Quality Assurance (QA) : Cross Referencing The Management Procedures of The Laboratory

Download as docx, pdf, or txt
Download as docx, pdf, or txt
You are on page 1of 9

Quality assurance (QA)

Quality assurance (QA) refers to the full range of practices employed to ensure that laboratory results
are reliable. The term encompasses internal and external quality control, but these specific aspects of
AQA will be covered later. Quality assurance may be defined as the system of documenting and
cross referencing the management procedures of the laboratory.

Quality Assurance Diagram

Quality assurance achieves these objectives by establishing protocols and quality criteria for all
aspects of laboratory work, and provides a framework within which internal quality control (IQC) and
external quality control (EQC) programmes can be effective. It is primarily a management system,
and as such is analyte-independent, because it deals with the overall running of the laboratory rather
than focusing on individual analyses.

Components of Quality assurance (QA)


In order to provide a fuller explanation, it is more pertinent to study the components of a quality
assurance programme and to examine the procedures that are required for each one.

1. Management

One of the most important components of the quality assurance programme in a laboratory are the
comprehensive management documents which should describe, in detail, the management structure of
the laboratory.

 Management structure of the laboratory

Such documentation should provide clearly defined communication channels and a clear reporting
structure. Within that structure each member of staff should be able to locate his or her own job
description and responsibilities and their relationship with other staff members who are subordinate or
superior. From a stable management base all the other components of quality assurance can be put in
place. Without this the level of control necessary to ensure that all other components are effective is
impossible.

 Management documents

Management documents should specify the role of quality assurance within the laboratory and clearly
define who is responsible for each area and activity. The documents should also identify the records
that should be kept of routine operations, such as equipment calibration and maintenance, thus
ensuring that a logical, coherent system of record keeping is adopted. Such documentation should be
brought together as a single Quality Manual which will act a reference text for the whole quality
assurance programme.

 Quality assurance officers

In larger laboratories, proper management of QA will require the appointment of a quality assurance
officer to liaise with management, to manage data archives, to conduct regular audits and reviews of
the QA system and to report on any QA issues to the programme or institution manager. The officer is
responsible for regularly inspecting all aspects of the system to ensure staff compliance, for reporting
on such inspections and audits to management, and for recommending improvements. In practice, this
will involve regularly checking facilities and procedures as they are performed and conducting regular
audits, by tracing an analytical sample back through the system from report to sample receipt, and
ensuring that all appropriate records have been kept.

Role and duty of QA officer:


The QA officer’s duties must be clearly defined within the management documents in order for the
role to be effective. Appointment of a quality assurance officer may be difficult in a small laboratory
for financial or organisational reasons. In such cases the responsibilities for QA should be delegated
to a member of staff. This may create conflicts of interest if the member of staff has to monitor the
work conducted in his or her section. Senior management, who are always ultimately responsible for
QA, should ensure that such conflicts are minimised.

The QA officer’s role should be to monitor the system, to report on any deviations from the system,
and to recommend to management any changes that might be required. In order to be able to do this
effectively the QA officer should be free from management interference, while remaining responsible
to management for undertaking the required duties. As a consequence it is better if a QA officer is in a
middle management position, thus allowing effective communication with Laboratory Section Heads.
In larger organisations QA is the responsibility of a separate section. In such a situation many of the
management difficulties are minimised because the QA section is structured in a similar way to other
sections of the organisation. Whichever approach is used, it is necessary that management provide
adequate resources for this activity and ensure that all staff are clearly informed of their
responsibilities within the QA system.

2. Training

It is important that all staff are adequately trained for the task they have to perform. Training must be
documented in order that management and other personnel can verify that staff are competent to
conduct the duties required of them. The level of training required for each procedure should also be
clearly defined to ensure that staff ability and training are matched to procedural requirements.
Criteria for the correct levels of training or competence for particular procedures, and job roles, are
often specified by national and international agencies and, in some cases, by professional associations.
In line with the principle of traceability outlined above, laboratory criteria for training standards
should reflect the external criteria which apply. This should be clearly demonstrated in the
documentation.

3. Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) provide the core of most of the day to day running of any
quality assurance programme. They are the documents describing in detail every procedure conducted
by the laboratory. This includes:

 sampling,
 transportation,
 analysis,
 use of equipment,
 quality control,
 calibration,
 production of reports etc.

They are the laboratory’s internal reference manual for the particular procedure to which they are
dedicated and, for that reason, SOPs must document every relevant step in the procedure. Thus,
anyone of the appropriate training grade should be able to apply the procedure when following the
SOP. In addition, the SOP must cross reference and, where necessary, expand any other SOPs which
are related to it.

