XYZ Laboratory is guided by a commitment to excellence, and endorses the core values of XYZ State University, including inquiry and knowledge, application, leadership, character, stewardship, and diversity.
The quality system of XYZ LAB is comprised of all of the policies in this Quality Manual and referenced procedures and documents. This system was established to guide the staff in the performance of good laboratory practices and the production of quality outputs. The requirements of the quality system apply to all technical work of the laboratory.
The laboratory intends to provide clients or other concerned parties with the highest quality services and data and is committed to meeting or exceeding the client's requirements.
The purpose of the quality system is to help fulfill the mission of XYZ LAB. All XYZ LAB personnel are to implement and follow the policies contained within this Quality Manual, the procedures referenced by this Manual, and to the principles and current standards of the American Association of Veterinary Laboratory Diagnosticians’ (AAVLD) Requirements, ISO/IEC 17025:1999 and OIE. Each employee has a role in the quality of the laboratory's work and has a responsibility for its implementation according to his/her technical and/or managerial responsibilities.
Each member of the XYZ LAB staff shall be alert to problems or sources of error that could compromise the quality of technical work performed throughout the laboratory. Problems or sources of error shall be reported to the Section Heads or the Director.
Note: The term “Director” refers to both the Executive Director and Director throughout the Quality Manual.
The objective of the quality control program is to assure the scientific reliability of laboratory data. Management, administrative, statistical, investigative, preventative and corrective techniques will be employed to maximize reliability of the data.
Quality Policy Authorized By: Date:
Director
4. 0 MANAGEMENT REQUIREMENTS
4.1 ORGANIZATION
4.1.1 XYZ Laboratory (XYZ LAB) was created by legislative mandate in 1974 with a mission to “provide appropriate and timely veterinary diagnostic services to safeguard the health of livestock, pets, and poultry in the State of XYZ and to protect the public from zoonotic diseases”. The state of XYZ also established a poultry diagnostic laboratory in EFG, and in July 1, 1994 this laboratory was renamed the XYZ Branch Laboratory and placed under the administrative and fiscal responsibility of XYZ LAB and the College of Veterinary Medicine. In 1995 a new state appropriation was provided to the laboratory with a legislative mandate to provide diagnostic and health certification services to the aquaculture industry. Samples, supplies, and mail for XYZ LAB are received at:
XYZ Laboratory
XYZ State University
College of Veterinary Medicine
PO Box XXX
ABC, ZR XXXXX-XXXX
OR
XYZ Branch Laboratory
XYZ Laboratory
2607 West Lane
EFG, ZR XXXXX-XXXX
The XYZ LAB is an integral part of the Agricultural Animal Health Program (AAHP) in the College of Veterinary Medicine. Allied units within the AAHP include the Field Disease Investigation Unit, the Animal Health Research Center, and the ARS Animal Disease Research Unit. The mission of the AAHP is to enhance the well being of agricultural animals and wholesomeness of food animal products through integrated disease diagnosis, field investigation, and research.
4.1.2 XYZ LAB intends to conform to all requirements of the AAVLD Requirements, ISO/IEC 17025:1999 / OIE, while satisfying the needs of its clients.
4.1.3 The XYZ LAB management system is described by the policies in this document as well as the documents referenced by this document, and is intended to cover all aspects of the analytical services provided.
4.1.4 XYZ LAB is an integral part of XYZ State University’s College of Veterinary Medicine, and the university and the college policies act to protect XYZ LAB from potential conflicts of interest. The laboratory is not formally affiliated with any companies or corporations that might be a source of potential conflicts of interest. Potential conflicts of interest are governed by the regulations of the state of XYZ (RCW 42.52.020, see Appendix 3).
4.1.5 Laboratory Resources
4.1.5.1 XYZ LAB management has the responsibility and authority for supervising and administering the quality system. Management provides both the necessary resources (people, equipment, supplies, etc.) and the environment in which quality work shall be safely produced. Management ensures that employees conduct themselves in an ethical manner at all times. Policies and procedures of the State of XYZ relevant to ethics are described in the QRS Policies and Procedures Manual (see Appendix 4).
4.1.5.2 The laboratory protects the confidential information and proprietary rights of its clients during the analysis period and when issuing hard copy or electronic reports. The XYZ Laboratory (“XYZ LAB”) treats all its consultations as fully confidential medical protocols. XYZ LAB will maintain all material and information it obtains in the course of its professional consultations in the strictest confidence, to the extent allowed by the laws of the State of XYZ. No material relating to any client consultation will be disclosed except as required under such laws, absent consent of the client to disclosure. To assist it in these efforts, XYZ LAB expects all its clients to cooperate fully and to provide XYZ LAB with assistance in any proceedings or other actions that may be necessary to maintain confidentiality.
