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SD Proficiency TestingQuality Systems and Policy

Issue Date:06/06/2014

Doc: QM001 Revision Date:10/10/2015

CONTROLLED DOCUMENT COVER SHEET

Document Title: Document Number:

REVISION DATE DESCRIPTION OF CHANGE

6/6/14 Document Creation

8/10/14 Final issue

10/10/15 Review and implementation

Prepared by: Date: 6/6/2014

Approved by Date: 10/10/2015

Page 1 of 20Electronic version is the only Controlled CopyAll printed copies are Uncontrolled




Contents page

1. Scope 3

2. References 3

3. Terms and Definitions 3

4. Management Systems 5 4.1 Organization 7

4.2 Management system 74.3 Document control 84.4 Review of requests, tenders and contracts 84.5 Subcontracting services 94.6 Purchasing services and supplies 94.7 Service to the customer 94.8 Complaints and appeals 104.9 Control of nonconforming work 104.10 Improvement 104.11 Corrective actions 104.12 Preventive actions 114.13 Control of records 114.14 Internal audits 124.15 Management reviews 12

5. Technical Requirements 125.1 General 125.2 Personnel 125.3 Equipment, accommodation and environment 135.4 Design of proficiency testing schemes 13 5.4.6 Choice of method or procedure 16 5.5 Operation of proficiency testing schemes 165.6 Data analysis and evaluation of proficiency testing scheme 175.7 Reports 185.8 Communication with participants 195.9 Confidentiality 20





1. ScopeThis document applies to all aspects of the operations of SD Proficiency Testing, LLC.

2. ReferencesISO/IEC 17043:2010R103 - 2013.pdfciency Testing for ISO/IEC 17025 Laboratories - 2013R103a - Annex: Proficiency Testing for ISO/IEC 17025 LaboratoriesC106 - General Checklist: Proficiency Testing for ISO/IEC 17025 LaboratoriesF327 - Scope of Accreditation Selection List: ISO/IEC 17043 Proficiency Testing ProvidersR302 - General Requirements: Accreditation of ISO/IEC 17043 Proficiency Testing ProvidersA316 - Guidance for Review of Proficiency Testing Reports (word) Selection, Use and Interpretation of PT Schemes, Eurachem - 2nd ed.

3. Terms and Definitions

3.1 assigned valuethe value attributed to a particular property of an artifact3.2 coordinatorone or more individuals with responsibility for organizing and managing all of the activities involved in the operation of a proficiency testing scheme3.3 customerorganization or individual for which a proficiency testing scheme is provided through a contractual arrangement3.4 interlaboratory comparisonorganization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions3.5 outlierobservation in a set of data that appears to be inconsistent with the remainder of that setNOTE: An outlier can originate from a different population or be the result of an incorrect recording or other gross error.3.6 participantlaboratory, organization or individual that receives proficiency test items and submits results for review by the proficiency testing provider NOTE: In some cases, the participant can be an inspection body.3.7 proficiency testingevaluation of participant performance against pre-established criteria by means of interlaboratory comparisons NOTE 1: For the purposes of this International Standard, the term “proficiency testing” is taken in its widest sense and includes, but is not limited to:a) quantitative scheme — where the objective is to quantify one or more measurands of the proficiency test item; b) qualitative scheme — where the objective is to identify or describe one or more characteristics of the proficiency test item; c) sequential scheme — where one or more proficiency test items are distributed sequentially for testing or measurement and returned to the proficiency testing provider at intervals;


http://www.eurachem.org/images/stories/Guides/pdf/Eurachem_PT_Guide_2011.pdf

http://a2la.org/checklists/pt_guidance_Checklist.doc

http://a2la.org/requirements/PT_PROVIDERS_ACCREDITATION_REQUIREMENTS.pdf

http://a2la.org/selectionlists/A2LA_F327.doc

http://a2la.org/CHECKLISTS/C106_2013.doc

http://a2la.org/requirements/Annex_to_the_A2LA_General_Requirements_for_Proficiency_Testing.pdf

