ISO/lEC 17025:200 Quality System Procedures …inweh.unu.edu/wp-content/uploads/2013/05/GLIER_QSP_Technical...quality policy objectives are being implemented in a reasonable time frame?

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ISO/lEC 17025 :200 I Quality System Procedures GLJER - Analytical Laboratories

Appendix 4.1 Confidentiality Agreement

Revision 06 Issued: August 2004

Confidentiality Agreement

between

GLIER LABORA TORIES

and

I (Please Print Name)

By accepting employment with the University of Windsor, you acknowledge that you will acquire knowledge of technical and other confidential information unique to GLiER LABORA TORIES and the University of Windsor as well as confidential information in regard to our customers, suppliers, pricing and costs. You agree that during your employment with GLiER LABORATORIES and subsequent cessation of employment with GLiER LABORATORIES, whether such cessation was initiated by you or this Institution, and whether or not termination was for just cause, you will not in any manner, directly or indirectly, disclose or use any such technical or confidential information or in any manner which could harm the business or proprietary interests of GLiER LABORATORIES, its customers, suppliers, or affiliates. You acknowledge that the scope of this covenant is in all respects necessary and reasonable and further acknowledge that, without prejudice to any and all rights, an injunction is the only effective remedy to protect the Company's rights as set out in this paragraph.

Employee Signature Date

GUER - Analytical Laboratories ISO/lEe 17025:200 1

Standard Operating Procedures

Appendix - 4.2.3 Quality System-

Routine Monitoring Page 1 of 1

Revision 06 Issued:

August 2004

Appendix - 4.2.3 Laboratory Monitoring Routines

DAILY: Refridgerators and freezers; Temperature MQ solvent Water; Conductivity (on line basis, display)

WEEKLY: Computer; Back up to Novell (Manually, drag and drop)

AS USED: Balance; Calibration Check Weight (ie; MWbal) Heating eq'p (non critical) ; Temperature

MONTHLY: Internal Audits Update control chart files verify backup (manual and automatic) Lab thermometers; Cross Calibration (as per monitoring s sheets)

SEMI-ANNUAL: MQ solvent water; Conductivity (off line basis, external readings) Balance; Full Calibration based on Certified (SI) Weights

Management Review ANNUAL:

IS()J LC 17025 :2005 Qual ity System Procedures

,\I'pL'jilll.\ 4,3 Revision 01 Data \ Llll~I.o'L':11l'nt- ILick Up Page I 01'1 Issued:l

ill"ll'l'dllres -'-------~~ __L November 2006

1.11,llll' h IS h()()l\:d lip into Microsoft and Nlwell nctwork. ~',\I\l'11 ('lien!:

- cntr + alt + delete - usernamc: barretb - password: caJculatiun

\\ Illdo\\'~ Wurkstation: - Name: Administrator - from: Metals Lab - Password: 5str5119l1

2. ( )1','1, \\i i "I,)\\S I:.\I'lun:r 3. Sl'rulll,1 \'lvell hack-up location

I,ucation Dcscription l\'lvell: .I:/barretb on'Gamll1a\GLIER\Users'

\\Iris-TJA Instrument PC, ICP-OES \\.Icoll ()rlice PC, .IC

\\NSTVRI Data Pc, LIMS server \\SQ[~ database (L2K GLlER) Data PC, LlMSser(linkedST.) \UI'v1S ST D~lta Pc. LlMS ST ,\:'vklals LIMS Sl \' ()r.o'~lI1ic LIMS St

4. Copy C~ICI1, 'i tii,' i i \'C II ircctul'ies listed above 1i'om the locatiol1 described one at a time through till' Ili[C:\\~ol'lncl\\(lrk and paste onto the novel I drin:,

5. Overrick tl\l' I~IS', -l~lte stored directory,

Notes: - Wil1d(1\\~ .:'.()()() :\utolllalic hack-up program bas been investigated. see Data Manageillcilt l,ll:c, huok N0\2002 - Novell rl'lILliIT:; tile dl'~lg ~1I1d drop method therefore the automatic was not used. (It could be Ill(lk','ll i:l\O 111,1I'C )

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ISO/IEC 17025:2001 Quality System Procedures GLIER - Analytical Laboratories

Appendix 4.5.4 Subcontractor List Page lof 1

Revision 07 Issued:

April 2007

Subcontracting Laboratory Contact Personnel Approved Services

None currently active

DFO removed from Rev. 06

GLIER - Analytical Laboratories ISO/IEe 17025:2001

Quality System Procedures

Appendix 4.6 Approved Suppliers List Page I of 1

Revision 06 Issued:

August 2004

Approved Supplier Supplied Product(s)

Organic Laboratory

VWR SCIENTIFIC BULL WELDING. HEWLETT PACKARD LTD. SUPELCO CHROMATOGRAPHIC SPECIALTIES BIO-RAD ACCUSTANDARD

Metals Laboratory

VWR SCIENTIFIC/FISHER PRAXAIR SCP SCIENTIFIC VARIAN NRCC/NIST

Solvents, reagents and labware Compressed gases Instrument Parts

Chromatographic Supplies Chromatographic Supplies

Resins for GPC Certified Standard Solutions

Solvents, reagents and labware Compressed gases, Liquid Argon

Certified Reference Standard, Instrument Tubes and Graphite Electrodes

Sediment, Bio tissue and Water Standard Reference Material

I

ISO/IEC 17025 :200 I GLIER - Analytical Laboratories Quality System Procedures

Appendix 4.6.3. I Revision 01

I

Supplier Questionnaire Page I of 1 Issued: December 2004

Supplier Questionnaire

We, the Quality Management representatives for GLIER Laboratories, request that a representative of COMPANYNAME HERE quality team complete the following supplier questionnaire for the purposes of quality assessment in accordance with the GLIER Laboratories quality system. This evaluation is an essential component in maintaining a professional integrity with our suppliers, our certification requirements under the Guide 25: ISO/IEC 17025 quality system, as well as providing an enhanced level of accountability to the GLlER Laboratory customers.