4.1.5.3 XYZ LAB management and staff do not engage in any outside activities that would compromise their ability to generate quality and legally defensible data, as specified by the regulations of the State of XYZ (RCW 42.52.020, see Appendix 3).
4.1.5.4 The XYZ LAB technical staff members report to Laboratory Managers (if present) and Section Heads. The Section Heads report to the Director, who in turn reports to the Executive Director. The Quality Systems Manager, also reports to the Director. The XYZ LAB Administrative Manager maintains a complete and current organizational chart (see Appendix 2).
4.1.5.5 The job responsibilities and authorities for all personnel shall be found in their Job Descriptions, which are filed with the Administrative Manager and optionally in the staff member’s department.
4.1.5.6 The Laboratory Section Heads enforce the quality and safety policies within their sections. It is their responsibility that all requirements of the quality system and of the clients are strictly followed. The Section Heads have meetings with their staff, addressing quality assurance and safety topics relevant to the work performed in their respective areas.
4.1.5.7 The Laboratory Manager, when present, is responsible to ensure the quality and safety policies are followed and utilized during the daily operation of the laboratory. This includes but is not limited to:
§ Ensuring required SOPs are available, current and utilized by laboratory staff
§ Ensuring laboratory staff is appropriately trained and competent to perform the assigned technical tasks and follow SOPs
§ Ensuring equipment SOPs are available, equipment is identified, monitored, maintained, calibrated or serviced as required
§ Ensuring test results are qualified by using appropriate controls, and verified before reporting in a clear and timely manner
§ Ensuring applicable quality practices are documented as required
§ Ensuring applicable biosafety equipment and practices are in place and utilized by laboratory staff
§ Ensuring applicable safety procedures are in place and utilized by laboratory staff
§ Initiating appropriate Nonconformances, Corrective and Preventive Actions and Client Complaints and investigating as appropriate to reveal the root cause
§ Performing periodic laboratory audits to assure compliance with the quality and safety requirements in their laboratory
4.1.5.8 The Director has overall responsibility for the technical operations within the laboratory and supervises the Section Heads, listed in Appendix 1. The XYZ LAB faculty meet periodically as a technical committee to evaluate current testing methods and to set priorities for future test development. Responsibilities for the Director include but are not limited to:
· Enforcing the quality and safety policies within the laboratory;
· Facilitating resolution of conflicting issues involving two or more sections within the laboratory;
· Approving departures from documented policies and procedures and;
· Ensuring compliance with the current version of the AAVLD Requirements, ISO/IEC 17025:current version, as applicable and OIE standards.
4.1.5.9 The Quality Systems Manager is appointed by and reports to the Director. The Quality Systems Manager has responsibility and authority for:
· Ensuring that the quality system is implemented and followed at all times;
· Ensuring compliance with the AAVLD Requirements: current version and ISO 17025: current version, as applicable and OIE Standards;
· Stopping work for reasons of doubtful quality;
· Working directly with Section Heads and other employees concerning quality assurance;
· Reviewing and approving quality policies and procedures, as well as technical and administrative procedures to ensure that quality assurance and safety principles are included;
· Issuing revisions of the Quality Manual and quality procedures as necessary; and
· Establishing the schedule for internal auditing, selecting the employees to perform the internal audits, and providing training and direction for each audit team member during the course of the audit process.
4.1.5.10 Deputies for key managerial personnel
4.1.5.10.1 In the absence of the Quality Systems Manager, the deputy is the Director or an employee designated by the Director.
4.1.5.10.2 In the absence of any laboratory Section Head, the deputy is the Lab Manager or other qualified staff member designated by the Section Head for that absence. In the event that the Section Head has not designated a deputy, the Laboratory Manager, the Director or an employee assigned by the Director is the deputy Section Head.
4.1.5.10.3 In the absence of the Director, the deputy is the Associate Director, Section Head assigned by the Director, or the Executive Director.
4.1.5.10.4 Deputies for technical staff are not specifically nominated since each position has at least one competent and authorized backup staff member.
4.2 QUALITY SYSTEM
4.2.1 The quality system of XYZ LAB has been established to formalize the quality practices employed to meet the scope, mission, and quality objectives of the laboratory. Documentation used in the quality system is controlled in accordance with SOP 101 Document Control.
