Proficiency Testing Requirements while ISO 17025 Accreditation

ISO/IEC 17025 is the global standard for quality and calibration laboratories. It is the basis for the accreditation of a certification body. There are two main clauses of ISO/IEC 17025 – Management Requirements and Technical Requirements. Management requirements are related to the operation and effectiveness of the quality management system within the laboratory, and this clause has similar requirements to ISO 9001. Technical requirements address the competence of staff; testing methodology; equipment and quality; and reporting of test and calibration results.

Regardless of ISO 17025 Standard the system of the quality of your calibration laboratory is based on the Proficiency Testing is a great way to validate its measurement process. Proficiency tests can validate the method of measurement participating laboratory, technical training, traceability standards, and uncertainty budgets. Although the lab has been more rigorous in the development of the above laboratory processes, it is important to use proficiency tests as an additional means of checking that all aspects of the laboratory measurement system. For a calibration laboratory to be accredited to ISO 17025 Documents, the accreditation body often has specific requirements for participation in proficiency tests. Before discussing the proficiency testing requirements specific accreditation body, it is helpful to understand why proficiency tests are required to be accredited.

What is Proficiency Test (PT)

A proficiency test (PT) is simply a method that you can use to validate a particular measurement process. The reference value of the artifact is not known by the participating laboratory at the time of measurement (test). In a competency test well designed, the reference value for the artifact should be mainly determined by a competent laboratory with proper traceability to International System of Units (IS). The reference laboratory should also have demonstrated competency if key comparisons, inter laboratory comparisons, or appropriate skill checks to validate their measurement capability. It is also preferable that the laboratory had jurisdiction independently evaluated by the process of laboratory accreditation.

Proficiency Testing Plan:

When developing an aptitude test plan for your lab, the first element to consider is the length of the proficiency testing cycle for your laboratory. The laboratory should plan to participate in proficiency testing activities enough to cover the technical scope of the laboratory. If your laboratory is not accredited, you can select any length of time for the cycle for you, but if you make an application for certification, it is advisable to align your test plan skill requirements of the agency Accreditation to which you are applying. If you are an accredited laboratory, the maximum cycle time that you can select is four years. It is important to note that the laboratory can choose a small period of time for the proficiency testing cycle. A shorter cycle may be necessary for laboratories with a small technical scope of accreditation to meet the additional accreditation body, or may be desirable if the laboratory is interested in a more comprehensive quality program. For accredited laboratories, starting with the selection of the maximum four-year cycle time minimizes the cost to the laboratory while ensuring compliance with applicable requirements.

Proficiency testing plan comprises following key points:

• Include information such as an explanation of why proficiency testing may not be possible for certain major sub-areas.
• Address the laboratory’s process for timely submission of proficiency testing results to the accreditation body in the required time frame.
• Complete and implement corrective actions for measurement areas that have received unsatisfactory proficiency testing results and submit the information to the accreditation body in a timely manner.

Overview of Proficiency Testing for Lab Accreditation

The Proficiency testing programs are type of an external quality assessment in which simulated patient specimens made from a common pool are analyzed by the laboratories enrolled in the program. The results are then evaluated to determine the quality of each laboratory’s performance. Government and licensing agencies increasingly use PT as a method for laboratories accrediting thereby giving them official authorization to operate. The performance characteristics of PT programs for detecting bias and imprecision are evaluated using methods similar to those as assessing internal QC.

A common evaluation criterion is comparison of PT test results with those of peer groups, considering all values that exceed 2SD to be unacceptable. To be totally successful a lab accreditation should produce correct results on 4 out of 5 specimens for each of the analyses and have an overall score of at least 80% for 3 consecutive challenges. If a laboratory has 2 or more incorrect results for any analytic or has an overall score <80% on tow of 3 consecutive surveys, it is suspended.

For Proficiency testing the sample are made by agencies which has target value established by definitive or reference methods. If definitive method is not available a comparative method may be used. If the method group is <20 participants, target value means the overall mean after outliers removal. Or in absence of definitive method, then peer group mean values or groups of methods that agree with the definitive method can be used. This target value is termed the definitive method corrected target value.

GPTS Organizes Waste Water Proficiency Testing Program in January-2015

January 06, 2015, Ahmedabad – GPTS has announced the launch of its third fully-technical PT program – GPTS/PT-03 for Effluent Wastewater in chemical at Ahmedabad, Gujarat, India. Testing laboratories in India that are NABL accredited or going for NABL, can take part in this Waste water PT program, scheduled on 5^th January 2015. Registration for this Waste water PT is end on 31^st December 2014. Such organizations looking for PT provider in India for waste water proficiency testing can contact GPTS for quick registration.

