Quality Issues in the Analytical Laboratory - Coursework Example

ANALYSIS & QUALITY- ‘QUALITY ISSUES IN THE ANALYTICAL LABORATORY’ Academia-Research Order 584966 ID: 21516 CONTENTS INTRODUCTION 3 2. DEFINITION OF QUALITY 3 3. SELECTING A CONTEXT- THE ANALYTICAL LABORATORY 4 4. QUALITY ISSUES RELEVANT TO AN ANALYTICAL LABORATORY 4 5. HOW ISO 17205 IMPACTS ON THE ANALYTICAL LABORATORY 11 6. CONCLUSION 13 7. REFERENCES 13 8. EXPLANATION OF TECHNICAL TERMS 15 1. INTRODUCTION In the highly competitive global industrial scenario of our times, where sweeping political and economic changes are taking place almost every day, and trade boundaries are fast disappearing, quality of the product or services delivered by an organization decides its future prospects. Since quality of products and services constitute the common basis on which trade is undertaken globally, quality improvement can definitely improve the performance of an organization in the long run. Customer expectations can be fulfilled or even exceeded by opting for quality systems whether the organization concerned is a manufacturing industry or an analytical laboratory offering services of chemical analyses. 2. DEFINITION OF QUALITY According to Mulmi,(2009, p7-8)the term ‘Quality’ has been defined in many a different way by various authorities on quality . For example he cites, Joseph M Juran’s definition of quality as ‘fitness for use’, Philip B Crosby’s definition as ‘Quality is conformance to requirement, it is respect to humanity’ and the American National Standards Institute’s definition of quality as the ‘totality of the features and characteristics of a product that bears on its ability to satisfy the stated or implied needs’. The International Organization for Standardization has defined quality as the ‘Degree to which a set of inherent characteristics fulfils requirements’ (ISO: 2005a, 3.1.1). According to Taguchi’s definition of quality, ‘Product quality is proportional to the loss caused to society due to deviation from target (required) values’ (Scribd, 2011). The loss caused is monetary in nature, which Taguchi expressed mathematically as a loss function and which occurs due to the combination of several factors such as customer dissatisfaction, alterations, production breaks and wastages. 3. SELECTIING A CONTEXT-THE ANALYTICAL LABORATORY Cases (2000,p xix) defines Analytical Chemistry as a ‘metrological science that develops, optimizes and applies measurement processes intended to derive quality biochemical information of global or partial type from natural or artificial objects or systems in order to solve analytical problems’. Fifield & Kealy (2000,p524) point out that a typical analytical laboratory carries out development and day-to-day application of analytical methods in optimum conditions. According to them, the successful functioning of activities in an analytical laboratory necessitates simultaneous management of a number of related but different operations. Reproducibility, reliability and efficiency of operation of various instruments are as much necessary as are collation and interpretation of data which result in the generation of valid conclusions drawn from them. In the present context, the Analytical Laboratory has been taken to illustrate the impact of quality issues in this dissertation. 4. QUALITY ISSUES RELEVANT TO AN ANALYTICAL LABORATORY Analytical laboratories are organizations that obtain process and communicate information about the composition, structure and relative amounts of constituent elements in matter or systems, from a chemical or biochemical point of view. The quality system, administrative system and technical system that govern the operations of a laboratory are together termed as the management system by the ISO ( 2005b, p1). Due to the increasing use of management systems, it is becoming increasingly important to ensure that analytical laboratories do operate to a quality management system while at the same time become capable of demonstrating their technical competency to international standards. This need has been addressed by the publication of the International Standard ‘General Requirements for the Competence of Testing and Calibration Laboratories ISO 17205’ which identifies the various quality issues to be complied with by laboratories. According to the ISO (2008, pv) the application of a system of processes within an organization together with the identification and interactions of these processes and their management to produce the desired outcome is referred to as the process approach. The ISO standards such as ISO 9000 series standards and the ISO 17025 use the process approach when developing and establishing a quality management system. The process approach provides a control not only over the linkage between individual processes within the system of processes, but also over their combination and interaction, and facilitates continual improvement. Quality management as envisaged by the above ISO standard is implemented by the PCDA methodology which stands for a cycle of the four operations – Plan, Do, Check and Act- repeated again and again in all individual processes. This can be elaborated as follows (Eurolab,2003,p7) :- 1. Plan: In this phase the objectives and processes required for delivering the results to meet the customer’s requirements are established in harmony with stated policies of the laboratory. 