 In practice, an SOP should present the procedure in a way that avoids all potential
differences in interpretation, thereby avoiding subtle changes in the way methods are
performed or equipment is used. Such differences can, and do, have a marked effect on
accuracy and precision.
 An SOP should be clear, concise and contain all the relevant information to perform the
procedure it describes.
 In addition, it should include the methods and the frequency of calibration, maintenance
and quality control, as well as the remedial action to be taken in the event of malfunction or
loss of control.

The SOP is the laboratory’s reference to a given procedure and, therefore, it must be regularly
reviewed and, if necessary, updated. Issue and availability of SOPs should be carefully controlled to
ensure that they are used only by appropriately trained staff and to ensure that out of date copies of
SOPs do not remain in circulation (thereby defeating their original objective). When a new or
amended SOP is published in a laboratory all copies of the old SOP must be taken out of circulation.
Consequently, it is necessary to have an issue log for all SOPs in the system, so that all copies of each
SOP can be located.

While all procedures require SOPs, it is not necessary to generate new documents where appropriate
ones exist. For example, standard analytical methods published by recognised authorities (such as the
United States Environmental Protection Agency), or manufacturers manuals for specific pieces of
equipment, may be adopted as SOPs if they meet the need of the laboratory and if this is properly
documented and sanctioned by the management and, or, the QA officer.
4. Laboratory facilities

Resources are required for regular laboratory work as well as for the additional workload associated
with quality assurance. It is essential that these resources, i.e.

 space,
 staff,
 equipment and
 supplies, are sufficient for the volume of work to be done.

Space should be adequate and sufficient equipment should be available to allow the procedures
performed in the laboratory to be conducted efficiently. The environment in which the work is
conducted must be well controlled. It should be clean and tidy, have adequate space in which to work
without risk to personnel or to the analytical sample, and there should be sufficient storage space for
glassware, chemicals, samples and consumables. It is also essential that there are adequate numbers of
appropriately trained staff available to undertake all the required tasks. Management policy should
ensure that these facilities are available before any laboratory work is commenced. In practice,
anything that restricts the efficient running of the laboratory would be a cause for concern, and should
lead to noncompliance with the quality assurance system.

5. Equipment maintenance and calibration

All equipment must be maintained on a regular basis, consistent with the documented criteria of the
laboratory and normally accepted codes of practice. This should be checked by the quality assurance
officer, and be corrected if inappropriate. These principles apply to general laboratory equipment such
as glassware as well as to sophisticated analytical instruments. The care and cleaning of this type of
equipment is extremely important to ensure quality and should not be overlooked. Frequent checks
on the reliability of equipment must also be performed. This includes calibration checks on all
relevant equipment, such as balances, pipettes, etc. The frequency of these checks will depend on the
stability of the equipment in question. In some instances calibration checks may be done as a part of
normal maintenance. Again, the criteria for checking should be based on established acceptable
practice.

Equipment calibration and maintenance records should be kept for all equipment, thus allowing the
repair status of each piece of apparatus to be monitored. This reduces the likelihood that
malfunctioning equipment will be used for analysis (thereby leading to poor analytical data), and
allows any problems with equipment to be more quickly diagnosed and corrected.
6. Sampling

Procedures for sampling operations should be carefully documented. In particular, clear details should
be given for precautions to be taken while sampling and the sampling strategies to be employed.
Careful documentation during sampling is required so that all relevant information on the nature of
the sample (when it was taken, where it was taken and under what conditions it was taken) are clearly
recorded on site at the time of sampling by the person conducting the sampling. This is necessary
because variations in sampling procedures can have a marked effect on the results of analysis. It is
very difficult to quantify these effects and, therefore, the most practical way to control this stage of
the analytical process is to document sampling conditions as fully as possible. It is very important to
ensure that all relevant information is made available to the analyst. Quality assurance of sampling
can be achieved in the following ways:

 Strictly adhere to standard operating procedures for sampling.


 Ensure all equipment is clean and in working order.
 Record all conditions which applied during sampling.
 Take strict precautions to avoid contamination.

Sample Analysis

Following those simple procedures should help to ensure that the quality of samples matches the
quality of analysis.

7. Sample receipt, storage and disposal

Almost as important as proper sampling, is the proper storage of samples prior to analysis. It is
important to ensure that the passage of a sample through the laboratory’s analytical systems is fully
documented, and corresponds to the practices laid down in the relevant SOPs. Equally important are
the arrangements for disposal of samples. This should be done when the sample exceeds its stable
storage time. With some forms of analysis which are required for legal or for regulatory reasons there
may be a requirement to store a suitable aliquot of a sample safely, for a given time, to allow for re-
examination should this be considered necessary. The systems in place should take these factors into
account.

