QUALITY MANUAL GREAT LAKES INSTITUTE FOR ENVIRONMENTAL RESEARCH ANALYTICAL LABORATORIES. October 2008 Revision 08

Transcription

1 QUALITY MANUAL GREAT LAKES INSTITUTE FOR ENVIRONMENTAL RESEARCH ANALYTICAL LABORATORIES October 2008 Revision 08 Great Lakes Institute for Environmental Research University of Windsor Windsor, Ontario N9B 3P4 (519) , Ext K.G. Drouillard, Head, Organic B. J. Fryer, Head, Inorganic Date Date

2 PREFACE The Great Lakes Institute For Environmental Research (GLIER) Quality Manual, Standard Operating Procedures and Related Procedures identify the policies, analytical methodology and procedures adopted by the GLIER Laboratories at the University of Windsor. These methods and procedures are used for the examination of biological tissue, sediments, vegetation and water to ensure that it consistently delivers the highest standard of service to its clients. All methods and procedures described in these documents are currently used in the GLIER Laboratory at the University of Windsor. This laboratory operates in two Units: the Organic Analytical Unit and the Metals Analytical Unit. These documents were developed to provide a consolidated reference for the GLIER Laboratory. The policies and procedures cited are binding on all affected personnel and conform to the requirements of the relevant national and international standards for laboratory competency; viz. - CAN-P-4D - Requirements for the Competence of Environmental Analytical Laboratories; and, - ISO/IEC General Requirements for the Competence of Calibration and Testing Laboratories. These documents, in addition to their daily use, will be used by the GLIER Laboratory in its staff training programs and to meet requirements for Laboratory Accreditation. These documents are presented in loose-leaf form. Each of the three documents has a pagination scheme, which identifies pages within sections. Revised pages to the Manual will be indicated as a revision and dated. The Manual will be located in each unit of the GLIER Laboratory with a record of revisions dated as they occur. The GLIER Laboratory Manual was developed from information compiled and organized by Mr. J. C. Barrette, Supervisor, Inorganic Unit and Dr. Rodica Lazar, Supervisor, Organic Unit/Laboratory Supervisor with special acknowledgement to Jeanie LaForge. Mr. Harold Hagen (Acting Q.M. 2002) is also recognized for assistance in initiating our conversion to ISO Appreciation is also extended to Mr. Haig Agemian, Chief, Environmental Chemistry and Inorganic Methods Development, NWRI, Environment Canada and also Mr. Keijo Aspila for their assistance.

3 INTRODUCTION The GLIER Laboratory attempts to use the best available methodology and procedures for the analysis of biological tissues, sediments, vegetation and water. Such procedures are presented in these documents. The following criteria were used in the selection of methodology: o versatility of a test to analyze a variety of samples with different matrices and interferences without loss of precision or accuracy; o use of a standardized test wherever suitable; and, o acceptable quality control data to ensure that the procedure is capable of producing both valid and reliable results. Methodology and related test procedures were carefully selected from a variety of sources, as shown by the list of references. Some published procedures were modified and others were developed in the GLIER Laboratories to meet the special needs required by the samples. For each method, quality control data are included where available, either quoted from references or from procedures that were developed or modified at GLIER Laboratories. To ensure the reliability and validity of analytical data, the staff at GLIER Laboratories generate quality control data on a periodic basis. Most methods identify whether a total, dissolved or extractable constituent is measured. "Extractable" is defined as the dissolved constituent which is extracted from a solid or liquid sample, either by organic solvent extraction (for Organic Compounds Analysis) or by digestion with acid (for Metals Analysis). This manual deals with organic and inorganic chemistry. However, inorganic chemistry refers specifically to metals only. For descriptive purposes, references are occasionally made to specific commercial products or instrumentation. This reference does not constitute endorsement or recommendation for use by the GLIER Laboratory or the University of Windsor.

