GLIER_QSP_Managementrequirements

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001Quality System Procedures

Section 4, 5Table of Contents Page 1 of 1

Revision 07Issued:

December 2004

Quality System Procedures

TABLE OF CONTENTS

4 Management requirements

4.1 Organization4.2 Quality System4.3 Document Control4.4 Review of requests, tenders and contracts4.5 Subcontracting of tests and calibrations4.6 Purchasing services and supplies4.7 Services to the client4.8 Complaints4.9 Control of nonconforming testing and/or calibration work4.10 Corrective action4.11 Preventative action4.12 Control of records4.13 Internal audits4.14 Management review

5 Technical requirements

5.2 Personnel5.3 Accommodation and environmental conditions5.4 Test and calibration methods and method validation5.5 Equipment5.6 Measurement traceability5.7 Sampling5.8 Handling of test and calibration items5.9 Assuring the quality of test and calibration results5.10 Reporting the results


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ISO/IEC 17025Quality System Procedures

Section 4.1Laboratory Organisation Page 1 of 7

Revision 08Issued: Oct. 2008

4.1 Quality Manual Author isation and Approval

The following section of this Quality Manual has been reviewed and approved for issuance bythe commissioned management personnel. This is a controlled document, and unauthorised

printing or photocopying is prohibited. Copies not showing the original signature are considereduncontrolled copies, and may not reflect currently issued policy/procedure.

____________________________________________________________________Laboratory Director Date


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Management Requirements

4.1 Laboratory Organisation

4.1.1 RegistrationGLIER Laboratories were established in 1984 and is owned and registered as a legalentity of the University of Windsor, Windsor, Ontario, N9B 3P4 Canada.

4.1.2 AccreditationGLIER Laboratories have been accredited for specific tests since 1998, through theStandards Council of Canadas (SCC) Program for the Accreditation of Laboratories(PALCAN), and their assessment body, the Canadian Association for EnvironmentalAnalytical Laboratories (CAEAL).

ResponsibilitiesThe major focus at the GLIER Laboratories is environmental testing, providing servicesfor a range of environmental samples. This range includes solid wastes, effluents,receiving waters, ground waters, soils, sediments, plant, animal and fish tissues (SeeSection 5.4 for a complete list of Test Methods).

Clients ServedThe GLIER Laboratories provide analytical science services to all interested parties:government, industry, and private individuals.

4.1.3 Operational FacilitiesThis Quality System covers activities at the GLIER Laboratorys permanent facility only.GLIER Laboratories is comprised of two units - the Organic Analytical Unit and theMetals Analytical Unit. Staff from each unit report to the Laboratory Supervisor whomreports to the respective Laboratory Head.

4.1.4 Conflict of InterestGLIER Laboratories operates as an impartial body within the institution of the Universityof 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 PolicyConflict of interest or Commitment Policy' November 1999 .

4.1.5 Management ResponsibilityTechnical Operations. Overall responsibility for Technical Operations in the laboratoryis assigned to the Laboratory Supervisor within each respective Unit.


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Lab Heads. Are Management representatives for the GLIER Laboratory operationswith 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 andavailability of all resources for implementation within the GLIER quality system.

Quality Assurance. Overall responsibility for quality assurance in each laboratory resideswith the respective Laboratory Supervisor. This overall responsibility includesimplementing a system which is understood, accepted and documented and whichincorporates adequate review, audit and internal quality control. This responsibilityincludes documenting work instructions for the unit and ensuring adequate training andsupervision for staff. It also includes, where appropriate, validation of test methods andapplication of adequate internal quality control.

Client Confidentiality . All staff employed by the GLIER Laboratory, University ofWindsor shall be required to sign a confidentiality agreement which includes anagreement, on the part of the employee, to hold in confidence all confidential informationrelating to a client, including proprietary rights. Confidentiality Agreement Forms aredrafted 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 AdministrativeServices Section ( See Appendix 4. 1 )

Job Descriptions . All laboratory job descriptions shall be prepared and approved by theimmediate Supervisor. Copies of all current job descriptions for managerial, professionaland 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 Dr. Ken G DrouillardLab Head Metals Laboratory Dr. Brian J. FryerQuality Manager Mr. Jean Claude BarretteLaboratory Supervisor - Organic Laboratory Dr. Nargis IsmailLaboratory Technician - Organic Laboratory Mr. David Wei QiuLaboratory Supervisor- Metals Laboratory Mr. Jean Claude BarretteGLIER Office Administrator Ms. Mary Lou Scratch

Chart A provides an organisational outline for the GLIER Laboratories, University ofWindsor.