As per technical manager of GPTS said that more than 15 laboratories are already registered for their participation in Wastewater PT and many few places are left. GPTS focuses to serve effluent waste water PT for pH, Conductivity, Total Dissolved Solids, Total Suspended Solids, total hardness etc. We will start to send water sample to testing laboratories in first week of January and they will analyze our samples and will submit their report to GPTS till end of January 2015. Our proficiency testing executives will review and analyze results and compares the measuring results obtained by different laboratories. The results reported by each laboratory for a measured are compared to the reference value for that measured by combining an in-depth analysis of reference value obtained and release final report few months.

Global Proficiency Testing Services supports own internal quality control and quality assurance procedures of laboratories by providing an additional external assessment of their testing capability. Any organization from India including service providers, NABL accredited water testing laboratory, non-accredited laboratories, testing and inspection departments of government and regulators as well as research laboratories can take this PT program. The company organization minimum 1 Effluent waste water testing PT program per quarter for such laboratory

Read more about Upcoming PT Programs – 2014 at GPTS.

About Globalptservices.com

Global Proficiency Testing Services is a group company of Global Manager Group, will work as independent agency and having technical personnel for the evaluation, analysis of the results collected from the participants. Activities like statistical check of homogeneity, compilation, and analysis of results and report preparation will be done by GPTS based on ISO/IEC 17043 and ISO 13528. GPTS is also organizing PT programs like Aggregate, Stainless steel, Soil, Bitumen, Wastewater etc regularly. Visit website www.Globalptservices.com for more details.

What is Limitation of Proficiency Testing?

The Proficiency Testing fulfils a necessary role in the production of data that are fir for purpose, but needs to be carried out in context of the IQC practice outlined above. Like all such measures, proficiency testing has its own particular features and limitation that need to be considered when it is used as part of a laboratories quality system.

The retrospective natures of proficiency testing

The organization structures of a PT Program returns results to and external coordinator, the subsequent processing of result and the distribution of a performance report to the participant entails an unavoidable time delay in the assessment of laboratory data quality. Proficiency testing is therefore retrospective in nature and performance scores reflect the quality of a laboratories analyses at some fixed point in the past several day to a few week may elapse before performance assessment are returned to participating laboratories. Under such circumstances it is not acceptable to rally exclusively on proficiency testing to ensure the day to day quality of a test laboratories data. Internal quality control must also be employed. IQC then ensures laboratory consistency from run to run while the PT scheme provides a regular, but less frequent, external check of data accuracy.

Characteristics of Proficiency Test Material

The suitability and quality of the test material distributed are important determinants of the effectiveness of a PT scheme. The proficiency test material should resemble the routine test materials closely and the assigned values for the various anklets must be reliably established, preferably by specialist laboratories using well validated methodology. However, in instances these requirements simply cannot be met for a variety of reasons. In such circumstances the usefulness of the scheme may be compromised. For example, if it is necessary to prepare PT material by spiking a matrix with the analyses of interest caution will be required when drawing conclusions regarding laboratory performance on test materials. If the assigned values for the PT material have to be established from the consensus of participant results, it should be realized that such assigned values could be biased. Consequently, performance score based on such a value could be in error.

The Analysis Covered by a Proficiency Testing Program

The extent of proficiency testing is obviously limited by financial constraints. In laboratories that undertake a very wide range of analyses, only a small fraction of them can be subject to a proficiency test. This fraction has to be regarded in some sense as representative of the general performance of the laboratory. There is no guarantee that is a correct assumption.

The performance data provided by PT are often restricted to a small range of particular sample type. However, it is not unknown for closely related test to be conducted with different degrees of accuracy among a group of laboratories. Thus while a laboratory may perform well in the determination of zinc in a foodstuff by flame atomic absorption spectrophoto marty, it does  not automatically follow that it would perform equally well in the determination of calcium in the same b the same technique. Hence for performance on one analyze to be taken as indicative of likely performance on another analyze, a detailed and expert technical knowledge in required.

In the longer term, this specificity in the effect of proficiency tests may become less evident. Proficiency testing in specific tests should result in general improvements of IQC system in a laboratory and that in turn should result in improvements in quality in all analytical procedures, even those not the subject of proficiency testing. However, there is no experimental evidence to support this conjectures at present.

The Disclosed Declared Nature of Proficiency Testing

When laboratories participate in PT program, they are usually aware that they are being tested. In such circumstances there always exists the possibility that extra effort will be applied to the PT sample compared with that normally applied to routine sample. For example to the PT sample might be analyzed in duplicate where single analyses are the norm in routine work. Because of such factors, the reliability of proficiency testing as an indicator of routine performance depends upon the participating laboratories observing the spirit of proficiency testing, which I to treat PT samples in exactly the same manner as routine sample.

