ISO 17025 Quality Manual Template
Wednesday, September 27, 2006
Terms, Definitions, and References
Definitions:
1. Accuracy: The closeness of agreement between the measured value and the accepted, “true,” or reference value. Accuracy is indicative of the bias of the measurement process. Accuracy is often evaluated by repetitively spiking the matrix or placebo with known levels of analyte standards at or near target values. The fraction or percentage of added analyte recovered from a blank matrix is often used as the index of accuracy. Added analyte, however, may not always reflect the condition of the natural analyte in the materials submitted for analysis. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E).
Accuracy: Closeness of agreement between a measured quantity value and a true quantity value of the measurand. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.13 without notes)
2. Audit: A systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled (ISO 9000:2000 3.9.1 without notes)
3. Bias: Systematic measurement error or its estimate, with respect to a reference quantity value. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.19)
4. Certified reference culture: Microbiological; a reference culture certified by technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body; e.g., cultures used for verifying test systems, validation of methods; quality control of test media must be traceable to a type culture collection.
5. Certified reference material: A reference material, accompanied by documentation issued by an authoritative body and referring to valid procedures used to obtain a specified property value with uncertainty and traceability. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 5.14 without notes)
Certified reference material (CRM): A reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body (ISO Guide 30:1992 2.2), e.g., NIST infant milk standards with established levels of vitamins.
6. Customer: Organization or person that receives a product. Example: Consumer, client, end-user, retailer, beneficiary and purchaser.
Notes:
A supplier can be internal or external to the organization.
(ISO 9000:2000 3.3.5)
7. Conformity assessment: Demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled.(ISO/IEC 17000:2004 2.1 without notes)
8. Controlled document: A document that is subjected to controls to ensure that the same version of the document and any revisions are held by or available to all personnel to whom the document is applicable.
9. Corrective action: Action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
Notes:
There can be more than one cause for a nonconformity.
Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence.
There is a distinction between correction and corrective action.
(ISO 9000:2000 3.6.5)
10. Correction: Action taken to eliminate a detected nonconformity.
Notes:
A correction can be made in conjunction with a corrective action.
A correction can be, for example, rework or regrade.
(ISO 9000:2000 3.6.6)
Correction: Modification applied to a measured quantity value, to compensate for a known systemantic effect (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.53 without notes)
11. Document: Information and its supporting medium. Examples: Record, specification, procedure document, drawing, report, standard.
Notes:
The medium can be paper, magnetic, electronic or optical computer disk, photograph or master sample, or a combination thereof.
A set of documents, for example specifications and records, is frequently called “documentation.”
Some requirements (e.g., the requirement to be readable) relate to all types of documents; however, there can be different requirements for specifications (e.g., the requirement to be revision controlled) and records (e.g., the requirement to be retrievable)
(ISO 9000:2000 3.7.2)
12. Empirical method: A method that determines a value that can only be arrived at in terms of the method per se and serves by definition as the only method for establishing the accepted value of the item measured.
13. Inspection: Examination of a product design, product, process or installation and determination of its conformity with specific requirements or, on the basis of professional judgment, with general requirements.
Notes:
Inspection of a process may include inspection of persons, facilities, technology and methodology.
(ISO/IEC 17000:2004 4.3)
14. Intermediate precision: The precision of an analytical procedure expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).
Intermediate precision: Measurement precision under a ser of conditions of measurement. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.24 without notes)
15. Internal audit: A formal review of the performance of a quality system conducted by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.
16. Laboratory: Body that calibrates and/or tests.
17. Laboratory control sample: See Quality control sample.
18. Limit of detection (LOD): The LOD is the smallest quantity of analyte that can be shown to be significantly greater than the measurement (random) error of the blank at a prescribed level of confidence (usually 95%). It is often taken as the blank value (or background) plus 3 times the standard deviation. When the LOD is calculated, it should be stated what definition and method are used. More rigorous definitions require consideration of false positives as well as false negatives. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
Limit of detection: Measured quantity value, obtained by a given measurement procedure, for which the probability of obtaining a false negative value is ß, given a probability of a false positive value. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 5.19 without notes)
19. Limit of quantitation (LOQ): The LOQ is the smallest amount of analyte in a test sample that can be quantitatively determined with suitable precision and accuracy under previously established method conditions. The LOQ is a crucial parameter in assays of low levels of compounds and in the determination of impurities, contaminants, or degradation products. It is often taken as the blank value (or background) plus 10 times the standard deviation. When the LOQ is calculated, it should be stated what definition and method are used. A multiple, e.g., 2, 3, or 5, of LOQ is often used to establish a level of fortification in residue recovery studies.
The validation of LOD and LOQ is not required when the analyte is within the useful range of the assay. They are important in the determination of low levels of residues and contaminants for exposure estimates required in risk assessments and for surveys of low levels of analytes. Because LOD and LOQ are determined at the lowest useful ranges of the methods, which tend to be regions of poor accuracy and precision, they can be expected to vary considerably. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
20. Linearity: The ability of an analytical method to elicit test results that are directly, or by a well defined mathematical transformation, proportional to the concentration of analyte in samples within a given range (USP NF)
21. Measurement uncertainty: Parameter characterizing the dispersion of the quantity values being attributed to a measurand (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.27 without notes)
22. Non-conformity: The non-fulfillment of a requirement (ISO 9000:2000 3.6.2).
23. Pharmaceutical testing laboratory: Laboratory that performs tests on finished pharmaceutical products, ingredients, raw materials, in-process samples, and associated environmental samples.
24. Precision: It is a general term for the variability among repeated tests under specified conditions. Two types of precision, repeatability and reproducibility, have been found necessary and, for many practical cases, sufficient for describing the variability of a test method (1). Precision expresses the closeness of agreement (degree of scatter) among a series of measurements obtained from multiple testing of a homogeneous test sample under the method’s established conditions. It should be investigated with homogeneous test samples, representative of the matrixes to which the method will be applied and containing the expected range of analyte concentrations within these matrixes. If it is not possible to obtain homogeneous test samples, however, precision may be investigated using test samples artificially prepared in the laboratory to simulate the original test samples. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
Precision: Closeness of agreement between indications obtained by replicate measurements on the same or similar objects under stated specified conditions. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.16 without notes)
25. Proficiency testing: Proficiency testing is a program external to the laboratory that compares the analytical performance of a group of laboratories. Such external validation gives the laboratory and client assurance that the work performed in the laboratory is at least comparable to the analytical results produced by other laboratories. If formulated, homogeneous matrixes are used, and the program also provides information on the bias of individual laboratories. In proficiency testing, laboratories are not restricted as to what method will be used. Therefore, it does not provide information on method performance unless such information is specifically requested. In very large proficiency programs, sufficient information may often be provided so that conclusions may be reached regarding method performance as well as analyst and laboratory performance. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
26. Proficiency test sample: Test material with microorganisms or chemical analytes that is tested periodically by a number of locations to determine the proficiency of recovery, using statistical analysis where appropriate.
27. Preventive action: Action taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation.
Notes:
There can be more than one cause for a potential nonconformity.
Preventive action is taken to prevent occurrence, whereas corrective action is taken to prevent recurrence.