2. Do: The processes are implemented as per the plan. 3. Check: The processes are checked and measured to verify that they do meet the requirements of products or service as also the policies and objectives of the laboratory. 4. Act: Based on the feedback obtained from the verification as mentioned above, further action is taken to improve the process performance continually. The implementation of a quality management system requires documentation and records for the purpose of defining objectives and policies, for ensuring a constant level of performance and for ensuring the traceability of process results. These and the establishment of a set of documents such as the quality manual and standard operation procedures are called for by the ISO 9000 series of standards which comprise of a set of five individual and related international standards on quality management and documentation of its quality system elements. Other quality issues such as training of personnel, audits, management reviews, corrective actions and preventive actions are also dealt with in the above standards. These standards are generic in nature and can be adopted by any industry including an analytical laboratory. Out of these five standards, ISO 9001 is the most comprehensive one containing the following twenty elements necessary for standardizing the quality system of any organization performing design, manufacturing or services activities(Badiru,1995,p70-81):- 1) Management responsibility 2) Quality system documentation 3) Contract review 4) Design control 5) Document control 6) Purchasing 7) Purchase supplied product 8) Product identification and traceability 9) Process control 10) Inspection and testing 11) Inspection, measuring and test equipment 12) Inspection and test status 13) Control of nonconforming product 14) Corrective action 15) Handling, storage, packaging and delivery 16) Quality records audits 17) Internal quality audits 18) Training 19) Servicing 20) Statistical techniques While the quality system of a supplier of a product or service can be evaluated and registered by ISO 9000 certification, the general requirements to assess the competence of an analytical laboratory which carries out tests and calibration activities are as specified in ISO 17205 which was first published in 1999. Consequent to the issuing of revised ISO 9001 in 2000, the ISO 17205 was also revised to cover all the management requirements of ISO: 9001:2000 and reissued as ISO 17205:2005. The ISO 17025:2005 contains twenty five elements or requirements which include fifteen management requirements and ten technical requirements as given below, that any analytical laboratory would have to meet if it wishes to demonstrate that it can operate a management system, is technically competent and is able to generate technically valid results(ISO, 2005b p1-23):- Management Requirements 1. Organization 2. Management system 3. Document control 4. Review of requests, tenders and contracts 5. Subcontracting of tests and calibrations 6. Purchasing services and supplies 7. Service to the customer 8. Complaints 9. Control of nonconforming testing and/or calibration work 10. Improvement 11. Corrective action 12. Preventive action 13. Control of records 14. Internal audits 15. Management reviews. Technical Requirements 1. General requirements 2. Personnel 3. Accommodation and environmental conditions 4. Test and calibration methods and method validation 5. Equipment 6. Measurement traceability 7. Sampling 8. Handling of test and calibration items 9. Assuring the quality of test and calibration results 10. Reporting the results. ISO (2005b, p, vi) further points out that those testing and calibration laboratories which comply with ISO 17205 also operate in accordance with ISO 9001. On the other hand, the Eurachem (1998, p1) has recommended that all analytical laboratories should have the following six characteristics:- 1. An agreed requirement being met by making analytical measurements 2. Use of only those methods and equipment which are fit for the purpose of tests and analysis. 3. Employment of only qualified and competent staff to undertake testing and analysis. 4. Regular and independent assessment of the laboratory being ensured. 5. Consistency of analytical measurement made at one location with those made at another location. 