Professional Documents
Culture Documents
Learning Guide
Unit of Competence Apply Quality Control
Module Title Apply Quality Control
LG Code: BUF ACB3 21 0812
TTLM Code: BUF ACB3M 21 0812
INTRODUCTION
Welcome to the module “Apply Quality Control”. This learner’s guide was prepared to help you achieve the
required competence in “Accounts and Budget Support Level III”. This will be the source of information for you to
acquire knowledge attitude and skills in this particular occupation with minimum supervision or help from your trainer.
o Read through the Learning Guide carefully. It is divided into sections that cover all the knowledge, skills and
attitude that you need.
o Read Information Sheets and complete the Self-Check at the end of each section to check your progress
o Read and make sure to Practice the activities in the Operation Sheets. Ask your trainer to show you the
correct way to do things or talk to more experienced person for guidance.
o When you are ready, ask your trainer for institutional assessment and provide you with feedback from your
performance.
1
TTLM Development Manual Date: January 30,2017
Compiled by : Acct department
Mekele poly technique college
Training, Teaching and Learning Materials
What is Quality?
The term "quality" has a relative meaning. This is expressed by the ISO definition: "The totality of features and
characteristics of a product or service that bear on its ability to satisfy stated or implied needs". In simpler words, one
can say that a product has good quality when it "complies with the requirements specified by the client".When
projected on analytical work, quality can be defined as "delivery of reliable information within an agreed span of time
under agreed conditions, at agreed costs, and with necessary aftercare". The "agreed conditions" should include a
specification as to the precision and accuracy of the data which is directly related to "fitness of use" and which may
differ for different applications. Yet, in many cases the reliability of data is not questioned and the request for
specifications omitted. Many laboratories work according to established methods and procedures which are not
readily changed and have inherent default specifications. Moreover, not all future uses of the data and reports can be
foreseen so that specifications about required precision and accuracy cannot even be given. Consequently, this
aspect of quality is usually left to the discretion of the laboratory. However, all too often the embarrassing situation
exists that a laboratory cannot evaluate and account for its quality simply because the necessary documentation is
lacking.
In the ensuing discussions numerous activities aimed at maintaining the production of quality are dealt with. In
principle, three levels of organization of these activities can be distinguished. From the top down these levels are:
1.QualityManagement(QM)
2.QualityAssurance(QA)
3. Quality Control (QC)
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 (by the institute's directorate). 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. These
are discussed below in Section 1.5.
Note. An even wider concept of quality management is presently coming into vogue: "Total Quality Management"
(TQM). This concept includes additional aspects such as leadership style, ethics of the work, social aspects, relation
to society, etc. For an introduction to TQM the reader is referred to Parkany (1995).
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.
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. "An important part of the 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.
2
TTLM Development Manual Date: January 30,2017
Compiled by : Acct department
Mekele poly technique college
Training, Teaching and Learning Materials
3
TTLM Development Manual Date: January 30,2017
Compiled by : Acct department
Training, Teaching and Learning Materials
A B C
Objectivity: That the information is presented in a manner free from propaganda or disinformation.
Completeness: That the information is a complete, not a partial picture of the subject
Pluralism: That all aspects of the information are given and are not restricted to present a particular viewpoint, as in the
case of censorship. [1]
To achieve quality in electronic information, it is necessary to be sure that one is retrieving all of the relevant information, and
then to determine what of the retrieved information is valuable; what information is free of bias, propaganda, or omissions. To
have quality information, three things are necessary:
The World Wide Web holds the potential for becoming the greatest repository of knowledge ever created. Different from the
traditional library, material on the Web is frequently self-published, stored in quasi-secured repositories, and often, of unknown
validity.
1 2 3 4
5
Training, Teaching and Learning Materials
size
durability
product variations
materials
alignment
color
damage and imperfections
Quality checks may include
visual inspection
physical measurements
checks against patterns, templates and guides
INFORMATION SHEET
Quality control is primarily aimed at the prevention of errors. Yet, despite all efforts, it remains inevitable that errors
are be made. Therefore, the control system should have checks to detect them. When errors or mistakes are
suspected or discovered it is essential that the "Five Ws" are trailed:
-whaterrorwasmade?
-wherewasitmade?
-whenwasitmade?
-whomadeit?
- why was it made?
Only when all these questions are answered, proper action can be taken to correct the error and prevent the same
mistake being repeated.
The techniques and activities involved in Quality Control can be divided into four levels of operation:
4. Fourth-line control: Overall check (external checks: reference samples, interlaboratory exchange programmes).
Because the first two control levels both apply to the correct functioning of the instruments they are often taken
together and then only three levels are distinguished. This designation is used throughout the present Guidelines:
6
Training, Teaching and Learning Materials
It will be clear that producing quality in the laboratory is a major enterprise requiring a continuous human effort and
input of money. The rule-of-fist is that 10-20% of the total costs of analysis should be spent on quality control.
Therefore, for quality work at least four conditions should be fulfilled:
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. This is done in
the ensuing chapters of this manual.
Quality Management in the present context can be considered a modem version of the hitherto much used concept
"Good Laboratory Practice" (GLP) with a somewhat wider interpretation. The OECD Document defines GLP as
follows: "Good Laboratory Practice (GLP) is concerned with the organizational process and the conditions under
which laboratory studies are planned, performed, monitored, recorded, and reported."