4.2.2 The quality policy and objectives of XYZ LAB are stated in Section 3.0 of this manual.
4.2.3 All elements of the quality system, those developed by the laboratory and those taken from outside sources, are formally documented. The structure of the quality system documentation is outlined in Section 2.0 of this manual and the details are found in a Master List generated from the XYZ LAB web site and maintained by the Quality Systems Manager.
4.2.4 The roles and responsibilities of the Director and the Quality Systems Manager are provided in Sections 4.1.5.7 and 4.1.5.8 of this manual.
4.3 DOCUMENT CONTROL
4.3.1 Controlled copies of all quality system documents (this Quality Manual, system procedures referenced in this manual, and technical procedures) used in XYZ LAB are available to all laboratory personnel and are controlled as described in SOP 101 Document Control.
4.3.2 Document Approval and Issue
4.3.2.1 All documents issued to personnel are reviewed and approved by the appropriate Section Head, Lab Manager or other approved laboratory staff member (approved by the Section Head and/or Director). When approved, the documents, as pdfs, are placed in a web folder entitled ‘Standard Operating Procedures’ or ‘Forms’ that is accessible to all XYZ LAB personnel. The titles of the files in this folder constitute the Master List of XYZ LAB quality documents. The Quality Systems Manager has read / write access to this folder and is responsible for maintaining the Master List and posting new procedures to the XYZ LAB web site. The Director approves all Quality System procedures.
4.3.2.2 Authorized editions of all documents pertinent to XYZ LAB operations are available on-line to all XYZ LAB employees at https://w3.vetmed.qrs.edu/XYZ Lab/docs. Controlled hard copies of procedures are issued by the Quality Systems Manager and identified by the ”Controlled Document Mark” printed at the bottom or near the lower left corner of each page. Each department stamps the document with a red “Entered” stamp (with initials and date) when the document is placed into the SOP manual. Documents posted on the web page are marked “Uncontrolled Document” in the background of each page. Non-official printed copies of any XYZ LAB procedure (i.e., those lacking the Controlled Document Mark, red stamp, and differing in version number from the current on-line version) are invalid and must be immediately removed from the SOP manuals and recycled according to the policies in SOP 101: Document Control. Copies with a version number different from the current web version are obsolete and should be immediately recycled, unless approved to remain in use by the Quality Systems Manager and stamped “Obsolete” or otherwise indicated as not controlled.
4.3.2.3 Quality System documents are periodically reviewed by the Quality Systems Manager and/or Director or his designee.
4.3.2.4 Invalid and obsolete documents are promptly removed from the ‘Standard Operating Procedures’ and ‘Forms’ folders, and automatically placed into a folder entitled ‘Obsolete’ or ‘Snapshots’. Printed copies of obsolete procedures may be retrieved by or returned to the Quality Systems Manager to be recycled or destroyed, or the Section Head, Laboratory Manager or designee, may do this, with approval of the Quality Manager. The folders, Obsolete and Snapshots, are available only to the Director, the Quality Systems Manager, and to XYZ LAB Information Systems staff. Both authorized and archived document directories are copied and archived indefinitely as described in SOP 102 Information Systems.
4.3.3 Document Changes
4.3.3.1 Document changes are proposed by the laboratory Section Heads, Laboratory Managers, or other laboratory staff member, reviewed and approved by the Laboratory Manager (as designated by the Section Head) or Section Heads or other approved laboratory staff member, and optionally reviewed by the Director or his designee.
4.3.3.2 Standard Operating Procedures, instructions and other applicable documents shall be reviewed on a periodic basis and revised as appropriate. Reviews are documented by each department individually, and revisions shall not be more than every three years. Procedures that require no revision after a three year period shall be reissued with a new version number as indicated in SOP 121: Creating and Maintaining Standard Operating Procedures.
4.3.3.3 Technical revisions to Standard Operating Procedures that will affect the quality of a test shall be revised as soon as possible.
4.3.3.4 The specific changes that result in a new version are clearly identified in the electronic version by using Microsoft Word® Track Changes during the review. Revisions to procedures are listed in a SOP Changes section in the newly issued document and may be promulgated to the laboratory staff by the Section Head or Laboratory Manager.
4.3.3.5 Hand amendments to printed copies of XYZ LAB documents are strongly discouraged. Changes to SOPs indicated by hand-written notes should be revised and issued in a new SOP version as soon as possible after the change is accepted by the laboratory Section Head or Laboratory Manager and staff. Printed XYZ LAB documents amended by hand are invalid and should be destroyed or recycled as soon as possible. Highlighting or underlining is not considered a document amendment.