Please feel free to contact our management staff concerning this survey if you have any questions, concerns, or suggestions. Contact information has been provided at the end of this survey. We appreciate your patronage, and look forward to continuing a successful business partnership with COMPANY NAME HERE.

Definitions: Product:

Tender:

Contract:

1. Organisation:

Company name:

Result of activities or processes.

Offer made by supplier in response to an invitation to satisfy a contract award to provide a product.

Agreed requirements between a supplier and customer transmitted by any means.

Company Address: _

Contact Information: Name: Title: Phone: Fax: E-mail: ~ _

2. Management Structure: Could you please provide an outline of COMPANY NAME HERE management structure in relation to Quality Systems maintenance:

GLIER - Analytical Laboratories ISO/IEe 17025 :200 I

Quality System Procedures Appendix 4.6.3.1

Supplier Questionnaire Page 2 of 1 Revision 01

Issued: December 2004

3. Certifications / Approvals: i) Is your company currently ISO 900 1:2000 certified? If so, please provide your registration number and date of certification:

ii) If no, is your company currently applying or working towards ISO certification?

4. Quality System Policies and Procedures: i) Has a quality system been implemented at COMPANY NAME HERE? If yes, please identify:

ii) Are quality procedures documented and implemented in your facility? If so, could you please provide a copy:

5. Management Responsibility to the Quality System i) Does COMPANY NAME HERE have a quality policy? If yes, could you please provide a copy.

ii) How has management communicated their commitment to quality within your facility?

iii) Are management reviews conducted at regular intervals to ensure the stated quality policy objectives are being implemented in a reasonable time frame?

iv) How does management ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction?

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I ISO/lEe 17025:2001 GLIER - Analytical Laboratories Quality System Procedures

Appendix 4.6.3.1 Revision 01 Supplier Questionnaire Page 3 of 1 Issued:

December 2004

6. Contract review: Are documented procedures in place to control for the review of a tender, contract or order to ensure that: i) the requirements are adequately defined and documented

ii) differences between the contract or order and the tender are resolved

iii) you have the capability to meet the specified requirements

7. Document and data control Does your facility maintain documented procedures to control all documents and data? If yes, please provide a copy of your documentation.

8. Purchasing i) Does COMPANY NAME HERE maintain documented procedures that ensure that purchased products conform to specified requirements? If yes, please provide a copy.

ii) Does your facility employ specific procedures for the evaluation of the ability of subcontractors/suppliers to meet contract requirements?

iii) Does your facility have a procedure for action when a subcontractor/supplier deliverable is late?

9. Control of Customer supplied product Does COMPANY NAME HERE maintain procedures to control for the verification, storage and/or maintenance of customer supplied products?

10. Product 10 and Traceability Do you have procedures in place to trace a product by suitable means from receipt and during all phases of production, delivery and installation?

GLiER - Analytical Laboratories ISO/IEC 17025 :200 1


I

Appendix 4.6.3.1 Supplier Questionnaire

I

Page 4 of 1 Revision 01


11. Process Control Are procedures in place to control for the production, installation and/or servicing processes which directly affect quality? Please provide examples.

12. Inspection and Testing i) Are records maintained to verify that the specified requirements for the product are met, and that product has passed inspection and/or testing activities? If yes, Please provide examples.

ii) Are documented procedures in place to ensure equipment is properly calibrated? If yes, please provide examples.

13. Control of Non-conforming product Are systems in place to ensure that a product that does not conform to specifications is prevented from unintended use, delivery or installation?

14. Corrective and Preventative Action Are procedures in place it ensure that any corrective or preventative actions taken to eliminate the causes of actual or potential non-conformities are conducted in a timely manner?

15. Product Delivery i) How does COMPANY NAME HERE ensure that delivery to customers is on time?

ii) What procedures are in place to monitor and remediate customer complaints relating to delivery? Please provide a recent example, if possible.

GLIER - Analytical Laboratories I

ISO/IEC 17025 :200 1 Quality System Procedures

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Appendix 4.6.3.1 Supplier Questionnaire Page 5 of 1

Revision 01 Issued:

December 2004

16. Control of Quality records What system does your facility implement to ensure quality records are stored and retained in a manner conducive to prevent damage, deterioration, or loss?

17. Internal Quality Audits i) Does COMPANY NAME HERE conduct regular quality system component audits? If yes, please provide a copy of your internal auditing schedule.

ii) How do you prioritise the status and importance of each activity being audited?

18. Training Is training for personnel on quality related issues a formalised and documented procedure?

19. Servicing What procedures are in place to verify that services rendered meet the specified requirements of your customers?

20. Statistical techniques Does COMPANY NAME HERE employ statistical techniques to establish, control and verify process and/or product quality? If yes, please provide examples.

GLJER - Analytical Laboratories ISO/IEC 17025:2001


Appendix 4.6.3.1 Supplier Questionnaire Page 6 of 1

Revision 01 Issued:

December 2004

We thank you for your time and commitment in completing this survey. The management of GLIER Laboratories ensures your responses will be held in strict

confidentiality, and used exclusively for the purposes of supplier assessment in accordance to this organisations quality management system.

GREAT LAKES INSTITUTE FOR ENVIRONMENTAL RESEARCH University of Windsor, 401 Sunset, Windsor, Ontario, N9B 3P4

Phone: (519) 250-3000 Fax: (519) 971-3616

I ISOIIEC 17025:2001 b- na ytIca La oratories GLIER A I . I

Quality System Procedures Section 4.9

Control of Non-conforming Testing

Page 1 of I Revision 07


NON-CONFORMANCE CORRECTIVE ACTION REPORT (C.A.R.)