6. Existence of well defined quality control and quality assurance procedures at the laboratory. Yet another point which is crucial in analytical laboratories is the importance of method validation and measurement uncertainty in relation to their role in traceability (Eurachem; 2003, p3-4). The strategy of linking all individual measurement results to some common reference standard is called traceability. The following sequence of activities is necessary for establishing traceability:- 1. The measureand, scope of measurements and the required uncertainty are specified. 2. An appropriate method or procedure (with equations or calculations) of estimating the value and measurement conditions are chosen. 3. Through validation, it is demonstrated that all the influence quantities that affect the result are included in the calculation and measurement conditions. 4. The relative importance of each influence quantity is identified. 5. The appropriate reference standards are chosen and applied 6. Uncertainty estimation is carried out. Computer system validation (CSV) and analytical instrument qualification (AIQ) are relevant in this context (Agilent 2009). Software and computer systems used for acquisition, processing, recording, storage and retrieval of test results need validation prior to use. The USP effective from 2008 has standardized AIQ and CSV procedures for use in the US pharmaceutical industries and laboratories (Scientific computing, 2011). It is pointed out by other authors such as Taverniers et al (2004, p550) that the three most important factors which have a real bearing on the quality of the analyses carried out by an analytical laboratory are (i) the quality of measurement data,(ii) the reporting of results with its measurement uncertainty along with traceability of results to stated standards or references and (iii) validation status of analytical methods employed. Cases (2000, p7-11) also echoes this view when he suggests that the main objective of analytical chemistry is to minimize uncertainty in the qualitative, quantitative and structural information about the material under investigation. For this to be achieved, he states that the use of reliable reference standards is indispensable. Improper use of reference materials can result in erroneous analytical results in an analytical laboratory even if the technical processes employed therein may be the most advanced and do meet high standards of performance. 5. HOW ISO 17025 IMPACTS ON THE ANALYTICAL LABORATORY The financial expenses involved in implementing ISO 17205 in a laboratory would be more than compensated by the positive impacts it would have on that laboratory and the benefits that would follow such an accreditation. The advantages of obtaining accreditation include increased access to contracts for testing/calibration, enhanced reputation, improving quality of analytical results and increasing compliance to GLP and GMP .Prichard & Barwick (2007, p226-228) have summarized the overall impact of ISO 17025 accreditation on a laboratory while pointing out that a beneficial effect in the functioning of the laboratory is achieved because of the necessity that certain requirements have to be met by it, which are described below. First of all, the laboratory has to establish a well-defined quality management system as described in its quality manual. The procedure followed for auditing and reviewing quality management need to be documented, which means that the laboratory gets capability to demonstrate its compliance to quality standards. A mechanism for demonstrating the competence and qualifications of its staff as also the training imparted to them also have to be established. In order to ensure that proper equipments are used, the specifications and other requirements of major equipments have to be listed including that of calibration and maintenance. Traceability of measurement instruments to national or international standards has to be demonstrated by the laboratory. Chemical analyses have to be corroborated by certified reference materials (CRMs) and comparisons with analysis done in other laboratories. Measurement uncertainty has to be carried out on the final results. The procedures used for sampling, handling, analysis and calculation of uncertainty have to the appropriate to the analysis and calibration work being carried out, Both standard and non-standard methods need to be validated and documented. The laboratory should be able to demonstrate that a work environment free from risk of contamination is established and maintained. There should be a documented system whereby the final disposal of analytical samples carried out can be demonstrated. The records of tests and analyses should be documented and readily available for future reference for a predetermined period of time. Documented system should be established for dealing with customer complaints, and all other forms correspondence with customers. In all cases of subcontracted work, a documented system should be established to ensure that the subcontractors are sufficiently accredited and have established adequate quality procedures in the scope of their area of work. Thus a laboratory accredited to ISO 17205 not only documents all its procedures and conducts them properly, but also is capable of demonstrating that all procedures are all under control and are being carried out as documented. 