Why you should mind your "P’s and Q’s" The uncertainty assigned by the PT provider should be smaller than the participants expanded uncertainty value. Labs must participate in PT testing before an initial accreditation. The minimum required participation prior to the initial assessment is one specific test from the proposed scope of accreditation. The scope of accreditation is a document listing a laboratory’s specific test or calibration capability as verified by the accreditation body.   What is Proficiency Testing? Why have Proficiency Testing? The laboratory will meet the requirements of ISO 17025 in the area of PT and comply with regulations and standards by other accredited bodies. PT aids the laboratory in accreditation and demonstrates compliance. Analytical competence is demonstrated by PT. The laboratory will have assurance of suitable performance and capabilities of the analytical staff. The laboratory staff gains confidence in their abilities and knowledge of their capabilities. What is a proficiency plan? A proficiency plan is maintained by Quality Control (QC). The QC lab will have procedures for monitoring the validity of tests and calibrations. The results will be recorded so that trends are detectable. The monitoring is planned and reviewed as per 17025 Guidelines, Section 5.9. This monitoring may include the use of Certified Reference Materials, participating in proficiency testing, replicate tests or calibrations using the same or different methods, retesting or recalibration of retained standards, correlation of results for different characteristics of a standard. If data fails specification, there must be a process in place to capture any non-conformances and to prevent incorrect results from being reported. The rationale behind the quality assurance section of ISO/IEC 17025: Ensure that an analyst within the lab is able to consistently reproduce the same result with the same sample. The result produced by an analyst should reflect the result that would have come from any other analyst in the lab. Any results from the laboratory as a whole should reflect the results that are agreed upon by many other participants. A proficiency plan is critical because the laboratory should verify its competence to successfully run the methods. This can be done by method and instrument validation and using proficiency test samples. Requirements of a Proficiency Plan The technical scope of the laboratory must be defined. The scope is a detailed description of the specific test and/or calibrations for which your laboratory is accredited. To ensure consistent uniformity for all scopes of accreditation the format must be written in accordance with NIST 811 and guidelines for the Expression of SI Units. Align your PT testing to Major Discipline and Major Sub-Areas as defined in your scope if accredited. PT cycle time must be determined for the laboratory. The PT will cover the technical scope of the laboratory. If the lab is not accredited, any time can be selected. The maximum cycle time is four years for accredited laboratories. PT is a process to evaluate laboratory performance, specifically measurement processes. PT is an essential element for Quality Control Laboratories. Laboratory staff can detect any difficulties they may have with analyses, identify training needs and have mechanisms where these requirements can be met. PT is advantageous in method and instrument validation. Laboratories can monitor and improve measurements with PT. Results are submitted and statistically evaluated by an independent laboratory. Customers may require PT. PT assures reliable products are available for regulators and industry. PT ensures that laboratory measurements are sound. PT establishes traceability in measurements where calibrations are not possible or available and/or Reference Materials, or when Certified Reference Materials are not available. Certain accreditation bodies state the proficiency test plan must include these criteria: Explain why PT may not be possible for certain major sub areas. Submission process of PT results to the accreditation body in a timely fashion. Act and investigate non-conformances that resulted from PT. Why do laboratories need a Proficiency Plan? PT is required for certification and accreditation bodies. PT is a way of validating analytical method measurements. PT also provides proof about the labs competence to management and customers. PT offers and insight into understanding the quality issues in the method or test. PT programs should be properly designed and statistically robust so it can gauge participants performance is properly conducted and the participants can monitor trends and identify gaps in their performance for corrective actions and improvements. Most accreditation bodies require accredited labs to participate every year in some form of PT or reasonable alternative if none is available. The maximum cycle time is 4 years. Limitations of Proficiency Testing PT cannot be used as a substitute for routine internal quality control. PT is not a means for training individual analysts or the participating laboratory. PT provides an indication of problems if they are present. It does not provide any diagnostics to help solve the problem. Success in PT for one analyte does not indicate that a laboratory is equally competent in determining an unrelated analyte. Quality System A Quality Management System (QMS) is beneficial when setting up a proficiency plan. A QMS is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization. ISO 9001:2008 is an example of a Quality Management System. QMS integrates the various internal processes within the organization and intends to provide a guideline for project execution. A process based QMS enables organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance. An ISO 9001 complete Quality Management System must address all the requirements of ISO 9001, and more specifically must meet the ISO 9001 documentation requirements. Why you should mind your "P’s and Q’s" Kathy Kiefer MilliporeSigma 595 North Harrison Rd. Bellefonte, PA 16823 Abstract Whether responding to recent requirements intended for accreditation bodies, or confirming that your laboratory quality system meets the requirements of ISO 17025 or USP, programs should be in place for Proficiency Testing and Analytical Instrument Qualifications.   Laboratories need consistent, reliable and accurate data. The data generated from laboratory equipment, instruments and computerized systems must be suitable for intended use. Acceptable performance must be demonstrated prior to accreditation. This is why proficiency testing and instrument qualification is mandatory for accredited laboratories. This presentation will discuss how proficiency testing and analytical instrument qualification will assist laboratories in their pursuit to qualify and validate instruments and operators. Why have Proficiency Testing? The laboratory will meet the requirements of ISO 17025 in the area of PT and comply with regulations and standards by other accredited bodies. PT aids the laboratory in accreditation and demonstrates compliance. Analytical competence is demonstrated by PT. The laboratory will have assurance of suitable performance and capabilities of the analytical staff. The laboratory staff gains confidence in their abilities and knowledge of their capabilities.   