https://www.a2la.org/requirements/R103_2013.pdf




d) simultaneous scheme — where proficiency test items are distributed for concurrent testing or measurement within a defined time period; e) single occasion exercise — where proficiency test items are provided on a single occasion; f) continuous scheme — where proficiency test items are provided at regular intervals; g) sampling — where samples are taken for subsequent analysis; and h) data transformation and interpretation — where sets of data or other information are furnished and the information is processed to provide an interpretation (or other outcome). 3.8 proficiency test itemsample, product, artifact, reference material, piece of equipment, measurement standard, data set or other information used for proficiency testingNOTE: SDPT utilizes multiple measurement standards to comprise a proficiency test item or artifact.3.9 proficiency testing providerorganization which takes responsibility for all tasks in the development and operation of a proficiency testing scheme3.10 proficiency testing roundsingle complete sequence of distribution of proficiency test items, and the evaluation and reporting of results to the participants3.11 proficiency testing schemeproficiency testing designed and operated in one or more rounds for a specified area of testing, measurement, calibration or inspection NOTE: A proficiency testing scheme might cover a particular type of test, calibration, inspection or a number of tests, calibrations or inspections on proficiency test items.3.12 robust statistical methodstatistical method insensitive to small departures from underlying assumptions surrounding an underlying probabilistic model3.13 standard deviation for proficiency assessmentmeasure of dispersion used in the evaluation of results of proficiency testing, based on the available information NOTE 1: The standard deviation applies only to ratio and differential scale results. NOTE 2: Not all proficiency testing schemes evaluate proficiency based on the dispersion of results.3.14 subcontractororganization or individual engaged by the proficiency testing provider to perform activities specified in this International Standard and that affect the quality of a proficiency testing scheme3.15 metrological traceabilityproperty of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertaintyNOTE 1: For this definition, a “reference” can be a definition of a measurement unit through its practical realization, or a measurement procedure including the measurement unit for a non-ordinal quantity, or a measurement standard. NOTE 2: Metrological traceability requires an established calibration hierarchy.NOTE 3: Specification of the reference must include the time at which this reference was used in establishing the calibration hierarchy, along with any other relevant metrological information about the reference, such as when the first calibration in the calibration hierarchy was performed.NOTE 4: For measurements with more than one input quantity in the measurement model, each of the input quantity values should itself be metrologically traceable and the calibration hierarchy involved may form a branched structure or a network. The effort involved in establishing metrological traceability for each input quantity value should be commensurate with its relative contribution to the measurement result.





NOTE 5: Metrological traceability of a measurement result does not ensure that the measurement uncertainty is adequate for a given purpose or that there is an absence of mistakes. NOTE 6: A comparison between two measurement standards may be viewed as a calibration if the comparison is used to check and, if necessary, correct the quantity value and measurement uncertainty attributed to one of the measurement standards. NOTE 7: The ILAC considers the elements for confirming metrological traceability to be an unbroken metrological traceability chain to an international measurement standard or a national measurement standard, a documented measurement uncertainty, a documented measurement procedure, accredited technical competence, metrological traceability to the SI, and calibration intervals (see ILAC P-10:2002).NOTE 8: The abbreviated term “traceability” is sometimes used to mean “metrological traceability” as well as other concepts, such as “sample traceability” or “document traceability” or “instrument traceability” or “material traceability”, where the history (“trace”) of an item is meant. Therefore, the full term of “metrological traceability” is preferred if there is any risk of confusion.3.16 measurement uncertainty(uncertainty of measurement )(uncertainty)(U)non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used NOTE 1: Measurement uncertainty includes components arising from systematic effects, such as components associated with corrections and the assigned quantity values of measurement standards, as well as the definitional uncertainty. Sometimes estimated systematic effects are not corrected for but, instead, associated measurement uncertainty components are incorporated. NOTE 2: The parameter may be, for example, a standard deviation called standard measurement uncertainty (or a specified multiple of it), or the half-width of an interval, having a stated coverage probability.NOTE 3 Measurement uncertainty comprises, in general, many components. Some of these may be evaluated by Type A evaluation of measurement uncertainty from the statistical distribution of the quantity values from series of measurements and can be characterized by standard deviations. The other components, which may be evaluated by Type B evaluation of measurement uncertainty, can also be characterized by standard deviations, evaluated from probability density functions based on experience or other information. NOTE 4: In general, for a given set of information, it is understood that the measurement uncertainty is associated with a stated quantity value attributed to the measurand. A modification of this value results in a modification of the associated uncertainty.

4. Management Systems4.1. Organization

4.1.1. SD Proficiency Testing (the company) is a limited liability corporation (LLC) formed in accordance with the laws of the State of North Carolina.

4.1.2. The company conducts business and carries out its testing operations in a manner that meets the requirements of this standard, satisfies the needs of its customers, regulatory authorities and organizations providing recognition.

4.1.3. This management system covers all work and services provided by the company.4.1.4. The company does not engage in any business other than proficiency testing, nor does

it engage in any activity that could throw doubt on the outcome of testing results, or the integrity of the company.