Procedures for sample handling should ensure that the sample is not compromised. The sample should
be logged in and stored in such a way as to minimise its deterioration. The condition of each sample
and its storage location should be recorded and, where appropriate, the analyses to which it is to be
subjected should also be recorded. Subsampling, splitting of the sample to allow for different storage
conditions, or sample pretreatment to increase stability must be recorded and the samples clearly and
uniquely marked to ensure that no confusion exists about the source and identity of any sample.

8. Reporting of results

The final products of the laboratory are the data that it reports. It, therefore, follows that the efforts of
quality assurance are directed towards seeing that these data are suitable for use in an assessment.
This includes the final stage of reporting and interpreting the results which have been generated.

The first stage in this process is examination of the data to determine whether the results are fit to
report. Data should be examined at many stages in the quality assurance system and no data should be
reported from assays that are out of control. However, once data are ready to report it is important to
ensure that they are reported accurately and in a manner that facilitates interpretation. Consequently, it
is often necessary to include information which may have a bearing on interpretation, such as that
related to the nature of the sample or the analytical procedure which was applied. All such
information must be available to the reporting analyst. Reports must be prepared according to an
agreed procedure and they must accurately reflect the findings of the study. They should include
reference to all calibration and quality control data and to any problems that were encountered during
the study (e.g. rejected analytical batches, loss of sample, etc.). All data included should have been
comprehensively checked by an experienced analyst.

Many laboratories have a system which requires checking of data records and countersigning of
analytical reports to act as a safeguard against erroneous or misleading data leaving the laboratory.
This type of system is only effective when conscientiously applied. Automatic signing of reports with
minimal checking is all too common and should be avoided.
Implementation of Quality assurance (QA)

The ultimate objective of a QA programme is to ensure that the laboratory functions efficiently
and effectively. The benefits in terms of increased reliability of results has already been mentioned. A
number of other benefits are also evident. The clear assignment of duties and adherence to written and
agreed protocols ensure that staff clearly understand their responsibilities. This allows lines of
communication to be clearly identified, making staff management easier. Calibration, maintenance
and record keeping, in general, assist laboratory staff to identify developing problems with equipment
earlier than would otherwise be the case. In addition, the sources of analytical problems can be more
rapidly identified leading to their rapid solution.

The implementation of a QA programme is, in principle, very simple and involves putting in place the
components listed above. In practice, this requires a considerable amount of effort and commitment
from all staff and takes a long time to set up. A clear plan of action must be formulated and clear
objectives and time scales identified for each stage. Staff who are involved with the implementation
should be well briefed on what is required of them. It is also wise to ask for the opinion of staff on the
proposed QA system, as this ensures that impractical procedures are avoided.

This is best done by inspection of key areas such as laboratory records and by conducting audits. An
efficient auditing system is to pick data at random and then trace the documentation pertaining to
those data back to sampling and sample receipt. Any breaks in the traceability of the data will become
apparent as a gap in the linking documentation. Deficiencies that become apparent should be
corrected at this stage. The review should also seek to identify and to remove any inefficient or
bureaucratic systems which serve no useful purpose.

 Method of Accreditation

A common method of implementing a QA programme is to apply for accreditation. Accreditation is


the implementation of a QA programme in conformity with a recognised QA system, such as
Good Laboratory Practice (GLP) or the National Measurement Accreditation System
(NAMAS). Quality Assurance is often linked with accreditation although this does not have to be the
case. While implementing QA in this way allows the programme to be independently assessed against
an agreed standard, it can be costly.

 Without Accreditation:

Alternatively, QA can be implemented by reference to international standards such as ISO 9000


without necessarily going to the expense of accreditation. However, commercial, legal or political
considerations may require that formal accreditation is adopted by the laboratory because this
formally records compliance with a recognised QA system (i.e. compliance that has been validated by
an official third party).

Checking compliance

In order to maintain the quality assurance system it is necessary to check periodically each area of
the laboratory for compliance with the QA system. This involves auditing of the component parts
to assess whether they continue to meet the original criteria. As with any other aspect of quality
assurance the procedures to be adopted for checking compliance should be formally documented.
Reports on all audits should be made available to management, and to the individuals responsible for
the work concerned. Deviations from required standards must be corrected immediately. As with any
check of such a complicated structure, the audit must be extensive and systematic in order to test
every part of the system. Such audits are also better done in a way that makes them hard to predict,
thereby minimising abuse of the system.

The audit must also be independent, hence the need for a quality assurance officer who reports
directly to the highest level of management. Regular comprehensive audit often requires a large input
of resources in order to be effective.

You might also like