4.3.3.4 The procedures used to identify and revise documents in the laboratory's computer system are found in SOP 102 Information Systems.
4.4 CONTRACT REVIEW
4.4.1 Client requests for testing are received in the form of specimens accompanied by a XYZ LAB Accession Form containing a request for any tests listed in the XYZ LAB fee schedules (http://www.vetmed.qrs.edu/depts_XYZ Lab/fees.aspx) are considered a request to contract services. All client requests for testing are reviewed and addressed as in SOP 103 Case Accession. If the accession is acceptable for testing by this SOP, a contract for XYZ LAB services is established. If an accession is unacceptable for testing by this SOP, a contract is not established and XYZ LAB will attempt to contact the submitter to indicate this within 24 hours. An evaluation of the laboratory's capabilities, resources, and capacity are an essential part of the review process before work is accepted for testing.
4.5 SUBCONTRACTING TESTS and FORWARDING OF TEST SPECIMENS
4.5.1 No XYZ LAB testing other than toxicology testing is sub-contracted.
4.5.2 When testing is requested that is not included in the range of XYZ LAB procedures, XYZ LAB will make efforts to find another accredited laboratory willing and capable of performing the requested testing, as described in SOP 104 Test Specimen Forwarding.
4.5.3 XYZ LAB makes no certification of the accuracy or acceptability of the quality systems of laboratories used for test specimen forwarding. Results of testing done at other laboratories after forwarding will be attached to XYZ LAB reports along with clear indication of the laboratory that is the source of these results.
4.5.4 Costs of specimen forwarding and the costs of the laboratory testing of forwarded specimens will be added to the XYZ LAB invoice with a shipping and handling charge.
4.5.5 The Quality Systems Manager maintains a list of tests and laboratories used for testing (See Appendix 1 of SOP 104: Test Specimen Forwarding) not included in the range of XYZ LAB test procedures in the XYZ LAB User Guide.
(http://www.vetmed.qrs.edu/depts_XYZ Lab/userguide.aspx)
4.6 PURCHASING SUPPLIES AND SERVICES
4.6.1 Services and supplies are purchased as described in SOP 106 Purchasing Supplies and Services.
4.6.2 All items received are visually inspected to ensure compliance with the order specifications. Verifications of the quality of consumable materials are also required, and records of those evaluations are maintained. All supplies are stored as specified in the related procedures.
4.6.3 The Section Heads or authorized Laboratory Manager approve purchases for materials that affect the quality of the work performed and records are maintained of the approval if appropriate. The Director has final approval for purchases of new equipment or materials that are over a certain budget amount.
4.6.4 Evaluations of the vendors of critical supplies and services are kept for 5 years in laboratory sections where this is a requirement.
4.7 SERVICE TO THE CLIENT
4.7.1 The laboratory services provided to clients are listed in the XYZ LAB User Guides (http://www.vetmed.qrs.edu/depts_XYZ Lab/userguide.aspx).
4.7.2 The laboratory provides clients with assistance in determining the appropriate test methods to be used, as well as in explaining the results of the tests. Details are found in SOP 107 Client Services.
4.7.3 In order to monitor the laboratory activities, clients are permitted to visit the laboratory at any time during normal operation provided safety and confidentiality policies and procedures are followed.
4.7.4 Client complaint policies and procedures are included in SOP 107 Client Services.
4.8 CORRECTIVE ACTIONS
4.8.1 Corrective Action is a process used to understand, resolve, monitor and document a problem that has occurred with a test, procedure, or the quality system. Corrective Actions are handled in accordance with SOP 108 Corrective Action. Records of all corrective actions are kept on Corrective Action Request forms (CARs) and maintained on file in the Quality Office (and for specific XYZ BRANCH LAB CARS, in the main office of XYZ BRANCH LAB). Investigation of problems that occur that are not necessarily systematic problems, but should be documented, may be treated as a Non-Conformance (see Section 4.10).
4.8.2 The responsibility for the management of corrective actions is as follows:
4.8.2.1 XYZ LAB staff are expected to initiate CARs for any problem within their job responsibilities, including testing discrepancies and Quality Control problems;
4.8.2.2 Section Heads or Laboratory Managers are expected to initiate CARs (or NCs, PARs) for deviations from laboratory policies and procedures. If the deviation is planned, documentation of the deviation and the approval is accomplished using the SOP Planned Deviation Documentation form (QC 025).