4.1.5. SD Proficiency Testing has implemented the following policies to ensure compliance with 4.1.4 above. The company:





a) has managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the management system or from the procedures for providing proficiency testing schemes, and to initiate actions to prevent or minimize such departures;b) has arrangements to ensure that all personnel are free from any undue internal or external commercial, financial and other pressures that may adversely affect the quality of their work;c) has policies and procedures to ensure the protection of its participants' information and proprietary rights, including procedures for their protection during electronic storage and transmission;d) has policies and procedures to avoid involvement in any activities that may diminish confidence in its competence, impartiality, judgment or operational integrity;e) defines the organization structure, and the relationships between quality management, technical operations and support services, if any;f) specifies the responsibility, authority, interrelationships and required competence of all personnel who manage, perform or verify work affecting the quality of the operation of proficiency testing schemes;g) ensures that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system;h) provides adequate supervision of staff, including trainees, by persons familiar with procedures for each activity;i) has technical management which have overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of proficiency testing schemes, including access to the necessary technical expertise and experience in the relevant field of testing, calibration or inspection, as well as statistics, as indicated in 5.4.1.4.j) has a member of staff as quality manager (named as appropriate) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the management system is implemented and followed at all times; the quality manager shall have direct access to the highest level of management at which decisions are taken on the proficiency testing provider's policies or resources; andk) appoints deputies for key managerial personnel.NOTE: Where proficiency testing providers have a small number of personnel, individuals can have more than one function and it can be impractical to appoint deputies for all major functions.

4.1.6. At present, the company is of a size that formal communications processes are not required.





4.2. Management system4.2.1. The company has implemented a management system appropriate to the scope of

activities currently engaged in.4.2.2. The company has defined and documented its policies and procedures, and instructions

exist to the extent that the quality aspects of all testing is assured. NOTE: These aspects include, but are not limited to, proficiency test item quality (e.g. homogeneity and stability), characterization (e.g. equipment calibration and method validation), assignment of property values (e.g. use of appropriate statistical procedures), evaluation of participant performance, distribution of proficiency test items, storage and transport procedures, statistical treatment of test results, and reporting.

4.2.3. SD Proficiency Testing’s Quality Policy :“The company is committed to providing meaningful and objective proficiency testing to its customers. We strive to maintain the highest standards of competency, quality and professionalism in all areas of our business. We pledge to our customers that we will execute our business dealings with them in this manner and will maintain the strictest confidentiality of their information. All of our schemes and policies are in accordance with the international standards governing proficiency testing, and applicable civil and regulatory governance as well.”

4.2.4. Management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness.

4.2.5. Management shall communicate to the organization the importance of meeting customer requirements, as well as statutory and regulatory requirements.

4.2.6. This quality manual includes references to procedures used in the testing process. It also outlines the document system structure.

4.2.7. Roles and responsibilities are of the companies personnel are described, including the responsibility for ensuring compliance with the international standard. (ISO-17043)

4.2.8. Company management shall ensure that should personnel change, the integrity if this management system shall be maintained.

4.2.9. SDPT Organizational Chart





4.3. Document control4.3.1. General

4.3.1.1. The company has established procedures to control all documents that form part of its management system (internally generated, or from external sources), such as regulations, standards, other normative documents, proficiency testing scheme protocols, test or calibration methods, or both test and calibration methods, as well as drawings, software specifications, instructions and manuals.

4.3.2. Document approval and issue4.3.2.1. All documents issued as part of the management system are reviewed and have

been approved for use. A master list exists, which identifies the current revision status and distribution of documents in the management system. This ensures that: a) authorized editions of appropriate documents are available at all locations where activities essential to the effective operation of proficiency testing schemes are performed;b) documents are periodically reviewed and updated, as necessary, to ensure continuing suitability and compliance with applicable requirements;c) invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use; andd) obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.

4.3.2.2. All documents generated by the company are uniquely identified. This includes date of issue, revision number, page numbering and total pages and the issuing authority.

4.3.3. Document revision4.3.3.1. Permanent changes to documents are made by the originator or other authorized

signatory. 4.3.3.2. Where practicable the changes are identified in the cover page/revision history of

the document.4.3.3.3. Documents may be amended by hand and shall include: the amendment, the date,

and the initials of the person making the change. A revised document shall be issued as soon as practicable.

4.3.3.4. SD Proficiency Testing utilizes an electronic document management system (EDMS) which is maintained on the company office computer, and is backed-up on an external hard drive for security purposes. The electronic version is the only controlled copy. Any printed copies are uncontrolled, and are identified as such.

