Supplementary Requirements for Accreditation of Chemical

Supplementary Requirements for Accreditation of Chemical Testing Laboratories Document ID LA/SR01 Issue Number 01 Revision Number 0 Effectivity Date J...

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Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 1 of 13

Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 2 of 13

Foreword

This Philippine Accreditation Bureau (PAB) Laboratory Accreditation Supplementary Requirements for Accreditation in Chemical Testing was developed by the Laboratory Accreditation Technical Committee (LATC) for Chemical Testing by providing specific technical criteria and guidelines for both assessors and for laboratories carrying out chemical testing. The numbering in the texts of this document follows the PNS ISO/IEC 17025:2005 numbering of requirements.

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

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Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 3 of 13

INTRODUCTION All accredited and applicant chemical testing laboratories are required to satisfy these Supplementary Requirements in addition to the general requirements for the competence of testing and calibration laboratories in PNS ISO/IEC 17025:2005.

2

AUTHORSHIP This document was prepared by the PAB Laboratory Accreditation Technical Committee for Chemical Testing through deliberation by a group of stakeholders convened by the PAB.

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DEFINITIONS

3.1

Laboratory: A facility where measurements related to chemical testing are taken.

3.1.1

Permanent laboratory: A testing laboratory situated on a fixed location for a period expected to be greater than three years.

3.1.2

Site laboratory: A testing laboratory facility set up in a dedicated area on-site for the duration of the testing activities but not for period expected to exceed three years.

3.1.3

Mobile laboratory: Fully equipped, self-contained, transportable testing laboratory capable of performing tests under controlled environmental conditions. (Note: Mobile laboratories are subject to the same terms of accreditation as a site laboratory. Mobile laboratories left at one site for three years or more will be subject to the same terms of accreditation as a permanent laboratory).

3.2

Field testing: Testing (including sampling where it forms part of the documented testing procedure) performed by staff of a laboratory or organization outside of the premises or grounds on which the permanent laboratory or the organization’s permanent base of headquarters is located. Field testing is normally performed under two categories: 

By staff sent out on-site by an accredited permanent laboratory.



By organizations that do not have a permanent laboratory.

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MANAGEMENT REQUIREMENTS

4.1

Organization

4.1.4

For laboratory staff that may also have production or marketing-related responsibilities, clear policies must be available to define how impartiality is assured for their testing responsibilities.

4.1.5h. The Technical operations of laboratories carrying out physico-chemical tests shall be under the Supervision of a competent Registered Chemist who has adequate non-academic laboratory experience and shall be on-site at least 50% of the time.

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 4 of 13

4.2

Management system

4.2.1

Management system documentation must include, or make reference to approved signatories, scope of accreditation and the policy on the use of the PAB laboratory accreditation endorsement.

4.2.2

Measurable quality objectives must be established showing key indicators, key result areas, or other criteria and reviewed during the management review.

4.5

Subcontracting of tests

4.5.1 This clause applies in those cases where a laboratory is required to subcontract part of its normal service e.g. due to temporary incapacity, excess workload or where a laboratory subcontracts due to need for further expertise and the result of the subcontracted service(s) are incorporated into the laboratory’s test reports (refer also 5.10.6). A competent subcontractor is defined as an accredited PAB laboratory or a laboratory accredited by one of PAB mutual recognition partners or a laboratory which, after thorough assessment and inspection, is found to have established quality assurance similar to the technical requirements set in PNS ISO/IEC 17025:2005. All results reported by the subcontractor shall be covered by an appropriate endorsed report. 4.12 Preventive action Preventive action is a proactive process to identify improvement opportunities, rather than a reaction to the identification of problems or complaints. Total quality management tools such as brainstorming, flowcharting; Pareto Charts, etc. may assist this process. Consideration should also be given to provide staff with a formal mechanism for contributing suggestions for improvement. 4.13

Control of records

4.13.1 Retention period of records shall be established based on the legislative, contractual and organizational requirements. However, if none of the requirements apply to the record in question, it is recommended to set the retention time to a minimum of 3 years or the maximum recalibration interval of equipment (whichever is the longer period). 4.13.2 Technical records 4.13.2.3 Alterations to data must also include the date the change was made. 4.14

Internal Audits The internal audit schedule needs to cover, over a twelve-month period, the management and technical requirements of PNS ISO/IEC 17025. Refer to PAB Guidelines on Internal Audit for Laboratories and Inspection Bodies, LA/GD15 for additional information.