(ISO9000:2000 3.6.4)
28. Quality assurance (QA): Part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000:2000 3.2.11).
29. Quality control (QC): Part of quality management focused on fulfilling quality requirements (ISO 9000:2000 3.2.10).
30. Quality control sample: A test portion sample with known contents of analytes to carry through the method to verify performance.
31. Quality management system: Management system to direct and control an organization with regard to quality (ISO 9000:2000 3.2.3).
32. Quality manual: A document specifying the quality management system of an organization (ISO 9000:2000 3.7.4 without notes).
Conmment:
The quality manual may cite other documentation relating to the laboratory’s quality arrangements.
33. Range: The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).
Comments:
For quantitative analysis, the working range for a method is determined by examining samples with different analyte concentrations and determining the concentration range for which acceptable uncertainty and precision can be achieved. The working range is generally more extensive than the linear range, which is determined by the analysis of a number of samples of varying analyte concentrations and calculating the regression from the results, usually using the method of least squares. The relationship of analyte response to concentration does not have to be perfectly linear for a method to be effective.” To demonstrate acceptable linearity, five different standards (plus a blank) that at a minimum encompass the anticipated analyte range plus modest upper and lower extensions are usually sufficient. Once the linear range has been established, two or three standards (plus a blank) are sufficient to define the day-to-day calibration line. More measurement standards will be required where linearity is poor. In qualitative analysis, it is commonplace to examine replicate samples and standards over a range of concentrations to establish at what concentration a reliable cut-off point can be drawn between detection and non-detection.
34. Reference culture (RC): A culture with characteristics sufficiently well established to be used to calibrate/verify test systems, and test media and to validate methods, e.g., cultures used for verifying test systems, and validation of methods; in addition to the use of “wild strains,” quality control of test media shall also be traceable to a type culture collection.
Comment:
For some analyses, such as screening tests for high consequence pathogens, Reference Cultures are not available to the testing laboratory. In this case, a culture with suitable properties should be used as a reference. The required properties of this culture should be characterized by repeat testing, preferably by more than one laboratory.
35. Reference material: A material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials (ISO Guide 30:1992 2.1 amended), e.g., USP Reference Material.
36. Reference standard: A measurement standard, designated for the calibration of working measurement standards for quantities of a given kind in a given organization or at a given location. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 5.6).
Comment:
Generally, this refers to recognized national or international traceable standards such as National Institute of Standards and Technology (NIST) thermometers and weights.
37. Repeatability (of results of measurements): Closeness of the agreement between the results of successive measurements of the same measurand carried out subject to all of the following conditions:
same measurement procedure
same observer
same measuring instrument, used under the same conditions
same location
repetition over a short period of time
(ISO Guide 30: 1992 A7)
Repeatability: Measurement precision under the set of repeatability conditions of measurement. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.22)
38. Replicate tests: An analysis of a laboratory sample, Certified Reference Material, or Reference Material can be performed more than once; the result of each individual analysis is a replicate test result. The replication can occur at any step in the procedure from laboratory sample, to test sample, to test portion, to test solution, to aliquot.
Comment:
An analytical method final result can be the average of more than one interim value.
39. Reproducibility (of results of measurements) : Closeness of the agreement between the results of measurements of the same measurand, where the measurements are carried out under changed conditions such as:
principle or method measurement
observer
measuring instrument
location
conditions of use
time
(ISO Guide 30:1992 A.8)
Reproducibility: Measurement precision under reproducibility conditions of measurement. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.26 without notes)
40. Requirement: Need or expectation that is stated, generally implied or obligatory. (ISO 9000:2000 3.1.2 without notes)
Requirement: Provision that conveys criteria to be fulfilled (ISO Guide 2:2004 7.5)
41. Review: Activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives.
Note:
Review can also include the determination of efficiency. Example: Management review, design, and development review; review of customer requirements; and nonconformity review (ISO 9000:2000 3.8.7).
42. Robustness: A measure of an analytical method capacity to remain unaffected by deliberate variations in method parameters. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).
43. Ruggedness: The ruggedness of an analytical procedure is its ability to tolerate small variations in procedural conditions, which may include variation in volumes, temperatures, concentrations, pH, and instrument settings, without affecting the analytical result. It provides an indication of the applicability of the method in a variety of laboratory conditions. Ruggedness is not a quantitative parameter. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
44. Sample: Any material brought into the laboratory for analysis.
45. Sample handling: The manipulation to which samples are subjected during the sampling process, from the selection from the original material through the disposal of all samples and test portions.
46. Sample preparation: This describes the procedures followed to select the test portion from the sample (or subsample) and includes in-laboratory processing, mixing, reducing, coring and quartering, riffling, and milling and grinding.
47. Sampling: Provision of a sample of the object of conformity assessment, according to a procedure. (ISO/IEC 17000:2004 4.1)
Comments:
This is a procedure whereby a part of a substance, material or product is taken to be used for testing or calibration as a representative sample of the whole. In some cases, such as forensic analysis, the sample may not be representative but is determined by availability.
Sampling procedures should describe the selection, sampling plan, withdrawal, and preparation of a sample. The resulting sample represents a larger quantity such as a lot or batch and as such, in a statistical sense, is a portion where the potential exists for a sampling error due to the heterogeneity of the parent population.
The laboratory staff is often not involved in the sampling process, but analysts may be consulted concerning proper sample size or the use of appropriate preservatives, and they may be asked to provide suitably prepared containers. ISO 17025 requires that, where relevant, a statement to the effect that the results relate only to the items tested shall be made.
48. Segregate: To set apart; can represent setting apart by space and time. An example would be the separation (segregation) of samples and standards to avoid cross-contamination.
49. Selectivity: Refers to the extent to which the [analytical] method can determine particular analyte(s) in a complex mixture without interference from the other components in the mixture. A method that is [perfectly] selective for an analyte or a group of analytes is said to be specific. The applicability of the method should be studied using various samples, ranging from pure measurement standards to mixtures with complex matrices. In each case, the recovery of the analyte(s) of interest should be determined and the influences of suspected interferences duly stated. Any restrictions in the applicability of the technique should be documented in the method. The analytical community is moving towards the use of the word specificity.
50. Sensitivity: Describes the change in instrument response for a given concentration change. It is represented by the slope of the calibration curve and can be determined by a least squares procedure, or experimentally, using samples containing various concentrations of the analyte.
51. Specificity: The ability of a method to respond exclusively to the target analyte and not to any degradant, impurity, or other component of the matrix. Very few methods are absolutely specific, so the term “selectivity” is often used for this property. This parameter shows that the method can be used to quantitate the analyte without interference. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
Specificity: Ability to assess unequivocally the analyte in the presence of components which may be expected to be present. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).
52. System Suitability: An important concept designated as “systems suitability” has evolved in chromatographic and instrumental analyses to permit use of columns and instruments that may differ somewhat from each other and from the initial specifications. The desired output is defined in terms of such properties as the relative standard deviation of repeated injections of a standard solution, peak shape or symmetry, resolution from an internal standard or associated analyte, ratio of peak height to peak width at a specified fractional peak height, peak-to-noise ratio, sensitivity (signal intensity per unit concentration), and similar properties. Column and solvent composition or instrument settings may be adjusted to obtain acceptable output within predetermined parameters. In such cases, the system suitability specifications and the settings used to attain the desired output must be documented. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
System suitability tests: These tests are based on the “holistic” concept that the aggregate equipment assembly shall demonstrate performance characteristics to show that it is suitable for its intended use.
