Introduction to Quality Assurance The aim of this book is to provide an understanding of the principles of quality assurance. The book will explain the way in which these quality assurance principles relate and can be applied to the design, development, manufacture and delivery of products and services. The object being to enhance the reader's awareness of Quality Assurance and its terminology and bring the subject alive sufficiently to encourage and motivate for quality assurance. Statistical methods are a vital part of any Quality Assurance or Total Quality Management initiative and it is for this reason a practical approach has been adopted in the explanation of this important topic. Information is provided by practical example of the application of statistics in the quality environment. The book covers the Institute of Quality Assurance (IQA) A11 syllabus and is of obvious application for students participating in the IQA A11 examination. As a result of adhering to the requirements of the IQA A11 syllabus, the book's content reflects the current thinking of the IQA, in terms of the latest key quality issues facing Directors, Managers and Technicians. The book provides clear approaches and examples of how to respond to these key quality issues.
There is naturally and correctly some overlap with the accompanying sister publication, Quality Management (Principles & Techniques), as certain explanations would not be clear.
The book is divided into three parts, below is an outline of the contents of each section and what could reasonably expected to be appreciated having studied each section.
PART A
The Need for Quality Assurance and Quality Control.
The Concept of Quality and its Control.
This section is intended to provide sufficient information to....
understand the concepts of quality and its control and various definitions associated with quality and reliability,
ability to establishment and interpret company quality policy,
understand the concept of total involvement in quality assurance and the importance of communication and feedback of information,
justify quality assurance activities with regard to commercial, legal responsibilities and cost reduction.
Standards and Specifications.
This section is intended to provide sufficient information to....
describe the need, importance and application of specifications and standardisation in the quality control system,
prepare specifications for purposes of testing a product or service,
use a product or service specification as a basis for a contract or conducting an external audit,
determine from the product or service specification the process measurement criteria (Process Capability Studies),
determine the ability of the process to meet specification (Process Capability Studies),
understand the relationship between specifications, measurements and process capabilities.
Natural, Material and Subjective Standards.
This section is intended to provide sufficient information to....
understand natural, material and subjective standards and their applicability, develop and create a calibration system,
understand the concepts of traceability and hierarchy in connection with inspection and testing measuring equipment.
Standards and Standardising Organisations.
This section is intended to provide sufficient information to....
describe the roles and responsibilities of the various standardising organisations (company, industrial, national and international) and the importance of international standards harmonisation,
understand and complete the process or procedure for obtaining product certification including a third party.
Cost of Quality.
This section is intended to provide sufficient information to:
complete a quality cost analysis of the prevention, appraisal and failure costs associated with an organisation.
PART B
Design for Quality.
This section is intended to provide sufficient information to....
understand the concept of value and economics in design quality, specifications and tolerancing,
use specifications as an essential part of communication,
understand the purpose of standards specification and the role of BSI and ISO,
ensure an effective contribution of the quality assurance department during design and development; prototype testing, field trials phases of a design project,
understand how to complete a hazard assessment, failure mode and effect and criticality analysis,
understand how to complete an analysis of tolerance requirements and a statistical analysis of tolerancing,
prepare quality control schemes and their documentation,
control specification amendment and implement a concession procedure,
rationalise product ranges and use preferred numbers and variety reduction,
understand the need and application of design codes of practice and design guides.
Reliability.
This section is intended to provide sufficient information to....
be able to define reliability, with specific regard to BS 4778,
interpret lifetime distributions in terms of probability density function and reliability function,
understand the basic concepts of simple series and parallel systems and the use of redundancy to improve reliability.
PART C
Control of Supplies.
This section is intended to provide sufficient information to....
control the process of procuring bought-in goods and services,
complete a supplier evaluation and vendor rating,
organise and document purchasing and sub-contracting procedures,
control quarantine and bonded stores.
Quality Control of Processes.
This section is intended to provide sufficient information to....
use process capability analysis to understand the ability of the process to meet the quality requirements,
identify and establish a quality control strategy and inspection procedures (e.g. 1st - off, last - off, patrol inspection, choice of inspection stages, etc.),
understand the responsibilities to the customer for final inspection and test,
create batch identification procedures for safety-critical products,
understand the need for protective packaging.
Inspection of Processes.
This section is intended to provide sufficient information to....
establish and create inspection procedures,
determine the factors influencing the choice of 100% inspection versus sampling, variables versus attributes etc.,
establish, create and implement procedures for dealing with defective supplies,
understand the application of automatic inspection methods,
understand how computers can be used for data handling and process control,
understand the Quality Control issues and problems associated with high/low volume throughput processes.
PART D
Basic Statistical Methods.
This section is intended to provide sufficient information to....
understand the concept of variability when applied to continuous and discrete random variables,
calculate binomial and poisson distributions,
apply acceptance sampling by attributes,
construct operating characteristics curve for a single sampling plan,
interpret the implications of an operating characteristic curve and understand the risks involved in sampling,
calculate probability distributions for continuous random variables,
calculate and establish normal distribution and explain the reasons for widespread use of normal distribution to model production and service processes,
understand the basic ideas of control charts and compile control charts for means and
ranges of measured variables and number defective and proportion defective,
calculation and use of decision lines on control charts,
understand, calculate and apply cusum charts.