4.4. Review of requests, tenders and contracts4.4.1. The company has policies and procedures for the review of requests, tenders and

contracts. These reviews ensure that:a) the requirements, including those for test and calibration methods, measuring equipment and proficiency test items to be used, are adequately defined, documented and understood;b) the company has the capability and resources to meet the requirements; and





c) the proficiency testing scheme is technically appropriate.NOTE 1: This review is particularly important when a customer requests a proficiency testing scheme to be created for a specific purpose or for a different level or frequency of participation from that normally offered.NOTE 2: This review can be simplified when the proficiency test scheme is fully described in a catalogue or other notice, and the participant is enrolling for a routine shipment.

4.4.2. Records such as quotes, purchase orders, emails and any other communication with participants are maintained for a minimum of three years.

4.4.3. The company does not subcontract testing control, direction, analysis or reporting.4.4.4. Participants are notified in writing of any changes to the contract or the scheme.4.4.5. In the event a request or contract is amended during a PT scheme, the review shall be

repeated and amendments communicated to all involved.4.5. Subcontracting services

4.5.1. The company Does not currently subcontract any activity.:4.5.1.1. Planning, execution, evaluation and reporting of the scheme are performed

internally.

4.6. Purchasing services and supplies4.6.1. The company does not use any reagents or consumable materials is its testing

schemes. 4.6.2. Development, service and calibration of artifacts. Physical components of the scheme

that are used for calibration purposes (as a reference standard for comparison of the measurand) are calibrated by a laboratory that has demonstrated competency in the area and is currently accredited to ISO-17025. By utilizing the services of an accredited laboratory, traceability, and measurement uncertainty are established.

4.6.3. Quotes, contracts and reports shall contain a statement to the effect: “Service and calibration of reference standards used in this testing scheme are performed by a supplier of critical services, who is technically proficient and fully accredited to ISO/IEC-17025:2005 and ANSI/NCSL Z540-1-1994. SD Proficiency Testing maintains full oversight and responsibility of this work.”

4.6.4. The company maintains a list of all vendors which includes a record of competence, where applicable and/or demonstration of successful assessment to the applicable international standard. All artifacts which have been purchased for service or calibration are verified by the company at the supplier's facility prior to use, and records of measurement, repeatability and stability are maintained.

4.6.5. Purchasing activity shall follow the following procedure:4.6.5.1. The company shall issue a request for quote (RFQ) that specifies the services or

items to be purchased.4.6.5.2. The supplier shall issue a quote that specifies the activity or materials, and

requests clarification for any areas in doubt.4.6.5.3. The company issues a purchase order (PO) when satisfied the supplier

understands the requirements.4.6.5.4. The company initials and dates the invoice indicating the services or purchased

items have been inspected for accuracy prior to being accepted..4.7. Service to the customer





4.7.1. The company will cooperate with participants in clarifying requests and monitoring performance. The company will ensure that confidentiality of participant information and results are maintained.

4.7.2. Feedback will be solicited form participants through surveys and during the process of reviewing results.

4.8. Complaints and appeals4.8.1. As part of its corrective and preventative action program, the company will have policy

and procedures for the resolution of participant complaints, appeals investigations and corrective actions. Records of this process shall be maintained for a minimum of three years.

4.9. Control of non-conforming work 4.9.1. When any aspect of its activities does not conform to its own procedures or the agreed

requirements of its customers, the company has a policy and procedure(s) that shall be implemented to ensure that:a) the responsibilities and authorities for the management of nonconforming work are designated and actions (including halting work of ongoing programs and withholding reports, as necessary) are defined and taken when nonconforming work is identified;b) an evaluation of the significance of the nonconforming work is made;c) a decision on the need for action and timescale is taken immediately, together with any decision about the acceptability of the nonconforming work;d) proficiency testing scheme participants and other customers, as appropriate, are informed and the nonconforming proficiency test items or reports already sent to participants are recalled or disregarded; ande) the responsibility for authorization of the resumption of work is defined.NOTE: Identification of nonconforming work or problems with the management system or with technical activities can occur at various places within the management system and technical operations. Examples are participant complaints, management reviews and internal or external audits, quality control, preparations of proficiency test items, homogeneity and stability tests, data analysis, instructions to participants, and materials handling and storage.

4.9.2. Where the evaluation indicates that nonconforming work could recur or that there is doubt about the compliance of the company or subcontractor with their own policies and procedures, the corrective action procedure in 4.11 shall be promptly followed.

4.10. Improvement4.10.1. The company shall continually improve the effectiveness of its management system

through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

4.11. Corrective actions 4.11.1. General - The proficiency testing provider shall establish a policy and procedure(s)

and shall designate appropriate personnel for implementing corrective actions when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified.