GPTS Organizes Aggregate Proficiency Testing Program from 1st December 2014

GPTS has announced the launch of its second fully-technical PT program – GPTS/PT-02 for aggregate material testing at Ahmedabad, Gujarat, India. Testing laboratories like NABL accredited or going for NABL, can take parts in this Aggregate PT program, as mandatory requirements mentioned under NABL standard guidelines. Such organizations looking for PT provider in India can contact GPTS for quick registration till 30^th November, 2014.

As per technical manager of GPTS said that more than 20 laboratories are already registered for their participation in this PT program in Ahmedabad and many few places are left. We will send sample material to testing laboratories in first week of December and they will analyze material and have to submit their report to GPTS till 31^st December 2014. GPTS engineers review and analyze results and compares the measuring results obtained by different laboratories. The results reported by each laboratory for a measurand are compared to the reference value for that measurand by combining an in-depth analysis of reference value obtained and release final report till 15^th January 2015.

Proficiency Testing by GPTS supports own internal quality control and quality assurance procedures of laboratories by providing an additional external assessment of their testing capability. Any service providers, NABL accredited testing laboratory, non-accredited laboratories, manufacturing companies, testing and inspection departments of government and regulators as well as research laboratories can take this PT program. GPTS focuses to serve Aggregate material PT for parameters like specific gravity, water absorption, Flakiness, Elongation, Los Angeles abrasion value etc. with reference test standard IS 2386:1963. The company is aiming to organizing minimum 1 Aggregate Proficiency Testing program per quarter for such laboratories.

Read more about Upcoming PT Programs – 2014 at GPTS.

Aspect of Analytical Quality Assessed in Proficiency Testing

The basic concern of Proficiency Testing in accuracy the closeness of agreement between a test result x submitted by a participant and the assigned value x, set by the organizer. Clearly any inaccuracy contains a systematic aspect, and a random aspect characterized by the precision of the measuring procedures. However PT schemes do not normally address the magnitude of this precision separately.  The participant laboratory can easily determine for itself whether imprecision of bias in the main determent of its inaccuracy.

In practice each laboratory is scored on accuracy for each analyze in each test material in each round of the test. The error X-Xa is converted into a score by the use of a scaling factor. PT program in India detects errors of a serious magnitude through the occurrence of abnormally high scores. The detection of such an unexpected error acts as a warning to the participant that both the analytical procedures and the quality assurance measures undertaken in the laboratory are inadequate.

A PT program is also addresses trueness in the sense of the ISO definition. The average value of a large series of test results can also be compared with the accepted reference value, although this is rarely an explicit part of the testing protocol. However there is a more important séance of ‘trueness’ that impinges on laboratories proficiency testing. If the assigned value used is taken simply as the consensus of the participants rustle in that round, then the scheme merely encourages the laboratories towards consistency. While such practice my in circumstances produce a true result, in others it could institutionalize the use of inept analytical methods. Most analytical chemist embraces the ideal of striving towards the true value of the measured. This ideal can be raised in Proficiency Testing only by the use of an assigned value that is the best available estimate of the true value. Thus the choice of the procedures used to establish the assigned value is a critical feature in proficiency testing. This is exemplified by the experience of clinical proficiency testing in the India; there participant consensus values for iron in serum were consistently low compared to the values found by reference procedures.

Other features of a laboratory’s performance play a role in proficiency tests. For example, it is the ethos of PT that a participant laboratory should be using its routine methods of operation, so that the quality of its results reflects its normal output. Therefore the reported result should be in exactly the same form as would be supplied to a normal customer of the laboratory. There can therefore be no opportunity for the laboratory to correct inadvertent mistakes in reporting any more than there could be in reporting results to normal client.

In general, schemes set a strict deadline for the return of results by participants. This is essentially a matter of organizational convenience, however and participants are not usually scored on timelines, although some scheme organizer may wish to use this as one criterion for assessing competence.

GPTS Organizes Proficiency Testing Programs for Stainless Steel

Global Proficiency Testing Services – GPTS, Ahmedabad, India is pioneer of providing technical information on a wide range of proficiency testing, PT programs and PT provider organization in Gujarat. GPTS recently organizes Stainless Steel PT program in November 2014 at Ahmedabad, Gujarat, India.  More than 15 material testing laboratories are already registered to participate in this PT program and few spots are left. This PT program will cover key parameters like % C, % Si, % Mn, % P, % S, % Cr, % Ni, % Mo etc and it will be done as per ASTME 1086 reference standard guidelines. GPTS also announced to organize PT for Aggregate (mechanical) material in December.

Applicability of Proficiency Testing

While in principle, proficiency testing could be applied in most chemical measurement sector, it is by its nature more readily applicable in particular circumstances. One important consideration, particularly for scheme organizer, is the minimum number of participating laboratories needed to ensure the technical viability of a proposed PT schemes. This factor will be especially important in those schemes using the mean of participant’s results to determine the assigned values of test materials. When this is the case the general view of organizers of lab proficiency testing schemes us that the minimum number of participants should be at the least 10 and preferably 30 if a scheme is to be technically viable. However where the assigned value is established independently of participants results, it would be possible in principle, to run a PT sachem fir a single laboratory of curse an important feature affecting minimum size is fiance. As most PT schemes are paid for from the fees paid by participants, another important consideration for organizer is the minimum participant numbers required to ensure the fanatical viability of schemes.

