GLIER QSP Managementrequirements

GLIER - Analytical Laboratories
Section 4, 5 Table of Contents
ISO/IEC 17025:2001 Quality System Procedures Revision 07 Page 1 of 1 Issued: December 2004
Quality System Procedures
TABLE OF CONTENTS
Management requirements 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 Organization Quality System Document Control Review of requests, tenders and contracts Subcontracting of tests and calibrations Purchasing services and supplies Services to the client Complaints Control of nonconforming testing and/or calibration work Corrective action Preventative action Control of records Internal audits Management review
Technical requirements 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 Personnel Accommodation and environmental conditions Test and calibration methods and method validation Equipment Measurement traceability Sampling Handling of test and calibration items Assuring the quality of test and calibration results Reporting the results
Section 4.1 Laboratory Organisation
ISO/IEC 17025 Quality System Procedures Revision 08 Page 1 of 7 Issued: Oct. 2008
4.1
Quality Manual Authorisation and Approval
The following section of this Quality Manual has been reviewed and approved for issuance by the commissioned management personnel. This is a controlled document, and unauthorised printing or photocopying is prohibited. Copies not showing the original signature are considered uncontrolled copies, and may not reflect currently issued policy/procedure.
____________________________________________________________________ Laboratory Director Date
Management Requirements 4.1 4.1.1 Laboratory Organisation

Registration
GLIER Laboratories were established in 1984 and is owned and registered as a legal entity of the University of Windsor, Windsor, Ontario, N9B 3P4 Canada. 4.1.2 Accreditation GLIER Laboratories have been accredited for specific tests since 1998, through the Standards Council of Canadas (SCC) Program for the Accreditation of Laboratories (PALCAN), and their assessment body, the Canadian Association for Environmental Analytical Laboratories (CAEAL). Responsibilities The major focus at the GLIER Laboratories is environmental testing, providing services for a range of environmental samples. This range includes solid wastes, effluents, receiving waters, ground waters, soils, sediments, plant, animal and fish tissues (See Section 5.4 for a complete list of Test Methods). Clients Served The GLIER Laboratories provide analytical science services to all interested parties: government, industry, and private individuals. 4.1.3 Operational Facilities This Quality System covers activities at the GLIER Laboratorys permanent facility only. GLIER Laboratories is comprised of two units - the Organic Analytical Unit and the Metals Analytical Unit. Staff from each unit report to the Laboratory Supervisor whom reports to the respective Laboratory Head. Conflict of Interest GLIER Laboratories operates as an impartial body within the institution of the University of Windsor, and is free from undue pressures that would affect its independence of judgement or integrity to its client as set out by the University of Windsor Policy Conflict of interest or Commitment Policy' November 1999. Management Responsibility Technical Operations. Overall responsibility for Technical Operations in the laboratory is assigned to the Laboratory Supervisor within each respective Unit.
4.1.4
4.1.5
Lab Heads. Are Management representatives for the GLIER Laboratory operations with key function in authorization of management system and management review 4.10 (review, continual improvements, departures and prevention). See Also 4.6.1.3 Quality Manager. Representative for the implementation of the ISO17025 System and availability of all resources for implementation within the GLIER quality system. Quality Assurance. Overall responsibility for quality assurance in each laboratory resides with the respective Laboratory Supervisor. This overall responsibility includes implementing a system which is understood, accepted and documented and which incorporates adequate review, audit and internal quality control. This responsibility includes documenting work instructions for the unit and ensuring adequate training and supervision for staff. It also includes, where appropriate, validation of test methods and application of adequate internal quality control. Client Confidentiality. All staff employed by the GLIER Laboratory, University of Windsor shall be required to sign a confidentiality agreement which includes an agreement, on the part of the employee, to hold in confidence all confidential information relating to a client, including proprietary rights. Confidentiality Agreement Forms are drafted by Legal Counsel at the University of Windsor and are signed by all staff. Copies of confidentiality agreements shall be maintained on file in the Administrative Services Section (See Appendix 4.1 ) Job Descriptions. All laboratory job descriptions shall be prepared and approved by the immediate Supervisor. Copies of all current job descriptions for managerial, professional and technical staff shall be maintained on file in the Administrative Office. Key Positions. The staff filling the key positions identified above are:
Lab Head - Organic Laboratory Lab Head Metals Laboratory Quality Manager Laboratory Supervisor - Organic Laboratory Laboratory Technician - Organic Laboratory Laboratory Supervisor- Metals Laboratory GLIER Office Administrator Dr. Ken G Drouillard Dr. Brian J. Fryer Mr. Jean Claude Barrette Dr. Nargis Ismail Mr. David Wei Qiu Mr. Jean Claude Barrette Ms. Mary Lou Scratch
Chart A provides an organisational outline for the GLIER Laboratories, University of Windsor.
Staff Substitution. Substitution arrangements for key managerial position when practical is as follows Position
Lab Director Head Metals Lab Head Organic Quality Manager
Substitution
Lab Heads Head Organic Head Metals Lab Lab Supervisors
Workload. The Laboratory processes approximately 1,500 samples annually. The breakdown by Unit together with assigned staff follows: Unit No. of Staff No. of Samples Inorganic Chemistry Organic Chemistry Total 1 2 3 500 1,000 1,500
GLIER Laboratory Organisational Chart A