4.11.2. Cause analysis - The procedure for corrective action shall start with an investigation to determine the root cause(s) of the problem. NOTE: Cause analysis is the key and sometimes the most difficult part in the corrective action procedure. Often, the root cause is not obvious and thus a careful analysis of all potential causes of the problem is





required. Potential causes could include customer requirements, proficiency test items and their specifications, methods and procedures, staff skills and training, consumable supplies, preparations of proficiency test items, homogeneity and stability tests, statistical design, instructions to participants, and materials handling and storage.

4.11.3. Selection and implementation of corrective actions – When corrective actions are necessary, the company shall select the actions most likely to eliminate the problem and prevent reoccurrence. Actions shall be appropriate to the magnitude of the problem, shall be documented and monitored to ensure the actions have been effective.

4.11.4. Additional audits - Where the identification of nonconforming activities or departures from authorized procedures cast doubts on the compliance of the company with its own policies and procedures, or on its compliance with this International Standard, the company shall ensure that the appropriate areas of activity are audited in accordance with 4.14 as soon as possible.NOTE: Such additional audits often follow the implementation of the corrective actions to confirm their effectiveness.

4.12. Preventative actions4.12.1. Areas for improvements and potential sources of nonconforming work, either technical

or concerning the management system, shall be identified. When improvement opportunities are identified, or if preventive action is required, action plans shall be developed, implemented and monitored, to reduce the likelihood of such nonconforming work and to take advantage of the opportunities for improvement.

4.12.2. Any procedure for preventive action shall include the initiation of such actions and application of controls to ensure that they are effective.

4.13. Control of records4.13.1. General – The company maintains all quality, technical and administrative records

electronically for a minimum of three years. All company records are maintained on the central office computer hard drive, as well as a back-up external hard drive for security. Only company employees with the proper authorization and password credentials have access to these records. The company maintains strict confidentiality of all records.

4.13.2. Technical records - The company retains records all technical data relating to each proficiency testing round for a minimum of three years, including, but not necessarily limited to:a) results of homogeneity and stability testing;b) instructions to participants;c) participants' original responses;d) collated data for statistical analysis;e) information required for reports (see 4.8); andf) final reports (summary or individual, or both).NOTE 1: It is advisable to retain sufficient information to establish an audit trail for the processing of results from proficiency testing rounds.NOTE 2: Technical records are accumulations of data and information which result from carrying out all proficiency testing activities. They can include forms, contracts, work sheets, work books, check sheets, work notes, sub-contractor reports and participant feedback.





4.13.2.1. Data entry, checking and calculations shall be recorded at the time they are made and shall be identifiable to the specific task and to the personnel responsible.

4.13.2.2. When mistakes occur in records and alterations are made, actions are taken to:a) identify the change and date of alteration;b) avoid loss of original data; andc) identify the person making the alteration.

4.14. Internal Audits4.14.1. Annually, or sooner if deemed necessary, the company audit its systems. This

includes management systems, technical systems and reporting systems. There is a record of the findings of these audits, and findings are incorporated into the corrective and preventative action program (CAPA). Depending on the impact of the results on testing schemes, follow-up reviews may be scheduled.

4.15. Management reviews4.15.1. The company conducts an annual management review to ensure effectiveness of the

systems. Findings of the review are recorded and retained for a minimum of three years. This review includes:a) the suitability of policies and procedures;b) reports from management and supervisory personnel;c) the outcome of recent internal audits;d) corrective and preventive actions;e) assessments by external bodies;f) changes in the volume and type of work;g) customer, advisory group or participant feedback;h) complaints and appeals;i) recommendations for improvement; andj) other relevant factors, such as resources and staff trainingk) Action Items

5. Technical Requirements5.1. General – The proficiency testing schemes and interlaboratory comparisons conducted by

the company are developed and conducted, drawing on twenty-plus years of expertise in mass and volumetric flow calibration and metrology. Subcontracting is carried out by an ISO-17025 accredited laboratory.

5.2. Personnel5.2.1. The company has personnel with the necessary authority, resources and technical

competence required to perform their duties.5.2.2. The company defines the minimum levels of qualification and experiences necessary for

key positions within the company and ensures those qualifications are met.5.2.3. The company utilizes personnel who are either employed by, or under contract to it.

Where contracted and additional technical and key support personnel are used, the company ensures that such personnel are supervised and competent and that they work in accordance with the established system.