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Staff Substitution. Substitution arrangements for key managerial position when practical is as follows

Position SubstitutionLab Director Lab HeadsHead Metals Lab Head OrganicHead Organic Head Metals LabQuality Manager 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 1 500Organic Chemistry 2 1,000

Total 3 1,500


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GLIER Laboratory Organisational Chart A

Vice-President Academic

Universit of Windsor

GLIERExecutive Director

GLIER

AdministrationML Scratch

Laboratory DirectorBJ Fryer

Laboratory HeadOrganic Lab

KG Drouillard

Laboratory HeadMetals Lab

B Fr er

Quality Manager

JC Barrette

Organic Lab SupervisorNargis Ismail

Lab TechnicianD. Qiu

Metals Lab Supervisor JC Barrette


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University of Windsor Academic Oper ati ons

Executive Assistant

to the Vice-President Academic

Director Great Lakes Institute

Executive Secretary

to the Vice-President Academic

Associate Vice-President Academic Affairs

Associate Vice-PresidentResearch

Special Assistant to the VPA &Director, Faculty Recruitment & Retention

Director, Division of InstructionalDevelopment and Co-ordinator of

Academic Computing

University Academic Structure

Vice-President, Academic

President


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APPENDIX A REVISION HISTORY

Revision 0 April 23, 2003H.Hagen-new issue of revised format Quality manual

Revision 1.1 June 14, 2004H.Hagen- Organisational chart update - Haffner to Drouillard, use Manager instead of Supervisorterminology

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06 Aug. 9,2004

JC Barrette 4.1Appendix AApproval

Change rev.no. to follow Q.M.2003add revision tableadd approval/authorization page

07 Dec.2004

JC Barrette 4.1 Org. Chartall text4.1.5Title page

Title terminology, re-organized similar to2003Change terminology of Lab Manager back to SupervisorStaff Substitution added similar to 2003Approval by Lab Director

08 Oct.2008

JC Barrette Header4.1.1 Registration4.1.2 clientsKeyposition/Chart

4.1.5Resposibility

List 17025 only. Not 17025:2001, year of doc. revisionGLIER legal entity of University of WindsorRemoved consultants from clients servedRemove vacant for Nargis Ismail, Org Lab

Defined Lab Head and Quality Manager Responsibilities


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Section 4.2Quality System Page 1 of 4

Revision 07Issued:

December 2004


The following section of this Quality Manual has been reviewed and approved forissuance by the commissioned management personnel. This is a controlled document,and unauthorised printing or photocopying is prohibited. Copies not showing the originalsignature are considered uncontrolled copies, and may not reflect currently issued

policy/procedure.

______________________________________________________________________Laboratory Director Date


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Revision 07Issued:

December 2004


4.2 Quality System

4.2.1 ScopeGLIER Laboratories maintain a quality system in accordance to ISO/IEC 17025-2001guidelines. Policies, systems, programmes, procedures and instructions whichencompass this Quality Assurance programme are documented to ensure the quality oftesting 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.4.2.2 Quality Objective

The quality objective is to ensure that a well structured and documented GLIER QualityManagement System (QMS) is in place, and that this system incorporates adequatereview, audit, and internal quality control. The purpose of the QMS is to ensure theservices and advice offered by GLIER meet the needs of our clients and the requirementsof 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 orstandardised 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 theimplementation of the GLIER Quality Management System within the Laboratory. Itspecifies the activities required to achieve the quality goals established by GLIER. TheQSM is updated as required and is approved by the respective Laboratory Heads.


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Revision 07Issued:

December 2004

Quality System Procedures (QSP)

The Quality System Procedures are the second level documents which outline the detailof management strategies for carrying out policies and objectives specified in the QSM.The sections within this document describe, in a systematic manner, the measures whichthe laboratory employs to implement the QA program.

Standard Operating Procedures (SOPs)

These documents describe all the written instructions necessary to utilise Laboratorytesting procedures (i.e. methods) within GLIER and provide a working document whereall details are specified. SOPs are updated on a regular basis by the LaboratorySupervisors and approved by the appropriate Laboratory Head. They are kept in a centralarea within each analytical laboratory. SOP documents are revised, controlled anddistributed 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 thelaboratory or across a series of analytical methods. These include procedures such assample receiving, data management, preparation of standards and analyst proficiencyrecords. Upon revision, the latest version is approved by the appropriate LaboratoryHead 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 documentationare retained in the Quality Assurance office for use by technical personnel charged withcarrying out any related activities.