Auditor: Party Involved:(Employees) -----------------

o Scheduled review 0 Deficiency 0 Preventative Action Description: _

1. Non-C. Parameter / Heading _ 2. *Accredition Body Ref. No. 3. *GLI Manual Ref. No.

* Attach revelant supporting documents

Description of Non Conformance: (Actual Observation)

Name: Date: _

Immediate Disposition (current recommendation to rectify) & Root Cause (describe)

Name: Date: _

Assigned Individual Responsible: Planned Implementation Date:

copy _

0

(Accept / Signature) _

Corrective Action (Following Investigation & Implementation)

Name: Date: _

Follow-Up and Closure Meeting on Audit

1. Actual Implementation Date: Explain problem:

Final Draft? 0 Yes(Close) 0 NO(Explain)

2. Second Follow-Up Required: DYes (Describe) DNa (Close) Date for fa IIow-Up, _ Describe solution:

Closed Date: Management Review Date:

(Lab Director) (Lab Supervisor/Q. Manager)

GLIER - Analytical Laboratories ISO/IEC 17025:2005


Appendix 4.10 Corrective Action Reports Page 1 of 1

Revision 01 Issued:

October 2006

PROCEDURE FOR CORRECTIVE ACTION REPORT (C.A.R.)

1. The laQ~rs()nnel initiates a corrective action report if a suspect failure (nonconformance) of laboratory protocol exists. See Q.S.P. 4.9 and 4.10 for details.

2. Complete CAR as per form, from description, immediate disposition and corrective action as layout on form (appendix 4.9).

3. Any supporting information must be attached C.A.R.

4. Present CAR to Lab Head to approve of action implemented.

5. The individJIill initiating the C.A.R. ensures all associated corrective actions are carried out. The QLJality Mani!ger must updatelissue any controlled documentation as necessary.

6. C.A. R. is officially closed by management sign off at Management Review meeting

--

QUALllY AUDIT SCHEDULE(lnternal)/ AUDITS PERFORMED PER YEAR Off C:/metalsllabmanuaV(latestyr)/misclauditsch.wk4

yEAR _

1 Pre-determine parameters (quality scope) for each respective month 2 Assign Auditor responsible to conduct year and approval by management

3 Supporting records will follow for the year enclosed.

/A.udit Scope Parameter Jan Feb Mar Apr May Jun [J~Au!lJ Sep rocrl Nov re~ No. 1 Eq~i~~I1t1Cal. 2 Facilities

' '-

3 Staff Training 4 Document Control 5 Data Management 6 Workload Managel!'e!'!t 7 Logs a!!C! Ac~iol1s .

f--.

8 Procurement 1---'9 MethodValidation

10 Internal Quality Control -

11 Work Instruction 12 Sample Reception

ManaQement Review --f

13

Assigned individual Lab Director to conduct audits . ,

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GLIER - Analytical Laboratories ISO/lEe 17025 :2001


Appendix 4.13A Internal Audits Procedure Page 1 of 1

Revision 02 Issued:

August 2006

PROCEDURE FOR INTERNAL AUDIT

1. The Audit Schedule is predetermined and approved at the last Management review meeting for the following year. The listed scope must be conducted at least yearly.

2. One parameter must be audited once for each lab reversing the role of the auditor and auditee ie: each respective lab supervisor. (Personnel cannot audit their own activities)

3. 3.1 Conduct the audit using pre-prepared Quality Audit Reports (13 parameters of criteria) found in the Q.M. 2.11 Appendix 4

3.2 Chose the appropriate Audit Report as dictated by the Schedule set by management, Q.M. 2.11 Appendix 7

3.3 Any investigations/analysis yielding non conformities of actual practice relative to the Q. M. must be documented in the Audit Report as well as attached C.A.R.

3.4 Complete a C.A.R. for the non confonnity.

3.5 Copy the C.A.R. to the individual assigned to implement the corrective action.

3.6 Any additional new findings/discussions with respect to preventative/continual improvements must be recorded via additional C.A.R.S.

4. A follow up and close will occur within the C.A.R. at the next audit meeting. Review and follow-up any previous open C.A.R.s from the last months Internal Audit to ensure action implementation. If secondary improvement is required the follow-up section states information required for close and/or spin-off.

5. The individual closing the C.A.R. ensures al associated actions are carried out. ie; document control edits ect. ..

6. C.A.R. is officially closed by management sign off at Management Review meeting.

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Appendix 5.2.1 Personnel - Competence Page 1 of 1

Revision 07 Issued:

September 2006

Appendix 5.2.1 PROCEDURES FOR IN-HOUSE TRAINING

The analyst will be trained in-house and responsible for the following:

• Quality Manual Policies and Strategies

• glassware washing, all associated related techniques to analytical laboratory cleanliness;

• bench work chemistry:

• all associated procedures such as; sample preparation; reagent preparation; percentage of water determinations.

• maintains check lists of samples analyzed, as well as samples received;

( • data entry into computer of samples analyzed.

External Provisions of Training:

Manufacturer -analytical instrumentation new product seminars • Current housed Instrumentation Training done externally • New instrumentation training install on site or done externally •

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ISO/lEe 17025:2001 OLlER - Analytical Laboratories Quality System Procedures

.~+--------~~R-e-V-i-si-o-n-0-6---lAppendix 5.2.1 B

Personnel - Training Page 1 of 1 Issued:[ August 2004 ~~----

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Appendix 5.2.18 STAFF TRAINING

1.Train technicians and assistants according to Procedure for In-House Training Appendix 5.2. 1 or as required. 2. Perform t\nalyst Evaluation Appendix 5.2.2 as required for new training tasks laboratory tests. 3.Have Employee Sign-off. Records are documented and kept by each respective Laboratory Supervisor.

