Section 4, 5 Table of Contents Page 1 of 1 TABLE OF CONTENTS

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4, 5

Table of Contents Page 1 of 1

Revision 07 Issued: December 2004

Quality System Procedures

TABLE OF CONTENTS

4 Management requirements 4.1 Organization 4.2 Quality System 4.3 Document Control

4.4 Review of requests, tenders and contracts 4.5 Subcontracting of tests and calibrations 4.6 Purchasing services and supplies 4.7 Services to the client

4.8 Complaints

4.9 Control of nonconforming testing and/or calibration work 4.10 Corrective action 4.11 Preventative action 4.12 Control of records 4.13 Internal audits 4.14 Management review 5 Technical requirements 5.2 Personnel

5.3 Accommodation and environmental conditions 5.4 Test and calibration methods and method validation

5.5 Equipment

5.6 Measurement traceability

5.7 Sampling

5.8 Handling of test and calibration items

5.9 Assuring the quality of test and calibration results 5.10 Reporting the results

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Laboratory Organisation Page 1 of 7

Revision 08 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.

____________________________________________________________________

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Management Requirements

4.1 Laboratory Organisation

4.1.1 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 Canada’s (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 Laboratory’s 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.

4.1.4 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.

4.1.5 Management Responsibility

Technical Operations. Overall responsibility for Technical Operations in the laboratory

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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 Dr. Ken G Drouillard Lab Head – Metals Laboratory Dr. Brian J. Fryer Quality Manager Mr. Jean Claude Barrette Laboratory Supervisor - Organic Laboratory Dr. Nargis Ismail Laboratory Technician - Organic Laboratory Mr. David Wei Qiu Laboratory Supervisor- Metals Laboratory Mr. Jean Claude Barrette GLIER Office Administrator Ms. Mary Lou Scratch

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

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

Position Substitution

Lab Director Lab Heads Head – Metals Lab Head – Organic Head – Organic Head – Metals Lab Quality 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 1 500

Organic Chemistry 2 1,000

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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

Lab Technician D. Qiu

Metals Lab Supervisor JC Barrette

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University of Windsor

Academic Operations 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-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 Vice-President, Academic

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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. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.1 Appendix A Approval

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page 07 Dec.

2004

JC Barrette 4.1 Org. Chart

all text 4.1.5 Title 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 08 Oct. 2008 JC Barrette Header 4.1.1 Registration 4.1.2 clients Keyposition/Chart 4.1.5Resposibility

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

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ISO/IEC 17025:2001 Quality System Procedures Section 4.2

Quality System Page 1 of 4

Revision 07 Issued: December 2004

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.

______________________________________________________________________

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Quality System Page 2 of 4

Revision 07 Issued: December 2004 Management Requirements 4.2 Quality System 4.2.1 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.

4.2.2 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: ¾ utilizing SOP’s to ensure data consistency in the measurement process;

¾ auditing operational performance of the laboratory on a routine basis and providing corrective action if needed;

¾ 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.

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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 (SOP’s)

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. SOP’s 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

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ISO/IEC 17025:2001 Quality System Procedures Section 4.2

Quality System Page 4 of 4

Revision 07 Issued: December 2004

APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.2 Appendix A Approval

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page

07 Dec. 8,

04

JC 4.2.1 Title Page

Scope statement expanded to responsibility to Quality Manager

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ISO/IEC 17025 Quality System Procedures Section 4.3

Document Control Page 1 of 8

Revision 10 Issued: October 2008

4.3 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.

______________________________________________________________________

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Document Control Page 2 of 8

Revision 10 Issued: October 2008 Management Requirements 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 a controlled distribution include, but are not limited to: the QM, the SOP’s. 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.

• 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. 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, 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.

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1) Standard Operating Procedures (SOP’s)

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 Metals Lab

S.O.P. Sample Preparation Lab Sample Preparation Lab

Instrument Lab

Data Management Lab Related Prod. Sample Preparation Lab Sample Preparation Lab

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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.