4.8.2.3 Technical and quality management are expected to initiate CARs for all other issues;
4.8.2.4 The Quality Systems Manager (or Director, Section Head or Laboratory Manager) has the authority to stop any nonconforming testing work. The Director or Quality Manager reinitiate work following appropriate corrective actions; and
4.8.2.5 The Director or designated Section Head will notify in writing any clients who have received nonconforming work and will recall such work.
4.8.3 After evaluating the situation initiated by the CAR, the Quality Systems Manager is authorized to conduct a detailed internal audit in the appropriate area, if there are indications the problem could recur.
4.8.4 All corrective actions require an investigation to determine the root cause of problems detailed in the CAR. This root cause analysis is done according to SOP 108 Corrective Action.
4.8.5 Selection of the required corrective action takes into account the impact of the problems and non-conformances and the probability of their reoccurrence.
4.8.6 Usually the XYZ LAB staff conducts the monitoring of corrective actions. Final disposition of a CAR requires the approval of the Quality Systems Manager.
4.9 PREVENTIVE ACTIONS
4.9.1 Procedures for the improvement of the laboratory's quality system and identification of actions to prevent potential problems are addressed in SOP 109 Preventive Action.
4.9.2 Examples of preventive action include monitoring trends in control charts and actions taken to preclude out-of-control situations, applying corrective actions to new situations, and responding to employee suggestions for quality improvements.
4.9.3 Control charts and proficiency testing results are used to demonstrate that preventive actions taken are effective.
4.10 NON-CONFORMING WORK
4.10.1 Non-Conformances are handled according to SOP 124: Procedure for Handling a Non-Conformance.
4.11 RECORDS MANAGEMENT
4.11.1 It is the responsibility of all laboratory personnel to keep records of all work or operations performed in the format prescribed by the various policies and procedures of the quality system. All records shall contain the date of creation and identification of the person responsible for their creation. All records shall be made in a permanent and legible manner.
4.11.2 The Quality Systems Manager is the custodian of quality records, including internal and external audits, management reviews, corrective actions, preventive actions, proficiency test results, and other related records.
4.11.3 The Section Head and Laboratory Manager of each laboratory section are responsible for the completed technical records (laboratory notebooks, worksheets, reports, electronic data stored on computers, etc.) generated by the staff in their section.
4.11.4 The identification, collection, indexing, access, filing, storage, maintenance and disposal of records generated in the laboratory are defined in SOP 110 Records Management.
4.11.5 All records of the laboratory are maintained in the respective access-controlled XYZ LAB laboratory sections, XYZ LAB Business Office or XYZ BRANCH LAB main office for one year or longer, depending on the space available. After that the records shall be archived in the appropriate access-controlled storage areas. . Refer to SOP 110: Records Management for details. In addition, all records available in electronic form will be maintained and archived as described in SOP 102 Information Systems. The record retention time of XYZ LAB is defined by the QRS Policies and Procedures Manual.
4.11.6 Computer records are protected and backed-up according to SOP 110 Records Management.
4.11.7 All records shall be recorded contemporaneously with their creation.
4.11.7.1 Hand-written Corrections: Corrections to hard copy (paper) record errors are made using a single-line strike through, writing the correct information alongside, specifying the reason for the change (if needed), and initialing and dating each correction.
4.11.7.2 Electronic Corrections: Corrections to record errors in the LIMS are done through an audit trail providing date/time stamping and identification of the person making the change.
4.12 INTERNAL AUDITS
4.12.1 Internal audits of all policies and procedures in the laboratory's quality system are conducted to ensure compliance with the quality system according to the schedule published by the Quality Systems Manager and according to the procedures described in SOP 111 Internal Audits.
4.12.2 The Quality Systems Manager or other qualified staff approved by the Director conduct internal audits. When an audit casts doubt on the effectiveness of operations or correctness of laboratory results timely corrective action shall be taken. Should the audits show that client results have been compromised the Director should immediately notify the affected clients in writing of the situation.
4.12.3 All audit findings are recorded on Internal Audit forms and related corrective actions are recorded on CAR forms.
4.12.4 Follow-up monitoring and other activities are taken to ensure corrective actions have been effective.
4.13 MANAGEMENT REVIEWS
4.13.1 The Director and the Executive Director, along with the Quality Manger review all aspects of the quality system according to the schedule and procedure defined in SOP 112 Management Review. This procedure outlines all the topics that are to be addressed. The goal of the management review is to determine if the laboratory's quality system is suitable and effective in meeting the quality objectives of the laboratory.
