Beruflich Dokumente
Kultur Dokumente
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At the end of this chapter, students should be able to:
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Definitions:
Quality System:
The collective plans, activities, and events that are
provided to ensure that a product, process, or services
will satify given needs.
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Overview
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Three (3) Important Aspects of Quality Systems
(1) Planning of quality
Identify the customer needs, design the products and services.
Training of staff
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Quality Management
PDCA Methodology
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Quality System in Laboratory:
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QUALITY SYSTEMS DOCUMENTATION
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WHY GLP?
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2. FACILITIES 3. QUALITY
1. MANAGEMENT ASSURANCE
PROGRAMME
GLP
REQUIREMENTS 8. DATA
STORAGE
4. TEST FACILITIES
WORKING PROCEDURE
7. FINAL REPORT
5. EQUIPMENT
6. PLANNING AND
CONDUCT OF STUDY
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1. MANAGEMENT
The responsibilities of personnel and the laboratorys management
structure must be clearly defined (eg: organisational charts, job
description, updated records of qualification, staff training to show their
competency to carry out work. Appointment of Study Director.
2. FACILITIES
Must be appropriate for the work being carried out (receipt of test
materials, their handling and storage, how the substances are issues
for use thus the record of the use of the test materials can be audited.
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4. TEST FACILITIES WORKING PROCEDURE
SOPs should be properly autorised, documented and available to the
staff carrying out the work. It should be regularly reviewed to ensure
that they are still appropriate for their purpose.
5. EQUIPMENT
Equipment must be suitable , mantained and calibrated.
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Good manufacturing practice (GMP)
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Benefit of a Quality System:
1. Reduce the mistake during the analysis, expecially for the bigger
laboratory.
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TYPES OF QUALITY STANDARD FOR LABORATORIES
Different individuals and different laboratories can have different views of
which quality issues are important and what standards need to be set.
Three principal groups which have prepared and published standards for
Quality Systems which are relevant to analytical chemistry laboratories:
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Quality Audit and Quality System Reviews
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Internal audits
The laboratory shall periodically and in accordance with a
predetermined shedule and procedure :
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INTERNAL AUDIT VERIFICATION
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Introduction to ISO 9000
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Introduction to ISO 9000 (continued)
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ISO 9000 is actually a series of standards with five documents:
ISO 9001 - covers all aspects of production ranging from research and
design, development, production, installation and servicing.
ISO 9002 - is a subset of ISO 9001 and does not deal with design or
servicing. It does deal with quality assurance, production and
installation capability.
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ISO 14000
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The major objective of the ISO 14000 series:
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ISO 14001:2004
The requirements of ISO 14001:2004 is a management
tool enabling an organization of any size or type to:
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ISO 17025
ISO 17025/IEC 17025 is an international standard for calibration
and testing labs.
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ISO 17025 (continued)
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Assuring the Quality of the Test and Calibration Results- ISO 17025
The resulting data shall be recorded in such a way that trends are
detectable and where practicable, statistical techniques shall be
applied to the reviewing of the results.
The monitoring shall be planned and reviewed and may include:
i) regular use of certified reference materials,
ii) participation in inter-laboratory comparison,
iii) replicate tests or calibrations using the same or different
methods,
iv) correlation results for different characteristic of an item.
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Document Changes: ISO/IEC 17025
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FOUR ASPECTS OF ISO 17025
In the context of a laboratory making measurement,
accreditation is a formal recognition that a laboratory is
competent to carry out specific calibration.
1. process-compliant laboratory
2. accredited laboratory
3. conformant service
4. accredited service
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1. ISO 17025 process-compliant laboratory
This satisfies the needs of people who just need to be
confident that the lab is competent and has adequate
quality built into its processes.
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3. ISO 17025- conformant service
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4. ISO 17025 accredited service
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Benefits of ISO 17025 series.
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Main purpose of ISO series:
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STANDARD OPERATING PROCEDURES (SOP)
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A number of important SOP types are:
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Preparation of SOPs:
1. Each page should have a heading and/or footing mentioning:
a. date of approval and/or version number;
b. a unique title (abbreviated if desired);
c. the number of the SOP (preferably with category);
d. page number and total number of pages of the SOP.
e. the heading (or only the logo) of originals should preferably be
printed in another colour than black.
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2. The first page, the title page, should mention:
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Preparation of SOPs (continued)
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TOTAL QUALITY MANAGEMENT (TQM)
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The process of TQM consists of three major activities:
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Management of organization:
Organization structure
Management structure
Information system
Communication
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TQM emphasis on the following:
clear focus on customer needs
continuous improvement and innovation of all processes,
services, and products.
effective empowerment and recognition of individuals under a
team involvement approach, including essential programs of
education and training.
productivity, cost reduction, and profitability enhancements.
strong leadership by management at all levels.
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TQM emphasis (continued)
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Benefits of TQM
continuous improvement of processes and products, and enhance efficiency of
people and machines leading to improved quality.
process efficiency leading to improved profit per product or service fiscal
discipline through elimination of unnecessary steps and wasteful expenditure
focused, systematic and structured approach to enhancing customer's
satisfaction.
Process improvement methods that reduce or eliminate problems i.e. non
conformance costs.
Delivering what the customer needs in terms of service, product and the
whole experience.
Intrinsic motivation and improved attitudes throughout the workforce.
Workforce is proactive - prevention orientated.
Enhanced communication.
Reduction in waste and rework.
Increase in process ownership- employee involvement and empowerment.
Everyone from top to bottom educated.
Improved customer/supplier relationships (internally & externally).
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