I Date Employee Training (Job/Skill) , Employee Signature II II

r ISO/IEC 17025:200 1GLiER - :alytical Laboratories Quality System Procedures

._--. Appendix 5.2.2

Revision 06 ( l_ Personnel - Proficiency Page 1 of 1 Issued: ______[._ __August 2004

Appendix 5.2.2 ANALYST PROFICIENCYIEVALUATION

Analyst Name: _~ _ Employment Type: 0 Full Time, 0 Part Time, o Student Research Supervisor/Evaluator: . Laboratory: 0 Inorganic Method No.: 01- _

o Organic 02Method Title:

-~-

----------------~

Parameters Monitored: o General Evaluation

o Related Procedures

Acceptable Unacceptable1) Work Organization:

o Judgement (are results based on sound decisions) 0 o o Dependability (reliability) 0 o o Safety

2) Procedure QA/QC Results (compare to SOP Control Limit tables)

o Reagent Blanks 0 o o In House Control o o o Certified Reference o o o Duplicates o o

DS~~ 0 o 3) Instrument QA/QC Results (compare to SOP Control Limit Tables)

o Calibration Blank 0 o o Calibration Standard (Drift) o o o In House Calibration Control IJ o

Specific Training Skill: _

General Comments:

I ISO/lEe 17025:200I GLIER - Analytical Laboratories Quality System Procedures

Appendix 5.2.28 Revision 06 Personnel - Staff Records Page I of I Issued:

August 2004 ~

Appendix 5.2.28 TECHNICAL PERSONNEL - STAFF RECORDS

Start-Up: 1. Record individuals status below upon hiring and authorize. Ongoing: 2. Record Analyst Proficiency and Staff Training forms as applicable.

~IEmPIOyee ISkills and Experience !Training IEducation IASSignment IE]

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GLIER - Analytical Laboratories ISO/IEe 17025:2001


Appendix 5.3.2 Technical Requirements:

Accommodations and environmental conditions


Issued: August 2004

Appendix 5.3.2 Health and Safety (REFRIGERATORS)

FRIDGES FOR LABORATORY CHEMICAL STORAGE ONLY

- Storage for chemicals specific to respective laboratory

- Absolutely no food or drink in refrigerator

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GLIER - Analytical Laboratories ISO/lEe 17025:2001


Appendix 5.3.3 Technical Requirements:

Accommodations and environmental conditions


Issued: August 2004

Appendix 5.3.3 Housekeeping (Pest Control)

PLEASE DO NOT USE

PESTICIDES I INSECTICIDES

NEAR THIS

LABORATORY AREA Rooms 220-224

(Laboratory Analysis may be contaminated by the Housekeeping chemicals) ie; Avar -Crawling Insect Killer

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I~ ISO/lEC 17025:2001 Standard Operating Procedures

Appendix - 5.4.6 Test and calibrations-

Uncertainty of measurement Page 1 of 8

Revision 01 Issued: December 2004

Appendix - 5.4.6 Determination of Uncertainty in Analytical Measurement

1. Introduction

This procedure is applicable to individual measurements of mass, volume and uncertainty in analytical sample results. This procedure is applicable to all test methods used within the laboratory.

2. Principle of Method

This procedure details the calculation, use and reporting of uncertainty in individual measurements of mass, temperature and volume as well as uncertainty of the analytical test results.

ISO 17025 requires that "laboratories have and shall apply procedures for estimating uncertainty of measurement". This is the requirement to establish the confidence of analytical results.

The uncertainty of a measurement is the range of values that could reasonably be attributed to the measured quantity. The uncertainty value presents the variability of the result, due to both random and systematic causes, thus providing a level of confidence when making a decision using the result.

All uncertainty components that are important to the analysis are taken into account. A good estimate of uncertainty can be made by concentrating effort on the largest contributions or those values that include contribution for various sources of uncertainty. Uncertainties are calculated using the methods detailed in the SOP for Calculating the Uncertainty of Analytical Measurements. Blunders or outright human errors are not incorporated into the calculations. Uncertainty is commonly expressed as the standard deviation of the mean of a set of data expressed in the normal reporting units.

Measurement of uncertainty need only be calculated once unless the procedure itself or the equipment used is changed, in which case the uncertainty estimate would be re-evaluated.

3. Definitions:

3.1 Accuracy: a measure of the closeness of an individual measurement or the average of a number of measurements to the true value. Accuracy includes a combination of random error (precision) and systematic error (bias) components

I~ ISO/lEe 17025:2001 Standard Operating Procedures




that are due to sampling and analytical operations, EPA recommends using the terms "precision" and "bias", rather than "accuracy," to convey the information usually associated with accuracy.

3.2 Bias: the systematic or persistent distortion ofa measurements process, which causes errors in one direction (i.e., the expected sample measurement is different from the sample's true value).

3.3 Calibration: comparison of a measurement standard, instrument, or item with a standard or instrument of higher accuracy to detect and quantify inaccuracies and to report or eliminate those inaccuracies by adjustments.

3.4 Distributions: There are three types of distributions that are useful in the determination of uncertainties. A distribution factor (expressed herein as a divisor) specific to each distribution will be used to bring the standard deviation to a I sigma level. An additional divisor of2 will convert from k=2 to k=l for calculation.

3.5 Normal: When a large number of the measurement results are falling close to the mean with progressively fewer further from the mean, we say that this type of behaviour follows the normal distribution type. Divisor=l

3.6 Precision: Random error introduced during performance of the method. The degree to which a set of observations or measurements of the same property, obtained under similar conditions, conform to themselves; a data quality indicator. Precision is usually expressed as standard deviation, variance or range, in either absolute or relative terms. (NELAC). Also a measure of mutual agreement among individual measurements of the same property, usually under prescribed similar conditions, expressed generally in terms of the standard deviation.

3.7 Relative Uncertainty: expression of reliability defined as the fraction obtained by dividing the absolute uncertainty by the value of the result.

3.8 Standard Deviation (SO): measure of the dispersion or imprecision of a sample or population distribution expressed as the positive square root of the variance and has the same unit of measurement as the mean.

4. Responsibilities:

4.1 Quality Manager:

_To ensure the quality system is adhered to

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I~ ISO/IEC 17025:2001 Standard Operating Procedures




- To calculate or delegate calculation of measurements of uncertainty for all applicable tests - To ensure procedures are adhered to when calculating measurement uncertainties - To ensure that uncertainties when reported clearly state the k value and the source and application of the uncertainty. - To recalculate measurement of uncertainty is when significant changes to the method occur. - To ensure that the uncertainty of critical measuring equipment used (e.g. balances, thermometers, and volumetric) is fit for the intended use and does not compromise the precision or accuracy of the measurement.