4.13.2 All findings from management reviews are recorded.
5.0 TECHNICAL REQUIREMENTS
5.1 GENERAL
5.1.1 Management has developed the technical requirements of its quality system recognizing that the factors in the following sections are critical in determining the correctness and reliability of tests and it has addressed these factors with policies and procedures to reduce the uncertainty of the tests performed.
5.2 PERSONNEL
5.2.1 The Section Heads are responsible for ensuring that all laboratory staff in their section are competent and have received all required training prior to allowing them to work on client samples.
5.2.2 The Section Heads ensure that the training records of all members are current and on file in their laboratory section or in the XYZ BRANCH LAB main office.
5.2.3 The process of defining individual training needs and providing that training is described in SOP 113 Training of Personnel. The demonstration of competence of the staff is an ongoing activity and is monitored through the use of QC control samples, proficiency testing, and observation by the Section Head or Laboratory Manager, and documented annually. The data used to demonstrate analyst competency is kept in that person's training records. The analyst's Section Head shall authorize the analyst to conduct the tasks and tests and to operate specific equipment.
5.2.4 The laboratory uses personnel who are permanently employed or under contract. When part-time employees are used their work shall be compliant with the laboratory's quality system, and shall be subject to all policies and procedures on training and demonstration of competency.
5.2.5 For each position appearing on the organizational chart, the laboratory has a Job Description. The job responsibilities and authorities for all personnel shall be found in their Job Descriptions, which are filed in the office of the Administrative Manager, the XYZ BRANCH LAB main office and optionally the staff member’s laboratory section.
5.2.6 Participation in inter-laboratory proficiency testing programs serves as a tool for qualifying laboratory personnel and aids management in authorizing personnel to perform particular laboratory tasks. Where inter-laboratory proficiency tests do not exist Section Heads have the option to implement intra-laboratory proficiency tests as a substitute. Results of proficiency tests are maintained by the Section Heads (and Quality Manager) to document the performance of employees in such tests. Any corrective action taken as a consequence of the results is included in the training records.
5.3 ACCOMODATION AND ENVIRONMENTAL CONDITIONS
5.3.1 The XYZ LAB has two laboratory locations. The main laboratory is located in Eastern XYZ and housed in 123 Hall on the ABC campus of XYZ State University, is accommodated in rooms and laboratories totaling approximately 14,500 square feet. The XYZ LAB Branch Laboratory is located in western XYZ and housed in a 5,620 square feet facility located on the XYZ Research and Extension Center campus of XYZ State University. Both laboratories have designated areas for centralized functions, e.g. office functions, sample receiving and processing, glassware washing and media preparation, chemical and reagent storage, autoclaving, and shared instrumentation. General safety rules and chemical handling processes are described in SOP 192 Chemical Hygiene and Safety Plan. Fume hoods and biosafety cabinets are located throughout the laboratories to facilitate quality and safety requirements.
5.3.2 Environmental temperatures in the laboratory, including the temperature in rooms, on lab benches (when applicable), refrigerators, freezers, ovens, and incubators, are monitored, as described in SOP 115 Facility Monitoring.
5.3.3 Access to most areas of the main laboratory is controlled by a security card access system. The branch laboratory has access by key to the main building with an alarm system. SOP 115 Facility Monitoring addresses access control.
5.3.4 Section Heads and Laboratory Managers are responsible fora clean work area. This helps to facilitate the laboratory operations and serves to protect the health and safety of the staff. Safe collection, storage, and disposal practices are followed as described in SOP 190.5 XYZ LAB Medical Waste Disposal Procedures and SOP 192 Chemical Hygiene and Safety Plan. Requirements forhandling and storing compressed gas cylinders are also found in the same procedure.
5.4 TEST METHODS
5.4.1 Testing is conducted following the requirements of the Technical Procedures in the 200, 300, 400, 500, 600, 700, 800, 900, 100, 1100, 1200, 1300 and 1400 Series SOPs. These procedures address sample preparation, analysis, and quality control, general work instructions, as well as data recording and reporting. These same or separate procedures address the use of laboratory equipment and instrumentation. Copies of technical procedures are kept up to date and are distributed to the staff as specified in SOP 101 Document Control.
