TECHNICAL AND PRODUCTION REQUIREMENTS of ISO Guide 34:2009
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1 SANAS Accr. No/s. TECHNICAL AND PRODUCTION REQUIREMENTS of ISO Guide 34:2009 Date/s of evaluation Assessor/s & Observers Facility Area / field of Representative operation This report covers the following: Document Review only Implementation on Site Visit only Document Review and Site Visit Other Clause REQUIREMENTS & COMMENTS. Compliance = C, Non-compliance = NC, Not applicable = NA C Comment below on adequacy of how requirements have been addressed, documented and/or NC NA implemented. References to ISO Guide 34:2009 are in italics. The order of assessment need not follow the order of the checklist. Assessors are expected to know & have the guide, this worksheet is designed as guidance to prompt detailed recording of the process. REFER TO ISO Guide 34: 2009 FOR DETAIL AND FOR CLARIFICATION NOTES. 5 TECHNICAL AND PRODUCTION REQUIREMENTS 5.1 General: Not all requirements are necessary for non-certified reference material (see text) 5.2 Personnel: How are the following addressed/implemented? Does the RM producer have (where possible) competence in the production of the type of reference material? Does the producer have access to experience for the properties being determined? Are the personnel who undertake the production of the reference materials competent? Are there sufficient personnel having technical knowledge, education, training and experience to fulfil their assigned functions? Has the producer formulated the goals with respect to the education, training and skills of personnel? Is there a policy for the identification of training needs? Is the effectiveness of training evaluated? Do training policies consider technological changes? Is there an up to date record of job descriptions for managerial, technical and support staff? Where contracted and additional staff are used are they supervised, and are they competent? Are personnel authorized to perform particular activities? Is there an up-to-date record of authorizations, competence, educational & professional qualifications? Are the authorizations dated? SANAS Page 1 of 16
2 Additional / General Comments This space may also be used to expand on comments in specific sections SANAS Page 2 of 16
3 5.3 Subcontractors: How are the following addressed/implemented? Has the producer determined that the competence of a subcontractor and the results are of the required quality? Has the RM producer information to confirm the subcontractor s knowledge and past experience? Is the accommodation and environmental conditions, instrumentation and measuring equipment appropriate for the work conducted by the sub-contractor? Does the producer subcontract any of the following: project planning, selection of subcontractors, decision of property values, issue of certificates? Are records of the subcontractor s competence maintained? Where appropriate are subcontractors accredited to ISO/IEC 17025? Has the competence of the subcontractor been evaluated on site? Where the producer has no laboratory or processing facility and makes use of subcontractors, are these activities carried out according to the requirements of ISO Guide 34 and ISO/IEC 17025? (details of their accreditation/quality system/ and other forms of competence included) Is a register or database of all subcontractors available? Does it include accreditation for testing, calibration and measurement activities, certification for management systems, or other forms of competence? 5.4 Production Planning: How are the following addressed/implemented? Has the producer identified those processes that effect the quality of the reference material production? Are procedures available and these used for these processes? Where organizational and technical input from subcontractors is used, has it been documented and reviewed? Is a mechanism (e.g. management/advisory group) available to advise on the planning of the production process? In planning the production process does the producer have procedures, and facilities for: a) storage conditions; b) material selection(incl. sampling); c) maintenance of a suitable environment for all aspects of production; d) material processing; e) measuring/testing; f) validation of measurement methods; g) verification and calibration of equipment; h) assessing homogeneity; i) material stability; j) organizing inter-lab exercises; k) assessing commutability; l) assigning property values based on measurement results; m) establishing uncertainty budgets; n) defining acceptance criteria, verifying uncertainty estimates; o) establishing metrological traceability; p) issuing certificates; q) adequate storage facilities and conditions; r) labelling and packaging meeting safety requirements; s) transport arrangements, complying with shipping regulations; t) post certification stability monitoring; u) ensuring and adequate post distribution service SANAS Page 3 of 16
4 Additional / General Comments This space may also be used to expand on comments in specific sections SANAS Page 4 of 16
5 5.5 Production Control: How are the following addressed/implemented? Are there verification procedures to ensure the quality at each stage of the RM production? Are there adequate resources for inspection, testing and monitoring at all stages of production? F Accommodation and Environmental conditions: How are the following addressed /implemented? Is the environment (energy sources, lighting, temperature, pressure and ventilation) of the laboratory accommodation, calibration and measurement areas, material processing and packaging areas adequate to facilitate proper preparation, packaging, calibration and measurement of reference materials? Are precautions taken to prevent contamination of RM during processing and characterization? Do production and testing areas satisfy the requirements for humidity and temperature? Are production and testing areas protected from vibration, airborne dust, microbiological contamination, magnetic fields and electromagnetic radiation (as appropriate)? Is the environment monitored and controlled, and are records available? Is the equipment used to monitor the environment calibrated, and are records available? Are appropriate health, safety and environmental protection precautions implemented? 