CHAPTER 9

:
QUALITY MANAGMENT

CONCEPT
Quality Management is the assembly
and management of all activities aimed at
the production of quality by organizations of
various kinds. In the present case this
implies the introduction and proper running
of a “QUALITY SYSTEM” in laboratories.

QUALITY ASSURANCE
Proper Quality Management implies
consequent implementation of the next
level: Quality Assurance. The ISO definition
reads: “The assembly of all planned and
systematic actions necessary to provide
adequate confidence that a product,
process or services will satisfy given quality
requirements”.

. the control system should have checks to detect them. it remains inevitable that errors are be made.” Quality control is primarily aimed at the prevention of errors. despite all efforts. Yet. Therefore. QUALITY CONTROL A major part of the quality assurance is the Quality Control defined by ISO as the “operational techniques and activities that are used to satisfy quality requirements.

When errors or mistakes are suspected or discovered it is essential that the “5 Ws” are trailed: 1. When was it made? 4. Why it is made? . What error was made? 2. Who made it? 5. Where was it made? 3.

First-line control: Instrument performance check. Second-line control: Check of calibration or standardization. Third-line control: Batch control. 3. Fourth-line control: Overall check. . 2. The techniques and activities involved in Quality Control can be divided into four levels of operation: 1. 4.

. This designation is used throughout the present Guidelines: • First-line control: Instrument check/calibration • Second-line control: Batch control • Third-line control: External check. It will be clear that producing quality in the laboratory is a major enterprise requiring a continuous human effort and input of money.

Therefore. 2. Efficient use of time and means 3. for quality work at least four condition should be fulfilled: 1. Means are available. Upholding and improving level of output . Expertise is available 4.

Improve safety 7.Minimize errors 4.Allow quality control 5. Good Laboratory Practice should then: 1. both internally and externally.Improve efficiency 3.Stimulate and motivate all personnel 6.GOOD LABORATORY PRACTICE When properly applied.Allow better laboratory management 2.Improve communication possibilities. .

Say what you do 2.The result of GLP is that the performance of a laboratory is improved and its working effectively controlled.Do what you say 3. In short. This results to an improved reputations for the laboratory.Do it better 4. An important aspect is also that the standards of quality are documented and can be demonstrated to authorities and clients. . the message is: 1.Be able to show what you have done.

Facilities 3.Reporting and filing of results .Analytical or testing systems 5. QUALITY MANUAL This comprises then all relevant information on: 1.Equipment and Working materials 4.Organization and Personnel 2.Quality Control 6.

. or how it compares to competitors in the marketplace. conditional and somewhat subjective attribute and may be understood differently by different people. engineering and manufacturing has a pragmatic interpretation as the non-inferiority or superiority of something. CONCEPT OF QUALITY Quality in business. Quality is a perceptual. Consumers may focus on the specification quality of a product/service.

. CONCEPT OF QUALITY Producers might measure the conformance quality or degree to which the product/service was produced correctly. Numerous definitions and methodologies have been created to assists in managing the quality- affecting aspects of business operations.

. One is quality assurance which is the prevention of defects. such a by the deployment of a quality management system and preventative activities like FMEA. CONCEPT OF QUALITY Many different techniques and concepts have evolved to improve products or service quality. There are two common quality- related functions within a business.

Various interpretation are: •ISO 9000: “Degree to which a set of inherent characteristics fulfills requirements. Juran: “Fitness for use” .” •Joseph M.” •Subir Chowdhury: “Quality combines people power and process power” •Philip B. DEFINITIONS The business meanings of quality have developed over time. Crosby: “Conformance to requirements.” •SIX SIGMA: “Number of defects per million opportunities.

present in two- dimensional model of quality: “Must be quality” and “attractive quality” • Robert Pirsig: “The result of care” • Ginichi Taguchi. DEFINITION • Noriaki Kano and others. With two definitions: – “Uniformity around a target” – “The loss a product imposes on society after it is shipped” .