4 Quality Manual TABLE OF CONTENTS Preface Introduction 1. Introduction 2. Scope 3. Authorization 4. Distribution 5. Revisions 6. Quality Policy 7. Organization 8. Quality System 9. Document and Data Control 10. Review of requests, Tenders and Contracts 11. Subcontracting of Test and Calibrations 12. Purchasing 13. Services to Client 14. Customer Complaints 15. Control of Non-Conforming Testing Work 16. Corrective and Preventative Action System 17. Control of Quality Records 18. Internal Quality Audits 19. Management Review 20. Technical Requirements Appendix A Revision History

5 1. Introduction The Great Lakes Institute for Environmental Research (GLIER) is a consortium of researchers at the University of Windsor and elsewhere. The institute s interdisciplinary research is directed toward: conservation and resource management; health, toxicology and risk assessment; aquatic ecosystems; policy and economics; and sustainable design and development. GLIER Laboratories are housed in the University of Windsor's Great Lakes Institute for Environmental Research building. It is the mission of GLIER Laboratories to contribute to the development and application of sound, science-based knowledge for balanced effective ecosystem management. The employees of GLIER Laboratories are committed to providing high quality analytical laboratory and research services to both internal and external research partners dedicated in the pursuit and advancement of scientific knowledge of environmental systems. This manual provides the basis for a sound, technically competent quality system, and follows guidelines stated by ANSI Q quality system and the laboratory compliance standard CAN-P-4D (ISO/IEC 17025). It is the aim of this organisation to enhance client satisfaction and research collaboration through the effective application of this quality system. 2. Scope This manual outlines GLIER Laboratories quality system for its analytical testing activities in both metals and organic laboratories. GLIER Laboratories were established in 1984 and is owned and operated by the University of Windsor, Windsor, Ontario, N9B 3P4 Canada. The address is: GLIER Laboratory Great Lakes Institute for Environmental Research 2990 Riverside Drive West University of Windsor Windsor, ON N9B 3P4. This Quality Management System (QMS) will function as stated in this manual under the authority of the Laboratory Heads, Laboratory Managers and Quality Manager. 3. Authorisation The GLIER Laboratory Quality Management System, which includes this Quality System Manual (QSM), Quality System Procedures (QSP), Standard Operating Procedures (SOP) and Related Procedures (RP), are authorised and approved by the both Laboratory Heads. Revision: 08 Issued: October 2008 Page 5of 12

6 4. Distribution The Quality Manager maintains one hardcopy of all QMS and SOP documentation containing original authorisation signatures, and is maintained in the quality control office. Distribution is limited to the approval of the Quality Manager, and any authorised distributed copies are identified by the revision number and marked as 'Copy' on the front cover. The current revision and all previous reversion copies are maintained electronically in the Quality Control computer located in the organic laboratory office. 5. Revisions All revisions to this Quality Manual and related quality documentation are summarised in the revisions section of each controlled document, and maintained by the Quality Manager. 6. Quality Policy Our policy is to provide the highest standard of analytical service to our clients, based on best professional practice and the highest quality of service. With over 30 years combined experience, our professional staff provide outstanding analytical expertise performing SCC/CAEAL accredited methodologies for several environmental matrices. It is the policy of GLIER Laboratories to perform all laboratory quality assurance tests necessary to ensure analytical results are of sufficient accuracy and precision to meet the requirements of our customers. Roles and Responsibilities: Quality Manager - Ensure Quality Policy is enforced via resources and maintenance of Quality Manual and Quality System Procedures. Lab Supervisor - In charge of Laboratory practices under the GLIER Quality Policy The GLIER Laboratories standard of service is guided by the following commitment: Maintain compliance with the national regulating policy CAN-P-4D (ISO/IEC 17025) Maintaining excellence in proficiency testing by means of inter- laboratory trials and a rigid internal quality control policy Ensure all test and/or calibrations will be performed by properly trained personnel knowledgeable with the GLIER Laboratory s Quality System, using generally accepted best laboratory practices All tests and/or calibrations will be performed using only approved programs, procedures and forms as outlined in the laboratory quality management system All standard solutions and analytical instrumentation used to perform quality assurance tests will be traceable to international standards Continual improvement of Quality System Meet client objectives and requirements as well as statutory and regulatory requirements GLIER Laboratory Director Date Revision: 08 Issued: October 2008 Page 6of 12