Comment:
For chromatographic procedures this may involve measures of precision of replicate injections, column efficiency, peak tailing, etc.
53. Test: A technical operation that consists of the determination of one or more characteristics or the performance of a given product, material, equipment, organism, physical phenomenon, process, or service according to a specified procedure.
Comment:
The result of a test is normally recorded in a document sometimes called a test report or a test certificate.
Testing: Determiantion of one or more characteristics of an object of conformity assessment, according to a procedure. (ISO 17000:2004 4.2)
54. Testing laboratory: Laboratory that performs tests.
55. Test method: Specified technical procedure for performing a test.
56. Test portion: The actual material weighed or measured for the analysis.
57. Traceability Chain: Sequence of measurement standards and calibrations that is used to relate a measurement result to a stated metrological reference. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.42 without notes).
Traceability: Ability to trace the history, application or location of that which is under consideration. (ISO 9000:2000 3.5.4)
58. Trueness: The closeness of agreement between the average of an infinite number of replicate measured quantity values and a reference quantity value. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.15 without notes)
Comments:
The measure of trueness is usually expressed in terms of bias.
Trueness has been referred to as “accuracy of the mean.” This usage is not recommended
59. Uncertainty: See Measurement uncertainty.
60. Validated method: The planned and documented procedure to establish the method’s performance characteristics. The performance characteristics or the validation parameters of the method determine the suitability for its intended use. They define what the method can do under optimized conditions of matrix solution, analyte isolation, instrumental settings, and other experimental features. The inclusion of particular validation parameters in a validation protocol depends on the application, the test samples, the goal of the method, and domestic or international guidelines or regulations, as applicable. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
Comments:
Validation of a method establishes, by systematic laboratory studies that the method is fit-for-purpose, i.e., its performance characteristics are capable of producing results in line with the needs of the analytical problem. The important performance characteristics include: Selectivity and specificity (Description of the measurand), Measurement range, Calibration and traceability, Bias linearity, Limit of detection/limit of quantitation, Ruggedness, Precision. The above characteristics are interrelated, many of these contribute to the overall measurement uncertainty and the data generated may be used to evaluate the measurement uncertainty. The extent of validation must be clearly stated in the documented method so that users can assess the suitability of the method for their particular needs.
Examples of validated method can be obtained from specific organizations such as AOAC INTERNATIONAL.
61. Verification: Provision of objective evidence that a given item fulfills specified requirements, taking any measurement uncertainty into consideration.( ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.44 without notes)
Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled (ISO 9000:2000 3.8.4 without notes).
Comment:
In connection with the management of measuring equipment, verification provides a means for checking that the deviations between values indicated by a measuring instrument and corresponding known values of a measured quantity are consistently smaller than the maximum allowable error defined in a standard, regulation, or specification peculiar to the management of the measuring equipment. The result of verification leads to a decision either to restore in service, perform adjustments, or repair, or to downgrade, or to declare obsolete. In all cases it is required that a written trace of the verification performed shall be kept on the measuring instrument’s individual record.
Terms and Definitions Bibliography
1.- ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition. (To be published)
2.-Conformity assessment –Vocabulary and general principles. ISO/IEC 170000:2004.
3.-Quality management systems –Fundamentals and vocabulary. ISO 9000:2000
4.-Terms and definitions used in connection with reference materials. ISO Guide 30:1992
5.-Standardization and related activities –General vocabulary. ISO Guide 2:2004
6.-Unates States Pharmacopoeia and National Formulary (USP/NF)
7.-International Committee of Harmonization (ICH): Validation of Analytical Procedures: Text and Methodology, Q2R.
8.-Official methods of Analysis of AOAC International 18th Edition, Appendix E
Reference:
AOAC INTERNATIONAL Quality Assurance Principles for Analytical Labs 3rd Ed, available for purchase from www.aoac.org
Brown, M.R.W., & Gilbert, P. (1995) Microbiological Quality Assurance, A Guide Towards Relevance and Reproducibility of Inocula, CRC Press, Boca Raton, FL
Eurachem: http://www.eurachem.ul.pt/
Eurachem Guide: Traceability in Chemical Measurement (2003)
Eurachem Guide: The Selection and use of Reference Materials (2002)
Eurachem Guide: Guide to Quality in Analytical Chemistry: An Aid to Accreditation (2002)
Eurachem Guide: Accreditation for Microbiological Laboratories (2002)
Eurachem Guide: Selection, Use and Interpretation of Proficiency Testing (PT) Schemes by Laboratories (2000)
Eurachem Guide: Quantifying Uncertainty in Analytical Measurement, 2nd Edition (2000)
Eurachem Guide: The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics (1998)
Eurachem Guide: Harmonised Guidelines for the Use of Recovery Information in Analytical Measurements (1998)
Eurachem Guide: Quality Assurance for Research and Development and Non-routine Analysis (1998)
Eurachem Guide: Selection, Use and Interpretation of Proficiency Testing
ICH: http://www.ich.org/cache/compo/276-254-1.html
International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use ICH Harmonised Tripartite Guideline VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1) Current Step 4 version Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)
ISO: http://www.iso.org/iso/en/ISOOnline.frontpage
ISO/IEC Guide 2:2004 Standardization and related activities –General Vocabulary
ISO/IEC 17025:2005, General Requirements for the Competence of Calibration and Testing Laboratories
ISO/IEC Guide 30: 1992, Terms and Definitions Used in Connection with Reference Materials
ISO 9000: 2000, Quality Management and Quality Assurance—Vocabulary
ISO 9001:2000, Quality management systems – Requirements
ISO 9004:2000, Quality management systems -- Guidelines for performance improvements
ISO/TR 10013:2001, Guidelines for quality management system documentation
ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
ISO 10012:2003, Measurement management systems -- Requirements for measurement processes and measuring equipment
ISO/DGuide 99999, International vocabulary of basic and general terms in metrology (VIM) -- Third edition
USP United States Pharmacopeia
USP: http://www.usp.org/
EP European Pharmacopoeia
EP: http://www.pheur.org/site/page_628.php
CITAC: http://www.citac.cc/
Eurachem/CITAC Guide 2003 Traceability in Chemical Measurements. A guide to achieving comparable measurement results
LGC/VAM: VAM Guides can be downloaded from the VAM website http://www.vam.org.uk A user login is required but there is no charge.