Vice-President Academic University of Windsor
GLIER Executive Director GLIER Administration ML Scratch Laboratory Director BJ Fryer
Laboratory Head Organic Lab KG Drouillard
Laboratory Head Metals Lab BJ Fryer
Quality Manager JC Barrette
Organic Lab Supervisor Nargis Ismail
Metals Lab Supervisor JC Barrette
Lab Technician D. Qiu
University of Windsor
Academic Operations President
Vice-President, Academic Executive Assistant to the Vice-President Academic Executive Secretary to the Vice-President Academic
Director Great Lakes Institute Associate Vice-President Academic Affairs Associate Vice-President Research
Special Assistant to the VPA & Director, Faculty Recruitment & Retention
Director, Division of Instructional Development and Co-ordinator of Academic Computing
University Academic Structure
Section 4.1 Laboratory Organisation APPENDIX A REVISION HISTORY
Revision 0 April 23, 2003 H.Hagen -new issue of revised format Quality manual Revision 1.1 June 14, 2004 H.Hagen - Organisational chart update - Haffner to Drouillard, use Manager instead of Supervisor terminology Rev. No.
06
Rev. Date
Aug. 9, 2004 Dec. 2004
Revised by
JC Barrette
Sections Affected
4.1 Appendix A Approval 4.1 Org. Chart all text 4.1.5 Title page Header 4.1.1 Registration 4.1.2 clients Keyposition/Chart 4.1.5Resposibility
Description
Auth.
07
JC Barrette
Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Title terminology, re-organized similar to2003 Change terminology of Lab Manager back to Supervisor Staff Substitution added similar to 2003 Approval by Lab Director List 17025 only. Not 17025:2001, year of doc. revision GLIER legal entity of University of Windsor Removed consultants from clients served Remove vacant for Nargis Ismail, Org Lab Defined Lab Head and Quality Manager Responsibilities
08
Oct. 2008
JC Barrette
Section 4.2 Quality System
4.2
Quality Manual Authorisation and Approval The following section of this Quality Manual has been reviewed and approved for issuance by the commissioned management personnel. This is a controlled document, and unauthorised printing or photocopying is prohibited. Copies not showing the original signature are considered uncontrolled copies, and may not reflect currently issued policy/procedure.
______________________________________________________________________ Laboratory Director Date
Management Requirements 4.2 4.2.1 Quality System Scope GLIER Laboratories maintain a quality system in accordance to ISO/IEC 17025-2001 guidelines. Policies, systems, programmes, procedures and instructions which encompass this Quality Assurance programme are documented to ensure the quality of testing results. The Quality Manager is responsible for implementing and overseeing the quality system. The assigned inividual has the authority to use the resources available at GLIER to enforce the Quality System Procedures. Quality Objective The quality objective is to ensure that a well structured and documented GLIER Quality Management System (QMS) is in place, and that this system incorporates adequate review, audit, and internal quality control. The purpose of the QMS is to ensure the services and advice offered by GLIER meet the needs of our clients and the requirements of the accrediting agency. The QMS is a structured management system of principles, objectives, policies, responsibilities and implementation plans at the organisational and project-specific levels. It provides the structure within which planning, implementation and performance assessment may occur. The organisational system of the QMS regulates activities that support common or standardised functions. Some examples of the types of controls used in GLIER include: utilizing SOPs to ensure data consistency in the measurement process; auditing operational performance of the laboratory on a routine basis and providing corrective action if needed; maintaining complete records of sample receipt, laboratory analysis and data reporting. 4.2.3 Quality Documentation Quality Policy and Quality System Manual (QSM) The Quality System Manual is the first level document, which describes the implementation of the GLIER Quality Management System within the Laboratory. It specifies the activities required to achieve the quality goals established by GLIER. The QSM is updated as required and is approved by the respective Laboratory Heads.
4.2.2
Quality System Procedures (QSP) The Quality System Procedures are the second level documents which outline the detail of management strategies for carrying out policies and objectives specified in the QSM. The sections within this document describe, in a systematic manner, the measures which the laboratory employs to implement the QA program. Standard Operating Procedures (SOPs) These documents describe all the written instructions necessary to utilise Laboratory testing procedures (i.e. methods) within GLIER and provide a working document where all details are specified. SOPs are updated on a regular basis by the Laboratory Supervisors and approved by the appropriate Laboratory Head. They are kept in a central area within each analytical laboratory. SOP documents are revised, controlled and distributed through the Administration Office. Related Procedures (RP) These documents specify the sets of definitive instructions which must be followed, without exception, by all staff, for those procedures that are standard across the laboratory or across a series of analytical methods. These include procedures such as sample receiving, data management, preparation of standards and analyst proficiency records. Upon revision, the latest version is approved by the appropriate Laboratory Head and forwarded to each Laboratory Supervisor for use in appropriate Laboratory. Forms and Records All relevant forms and working documents outlined in the GLIER QMS documentation are retained in the Quality Assurance office for use by technical personnel charged with carrying out any related activities. Records are maintained by the responsible personnel according to the respective SOP and/or RP, and stored at locations specific to the ordered task. Examples include logbooks, training records, equipment monitoring. See (Appendix 4.2.3 Workload Management) as a guide to records controls for routine monitoring
APPENDIX A
REVISION HISTORY
Rev. No.
06
Rev. Date
Aug. 9, 2004 Dec. 8, 04
Revised by
JC Barrette
Sections Affected
4.2 Appendix A Approval 4.2.1 Title Page
Description
Auth.
07
JC
Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Scope statement expanded to responsibility to Quality Manager Lab Director Approval
ISO/IEC 17025 Quality System Procedures Page 1 of 8 Revision 10 Issued: October 2008
Section 4.3 Document Control
4.3
Management Requirements 4.3 4.3.1 Document Control General Document Control is necessary to ensure that lab personnel have access to current policies and procedures at all times. Quality documents that are placed under a controlled distribution include, but are not limited to: the QM, the SOPs. Related Procedures, and Forms. Control is maintained by initially distributing the documents to the staff members who need to be aware of or need to follow the contained information or procedures. The Quality Manager ensures that all quality documentation is adequately controlled using a Document Header with the following information including the first page as authorization. 4.3.2 identified by subject, date of issue, revision number and page numbering with total pages; reviewed for accuracy; approved by authorised person; available when required; replaced when obsolete.
Document Approval and Issue
4.3.2.1 Master List. A master list of all quality documentation, which identifies all current revisions, is located at the front of this document, and in the Quality Control Office. Laboratory Head signatures located on the authorisation sections of each quality document are evidence of document control. The master list includes the following documentation: Quality Policy and Quality System Manual (QSM) The Quality System Manual is the first level document, which describes the implementation of the GLIER Quality Management System within the Laboratory. Quality System Procedures (QSP) The Quality System Procedures are the second level documents which outline the detail of management strategies for carrying out policies and objectives specified in the QSM.
1) Standard Operating Procedures (SOPs) These documents describe all the written instructions necessary to utilise Laboratory testing procedures (i.e. methods) within GLIER and provide a working document where all details are specified. 2) SOP Validation data Validation Data binder tabulated with data sourced from the QA/QC SOP log files. Tabulated as per 5.4.5.1 validation parameters. Related Procedures (RP) These documents specify the sets of definitive instructions which must be followed, without exception, by all staff, for those procedures that are standard across the laboratory or across a series of analytical methods. Forms and Records All relevant forms and working documents outlined in the GLIER QMS documentation are retained for use by technical personnel charged with carrying out any related activities. 4.3.2.2 Availability and Review Distribution A distribution list of all quality documentation is maintained in the Quality Control Office, and the Quality Manager ensures that all persons identified on the distribution list receive updated documents and return all obsolete documents. Distribution list will be as follows: Manuals in Circulation Complete manual: Home copy (1 copy) - Quality Control Office Partial manuals: Standard Operating Procedures (6 Copies) Organic Lab Sample Preparation Lab Metals Lab Sample Preparation Lab Instrument Lab Data Management Lab Sample Preparation Lab Sample Preparation Lab
S.O.P.
Related Prod. Sample Preparation Lab SOP-Validation Data Sample Preparation Lab
Review and Approval The Quality Manager ensures that all changes or additions to the quality documentation undergo adequate review and are approved by the respective Laboratory Head. Obsolete Documentation Obsolete documentation retained for legal or reference purposes will be maintained in file and suitably identified by denoting obsolete over the controlled document label. Controlled copies will be marked accordingly. Documents in circulation will be considered uncontrolled copies, and require validation of revision number before use. If the obsolete method is re-instituted as a regular or non-routine test method, it will first be subjected to documented validation procedures according to ISO/IEC 17025 section 4.3. 4.3.3 Documentation Changes
4.3.3.1 Changes or Additions Changes or additions to the quality documentation may be initiated by anyone on written application to the Quality Manager and/or Laboratory Head or as a result of corrective action, but they must follow the approval process, including a management review and authorisation, before changes can be formally instituted and a revision issued. 4.3.3.2 Revisions A log of revisions to quality documentation will appear in the revisions section of each controlled document, and is approved by the respective Laboratory Head for Laboratory SOP and RP. The Quality Manual and Quality System procedures is approved by the Laboratory Director. 4.3.3.3 Hand-written Amendments Hand-written amendments to quality documents may be conducted on controlled quality documents only, dated and initialled by the lab supervisor. Changes to quality documentation must comply to regulations set out in section 4.3.3.2 before formal approval and reissue.
Amendments may, upon approval, involve expeditiously issuing entire new documents, issuing replacement pages or dated and initialled changes in ink to the original document. Revisions will be clearly marked, initialled, and dated by the Laboratory Manager. Exceptions to the above rules are valid for data collection forms, laboratory logs, and similar documents which do not require management authorisation. 4.3.3.4 Electronic Document Control Storage Method - the revision&date directory will change as per edits, use most current. - all files feed from: LimsSTD:\AnaLabsAdm\LabManual\\ Quality Manual: \\Quality Manual\ Revision&Date \ GLIER Laboratory Quality Manualdoc Quality System Procedures: \\Q.Sys.Prod\Appendix\Revision&Date \ appendicesdoc \\Q.Sys.Prod\Section 4\ Revision&Date \ QSP 4.1doc \\Q.Sys.Prod\Section 5\ Revision&Date \ QSP 5.2doc Standard Operating Procedures: \\SOP\Metals\ Revision&Date \ 01-001wpd \\SOP\Organic\ Revision&Date \ SOPORGwpd Related Procedures: \\Rel.Prod.\Metals\ Revision&Date \ relprodwpd \\Rel.Prod.\Organic\ Revision&Date \ rpwpd SOP Validation Data \\SOPValidationData\Revision&Date \metals&organic.doc
Reference 4.12.2.1.4 for Back up of records. Changes to Electronic Documentation The new document is saved/stored in a newly created folder named with a higher revision number. The previous file remains in its respective revision folder. The revision history/record contains all necessary descriptions of changes for reference. The document is reissued, as outlined in section 4.3.3.
All text formatting (as outlined above) will be removed upon formal reissue of document, and final changes included in the revision record located at the front of each controlled document. Departures from Quality Documentation Departures from policies, procedures or methodologies documented in the Quality Manual, Standard Operating Procedures and Related Procedures may be permitted under exceptional circumstances. All departures must receive prior written approval from the appropriate authority. 4.3.4 Data Management To ensure data management procedures that incorporate adequate procedures for the security, recording, calculation, validation, authorization, transmittal, storage and disposal of all test data and related records. The Laboratory Supervisor is responsible to retain all technical records pertaining to the execution of data analysis. This includes, but is not limited to, sample submission, original observations, calibration records, sample process and analysis, data generation, test performance, report generation and client feedback.
4.3.4.1 Corrections to Original Test Data It is GLIER Laboratory policy to ensure mistakes to test data made during recording are not erased, made illegible, or deleted in any way that may render the recorded entry insubmissable as a legal document. At the time of data recording, situations were corrections to mistakes in original test data may be required. Mistakes are crossed out and initialed by the recording technician, and subsequent corrections entered alongside the original data. The use of correction mediums (White Out) is prohibited from use in any recording documents. In the case of electronic records, the data (cell on spreadsheet) must be highlighted using special, i.e. cross out, bold, highlight., as available by program.
4.3.4.2 Storage and Disposal of Records It shall be the responsibility of the respective Laboratory Supervisor to ensure that records identified in this Manual and under their responsibility are easily retrievable and stored in a secure manner. As soon as such records no longer serve a useful purpose within an individual section they remain in the custody of the respective Laboratory Supervisor, stored in records storage. All records may be disposed of after a period of five (5) years or as necessary, unless otherwise specified by legal or contractual obligations. Each respective Laboratory Head is responsible for disposal of any records kept.
4.3.4.3 Maintenance of Computer Files The laboratories central computer (LIMS ST - running windows 2000) is backed up weekly onto an external drive source. The external drive source is supplied by the University under the Novell network (having its own back-up). This task is done manually in Windows explorer by the drag an drop method. Refer to the equipment binder under computers and Appendix 8.1 for procedure. 4.3.4.4 Maintenance of Equipment log books and binders. Log books and clipboards (log worksheets) for Internal Quality Control are all returned to a home Equipment binder. It contains sections such as balances, temperature, water, computers. 4.3.4.5 Computer Data Protection and Confidentiality Each Laboratory has one dedicated computer workstation that must be securepassword protected and have data storage back-up. - Windows operated computers must be password protected on boot up and have a time out password prompt as well (screensaver). User specific accounts for privileged access to specific folders should also be activated as necessary. See Equipment Binder under Computer Maintenance for set-up details.
APPENDIX A
REVISION HISTORY
Revision 5.1 April 23, 2003 H.Hagen -new issue of revised format Quality manual Revision 5.2 June 17, 2004 H.Hagen - addition of Appendix A: Revision History section - updates to Storage Hard drive information Rev. No. Rev. Date
Aug. 9, 2004 Aug. 9, 2004 Dec. 8, 04
Revised by
JC Barrette JC Barrette
Sections Affected
4.3.3.4 4.3 Appendix A Approval Hagen Rev. No.s 4.3.3.3 elec. Doc. 4.3.3.1 changes 4.3.3.2 Title page 4.3.4 Data Management
Description
Auth.
edit file storage location and reference back-up records change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Change listed version 0, 1.1 to 5.1, 5.2 Actual practices listed Quality manager responsible for document changes Clarify approval of QM, QSP by Lab Director Lab Director Approval 2003 QM format change, copy over missed edited 4.3.4 for QSP 2006
06
07
JC
08
Nov 2, 06
JC Barrette
09
Oct 18, 07
JC Barrette
4.3.2.1& 4.3.2.2Master List 4.3.3.3 Handwritten amendts. Header 4.3.1
add SOP Validation Binder yes to controlled documents by lab Supervisor with date and initial
10
Oct. 2008
JC Barrette
Remove year in 17025:2005 Headers, Page numbering and page total
Section 4.4 Review of Requests, Tenders and Contracts
4.4
Section 4.4 Review of Requests, Tenders and Contracts i) Purpose
This procedure defines the authority, responsibilities, and system for review of requests, tenders and contracts that lead to a contract for services by GLIER Laboratories. ii) Scope 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 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 iii) Definitions Contract: A contract may be defined either as a written document or verbal agreement held between the client, Laboratory Head and University of Windsor which outlines the intent to procure services. iii) Authorities and Responsibilities The request, tender and contract review procedure will be conducted by the Laboratory Head of each respective laboratory, and the process will remain consistent for both internal and external customers. Formal written contract proposals are reviewed and authorised by the both the GLIER Director and University of Windsor Associate Vice-president of Research. The GLIER Administrator is responsible for coordinating and maintaining all financial records pertaining to execution of the contract grant account with the University of Windsor's Financial Services department.
Section 4.4 Review of Requests, Tenders and Contracts Management Requirements
4.4 4.4.1
Review of Requests, Tenders and Contracts Request, Tender and Contract Review Procedure This procedure defines the authority, responsibilities, and system for review of requests, tenders and contracts that lead to a contract for services by GLIER Laboratories. i) Client and Laboratory Head agree on the terms and conditions regarding a requested contract of service by the GLIER Laboratories. The Lab Manager initiates the inter university verification process by completing a UofW Research Contract form Upon Director authorisation, the research contract form and client contract are submitted for approval to the office of Research Services. One copy is retained by the GLIER Administrator in central files; Office of Research Services sends the authorised form and client contract to Financial services to open a Grant account; Confirmation of Grant account is received by the GLIER Administrator, which is appended to the central file contract; Upon completion of required contract services, the GLIER Administrator notifies Financial services to invoice client for services rendered, and a copy of the requested invoice is appended to the contract in central files; Confirmation of payment is received by the GLIER Administrator internally, and contract is closed.
ii)
iii)
iv)
v)
vi)
4.4.2
Terms of Agreements This procedure shall ensure that: All requirements including methodology used will be adequately defined, documented and understood by the customer. Agreements regarding testing time line and sample disposal, storage or return shall be made.
The laboratory has the required technical and managerial capability and resources to meet the customer's requirements. The appropriate method and/or calibration is agreed upon by customer prior to start of analysis. The request, tender and contract review procedure will be conducted by the Laboratory Head of each respective laboratory, and the process will remain consistent for both internal and external customers. The review will be conducted in a practical and efficient manner, incorporate financial, legal, and scheduling objectives of both the customer and laboratory. The Laboratory Supervisor will use routine methods that are approved by the Laboratory Head, selected from the approved and authorised Standard Operating Procedure (SOP) of the GLIER Quality Manual. The routine methods used are based on the latest edition of published international, national and regional standards which enlist a validated SOP quality assurance/quality control procedure. The Laboratory Supervisor is responsible for ensuring that the laboratory is physically capable of performing the analysis, will select the most appropriate method, and ensure the required analytical personnel with the necessary skills and expertise to perform the analysis are available. A contract may be defined either as a written document or verbal agreement held between the customer and Laboratory Head which outlines the intent to procure services. 4.4.3 Records of Reviews Reviews and amendments to contracts will be carried out by Laboratory Heads as necessary, and changes recorded in management meeting minutes. All correspondence with the client regarding the contract agreement will be recorded and maintained in the clients contract file. Any reviews done by the Lab Heads having technical relevance must be communicated to the Lab Supervisor of the respective lab. 4.4.4 Subcontracting Review Reviews and amendments relating to subcontracted work will be carried out by Laboratory Heads as necessary, and a record maintained in management meeting minutes.
4.4.5
Client Notification Changes to a clients contract are admissible under specific instruction, notification, and authorisation from the client. In the event changes are anticipated for any of the outlined procedures relating to a contract agreement, the client will be notified by the Lab Heads or as delegated. Such notification will be in writing of such changes if they are deemed to affect the normal execution of their contract provisions.
Section 4.4 Review of Requests, Tenders and Contracts APPENDIX A Rev. No.
06
REVISION HISTORY Sections Affected