Records are maintained by the responsible personnel according to the respective SOPand/or RP, and stored at locations specific to the ordered task. Examples includelogbooks, training records, equipment monitoring.

See (Appendix 4.2.3 Workload Management) as a guide to records controls for routinemonitoring


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Revision 07Issued:

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07 Dec. 8,04

JC 4.2.1

Title Page

Scope statement expanded to responsibility to QualityManagerLab Director Approval


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Section 4.3Document Control Page 1 of 8

Revision 10Issued:

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policy/procedure.



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Revision 10Issued:

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4.3 Document Control

4.3.1 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 acontrolled distribution include, but are not limited to: the QM, the SOPs. RelatedProcedures, and Forms. Control is maintained by initially distributing the documents tothe 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 controlledusing a Document Header with the following information including the first page asauthorization.

identified by subject, date of issue, revision number and page numberingwith total pages;

reviewed for accuracy; approved by authorised person; available when required;

replaced when obsolete.

4.3.2 Document Approval and Issue

4.3.2.1 Master List.

A master list of all quality documentation, which identifies all current revisions, islocated at the front of this document, and in the Quality Control Office. Laboratory Headsignatures located on the authorisation sections of each quality document are evidence ofdocument 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 theimplementation 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 detailof management strategies for carrying out policies and objectives specified in the QSM.


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Revision 10Issued:

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1) Standard Operating Procedures (SOPs)

These documents describe all the written instructions necessary to utilise Laboratorytesting procedures (i.e. methods) within GLIER and provide a working document whereall 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 thelaboratory or across a series of analytical methods.

Forms and Records

All relevant forms and working documents outlined in the GLIER QMS documentationare retained for use by technical personnel charged with carrying out any relatedactivities.

4.3.2.2 Availability and Review

Distribution

A distribution list of all quality documentation is maintained in the Quality ControlOffice, and the Quality Manager ensures that all persons identified on the distribution listreceive updated documents and return all obsolete documents. Distribution list will be asfollows:

Manuals in Circulation

Complete manual: Home copy (1 copy) - Quality Control OfficePartial manuals: Standard Operating Procedures (6 Copies)

Organic Lab Metals LabS.O.P. Sample Preparation Lab Sample Preparation Lab

Instrument LabData Management Lab

Related Prod. Sample Preparation Lab Sample Preparation LabSOP-Validation Data Sample Preparation Lab Sample Preparation Lab


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Revision 10Issued:

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Review and Approval

The Quality Manager ensures that all changes or additions to the quality documentationundergo adequate review and are approved by the respective Laboratory Head.

Obsolete Documentation

Obsolete documentation retained for legal or reference purposes will be maintained in fileand suitably identified by denoting obsolete over the controlled document label.Controlled copies will be marked accordingly. Documents in circulation will beconsidered 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 section4.3.

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 writtenapplication 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 andauthorisation, 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 eachcontrolled document, and is approved by the respective Laboratory Head for LaboratorySOP and RP. The Quality Manual and Quality System procedures is approved by theLaboratory Director.

4.3.3.3 Hand-written Amendments

Hand-written amendments to quality documents may be conducted on controlled qualitydocuments only, dated and initialled by the lab supervisor. Changes to qualitydocumentation must comply to regulations set out in section 4.3.3.2 before formalapproval and reissue.


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Revision 10Issued:

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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, andsimilar 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: LimsST D:\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 revisionnumber. The previous file remains in its respective revision folder. The revisionhistory/record contains all necessary descriptions of changes for reference. Thedocument is reissued, as outlined in section 4.3.3.


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Revision 10Issued:

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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 controlleddocument.

Departures from Quality Documentation

Departures from policies, procedures or methodologies documented in the QualityManual, Standard Operating Procedures and Related Procedures may be permitted underexceptional circumstances. All departures must receive prior written approval from theappropriate authority.

4.3.4 Data Management

To ensure data management procedures that incorporate adequate procedures for thesecurity, recording, calculation, validation, authorization, transmittal, storage anddisposal of all test data and related records.

The Laboratory Supervisor is responsible to retain all technical records pertaining to theexecution 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 duringrecording are not erased, made illegible, or deleted in any way that may render therecorded entry insubmissable as a legal document.