4.2 Analyst

- To perform ongoing QC and method validation documentation on a continual basis that can be used to calculate uncertainty of measurement _To follow statistical control procedures as defined in the SOP for Control Charts _To perform method validation when required and provide data for assessment and calculation of uncertainty

5 Factors Affecting Uncertainty:

Many factors can have an effect on the uncertainty of an analytical measurement. These factors can be both external and internal to the laboratory. Sampling factors usually have the most significant contribution to the uncertainty of analytical data. Sampling factors are outside of the control of the laboratory and are not included in the measurement uncertainties reported by the laboratory.

5.1 Field Sampling Factors(External):

- field site sample homogeneity - sampling technique _cleanliness of sampling equipment and sample containers - cross contamination of samples - environmental conditions(weather) - sub-sampling techniques - preservation techniques _sample storage and time to submit to laboratory

5.2 Laboratory Factors:

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,~ ISO/IEe 17025:2001 Standard Operating Procedures




- Temperature measurement (all laboratory temperature measurements are traceable to NIST)

o measurement device type and readout accuracy o readability, resolution o drift o reproducibility o stability and uniformity of bath used for measurement

-Mass measurement (all laboratory mass measurements are traceable to NIST or NRC) o certified calibration weight uncertainty o balance linearity o repeatability o buoyancy effect of calibration weight o readability o drift o eccentricity

- Volume measurement (laboratory volume measurements may be traceable to NIST) o calibration uncertainty o readability o effect of heat or wear on calibrated volume

- storage conditions of samples, standards and reagents - environmental conditions in the laboratory (temperature, humidity) - purity of standards and reagents - sample preparation techniques and staff technique - instrument parameters, i.e. calibration, stability, sensitivity etc.

6 Procedures for Determining Uncertainty

6.1 Uncertainty in Mass Determination

in tests where mass determinations are a critical measurement, the balances used must be shown to be fit for the intended use. Uncertainty of determination must be less than the test's reporting limit. A one-time uncertainty budget should be calculated for each balance where critical measurements are made.

I~ ISOIIEC 17025:2001 Standard Operating Procedures




6.1.1 Obtain the following:

- Certified weight uncertainty from the calibration certificate. Type B, rectangular. - Readability of the balance. Type B, rectangular.

6.1.2 Calculate the following using the forms in Appendix A. Type A, normal.

- The balance linearity (also includes hysteresis) - The balance repeatability (includes eccentricity)

6.1.3 Estimate the buoyancy effect or neglect it using the worst-case scenario (30DC and 70% Relative Humidity, 95000 pascals on a 200g weight).

6.1.3 Calculate the combined uncertainty budget for the balance using the form in Appendix A.

6.2 Uncertainty in Volume measurement: The devices and measurements of critical volumes must be appropriate for the intended use. All critical measurements use class A glassware or Class A tolerances. Monitoring & Calibration of Weights & Measures. Calculation of uncertainty budgets is not necessary.

6.3 Uncertainty in Sample Results: calculating uncertainty for each component and mathematically calculating a total uncertainty using an uncertainty budget may determine Uncertainty. Alternatively, uncertainty may be calculated from a source that includes all components of uncertainty within the result, such as the laboratory control sample. Uncertainty Calculations are performed using the certified external control reference material. These contain uncertainty components that may be introduced within the laboratory. Duplicates and matrix spikes were not chosen to calculate uncertainty, because they include uncertainty outside of laboratory control. This includes sample matrix, sample homogeneity and the ability of the analyst to obtain a representative sample. Each laboratory and indeed each time period would have different combinations of sample matrices relative to the total database. Some labs/time periods analyze a sample type that can exist in a variety of matrix types. Uncertainties would vary greatly for each of these and the values obtained would represent the average, rather than any particular matrix.

6.4 The calculation selected is simple, to enable rapid calculation of many analyses.

6.4.1 Obtain a minimum of 50 historical data points from the analysis of the laboratory external control samples for each analyze. One year of data is recommended, but

7

r~ ISO/IEC 17025:2001 Standard Operating Procedures




more may be taken if necessary to complete 50 points or even out short-term trends. Data will be taken from less than one year if the procedure has changed or the procedure is new. The lab makes the assumption that this data set is normally distributed.

6.4.2 Remove outliers if their presence is suspected.

6.4.3 Calculate the uncertainty of measurement. Refer to QA logging files to perform these calculations. Method 1 is preferred. If appropriate other programs may also be used.

6.4.3.1 Method 1- simplest estimation of uncertainty, valid only at the level of the control sample. Calculate the standard deviation and the expanded uncertainty at k=2 (2x std.dev.).

6.4.3.2 Method 2- an estimation of uncertainty that accounts for precision, accuracy and corrects for the sample concentration. Include the external control sample target, mean and standard deviation with the laboratory sample concentrations and the combined expanded uncertainty is calculated.

6.4.3.3 Report the Uncertainty as required.

Reporting Uncertainty of Measurement

7.1 Format and Reporting Comment

It is not current policy to report measurement uncertainty as a standard procedure, however this policy may be changed without rewriting this SOP. Uncertainties may be calculated and reported if requested by the client.

It will reported via Method 1 or 2. Method 1 is preferred. It is important that the Uncertainty source be explained when reported.

Method 1: Method 1 is a very simple calculation based on the standard deviation of the laboratory control sample as shown in the example below, (for a analytical value of 10.0mg/L). The k=2 specifies that the confidence interval is 95%, i.e. 95% of the time the result for this analyze on this sample will fall within the range

of9.70 to 10.3 mg/L. U <uncertainty) =result + 2x Std.Dev., (and for method 1 only): determined at

concentration of unknown 'certified' sample.