4.4 Appendix A Approval All text Title page 4.4.3 records rev. 4.4.4 subcon. Rev. 4.4.3 records rev. 4.4.5 client not. Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Terminology of Lab Manager back to Supervisor Lab Director Approval Specify Lab Head carries out review Specify Lab Head carries out review Head must communicate technical change to Supervisor Add statement; initiated by the lab Head or as delegated
Rev. Date
Aug. 9, 2004 Dec. 8, 04
Revised by
JC Barrette
Description
Auth.
07
JC
Section 4.5 Subcontracting of Tests
ISO/IEC 17025 Quality System Procedures Revision 08 Page 1 of 4 Issued: October 2008
4.5
i)
Purpose This procedure outlines the system used by GLIER Laboratories to implement subcontracting of analytical services, and applies to all contracted services which may impact the quality of results reported to the customer.
ii)
Scope In order to execute client requests for services not offered by GLIER Laboratories, this section outlines the requirements that will be met to ensure the competence of the subcontractor to complete any required test(s) that may impact the quality of results.
iii)
Definitions Sub-Contractor: Vendor/Supplier of analytical services required to complete the requirements of a contract agreement.
iii)
Authorities and Responsibilities Terms of the subcontractor agreement are authorised by the Laboratory Head, with intended to reflect the client requirements.
4.5.1
Subcontractor Competence GLIER Laboratories may, from time to time, enter into agreements with other laboratories to conduct analytical work on behalf of clients. As per the discretion of the Laboratory Head, testing work may be completed by the subcontracting laboratory. The Laboratory Head is responsible for securing a competent subcontractor. A minimum competency must be shown via conformance to ISO 17025 requirements. Proof of competency will be required from each subcontracted service, and may take the form of conformance to international standards of service, work history and/or completion of a supplier/contractor competence survey. The ideal situation when subcontracting is to hire another CAEAL accredited laboratory. However, if that is not possible, the subcontractor could be required to participate in interlab comparisons for the suite of parameters involved. If this is not available, incorporate another laboratory to split or share samples in order to cross check work of the laboratory performing the analytical work. If knowledge of certain Reference Material is available, results of analysis could be supplied in support of the Reference Material. Also, samples of known composition could be analysed by the subcontracting laboratory to verify results.
4.5.2
Client Notification The respective Laboratory Heads shall obtain prior permission from the client in writing to sub-contract any portion of the client's testing to another party. These arrangements are made on a project-specific basis, and agreements are confirmed in writing before any action is taken. Any amendments to original must be signed by Lab Head to supersede. All original subcontractor reports are submitted in writing or electronically and kept by the respective Laboratory.
4.5.3
Responsibility to Client A Quality Assurance Plan must accompany the agreement, and be approved by the respective Laboratory Head. The purpose of this Plan is to ensure that results obtained by the sub-contracting laboratory will demonstrate the quality of its analytical work.
4.5.4
Sub-Contractor Register
The Laboratory Manager shall maintain a record of all sub-contractors and a record of the evidence of compliance with CAN-P-4D for those sub-contractors providing service for GLIER Laboratory accredited methodologies only.
Through the use of various GLIER management appointed assessment methods, subcontracting laboratory(s) have been able to demonstrate the quality of its analytical work. A list of currently appointed subcontractors appears in Appendix 4.5.4.
APPENDIX A Rev. No.