5.2.4. The company authorizes specific personnel to:a) select appropriate proficiency test items;b) plan proficiency testing schemes;c) operate specific equipment;d) conduct measurements to determine stability and homogeneity, as well as assigned values and associated uncertainties of the measurands of the proficiency test item;e) prepare, handle and distribute proficiency test items;f) operate the data processing system;g) conduct statistical analysis;h) evaluate the performance of proficiency testing participants;i) give opinions and interpretations; andj) authorize the issuance of proficiency testing reports.

5.2.5. The company maintains up-to-date records of the relevant competence, educational and professional qualifications, training, skills and experience of all personnel, including contracted personnel. This information shall be readily available and shall include the date on which competence to perform their assigned tasks was assessed and confirmed.

5.2.6. The company formulates objectives with respect to the education, training, and skills for each staff member involved with the operation of the proficiency testing scheme. The company identifies training needs and provides training for personnel. The training program is relevant to the present and anticipated needs of the proficiency testing provider.

5.2.7. The company shall ensures that staff receives the necessary training to ensure competent performance of measurements, operation of equipment and any other activities which affect the quality of the proficiency testing scheme. The effectiveness of training activities shall be evaluated.

5.3. Equipment, accommodation and environment5.3.1. The company has evaluated the requirements for the proficiency testing scheme. This

includes facilities and equipment for proficiency test item manufacturing, handling, calibration, storage and dispatch, for data processing, for communications, and for retrieval of equipment and records. All areas include appropriate accommodation for environmental conditions, such that the results of testing schemes are not compromised.

5.3.2. Environmental conditions that could affect the outcome of testing schemes are controlled and monitored by the subcontractor. The company monitors those conditions and verifies that during the period it’s artifacts are being calibrated, conditions at the subcontractor’s laboratory are within specified conditions.

5.4. Design of proficiency testing schemes5.4.1. Planning

5.4.1.1. The company has identified and documented the procedures for the proficiency testing (PT) schemes, and conducts those schemes in accordance with proscribed procedures.

5.4.1.2. Planning, administration and reporting of the PT schemes are not subcontracted.





5.4.1.3. The company has documented a plan for the development of PT schemes that addresses the objectives, purpose and basic design of the proficiency testing scheme, including the following information and, where practicable, reasons for its selection or exclusion:a) the name and address of the companyb) the name, address and affiliation of the coordinator and other personnel involved in the design and operation of the proficiency testing scheme;c) the activities to be subcontracted and the names and addresses of subcontractors involved in the operation of the proficiency testing scheme;d) criteria to be met for participation;e) the number and type of expected participants in the proficiency testing scheme;f) selection of the measurand(s) or characteristic(s) of interest, including information on what the participants are to identify, measure, or test for in the specific proficiency testing round;g) a description of the range of values or characteristics, or both, to be expected for the proficiency test items;h) the potential major sources of errors involved in the area of proficiency testing offered;i) requirements for the production, quality control, storage and distribution of proficiency test items;j) reasonable precautions to prevent collusion between participants or falsification of results, and procedures to be employed if collusion or falsification of results is suspected;k) a description of the information which is to be supplied to participants and the time schedule for the various phases of the proficiency testing scheme;l) for continuous proficiency testing schemes, the frequency or dates upon which proficiency test items are to be distributed to participants, the deadlines for the return of results by participants and, where appropriate, the dates on which testing or measurement is to be carried out by participants;m) any information on methods or procedures which participants need to use to prepare the artifact and perform the tests or measurements;n) procedures for the measurement methods to be used for the stability testing of proficiency test items,o) preparation of any standardized reporting formats to be used by participants;p) a detailed description of the statistical analysis to be used;q) the origin, metrological traceability and measurement uncertainty of any assigned values;r) criteria for the evaluation of performance of participants;s) a description of the data, interim reports or information to be returned to participants;t) a description of the extent to which participant results, and the conclusions that will be based on the outcome of the proficiency testing scheme, are to be made public; u) actions to be taken in the case of lost or damaged proficiency test items.





5.4.1.4. The company and its subcontractor possess the required technical expertise to ensure all of the requirements of the standards (ISO-17043 and ISO-17025) and of this policy are achieved or surpassed

5.4.2. Preparation of proficiency test items5.4.2.1. The company has procedures described in the testing scheme that ensure

compliance with the plan described in 5.4.1, including preparation, handling, storage, (environmental conditions and artifact safety) operation, data collection and submission of results to the company.

5.4.3. Homogeneity and stability5.4.3.1. Homogeneity is not a factor in the schemes for PT of flow. Stability of artifacts

however is of serious concern. The company has procedures in place to ensure that each participant receives an artifact that is identical to each other participant, and that the stability of the artifact is verified and recorded throughout the PT round. Statistical consideration for drift of artifacts is taken into consideration and accommodated for in the evaluation of participant performance.

