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h QUALITY is ³the degree to which a set of inherent characteristics fulfils requirements´ [ISO 9000-2000]. 9000-2000]
h In analytical work, QUALITY can be defined as
³delivery of reliable information within an agreed spare of time and under agreed conditions, at agreed costs and with necessary aftercare´. aftercare´.
To achieve Quality and optimal performance it is necessary to develop and put in practice the concepts of:
h QUALITY MANAGEMENT h QUALITY ASSURANCE h QUALITY CONTROL
QUALITY MANAGEMENT (QM) represents ³the coordinated activities to direct and control an organization with regard to quality´.
[ISO 9000-2000]. 9000-
In testing laboratories, QM means: h creating a good structure; h providing support for developing; h validating methodologies; h verifying performance.
9000- QMS includes: h organizatoric structure.QUALITY MANAGEMENT SYSTEM (QMS) is ³the management system to direct and control an organization with regard to quality´ [ISO 9000-2000]. h procedures / processes. h resources necessary for implementation of QM. .
controlled. . h reported.QUALITY ASSURANCE (QA) is ³part of the QM focused on providing confidence that quality requirements will be fulfilled´ [ISO 9000-2000]. 9000- QA implies that the organization of the activities and the conditions under which this takes place are: are: h controlled. reported. filed. h filed.
QA means: h h h h SAY WHAT YOU DO DO WHAT YOU SAY DO IT BETTER BE ABLE TO SHOW WHAT YOU HAVE DONE .In short.
. improve efficiency. stimulate and motivate personnel. minimize errors. improve reputation of the laboratory.QA implementation conduct to: h h h h h better laboratory management.
QUALITY CONTROL (QC) is a ³major part of QM, focused on fulfilling quality requirements´ [ISO 9000-2000]. 9000For analytical activity, QC represents: ³a set of procedures undertaken by the laboratory for continuous monitoring of operations and results in order to decide whether the results are reliable enough to be realized´.
QC is divided into three levels: 1. first level of control (internal control): realized by the analyst; 2. second level of control (internal control): realized by the QA Manager/Head of Laboratory; 3. third level of control (external control): interlaboratory proficiency testing
Sample data Quality assesment Data QC samples Specification Accept/use data
Check samples given by Qality manager Third Level Laboratory performance study
The main QMS elements are: h Quality policy. h Procedures. they have a pyramidal structure. structure. . instructions. h Quality Manual. Function of their importance. h Records. h Quality objectives.
QUALITY STANDARD QUALITY POLICY QUALITY OBJECTIVES QUALITY MANUAL PROCEDURES INSTRUCTIONS RECORDS .
h QUALITY POLICY must be written down and familiar to all personnel from the laboratory. h QUALITY POLICY is established by the highest level of authority from the laboratory.h QUALITY POLICY attest the intentions and direction for maintaining a high level of quality in the activity of the laboratory. .
h requirements of regulatory or accreditation body. h results of audits. h customer complaints.QUALITY OBJECTIVES ARE BASED ON: h particular laboratory priorities and field of interest. .
h attainable and very clear defined .QUALITY OBJECTIVES SHOULD BE: h quantified in so far as possible (numerical values. target dates).
To make changes in the routine methodology in order to respond to the performance needs. .THE MAIN QUALITY OBJESTIVES IN A TEST LABORATORY ARE: . .To achieve and maintain consistent.To ensure that all personnel is trained at high level of technology.To maximize the quality of the data by improving precision and accuracy. uniform levels of quality. . .
The QUALITY MANUAL is elaborated by the Manager of the Laboratory and the Quality Manager. h the Quality Policy. h the responsibilities and authorities of the personnel.QUALITY MANUAL is the ³document specifying the QMS of the organization´[ISO 9000-2000]. h the procedures of QMS or a short presentation of them.up to date and control of the Manual. beginning . The QUALITY MANUAL includes: h a short presentation of the Laboratory and of the Company. . h a specification concerning elaboration.
h standard operating procedures ± for testing methods . h system procedures ± for the management and the technical requirements from ISO 17025 standard. Types of procedures function of the activities described: h general or fundamental procedures ± how to elaborate procedures.PROCEDURES are ³specified ways to carry out an activity or process´ [ISO 9000-2000].