06

4.5 Appendix A Approval Title page 4.5.2 Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Lab Director Approval Add amendment requires Lab Head signature.
Rev. Date
Aug. 9, 2004 Dec. 8, 04
Revised by
JC Barrette
Description
Auth.
07
JC
08
Oct. 2008
JC Barrette
Header 4.5.1 4.5.2
List 17025 only. Not 17025:2001, year of doc. revision Minimum competency required as 17025 accreditation Subcontractor reports are submitted in writing or elec.
Section 4.6 Purchasing Services and Supplies
4.6
Section 4.6 Purchasing Services and Supplies Management Requirements 4.6 4.6.1 Purchasing Services and Supplies
Equipment, Service and Supply Procurement
4.6.1.1 Purpose To ensure all equipment, supplies and services are functioning properly and/or meet required specifications, and define the authority, responsibilities, and system for the purchase of quality critical equipment, materials and services for use in GLI Laboratories. 4.6.1.2 Scope This procedure applies to all analytical and quality critical equipment, materials and services used by GLI Laboratories to carry out analysis of testing as outlined in SCC accredited methodologies . 4.6.1.3 Procurement The respective Laboratory Supervisors shall be responsible for preparing specifications for all purchased services, equipment and supplies used in the conduct of laboratory testing. Supplies will include test organisms, reagents, glassware, spare parts etc. Services will include sub-contracted testing, as well as equipment servicing. The Laboratory Head has final approval of request from the Lab Supervisor via purchase requisitions or tenders. The results of such assessments shall be communicated to the Laboratory Supervisor. The Laboratory Supervisor shall maintain a list of all approved suppliers, including subcontractors from whom the laboratory obtains goods or services. The individual(s) approving the specifications shall also be responsible for (i) issuing related tenders or requests for proposal; (ii) evaluating related bids and proposals; and (iii) either approving related purchase orders or contracts, or seeking approval by the designated spending authority. The respective Laboratory Supervisor maintains an appropriate inventory for ongoing consumables.
The respective Laboratory Supervisor shall maintain a file that identifies all purchased goods by: purchase order number; description, including grade/batch number, species/lot number, model/serial number, etc.; vendor name; date of receipt; ID of person checking order; disposition of order and reason for acceptance or rejection; assigned inventory number, if applicable. Prior to acceptance all purchased goods shall be checked by (i) verifying appropriate correspondence between the purchase order and packing slip; and (ii) verifying, when applicable, conformance to any prescribed specifications. Such checking shall normally be carried out by the individual(s) initiating the purchase order. 4.6.1.4 Sole Source Procurement (University of Windsor Financial Services Policy) In the case of purchasing goods and/or services from a sole supplier, Purchasing Services requires a written explanation by the requisitioner which explains in detail why the goods and/or services can only be provided by the supplier mentioned in the purchase requisition. The explanation will be kept on file with the Purchase Order for auditor's review. In order to meet the requirements as a sole source provider , the goods and/or services should meet the following: to ensure compatibility with an existing product to protect copyrights or patents for the maintenance or repair of specialised equipment that must be carried out by the manufacturer or its representatives if, for specific research or scientific reasons, the product is only available from one source. In this case, the requisitioner accepts personal responsibility that no other product and/or service can meet the specifications required for his/her research or scientific needs. 4.6.2 Inspection and Verification Laboratory Supervisors verify items for ensuring purchased materials that affect the quality of testing are properly inspected/tested to ensure the materials comply with standard specifications as outlined in the pertaining test method. .
Section 4.6 Purchasing Services and Supplies 4.6.3 Purchasing Documents
Purchasing documents are issued and maintained by the University of Windsor Financial Department. These documents contain all relevant information to facilitate the identification and communication of required product specifications to the supplier. The Laboratory Supervisor issuing the purchase request is charged with ensuring the proper specifications are identified on the requisition document. 4.6.3.1 Purchase of Critical Equipment, Services and Supplies 4.6.3.1.1 Definitions Quality Critical Equipment: Equipment, materials or services that have been determined to potentially affect the quality of results reported to GLIER Laboratory customer agents. This definition also includes the purchase of calibration services deemed necessary to implement SOP, as well as QA/QC guidelines. Critical Supplier: Vendor/supplier of products or services deemed quality critical to the laboratory's ability to report quality analytical results to its customers. The Lab Head is responsible approving specifications on critical equipment. 4.6.3.1.2 Procedure Specifications for quality critical laboratory equipment, materials, and services are defined and approved by the Lab Heads. Vendor approval is based on the Laboratory Managers recommendations, past performance, reputation, questionnaires, and/or published methodologies. Current/additional suppliers may only be used after formal evaluation, which requires notification of required certificates by suppliers to distribute critical equipment as outlined in ISO/IEC 17025 and the affected SOP/QA/QC documentation. Purchase requisitions/orders clearly specify technical requirements of the equipment. materials and/or service being ordered. Formal evaluation of suppliers is carried out via a questionnaire. See Appendix 4.6.3.1
4.6.4
Supplier Approval The individual(s) approving the specifications for goods and services shall, where appropriate, carry out an assessment of suppliers, which may include, but not be limited to, recommendations, past performance, questionnaires and/or published methodologies. Approved suppliers shall (i) provide goods and services that are of adequate quality to sustain confidence in the laboratory's tests; or (ii) in the case of sub-contracted testing, provide services that meet standards of competence equivalent to those in place at the GLIER Laboratories, University of Windsor. An approved suppliers list is maintained in Appendix 4.6.
Section 4.6 Purchasing Services and Supplies APPENDIX A Rev. No.