U=1 0.0±0.3mg/L (k=2)

8

ISO/IEC 17025:2001 Standard Operating Procedures

Appendix - 5.4.6 Revision 01 Test and calibrations Page 7 of 8 Issued: December 2004

Uncertainty of measurement

The source of uncertainty for Method 1 may be explained as follows: The uncertainty is calculated from more than 50 individual determinations of the external certified control sample. It is not corrected for accuracy or bias, or the variation inherent in the determination of the target (certified value). It is not corrected for the mean value or the reported sample result; therefore it is a statement of uncertainty applicable only at the control sample concentration.

Method 2: Uncertainty may be used without qualification if the uncertainty is corrected to the reported concentration. It is a more complex calculation. The source of uncertainty may be explained as follows: The uncertainty is calculated from more than 50 individual determinations of the control sample. It includes precision and accuracy and is corrected for sample concentration.

7.2 Significant Figures - Report the same numbers of significant figures as the analytical results. Use only figures justified by the accuracy of the event (e.g. weight or volume) or method (final result). Generally, two or three figures are reported.

7.3 Interpretation of Data: Interpretation is the responsibility of the client.

Calculations

8.1 Mean: the mean of the replicate measurements.

8.2 Standard Deviation (Precision) - single data points

8.3 Combined Standard Uncertainty (uc): is the summation of all the individual uncertainties that exist in an analytical procedure. It is calculated using the "root/sum/square" method or by squaring each uncertainty value, adding the values and taking the square root of the sum.

8.4 Expanded Uncertainty(U): the expanded uncertainty is calculated by multiplying the combined.

8.5 Relative Uncertainty

8.6 Average Relative Uncertainty

r~ ISO/IEC 17025:2001 Standard Operating Procedures




9 Documentation

9.1 Calculation records and raw data, if not available database must be stored so that calculations and calculation techniques may be evaluated.

9.2 The records may be stored indefinitely, but must be stored for a minimum of 5 years.

10 References:

10.1 "Quality Control for Environmental Laboratories", CAEAL - Neil R. McQuaker, Revision 4.5, October 2001. (Training Course Material)

10.2 "Quantifying Uncertainty in Analytical Measurement", EURACHEM/CITAC Guide, 2nd Edition: 2000(Eurachem)

10.3 "Protocol for Estimating Measurement Uncertainty Using QC Data - TypeA" ,CCIL, Revision 1.0, June 2003. (Canadian Council ofIndependent Laboratories)

11 Revision History:

Rev. No.

Rev. Date

Revised by

Sections Affected

Description Auth.

00 Aug.12 2004

David Qiu JC Barrette

5.4.6 First Draft

01 Dec. 9, 04

JC 5.4.3 7.1

Reference QA logging files Method of choice hightighted

12 Calculation Tables: * See SOP

GLiER - Analytical Laboratories ISOIIEC 17025:2001


Appendix 5.5 Equipment - Inventory Page 1 of 3

Revision 06 Issued:

August 2004

Appendix 5.5 EQUIPMENT INVENTORY

ORGANIC LASORATORY

DESCRIPTION MODEL # SERIAL # RM# INV#

1 Hewlett Packard GC-MSD 6890GC-5973MSD USOO025978-GC 1 Hewlett Packard GC-MSD 5890 Series II 2921A23719 'I Hewlett Packard GC-ECD 5890 2919A22444 1 Hewlett Packard GC-ECD 5890 Series II Plus 3336A56208 1 Ultrasonic Cleaner 50HT 16423 1 Mettler Balance AE260-S H90288 1 Mettler 8alance PJ3000 H90327 'I Muffle Furnace F62735 107598015-9818 Gravity Convection Oven 16EG 10AP-7

1 Despatch Oven LEB-1-20 96799

1 Laboratory Oven LO-201C 1 Lauda Recirculator/Cooler Endocal RTE-11 0 92DML20970-5

1 Caframo Rotaevaporator W2000-L1FT 69108563

1 80chi Rotaevaporator RE111 187031595

1 80chi Rotaevaporator RE111 187050664

1 Polytron Homogenizer Kinematica CH-601 0 14207

1 Polytron Homogenizer Kinematica DG 18113

1 Waring Commercial 81ender 5011 1 Hand Food Processor Type E-23 1 Vortex-Genie Mixer K-550-6 28773

1 Vortex-Genie Mixer 3644 5306

1 Pierce React Evaporating Unit 18780,18870 548930255149

1 General Electric Refrigerator 04T17 LX301629

1 Kenmore Refrigerator-20 Series C970-20700-2 ND00501371

1 Kenmore Upright Freezer 83680-0X 00163699

2 Rack with 6 hot plates (Soxhlet) 5000 0585

1 386 Computer 90191290

1 Pentium 1\ Computer E781274053

1 Beckman HPLC -508Autosampler AOO06

- 126Pumps System 068-16752228

- 168Detector 068-1863 - Fluorescense Detector FP-920 P398-17802228

_Separation Module SC100 2075522228

- Computer, IBM-350 78PGMNB-P200

228B 222B 222B 222B 222B 222B 222 222 222 222 222 222 222 222 222 222 237 222 222 222

222 222 220 222C 222 220 220 222B

2228

222B

GLIER - Analytical Laboratories ISO/lEe 17025 :200 1


Appendix 5.5 Equipment - Inventory Page 2 of 3

Revision 06 Issued:

August 2004

METALS LASORA TORY

NO. DESCRIPTION INVEN#

1 (AAS) Varian Model Atomic Absorption Spectrometer-Flame Furnace & Hydride Methods

1 (ICP-OES) Thermo Jarrell Ash -Inductively Coupled Plasma Optical Emission Spectrometer & Recirculator

1 (ICP-MS) Thermo Jarrell Ash - Inductively Coupled Plasma Mass Spectrometer & Recirculator

1 Sartorius Balance 1 Sartorius Balance 1 Mettler Balance 1 Mettler Balance 1 Sartorius Balance 1 Mettler Balance 1 Mettler Balance

1 Microzone Laminar Flow Fumehood (PVC Construction)

1 Lindberg Box Furnace 1 Westbend Digestion Hot Plate 1 Toastess Digestion Hot Plate 1 Precision Water Bath 1 Scientific Products Water Bath 1 Corning Glass Distillation