.PROCEDURES MUST CONTAIN A MINIMUM NUMBER OF REQUIREMENTS: ON EACH PAGE TO BE MENTIONED: .the version and revision number. . .page number and the total number of pages. .number of copies. .the code and number of the procedure.the complete title.
. including date of signing .name and signature of person who authorized the implementation of the procedure.name and signature of author.PROCEDURES MUST CONTAIN A MINIMUM NUMBER OF REQUIREMENTS: THE FIRST PAGE SHOULD CONTAIN: .general information mentioned above. . .
responsibilities for achieving the activities.PROCEDURES MUST CONTAIN A MINIMUM NUMBER OF REQUIREMENTS: THE CONTENT MUST INCLUDE: .list of references. .a clear description of the activity. . . .purpose and field of application.
accreditation body and regulatory authorities concerning the quality of the analytical activity of the laboratory.RECORDS represent the objectives proofs for the laboratory clients. h Records are the basic elements of the QMS. loss or change of original data. h Records are produced every day. h Records must be kept in order and good conditions to prevent damage. .
second and third party laboratories which perform tests. Specification with guidance for use . including sampling ISO 9001 Quality Management System requirements For laboratories which conduct research and development activities For laboratories which perform monitoring of the environment ISO 14001 Environmental Management Systems.QMS for environmental laboratories (I): ISO/IEC 17025 General requirements for competence of testing and calibration laboratories For first.
QMS for environmental laboratories (II): Function of the activity an environmental laboratory can implement integrated QMS: h ISO 9001 ± ISO 17025 h ISO 17025 ± ISO 14001 h ISO 9001 ± ISO 17025 ± ISO 14001 .
documentat ion) Management rewiews Services to the clients Complaints Management responsability Control of nonconforming tests Corrective and preventive actions Measurement. analysis and improvement Traceability Assuring Quality of tests Internal Audit Document control Control of records Personnel Accomodation and environmental conditions Resource management Product realisation Rewiew of requests.objecti ves. tender and contracts Handeling of test items Sampling Sub-contracting ot tests Purchasing services and supplies Test and method validation Reporting results Equipment .Procedures in the integrated quality system ISO 9001-ISO 17025 ISO 17025 Management and Organization ISO 9001 Quality System (politics.
. -accreditation bodies.clients.regulatory authorities. . h Confirm or recognize the competence of the laboratory towards : .ACCREDITATION ISO 17025 offers: h Independent assessment of quality management system and technical competence of the laboratory.
h ACCREDITATION ISO 17025 is realized by the National Accreditation Body. h REACCREDITATION at 2-5 years.h ACCREDITATION ISO 17025 process is voluntary. .
h to respond to the 10 technical requirements.ACCREDITATION ISO 17025 Requirements for accreditation ISO 17025: h to respond to the 14 management requirements. .
financial or other pressures which might influence their technical judgment.1 ORGANIZATION (I) Laboratory must: h be entity legally responsible. h satisfy the needs of the client. regulatory authorities or accreditation body. h have an organigram in which to define the organization. h identify potential conflicts of interest (if laboratory is part of an organization).MANAGEMENT REQUIREMENTS 4. structure and management . h be able to demonstrate the impartiality and that the personnel is free from commercial.
h have technical management with responsibilities for technical activities and of provisions of the resources needed to ensure the required quality.ORGANIZATION (II): h have sufficient qualified staff for all the activities (professional requirements described in the Job Description). h have a quality manager. h have deputies for key managerial personnel. .
commitment to good professional practice and to quality of the test services.commitment that all personnel concerned with testing activity will know and implement the policies and procedures in their work.2 QUALITY SISTEM For implementing and maintaining the QMS the laboratory must have: h Quality policy statement . .commitment to compliance with the standard. . h Quality Manual . .4.objectives of the quality system.
. procedure.authorizing. h possession and/or changing of documents. which define.4. h distribution of documents. result´. h destroying and archiving of documents. . [ISO 9000-2000] Laboratory must maintain full control over the: h evaluation of documents ± drafting.verifying. describe or report an activity. .3 DOCUMENT CONTROL (I) Document is ³written down or digital information.
EXTERNAL SOURCES Standards. DOCUMENTS Quality policy and objectives. Books.DOCUMENT CONTROL (II) Quality Documents can be: Quality Manual. . Instructions. INTERNALLY GENERATED Procedures. Norms. manuals. Technical specification . regulations.