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Revision 10 Issued: October 2008 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 Manual…doc Quality System Procedures:

\\Q.Sys.Prod\Appendix\Revision&Date \ appendices…doc \\Q.Sys.Prod\Section 4\ Revision&Date \ QSP 4.1…doc \\Q.Sys.Prod\Section 5\ Revision&Date \ QSP 5.2…doc Standard Operating Procedures:

\\SOP\Metals\ Revision&Date \ 01-001…wpd \\SOP\Organic\ Revision&Date \ SOPORG…wpd Related Procedures:

\\Rel.Prod.\Metals\ Revision&Date \ relprod…wpd \\Rel.Prod.\Organic\ Revision&Date \ rp…wpd 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.

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Revision 10 Issued: October 2008

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

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Revision 10 Issued: October 2008 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 secure-password 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.

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ISO/IEC 17025 Quality System Procedures Section 4.3

Document Control Page 8 of 8

Revision 10 Issued: October 2008

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 Revised by Sections Affected Description Auth. Aug. 9, 2004

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

06 Aug. 9,

2004

JC Barrette 4.3

Appendix A Approval

change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page

07 Dec. 8,

04

JC Hagen Rev. No.s

4.3.3.3 elec. Doc. 4.3.3.1 changes 4.3.3.2 Title 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

08 Nov 2,

06

JC Barrette 4.3.4 Data

Management

2003 QM format change, copy over missed edited 4.3.4 for QSP 2006 09 Oct 18, 07 JC Barrette 4.3.2.1& 4.3.2.2Master List 4.3.3.3 Hand-written amendts.

- add SOP Validation Binder

- yes to controlled documents by lab

Supervisor with date and initial

10 Oct. 2008 JC Barrette Header 4.3.1 Remove year in 17025:2005

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ISO/IEC 17025:2001 Quality System Procedures Section 4.4

Review of Requests, Tenders and Contracts

Page 1 of 6

Revision 07 Issued: December 2004

4.4 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.

______________________________________________________________________

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ISO/IEC 17025:2001 Quality System Procedures Section 4.4

Review of Requests, Tenders and Contracts Page 2 of 6 Revision 07 Issued: December 2004 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:

¾ All customer requirements will be adequately understood, documented and agreed upon:

¾ The laboratory has all necessary resources available to carry out the agreed requirements;

¾ 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.

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ISO/IEC 17025:2001 Quality System Procedures Section 4.4

Review of Requests, Tenders and Contracts Page 3 of 6 Revision 07 Issued: December 2004 Management Requirements

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 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

ii) 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;

iii) Office of Research Services sends the authorised form and client contract to 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 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; vi) Confirmation of payment is received by the GLIER Administrator

internally, and contract is closed.

4.4.2 Terms of Agreements

This procedure shall ensure that:

¾ All requirements including methodology used will be adequately defined, documented and understood by the customer.

¾ Agreements regarding testing time line and sample disposal, storage or return shall be made.

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Review of Requests, Tenders and Contracts

Page 4 of 6

Revision 07 Issued: December 2004 ¾ The laboratory has the required technical and managerial capability and resources

to meet the customer's requirements.

¾ 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.

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ISO/IEC 17025:2001 Quality System Procedures Section 4.4

Review of Requests, Tenders and Contracts Page 5 of 6 Revision 07 Issued: December 2004 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.

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ISO/IEC 17025:2001 Quality System Procedures Section 4.4

Review of Requests, Tenders and Contracts

Page 6 of 6

Revision 07 Issued: December 2004

APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.4 Appendix A Approval

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page

07 Dec. 8, 04 JC All text Title page 4.4.3 records rev. 4.4.4 subcon. Rev. 4.4.3 records rev. 4.4.5 client not.

Terminology of Lab Manager back to 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

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ISO/IEC 17025 Quality System Procedures Section 4.5

Subcontracting of Tests Page 1 of 4

Revision 08 Issued: October 2008

4.5 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.

______________________________________________________________________

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ISO/IEC 17025 Quality System Procedures Section 4.5

Subcontracting of Tests Page 2 of 4

Revision 08 Issued: October 2008

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.

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GLIER - Analytical Laboratories

ISO/IEC 17025 Quality System Procedures Section 4.5

Subcontracting of Tests Page 3 of 4

Revision 08 Issued: October 2008

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.