At the time of data recording, situations were corrections to mistakes in originaltest data may be required. Mistakes are crossed out and initialed by the recordingtechnician, and subsequent corrections entered alongside the original data. The

use of correction mediums (White Out) is prohibited from use in any recordingdocuments.

In the case of electronic records, the data (cell on spreadsheet) must behighlighted using special, i.e. cross out, bold, highlight., as available by program.


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Revision 10Issued:

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4.3.4.2 Storage and Disposal of Records

It shall be the responsibility of the respective Laboratory Supervisor to ensure thatrecords identified in this Manual and under their responsibility are easilyretrievable and stored in a secure manner.

As soon as such records no longer serve a useful purpose within an individualsection they remain in the custody of the respective Laboratory Supervisor, storedin 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 backedup weekly onto an external drive source. The external drive source is supplied bythe 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 allreturned 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 secure- password protected and have data storage back-up.

- Windows operated computers must be password protected on boot upand have a time out password prompt as well (screensaver). User specificaccounts for privileged access to specific folders should also be activatedas necessary.

See Equipment Binder under Computer Maintenance for set-up details.


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Revision 10Issued:

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Revision 5.1 April 23, 2003H.Hagen-new issue of revised format Quality manual

Revision 5.2 June 17, 2004H.Hagen- addition of Appendix A: Revision History section- updates to Storage Hard drive information

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Aug. 9,2004

JC Barrette 4.3.3.4 edit file storage location and reference back-up records

06 Aug. 9,2004


change rev.no. to follow Q.M.2003add revision tableadd approval/authorization page

07 Dec. 8,04

JC Hagen Rev. No.s4.3.3.3 elec. Doc.4.3.3.1 changes4.3.3.2Title page

Change listed version 0, 1.1 to 5.1, 5.2Actual practices listedQuality manager responsible for document changesClarify approval of QM, QSP by Lab DirectorLab Director Approval

08 Nov 2,06

JC Barrette 4.3.4 DataManagement

2003 QM format change, copy over missededited 4.3.4 for QSP 2006

09 Oct 18,07

JC Barrette 4.3.2.1&4.3.2.2Master List4.3.3.3 Hand-written amendts.

- add SOP Validation Binder- yes to controlled documents by lab

Supervisor with date and initial

10 Oct.2008

JC Barrette Header4.3.1

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


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Section 4.4Review of Requests, Tenders

and ContractsPage 1 of 6

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policy/procedure.



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Revision 07Issued:

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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 bemet:

All customer requirements will be adequately understood, documented and agreedupon:

The laboratory has all necessary resources available to carry out the agreedrequirements;

The test method chosen is accepted by the client to be technically sufficient tomeet their requirements

iii) Definitions

Contract : A contract may be defined either as a written document or verbal agreementheld between the client, Laboratory Head and University of Windsor which outlines theintent to procure services.

iii) Author ities and Respons ibili ties

The request, tender and contract review procedure will be conducted by the LaboratoryHead of each respective laboratory, and the process will remain consistent for bothinternal and external customers.

Formal written contract proposals are reviewed and authorised by the both the GLIERDirector and University of Windsor Associate Vice-president of Research.

The GLIER Administrator is responsible for coordinating and maintaining all financialrecords pertaining to execution of the contract grant account with the University ofWindsor's Financial Services department.


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4.4 Review of Requests , Tenders and Contracts

4.4.1 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 arequested contract of service by the GLIER Laboratories. The LabManager initiates the inter university verification process by completing aUofW Research Contract form

ii) Upon Director authorisation, the research contract form and clientcontract are submitted for approval to the office of Research Services. Onecopy is retained by the GLIER Administrator in central files;

iii) Office of Research Services sends the authorised form and client contractto Financial services to open a Grant account;

iv) Confirmation of Grant account is received by the GLIER Administrator,which is appended to the central file contract;

v) Upon completion of required contract services, the GLIER Administratornotifies Financial services to invoice client for services rendered, and acopy of the requested invoice is appended to the contract in central files;

vi) Confirmation of payment is received by the GLIER Administratorinternally, and contract is closed.

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 returnshall be made.


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Revision 07Issued:

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The laboratory has the required technical and managerial capability and resourcesto meet the customer's requirements.

The appropriate method and/or calibration is agreed upon by customer prior tostart of analysis.

The request, tender and contract review procedure will be conducted by the LaboratoryHead of each respective laboratory, and the process will remain consistent for bothinternal and external customers. The review will be conducted in a practical and efficientmanner, incorporate financial, legal, and scheduling objectives of both the customer andlaboratory.