Water Unit 1 Millipore Water Filtration System 1 486 DX Computer with Modem 1 386 DX Computer with Modem 1 Thermodyne Cimerac 2 Stirrer/

Hot Plate 1 Laser Printer

MODEL # SERIAL # RM#

AA300-0011039 0011039 224 11586

701776 148 226

Plasma Quad 3 2037 226

BP410 90908588 225B BP221S AB204 PB3001 BP2100S AE240 PJ400

V8MW99C

Blue 847 709M 762087 183 B7005-2 AG1a

Milli-Q RG

EMPac SP46925

91008042 225B 1116490909 225C 1116302418 225C 91110231 225D G44278 2250 G94469 MOBILE

806-8103 225

W30D-184951-XD 225 225 225 225

0976 225 787 225

F4CM75675C 255 231 231

46906017 225

231

ISO/lEe 17025:2001 IGLIER - Analytical Laboratories i Quality System Procedures

Appendix 5.5

Equipment-Inventory

ADMINISTRATION

NO. DESCRIPTION INVEN#

1 486 OX Computer with Modem 1 486 OX Computer with Modem 1 486 OX Computer with Modem 1 HP Laser Jet liP Printer 1 HP Laser Jet IIIP Printer 1 Doidge NP-3025 Copy Machine 1 Ricoh 20 E Fax Machine 1 28 ft. Research Vessel 1 21 ft. Research Vessel (Monark) 1 Trailer (Monark) 1 Boat Trailer (Blue Fin)

1989 Dodge Van 1 Kenmore Freezer 1 Kenmore Freezer 1 Kenmore Freezer

I Revision 06I

g1 p_a_e_3_O_f_3__--'--- ......ls'---s_u_ed_._--'~ i August 2004

MODEL # SERIAL # RM#

1465 MC-30704764 249A 234 234

HP 33471A 3049J02AY9 249A1 HP 234

F11680 CC102270 249B 20 E 80500288 249B 28-9.5-4 Hull #3 2294147844 Colchester

18E151712 Univ. Cmp. TRB 2T921T333JW047104 Univ. Cmp. SIL 07070 Univ. 1 150 2B4HB15Y8KK327844 Univ. 3-31416 128 3-3146 128 3-3146 128

ISOIIEC 17025:2001 I I

GLIER - Analytical Laboratories Quality System Procedures

Appendix 5.6.3 Revision 07 Measurement Traceability Page 1 of 1 Issued:

Reference Materials August 2004

Appendix 5.6.3 LIST OF CERTIFIED REFERENCE MATERIALS

IN USE IN METALS ANALYTICAL LABORATORY

I) N.I.S.T. - National Institute of Standards and Technology

i) Agricultural Material - SRM # 1575 (Pine Needles) - SRM #1547 (Peach Leaves)

ii) Water Sample - SLRS-4

2) N.R.C.C - National Research Council of Canada

i) Marine Sediment MESS-3 PACS-2

ii) Biological Tissues - DORM-2 - Dogfish muscle and liver pool, defatted and dehydrated - DOLT-3 - Dogfish muscle and liver pool, defatted and dehydrated - LUTS- J - Lobster hepatopancreas, nondefatted and nondehydrated

IN USE IN ORGANIC ANALYTICAL LABORATORY:

J) 8929 Reference - Herring Gull Eggpool provided by CWS for OCs and PCBs Quality Control.

2) NIST - SRM 149: Aromatic Hydrocarbons in hexane/toluene

3) NIST - Biological SRM 1588: Organics in Cod Liver Oil.

4a) NIST - Sediment SRM 1939a: PCBs in River Sediment 4b) NIST - Sediment SRM 1944: Organics (OCs, PCB and PAH) in New

York / New Jersey waterway Sediment

5) NIST - Water SRM 1639: Halocarbons in Methanol for Water Analysis

6) NIST - SRM 1945: Organics in Whale Blubber

------------

----------

GLIER - Analytical Laboratories ISO/IEC 17025:200 1


Appendix 5.8.1 Revision 07 Handling of test and calibration Page I of I Issued:

I items - Sample Submission September 2005

Appendix 5.8.1 SAMPLE SUBMISSIONIRECEPTION FORM

Client I.D. Lab Sample Code Range _ * Verify Lab/Client codes on sample jars

OrganizationJDepartment _ Date Submitted'-~~-~--~--

Name of Submitter Date Sampled _

Signature of Submitter ~ _ Analysis Period. _

Client Contact Total # of Samples _ --~~--------

Contract # (charge#) _ Contract Attached: Yes 0 No 0

Sample Type (species, matrix) ~_~ _

Area of Collection (location, sites) _~ ~ _

Sample History (received preserved, container suitability) _

Field Supplies requested by Client? No 0 Yes 0 Via Organic 0 Metals 0

Type of Container _ ( AI. foil, amber glass jars, Whiribag, HDPE-LDPE bottles & size, LDPE jars-I OOmL .. , )

Pre-test requirement _ (homogenization, subsampling, pooling, remove unwanted material, insufficient amount)

Storage Location. _ Storage Conditions (4'C/-20'C) _ After Processing:

Sample to be Stored o Yes o No Return to client o Yes o No

Comments of Receptionist: _

(Container material, sample size, sample integrity, type of homogenization, i.e. metals/organics container requirements, etc.)