5.4.2 Analytical work is accomplished using methodology appropriate forthe specific purpose. The methodology to be used is available to the client by request. The methods include standard methods, methods having peer recognition, and methods mandated by legal requirements. If a client requests use of methodology other than that described in laboratory Technical Procedures, this request will be considered in light of the Section Heads’ or Pathologists’ judgment regarding the methodology as described in SOP 103 Case Accession.
5.4.3 Any deviations fromtest methods are specifically recorded, technically justified, and approved by management and the client prior to implementation.
5.4.4 The laboratory develops test methods, takes test methods fromauthoritative sources, and adapts or modifies test methods from the refereed scientific literature or from other AAVLD accredited laboratories. The laboratory ensures that the latest version of each test method is utilized, except as approved by the Section Head. New test methods are validated according to SOP 126: Method Validation. No methods are used to obtain data forroutine samples until their applicability has been established and the competence of each technical staff member to use those methods has been demonstrated and documented as described in SOP 113 Training of Personnel. Once the test has been approved for routine testing, its performance is monitored by the routine use of control samples or reference standards to assure the ongoing validity of the test.
5.4.5 Control charts for each applicable quantitative method are developed to establish quality control acceptance criteria. The development of control charts is described in SOP 116 Trend Analysis Using Control Charts or Other Statistical Methods.
5.4.6 The data taken from the control charts may be utilized to estimate the measurement uncertainty of the test method. When available and as appropriate, records of the measurement uncertainty, sensitivity, specificity, etc., for each test method are filed in the applicable laboratory section.
5.4.7 Control data from qualitative testing is logged to allow ongoing evaluation and trend tracking over time.
5.4.8 All manual data calculations and data transfers are reviewed and approved by a second reviewer (normally another analyst) in accordance with the requirements SOP 117 Data Review and Approval.
5.4.9 The protection and security of data that is recorded, processed, stored, reported, or retrieved via computers is addressed in SOP 110 Records Management.
5.4.10 All computers and automated equipment are maintained as specified in SOP 118 Laboratory Equipment.
5.5 EQUIPMENT
5.5.1 The requirements for the acceptance, use, and maintenance of laboratory equipment, instrumentation and computers are found in SOP 118 Laboratory Equipment and the Technical Procedures (SOP 200s, 300s, 400s, etc.).
5.5.2 Equipment SOPs for each piece of equipment are readily available to the equipment operators. These documents are maintained according to SOP 101 Document Control. It is the responsibility of each employee to read and understand the procedures for all equipment they use.
5.5.3 The Section Heads ensure the competence level all of their staff members in the operation of any laboratory equipment via proficiency testing as described in SOP 113 Training of Personnel.
5.5.4 No equipment is used until it is in a safe and reliable operational state, and then only by personnel who have been trained and qualified as operators. Equipment and its associated reference materials are identified and labeled, marked, or qualified by calibration data to indicate their calibration status as required by SOP 118 Laboratory Equipment.
5.5.5 Maintenance Records of all equipment are kept as specified by SOP 118 Laboratory Equipment.
5.5.6 Equipment that gives suspect results or is not functioning is removed from service and labeled “out of service”. If defective equipment is suspected to have a detrimental effect on test results, a Non-Conformance or Corrective Action should be initiated to determine the scope of the problem. The Director or Section Head will inform the applicable clients of the problem, if needed.
5.5.7 Equipment sent outside the control of the laboratory for repair is checked for function and calibration status before being placed back into service.
5.5.8 Intermediate checks used to maintain confidence in the calibration status of equipment are described in the Technical Procedures. These checks serve to safe guard the equipment to ensure the acceptance of data.
5.5.9 Equipment and software are to be protected from adjustments or changes that could invalidate test results.
5.6 MEASUREMENT TRACEABILITY
5.6.1 All equipment and instrumentation employed whose performance shall have a bearing on any results supplied to clients is calibrated and/or verified before it is used in accordance with requirements in SOP 118 Laboratory Equipment and the applicable Technical Procedures.
5.6.2 Reference Standards and Reference Materials
5.6.2.1 Where relevant, XYZ LAB uses Reference Standards traceable to NIST wherever possible (weights/masses, thermometers, metal analysis standards, etc.) or ISO 17025 accredited vendors who provide traceability via Calibration Certificates or Certificates of Analysis containing appropriate measurement uncertainty estimates. These standards and materials are calibrated and/or verified according to the procedures in SOP 119 Reference Standards and Materials.
5.6.2.2 Where traceability to standard reference materials is not possible and/or not relevant, other methods are used to establish confidence in the results, e.g. participation in proficiency testing programs, interlaboratory comparisons, use of reference materials (certified if available), testing by another technical procedure, or ratio-type measurements.