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

4.15

Document ID Issue Number Revision Number Effectivity Date Page

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Management reviews The effectiveness of the management system shall be reviewed by the laboratory’s management at least once per year. Please refer to PAB Guidelines on Management Review for Laboratories and Inspection Bodies, LA/GD16 for additional information.

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TECHNICAL REQUIREMENTS

5.2

Personnel Any testing conducted on site, mobile and field laboratories must also be under adequate technical control. This is carried-out either by having an approved signatory at each facility or having an approved signatory regularly visit the facility and maintaining a record of the dates and relevant activities of each visit. For PAB endorsed test reports, the Approved Signatory assumes the responsibility for field tests carried out by other staff. An approved signatory must be involved in the setting up of a field or site laboratory. See also PAB Guidelines for Laboratory Personnel and Approved Signatories, LA/GD07.

5.3

Accommodation and environmental conditions

5.3.1

A laboratory undertaking analyses at trace concentration shall take special precautions to prevent sample contamination. It may also be necessary to monitor the testing environment to demonstrate that contamination does not occur. Where dedicated clean rooms are required, they must also be monitored for freedom from contamination. When testing in the field, testing site must be chosen to minimize the effects of environmental conditions and contamination. All relevant environmental conditions must be recorded and the records retained with other test data.

5.4

Test methods and method validation

5.4.2

Selection of test methods Common sources of methods covered by the accreditation include the American Society for Testing and Materials (ASTM), American Public Health Association (APHA), United States Environmental Protection Agency (USEPA), Association of Official Analytical Chemists (AOAC), British Pharmacopeia (BP), United States Pharmacopeia (USP), Philippine National Standards (PNS), and other recognized technical publications. Published test methods must be verified by the laboratory to demonstrate it can achieve the expected results. Records of the verification must be retained. For published test method that does not include precision data, the laboratory must determine its own precision data based on test data. All methods must include criteria for rejecting suspect results.

5.4.4

Non-standards methods For new test methods, procedures should be developed prior to tests performed and should contain at least the following information as specified in 5.4.4, Note.

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 6 of 13

PAB will consider requests for accreditation for a test kit method provided that: a) the laboratory has records of its own validation of the method for all matrices against an appropriate standard method;

applicable

b) the laboratory is capable of using a standard confirmatory method in the event of dispute. PAB does not provide accreditation to applicant laboratories using methods based on draft standards. Laboratories may, however, can be accredited for such methods if they are documented and validated as laboratory-developed methods. 5.4.5

Validation of methods

5.4.5.2 Methods may be validated by comparison with other established methods using appropriate certified reference materials. In developing and validating test methods, the following parameters among others may need to be determined: a) b) c) d) e) f)

precision accuracy specificity linear range limit of detection limit of quantification

The laboratory must have documented procedures for method validation. The procedures need to include details of the statistical analysis to be applied when deriving precision data. Records of the application of these procedures must be retained and will be reviewed at each assessment. 5.4.6

Estimation of uncertainty of measurement

5.4.6.1 The extent to which the estimation of uncertainty of measurement is applicable and is required in chemical testing. Refer to PAB Guidelines on Estimation of Uncertainty of Measurement in Testing (APLAC TC005) LA/GD05. 5.5 5.5.1

Equipment For calibrations or verifications done by the laboratory records must include: a) full details (including raw data) for each calibration or verification b) identity of the calibrating officer

5.6

Measurement traceability

5.6.1

Test and calibration equipment that has significant effect on the reported results and associated uncertainties of measurement (including, where relevant, instrument used for monitoring critical environmental conditions) shall be calibrated by laboratories complying with the traceability requirements. Refer to Supplementary Requirements for Traceability of Measurements LA/SR10.

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 7 of 13

5.6.2.2 Testing Reference standards and equipment shall be calibrated over the range and to the appropriate level of accuracy specified in relevant test methods. A laboratory performing its own calibrations may also be subject to proficiency testing and technical assessment to ensure that all the relevant requirements of ISO/IEC 17025 are met (e.g. adequately documented procedures, procedures to estimate the uncertainty of measurement, complete records of calibration data). 5.6.3