7 7. Organisation GLIER Laboratories operate under authorisation of the University of Windsor, and are dedicated to furthering scientific knowledge and excellence to promote collaborative relationships within the scientific community. Organisation charts can be viewed in QSP 4.1. Job Descriptions are maintain in the Administration office for the following positions: Executive Director Laboratory Head Laboratory Supervisor Quality Manager Laboratory Technicians 8. Quality System The GLIER Laboratories quality system has been developed to satisfy its commitment to the laboratory quality policy, and to ensure compliance with the international standard ISO/IEC 17025:2001. The documents included under the heading of Quality Management System include this Quality System Manual, Quality System Procedures, Standard Operating Procedures and Related Procedures, Forms and Records. The quality system is described in detail under QSP 4.2. This QMS has been instituted to ensure this organisation and related personnel are able to identify the required processes needed for quality system application, the sequence and interaction of those processes, determine criteria and methods required to ensure efficient process control, ensure the necessary resources and information are in place, and continue to monitor, measure, analyse, and implement proper actions to ensure continual improvement of those processes. 9. Document and Data Control GLIER Laboratories maintain a document system designed to ensure control of all aspects of the GLIER QMS and ISO/IEC All documentation and data relating to these quality systems are controlled to ensure that only current documents and data are used. All documents are reviewed by each respective Laboratory Supervisor, and authorised by the Laboratory Head. Details relating to the GLIER QMS Document Control procedures are contained in QSP-4.3. The quality manual document system shall include documented statements of a quality policy and quality objectives, a quality manual, documented procedures, planning, operation and control documentation, and records required to conform with the instituted policies advocated within the GLIER QMS. Revision: 08 Issued: October 2008 Page 7of 12

8 10. Review of requests, Tenders and Contracts Prior to accepting to perform any services for our clients, the following conditions will be met: All customer requirements will be adequately understood, documented and agreed upon: The laboratory has or can obtain all necessary resources available to carry out the agreed requirements; The test method chosen is accepted by the client to be technically sufficient to meet their requirements Detailed overview of this section is outlined in QSP Subcontracting of Tests and Calibrations Subcontracting services can be employed to complete client requested testing which is not within the scope or technical abilities of GLIER Laboratories. Subcontractors are evaluated and selected based on their ability to meet performance and quality requirements as outlined by the GLIER Laboratories Quality Management System.. The procurement system used to implement the subcontracting of analytical services not offered by GLIER Laboratories is outlined in QSP 4.5, and applies to all contracted services which may impact the quality of results reported to the customer. 12. Purchasing Purchasing Services provides the GLIER Laboratories with acquisition services for products used for the purpose of sample analysis. The purpose of the University of Windsor Purchasing Services is to supply quality educational and research products, maintenance materials, operating supplies and services at the lowest possible cost to the University while complying with audit standards, legal requirements and government standards for public institutions. It is the intention of Purchasing Services to add value to the purchasing function by providing knowledge and expertise in the acquisition of goods and services from vendors and to expedite delivery to the campus community. The procurement procedures are outlined in QSP Services to Client GLIER Laboratories will maintain the highest regard for client confidentiality for all information obtained regarding client contracts. Final results and discussions regarding contract details will only be communicated to designated representatives of the client. Revision: 08 Issued: October 2008 Page 8of 12

9 Confidentiality agreements will be maintained in accordance to University of Windsor policies. Client requested access to laboratory operations will be granted once management representatives determine the integrity of confidentiality to all clients products and intellectual information will not be compromised in any way. Service to client procedures are outlined in QSP Customer Complaints GLIER Laboratories maintain procedures for the resolution of complaints received from clients or client representatives. Management authorisation is required to ensure client satisfaction and direct any follow-up activities. QSP 4.8 details procedures enlisted by this organisation when dealing with client complaint problems. 15. Control of Non-Conforming Testing Work Inspection, measuring and test equipment are controlled and their maintenance records maintained. Documentation procedures are outlined in the Control of Non-Conforming testing work section 16. Corrective and Preventative Action System A documented procedure is maintained for laboratory corrective and preventative actions associated with ISO/IEC quality system. Procedures are outlined in Corrective Actions Sect 4.10 and Preventive Actions Sect 4.11 Its purpose is to eliminate service, process and system nonconformances through root cause analysis. Any corrective or preventative actions taken to eliminate the causes of actual or potential non-conformances are to a degree appropriate to the magnitude of the problem and commensurate with the risks encountered. Any changes to the laboratory documented procedures resulting from corrective and preventative actions are recorded and controlled by the Quality Manager. 17. Control of Quality Records Quality records are maintained to demonstrate conformance with specified requirements and the effective operation of the quality system. Sect 4.12 Control of Records outlines GLIER Laboratories procedure for the indexing, accessing, filing, storing, maintaining, and disposal of quality records. Records are maintained in a legible format, readily retrievable, and in a suitably protective environment. Policy dictates that all records will be maintain for a period of five (5) years, unless otherwise noted. Records may be retained for longer periods of time if deemed necessary for legal or research purposes. 18. Internal Quality Audits GLIER Laboratories uses quality system approach to ensure that services they provide meet specified customer requirements and that all quality related activities conform to approved Revision: 08 Issued: October 2008 Page 9of 12