5.6.2.3 Intermediate checks are performed on reference standards and materials as appropriate, and are described in SOP 119 Reference Standards and Materials and in the applicable laboratory section procedures.
5.6.3 The laboratory handles and stores reference standards and materials according SOP 119 Reference Standards and Materials.
5.7 SAMPLING
5.7.1 Sampling is a critical step in the analytical process, but is the responsibility of the laboratory's clients rather than XYZ LAB technical staff, with the exceptions below. Therefore, acceptance/rejection criteria are established for samples that are directed at minimum acceptable requirements to accomplish quality service as described in SOP 103 Case Accession.
5.7.2 Sampling is performed by XYZ LAB pathologists during necropsies and may be performed by the Aquaculture laboratory section.
5.7.3 Sampling for Aquaculture and during Necropsy is performed according to Standard Operating Procedures for sampling that includes sample collection, processing (when applicable) and preservation. The procedures are available where the sampling is performed. Relevant data pertaining to sampling is recorded during the sampling event, including the collection procedure used, the sampler identity, environmental conditions (where relevant), and diagrams or other means to identify the collection location, and when applicable, the statistics the sampling procedures are based on.
5.8 HANDLING OF SAMPLES
5.8.1 Samples submitted by clients are handled in accordance with the requirements of SOP 103 Case Accession.
5.8.2 The scope of sample handling includes receipt and login, chain of custody, storage and disposal.
5.8.3 Abnormalities and departures are recorded as described in the referenced SOP.
5.9 ASSURING THE QUALITY OF TEST RESULTS
5.9.1 The laboratory monitors the quality (accuracy and precision) of test results by the inclusion of appropriate quality control measures on all tests done in XYZ LAB (See the Technical Procedures). The establishment of acceptance criteria is based on these historical quality measurements and trend analysis is employed for routine quantitative tests as described in SOP 116 Control Charts.
5.9.2 XYZ LAB participates in proficiency testing exercises as detailed below.
· African Swine Fever Virus Real Time PCR
· Anaplasmosis cELISA
· Avian Influenza AGID
· Avian Influenza Real Time PCR
· Avian Paramyxovirus PCR
· Bacteriology Interlaboratory Survey
· Bluetongue (BT)
· Bovine Leukosis (BLV)
· Bovine Spongiform Encephalopathy (BSE) ELISA
· Bovine Viral Diarrhea Virus, Antigen, Virus Isolation, IHC Ring Test
· Brucellosis Serologic Tests
· Chronic Wasting Disease, ELISA, IHC
· Classical Swine Fever Virus, PCR
· Equine Infectious Anemia (EIA)
· Equine Viral Arteritis (EVA)
· Foot and Mouth Disease Virus, PCR
· IBR Virus IHC Ring Test
· Johne’s Disease, Liquid culture, ELISAS, fecal Real Time PCR
· Koi Herpes Virus PCR International Ring Trial
· Leptospira, MAT
· Newcastle Disease Real Time PCR
· Porcine Reproductive and Respiratory Syndrome (PRRS)
· Pseudorabies (PRV) Serology, LA, gB ELISA, gl ELISA
· Rinderpest Virus Real Time PCR
· Salmonella in Liquid Egg
· Scrapie, IHC
· Vesicular Stomatitis Serum Viral Neutralization (SVN), PCR
· West Nile Virus ELISA
· Yersinia pestis Real Time PCR
5.10 REPORTING THE RESULTS
5.10.1 Test results are provided to clients via test reports as specified in SOP 120 Report Generation. Each test report contains all information required by the client to whom the report is sent, and is intended to meet the requirements of Sections 5.10.2 through 5.10.3 of the ISO/IEC 17025: Standard, current version. If the client does not want all the required information, it is readily available in the laboratory with the exception of those items pertaining to sampling.
5.10.2 The laboratory provides opinions and interpretations of reported data by faculty qualified based on experience and training (e.g. Ph.D., D.V.M., and diplomates of the ACVP, ACPV, ACLAM and ACVM) or other appropriately qualified and authorized Section Heads or Laboratory Managers.
5.10.3 Results of tests performed on the specimens forwarded to other laboratories are clearly identified on test reports.
5.10.4 The issuance of electronic reports is addressed in SOP 120 Report Generation and the confidentiality policy described in 4.1.5.2 of this document.
5.10.5 The format for test reports and the requirements for submitting amendments or supplements to test reports are also addressed in SOP 120 Report Generation.
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