From the viewpoint of participant a proficiency testing schemes is most applicable as a quality assurance procedure where the laboratory has a large throughput of routine samples and tests of the type covered by the PT scheme. In these circumstances the laboratory can incorporate the PT materials into their routine work schedule without the need to make special arrangements for their analysis. This course is how proficiency testing should always be tackled by analytical laboratories, so that the performance assessment obtained is a useful reflection of the quality if routine work. Where routine throughput is small, a laboratory may find that the costs of participation in a PT scheme are large in relation to the income they generate from their day to day work from the particular tests concerned.

Despite this however the survey of participants showed that there are instances where laboratories find proficiency testing applicable to their situation even though they have little routing work in the tests concerned. Such benefits as staff training, maintenance of expertise and demonstration of a commitment to quality were cited by these laboratories. Usually therefore proficiency testing is most readily applicable where a large number of laboratories are regularly carrying out at least moderate numbers of routine analyses. In such circumstances, the need for a regular assessment and demonstration of the quality of routine data is self evident. Meeting such a need through proficiency testing is likely to be technically and economically feasible.

Proficiency testing is especially relevant to test sectors where reference materials are difficult or impossible to obtain. The materials distributed in a PT schemes, while of a lower petrological level than certified reference materials are nevertheless well-characterized for the analyses of interest and therefore provide a vital substitute for CRM where the latter are enviable. In this context the establishment of schemes for environmental analysis for example, might be considered of higher priority in terms of promoting valid measurements, than the establishment of schemes for metallurgical analysis, where CRM are readily available.

Proficiency testing is especially appropriate where a wide variety of analytical methods are in use for a given demonstrate. However, where analytical methodology is non-routine or under development, proficiency testing is hardly applicable. In such cases there is no sound basis for establishing assigned values. Furthermore, a PT schemes could not be relied upon to give an accurate assessment of laboratory proficiency testing. Performance scores attributed to laboratories would be just as likely to reflect inherent problems in methodology rather than laboratory competence.

Finally it may be noted that the nature of the test materials themselves may impose a limitation on the type of PT scheme that can be organize. Very hazardous materials might pose insuperable safety problems in relation to predation and distribution of the materials. Likewise it may be impossible to organize proficiency tests for very labile analyses.

Why does Your Laboratory Requires Proficiency Testing Plan?

Regardless of the standard that your testing laboratory’s quality system is based upon, Proficiency Testing is an excellent way to validate one’s measurement processes. As per NABL guidelines every testing laboratory must have to participate in PT program to evaluate accuracy of their testing results. Proficiency tests by GPTS can validate the participating laboratory’s measurement method, technical training, traceability of standards, and uncertainty budgets. Even though the laboratory has been most rigorous in developing the aforementioned laboratory processes, it is important to use proficiency testing as an additional way to verify that all aspects of the laboratory measurement system are sound.

For laboratories that must either comply to or be accredited to ISO 17025, this document provides specific guidance why proficiency testing is important, and why it is preferable to develop a Proficiency Testing Plan. Section 5.9 of ISO 17025, assuring the quality of test and calibration results, states that the laboratory is required to have procedures to monitor the validity of calibrations. The laboratory is required PT provider to plan and review the monitoring process. This section goes on to suggest several ways to accomplish the monitoring, one of which is participation in proficiency tests.

Benefits of Proficiency Testing

In the complex process of assessing a facility’s competence, reviewing performance in proficiency testing (PT) has a significant place as a meaningful and helpful indicator. Proficiency testing supplements the internal quality control system of a facility, providing a means of external assessment of its testing or measurement capabilities. It is a valuable tool for facilities to compare their performance with that of the other participants in the same program. This in turn provides the opportunity to investigate any outlive results, identify the root cause of the problem and improve the performance where needed.

 The benefits of proficiency testing are widely recognized. These include:

• Comparison of a facility’s performance with that of other participating facilities
• Monitoring of a long-term facility performance
• Improvement in the performance of tests/calibrations following investigation and identification of the cause of unsatisfactory PT performance, and the introduction of corrective action to prevent re-occurrence
• Staff education, training and competence monitoring
• Evaluation of methods, including the establishment of method precision and accuracy
• Estimation of measurement uncertainty
• Contribution to the facility’s overall risk management system
• Confidence building with interested parties, e.g. customers, accreditation bodies, regulators, specifies

You can get more information about proficiency testing services, Visit @ www.Globalptservices.com