.date of revision. . . h periodically reviewed /revised. h original with all accompanying change notice retained as historical file.the issuing authority.date of issue. .a code/number.page numbering. . hdestroyed when are out of use to avoid unintended use.DOCUMENT CONTROL (III) Documents generated by the laboratory should be: h uniquely identified by : .
. documented and capable of meeting the clients requirements.4. TENDERS AND CONTRACTS (I) Before doing a contract.4 REVIEW OF REQUESTS. laboratory must proof that: h it posses the skilled personnel for the performance of the tests in question. h methods to be used are adequately defined. h the financial. legal and time schedule aspects were taken into account.
h any deviations announced to the client. or the agreement between the client and the laboratory shall be: h signed by both partners. TENDERS AND CONTRACTS (II): The contract. .REVIEW OF REQUESTS.
workload. h Maintain a register with all subcontractors. .5 SUBCONTRACTING OF TESTS h Temporary subcontracting activity .certificate of accreditation.temporary incapacity. h Laboratory is responsible to the client for subcontractor¶s work.audit. .need for further expertise.4. . . h Permanent subcontracting activity h Selection of subcontracting laboratories by: .
6 PURCHASING SERVICES AND SUPPLIES (I) h Procedures for purchasing and storage of: .4. . . accompanying certificate are used for identification of the material received.quality specification.quantity. h Purchase documents. . h Purchase order must contain: . . . . like purchase order.equipment.services. receiving documents.complete name of the product/service.reagents.consumable materials.
h Records of actions taken. h Evaluation of suppliers and maintaining records of these evaluations.PURCHASING SERVICES AND SUPPLIES (II) h Inspection of the purchase services and supplies before being used. .
4. .providing the client access to relevant areas of the laboratory for the witnessing of tests performed for the clients.7 SERVICE TO THE CLIENT h Co-operation with clients: . . h Information of the client of any major deviations and delays. packaging and dispatch of test items needed by the client for verification purposes.preparation. . h Feedback (positive and negative) from the client.technical advices and interpretation based on results.
h Received from clients, regulatory or accreditation bodies.
h Steps for solving a complaint:
- preliminary investigation to determine the nature and validity of the complaint; - solving the problem which generated the complaint; - initiating a request for corrective actions, if necessary; - report to manager about the status of the complaint.
hRecords of complaints, of investigations and corrective actions taken
4.9 CONTROL OF NONCONFORMING TESTING WORK (I) Nonconformity may occur :
h Within the Quality System: - internal or external audits; - customer complaints; - staff observations; - management review.
h Within technical operation:
- instrument calibration; - data validation; - test report checking.
4.9 CONTROL OF NONCONFORMING TESTING WORK (II) h Procedure must include:
- reporting and recording the occurrence of a nonconforming event ; - suspension of work and commencement of an investigation ; - report to the customer; - repetition of the test; - initiation of corrective action.
.Report of nonconforming activities.12 CONTROL OF RECORDS (I) Records are ³written objective proofs concerning the activities performed and the results´ [ISO 9000-2000]. .Control charts. .Management review report.Cheek sheets. . RECORDS .Work notes. QUALITY RECORDS RECORDS TECHNICAL RECORDS .Report of corrective/preventive actions. .Calibrations certifications. . .4.Laboratory notebooks.Report of audit.Test reports. . .Training report. Records can be classified as: .
access. of Quality and technical records. .disproval. .CONTROL OF RECORDS (II) Laboratory must maintain procedure for: . . . .collection.maintenance.storage.identification.filling. . .
loss or degradation due to atmospheric conditions. .CONTROL OF RECORDS (III) h Records must be: . .protected of damage.protected of unauthorized access.legible. . .stored in proper conditions. h Equivalent measures must be taken for records stored electronically for avoiding loss or change of original data.