Reference standards and reference materials

5.6.3.2 Reference materials When the laboratory undertakes calibration of equipment using certified reference materials or reference materials developed through comparison with certified reference materials it must be able to demonstrate that it has: a) sufficient reference materials to calibrate the relevant items of equipment over the desired measurement ranges; b) full records of the identity and source of each reference material; c) full documentation of the assigned values (and associated measurement uncertainty) of each reference material including details of the mode of validation; d) taken all necessary precautions to match the matrices of the reference material to those encountered in the laboratory’s test samples, or determined and accounted for the effects of any non-matching of matrices. It is the responsibility of the laboratory to ensure that traceability of reference materials is demonstrated. It may well be necessary to verify at least the identity of the reference compound. At the very least the following information must be obtained for purchased reference material:     

certified values (and associated uncertainties, if a certified reference material); technique(s) by which the certified/assigned values were established; date of certification; period for which certification is valid; storage condition

5.6.3.4 Transport and storage Consumable materials must be appropriately stored. Shelf lives of perishable materials must be set, documented and applied. The following details of standard solutions must be recorded and retained along with other analytical data:  

all raw data relating to preparation (weights, volumes, etc.); result of standardization, if applicable (including standard curves);

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

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date of preparation and preferably an expiry date; the identity of the person who prepared

Each container of standard solution must be labelled with the date of preparation, the concentration, and the identity of the one who prepared and preferably, an expiry date. 5.7

Sampling The extent to which laboratories are involved in sampling varies greatly. Some have no involvement whatsoever, others have an over-viewing responsibility, and some take charge of the total process. In the last case, laboratories are recommended to gain accreditation to cover sampling as well as testing. The following conditions apply to accreditation for sampling: a) The laboratory must have documented sampling procedures. These may be national or international standards. If in-house methods are used, their validity for the intended purpose must be demonstrated by appropriate data. b) The sampling procedure must be cited on the test report whenever the laboratory wishes to extend the test results from a sample to an entire batch. When the laboratory has partial or no control over sampling the following issues must be addressed: a) Test documents must include details of the supplier of the sample and other relevant historical information such as condition on receipt, reported date of sampling. If a sample has a characteristic that casts doubt on its validity, but it is not possible to reject the sample, a clear statement of the perceived deficiencies must be made on the report. b) When non-laboratory staffs such as customers, suppliers or factory personnel take samples, they are provided with sampling instructions as necessary. It may be necessary for the laboratory to supply clean and labeled sampling containers and/ or training in sampling techniques. c) If the test method specifies the use of a particular sampling method, and the laboratory has no evidence as to whether the sampler followed this method, this fact must be acknowledged on reports.

5.8

Handling of test and calibration items

5.8.1

Sample containers must be leak-proof and impervious to contamination during transport. Any temperature or other environmental tolerances specified in the method must be satisfied during transport and storage. It may be necessary to test containers before use to ensure freedom from contamination.

5.8.2

Identification labels must be secure and legible. Labelling on caps or lids alone is not acceptable because of the risk of wrongly replacing lids during testing like batches.

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

5.9

Document ID Issue Number Revision Number Effectivity Date Page

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Assuring the quality of test results Refer to Supplementary Requirements on Participation to Proficiency Testing Programs LA/SR09 for additional information relating to requirements on proficiency testing. The program for monitoring the reliability of test results must include criteria for rejecting suspect results. Factors that influence the design of the program include the availability of reference materials, the nature and range of the test, and the number of testing staff. Quality control data must be fully documented in such a way that they are readily accessible for evaluation of trends in analysis, and these trends must be monitored with appropriate action being taken when necessary. In general, the laboratory must carry out regular (e.g. every 1 to 3 months depending on the technique/test) performance checks on infrequently performed techniques/tests to demonstrate continuing competence to perform them in order to maintain accreditation. Records of these checks and their results must be kept with other quality control data and must be available for examination during assessments.

5.10

Reporting the results

5.10.2 Test reports and calibration certificates PAB endorsement Accredited laboratories are encouraged to apply the tests/calibrations/measurements covered by their accreditation.

PAB

endorsement

for

Endorsed test documents must include the information (a)-(k) detailed in this clause of the PNS/ISO/IEC 17025:2005. The name in which accreditation is held, the relevant accreditation number of the laboratory and the date of issue of the endorsed test document must also be included. Additional details relating to the appropriate forms of endorsement and the reproduction of endorsed reports are provided in the Requirements for the Use of PAB Laboratory and Inspection Body Accreditation Symbol LA/SR11. When a batch or consignment is sampled in accordance with a method included in the scope of accreditation, the PAB endorsement may be applied to documents extending test results for samples to the batches or consignments from which they are drawn. Each page of a multi-page document shall bear a statement of the page number and the total number of pages. Approved signatories The test report must further be signed by a PAB approved signatory. See requirements relating to approved signatories in PAB Guidelines for Laboratory Personnel and Approved Signatories, LA/GD07. In general, approved signatories are expected to apply their signatures in manuscript. The use of photographic, electronic and mechanical means of reproduction of signatures or names of signatories, where applicable, will be reviewed at assessments. A protocol must