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GLIER - Analytical Laboratories

ISO/IEC 17025 Quality System Procedures Section 4.5

Subcontracting of Tests Page 4 of 4

Revision 08 Issued: October 2008

APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.5 Appendix A Approval

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page

07 Dec. 8,

04

JC Title page

4.5.2

Lab Director Approval

Add amendment requires Lab Head signature.

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.

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.6

Purchasing Services and Supplies

Page 1 of 6

Revision 07 Issued: December 2004

4.6 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.

______________________________________________________________________

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.6

Purchasing Services and Supplies Page 2 of 6 Revision 07 Issued: December 2004 Management Requirements

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 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 sub-contractors 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.

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.6

Purchasing Services and Supplies

Page 3 of 6

Revision 07 Issued: December 2004

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.

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.6

Purchasing Services and Supplies Page 4 of 6 Revision 07 Issued: December 2004 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.

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.6

Purchasing Services and Supplies Page 5 of 6 Revision 07 Issued: December 2004 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.

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.6

Purchasing Services and Supplies

Page 6 of 6

Revision 07 Issued: December 2004

APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.6 Appendix A Approval

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page

07 Dec. 8, 04 JC 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 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 eq’m specs Lab Head replaces Lab Manager Reference to questionnaire

Add H.Hagen draft of questionnaire to appendix Lab Director approval

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.7

Service to Client Page 1 of 3

Revision 07 Issued: December 2004

4.7 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.

______________________________________________________________________

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.7

Service to Client Page 2 of 3

Revision 07 Issued: December 2004 Management Requirements 4.7 Service to Client 4.7.1 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.

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.7

Service to Client Page 3 of 3

Revision 07 Issued: December 2004

APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.7 Appendix A Approval Scope

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page collaborator/client definition

07 Dec. 9,

04

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.8

Customer Complaints Page 1 of 3

Revision 07 Issued: December 2004

4.8 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.

______________________________________________________________________

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.8

Customer Complaints Page 2 of 3

Revision 07 Issued: December 2004 Management Requirements 4.8 Complaints 4.8.1 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.

4.8.2 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).

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.8

Customer Complaints Page 3 of 3

Revision 07 Issued: December 2004

APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.8 Appendix A Approval

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page

07 Dec. 8, 04 JC 4.8.2 all text 4.8.3 complaints Title 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

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GLIER - Analytical Laboratories

ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 1 of 5 Revision 08 Issued: October 2008

4.9 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.

______________________________________________________________________

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GLIER - Analytical Laboratories

ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 2 of 5 Revision 08 Issued: October 2008 Management Requirements

4.9 Control of Non-conforming Testing 4.9.1 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

4.9.2 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.

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GLIER - Analytical Laboratories

ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 3 of 5 Revision 08 Issued: October 2008 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 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 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

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GLIER - Analytical Laboratories

ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 4 of 5 Revision 08 Issued: October 2008

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 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 non-conformance is initiated. As soon as the non-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 non-conformance 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.

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GLIER - Analytical Laboratories

ISO/IEC 17025 Quality System Procedures Section 4.9 Control of Non-conforming Testing Page 5 of 5 Revision 08 Issued: October 2008

APPENDIX A REVISION HISTORY

Rev. No. Rev. Date Revised by Sections Affected Description Auth. 06 Aug. 9, 2004 JC Barrette 4.9 Appendix A Approval

Change rev.no. to follow Q.M.2003 add revision table

add approval/authorization page

07 Dec. 8, 04 JC All text 4.9.3 4.9.4 Title page

Lab manager to Supervisor

Clarify responsibility of CAR to Lab Supervisor and Quality Manager

Lab Supervisor authorizes work start up after non-conformance

Lab Director approval 08 Oct. 2008 JC Barrette Header 4.9.2 4.9.3 Remove 2001 from 17025

A simplified definition of non-conformance Clarify client notification and work recall

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.10

Corrective Action Page 1 of 4

Revision 07 Issued: December 2004

4.10 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.

______________________________________________________________________

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.10

Corrective Action Page 2 of 4

Revision 07 Issued: December 2004 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 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 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

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GLIER - Analytical Laboratories

ISO/IEC 17025:2001 Quality System Procedures Section 4.10

Corrective Action Page 3 of 4

Revision 07 Issued: December 2004 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.

Figure

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References

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