5.4.3.2. Artifacts are developed and stability testing is conducted periodically to demonstrate the suitability of the PT items. A star type scheme is utilized based on the following:a) the artifact is developed and calibrated,b) stability testing is conducted to establish reference numbers and drift,c) prior to conducting a round, addition stability testing is conducted to verify the reference numbers.d) the artifact is shipped to the first participant who completes the scheme testing and returns the artifact to the companye) another set of stability data is taken to verify the reference numbers and the artifact is shipped to the next participant, and so on…f) where long-term stability of an artifact has been determined, the scheme may adopt a modified petal design

5.4.4. Statistical design5.4.4.1. Results of participation in the PT schemes are quantitative in nature and reported

based on statistical designs common in the industry. Initial reports, issued upon completion of testing by an individual participant, include the En numbers calculated using the following equation where:

x is the participant’s result;X is the assigned value;Ulab is the expanded uncertainty of the participant’s result;Uref is the expanded uncertainty of the reference laboratory’s assigned value.

En=¿ x−X

√U lab 2+U ref 2¿





5.4.4.2.Upon completion of a PT cycle, all participants data will be reported using data analysis methods that are documented and based on sound assumptions and giving consideration to the following: a) the accuracy (trueness and precision) as well as the measurement uncertainty required or expected for each measurand or characteristic in the proficiency testing;b) the minimum number of participants in the proficiency testing scheme needed to meet the objectives of the statistical design; in cases where there is an insufficient number of participants to meet these objectives or to produce statistically meaningful analysis of results, the proficiency testing provider shall document, and provide to participants, details of the alternative approaches used to assess participant performance; c) the relevance of significant figures to the reported result, including the number of decimal places;d) the number of proficiency test items to be tested or measured and the number of repeat tests, calibrations or measurements to be conducted on each proficiency test item or for each determination;e) the procedures used to establish the standard deviation for proficiency assessment or other evaluation criteria;f) procedures to be used to identify or handle outliers, or both;g) where relevant, the procedures for the evaluation of values excluded from statistical analysis; andh) where appropriate, the objectives to be met for the design and the frequency of proficiency testing rounds.

5.4.5. Assigned Values5.4.5.1. The method for determining the values is documented in the PT Schemes SOP.

This method takes into account the metrological traceability and uncertainty used to determine the values. Note 1: Both assigned values (determined by the PTP) and consensus values are reported to the participants as part of the PT scheme. Both are covered in the PT Scheme SOP.Note 2: The scheme includes policy which precludes the possibility of participants gaining any advantage from early disclosure and maintains confidentiality of participant information.

5.4.6. Choice of method or procedure5.4.6.1. Participants will be given instructions for the set-up and operation of the artifact,

but will be expected to utilize their own methods for measuring the output of the artifact.

5.5.Operation of proficiency testing schemes5.5.1. Instructions for participants





5.5.1.1. Sufficient notice, in the form of a PT cycle schedule will be provided to the participants. Since the artifact does not have a life cycle or expiration timing of the cycle is not critical to the success or outcome of the results.

5.5.1.2. Participants are given detailed instructions in the requirements of the scheme to ensure any factors that could affect the outcome of the scheme are consistent. This includes: a) detailed procedure for preparing or conditioning, or both preparing and conditioning, of the PT artifact before conducting the calibrations;b) any appropriate instructions on handling the PT artifact, including any safety requirements;c) any specific environmental conditions for the participant to conduct calibrations, and, if relevant, any requirement for the participants to report relevant environmental conditions during the time of the measurement;d) specific and detailed instructions on the manner of recording and reporting test or measurement results and associated uncertainties. If the instructions include reporting of the uncertainty of the reported result or measurement, this shall include the coverage factor and, whenever practicable, the coverage probability;NOTE: This instruction includes parameters such as the units of measurement, the number of significant figures or decimal places and reporting basis e) the latest date for the provider to receive the proficiency testing or measurement results for analysis;f) information on the contact details of the proficiency testing provider for enquiries; andg) instructions on return of the proficiency test items.

5.5.2. PT artifact, handling and storage5.5.2.1. Sufficient instructions are provided to each participant, detailing the manner in

which the PT artifact is to be handled, including transportation/shipping and storage while at the participants location. Also included in the instructions is a damage liability clause which informs the participant of the financial liability incurred if mishandling, damage or loss occurs while the PT artifact is in the possession of the participant.

5.6.Data analysis and evaluation of PT scheme results5.6.1. Data analysis and records

5.6.1.1. Data processing equipment and software is off the shelf and assumed to be validated by the originator/OEM.

5.6.1.2. All data and records are backed-up on an external hard drive to preserve information in the event of primary equipment failure.