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 10 of 13

be in place to demonstrate that the approved signatory authorized the test report at the time of its issue, e.g. by use of password protected templates. Unendorsed reports An accredited laboratory may issue unendorsed reports within and outside its scope of accreditation. Such documents must not however include the PAB symbol, reference to the accreditation or any other reference to PAB. Unendorsed reports and associated work on tests within the scope of accreditation are expected to be of the same standards as required when endorsed reports are involved, unless the PAB has granted exemption from certain requirements for identified standards of testing. Unendorsed reports and the associated work on test outside the scope of accreditation are expected to avoid any conflict with the proper interest of the customer or the general public and to avoid the bringing of PAB into disrepute. Preliminary reports In circumstances where approval has been granted for accredited facilities to issue preliminary test reports prior to final endorsed reports, the final test report shall contain a reference to the preliminary report. 5.10.3.1b) Statement of compliance If the results of a test fall into the range where neither compliance nor non-compliance can be proved, taking into account the estimated uncertainty of the measurement, then the result and its associated measurement uncertainty shall be reported. A compliance statement may be made if the test specification: 

 

limits the major uncertainty components by prescribing specific types and classes or accuracy of measuring equipment and the test method and prescribes acceptance limits for test/measurement results, provided that the results meet the acceptance limits; or specifies numerical limits on the uncertainty of measurement and prescribes acceptance limits for test/measurement results, provided that the results meet the acceptance limits and the specified uncertainty limits have not been exceeded; or specifies numerical limits on actual values, provided that the results fall within the specified limits by an amount at least equivalent to the uncertainty of measurement.

Compliance statements shall indicate those sections or clauses of the test specification to which the compliance statement relates. 5.10.7 Electronic transmission and remote issue of results Test reports may be electronically issued (including from a site other than accredited laboratory) provided that the reports have been appropriately authorized for release. The adequacy of such arrangements will be reviewed at assessment.

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 11 of 13

Endorsed reports may be issued from a site other than the accredited laboratory provided they bear: a) the signature, facsimile signature or typescript name of an approved signatory; b) the signature of a checking officer at the issuing location, approved for this purpose. Copies of the documents shall be retained at the issuing site and at the laboratory. The laboratory must be able to demonstrate appropriate controls over the electronic generation, access, storage and back-up of results and reports and program control such as password protection. If the report is to be accessed from a web site by the client there must be an appropriate control in place to ensure the report can only be downloaded in a protected format. Printing issues may also need to be considered. Any information normally included in a hardcopy report must be included in the electronically-transmitted version and appear in any hard copy printed by the recipient. Flexible pagination to accommodate formatting changes when printed by the recipient may also be required.

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 12 of 13

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References

6.1

PNS ISO/IEC 17025:2005 – General requirements for the competence of testing and calibration laboratories

6.2

Requirements for the Use of PAB Laboratory and Inspection Body Accreditation Symbol, LA/SR11/Issue 1/January 2015

6.3

Supplementary Requirements on Traceability of Measurements, LA/SR10/Issue 1/ January 2015

6.4

Supplementary Requirements on LA/SR09/Issue 1/January 2015

6.5

Guidelines on the Estimation of Uncertainty of Measurement in Testing (APLAC TC 005), LA/GD 05/Issue 1/January 2015

6.6

Guidelines for Laboratory Personnel and Approved Signatories, LA/GD07/Issue 1/ January 2015

6.7

AS 2929 Test methods – Guide to the format, style and content provides guidance on the documentation of test methods.

6.8

PNS ISO Guide 31 – Contents of certificates of reference materials

6.9

PNS ISO Guide 32 - Calibration in analytical chemistry and use of certified reference material

Participation

to

Proficiency

Testing

Programs,

Philippine Accreditation Bureau Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Document ID Issue Number Revision Number Effectivity Date Page

LA/SR01 01 0 January 2015 Page 13 of 13

ISSUE AND AMENDMENT RECORD

Title Supplementary Requirements for Accreditation of Chemical Testing Laboratories

Issue

Date

01

January 2015

Amendment Initial Issue