Thus, GLP prescribes a laboratory to work according to a system of procedures and protocols. This implies the
organization of the activities and the conditions under which these take place are controlled, reported and filed. GLP
is a policy for all aspects of the laboratory which influence the quality of the analytical work. When properly applied,
GLP should then:
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 (and for the institute as a whole). In short, the
message is:
-saywhatyoudo
-dowhatyousay
-doitbetter
- be able to show what you have done
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
-Analyticalortestingsystems
-Qualitycontrol
- Reporting and filing of results
7
Training, Teaching and Learning Materials
Since institutions having a laboratory are of divergent natures, there is no standard format and each has to make its
own Quality Manual. The present Guidelines contain examples of forms, protocols, procedures and artificial
situations. They need at least to be adapted and many new ones will have to be made according to the specific
needs, but all have to fulfil the basic requirement of usefulness and verifiability.
As already indicated, the guidelines for Quality Management given here are mainly based on the principles of Good
Laboratory Practice as they are laid down in various relevant documents such as ISO and ISO/IEC guides, ISO 9000
series, OECD and CEN (EN 45000 series) documents, national standards (e.g. NEN standards)*, as well as a
number of text books. The consulted documents are listed in the Literature. Use is also made of documents
developed by institutes which have obtained accreditation or are working towards this. This concerns mainly so-called
Standard Operating Procedures (SOPs) and Protocols. Sometimes these documents are hard to acquire as they are
classified information for reasons of competitiveness. The institutes and persons which cooperated in the
development of these Guidelines are listed in the Acknowledgements.
* ISO: International Standardization Organization; IEC: International Electrical Commission; OECD: Organization for
Economic Cooperation and Development; CEN: European Committee for Standardization, EN: European Standard;
NEN: Dutch Standard.
Proper records help us to recall details accurately and provide a factual record
That may be needed at a later date.
Why record?
Service rendering
What is recorded must be linked with who it is that is making a record, the context and the
Reasons. The following are essential:-
Information to be
o factual
o accurate
o Clear.
8
Training, Teaching and Learning Materials
If information if not first-hand or there are doubts about its accuracy, the note should
Be endorsed to this effect with reasons for that conclusion.
How to record?
Given the right of individuals to have access to their records, it is important that records are
Properly written.
We should:
o Only be recording information necessary for the purpose;
o emphasize strengths and positive steps that can be taken to improve a situation,
Rather than labeling the person and their world;
Keeping it safe
Confidential information must be kept in a secure and safe place, preferably in a locked
cabinet and access should be restricted to the incumbent and one or two other named
People in responsible positions.
accurate;
secure;
Personal data covers both facts and opinions about the individual. It also includes
Information regarding the intentions of the data controller towards the individual, although in
Some limited circumstances exemptions will apply. With processing, the definition is far wider
9
Training, Teaching and Learning Materials
than before. For example, it incorporates the concepts of ‘obtaining’, ‘holding’ and
‘Disclosing’.
The individual’s right of access extends to children and young people under 18 who
Understand what it means to exercise that right. If a young person asks for access to their
records, an authority will need to decide whether or not they have sufficient understanding
To do so.
Documentation, the recording of organizational structures, policies, actions, and goals, is vital to any business.
Documentation will continue to be important going forward: with so much to manage, it's unlikely to remember exactly many
things.
Documentation plays a fundamental role in business. It codifies procedures, ensuring everyone in the company does things the
same way.
It streamlines processes, allowing people to look up answers instead of asking coworkers or reinventing the wheel. And it acts as
protection during audits, helping to locate any actions taken against policy.
The need to document is like insurance - you don't appreciate it until the day you actually use it. Until then, most just see it as
an unnecessary burden and expense.
It is now very important that you document your accomplishments on a daily basis. Not simply for career purposes; but also as a
means of self-preservation.
The procedures of documentation vary from one sector, or one type, to another. In general, these may involve document drafting,
formatting, submitting, reviewing, approving, distributing, repositing and tracking, etc
for me, and other fields are set up to ease entering that information. This took a bit of extra effort to set up at first, but it reduces
the ongoing work.
Third, be sure to structure your documentation. If you're documenting your work as you do it, it's likely that the documentation
will be close to the actual work, both in detail and in location. That is wonderfully helpful when you're already looking at a
specific piece of work, but what if you're trying to find that piece among all the rest? For that, you need higher-level
documentation that gives the general structure of your work, explaining each piece and where to find it. It might also be helpful
to give pointers to this general documentation from the specific pieces so you will be able to follow it back. However you choose
to do it, make sure that your documentation gives a clear starting point to someone who doesn't already know what they're doing.
Hunting for the right documentation is often just as frustrating as trying to understand the work itself.
As we come to grips with the code we have to work with and the duties we are expected to perform, we will be reading, updating,
and creating the documentation. With these principles we can efficiently create documentation enabling us and anyone else who
reads it to get up to speed quickly and get the work done.
Defining Information Quality
The most basic requirements of good information are:
Objectivity: That the information is presented in a manner free from propaganda or disinformation.
Completeness: That the information is a complete, not a partial picture of the subject
Pluralism: That all aspects of the information are given and are not restricted to present a particular viewpoint, as in the
case of censorship. [1]
To achieve quality in electronic information, it is necessary to be sure that one is retrieving all of the relevant information, and
then to determine what of the retrieved information is valuable; what information is free of bias, propaganda, or omissions. To
have quality information, three things are necessary:
11
LIBANOS information technology college
Training, Teaching and Learning Materials