06

4.6 Appendix A Approval All text 4.6.2 4.6.2 4.6.3.1.2 4.6.1.3 proc. 4.6.3.1.1 purc. 4.6.3.1.2 prod. 4.6.3.1.2 prod. Title page Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Change terminology of Lab Manager back to Supervisor Lab Supervisor inspects goods, not technician Delete reference to SOP Lab Head define approval of critical purchases Lab Head has final approval Lab Head approval on critical eqm specs Lab Head replaces Lab Manager Reference to questionnaire Add H.Hagen draft of questionnaire to appendix Lab Director approval
Rev. Date
Aug. 9, 2004 Dec. 8, 04
Revised by
JC Barrette
Description
Auth.
07
JC
Section 4.7 Service to Client
4.7
Management Requirements 4.7 4.7.1 Service to Client Purpose This procedure defines the authority, responsibilities, and system used to ensure the value of the services offered to clients of GLIER Laboratories . 4.7.2 Scope This procedure applies to all analytical services offered by GLIER Laboratories. GLIER laboratories engage primarily in not for profit research projects with partner groups and researchers within the public and private sector. In such capacity, collaborative projects with our clients contribute to the advancement of science through publications in peer reviewed journals, and thus are not based on the more traditional market strategies of service-oriented laboratories. 4.7.3 Procedure GLIER Laboratory services and associated personnel will maintain a strict level of confidentiality for all information pertinent to its clients. Any information pertaining to laboratory services, including final results, will only be released directly to the customer, or a designated customer representative. When not deemed to affect the confidentiality of laboratory clients, GLIER laboratories will afford the client reasonable access to areas of the laboratory for the purpose of reviewing procedures and the witnessing of analysis performed for the client. Confidentiality agreements maintained between GLIER Laboratories and its customers will supersede specific client requests for admittance to facility or documentation when deemed ethically inappropriate. This responsibility remains the decision of the Laboratory Head, and shall be considered prior to approving customer requests for visitation of said facility. All attempts to ensure good customer relations, including advice, guidance in technical matters, and interpretations of results, will be maintained.
APPENDIX A Rev. No.

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4.7 Appendix A Approval Scope Title page Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page collaborator/client definition Lab Director Approval
Rev. Date
Aug. 9, 2004
Revised by
JC Barrette
Description
Auth.
07
Dec. 9, 04
JC
Section 4.8 Customer Complaints
4.8
Management Requirements 4.8 4.8.1 Complaints Purpose This procedure defines the authority, responsibilities, and quality system used to ensure that all customer complaints are received, documented, assessed and responded to in a timely basis. Customer Complaints All technical complaints originating from clients, or other external sources, are directed to the respective Laboratory Supervisor. Where situations (ie: previously issued test reports) warrant follow-up activities, a corrective action report form is initiated. An acceptable resolution may include any combination of retest, third party testing, credit or refund as approved by the respective Laboratory Heads. Before a resolution is announced, the Laboratory Supervisor determines that the resolution or the action meets with the client's satisfaction, and obtains authorisation from the Laboratory Head. All non-technical complaints are addressed by the Lab Heads. 4.8.3 Complaints Records The Laboratory Supervisor and/or Quality Manager as applicable maintains a record of all complaints and the corrective actions taken. (see file, customer complaints/client feedback).
4.8.2
APPENDIX A Rev. No.

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4.8 Appendix A Approval 4.8.2 all text 4.8.3 complaints Title page Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Add non-technical issues are addressed by Lab Heads Change terminology of Lab Manager ot Supervisor Responsibility to Job Title for record keeping Lab Director approval
Rev. Date
Aug. 9, 2004 Dec. 8, 04
Revised by
JC Barrette
Description
Auth.
07
JC
Section 4.9 Control of Non-conforming Testing
4.9
Section 4.9 Control of Non-conforming Testing Management Requirements 4.9 4.9.1 Control of Non-conforming Testing
Purpose This procedure defines the authority, responsibilities, and quality system used to ensure that all customer complaints are received, documented, assessed and responded to in a timely basis Definitions A non-conformance is any analytical result, which may be outside acceptable error due to the use of an incorrectly calibrated instrument or an instrument found to be out of range of acceptable deviation during a quality assurance test. In other words, a system that is not compliant to its normal operating specifications outside of regular maintenance. A non-conformance is a deviation from an established protocol or plan, such as: failure of resources (i.e. personnel, equipment, facilities, work instructions) to meet performance requirements or other specified requirements; failure of personnel to comply with documented work instructions or operational procedures; failure of test data to meet required standards due to: failure (or suspected failure) to meet all conditions necessary to ensure the integrity and representatives of the sample, i.e. sample history deficiencies exist; failure (or suspected failure) to comply with the test method SOP's; failure (or suspected failure) in method performance as demonstrated by results provided by quality control samples; inherent property of a sample that compromises the testing, e.g. as verified by the method of standard additions; Relevant evidence provided by data validation e.g. as a result of comparison with expected values, ranges or relationships. If any of these causes is due to circumstances outside the control of GLIER, then it is termed a deficiency. Deficiencies are handled through the use of a Sample Submission/Reception form, at the sample receiving area. The client is contacted and the problem resolved before the samples are processed.
4.9.2
Section 4.9 Control of Non-conforming Testing 4.9.3 Non-Conforming Test Data
Test data will be considered to be nonconforming, if any of the following conditions exist: failure (or suspected failure) to meet all conditions necessary to ensure the integrity and representativeness of the sample, i.e. sample history deficiencies exist; failure (or suspected failure) to comply with the test method or supporting work instructions; failure (or suspected failure) in method performance as demonstrated by results provided by quality control samples; inherent property of sample that compromises the testing, e.g. as verified by the method of standard additions; relevant evidence provided by data validation, e.g. as a result of comparison with expected values, ranges or relationships. Non-conformance logs are initiated using the Non-Conformance Report (form 4.9) located in the appendix binder. Each Laboratory Supervisor shall ensure that records of non-conformances and the actions taken are kept. If applicable, in the case of a nonconformance applies to both labs the Quality Manager ensures that the record is kept and actions are followed up. It is also the responsibility of the Quality Manager to have the CAR reviewed at year end during QA and or management review. Manual flags are assigned to nonconforming test results. They shall exist at the following steps in the data management process: sample reception; sample analysis; data validation. The provision shall exist for each assigned flag to be accompanied by an explanatory comment. Prior to reporting nonconforming or suspected nonconforming data, the Laboratory Supervisor shall advise the client and seek further instructions. If for any reason it is suspected that nonconforming data may have been reported, i.e., as a result of audit findings, proficiency testing, client feedback or any other circumstance, the Laboratory Supervisor shall immediately notify any client whose data may have been affected. After conferring with the client work may be recalled and followed by a superseded report as necessary.
Section 4.9 Control of Non-conforming Testing
4.9.4
Procedure for Remedial Action of Non-conformance The Laboratory Supervisor ultimately assumes responsibility for ensuring any nonconformance identified in the laboratory is identified and corrected. The Quality Manager is responsible for ensuring all necessary resources are made available to the laboratories for the maintenance of the Quality System. The Lab Supervisor authorizes a resume work (start up) when non-conformance is corrected. If an instrument or piece of testing equipment is found to be out of calibration, and is deemed to possibly impact the quality of the data reported to the customer, an investigation into the root cause and evaluation of the significance of the nonconformance is initiated. As soon as the non-conformance has been identified, the following procedure is conducted: The instrument will be identified as out of service. Any other instrument or piece of equipment that may have be adversely affected by the nonconformity, or is subject to similar fault, will also be evaluated in the same manner. The reporting of any future results generated by the instrumentation will be withheld until the root cause and net analytical effect can be determined. Any further work on the instrument will be halted until the extent and significance of the non-conformance is determined. A decision on the acceptability of the results produced since the last calibration will be made to determine if non-conforming results may have been generated and reported between calibrations. If the possibility exists, client(s) whose data have been affected by the nonconformance are notified in writing, and individual concerns and the significance of potential deviations are determined. As soon as remedial action is taken, the Laboratory Supervisor authorises the instrument to be placed back into service. If the instrument cannot be returned to service immediately, and an acceptable backup method exists, results may be generated using the backup method. After the instrument has been returned to service, its performance shall be monitored regularly to ensure corrective action taken was effective. If doubt exists concerning the ability of the instrument to continue to produce reliable results, the Laboratory Supervisor will devise a long-term strategy for the repair, replacement, or acceptance of an alternative method.
Section 4.9 Control of Non-conforming Testing APPENDIX A Rev. No.