. .10 CORRECTIVE ACTIONS Corrective actions have ³the role to eliminate the causes of a nonconformity and to prevent recurrence of the undesirable potential situation´.selection and implementation of corrective action. method of analysis. h Steps for implementing a corrective action: .investigation of the root cause of the problem (possible causes: sampling. equipment.4. staff skills.).monitor the results to ensure that the corrective action was effective. . etc.
results of the management review.participation to trainings or changes of experience. .participation to interlaboratory schemes.4. h Preventive actions can result from: .17 PREVENTIVE ACTIONS ³Pro-active process of identification of potential sources of nonconfomities either technical or concerning the Quality System´. . . .market analysis.feed-back from clients. .
h Corrective actions must be taken. h Planned by the QA Manager at least annually. h All the Management and Technical elements of the QMS are checked. h Carried out by trained personnel. independent and documented process for verifying and obtaining evidence that operations in the laboratory continue to comply with the requirements of the QMS and the referential standard´.4.13 INTERNAL AUDIT ³A systematic. .
the outcome of internal and external audits.results of interlaboratory proficiency tests.changes in the type and volume of work h Findings from the management reviews represent: .14 MANAGEMENT REVIEWS h The executy manager shall conduct once by year a review of the QMS in which to take account of: .corrective and preventive actions.4. . . .clients feedback. . .goals.objectives. .complaints. .action plans. . for the next year and must be recorded.
technical and key support personnel involved in test activity h All information about personnel should be recorded .2 PERSONNEL AND TRAINING (I) h The laboratory must have sufficient qualified and experienced personnel h The laboratory must maintain current job description for managerial.TECHNICAL REQUIREMENTS 5.
use of the new equipment.data handling. . . . use of computers.development in analytical techniques.PERSONNEL AND TRAINING (II) h All personnel involved in any function affecting quality should have sufficient training in their appointed job h The training program may concern: .laboratory QMS. .
h The laboratory shall maintain up-to-date records of the trainings received by the staff of the laboratory. h At the end of the training: .centrally conducted courses. if necessary abroad.evaluation of the effective training.PERSONNEL AND TRAINING (III) h Trainings developed: .certificates / diplomas.within the laboratory. . . .by outside specialist. .
): .3 ACCOMODATION AND ENVIRONMENTAL CONDITIONS (I) h Laboratories must have uncrowded.storage room for chemicals. .storage room for samples (with shelves. .5.service rooms (storage of distilled water.rooms for preliminary operation (extraction.room for receipt and registration of the samples. . . refrigerators). . . . acid digestion.³clean room´ for equipment. etc. washing of glassware).room for general chemical analysis. distillation.rooms for administration office. clean and tidy room divided into ³chemical´ and ³not chemical´ areas: .
.humidity.ACCOMODATION AND ENVIRONMENTAL CONDITIONS (II) h Appropriate environmental conditions: . inspectors must be in charge of one member of the laboratory . . .freedom of vibration. hMonitoring of temperature and humidity hAdmission in laboratory only for authorized persons h Visitors.clean air. .temperature.freedom of air borne and dust.
5.4 TEST METHODS AND METHOD VALIDATION hAppropriate methods and procedures for all test activities h Test methods must be: .authorized. . .technically justified. .verified for use in the laboratory.
8402-94). . h Verification means ³ confirmation by examination and provision of objective evidence that specified requirements have been fulfilled´ (ISO 8402-94).METHOD VALIDATION (I) h Validation means ³confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled ³ (ISO.
. .laboratory.non-standard methods.designed/developed methods.standard methods used outside their intended scope.changes of standard methods . . h Validation is applied for: .METHOD VALIDATION (II) hVerification is applied for checking the standard method.
. .detection limit.specificity /selectivity.ruggedness or robustness. .repeatability.METHOD VALIDATION (III) h In validation process are established the performance characteristics of the method: .recovery. .quantification limit. .reproducibility. . .
h Type B components .UNCERTAINTY OF MEASUREMENT (I) Testing laboratories must implement procedures for estimating uncertainty of measurement. h Uncertainty is ³the parameter associated with the result of a measurement that characterizes the dispersion of the values that could be reasonably attributed to the measurand ´. h Type A components ± may be evaluated from statistical distribution of the result of a series of measurements and is expressed as standard deviations. .may be evaluated from assumed probability distributions based on experience or other information. Is expressed as standard deviation.
UNCERTAINTY OF MEASUREMENT (II) h Standard Uncertainty ± u (xi). .uc(y). equal to the positive square root of a sum of terms being the variances or co-variances of these other quantities weighted according to how the measurement result varies with the quantities¶. is ³the uncertainty of the result of a measurement expressed as a standard deviation´. h Combined Standard Uncertainty . is µthe uncertainty of the result of a measurement when the result is obtained from the values of a number of other quantities.