The Laboratory Supervisor will use routine methods that are approved by the LaboratoryHead, selected from the approved and authorised Standard Operating Procedure (SOP) ofthe GLIER Quality Manual. The routine methods used are based on the latest edition of

published international, national and regional standards which enlist a validated SOPquality assurance/quality control procedure.

The Laboratory Supervisor is responsible for ensuring that the laboratory is physicallycapable of performing the analysis, will select the most appropriate method, and ensurethe required analytical personnel with the necessary skills and expertise to perform theanalysis are available.

A contract may be defined either as a written document or verbal agreement held betweenthe 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 asnecessary, and changes recorded in management meeting minutes.

All correspondence with the client regarding the contract agreement will be recorded andmaintained in the clients contract file.

Any reviews done by the Lab Heads having technical relevance must be communicatedto the Lab Supervisor of the respective lab.

4.4.4 Subcontracting Review

Reviews and amendments relating to subcontracted work will be carried out byLaboratory Heads as necessary, and a record maintained in management meetingminutes.


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4.4.5 Client Notification

Changes to a clients contract are admissible under specific instruction, notification, andauthorisation 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 Headsor as delegated. Such notification will be in writing of such changes if they are deemedto affect the normal execution of their contract provisions.


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Revision 07Issued:

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07 Dec. 8,04

JC All textTitle page4.4.3 records rev.4.4.4 subcon. Rev.4.4.3 records rev.4.4.5 client not.

Terminology of Lab Manager back to SupervisorLab Director ApprovalSpecify Lab Head carries out reviewSpecify Lab Head carries out reviewHead must communicate technical change to SupervisorAdd statement; initiated by the lab Head or as delegated


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Section 4.5Subcontracting of Tests Page 1 of 4

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i) Purpose

This procedure outlines the system used by GLIER Laboratories to implementsubcontracting of analytical services, and applies to all contracted services which mayimpact the quality of results reported to the customer.

ii) Scope

In order to execute client requests for services not offered by GLIER Laboratories, thissection outlines the requirements that will be met to ensure the competence of thesubcontractor 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 therequirements of a contract agreement.

iii) Author ities and Respons ibili ties

Terms of the subcontractor agreement are authorised by the Laboratory Head, withintended to reflect the client requirements.


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Revision 08Issued:

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4.5.1 Subcontractor Competence

GLIER Laboratories may, from time to time, enter into agreements with otherlaboratories to conduct analytical work on behalf of clients. As per the discretion of theLaboratory Head, testing work may be completed by the subcontracting laboratory. TheLaboratory Head is responsible for securing a competent subcontractor. A minimumcompetency must be shown via conformance to ISO 17025 requirements.

Proof of competency will be required from each subcontracted service, and may take theform of conformance to international standards of service, work history and/orcompletion 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 ininterlab 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 ofthe laboratory performing the analytical work. If knowledge of certain ReferenceMaterial is available, results of analysis could be supplied in support of the ReferenceMaterial. Also, samples of known composition could be analysed by the subcontractinglaboratory to verify results.

4.5.2 Client Notification

The respective Laboratory Heads shall obtain prior permission from the client in writingto sub-contract any portion of the client's testing to another party. These arrangementsare made on a project-specific basis, and agreements are confirmed in writing before anyaction 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 bythe respective Laboratory.

4.5.3 Responsibility to Client

A Quality Assurance Plan must accom pany the agreement, and be approved by therespective Laboratory Head. The purpose of this Plan is to ensure that results obtained bythe sub-contracting laboratory will demonstrate the quality of its analytical work.

4.5.4 Sub-Contractor RegisterThe Laboratory Manager shall maintain a record of all sub-contractors and a record ofthe evidence of compliance with CAN-P-4D for those sub-contractors providing servicefor 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 analyticalwork. A list of currently appointed subcontractors appears in Appendix 4.5.4 .


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Revision 08Issued:

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07 Dec. 8,04

JC Title page4.5.2

Lab Director ApprovalAdd amendment requires Lab Head signature.

08 Oct.2008

JC Barrette Header4.5.14.5.2

List 17025 only. Not 17025:2001, year of doc. revisionMinimum competency required as 17025 accreditationSubcontractor reports are submitted in writing or elec.


