Description
Book SynopsisThis 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.
Table of ContentsCHAPTER 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