6. CONCLUSION The industry standard ISO 9001 approach used by the ISO 17025 Quality Management System Model 17205 can be fully utilized to provide an infrastructure for quality systems of laboratories engaged in the business of testing and/or calibration activities and to streamline their quality issues to standardized requirements of present-day international trade. 7. REFERENCES # Abhiman Das Mulmi, (2009) Quality Concepts, ,[online] Avalilable at http://www.scribd.com/doc/13926561/Quality-Concepts [25Oct 2011] # Scribds (2011) Taguchi definition of Quality [online] Available at http://www.scribd.com/doc/31610666/62/Taguchi-definition-of-quality [25 Oct 2011] # F.W.Fifield & D Kealy (2000) Principles and Practice of Analytical Chemistry . 5th ed. Wiley-Blackwell # M.V. Cases(2000) Principles of Analytical Chemistry: a text book. Berlin : Springer-Verlag # Isabel Taverniers, Marc De Loose, Eric van Bock Staele (2004).Trends in quality in the analytical laboratory.II Analytical method validation and quality assurance 23 (8) 535-552 ISO(2005a): International Standard: Quality Management and Quality Assurance Standards: Guidelines for Use ISO9000:2005 # ISO(2005b) International Standard :General Requirements for the Competence of Testing and Calibration Laboratories ISO 17205:2005(E) # Eurolab(2003) Quality Management in Analytical Laboratories According to ISO/IEC17025 available at http://www.ecasia03.bam.de/pdf/golze_iso_17025.pdf [25Oct 2011] # Adedeji B. Badiru(1995) Industry’s Guide to ISO 9000 New York: John Wiley & Sons # Eurachem(1998) EURACHEM/CITAC GUIDE The Fitness for Purpose of Analytical Methods [online] available at http://www.eurachem.org/guides/pdf/valid.pdf [28 Oct 2011] # Eurachem(2003) EURACHEM/CITAC GUIDE Traceability in Chemical Measurement[online] available at http://www.eurachem.org/guides/pdf/EC_Trace_2003.pdf [28 Oct 2011] # Agilent Technologies(2009) Analytical Instrument Qualification and System Validation [online] available at http://www.chem.agilent.com/Library/primers/Public/5990-3288EN.pdf [28Oct 2011] # Scientific Computing (2011) United States Pharmacopeia Analytical Instrument qualification Effective [online] available at http://www.scientificcomputing.com/United-States-Pharmacopeia-1058-Analytical-Instrument-Qualification-Effective.aspx [28 Oct 2011] # F.E .Prichard and V.Barwick (2007) Quality Assurance in Analytical Chemistry Singapore: John Wiley &Sons 8. Explanation of Technical Terms Accreditation: Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specified tasks (ISO Guide 2-1996) Quality assurance: All those planned as systematic activities implemented within a quality system, and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality. Quality control: The operational techniques and activities that are used to fulfill requirements of quality. Quality manual: A document specifying the quality management system of an organization. Process: One event or a collection of events within which people, tools and materials interact to perform operations that cause one or more characteristics of a raw material to be altered or generated. Procedure: A document that specifies the way to perform an activity. Reference material: Material or substance, one or more of whose property values are sufficiently analogous and well established to be used for the calibration of an apparatus, an assessment of a measurement method or for assigning values to materials. Certified Reference Material (CRM): Reference material accompanied by a certificate, one or more of whose property values are certified by a procedure, which establishes its traceability to an accurate realization of the units in which the property values are expressed, and for which each certified value is accompanied by an uncertainty as a stated level of confidence. Traceability: Property of the result of a measurement or the value of a standard, whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties. Measureand: The specific quantity (of target material or component) intended to be measured. Verification: Provision of objective evidence that a given item fulfills specified requirements. Validation: Verification, where the specified requirements are adequate for an intended use. Measurement uncertainty (MU): A parameter associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measureand, Read More