LGC/VAM/2003/016, New Eurachem/CITAC guidance on traceability of chemical measurements: A paradigm for practical traceability
LGC/VVAM, Meeting the Traceability Requirements of ISO 17025, An Analyst's Guide 2nd Edition, November 2003
References on Sampling
Enell, J.W. (1984) J. Qual. Technol. 16, 168–171
Feder, P.I. (1975) J. Qual. Technol. 7, 53–58
Garfield, F.A. (1989) J. Assoc. Off. Anal. Chem. 72, 405–411
Horwitz, W. (1976) J. Assoc. Off. Anal. Chem. 59, 1197–1203
Horwitz, W. (1990) Pure Appl. Chem. 62, 1193–1208
ISO 7002:1986, Agricultural food products -- Layout for a standard method of sampling from a lot
ISO 8213:1986, Chemical products for industrial use -- Sampling techniques -- Solid chemical products in the form of particles varying from powders to coarse lumps
ISO 6206:1979, Chemical products for industrial use -- Sampling -- Vocabulary
ISO 2859-1:1999, Ed. 2 Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 2859-2:1985, Ed. 1 Sampling procedures for inspection by attributes -- Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
ISO 2859-3:2005, Ed. 2 Sampling procedures for inspection by attributes -- Part 3: Skip-lot sampling procedures
ISO 2859-4:2002, Ed. 2 Sampling procedures for inspection by attributes -- Part 4: Procedures for assessment of declared quality levels
ISO 2859-5:2005, Ed. 1 Sampling procedures for inspection by attributes -- Part 5: System of sequential sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 2859-10:2006, Ed. 1 Sampling procedures for inspection by attributes -- Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes
ISO 3951-1:2005, Ed. 1 Sampling procedures for inspection by variables -- Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL (available in English only)
ISO 3951-2:2006, Ed. 1 Sampling procedures for inspection by variables -- Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics (available in English only)
ISO 3951-5:2006, Ed. 1 Sampling procedures for inspection by variables -- Part 5: Sequential sampling plans indexed by acceptance quality limit (AQL) for inspection by variables (known standard deviation) (available in English only)
Kratochvil, B., & Taylor, J.K. (1981) Anal. Chem. 53, 924A–938A
Kratochvil, B., Wallace, D., & Taylor, J.K. (1984) Anal. Chem. 56, 113R–129R
Smith, R., & James, G.V. (1981) The Sampling of Bulk Materials, The Royal Society of Chemistry (Analytical Sciences Monographs No. 8), London, UK
ILAC: http://www.ilac.org/
ILAC-G3:1994 Guidelines for Training Courses for Assessors
ILAC-G8:1996 Guidelines on Assessment and Reporting of Compliance with Specification
ILAC-G9:2005 Guidelines for the Selection and Use of Reference Materials
ILAC-G10:1996 Harmonised Procedures for Surveillance & Reassessment of Accredited Laboratories
ILAC-G11:07/2006 Guidelines on Assessor Qualification and Competence of Assessors and Technical Experts
ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers
ILAC-G13:2000 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes
ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 1702
ILAC-G18:2002 The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing
ILAC-G20:2002 Guidelines on Grading of Non-Conformities
ILAC-G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing
Additional Web Sites:
European Co-operation for Accreditation: http://www.european-accreditation.org/default_flash.htm
Standards Council of Canada: http://www.scc.ca/
A2LA: http://www.a2la.org
AIHA: http://www.aiha.org
ANSI: http://www.ansi.org
IAAC: http://www.iaac.org.mx (Inter-American Accreditation Cooperation)
1. Accuracy: The closeness of agreement between the measured value and the accepted, “true,” or reference value. Accuracy is indicative of the bias of the measurement process. Accuracy is often evaluated by repetitively spiking the matrix or placebo with known levels of analyte standards at or near target values. The fraction or percentage of added analyte recovered from a blank matrix is often used as the index of accuracy. Added analyte, however, may not always reflect the condition of the natural analyte in the materials submitted for analysis. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E).
Accuracy: Closeness of agreement between a measured quantity value and a true quantity value of the measurand. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.13 without notes)
2. Audit: A systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled (ISO 9000:2000 3.9.1 without notes)
3. Bias: Systematic measurement error or its estimate, with respect to a reference quantity value. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.19)
4. Certified reference culture: Microbiological; a reference culture certified by technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body; e.g., cultures used for verifying test systems, validation of methods; quality control of test media must be traceable to a type culture collection.
5. Certified reference material: A reference material, accompanied by documentation issued by an authoritative body and referring to valid procedures used to obtain a specified property value with uncertainty and traceability. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 5.14 without notes)
Certified reference material (CRM): A reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body (ISO Guide 30:1992 2.2), e.g., NIST infant milk standards with established levels of vitamins.
6. Customer: Organization or person that receives a product. Example: Consumer, client, end-user, retailer, beneficiary and purchaser.
Notes:
A supplier can be internal or external to the organization.
(ISO 9000:2000 3.3.5)
7. Conformity assessment: Demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled.(ISO/IEC 17000:2004 2.1 without notes)
8. Controlled document: A document that is subjected to controls to ensure that the same version of the document and any revisions are held by or available to all personnel to whom the document is applicable.
9. Corrective action: Action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
Notes:
There can be more than one cause for a nonconformity.
Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence.
There is a distinction between correction and corrective action.
(ISO 9000:2000 3.6.5)
10. Correction: Action taken to eliminate a detected nonconformity.
Notes:
A correction can be made in conjunction with a corrective action.
A correction can be, for example, rework or regrade.
(ISO 9000:2000 3.6.6)
Correction: Modification applied to a measured quantity value, to compensate for a known systemantic effect (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.53 without notes)
11. Document: Information and its supporting medium. Examples: Record, specification, procedure document, drawing, report, standard.
Notes:
The medium can be paper, magnetic, electronic or optical computer disk, photograph or master sample, or a combination thereof.
A set of documents, for example specifications and records, is frequently called “documentation.”
Some requirements (e.g., the requirement to be readable) relate to all types of documents; however, there can be different requirements for specifications (e.g., the requirement to be revision controlled) and records (e.g., the requirement to be retrievable)
(ISO 9000:2000 3.7.2)
12. Empirical method: A method that determines a value that can only be arrived at in terms of the method per se and serves by definition as the only method for establishing the accepted value of the item measured.
13. Inspection: Examination of a product design, product, process or installation and determination of its conformity with specific requirements or, on the basis of professional judgment, with general requirements.
Notes:
Inspection of a process may include inspection of persons, facilities, technology and methodology.
(ISO/IEC 17000:2004 4.3)
14. Intermediate precision: The precision of an analytical procedure expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).
Intermediate precision: Measurement precision under a ser of conditions of measurement. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.24 without notes)
15. Internal audit: A formal review of the performance of a quality system conducted by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.
16. Laboratory: Body that calibrates and/or tests.
17. Laboratory control sample: See Quality control sample.
18. Limit of detection (LOD): The LOD is the smallest quantity of analyte that can be shown to be significantly greater than the measurement (random) error of the blank at a prescribed level of confidence (usually 95%). It is often taken as the blank value (or background) plus 3 times the standard deviation. When the LOD is calculated, it should be stated what definition and method are used. More rigorous definitions require consideration of false positives as well as false negatives. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
Limit of detection: Measured quantity value, obtained by a given measurement procedure, for which the probability of obtaining a false negative value is ß, given a probability of a false positive value. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 5.19 without notes)
19. Limit of quantitation (LOQ): The LOQ is the smallest amount of analyte in a test sample that can be quantitatively determined with suitable precision and accuracy under previously established method conditions. The LOQ is a crucial parameter in assays of low levels of compounds and in the determination of impurities, contaminants, or degradation products. It is often taken as the blank value (or background) plus 10 times the standard deviation. When the LOQ is calculated, it should be stated what definition and method are used. A multiple, e.g., 2, 3, or 5, of LOQ is often used to establish a level of fortification in residue recovery studies.
