2. 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. A
statement of objectives and policy to produce quality should be
made for the organization or department concerned. This
statement also identifies the internal organization and
responsibilities for the effective operation of the Quality System.
Quality Management can be considered a somewhat wider
interpretation of the concept of “Good Laboratory Practice” (GLP).
Therefore, inevitably the basics of the present Guidelines largely
coincide with those of GLP.
CONCEPT
3. • 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 service "will satisfy
given quality requirements." The result of these actions
aimed at the production of quality should ideally be
checked by someone independent of the work: the Quality
Assurance Officer. If no QA officer is available, then usually
the Head of Laboratory performs this job as part of his
quality management task. In case of special projects,
customers may require special quality assurance measures
or a Quality Plan.
QUALITY ASSURANCE
4. QUALITY CONTROL
A major part of quality assurance is the Quality Control defined by
ISO as "the operational techniques and activities that are used to
satisfy quality requirements." An important part of quality control is
the Quality Assessment: the system of activities to verify if the
quality control activities are effective, in other words: an evaluation
of the products themselves. Quality control is primarily aimed at the
prevention of errors. Yet, despite all efforts, it remains inevitable
that errors are made. Therefore, the control system should have
checks to detect them.
5. The techniques and activities involved in Quality Control
can be divided into four levels of operation:
1. First-line control: Instrument performance check.
2. Second-line control: Check of calibration or standardization.
3. Third-line control: Batch control.
4. Fourth-line control: Overall check.
6. Therefore, for quality work at least four conditions should
be fulfilled:
1. Means are available.
2. Efficient use of time and means.
3. Expertise is available
4. Upholding and improving level of output
In quality work, management aspects and technical aspects are
inherently cobbled together, and for a clear insight and proper
functioning of the laboratory, these aspects have to be broken
down into their components.
7. Quality Management in the present context can be
considered a modern version of the hitherto much
used concept “Good Laboratory Practice” with a
somewhat wider interpretation.
The OECD Document defines GLP as follows: "Good
Laboratory Practice is concerned with the
organizational process and the conditions under
which laboratory studies are planned, performed,
monitored, recorded, and reported."
GOOD LABORATORY PRACTICE
8. When properly applied, GLP should then:
• Allow better laboratory management
• Improve efficiency
• Minimize errors
• Allow quality control
• Stimulate and motivate all personnel
• Improve safety
• Improve communication possibilities, both internally and externally.
The result of GLP is that the performance of a laboratory is improved and
its working effectively controlled. An important aspect is also that the
standards of quality are documented and can be demonstrated to
authorities and clients. This results in an improved reputation for the
laboratory.
9. The basic rule is that all relevant plans, activities, conditions, and
situations are recorded and that these records are safely filed and can be
produced or retrieved when necessary. These aspects differ strongly in
character and need to be attended to individually.
As an assembly, the involved documents constitute a so-called Quality
Manual.
This comprises then all relevant information on:
• Organization and Personnel
• Facilities
• Equipment and Working materials
• Analytical or testing systems
• Quality control
• Reporting and filing of results.
10. QUALITY CONTROL
Quality control ensures that a product, service, or
process meets specific standards of quality. It
involves inspecting and verifying characteristics to
ensure dependability and satisfaction. If issues arise,
production may be halted, but quality control teams
typically do not fix the problems—other professionals
handle that. Quality control can also apply to
employees, ensuring they have the necessary skills
and training. It differs from quality assurance: quality
control focuses on the final product, while quality
assurance ensures that processes are correctly
designed to achieve quality outcomes.
11. 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 measures and depends on environment operation. The
costs of failure are very high, which makes the process of Quality
Assurance extensive, and it is acceptable to delay production until all
tests are done and double-checked.
12. STEPS FOR QUALITY ASSURANCE PROCESS
1.Plan to improve
2.Design to include improvements and requirements
3.Manufacture with improvements
4.Review new item and improvements
5.Test new item
The process for Quality Assurance is very rigorous and requires a lot
of testing and planning. The team or firm has to comply with
previous requirements, implement new requirements, and improve
the old item. Other than following requirements, the team or firm
has to comply with consumer needs.
13. Quality control emphasizes testing products to
uncover defects and reporting to management,
who then decide to allow or deny the release. In
contrast, quality assurance attempts to improve
and stabilize production and associated
processes to avoid, or at least minimize, defects.
When applying Quality Assurance in Education,
the purpose is to prevent mistakes from arising.
Several QA methodologies are used.