5.7 Material Handling and Storage: How are the following addressed/implemented? Are all candidate and reference materials identified, preserved and segregated from the time of preparation through to distribution? Are all RM s adequately packaged? Are secure storage/stock room/s available? Are appropriate methods available for the authorization of dispatch? Is the condition of stored items assessed at appropriate intervals? Is packing and marking controlled, to ensure conformity with safety and transport requirements? Does the RM produced ensure the integrity of the RM until the seal is broken? Are the RM labels securely attached to product packaging of each individual RM unit? Are the labels designed to remain legible within the validity of the RM? Does each label identify the material, the producer, the batch and catalogue numbers, and any other pertinent information, including reference to its certificate? Do the labels, where appropriate, include toxicity symbols? Are arrangements in place to ensure the integrity of the RM throughout the RM production? SANAS Page 5 of 16
6 Additional / General Comments This space may also be used to expand on comments in specific sections SANAS Page 6 of 16
7 5.8 Material processing: How are the following addressed/implemented? Do the procedures for the material preparation address (as appropriate): a) Qualitative analysis for the verification of the material type? b) Synthesis, purification and transformation (machining, grinding, blending, sieving etc.)? c) Homogenization? d) Proper handling i.e. protection from contamination? e) Measurement for processing control (size distribution, moisture etc.)? f) Cleaning of sample containers? g) Sterilization of material? h) Packaging (bottling, ampouling)? 5.9 Measurement methods: How are the following addressed/implemented? Does the producer meet the requirements of ISO/IEC for all tests, calibrations and measurements performed? Are the methods or procedures consistent with the required accuracy, and any relevant standard specification relevant to the measurement concerned? Are all measurement methods developed in-house validated and authorised? Do in-house developed methods clearly and exactly describe the conditions necessary commensurate with the accuracy required, for the intended purpose of the RM? Where sampling is part of the measurement method, is the procedure documented, and have appropriate statistical techniques been used? 5.10 Measuring equipment: How are the following addressed/implemented? Has all measuring equipment used in RM production been used in compliance with ISO/IEC 17025? Has it been calibrated, verified and maintained, and are records available? Where in-house calibration is performed are documented procedures available? Is the interval/period of the calibration and intermediate checks determined based on ISO ? (Cal interval shorter than period in which the equipment was found to drift) Is equipment that has been overloaded, or mishandled, or found to give suspect results withdrawn from service, identified, and stored in a specified location? Is the equipment only returned to service once repaired and calibrated? Are the results obtained from potentially faulty items of equipment reviewed? Where the review shows significant errors, are previous results checked, and remedial action taken? Are records available of these reviews? SANAS Page 7 of 16
8 Additional / General Comments This space may also be used to expand on comments in specific sections SANAS Page 8 of 16
9 Are all items of equipment used in the production process, labelled or marked to indicate the calibration status, and expiry date? Are all reagents used in the analysis process also labelled or marked, to indicate the expiry date? Is all measuring and testing equipment calibrated before being commissioned into service? Is there an established program for the calibration and in-service checking of measuring and testing equipment? Is the measurement program designed and operated so as to ensure that wherever possible the measurements are traceable to the SI system of units? Do the calibration certificates indicate the traceability chain, and associated UoM? 5.11 Data evaluation Are data transfers, and calculations subjected to appropriate checks? (including those from its own sources) a) Is computer software validated, and adequate for use? b) Are procedures available and implemented for the protection of data, during capture, storage, transmission, and processing? c) Is the data processing equipment maintained, and provided with a suitable environmental and operating condition so as to maintain data integrity? d) Are procedures established and implemented that address data security, unauthorized access, and amendment of computer records? Are hard copies of data, and computer disc copies maintained of computer programs? Addressed in Metrological Traceability Is documentary evidence available that measurements are metrologically traceable to a stated reference? Is the traceability to a measurement unit through practical realization, measurement procedure or a measurement standard? Is traceability achieved through an unbroken chain of calibrations, all having stated uncertainty? Where traceability is not possible, is there satisfactory evidence of correlation of results with other stated values? Where results are compared relative to one another (i.e. homogeneity): a) Is the measurand the same, as for the value being assigned? b) Is the measurement procedure valid for the range of the results? c) Is the measurement procedure sufficiently precise? Where absolute values are compared, is it ensured that a) The measurand the same? b) The procedure is valid for the range of the measurement results? c) The procedure have an appropriate limit of quantification? d) The measurement procedure sufficiently precise? e) The procedure calibrated with the same standards as the assigned value? f) All other input quantities appropriately calibrated? Does the producer have documentary evidence showing that the metrological traceability used for the measurement results is the same as the reference for the assigned values? SANAS Page 9 of 16