The validation of LOD and LOQ is not required when the analyte is within the useful range of the assay. They are important in the determination of low levels of residues and contaminants for exposure estimates required in risk assessments and for surveys of low levels of analytes. Because LOD and LOQ are determined at the lowest useful ranges of the methods, which tend to be regions of poor accuracy and precision, they can be expected to vary considerably. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
20. Linearity: The ability of an analytical method to elicit test results that are directly, or by a well defined mathematical transformation, proportional to the concentration of analyte in samples within a given range (USP NF)
21. Measurement uncertainty: Parameter characterizing the dispersion of the quantity values being attributed to a measurand (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.27 without notes)
22. Non-conformity: The non-fulfillment of a requirement (ISO 9000:2000 3.6.2).
23. Pharmaceutical testing laboratory: Laboratory that performs tests on finished pharmaceutical products, ingredients, raw materials, in-process samples, and associated environmental samples.
24. Precision: It is a general term for the variability among repeated tests under specified conditions. Two types of precision, repeatability and reproducibility, have been found necessary and, for many practical cases, sufficient for describing the variability of a test method (1). Precision expresses the closeness of agreement (degree of scatter) among a series of measurements obtained from multiple testing of a homogeneous test sample under the method’s established conditions. It should be investigated with homogeneous test samples, representative of the matrixes to which the method will be applied and containing the expected range of analyte concentrations within these matrixes. If it is not possible to obtain homogeneous test samples, however, precision may be investigated using test samples artificially prepared in the laboratory to simulate the original test samples. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
Precision: Closeness of agreement between indications obtained by replicate measurements on the same or similar objects under stated specified conditions. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.16 without notes)
25. Proficiency testing: Proficiency testing is a program external to the laboratory that compares the analytical performance of a group of laboratories. Such external validation gives the laboratory and client assurance that the work performed in the laboratory is at least comparable to the analytical results produced by other laboratories. If formulated, homogeneous matrixes are used, and the program also provides information on the bias of individual laboratories. In proficiency testing, laboratories are not restricted as to what method will be used. Therefore, it does not provide information on method performance unless such information is specifically requested. In very large proficiency programs, sufficient information may often be provided so that conclusions may be reached regarding method performance as well as analyst and laboratory performance. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
26. Proficiency test sample: Test material with microorganisms or chemical analytes that is tested periodically by a number of locations to determine the proficiency of recovery, using statistical analysis where appropriate.
27. Preventive action: Action taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation.
Notes:
There can be more than one cause for a potential nonconformity.
Preventive action is taken to prevent occurrence, whereas corrective action is taken to prevent recurrence.
(ISO9000:2000 3.6.4)
28. Quality assurance (QA): Part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000:2000 3.2.11).
29. Quality control (QC): Part of quality management focused on fulfilling quality requirements (ISO 9000:2000 3.2.10).
30. Quality control sample: A test portion sample with known contents of analytes to carry through the method to verify performance.
31. Quality management system: Management system to direct and control an organization with regard to quality (ISO 9000:2000 3.2.3).
32. Quality manual: A document specifying the quality management system of an organization (ISO 9000:2000 3.7.4 without notes).
Conmment:
The quality manual may cite other documentation relating to the laboratory’s quality arrangements.
33. Range: The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).
Comments:
For quantitative analysis, the working range for a method is determined by examining samples with different analyte concentrations and determining the concentration range for which acceptable uncertainty and precision can be achieved. The working range is generally more extensive than the linear range, which is determined by the analysis of a number of samples of varying analyte concentrations and calculating the regression from the results, usually using the method of least squares. The relationship of analyte response to concentration does not have to be perfectly linear for a method to be effective.” To demonstrate acceptable linearity, five different standards (plus a blank) that at a minimum encompass the anticipated analyte range plus modest upper and lower extensions are usually sufficient. Once the linear range has been established, two or three standards (plus a blank) are sufficient to define the day-to-day calibration line. More measurement standards will be required where linearity is poor. In qualitative analysis, it is commonplace to examine replicate samples and standards over a range of concentrations to establish at what concentration a reliable cut-off point can be drawn between detection and non-detection.
34. Reference culture (RC): A culture with characteristics sufficiently well established to be used to calibrate/verify test systems, and test media and to validate methods, e.g., cultures used for verifying test systems, and validation of methods; in addition to the use of “wild strains,” quality control of test media shall also be traceable to a type culture collection.
Comment:
For some analyses, such as screening tests for high consequence pathogens, Reference Cultures are not available to the testing laboratory. In this case, a culture with suitable properties should be used as a reference. The required properties of this culture should be characterized by repeat testing, preferably by more than one laboratory.
35. Reference material: A material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials (ISO Guide 30:1992 2.1 amended), e.g., USP Reference Material.
36. Reference standard: A measurement standard, designated for the calibration of working measurement standards for quantities of a given kind in a given organization or at a given location. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 5.6).
Comment:
Generally, this refers to recognized national or international traceable standards such as National Institute of Standards and Technology (NIST) thermometers and weights.
37. Repeatability (of results of measurements): Closeness of the agreement between the results of successive measurements of the same measurand carried out subject to all of the following conditions:
same measurement procedure
same observer
same measuring instrument, used under the same conditions
same location
repetition over a short period of time
(ISO Guide 30: 1992 A7)
Repeatability: Measurement precision under the set of repeatability conditions of measurement. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.22)
38. Replicate tests: An analysis of a laboratory sample, Certified Reference Material, or Reference Material can be performed more than once; the result of each individual analysis is a replicate test result. The replication can occur at any step in the procedure from laboratory sample, to test sample, to test portion, to test solution, to aliquot.
Comment:
An analytical method final result can be the average of more than one interim value.
39. Reproducibility (of results of measurements) : Closeness of the agreement between the results of measurements of the same measurand, where the measurements are carried out under changed conditions such as:
principle or method measurement
observer
measuring instrument
location
conditions of use
time
(ISO Guide 30:1992 A.8)
Reproducibility: Measurement precision under reproducibility conditions of measurement. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.26 without notes)
40. Requirement: Need or expectation that is stated, generally implied or obligatory. (ISO 9000:2000 3.1.2 without notes)
Requirement: Provision that conveys criteria to be fulfilled (ISO Guide 2:2004 7.5)
41. Review: Activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives.
Note:
Review can also include the determination of efficiency. Example: Management review, design, and development review; review of customer requirements; and nonconformity review (ISO 9000:2000 3.8.7).
42. Robustness: A measure of an analytical method capacity to remain unaffected by deliberate variations in method parameters. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).
43. Ruggedness: The ruggedness of an analytical procedure is its ability to tolerate small variations in procedural conditions, which may include variation in volumes, temperatures, concentrations, pH, and instrument settings, without affecting the analytical result. It provides an indication of the applicability of the method in a variety of laboratory conditions. Ruggedness is not a quantitative parameter. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
44. Sample: Any material brought into the laboratory for analysis.
45. Sample handling: The manipulation to which samples are subjected during the sampling process, from the selection from the original material through the disposal of all samples and test portions.