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Section 4.6Purchasing Services and

SuppliesPage 1 of 6

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SuppliesPage 2 of 6

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4.6 Purchasing Services and Supplies

4.6.1 Equipment, Service and Supply Procurement

4.6.1.1 Purpose

To ensure all equipment, supplies and services are functioning properly and/or meetrequired 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 andservices used by GLI Laboratories to carry out analysis of testing as outlined in SCCaccredited methodologies .

4.6.1.3 ProcurementThe respective Laboratory Supervisors shall be responsible for preparing specificationsfor all purchased services, equipment and supplies used in the conduct of laboratorytesting. 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 purchaserequisitions 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 sub-contractors from whom the laboratory obtains goods or services.

The individual(s) approving the specifications shall also be responsible for (i) issuingrelated tenders or requests for proposal; (ii) evaluating related bids and proposals; and

(iii) either approving related purchase orders or contracts, or seeking approval by thedesignated spending authority.

The respective Laboratory Supervisor maintains an appropriate inventory for ongoingconsumables.


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The respective Laboratory Supervisor shall maintain a file that identifies all purchasedgoods 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 appropriatecorrespondence between the purchase order and packing slip; and (ii) verifying, whenapplicable, 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 Servicesrequires a written explanation by the requisitioner which explains in detail why the goodsand/or services can only be provided by the supplier mentioned in the purchaserequisition. The explanation will be kept on file with the Purchase Order for auditor'sreview. In order to meet the requirements as a sole source provider , the goods and/orservices 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 noother product and/or service can meet the specifications required for his/herresearch or scientific needs.

4.6.2 Inspection and Verification

Laboratory Supervisors verify items for ensuring purchased materials that affect thequality of testing are properly inspected/tested to ensure the materials comply withstandard specifications as outlined in the pertaining test method.

.


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4.6.3 Purchasing Documents

Purchasing documents are issued and maintained by the University of Windsor FinancialDepartment. These documents contain all relevant information to facilitate theidentification 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 determinedto potentially affect the quality of results reported to GLIER Laboratory customer agents.This definition also includes the purchase of calibration services deemed necessary toimplement SOP, as well as QA/QC guidelines.

Critical Supplier: Vendor/supplier of products or services deemed quality critical to thelaboratory'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 aredefined and approved by the Lab Heads. Vendor approval is based on the LaboratoryManagers recommendations, past performance, reputation, questionnaires, and/or

published methodologies.

Current/additional suppliers may only be used after formal evaluation, which requiresnotification of required certificates by suppliers to distribute critical equipment asoutlined 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


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4.6.4 Supplier Approval

The individual(s) approving the specifications for goods and services shall, whereappropriate, carry out an assessment of suppliers, which may include, but not be limitedto, recommendations, past performance, questionnaires and/or published methodologies.

Approved suppliers shall (i) provide goods and services that are of adequate quality tosustain 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 theGLIER Laboratories, University of Windsor.

An approved suppliers list is maintained in Appendix 4.6 .


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4.7 Service to Client

4.7.1 Purpose

This procedure defines the authority, responsibilities, and system used to ensure the valueof 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 partnergroups 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 traditionalmarket 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 tolaboratory 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 laboratorieswill afford the client reasonable access to areas of the laboratory for the purpose ofreviewing procedures and the witnessing of analysis performed for the client.

Confidentiality agreements maintained between GLIER Laboratories and its customerswill supersede specific client requests for admittance to facility or documentation whendeemed ethically inappropriate. This responsibility remains the decision of the

Laboratory Head, and shall be considered prior to approving customer requests forvisitation of said facility.

All attempts to ensure good customer relations, including advice, guidance in technicalmatters, and interpretations of results, will be maintained.


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4.8 Complaints

4.8.1 PurposeThis procedure defines the authority, responsibilities, and quality system used to ensurethat all customer complaints are received, documented, assessed and responded to in atimely basis.

4.8.2 Customer Complaints

All technical complaints originating from clients, or other external sources, are directedto the respective Laboratory Supervisor. Where situations (ie: previously issued testreports) warrant follow-up activities, a corrective action report form is initiated.

An acceptable resolution may include any combination of retest, third party testing, creditor refund as approved by the respective Laboratory Heads. Before a resolution isannounced, the Laboratory Supervisor determines that the resolution or the action meetswith 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 ofall complaints and the corrective actions taken. (see file, customer complaints/clientfeedback).