UNCERTAINTY OF MEASUREMENT (II) h Expanded Uncertainty ± U=K. is ³the quantity defining an interval about a result of a measurement that may be expected to encompass a large fraction of the distribution of the values that could reasonably be attributed to the measurand´.uc. .
software are suitable validated.computers are maintained in proper condition.the protection of data is established. . . .CALCULATION AND DATA TRANSFER h Nominated persons from the laboratory must check the calculations and the data transfer in a systematic manner. during they are generated h When computers are used. it is necessary to ensure that: .
).EQUIPMENT (I) h The laboratories must be furnished with all categories of equipment. etc. flow meters.analytical equipment (spectrometers. like: .computers and data processors. chromatographs.sampling equipment. stirrers.). etc. furnaces. . . . . etc. electrochemical meters.primary measuring equipment (balances. .miscellaneous equipment (ovens. thermometers.).
.Maintenance Logbook.list of all available equipment.a Plan for Instrument Calibration / Maintenance.EQUIPMENT (II) h Records must be maintained for all equipment: . . .Operational Instructions Manual. .identification list for each equipment. .
h On the label must be mentioned: .the status of the calibration. .EQUIPMENT (III) hAll equipment must be labeled. .the identification number. or code of the equipment. .the date when last calibration was done.
are defective or outside specified limits. .mishandlings. .give suspect results. . . must be clearly labeled or marked and isolated to prevent unintended use.EQUIPMENT (IV) h Equipment that have been subject of: .overloading.
use of reference materials. .calibration of equipment and glassware.5. h Measurement traceability is realized by: . preferably to SI.5 MEASUREMENT TRACEABILITY (I) h Traceability concerns the requirements to relate the results of measurements to the values of reference standards. .
secondary reference materials (prepared in the laboratory and characterized by repeated tests. .certified reference materials.MEASUREMENT TRACEABILITY (II) Calibration is ³the process establishing how the response of a measurement process varies with respect to the parameter being measured´. . h Calibration is realized by the use of: . preferably by more than one laboratory or using different validated methods) .reference materials.
. .the level of uncertainty required. h Action to be taken for calibration of equipment must be included in procedure for analytical method.MEASUREMENT TRACEABILITY (III) h Individual calibration program must be establish depending on: .the analytical technique. .recommendation of the manufacturer.
the assessment of the measurement method or the assigning values to the materials´ (ISO Guide 30).REFERENCE MATERIAL (I) Reference material (RM) is a ³material or substance whose property values are sufficiently homogenous and well established to be used for the calibration of an apparatus. .
.REFERENCE MATERIAL (II) Certified reference material (CRM) is a ³reference material. one or more of whose property values are certified by a procedure which establishes traceability to an accurate realization of the unit in which the property values are expressed and for which each certificate value is accompanied by an uncertainty at a stated level of confidence´ (ISO Guide 30). accompanied by a certificate.
clearly labeled. .accompanied by certificates or other documents.REFERENCE MATERIAL (III) Reference materials must be: . .used only during the shelf life. .handled in order to safeguard against contamination or loss of determinand. .
material or product for testing as a representative sample of the whole´.6 SAMPLING (I) Sampling ± ³taken a part of a substance.5. . h Sampling is an error generating process (40 % from the total error induced during a test).
preservation of samples.personnel involved in this activity. .type of samples.packaging of sample.transport of samples. . .equipment used for sampling. . . . .number of samples.location.SAMPLING (II) A Sampling Plan must be elaborated in which to be mentioned: . .
labels.records with relevant data about sampling (sampling report). .SAMPLING (III) h Documentation of sampling activity by: . h When laboratory is not responsible for the sampling stage. it should state in the report that samples were analyzed as received from the client .
storage.receipt. .5.the interests of the laboratory and of the client.retention. .the integrity of the samples.7 HANDLING OF TEST ITEMS (I) h Handling of samples includes: . . . . h All these activities must be realized in such a way to protect: .transportation.disposal. .
