Guidelines for Laboratory Quality Managers

ISBN-13: 9783031117237 / Angielski / Twarda / 2022 / 160 str.

Saverio Mannino

Opis

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 technical requirements 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. 

Spis treści

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 conditions

6.4 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 records

7.6 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 methods

The 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 samples

Guidelines 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 metric

Conclusions

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 laboratory

Probability 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

O autorze

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.