Guidelines for Laboratory Quality Managers

Author:   Saverio Mannino
Publisher:   Springer International Publishing AG
Edition:   1st ed. 2023
Volume:   14
ISBN:  

9783031117237


Pages:   160
Publication Date:   23 November 2022
Format:   Hardback
Availability:   Manufactured on demand   Availability explained
We will order this item for you from a manufactured on demand supplier.

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Guidelines for Laboratory Quality Managers


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Overview

This useful and extensive set of guidelines is designed to assist food control laboratories in gaining accreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion.  Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source.  Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements, organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technicalrequirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation to distribution. Each section comes with helpful tips for lab managers plus definitions and terms.  Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers is the guide for accreditation for food control laboratories. 

Full Product Details

Author:   Saverio Mannino
Publisher:   Springer International Publishing AG
Imprint:   Springer International Publishing AG
Edition:   1st ed. 2023
Volume:   14
Weight:   0.436kg
ISBN:  

9783031117237


ISBN 10:   3031117239
Pages:   160
Publication Date:   23 November 2022
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Manufactured on demand   Availability explained
We will order this item for you from a manufactured on demand supplier.

Table of Contents

CHAPTER 1 Laboratory management and ISO 17025:2017 Clause 4: General requirements 4.1 Impartiality 4.2 Confidentiality Clause 5.0: Structural requirements Clause 6.0: Resource requirements 6.1: General 6.2 Personnel 6.3 Facilities and environmental conditions6.4 Equipment 6.5 Metrological traceability 6.6 Externally provided products and services Clause 7.0 Process requirements 7.1 Review of requests, tenders and contracts 7.2 Selection, verification and validation of the methods 7.3 Sampling 7.4 Handling of test or calibration itemsEnsuring the validity of the results 7.5 Technical records7.6 Evaluation of measurement uncertainty 7.7 Ensuring the validity of the results 7.8 Reporting results 7.9 Complaints 7.10 Non-conforming work 7.11 Control of data-information management Clause 8.0 Management system requirements 8.1 Management system documentation (Option A) 8.2 Control of Management system documents (Option A)8.3 Control of records (Option A) 8.4 Action to address risks and opportunities (Option A) 8.5 Improvement (Option A) 8.6 Corrective actions (Option A) 8.7 Internal audits (Option A) 8.8 Management Reviews (Option A) CHAPTER 2 Essential for Quality management in testing laboratories Managing the Quality of Laboratory Testing Processes Developing a Quality Management System (QMS) Plan Do Check Act cycle Six sigma quality management system Quality systems Quality system: quality assurance, quality assessment and Control Principles of Quality Control System planning Investigation phase Quality manager responsibility Steering Team responsibility Task team responsibility Time line Implementation phase Consolidating the program Monitoring and evaluating the program Management review Communication and motivation TIPS1: Human resources TIPS2: Scheduling and conducting a gap analysis TIP3: Quality Manual TIP 4: Example Scheme of task assignment TIP5: Example of Project Gantt chart CHAPTER3 Preparing for analysis: the analytical method Sources of methods Evaluation of published methodsThe codex Alimentarius commission The European Union The European Committee for standardization International Standard Organization CHAPTER4 Statistics for the Quality Control Laboratory Data presentation Measure of the central tendency (mean, median, mode)Measures of spread (range, variance, standard deviation) Normal distribution Using samples to estimate population values Standard error of the mean Shapiro-Wilks for testing normality Confidence Intervals Steps in the process of hypothesis testing Example of statistical tests routinely applied in the analytical laboratory F-test Outliers: Dixon test Outliers: Grubbs test Cochran Test for extreme value of variance (outlier variance) Combining (Pooling) Estimates of Standard Deviations Precision calculations Averages Comparing two averages by using the t-test The repeatability limit (r) The calibration process: Regression line Weighted regression line Method of Standard Addition (MOSA) Errors, linear regression analysis and method of standard addition The Youden approach to constant and proportional errors ANOVA- Analysis of Variance Two-way ANOVA Meaning of p-value CHAPTER 5 Uncertainty measurement Approaches to estimate measurement uncertainty The bottom up approach How to calculate the standard uncertainty for a type A evaluation How to calculate the standard uncertainty for a type B evaluation Top down approach Case study – determination of cholesterol in animal and vegetable fats and oils Other approaches to estimate measurement uncertainty: The Horwitz equation The Horrat value CHAPTER 6 Control Charts and Process capability Control Charts Construction of a Control Chart How to set the control limits for an X chart Type of control charts: Average, Range and Standard deviation control charts Quality Control samplesGuidelines on Interpretation of Control Charts Practical points in using a control chart TIP: Way to calculate Standard deviation calculation Process capability Capability Indices Cp and Cpk How to conduct a functional study Process capability Analysis: An example Six sigma and process capability Process capability index Cpk and Six-Sigma metricConclusions CHAPTER7 Risk Management Risk management in the new laboratory standard ISO 17025:2017 Addressing Opportunities Integrating and Implementing Actions Risk Management Risk identification Failure Modes and Effects Analysis (FMEA) for laboratoryProbability of Occurrence Probability of Occurrence with Standard Linear Scaling Severity Risk mitigation Detection level RPN calculation Examples Sampling frequency Frequency of Sampling/Analysis Useful readings Example of risk assessment for an analytical method from sampling collection to test results

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Author Information

Saverio Mannino is a former professor of Food Quality Control at the University of Milan in Milan, Italy. Author of about 150 publication concerning food analysis, at present international consultant and member of the Accreditation Committee of the Department of Testing Laboratories of Accredia  ( the Italian Laboratory Accreditation Body)  member of the European co-operation for Accreditation.

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