.HANDLING OF TEST ITEMS (II) h ³Chain of custody´ refers to the maintenance of unbroken record of possession of a sample from the time of its collection till the end of analytical investigation. h A person properly trained from the laboratory is responsible for the custody and identification of the sample and its accompanying documentation.
inspection of packaging.registration of sample into a sample logbook.HANDLING OF TEST ITEMS (III) The receipt of the test items implies: . .identification of the sample with an unique code (number). . correspondence between information from the labels and the sampling report. condition of samples. .observation in case the sample does not correspond to the description provided. .
humidity).to maintain its integrity. .HANDLING OF TEST ITEMS (IV) h Samples must be stored in such conditions: . temperature.g. . h Disposal of the samples must be done in a way prescribed by the local authorities and function of their composition.to avoid contamination or cross-contamination. .to avoid extremes environmental conditions (e.
replicate analysis (for check of repeatability).spiked samples (for effect of matrix). control charts (drift of the system).5.blank of reagents (for reagent contamination). . .8 ASSURANCE THE QUALITY OF TESTS RESULTS INTERNAL QC h The first level of control is assured by: . . .control samples.checks and correlations of the results. .
Control chart of the Range of Duplicates (R.Control charts of the mean ( x -chart) for the control of bias. . hMost used types of control charts: . .chart) for the control of precision.CONTROL CHART (I) h The control chart is a graphic method realized by systematic checks (per day or per batch). which shows that the test result remain reproducible and that the methodology of measuring the analyte is respected.
.calculation of: x 3s warning levels control levels .minimum 10 replicates results in each batch. in specific units. on the horizontal scale.CONTROL CHART (II) h The X. on the vertical scale. against time or sequence of tests.calculation of: x 2s .calculation of mean value (x) and standard deviation.chart is realized by plotting the analytical data. . h Are realized : .
Control chart of the Mean: +3s UCL +2s UWL X X -2s LWL -3s LCL Data/Batch .
minimum 10 initial pairs of duplicates. h Are realized: . .standard deviation of the range of all pairs of duplicates.mean difference between duplicate. .calculation of x 2s .calculation of: x 3s warning levels control levels .CONTROL CHART (III) h The R chart is obtained by running duplicate analysis in the same batch. on control samples or test samples. R: .
Control chart of the Range of Duplicates : +3s CL +2s WL R R Data/Batch .
.CONTROL CHART (IV) h Warning rule: one result beyond warning limits h Rejection rules: .two successive results beyond warning limit: . h Specific actions have to be taken.one result beyond control limit. .six out of seven successive points are in decreasing or increasing order. .ten successive results on the same side of the mean value.
the operating conditions. h The role is to establish the potential sources of errors induced by: .the equipment. . .the analyst.the calibration. .INTERNAL QC (I) h Second level of control is assured by: . . .intra laboratory testing or in-house proficiency testing of analysts.organized by QA Manager and the Head of Laboratory.
attitude and performance record Solutions and decision criteria .INTERNAL QC (II) Problems in assessing intra-laboratory tests: Problem No. 1 Kind of samples -Replicate samples of unknowns of reference materials -Samples must be exposed by the analyst to the same preparatory steps as normal unknown samples 2 Introducing the sample -Samples should have the same labels and appearance as unknowns -Supervisor can place knowns or replicates in the system occasionally -An aliquot from one day can be introduced for analysis by another analyst 3 Frequency of checking performance -Function of the method precision -Function of the degree of automation -Function of the analyst¶s training.
h Accreditation laboratories are required to participate to proficiency tests as a request of the accreditation bodies. h Participation to interlaboratory comparisons offers to a laboratory the possibility to monitor its performance against its own requirements and the norms of other laboratories. national or international level. .EXTERNAL QC(I) h The third level of control is represented by participation to interlaboratory comparisons organized at local. regional.
comparative studies h Laboratory performance studies: .collaborative studies .consensus studies .certification studies .proficiency tests h Material certification studies: .EXTERNAL QC(II) Types of interlaboratory comparisons: h Method performances studies: .
.unambiguously.in accordance with the test methods.5. .objectively.accurately. .clearly. . .10 REPORTING THE RESULTS (I) The results must be reported: .
³ .REPORTING THE RESULTS (II) h The results are reported in a test report h The test report may be issued as a hand copy or by electronic date h Amendments to a test report shall be made on a special form with the mention ³Supplement to Test Report no.
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