10 Additional / General Comments This space may also be used to expand on comments in specific sections SANAS Page 10 of 16
11 5.13 Assessment of Homogeneity: How are the following addressed/implemented? Has the producer conducted an assessment to establish the degree of homogeneity of the reference material with respect to the properties of interest? Has the producer carried out an assessment of the homogeneity of any candidate material? Are the homogeneity studies performed in accordance with ISO Guide 35? Where the reference material is produced in batches, has the equivalence of batches been established? Have the homogeneity studies been undertaken after being packaged in its final form? Is the amount of material tested for homogeneity specified on the documentation supplied by the producer? 5.14 Assessment of stability: How are the following addressed/implemented? Has the stability of the reference material been assessed? Are testing, calibration and measurements to establish stability conducted in accordance with ISO/IEC 17025? Is stability testing only conducted after adequate homogeneity has been demonstrated? Are stability studies conducted in accordance with ISO Guide 35? Are the properties of interest adapted for storage conditions? Has the stability of the material under transport conditions been established? Where appropriate, have assessments of the stability at periodic intervals after characterization been performed? Has the period of validity been stated on the certificate? Does the certificate clearly state the starting period of validity (i.e. certificate date, date of shipment, or date of opening)? Does the producer inform its customers about shelf life changes, and consequences of use? 5.15 Characterization : How are the following addressed/implemented? 5.14 Does the characterization of reference materials (where possible) comply with the requirements of ISO Guide 35? (Refer to ISO Guide 34 clause 5.14 for detail of acceptable methods) Has a technically valid approach been used to characterise the reference material, i.e. either a) Primary method in a single lab; b) To or more reference methods in one or more labs; c) One or methods performed in a network of labs, or d) Method specific, using a network of labs Are results from PT testing only used if the measurements are done in compliance with ISO/IEC Where a single method approach has been used, has metrological traceability been ensured? SANAS Page 11 of 16
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13 Additional / General Comments This space may also be used to expand on comments in specific sections SANAS Page 1 of 16
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15 5.16 Assignment of property values and their uncertainties: How are the following addressed/implemented? Are documented procedures available for the assignment of property values? Do the procedures include: a) details of experimental designs and statistical techniques used? b) policies on the treatment of statistical outliers and robust statistics? c)..any weighting techniques used for contributors derived from different methods and uncertainties? d) the methods used to assign uncertainties to property values? e) any other significant factors which may affect the assigned property values? Are outliers excluded solely on statistical evidence, without investigation to determine the cause of the discrepancies? (Robust statistics may be appropriate in certain instances) When different methods show significant difference in the results, is the mean used inappropriately? Are uncertainties resulting from the differences in results using different units, and storage and transportation included in the UoM estimation? Can the RM producer demonstrate traceability of the assigned values in accordance with ISO Guide 35? Have uncertainties been assigned to the property values? Have the uncertainties been estimated in accordance with the requirements of the GUM? Has the producer included a statement of measurement uncertainty for all certified values? 5.17 Certificates or documentation users: How are the following addressed/implemented? Has a certificate for CRM s and appropriate documentation for non-certified RM been issued? Does the certificate address (as required by ISO Guide 31): a) the property values? b) the meaning of the property values? c) the uncertainties at a defined confidence level? d) where appropriate, the expiry date of the material? e) information on the proper application of the RM? f) potential problems in use? g) Do the certificates comply with Guide 31? 5.18 Distribution Service: How are the following addressed/implemented? Has the distribution service been studied to avoid deterioration of the reference material? Have the conditions of shipment been determined? Has the maximum time a shipment may endure been determined? Has the documentation required to clear customs been determined? Is there an up-to-date record of sales or distribution? Does the producer provide reasonable guidance on its reference materials? Does the producer employ best efforts to notify customers of changes in the assigned values? If the producer allows resale of reference material through a distributor then has the producer ensured that all necessary information is passed on? (so as to provide an effective post distribution service) Does the producer ensure that the distributor complies with the relevant parts of this guide? does apply to resale by other organizations SANAS Page 1 of 16
16 General/additional comments and matters to follow up at next assessment Signed : Lead/Technical Assessor Date SANAS Page 2 of 16
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