5.6.1.3. Documented procedures for dealing with “outliers” or results that are obviously inconsistent with the scheme are contained in the PT Scheme SOP.





5.6.1.4. Stability checks are performed at predetermined intervals on the PT artifact to assure that the assigned values are consistent. In the event assigned values are found to have drifted significantly, the PT round will be temporarily suspended while the artifact is recalibrated by the subcontractor.

5.6.2. Evaluation of performance5.6.2.1. Evaluation of performance is based on the calculated En numbers for each

participant and is performed exclusively by SDPT.5.6.2.2. Additional performance information may be provided to the participant (where

applicable) with regard to the following: a) overall performance against prior expectations, taking measurement uncertainties into account;b) variation within and between participants, and comparisons with any previous proficiency testing rounds, similar proficiency testing schemes, or published precision data;c) variation between methods or procedures;d) possible sources of error (with reference to outliers) and suggestions for improving performance;e) advice and educational feedback to participants as part of the continual improvement procedures of participants;f) situations where unusual factors make evaluation of results and commentary on performance impossible;g) any other suggestions, recommendations or general comments; andh) conclusions.NOTE: It can be useful to provide individual summary sheets for participants periodically during or after completion of a particular proficiency testing scheme. These can include updated summaries of performance for individual participants over successive proficiency testing rounds of a continuous proficiency testing scheme. Such summaries can be further analysed and trends highlighted, if required.

5.7.Reports 5.7.1. PT reports contain clear and concise data including an indication of the performance of

the participant. The development, authorization and issuance of these reports is performed by SDPT and includes: a) the name and contact details for the proficiency testing provider;b) the name and contact details for the coordinator;c) the name, function, and signature or equivalent identification of the person authorizing the report;d) SDPT does not subcontract any activities except artifact calibratione) the date of issue and status (e.g. preliminary, interim, or final) of the report;f) page numbers and a clear indication of the end of the report;





g) a statement of the extent to which results are confidential;h) the report number and clear identification of the proficiency testing scheme;i) a clear description of the proficiency test items used, including necessary details of the proficiency test item's preparation and homogeneity and stability assessment;j) the participants' results;k) statistical data and summaries, including assigned values and range of acceptable results and graphical displays;l) procedures used to establish any assigned value;m) details of the metrological traceability and measurement uncertainty of any assigned value;n) procedures used to establish the standard deviation for proficiency assessment, or other criteria for evaluation;o) assigned values and summary statistics for test methods/procedures used by each group of participants (if different methods are used by different groups of participants);p) comments on participants' performance by the proficiency testing provider and technical advisers;q) information about the design and implementation of the proficiency testing scheme;r) procedures used to statistically analyze the data;s) advice on the interpretation of the statistical analysis; t) comments or recommendations, based on the outcomes of the proficiency testing round; andu) a statement to the effect that the information contained in a report is for the exclusive use of the participant, for the evaluation of their internal programs and systems.

5.7.2. Reports are made available to participants in a timely manner, consistent with the schedule.

5.7.3. When a new or amended report is issued for a given PT scheme, it shall include the following: a) a unique identification;b) a reference to the original report that it replaces or amends; andc) a statement concerning the reason for the amendment or re-issue.

5.8.Communication with participants5.8.1. SDPT shall make available to all participants, the following information:

a) relevant details of the scope of the proficiency testing scheme;b) any fees for participation;c) documented eligibility criteria for participation;d) confidentiality arrangements; ande) details of how to apply.





5.8.2. Participants shall be informed of any changes to scheme design or operation in a timely manner.

5.8.3. Participants who which to appeal any evaluations of performance made by SDPT, may do so as long as the appeal is made in writing within 14 days of receipt of the written report. This shall be stated in the application tendered by the participant.

5.8.4. Records of all communications between SDPT and the participants, is maintained for a minimum of three years.

5.9.Confidentiality5.9.1. Participant identity shall be known only to personnel of SDPT, unless this confidentiality

is waived by the participant for legitimate purposes.5.9.2. All information submitted by the participant to SDPT shall be treated as confidential.

NOTE Participants can elect to waive confidentiality within the proficiency testing scheme for the purposes of discussion and mutual assistance, e.g. to improve performance. Confidentiality can also be waived by the participant for regulatory or recognition purposes. In most instances, the proficiency testing results can be provided to the relevant authority by the participants themselves.

5.9.3. It is highly unlikely that there will be any regulatory requirements for information related to PT schemes. If, however this becomes necessary, the participant will be notified in writing of this action.

END
