Lecture 13 and 14

Process Requirements
 7.1 Review of request, tenders and
contracts
• The requirement formalizes the process of interaction
with the client on the selection of a method.
• The onus is on the laboratory to ensure that, as far as it
is possible to ascertain, the client receives a service
which meets their needs.
• Moreover, the laboratory must be satisfied, before
accepting the work, that it has the capability and
resources to conduct it.
• In practice, any responsible laboratory will go through
this process anyway, but ISO 17025 requires it to be
formalized and recorded.
 7.1 Review of request, tenders ……….
7.1.1 The lab shall have a procedure for the review of
requests, tenders and contracts. The procedure shall
ensure that:
a) the requirements (of customers) are adequately
defined, documented and understood;
b) the lab has the capability and resources to meet the
requirements;
c) where external providers are used, the requirements of
6.6 are applied and the lab advises the customer of the
specific lab activities to be performed by the external
provider and gains the customer’s approval;
d) the appropriate methods or producers are selected
and are capable of meeting the customers’
requirements
 7.1 Review of request, tenders and
contracts
• Externally provided lab activities can occur
when:
– The lab has the resources and competencies to
perform the activities, however, for unseen
reasons is unable to undertake these in part or full
– The lab does not have the recourses or
competence to perform the activities
• For internal or routine customers, ROR,
tenders and contracts can be performed in a
simplified way.
 7.1 Review of request, tenders and
contracts
7.1.2 The lab shall inform the customer when the
method requested by the customer is considered to
be inappropriate or out of date.

7.1.3 When the customer requests a statement of

conformity to a specification or standard for the
test or calibration (e.g. pass/fail, in-tolerance/out of
tolerance), the specification or standard and the
decision rule shall be clearly defined. Unless
inherent in the requested specification or standard,
the decision rule selected shall be communicated
to, and agreed with, the customer.
 7.1 Review of request, tenders and
contracts
7.1.4 Any deference between the request or
tender and the contract shall be resolved before
lab activities commence. Each contract shall be
acceptable both the lab and the customer.
Deviations requested by the customer shall not
impact the integrity of the lab or the validity of
the results.
The customer shall be informed of any deviation
from the contract.
7.1 Review of request, tenders………………
7.1.6 If contract is amended after work has
commenced, the contract review shall be
repeated, and any amendments shall be
communicated to all affected personnel.
7.1.7 The lab shall cooperate with customers or
their representatives in clarifying the customer’s
request and in monitoring the lab’s performance
in relation to the work performed.
(provide reasonable access to relevant areas of
the lab to witness customer-specific lab activities;
preparation, packaging, and dispatch of items
needed by the customer for verification purposes)
 7.1 Review of request, tenders and
contracts
7.1.8 Records of reviews, including any
significant changes, shall be retained.
Records shall also be retained of
pertinent discussions with a customer
relating to the customer’s
requirements or the results of the lab
activities.
 7.1 Review of request, tenders ………….
• Procedures shall ensure that:
– Requirements adequately defined, documented and
understood
– Lab has capability and resources
– Customer approves of any externally provided lab
activities
– Appropriate methods are selected
• Inform customer when they request a method that
is inappropriate or out of date
• Resolve differences before work commences,
communicate and address issues after work
underway
 7.1 Review of request, tenders and
contracts
• Customer requests shall not impact the integrity
of the laboratory or validity of results
• Inform customer of any deviations
• Repeats the contract review process when
amendments are made after the contract has
commenced
• Cooperate with customer to clarify the request
and monitor the performance of contracted
activities
• Retain records, including records of any
discussions with the customer
• The sequence of events in contract review should be
something like this:-
1. A written request is received from the client (RoR).
2. The laboratory determines whether the request is clear in
that it either identifies specifically the test or calibration
procedure required or makes clear the client’s objective in
requesting the work.
3. The laboratory identifies whether the requested work is
routine, in the sense that it has a validated, documented and
appropriate procedure. If the work is identified as routine, then
all that is necessary is for the laboratory to ensure that it can
meet the client’s requirements on turnaround. There might,
though, be an issue here if the work requested involves an
abnormally large number of samples, for example.
4. If the work is not identified as routine, then it will be
necessary for the laboratory to determine whether it can accept
it. This will require an assessment of whether the necessary
equipment and expertise is available. A method will also have to
be identified and arrangements made to validate it.
 7.1 Review of request, tenders and
contracts
• This complete process of contract review normally
involves interaction with the client, culminating in
the laboratory communicating its intentions to
the client and seeking their approval.
• All of this must be recorded, including notes of
telephone conversations, and correspondence
attached. The laboratory should have a simple
standard pro-forma for recording the steps in the
contract review
 7.1 Review of request, tenders….
• The pro-forma should identify who conducted the review, the
client details and contact information, and details of the work
requested.
• A part of the pro-forma should require and record an
assessment of whether the work is routine, or not.
• If non-routine-identification of the capabilities needed to carry
out the work: expertise, equipment, method selection and
validation, in particular need to be reviewed
• Client’s approval need to be recorded: who gave approval on
behalf of the client and the means, for example in writing, by
telephone, etc.
• This is the front end of the testing process.
• Repeat work from established clients need only be subject to
contract review at the initial setting up of the programme or,
subsequently, if there are any significant changes. For such
repeat work, the requirement to record contract review is
satisfied by recording the receipt of the work, the date and the
identity of the person conducting the work.
 7.2 Selection, verification and
validation of methods
• Methods and procedure
– Use of appropriate methods for
• Sampling
• Handling
• Transport
• Storage
• Preparation
• Testing
• Available to all relevant personnel
• Deviations authorized, technically justified and
accepted by the customer
 Relevant terms and definitions