Why do laboratories need a Proficiency Plan? PT is required for certification and accreditation bodies. PT is a way of validating analytical method measurements. PT also provides proof about the labs competence to management and customers. PT offers and insight into understanding the quality issues in the method or test. PT programs should be properly designed and statistically robust so it can gauge participants performance is properly conducted and the participants can monitor trends and identify gaps in their performance for corrective actions and improvements. Most accreditation bodies require accredited labs to participate every year in some form of PT or reasonable alternative if none is available. The maximum cycle time is 4 years. Limitations of Proficiency Testing PT cannot be used as a substitute for routine internal quality control. PT is not a means for training individual analysts or the participating laboratory. PT provides an indication of problems if they are present. It does not provide any diagnostics to help solve the problem. Success in PT for one analyte does not indicate that a laboratory is equally competent in determining an unrelated analyte.    Conclusion PT requirements must be understood from the accreditation body. A complete ISO 9001 Quality Management System will address PT criteria. A developed PT plan will allow the laboratory to meet accreditation requirements, establish quality, and verify the measurement processes. Proficiency Test Summary Quality System Proficiency Plan Define Scope Major discipline and major subareas Prepare Samples Assay Samples Analyze Data Report Results Notified of Results Pass Fail Nonconformance Instrument Validation Introduction Qualification of analytical instruments and validation of systems is required by many national and international regulations, quality standards such as ISO 17025 and company policies. There are many products being manufactured on a daily basis.  With certain products, especially those going into the medical, drug, and food industry, certain guidelines must be in place before products can be sold to the public. Instrument validation helps to improve instrument uptime and avoid out-of-specification situations (OOS) in laboratories. What is Instrument Validation? Instrument validation is a documented process that all users of an instrument must follow. These guidelines are written in a very clear, easy to follow way so anyone can apply them. Consistency is of the utmost importance when performing the validation of an instrument. The goal of the established guidelines is to make sure that all equipment is up to spec before any work is done. Why is Instrument Validation Necessary? Analytical instruments are used for a specific analysis. Regular performance verifications are made to ensure that the instrument to be used is suitable for its intended application. All equipment used in the production of products shall be properly validated and calibrated “to demonstrate that it is suitable for its intended purpose”. In I.Q, the setups of the unit connections are confirmed that they are correct. Any problems identified in I.Q must be investigated and appropriate actions must be taken. All such actions must be documented and approved by higher authority. O.Q includes procedures and documentation of the analytical instrument. When all procedures are executed and all items pass the inspection, it is verified that the system operates to satisfy the intended purpose. The PQ represents the final qualification of equipment or system. This incorporates a range of testing to simulate your production process options and provide assurance that systems and operating documentation are capable of subsequent process validation activities Conclusion Analytical Instrument Qualification establishes practices to maintain and calibrate instruments. Each assessment will depend on whether the instrument will be used according to GLP/GPC/GMP/ISO regulations. Each maintenance and calibration activity should be documented. Proficiency Testing Introduction Proficiency testing (PT) is one of the key tools used to assess laboratory competence. A proficiency testing plan assists the laboratory by revealing problems in testing methodologies, instrument or analyst’s performance. The laboratory results need to accurately represent the true value and offer objective evidence of laboratory competence. For these reasons it is important that the laboratory obtains the right answers. Obtaining the right answer supports consumer confidence that this data is what it states. PT techniques differ depending on the type of the test item, the method being utilized, and the number of laboratories contributing. PT can assist in recognizing any trends that suggest unreliable data is being generated. Customers have a greater level of confidence in a laboratory when they have the ability to carry out a test method in a manner that produces valid results when proficiency testing is employed.   What is a Proficiency Test? A proficiency test (PT) is a method that is used to validate a particular measurement process. The reference value is not known by the participating laboratory at the time of the test. The PT samples must be stable and homogeneous. A PT supplier distributes the samples to the participant with instructions. The participant then evaluates both the PT sample and their sample. Results are submitted to the PT supplier for statistical analysis. The participant is then supplied a report that allows them to compare their performance with other participants. The performance of the individual laboratories is only known by the participant laboratory. The PT may be either from a commercial provider, developed internally or completed through a cooperative effort. The PT must meet the applicable requirements of the accreditation body, such as ISO 17043.  Analytical Instrument Qualification Flow Chart Performance Qualification   Performance Qualification Definition of performance criteria and test procedures Selection of critical parameters, with predefined specifications Determination of the test intervals, e.g., - Everyday - Every time the system is used - Before, between and after a series of runs Define corrective actions on what to do if the system does not meet the established criteria Manufacturer Qualification Design Prerequisite Installation Qualification Confirmation of installation site and conditions Confirmation of delivered equipment Confirmation of documents (Instruction manuals, qualification protocol and certificates) Confirmation of analytical equipment specifications   Operation Qualification Operation check on each unit Operation check on overall system Software and Firmware check   References: ISO 9001:2008, Quality management systems-requirements, 2008 ISO/IEC 17025, General Requirements for the competence of testing and calibration laboratories, 2005. ISO/IEC 17043, Conformity assessment – general requirements for proficiency testing, 2010 USP 37 1058 Analytical Instrument Qualification sigma-aldrich.com/ MilliporeSigma and the M logo are trademarks of Merck KGaA, Darmstadt, Germany. © 2016 EMD Millipore Corporation, Billerica, MA USA. All rights reserved. Lit. No. T417020