QUALITY ASSURANCE VERSUS
QUALITY CONTROL
14. A valuable process to perform on a whole
consumer product is failure testing or stress
testing. In mechanical terms, this is the
operation of a product until it fails, often under
stresses such as increasing vibration,
temperature, and humidity.
This exposes many unanticipated weaknesses in
a product, and the data are used to drive
engineering and manufacturing process
improvements. Often quite simple changes can
dramatically improve product service, such as
changing to mold-resistant paint or adding lock-
washer placement to the training for new
assembly personnel.
Failure Testing
15. Many organizations use statistical process control to bring the organization
to Six Sigma levels of quality, in other words, so that the likelihood of an
unexpected failure is confined to six standard deviations on the normal
distribution. This probability is less than four one-millionths.
Items controlled often include clerical tasks such as order entry as well as
conventional manufacturing tasks. Traditional statistical process controls in
manufacturing operations usually proceed by randomly sampling and testing
a fraction of the output. Variances in critical tolerances are continuously
tracked and corrected before bad parts are produced.
STATISTICAL CONTROL
16. Invariably, the Quality of output is directly dependent upon
that of the participating constituents, some of which are
sustainably and effectively controlled, while others are not.
The fluid state spells lack of Quality control, and the properly
managed processes for Quality assurance pertain to Total
Quality Management.
The major problem leading to decreased sales was that the
specifications did not include the most important factor:
"What the specifications have to state in order to satisfy the
customer requirements?"
TOTAL QUALITY MANAGEMENT
17. The major characteristics ignored during the search to
improve manufacture and overall business performance were:
• Reliability
• Maintainability
• Safety
• Strength
As the most important factor had been ignored, a few
refinements had to be introduced:
• Marketing had to properly define the customer's specifications.
• Specifications had to be refined to conform to these requirements.
18. • Conformance specifications i.e. drawings, standards and other documents, were
introduced during manufacturing, planning and control.
• Management had to confirm all operators are equal to the work imposed on them
and holidays, celebrations and disputes did not affect any of the quality levels.
• Inspections and tests were carried out, and all components and materials conformed
to the specifications. The QA/QC department ensured the measuring equipment was
accurate.
• Customer complaints were satisfactorily dealt with in a timely manner.
• User/customer feedback was used to review designs.
• Consistent data recording, assessment, and documentation integrity were
maintained.
• Product and/or process change management and notification were implemented.
19. QA IN SOFTWARE DEVELOPMENT
MODELS AND STANDARD
ISO 17025 is an international standard specifying general
requirements for competence in testing and calibration. It
includes:
• 15 management requirements
• 10 technical requirements
20. A management system refers to the organization’s structure for
managing processes or activities that transform inputs into products or
services. This ensures that an organization:
• Meets customer quality requirements
• Complies with regulations
• Fulfills environmental objectives
The CMMI (Capability Maturity Model Integration) model is widely used
to implement Quality Assurance (PPQA) in organizations.
The CMMI maturity levels can be divided into 5 steps, which a company
can achieve by performing specific QA activities within the organization.
21. During the 1980s, the concept of “company quality” emerged, focusing on
management and people.
It was realized that if all departments approached quality with an open
mind, success was possible—provided management led the quality
improvement process.
QUALITY COMPANY
22. The company-wide quality approach places an emphasis on four aspects:
1. Elements such as controls, job management, adequate processes, performance
and integrity criteria and identification of records.
2. Competence such as knowledge, skills, experience, qualifications.
3. Soft elements, such as personnel integrity, confidence, organizational culture,
motivation, team spirit, and quality relationships.
4. Infrastructure.
QUALITY MANAGEMENT
23. The approach to quality management given here is therefore not limited to the
manufacturing theatre only but can be applied to any business or non-business
activity:
• Design work
• Administrative services
• Consulting
• Banking
• Insurance
• Computer software development
• Retailing
• Transportation
• Education
24. USING CONTRACTORS AND/OR CONSULTANTS
It has become customary to use consultants and contractors when
introducing new quality practices and methods, particularly where the
relevant skills and expertise are not available within the organization. In
addition, when new initiatives and improvements are required to boost
the current quality system, or perhaps improve upon current
manufacturing systems, the use of temporary consultants becomes a
viable solution when allocating valuable resources.
25. There are various types of consultants and contractors available in the market;
most will have the skills needed to facilitate improvement activities such as
Quality Management Systems (QMS) auditing and procedural documentation
writing. More experienced consultants are likely to have knowledge of
specialized quality improvement activity such as CMMI, six sigma, Measurement
System Analysis (MSA), Quality Function Deployment (QFD), Failure Mode and
Effects Analysis (FMEA), Advance Produft Quality Planning (APQD)