46. Sample preparation: This describes the procedures followed to select the test portion from the sample (or subsample) and includes in-laboratory processing, mixing, reducing, coring and quartering, riffling, and milling and grinding.
47. Sampling: Provision of a sample of the object of conformity assessment, according to a procedure. (ISO/IEC 17000:2004 4.1)
Comments:
This is a procedure whereby a part of a substance, material or product is taken to be used for testing or calibration as a representative sample of the whole. In some cases, such as forensic analysis, the sample may not be representative but is determined by availability.
Sampling procedures should describe the selection, sampling plan, withdrawal, and preparation of a sample. The resulting sample represents a larger quantity such as a lot or batch and as such, in a statistical sense, is a portion where the potential exists for a sampling error due to the heterogeneity of the parent population.
The laboratory staff is often not involved in the sampling process, but analysts may be consulted concerning proper sample size or the use of appropriate preservatives, and they may be asked to provide suitably prepared containers. ISO 17025 requires that, where relevant, a statement to the effect that the results relate only to the items tested shall be made.
48. Segregate: To set apart; can represent setting apart by space and time. An example would be the separation (segregation) of samples and standards to avoid cross-contamination.
49. Selectivity: Refers to the extent to which the [analytical] method can determine particular analyte(s) in a complex mixture without interference from the other components in the mixture. A method that is [perfectly] selective for an analyte or a group of analytes is said to be specific. The applicability of the method should be studied using various samples, ranging from pure measurement standards to mixtures with complex matrices. In each case, the recovery of the analyte(s) of interest should be determined and the influences of suspected interferences duly stated. Any restrictions in the applicability of the technique should be documented in the method. The analytical community is moving towards the use of the word specificity.
50. Sensitivity: Describes the change in instrument response for a given concentration change. It is represented by the slope of the calibration curve and can be determined by a least squares procedure, or experimentally, using samples containing various concentrations of the analyte.
51. Specificity: The ability of a method to respond exclusively to the target analyte and not to any degradant, impurity, or other component of the matrix. Very few methods are absolutely specific, so the term “selectivity” is often used for this property. This parameter shows that the method can be used to quantitate the analyte without interference. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
Specificity: Ability to assess unequivocally the analyte in the presence of components which may be expected to be present. (ICH Validation of Analytical Procedures: Text and Methodology, Q2R).
52. System Suitability: An important concept designated as “systems suitability” has evolved in chromatographic and instrumental analyses to permit use of columns and instruments that may differ somewhat from each other and from the initial specifications. The desired output is defined in terms of such properties as the relative standard deviation of repeated injections of a standard solution, peak shape or symmetry, resolution from an internal standard or associated analyte, ratio of peak height to peak width at a specified fractional peak height, peak-to-noise ratio, sensitivity (signal intensity per unit concentration), and similar properties. Column and solvent composition or instrument settings may be adjusted to obtain acceptable output within predetermined parameters. In such cases, the system suitability specifications and the settings used to attain the desired output must be documented. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
System suitability tests: These tests are based on the “holistic” concept that the aggregate equipment assembly shall demonstrate performance characteristics to show that it is suitable for its intended use.
Comment:
For chromatographic procedures this may involve measures of precision of replicate injections, column efficiency, peak tailing, etc.
53. Test: A technical operation that consists of the determination of one or more characteristics or the performance of a given product, material, equipment, organism, physical phenomenon, process, or service according to a specified procedure.
Comment:
The result of a test is normally recorded in a document sometimes called a test report or a test certificate.
Testing: Determiantion of one or more characteristics of an object of conformity assessment, according to a procedure. (ISO 17000:2004 4.2)
54. Testing laboratory: Laboratory that performs tests.
55. Test method: Specified technical procedure for performing a test.
56. Test portion: The actual material weighed or measured for the analysis.
57. Traceability Chain: Sequence of measurement standards and calibrations that is used to relate a measurement result to a stated metrological reference. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.42 without notes).
Traceability: Ability to trace the history, application or location of that which is under consideration. (ISO 9000:2000 3.5.4)
58. Trueness: The closeness of agreement between the average of an infinite number of replicate measured quantity values and a reference quantity value. (ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.15 without notes)
Comments:
The measure of trueness is usually expressed in terms of bias.
Trueness has been referred to as “accuracy of the mean.” This usage is not recommended
59. Uncertainty: See Measurement uncertainty.
60. Validated method: The planned and documented procedure to establish the method’s performance characteristics. The performance characteristics or the validation parameters of the method determine the suitability for its intended use. They define what the method can do under optimized conditions of matrix solution, analyte isolation, instrumental settings, and other experimental features. The inclusion of particular validation parameters in a validation protocol depends on the application, the test samples, the goal of the method, and domestic or international guidelines or regulations, as applicable. (Official Methods of Analysis of AOAC INTERNATIONAL, 18th, Edition, Appendix E)
Comments:
Validation of a method establishes, by systematic laboratory studies that the method is fit-for-purpose, i.e., its performance characteristics are capable of producing results in line with the needs of the analytical problem. The important performance characteristics include: Selectivity and specificity (Description of the measurand), Measurement range, Calibration and traceability, Bias linearity, Limit of detection/limit of quantitation, Ruggedness, Precision. The above characteristics are interrelated, many of these contribute to the overall measurement uncertainty and the data generated may be used to evaluate the measurement uncertainty. The extent of validation must be clearly stated in the documented method so that users can assess the suitability of the method for their particular needs.
Examples of validated method can be obtained from specific organizations such as AOAC INTERNATIONAL.
61. Verification: Provision of objective evidence that a given item fulfills specified requirements, taking any measurement uncertainty into consideration.( ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition, 2.44 without notes)
Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled (ISO 9000:2000 3.8.4 without notes).
Comment:
In connection with the management of measuring equipment, verification provides a means for checking that the deviations between values indicated by a measuring instrument and corresponding known values of a measured quantity are consistently smaller than the maximum allowable error defined in a standard, regulation, or specification peculiar to the management of the measuring equipment. The result of verification leads to a decision either to restore in service, perform adjustments, or repair, or to downgrade, or to declare obsolete. In all cases it is required that a written trace of the verification performed shall be kept on the measuring instrument’s individual record.
Terms and Definitions Bibliography
1.- ISO/DGuide 99999.2, International vocabulary of basic and general terms in metrology (VIM). Third edition. (To be published)
2.-Conformity assessment –Vocabulary and general principles. ISO/IEC 170000:2004.
3.-Quality management systems –Fundamentals and vocabulary. ISO 9000:2000
4.-Terms and definitions used in connection with reference materials. ISO Guide 30:1992
5.-Standardization and related activities –General vocabulary. ISO Guide 2:2004
6.-Unates States Pharmacopoeia and National Formulary (USP/NF)
7.-International Committee of Harmonization (ICH): Validation of Analytical Procedures: Text and Methodology, Q2R.