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4.9 Appendix A Approval All text 4.9.3 4.9.4 Title page Header 4.9.2 4.9.3 Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Lab manager to Supervisor Clarify responsibility of CAR to Lab Supervisor and Quality Manager Lab Supervisor authorizes work start up after nonconformance Lab Director approval Remove 2001 from 17025 A simplified definition of non-conformance Clarify client notification and work recall
Rev. Date
Aug. 9, 2004 Dec. 8, 04
Revised by
JC Barrette
Description
Auth.
07
JC
08
Oct. 2008
JC Barrette
Section 4.10 Corrective Action
4.10
Management Requirements 4.10 Corrective Action
4.10.1 General 4.10.1.1 Purpose This procedure outlines a system for identification and correction of existing quality nonconformities within the operations of GLIER Laboratories. Outlines for specific programs and procedures are addressed, with the objective of monitoring these corrective actions to achieve prevention of any recurrences. 4.10.1.2 Definition Corrective Action: A corrective action is a measure taken to rectify conditions that compromise the quality of a product or system, or in response to a customer complaint, and where possible, to preclude its recurrence. It usually identifies a response to an existing problem. 4.10.2 Cause Analysis Corrective actions are often carried out in response to a non-conformance (Section 4.9) and may include; an investigation of potential causes of nonconformity, and an analysis of possible contributing factors to determine the root cause. Potential causes can be assessed from various sources of information, including client feedback, sample specifications/condition, methods and procedures, training requirements for staff, or equipment calibrations.
4.10.3 Selection and Implementation of Corrective Actions It is the policy of GLIER Laboratories to initiate immediate action(s) to control or correct a non-conformance identified to affect the quality procedure. The Laboratory Manager assumes responsibility for investigating the problem and determination of the root cause, as well as assigning responsibility for the implementation of a corrective action procedure. The corrective action processes are maintained under document control procedures using Corrective Action Reports (Appendix 4.10), and required changes are implemented by the
Laboratory Supervisor with assistance from the Quality Manager and/or Laboratory Heads as required. Specific procedures are defined in Section 4.9, the laboratory standard operating procedures and work instructions, and may include; determining and initiating a preventative action to eliminate or control the problem or prevent its re-occurrence. implementation of the necessary corrective action and assessment of its effectiveness. Applying controls to prevent re-occurrence. Implementing and documenting changes resulting from the corrective action, as well as documenting its effectiveness.
4.10.4 Monitoring of Corrective Actions In the case of an internal method audit, proficiency testing, or any other corrective action, the following procedures are followed: An audit report is submitted from the Laboratory Head to the appropriate Laboratory Supervisor; A final decision is taken by management regarding the remedial action and a written reply is submitted from the responsible Laboratory Supervisor to the Laboratory Head within 15 days.
4.10.5 Additional Actions The necessity of initiating additional, follow-up, audits, in cases where a serious, persistent issue has not been solved using the above procedures may occur. Responsibility for initiating additional audits rests with the Laboratory Supervisor.
APPENDIX A Rev. No.

06

4.10 Appendix A Approval All text 4.10.3 Title page Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Lab Manager terminology to Supervisor Lab Supervisro implements CAR required changes Lab Director approval
Rev. Date
Aug. 9, 2004
Revised by
JC Barrette
Description
Auth.
Section 4.11 Preventative Action
ISO/IEC 17025:2001 Quality System Procedures Revision 08 Page 1 of 3 Issued: August 2006
4.11
Management Requirements 4.11 Preventative Action, Continual Improvement
4.11.1 Purpose This procedure outlines a system for identification and prevention of potential quality non-conformities within the operations of GLIER Laboratories. Outlines for specific programs and procedures are addressed, with the objective of monitoring these preventative actions to achieve prevention of any recurrences. 4.11.1.1 Definition Preventative Action: A preventative action refers to the identification of needed improvements and the prevention of potential non-conformities in quality and technical operations. 4.11.2 Primary Objective The primary objective of a preventative action is to prevent potential problems related to quality, reduction of errors, and quality enhancement. Preventative action plans can be identified from various resources, including: Customer feedback Internal/quality/management review audits Technical meetings Staff brainstorming Quality Control Charts-Predicting control chart trends - Refer to CAEAL document T27 for additional information. Copy also contained with Internal Audit File. Management meeting agenda of GLIER Laboratories representatives include discussions concerning Preventative Action objectives. It is the intention of GLIER Laboratories to develop long-term strategies that focus on Preventative Action training and incorporation into regular Quality Assurance activities. 4.11.3 Procedure Document any new ideas (or based on preventative resources as listed above) via C.A.R. forms Appendix 4.9.
APPENDIX A Rev. No.