10 procedures. The Quality Manager is responsible for providing adequate resources and trained personnel to ensure that verification activities meet international standards and conform to documented procedures. Trained personnel are assigned auditing activities in all areas affecting quality. Each person involved in verification must have received proper training on key elements of the standard, and is authorised to perform these activities. Internal auditing of laboratory activities is covered in Sect 4.13, which defines the responsibilities requirements and procedures for audits. Where possible, auditors independent of the work being performed conduct assessments. Follow-up audit activities are performed and recorded to verify that corrective actions are implemented and ensure effectiveness of process. 19. Management Review The GLIER Laboratory quality system is reviewed at a minimum frequency of once (1) per year by management staff according to procedures outlined in Sect This review procedure ensures that the quality systems are suitable and effective in satisfying the requirements of ISO The reviews are recorded and authorised by the respective Laboratory Heads. 20. Technical Requirements In accordance to GLIER Laboratories quality system and ISO 17025, known factors which contribute to affect the correctness and reliability of the results reported as a result of the tests performed by a laboratory include: I. Personnel Assurance of employee competence is maintained through strict educational and/or laboratory experience requirements and regular assessments of training requirements for each employee. Qualification requirements are outlined in the respective job descriptions of each position. Documented procedures are maintained in Sect 5.2. II. Accommodation GLIER Laboratories environmental controls are maintained through the University of Windsor's Building Maintenance department. Strict policies are enforced to ensure environmental conditions are consistent with requirements consistent with the normal operation of laboratory procedures. Documented requirements are maintained through the University of Windsor and outlined in Section 5.3 of this quality systems manual. III. Method Validation and calibration GLIER Laboratories uses only published internationally recognised methodologies for all accredited testing procedures. Procedure validation procedures are outlined in Sect 5.4. When requested by clients, non-standard methodologies are used, once quality assurance can be established through method validations and customer consultation. Non-standard methodologies are indicated and identified by the customers reference in the final report. Method selections are based on the following: Revision: 08 Issued: October 2008 Page 10of 12

11 uncertainty of results method detection limits selectivity of the method repeatability and/or reproducibility, robustness against external influences cross sensitivity against matrix interferences IV. Equipment To maintain a high level of quality for the results reported, GLIER Laboratories ensure equipment is maintained according to manufacturer specifications, and ensures calibrations on specific instruments are completed during regular intervals specified in the manual. Procedures are maintained in Sect 5.5. V. Measurement Traceability As outlined in Sect 5.6, all equipment used for testing are calibrated on set intervals using documented procedures before being put into service. All calibration test standards are known to be traceable to international standard units. All check standards are prepared independently from calibration standards. VI. Handling of Test Items Upon receipt of sample items from customers, all test items undergo a log in procedure which identifies each sample with a unique identification number. Relevant information regarding the work order are recorded. Procedures for the handling of test items are included in Sect 5.7. VII. Quality assurance of test results GLIER Laboratories utilise several methods to ensure quality assurance of test results. The type of monitoring employed is dependent upon the sample matrix, analysis requested and volume of samples. These methods include; regular use of certified reference standards and internal reference materials participation in CAEAL inter-laboratory proficiency testing programs use of replicate testing blanks and reference spike standards VIII. Results reporting GLIER Laboratories use a documented procedure for the generation of all reports as a result of analytical analysis requests. It provides the necessary information required by the customer is reported in an accurate, concise, unambiguous and objective format. Internal customers (University of Windsor) and outside customers that make special request can receive reduced format datasets, but all relevant reporting information is retained on file for future reference. Any work completed by a contract lab is clearly reported as such on the report. New test reports are uniquely identified as such. Revision: 08 Issued: October 2008 Page 11of 12

12 APPENDIX A REVISION HISTORY Issue Date Description Revision Number March 2003 Original Issue 0 June 2004 Revision of Quality Manual 1.0 Rev. Rev. Revised Sections Description Auth. No. Date by Affected 06 Aug. 9, 2004 JC Barrette Appendix A Q.M. Table of contents add revision table change rev.no. to follow Q.M.2003 added table of contents 07 Dec9, 2004 JCB All text 6. Quality Policy Lab Manager terminology changed back to Supervisor Add sign off by senior management 6. Quality Policy Add roles and responsibilities 08 Oct JC Barrette 6. Quality Policy Preface Committed to improvements and client requirements Lab manual history with personnel Revision: 08 Issued: October 2008 Page 12of 12