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4.9 Control of Non-conforming Testing

4.9.1 PurposeThis procedure defines the authority, responsibilities, and quality system used to ensurethat all customer complaints are received, documented, assessed and responded to in atimely basis

4.9.2 Definitions

A non-conformance is any analytical result, which may be outside acceptable error due tothe use of an incorrectly calibrated instrument or an instrument found to be out of rangeof acceptable deviation during a quality assurance test. In other words, a system that isnot 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 theintegrity and representatives of the sample, i.e. sample history deficienciesexist;

- 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 withexpected values, ranges or relationships.

If any of these causes is due to circumstances outside the control of GLIER, then it istermed a deficiency. Deficiencies are handled through the use of a SampleSubmission/Reception form, at the sample receiving area. The client is contacted and the

problem resolved before the samples are processed.


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4.9.3 Non-Conforming Test Data

Test data will be considered to be nonconforming, if any of the following conditionsexist:

failure (or suspected failure) to meet all conditions necessary toensure the integrity and representativeness of the sample, i.e. sample historydeficiencies exist;

failure (or suspected failure) to comply with the test method or supporting workinstructions;

failure (or suspected failure) in method performance as demonstrated by results provided by quality control samples; inherent property of sample thatcompromises the testing, e.g. as verified by the method of standard additions;

relevant evidence provided by data validation, e.g. as a result of comparisonwith 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 ofnon-conformances and the actions taken are kept. If applicable, in the case of a non-conformance applies to both labs the Quality Manager ensures that the record is kept andactions are followed up. It is also the responsibility of the Quality Manager to have theCAR 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 explanatorycomment. Prior to reporting nonconforming or suspected nonconforming data, theLaboratory 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., asa result of audit findings, proficiency testing, client feedback or any other circumstance,

the Laboratory Supervisor shall immediately notify any client whose data may have beenaffected. After conferring with the client work may be recalled and followed by asuperseded report as necessary.


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4.9.4 Procedure for Remedial Action of Non-conformance

The Laboratory Supervisor ultimately assumes responsibility for ensuring any non-conformance identified in the laboratory is identified and corrected. The QualityManager is responsible for ensuring all necessary resources are made available to thelaboratories for the maintenance of the Quality System.The Lab Supervisor authorizes a resume work (start up) when non-conformance iscorrected.If an instrument or piece of testing equipment is found to be out of calibration, and isdeemed to possibly impact the quality of the data reported to the customer, aninvestigation into the root cause and evaluation of the significance of the non-conformance is initiated. As soon as the non-conformance has been identified, thefollowing 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, oris subject to similar fault, will also be evaluated in the same manner.

The reporting of any future results generated by the instrumentation will bewithheld until the root cause and net analytical effect can be determined.

Any further work on the instrument will be halted until the extent andsignificance of the non-conformance is determined. A decision on the

acceptability of the results produced since the last calibration will be made todetermine 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 non-conformance are notified in writing, and individual concerns and the significanceof 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 toservice immediately, and an acceptable backup method exists, results may begenerated using the backup method.

After the instrument has been returned to service, its performance shall bemonitored regularly to ensure corrective action taken was effective. If doubtexists concerning the ability of the instrument to continue to produce reliableresults, the Laboratory Supervisor will devise a long-term strategy for the repair,replacement, or acceptance of an alternative method.


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4.10 Corrective Act ion

4.10.1 General

4.10.1.1 Purpose

This procedure outlines a system for identification and correction of existing quality non-conformities 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 thatcompromise 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 anexisting 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 correcta non-conformance identified to affect the quality procedure. The Laboratory Managerassumes 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 usingCorrective Action Reports ( Appendix 4.10 ), and required changes are implemented by the


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Laboratory Supervisor with assistance from the Quality Manager and/or LaboratoryHeads 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 itseffectiveness.

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 appropriateLaboratory Supervisor;

A final decision is taken by management regarding the remedial action and awritten reply is submitted from the responsible Laboratory Supervisor tothe 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.


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4.11 Preventative Action , Continual Improvement

4.11.1 Purpose

This procedure outlines a system for identification and prevention of potential qualitynon-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 neededimprovements and the prevention of potential non-conformities in quality and technicaloperations.

4.11.2 Primary Objective

The primary objective of a preventative action is to prevent potential problems related toquality, reduction of errors, and quality enhancement.

Preventative action plans can be identified from various resources, including:Customer feedbackInternal/quality/management review auditsTechnical meetingsStaff brainstormingQuality Control Charts-Predicting control chart trends

- Refer to CAEAL document T27 for additional information. Copy alsocontained with Internal Audit File.