06

4.11 Appendix A Approval 4.11.2 Title page 4.11.2 4.11.3 - new Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Add predicting trend problems Lab Director approval add refer to CAEAL T27 change resource to technical meeting procedure to initiate CAR record for new ideas
Rev. Date
Aug. 9, 2004 Dec. 8, 04 Aug. 31, 06
Revised by
JC Barrette
Description
Auth.
07 08
JC JC Barrette
Section 4.12 Control of Records
4.12
Management Requirements 4.12 Control of Records
4.12.1 General 4.12.1.1 Purpose To define the type, responsibility and retention time for quality records maintained to confirm the achievement of the required level of quality outlined in this Quality Management system. 4.12.1.2 Scope Management is responsible for incorporating adequate procedures for the recording, collection, indexing, authorisation, maintenance, storage and disposal of all quality and technical records 4.12.2 Procedures 4.12.2.1.1 Records Maintenance
Quality documentation is maintained in accordance to procedures set out both this section and in Sect. 4.3.1. The Quality Manager and Lab Supervisor is responsible for the control of quality records, including filing, storage, maintenance, and disposition of said records. Quality records are retained in the Quality control office, and are maintained in both hardcopy and electronic form. Copies of non-process related documents are available for duplication. Process related documents are maintained by the technical staff at the specific workstation to facilitate supply on demand and prevent work interruption. The following table includes some examples of documents maintained under this system. Key Laboratory Quality Records
Sample Logbook Customer Request for Tender and Contracts Customer Complaints Test Results Calibration Checks Compliance Certificates Traceability of Standards Non-Conformance Reports Records of Management Review Internal Quality Audit Reports Approved Sub-Contractor files
4.12.2.1.2 Management Review All relevant records relating to a quality audit, performance audit, client feedback and internal performance check shall be available for the quality system review. The results of the review and any actions taken shall be documented and filed by the Quality Manager who shall be responsible for preparing a report detailing the results of the review. 4.12.2.1.3 Storage, Disposal, Access and Integrity of Records
Storage It shall be the responsibility of the respective Laboratory Supervisor to ensure that records identified in this Manual and under their responsibility are easily retrievable and stored in a secure manner. As soon as such records no longer serve a useful purpose within an individual section they remain in the custody of the Quality Manager, stored in records storage. Disposal All records may be disposed of after a period of five (5) years or as necessary, unless otherwise specified by contractual obligations and/or by special request by client. Each respective Laboratory Head is responsible for disposal of any records kept. Access Unless access to specific records is specified by contract or mandated by audit, all client or other requests for access to records must be directed to the Laboratory Supervisor. Access to a client's own specific records will not be unreasonably denied. Requests by a third party must be accompanied by written consent from the client. Records that may be made available on request to the Laboratory Supervisor shall be limited to: staff curriculum vitae; records of analyst proficiency; equipment maintenance logs; reagent preparation logs; records of non-conformance; data validation records; original test data; logs or records relating to primary measurement, i.e. weight, volume, temperature; logs or records relating to water quality i.e. reagent water, dilution water; performance audit or quality audit results;
Under no circumstances, except as dictated by a Court of Law, shall records be removed from the laboratory. Requirements for ensuring client confidentiality shall be observed when making records available. Records Integrity Records are maintained in a secure and suitable environment outside the laboratories in office space adjacent to the labs. Maintenance of Equipment log books and binders. Log books and clipboards (log worksheets) for Internal Quality Control are all returned to a home Equipment binder. It contains sections such as balances, temperature, water, computers. 4.12.2.1.4
Protection, Backup and Access of Electronic Records
Maintenance of Computer Files 1) Metals Lab: The laboratories central computer (LIMS ST - running windows 2000) is backed up weekly onto an external drive source. The external drive source is supplied by the University under the Novell network (having its own back-up). This task is done manually in Windows explorer by the drag an drop method. Refer to the equipment binder under computers for procedure. Procedure: External Back-Up (LimsST to Novell) 1. Ensure PC is booted up into Microsoft and Novell network. Novell Client: - cntr + alt + delete - username: barretb - password: calculation Windows Workstation: - Name: Administrator - From: Metals Lab - Password: 5str5ll9t1 Open Windows Explorer Scroll to Novell back-up location Description Location Novell: J:/barretb on'Gamma\GLIER\Users' \\Iris-TJA Instrument PC, ICP-OES \\Jcoff Office PC, JC
2. 3.
4. 5.
\\NSTVR1 Data PC, LIMS server \\SQL database (L2K GLIER) Data PC, LIMS server(linked ST.) \\LIMS ST Data PC, LIMS ST \\Metals LIMS St \\Organic LIMS St Copy each of the Five directories listed above from the location described one at a time through the Microsoft network and paste onto the Novell drive. Override the last date stored directory.
Notes: - Windows 2000 automatic back-up program has been investigated , see Data Management Log book Nov2002 - Novell requires the drag and drop method therefore the automatic was not used. 2) Organic Lab: Back up methods 1. GC-MSD onto CD disks 2. Data processing PC onto external hard drive 4.12.3 Technical Records 4.12.3.1 Original Observations The Laboratory Supervisor will ensure that original observations, including recording of all relevant testing information, are maintained in a permanent form that facilitates reproduction of the test if required. 4.12.3.2 Calibration Records Calibration records shall include sufficient information to facilitate the duplication of that calibration under the same environmental conditions, should the need arise. 4.12.3.3 Staff Records Personnel records for all staff shall be maintained on file in the Administrative Services Section. These records shall include (i) employee curriculum vitae (ii) record of relevant training courses and (iii) confidentiality agreement signed by the employee. 4.12.3.4 Test Reports Copies of test reports are maintained by each respective Laboratory Supervisor. The format of test reports are outlined in Section 5.10.
4.12.3.5 Recording of Original Test Data All original test data, including QC data, shall be recorded in a permanent form, e.g. notebook, worksheet, instrument printout or magnetic media, using a permanent recording medium at the time observations are made. Under no circumstances is a pencil allowed as a recording media. The following information shall accompany the test data: name of analyst; sample ID; test method ID; date of test; test organism lot number, where applicable; equipment ID, where applicable.
Currently, data are manually entered into computers on a spreadsheet program (Quattro Pro) and moved to respective files to sort control and assurance data. Clients are provided with a hard copy of data results and upon request, a magnetic disk copy. All associated data with respect to a result is available for repetition under the original method conditions should identification of any suspect factors affection uncertainty be required. Absent Test Data Test data may be absent if any of the following conditions exist: damaged sample; insufficient sample; sample history deficiency; laboratory accident. Flags assigned manually to absent test data shall exist at the following steps in the data management process: Sample reception and sample analysis. The provision shall exist for each assigned flag to be accompanied by an explanatory comment. Absent data due to conditions other than a laboratory accident shall be confirmed at the time of sample reception (see Section 5.4.1). If a laboratory accident occurs the respective Laboratory Manager shall, prior to reporting absent or forming data, advise the client and seek further instructions.
4.12.3.6 Corrections of Original Records It is GLIER Laboratory policy to ensure mistakes to test data made during recording are not erased, made illegible, or deleted in any way that may render the recorded entry insubmissable as a legal document. At the time of data recording, situations were corrections to mistakes in original test data may be required. Mistakes are crossed out and initialled by the recording technician, and subsequent corrections entered alongside the original data. The use of correction mediums (White Out') is prohibited from use in any recording documents. 4.12.3.7 Corrections to Electronic Data In the case of electronic records, the data (cell on spreadsheet) must be highlighted using special a function (i.e. cross out, bold, highlight) as available by program. The Lab Supervisor must approve a change. Changes to electronic copies of quality documentation are reissued under procedures as outlined in section 4.3.3. as indicated by document revision record. Previous versions are stored via different revision numbers and therefore are not lost. The Quality Manager must approve Quality documentation changes.
APPENDIX A
REVISION HISTORY
Revision 0 March 25, 2003 H.Hagen -new issue of revised format Quality manual Revision 1.1 June 28, 2004 H.Hagen - Change Manager to Supervisor terminology Rev. No.
06
Rev. Date
Aug. 9, 2004 Dec. 8, 04
Revised by
JC Barrette
Sections Affected
4.12 Appendix A Approvals Title page All text 4.12.3.5 4.12.3.7 4.12.2.1.3 Header 4.12.2.1.3 4.12.2.1.4 4.12.3.5 4.12.3.5
Description
Auth.
07
JC
08
October 2008
JC Barrette
Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Lab Director approval Lab Manager terminology back to Supervisor Pencil not allowed Add responsibility of changes and edit for actual Record storage if requested by client Remove 2001 from 17025 Records integrity, storage within office space out of lab Computer file maintenance; Separate Metals and Organic Lab Methods Recording of data: Add original test data is available for repetition under original method conditions. Remove statement LIMS planning stages
Section 4.13 Internal Audits
4.13
Management Requirements 4.13 Internal Audits
4.13.1 General 4.13.1.1 Purpose To define the planning and implementation of internal quality audits to verify whether the quality activities and analytical results comply with approved procedures and to gauge the effectiveness and areas requiring improvement of the quality system. 4.13.1.2 Scope Internal quality audits will cover all elements of the quality system. The Quality Manager together with each Laboratory Supervisor operates a quality audit program by carrying out systematic examinations on an annual basis, e.g. through observation, interviews and examination of records/documentation. This program is in place to determine whether: i) policies, procedures and work instructions are implemented effectively as documented; and, ii) resources, policies and procedures are suitable to achieve the quality objectives. The Internal Audit system includes the following key elements: Internal Audit Key Elements
Equipment/Cal Facilities Staff Training Documents Control Data Management Workload Management Logs and actions Procurement Method Validation Internal Quality Control Work instruction Sample Reception Management Review
Results of audits will be forwarded by the Auditor to the respective Laboratory Supervisor. Original transcripts are maintained in document control by the Quality Manager.
4.13.1.3 Auditor Qualification 4.13.1.3.1 Administration of Audit Activities
GLIER Laboratories will ensure that, where resources permit, auditors will be deemed independent of the activity being audited. these activities are deemed the responsibility of the Quality Manager. In situations where personnel resources are limited, audit activities will be conducted by each Laboratory Supervisor on the other laboratory system, i.e. Metals Supervisor is authorised to audit the Organic Laboratory activities, and visa versa. 4.13.1.3.2 Auditor Training and Records
Auditors will have appropriate training by an external accredited organisation. Auditors will include proven methods for implementing an ISO 9000 quality system, as well as required standards outlined in ISO 17025. Training records qualified staff are maintained by the Quality Manager in the Quality Control Office. 4.13.2 Auditing Procedures 4.13.2.1 Quality System Audit Plan All procedures cited in the Quality Manual, together with those described in SOP's and Related Procedures, will be subject to internally-initiated audit. Other items can be specified and implemented by the Auditing personnel. The CAEAL Rating Guide CAN-P-1510D, or any other suitable check list, may be used when conducting an internal audit. The steps to be followed in conducting a quality audit are: notify relevant individuals regarding details of the audit schedule; hold pre-audit meeting and verify arrangements; conduct audit; hold post audit meeting and convey documented findings; develop appropriate corrective action schedule if necessary ensure follow up activities verify the implementation and effectiveness of the corrective action(s) taken The audit conclusions and any subsequent corrective action(s) shall be documented and filed by the Quality Manager with the assistance of Laboratory Managers. Corrective Action forms are used for each identified non-conformance. Summary results shall be communicated by the Quality Manager to the respective Laboratory Heads during Management Review meetings, unless actions require immediate implementation of upper management authority.
The Quality Manager will identify the auditors and the areas to be audited. Scheduled audits, in addition to any scheduled CAEAL or other accreditation audits, will occur, at least. In addition, unscheduled audits may be initiated by the Quality Manager any time. Such audits may respond to performance audit results, client feedback or any other circumstance challenging either the quality of the laboratory's' tests or compliance with the provisions of this Quality System. The Quality Manager, in co-operation with the respective Laboratory Heads, ensures that any actions identified in this way are completed according to the specified time frame. 4.13.2.2 Performance Testing The Quality Manager operates a performance audit program, which incorporates participation in proficiency testing and is supplemented by provision of check samples prepared by a qualified independent source, external to the laboratory. Both organic and inorganic sections will participate in the Performance Audit Program. If a performance audit provides results which challenge test method performance, the Quality Manager may, after appropriate investigation, initiate either corrective action or a quality audit. The results of performance audits and any subsequent actions shall be documented and filed by the Quality Manager. Copies of relevant (summary) information shall be circulated by the Quality Manager to the respective Laboratory Supervisor. Findings are defined as those noncompliant practices which require corrective action. Comments are considered advice and do not require a corrective action response. It is the responsibility of each respective Laboratory Manager to verify implementation of the corrective actions. 4.13.2.3 Client Notification It is the intention of GLIER Laboratories to ensure the maintenance of quality analytical performance. If testing results are deemed by the Auditing personnel to have been compromised in any manner that may affect the quality of reported results, the respective client(s) or their representative(s) in ownership of the testing agreement shall be notified in writing, details of the non-conformance articulated, and mutually acceptable remedial actions agreed upon. Records of communications with the client(s) will be maintained with the respective noconformance file. The client will be notified upon satisfactory completion of nonconformance to communicate resulting actions, and ensure client satisfaction.
Flowchart The following flowchart outlines the basic concepts for auditing procedures followed by GLIER Laboratories (Reprinted from ANSI/ISO/ASQ Q9000-2000).
APPENDIX A Rev. No.