Edwards Deming: “The efficient production of the quality that the market expects” • Gerald M. quality can have two meanings: – The characteristics of a product or service that bear on its ability to satisfy stated or implied needs. DEFINITION • American Society for Quality: “A subjective term for which each person has his or her own definition in technical usage.” • W. – A product of service free of deficiencies” • Peter Drucker: “Quality in a product or service is not what the supplier puts in. Weinberg: “Value to some person” . it is what the customer gets out and is willing to pay for.

Speed supports Flexibility 4. . Flexibility supports Cost. Dependability supports Speed 3. Quality supports Dependability 2. MARKET SECTOR PERSPECTIVE OPERATION MANAGEMENT The dimensions of quality refer to the attributes that quality achieves in Operation Management: 1.

employment opportunities and technological advances. MANUFACTURING In the manufacturing industry it is commonly stated that “Quality drives productivity”. The best way to think about quality is in process control. Improved productivity is a source of greater revenues. If the process is under control. inspection is not necessary. .

how well it was supported. . how it was performed. how it was delivered. etc. The customer have with the company’s product and services. For examples. and is by definition a combination of these. any time one buys a product one forms an impression based on how it was sold. CUSTOMERS The most progressive view of quality is that it is defined entirely by the customer or end user and is based upon that person’s evaluation of his or her entire customer experience.

QUALITY MANAGEMENT TECHNIQUES .

It normally involves measurements. gauges. Inspection are usually not destructive. INSPECTION An inspection is a formal examination or evaluation exercise. . thus ensuring safety and security for everyone. inspection is required at all levels in society to ensure that most ordinances are enforced as fairly and efficiently as possible. rather. and tests to determine whether the characteristics of the object or activity being inspected confirm to pre-decided standards.

. Therefore a good inspection guarantees public safety by enforcing municipal and state regulations typically for construction activities. INSPECTION Inspections such as home inspections and building inspections are highly beneficial to owners as well as to buyers who plan to make huge investments. standards of compliance in accordance with the state are ensured. In all inspections.

QUALITY CONTROL Quality control is a process employed to ensure a certain level of quality in a product or service. satisfactory and fiscally sound. . The basic goal of quality control is to ensure that the product. It may include whatever actions a business deems necessary to provided for the control and verification of certain characteristics of a product or service. services or processes provided to meet specific requirements and are dependable.

production or implementation may not cease entirely. the job of a quality control team or professional may involve stopping production temporarily. Quality control is concerned with the product. QUALITY CONTROL If a problem is identified. Depending on the particular service or product as well as the type of problem identified. while quality assurance is process- oriented. .

Do.Act: Apply actions necessary for improvement if the result requires changes. Check. . QUALITY ASSURANCE The four quality assurance steps within the Plan.Do: Implement the process developed.Plan: Establish objectives and processes required to deliver the desired results. 3. Act (PDCA) model stands for: 1. 2.Check: Monitor and evaluate the implemented process by testing the results against the predetermined objectives 4.

ACCURACY OF QUALITY ASSURANCE There is an extensive process of trial and error in order to ensure quality assurance. By the end of the trials you arrive at an acceptable process that helps you decide the reliability and efficiency of the sample. The process involves meeting specifications such as performance measure and depends on environment operation. .

STEPS FOR QUALITY ASSURANCE PROCESS • Plan to improve • Design to include improvements and requirements • Manufacture with improvements • Review new item and improvements • Test new item .

. and reporting to management who make the decision to allow or deny the release. to avoid or at least minimize. whereas quality assurance attempts to improve stabilize production. QUALITY ASSURANCE VERSUS QUALITY CONTROL Quality control emphasize testing of products to uncover defects. issues that led to the defects in the first place. and associated processes.

In mechanical terms. FAILURE TESTING A valuable process to perform on a whole consumer product is failure testing or stress testing. this is the operation of a product until it fails. This exposes many unanticipated weaknesses in a product. and humidity. temperature. . and the data are used to die engineering and manufacturing process improvements. often under stresses such as increasing vibration.

. so that the likelihood of an unexpected failure is confined to six standard deviations on the normal distribution. in other words. STATISTICAL CONTROL Many organizations use statistical process control to bring the organization to Six Sigma of quality. Traditional statistical process controls in manufacturing operations usually proceed by randomly sampling testing a fraction of the output.

TOTAL QUALITY MANAGEMENT .