Management meeting agenda of GLIER Laboratories representatives include discussionsconcerning Preventative Action objectives. It is the intention of GLIER Laboratories to

develop long-term strategies that focus on Preventative Action training and incorporationinto 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.


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4.12 Control of Records

4.12.1 General

4.12.1.1 PurposeTo define the type, responsibility and retention time for quality records maintained toconfirm the achievement of the required level of quality outlined in this QualityManagement system.

4.12.1.2 ScopeManagement is responsible for incorporating adequate procedures for the recording,

collection, indexing, authorisation, maintenance, storage and disposal of all quality andtechnical 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 bothhardcopy and electronic form. Copies of non-process related documents are available forduplication. Process related documents are maintained by the technical staff at thespecific 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 RecordsSample LogbookCustomer Request for Tender and ContractsCustomer ComplaintsTest ResultsCalibration ChecksCompliance Certificates

Traceability of Standards Non-Conformance ReportsRecords of Management ReviewInternal Quality Audit ReportsApproved Sub-Contractor files


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4.12.2.1.2 Management Review

All relevant records relating to a quality audit, performance audit, client feedback andinternal performance check shall be available for the quality system review. The resultsof the review and any actions taken shall be documented and filed by the QualityManager who shall be responsible for preparing a report detailing the results of thereview.

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 andstored in a secure manner.

As soon as such records no longer serve a useful purpose within an individual sectionthey 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, unlessotherwise specified by contractual obligations and/or by special request by client. Eachrespective 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 clientor 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 athird party must be accompanied by written consent from the client.

Records that may be made available on request to the Laboratory Supervisor shall belimited 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;


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Under no circumstances, except as dictated by a Court of Law, shall records be removedfrom the laboratory. Requirements for ensuring client confidentiality shall be observedwhen making records available.

Records Integrity

Records are maintained in a secure and suitable environment outside the laboratories inoffice 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 toa 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 Files1) Metals Lab:The laboratories central computer (LIMS ST - running windows 2000) is backed upweekly onto an external drive source. The external drive source is supplied by theUniversity under the Novell network (having its own back-up).

This task is done manually in Windows explorer by the drag an drop method. Refer tothe 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

2. Open Windows Explorer3. Scroll to Novell back-up location

Location Description Novell: J:/barretb on'Gamma\GLIER\Users'

\\Iris-TJA Instrument PC, ICP-OES\\Jcoff Office PC, JC


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\\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

4. Copy each of the Five directories listed above from the location described one at atime through the Microsoft network and paste onto the Novell drive.

5. Override the last date stored directory.

Notes: - Windows 2000 automatic back-up program has been investigated , see DataManagement Log book Nov2002- Novell requires the drag and drop method therefore the automatic was not

used.

2) Organic Lab: Back up methods1. GC-MSD onto CD disks2. 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 ofall relevant testing information, are maintained in a permanent form that facilitatesreproduction of the test if required.

4.12.3.2 Calibration Records

Calibration records shall include sufficient information to facilitate the duplication of thatcalibration 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 ServicesSection. These records shall include (i) employee curriculum vitae (ii) record of relevanttraining 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. Theformat of test reports are outlined in Section 5.10 .


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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 permanentrecording medium at the time observations are made. Under no circumstances is a pencilallowed 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 (QuattroPro) 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 originalmethod conditions should identification of any suspect factors affection uncertainty berequired.

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 datamanagement process: Sample reception and sample analysis. The provision shall existfor each assigned flag to be accompanied by an explanatory comment.

Absent data due to conditions other than a laboratory accident shall be confirmed at thetime of sample reception (see Section 5.4.1). If a laboratory accident occurs therespective Laboratory Manager shall, prior to reporting absent or forming data, advise theclient and seek further instructions.


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4.12.3.6 Corrections of Original Records

It is GLIER Laboratory policy to ensure mistakes to test data made during recording arenot erased, made illegible, or deleted in any way that may render the recorded entryinsubmissable as a legal document.

At the time of data recording, situations were corrections to mistakes in original test datamay be required. Mistakes are crossed out and initialled by the recording technician, andsubsequent corrections entered alongside the original data. The use of correctionmediums (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 usingspecial a function (i.e. cross out, bold, highlight) as available by program. The LabSupervisor must approve a change.

Changes to electronic copies of quality documentation are reissued under procedures asoutlined in section 4.3.3. as indicated by document revision record. Previous versions arestored via different revision numbers and therefore are not lost.

The Quality Manager must approve Quality documentation changes.


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