06

4.13 Appendix A Approval Title page All text I.Audit Prod. (App 4.13A) I.Audit Schedule (App 4.13B) Header 4.13.2.2 Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Lab Director approval Lab Manager terminology back to Supervisor Deleted from text, moved to Appendix and returned to 2003 version Copy from 2003 Quality Manual ,Appendix
Rev. Date
Aug. 9, 2004 Dec. 8, 04
Revised by
JC Barrette
Description
Auth.
07
JC
08
October 2008
JC Barrette
Remove 2001 from 17025 Remove reference to appendix that does not exist
Section 4.14 Management Reviews
4.14
Management Requirements 4.14 Management Review
4.14.1 General 4.14.1.1 Purpose To define management's responsibility to ensuring continued quality in areas of resource allocation for management system review. 4.14.1.2 Scope The quality management review process and subsequent report shall include at least the following sections: Introduction, statement of meeting objectives Review of minutes and actions from previous review Suitability of policies and procedures Reports from managerial and Managery personnel Review of recent internal audits Corrective and preventative actions Review of recent assessments by external bodies Results of recent inter-laboratory proficiency testing Assessment of workload Assessment of client feedback Corrective actions to any client complaints All other relevant factors regarding quality management Implementation of continual improvement
4.14.2 Review Procedures 4.14.2.1 Quality Management System Review Laboratory Heads and the Quality Manager meet, at least annually, to evaluate the quality system, to ensure its continuing suitability and effectiveness, and to introduce any necessary improvements. Management Review schedule is outlined in Appendix 4.14. All relevant records relating to a quality audit, performance audit, client feedback and internal performance check shall be available for the quality system review. The results of the review and any actions taken shall be documented and filed by the Quality
Manager who shall be responsible for preparing a report detailing the results of the review. The Quality Manager, in cooperation with the Laboratory Heads, ensures that any actions are discharged according to the agreed time frame.
APPENDIX A Rev. No.

06

4.14 Appendix A Approval Title page Change rev.no. to follow Q.M.2003 add revision table add approval/authorization page Lab Director Approval
Rev. Date
Aug. 9, 2004 Dec. 9, 04
Revised by
JC Barrette
Description
Auth.
07
JC

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GLIER - Analytical Laboratories

Section 4, 5 Table of Contents

GLIER - Analytical Laboratories

Section 4.1 Laboratory Organisation

Quality Manual Authorisation and Approval

____________________________________________________________________ Laboratory Director Date

GLIER - Analytical Laboratories

Section 4.1 Laboratory Organisation

Management Requirements 4.1 4.1.1 Laboratory Organisation

GLIER - Analytical Laboratories

Section 4.1 Laboratory Organisation

GLIER - Analytical Laboratories

Section 4.1 Laboratory Organisation

GLIER - Analytical Laboratories

Section 4.1 Laboratory Organisation

GLIER Laboratory Organisational Chart A

GLIER Executive Director GLIER Administration ML Scratch Laboratory Director BJ Fryer

Laboratory Head Organic Lab KG Drouillard

Laboratory Head Metals Lab BJ Fryer

Quality Manager JC Barrette

Organic Lab Supervisor Nargis Ismail

Metals Lab Supervisor JC Barrette

Lab Technician D. Qiu

GLIER - Analytical Laboratories

Section 4.1 Laboratory Organisation

Director, Division of Instructional Development and Co-ordinator of Academic Computing

University Academic Structure

GLIER - Analytical Laboratories

Section 4.1 Laboratory Organisation APPENDIX A REVISION HISTORY

GLIER - Analytical Laboratories

Section 4.2 Quality System

______________________________________________________________________ Laboratory Director Date

GLIER - Analytical Laboratories

Section 4.2 Quality System

GLIER - Analytical Laboratories

Section 4.2 Quality System

GLIER - Analytical Laboratories

Section 4.2 Quality System

GLIER - Analytical Laboratories

Section 4.3 Document Control

______________________________________________________________________ Laboratory Director Date

GLIER - Analytical Laboratories

Section 4.3 Document Control

Document Approval and Issue

GLIER - Analytical Laboratories

Section 4.3 Document Control

GLIER - Analytical Laboratories

Section 4.3 Document Control

GLIER - Analytical Laboratories

Section 4.3 Document Control

GLIER - Analytical Laboratories

Section 4.3 Document Control

GLIER - Analytical Laboratories

Section 4.3 Document Control

GLIER - Analytical Laboratories

Section 4.3 Document Control

4.3.2.1& 4.3.2.2Master List 4.3.3.3 Handwritten amendts. Header 4.3.1

Remove year in 17025:2005 Headers, Page numbering and page total

GLIER - Analytical Laboratories

Section 4.4 Review of Requests, Tenders and Contracts

______________________________________________________________________ Laboratory Director Date

GLIER - Analytical Laboratories

Section 4.4 Review of Requests, Tenders and Contracts i) Purpose