8.-Official methods of Analysis of AOAC International 18th Edition, Appendix E
Reference:
AOAC INTERNATIONAL Quality Assurance Principles for Analytical Labs 3rd Ed, available for purchase from www.aoac.org
Brown, M.R.W., & Gilbert, P. (1995) Microbiological Quality Assurance, A Guide Towards Relevance and Reproducibility of Inocula, CRC Press, Boca Raton, FL
Eurachem: http://www.eurachem.ul.pt/
Eurachem Guide: Traceability in Chemical Measurement (2003)
Eurachem Guide: The Selection and use of Reference Materials (2002)
Eurachem Guide: Guide to Quality in Analytical Chemistry: An Aid to Accreditation (2002)
Eurachem Guide: Accreditation for Microbiological Laboratories (2002)
Eurachem Guide: Selection, Use and Interpretation of Proficiency Testing (PT) Schemes by Laboratories (2000)
Eurachem Guide: Quantifying Uncertainty in Analytical Measurement, 2nd Edition (2000)
Eurachem Guide: The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics (1998)
Eurachem Guide: Harmonised Guidelines for the Use of Recovery Information in Analytical Measurements (1998)
Eurachem Guide: Quality Assurance for Research and Development and Non-routine Analysis (1998)
Eurachem Guide: Selection, Use and Interpretation of Proficiency Testing
ICH: http://www.ich.org/cache/compo/276-254-1.html
International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use ICH Harmonised Tripartite Guideline VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1) Current Step 4 version Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)
ISO: http://www.iso.org/iso/en/ISOOnline.frontpage
ISO/IEC Guide 2:2004 Standardization and related activities –General Vocabulary
ISO/IEC 17025:2005, General Requirements for the Competence of Calibration and Testing Laboratories
ISO/IEC Guide 30: 1992, Terms and Definitions Used in Connection with Reference Materials
ISO 9000: 2000, Quality Management and Quality Assurance—Vocabulary
ISO 9001:2000, Quality management systems – Requirements
ISO 9004:2000, Quality management systems -- Guidelines for performance improvements
ISO/TR 10013:2001, Guidelines for quality management system documentation
ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
ISO 10012:2003, Measurement management systems -- Requirements for measurement processes and measuring equipment
ISO/DGuide 99999, International vocabulary of basic and general terms in metrology (VIM) -- Third edition
USP United States Pharmacopeia
USP: http://www.usp.org/
EP European Pharmacopoeia
EP: http://www.pheur.org/site/page_628.php
CITAC: http://www.citac.cc/
Eurachem/CITAC Guide 2003 Traceability in Chemical Measurements. A guide to achieving comparable measurement results
LGC/VAM: VAM Guides can be downloaded from the VAM website http://www.vam.org.uk A user login is required but there is no charge.
LGC/VAM/2003/016, New Eurachem/CITAC guidance on traceability of chemical measurements: A paradigm for practical traceability
LGC/VVAM, Meeting the Traceability Requirements of ISO 17025, An Analyst's Guide 2nd Edition, November 2003
References on Sampling
Enell, J.W. (1984) J. Qual. Technol. 16, 168–171
Feder, P.I. (1975) J. Qual. Technol. 7, 53–58
Garfield, F.A. (1989) J. Assoc. Off. Anal. Chem. 72, 405–411
Horwitz, W. (1976) J. Assoc. Off. Anal. Chem. 59, 1197–1203
Horwitz, W. (1990) Pure Appl. Chem. 62, 1193–1208
ISO 7002:1986, Agricultural food products -- Layout for a standard method of sampling from a lot
ISO 8213:1986, Chemical products for industrial use -- Sampling techniques -- Solid chemical products in the form of particles varying from powders to coarse lumps
ISO 6206:1979, Chemical products for industrial use -- Sampling -- Vocabulary
ISO 2859-1:1999, Ed. 2 Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 2859-2:1985, Ed. 1 Sampling procedures for inspection by attributes -- Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
ISO 2859-3:2005, Ed. 2 Sampling procedures for inspection by attributes -- Part 3: Skip-lot sampling procedures
ISO 2859-4:2002, Ed. 2 Sampling procedures for inspection by attributes -- Part 4: Procedures for assessment of declared quality levels
ISO 2859-5:2005, Ed. 1 Sampling procedures for inspection by attributes -- Part 5: System of sequential sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 2859-10:2006, Ed. 1 Sampling procedures for inspection by attributes -- Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes
ISO 3951-1:2005, Ed. 1 Sampling procedures for inspection by variables -- Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL (available in English only)
ISO 3951-2:2006, Ed. 1 Sampling procedures for inspection by variables -- Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics (available in English only)
ISO 3951-5:2006, Ed. 1 Sampling procedures for inspection by variables -- Part 5: Sequential sampling plans indexed by acceptance quality limit (AQL) for inspection by variables (known standard deviation) (available in English only)
Kratochvil, B., & Taylor, J.K. (1981) Anal. Chem. 53, 924A–938A
Kratochvil, B., Wallace, D., & Taylor, J.K. (1984) Anal. Chem. 56, 113R–129R
Smith, R., & James, G.V. (1981) The Sampling of Bulk Materials, The Royal Society of Chemistry (Analytical Sciences Monographs No. 8), London, UK
ILAC: http://www.ilac.org/
ILAC-G3:1994 Guidelines for Training Courses for Assessors
ILAC-G8:1996 Guidelines on Assessment and Reporting of Compliance with Specification
ILAC-G9:2005 Guidelines for the Selection and Use of Reference Materials
ILAC-G10:1996 Harmonised Procedures for Surveillance & Reassessment of Accredited Laboratories
ILAC-G11:07/2006 Guidelines on Assessor Qualification and Competence of Assessors and Technical Experts
ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers
ILAC-G13:2000 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes
ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 1702
ILAC-G18:2002 The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing
ILAC-G20:2002 Guidelines on Grading of Non-Conformities
ILAC-G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing
Additional Web Sites:
European Co-operation for Accreditation: http://www.european-accreditation.org/default_flash.htm
Standards Council of Canada: http://www.scc.ca/
A2LA: http://www.a2la.org
AIHA: http://www.aiha.org
ANSI: http://www.ansi.org
IAAC: http://www.iaac.org.mx (Inter-American Accreditation Cooperation)
Tuesday, September 05, 2006
4.11 Corrective Action
4.11.3 Selection and implementation of corrective action
Once the cause(s) of the problem have been determined, potential corrective actions are identified. The most likely actions are selected and implemented to eliminate the problem and prevent recurrence.
Taking the initial corrective action will be the immediate fix, short-term fix, or the “band-aid”. You will put out the fire and make the customer satisfied. However, that’s not the end of what you need to do. Action also needs to be taken to prevent the problem from recurring. Therefore, something in the process must change to reduce the likelihood of recurrence.
If you use an example that involves a login problem at sample receiving what is the corrective action.
Do you retrain people? This isn’t always the most effective option. Clearly when employees understand what the process involves retraining is not the long term solution.
Do you need to change the procedure, process or environment? Do you change the location of login to reduce distractions? Do you change the process for maintaining updated customer product profiles? Do you change the process for identifying requests on submission forms by highlighting tests or denoting in some other fashion so they are more readily observable? Maybe. Do you do all of these things at once. Not likely.
Changing too many variables all at once makes it difficult to evaluate which actions were effective. Select the action that appears to be the one that will most likely fix the problem. Then monitor the process to see if the action taken resolves the problem. Record your investigations, findings, and actions taken so if the problem does happen again, you can see what was done in the past and select another action from your list. Once you are confident that the problem has been resolved, close out the corrective action as completed.