Receptionist Signature: _

Authorization: Lab Supervisor



I

Appendix 5.8.4 Handling oftest and calibration

items - Chain of Custody Page 1 of 1

Revision 06 Issued:

August 2004

Appendix 5.8.4 CHAIN OF CUSTODY FORM

ALL SAMPLES ARE RECEIVED BY A DESIGNATE AT THE ORGANIC LABORA TORY

SAMPLE RECEPTION

Date Received:

Received By:

STORAGE

Location:

Special Conditions

Comments:

ISOllEC 17025:2001 GLIER - Analytical Laboratories Quality System Procedures

Appendix 5.9 I Revision 06 Quality of test results - Page 1 of 1 Issued:

,---~_~ In~te_r_la_b_co_m-,p,-a_r_is_o_n_s -L[_ August 2004 __ '--

Appendix 5.9.3 INTERLABORATORY COMPARISONS (PROFICIENCY TESTING)

To date the following interlaboratory comparisons have been performed.

o July 1994, conducted by Environment Canada - National Water Research Institute, analysing ten water samples of varying matrices for trace metals.

o February 1993, an informal comparison in the National Laboratory, Environment Canada (CCIW) with two of our internal reference samples (biological tissues).

o September 1993, conducted by the Canadian Wildlife Service, analysing caribou tissue samples for Cadmium, Lead and Mercury.

o December 1992, CAPCO Wildlife Check Sample Program. GLIER placed first on the list with a score of 13 out of a maximum of 15.

o November 1990, CAPCO Wildlife Check Sample Program involved the analyses of herring gull egg homogenate for nine individual PCB congeners and seven organochlorine compounds. Of 13 laboratories participating, GLIER placed second scoring 13 out of a maximum of 16.

o July 1987, the study organized by CWS involved the analysis of herring gull egg homogenate for individual PCB congeners. Of 14 laboratories participating, GLIER placed first.

The following samples are analyzed twice per year for CAEAL Proficiency testing;

o 1995 to 2000, conducted by Canadian Association of Environmental Analytical Laboratories, analysing four transformer oil samples for total PCBs.

o 1995 to present, conducted by Canadian Association of Environmental Analytical Laboratories, analysing for total PCBs and pesticides in water.

o 1995 to present, conducted by Canadian Association for Environmental Analytical Laboratories analysing eight water samples for trace metals.

o 1995 to present, conducted by Canadian Association of Environmental Analytical Laboratories analysing 4 soil samples for metals and PAH compounds.

IREF. #

University of Windsor Research CONTRACT Application Approval Form

WOR ORS USE ONLY)

DATE:

PRINCIPAL INVESTIGATOR: PHONE #:

FACULTY DEPARTMENT

OTHER INVESTIGATORS (name and department affiliation):

1. SPONSOR:

PROGRAM

(e.g., operating, equipment, fellowship, partnership, etc.)

2.

___________ (day/month/year)

TERM: FROM

THROUGH

--------- (day/month/year)

3. TIME COMMITMENT ------- (%)

',. TITLE OF PROJECT:

Is it a Contract? Yes if: 1,) Outlines the scope and nature of the research 2) Establish payment schedules (payment may

be made as work accomplished is invoiced) 3,) Sets the time periods for activity 4,) Defines the deliverables 5,) Establishes ownership of the intel/ectual

property, patent rights and licensing agreements

6.) Provides for confidentiality of infonnation supplied and created

7,) Establishes considerations for acceptance and/or tennination

8.) Limits liability of the participants

KEYWORDS

5. DOES THIS PROJECT INVOLVE THE USE OF: a. human subjects? NO --- YES ---__ if yes, approval pending 0 or attached 0 b. vertebrate animals? NO --- YES ---__ If yes, approval pending 0 or attached 0 c. biological research hazards? NO YES - __ -+if yes, approval pending 0 or attached 0

6. BUDGET SUMMARY (BUDGET SUMMARY FROM PROPOSAL MUST BE ATIACHED):

TOTAL PROJECT COSTS Year 1 Year2 Year 3 Year 4 Year 5

a) OVERHEAD COSTS: (The University of Windsor charges a 30% flat rate on the total project cost on government and industry CONTRACTS (excluding Equipment Costs).

Cost (specify amount) of (specify base)

IMPORTANT SEE OVER/NEXT PAGE FOR REQUIRED SIGNATURES

Page 1 of 2

----

ISO/Jl,C 17025:2005

ApjX' 11 di\ Rl' \

Quality System Procedures ::-. iun 1-'j-S-U-j-l-')-'--~------~ "r 1 J----=R:--e v-O:i-s:-io-n--=0-=3:-----f

Pag\.' I () j 1 Issued: '-- ~ , I----l _ October 2006

APPENDIX RL\ISI()~ HISTORY

Rev.

No.

OJ

02

02

~-

01

01

Hl'\

Dat l'

Ik, I

11,1

SCI'. ei,

os

,\lIt' ; I, .It 0(,

Sl'pl II

t--- (),1 ~ I,

Oil

N<lI 1 .I!.' 0(,

I{n i-Sl'~--Appendix Description-k .- Auth.

h~ I Affected

1(, II~ -r--il, I Supplier ()ueSlOI1II,lIl'C :\C\\ II(~;-J 1;111 dOCUlllcnts I ,) ('AR !{L11101 c ,dd Il'l , c losc sign ofT add QManagcr 1.11/\ I.Audits-Schedule I'\C\\, c0l'il'(I Ilellll 200.3 Q,Manual

,) I ; 1\ L/\udits-l'l(lccdurc i\:c\\', c0l'icII 11(l1ll 20113 QManual j 1.1l Unccrtainly Rcfclencc (,J\ logging filt:s, Highlight method

J__ ----,---,-------c-----+-------c It ILllTe'lle' S.X I SampleSublllisslon ,\dd vcril) I '[,cllt/lab codes on sample jar

!{l'\ 07

II.IITC[k Add .3,(, IJI'c \clJUltivc lindings procedure 5,2.1 Training

13/\ LAudit I'roccdllrc Add cxtcrna I pmvisions sor senior staff

--f-----c-.--:-~VIISSlllg Irll( 11 '11m 11)\'mat change, added copy :lI1d 1I!11LiICd ·\s prc\lllUsly referenced in QSP ,1.11).,1I

Missillj.' I'rll! II ,-

211(),' IlJrll1at change, added copy 10 ()SI' 4.3

ILIITCllc 4.3 I)ala Managcll1cnt

f

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ISO/lEC 17025:200 Quality System Procedures …inweh.unu.edu/wp-content/uploads/2013/05/GLIER_QSP_Technical...quality policy objectives are being implemented in a reasonable time frame?