In the login example, an action definitely needed to be taken to prevent recurrence. But, what if after investigating it is determined that the problem was not with the process or training, but an isolated incident? For example, your investigation determines that a quality control sample did not perform properly because it was not injected into the instrument or inoculated into the well. Should you change the process because this happened once? In this case, you initiate the corrective action process by identifying the problem and investigating the circumstances surrounding it. This includes investigation to determine if this problem has occurred in the past, and if so, at what frequency. The corrective action may be to bring it to the attention of the analysts and monitor the process. If no instances occur in the defined monitoring period, close the action, but keep the record in the event the problem does recur in the future.
The corrective action system is the means for repairing problems in the laboratory. The key to effective corrective actions is to take the time to thoroughly investigate the problem. This allows the true root cause to be determined so that you fix the problem…not just the symptom.
Once the cause(s) of the problem have been determined, potential corrective actions are identified. The most likely actions are selected and implemented to eliminate the problem and prevent recurrence.
Taking the initial corrective action will be the immediate fix, short-term fix, or the “band-aid”. You will put out the fire and make the customer satisfied. However, that’s not the end of what you need to do. Action also needs to be taken to prevent the problem from recurring. Therefore, something in the process must change to reduce the likelihood of recurrence.
If you use an example that involves a login problem at sample receiving what is the corrective action.
Do you retrain people? This isn’t always the most effective option. Clearly when employees understand what the process involves retraining is not the long term solution.
Do you need to change the procedure, process or environment? Do you change the location of login to reduce distractions? Do you change the process for maintaining updated customer product profiles? Do you change the process for identifying requests on submission forms by highlighting tests or denoting in some other fashion so they are more readily observable? Maybe. Do you do all of these things at once. Not likely.
Changing too many variables all at once makes it difficult to evaluate which actions were effective. Select the action that appears to be the one that will most likely fix the problem. Then monitor the process to see if the action taken resolves the problem. Record your investigations, findings, and actions taken so if the problem does happen again, you can see what was done in the past and select another action from your list. Once you are confident that the problem has been resolved, close out the corrective action as completed.
In the login example, an action definitely needed to be taken to prevent recurrence. But, what if after investigating it is determined that the problem was not with the process or training, but an isolated incident? For example, your investigation determines that a quality control sample did not perform properly because it was not injected into the instrument or inoculated into the well. Should you change the process because this happened once? In this case, you initiate the corrective action process by identifying the problem and investigating the circumstances surrounding it. This includes investigation to determine if this problem has occurred in the past, and if so, at what frequency. The corrective action may be to bring it to the attention of the analysts and monitor the process. If no instances occur in the defined monitoring period, close the action, but keep the record in the event the problem does recur in the future.
The corrective action system is the means for repairing problems in the laboratory. The key to effective corrective actions is to take the time to thoroughly investigate the problem. This allows the true root cause to be determined so that you fix the problem…not just the symptom.
4.11 Corrective Action
4.11.3 Selection and implementation of corrective action
Once the cause(s) of the problem have been determined, potential corrective actions are identified. The most likely actions are selected and implemented to eliminate the problem and prevent recurrence.
Taking the initial corrective action will be the immediate fix, short-term fix, or the “band-aid”. You will put out the fire and make the customer satisfied. However, that’s not the end of what you need to do. Action also needs to be taken to prevent the problem from recurring. Therefore, something in the process must change to reduce the likelihood of recurrence.
If you use an example that involves a login problem at sample receiving what is the corrective action.
Do you retrain people? This isn’t always the most effective option. Clearly when employees understand what the process involves retraining is not the long term solution.
Do you need to change the procedure, process or environment? Do you change the location of login to reduce distractions? Do you change the process for maintaining updated customer product profiles? Do you change the process for identifying requests on submission forms by highlighting tests or denoting in some other fashion so they are more readily observable? Maybe. Do you do all of these things at once. Not likely.
Changing too many variables all at once makes it difficult to evaluate which actions were effective. Select the action that appears to be the one that will most likely fix the problem. Then monitor the process to see if the action taken resolves the problem. Record your investigations, findings, and actions taken so if the problem does happen again, you can see what was done in the past and select another action from your list. Once you are confident that the problem has been resolved, close out the corrective action as completed.
In the login example, an action definitely needed to be taken to prevent recurrence. But, what if after investigating it is determined that the problem was not with the process or training, but an isolated incident? For example, your investigation determines that a quality control sample did not perform properly because it was not injected into the instrument or inoculated into the well. Should you change the process because this happened once? In this case, you initiate the corrective action process by identifying the problem and investigating the circumstances surrounding it. This includes investigation to determine if this problem has occurred in the past, and if so, at what frequency. The corrective action may be to bring it to the attention of the analysts and monitor the process. If no instances occur in the defined monitoring period, close the action, but keep the record in the event the problem does recur in the future.
The corrective action system is the means for repairing problems in the laboratory. The key to effective corrective actions is to take the time to thoroughly investigate the problem. This allows the true root cause to be determined so that you fix the problem…not just the symptom.
Once the cause(s) of the problem have been determined, potential corrective actions are identified. The most likely actions are selected and implemented to eliminate the problem and prevent recurrence.
Taking the initial corrective action will be the immediate fix, short-term fix, or the “band-aid”. You will put out the fire and make the customer satisfied. However, that’s not the end of what you need to do. Action also needs to be taken to prevent the problem from recurring. Therefore, something in the process must change to reduce the likelihood of recurrence.
If you use an example that involves a login problem at sample receiving what is the corrective action.
Do you retrain people? This isn’t always the most effective option. Clearly when employees understand what the process involves retraining is not the long term solution.
Do you need to change the procedure, process or environment? Do you change the location of login to reduce distractions? Do you change the process for maintaining updated customer product profiles? Do you change the process for identifying requests on submission forms by highlighting tests or denoting in some other fashion so they are more readily observable? Maybe. Do you do all of these things at once. Not likely.
Changing too many variables all at once makes it difficult to evaluate which actions were effective. Select the action that appears to be the one that will most likely fix the problem. Then monitor the process to see if the action taken resolves the problem. Record your investigations, findings, and actions taken so if the problem does happen again, you can see what was done in the past and select another action from your list. Once you are confident that the problem has been resolved, close out the corrective action as completed.
In the login example, an action definitely needed to be taken to prevent recurrence. But, what if after investigating it is determined that the problem was not with the process or training, but an isolated incident? For example, your investigation determines that a quality control sample did not perform properly because it was not injected into the instrument or inoculated into the well. Should you change the process because this happened once? In this case, you initiate the corrective action process by identifying the problem and investigating the circumstances surrounding it. This includes investigation to determine if this problem has occurred in the past, and if so, at what frequency. The corrective action may be to bring it to the attention of the analysts and monitor the process. If no instances occur in the defined monitoring period, close the action, but keep the record in the event the problem does recur in the future.
The corrective action system is the means for repairing problems in the laboratory. The key to effective corrective actions is to take the time to thoroughly investigate the problem. This allows the true root cause to be determined so that you fix the problem…not just the symptom.