3.8 Verification-provision of objective evidence

that a given item fulfills specified.

3.9 Validation- verification, where the specified

requirements are adequate for an intended use
Selection, verification and validation of
methods: Choice of a method
• Methods used by laboratories fall into one of three
categories
• Standard methods which are published as standard
specifications:
for example ISO standards, ASTM (American Society for
Testing and Materials) and national standards, or are
published in the scientific literature; where laboratories claim
these as part of their scope they must be followed precisely
without variation from the published specification. The
laboratory will not have to carry out full method validation
but will have to have data to show that it can achieve the level
of performance which the standard specification claims for the
method or, failing that, a level of performance appropriate for
the purpose for which the measurement is being made.
 Choice of a method
• Documented in-house methods which are the
laboratory’s own methods; these must be
subject to a high level of validation.
The accreditation body will need to see the
validation data, and assessors will have to be
presented with data to satisfy them that the
method is technically sound, suitable for the
purpose claimed and acceptable to clients.
 Choice of a method
• Documented in-house methods based on standard
specifications;
This category makes up a major part of many
laboratories’ scopes since it avoids the commitment of being
pinned to the standard specification whilst maintaining the
credibility provided by the standard specification. Placing an in-
house method in this category will generally reduce the amount
of validation which a laboratory has to do. The degree to which
this is true, however, will depend on the extent of the departure
from the standard specification. Care needs to be taken, when
reporting data from such methods, to recognize the variation
from the standard specification. It is also necessary to ensure
that clients are aware of the variation and accept the resulting
data as still being suitable for their purposes.
 Method selection
• Select methods that
– Meet the needs of the customer
– Appropriate for the test
– Preferably published by a standard writing institution
• Consider:
– Environmental and accommodation requirements
– Staff capability
– Repeatability
– Reproducibility and uncertainty
– Recovery or matrix effects
– Safety
– Cost
– time
 7.2 Selection, verification and
validation of methods
7.2.1.1 The lab shall use appropriate methods for all lab
activities and, when appropriate, for evaluation of the
measurement uncertainty as well as statistical techniques
for analysis of data.

i.e. Use appropriate methods for:

- all lab activities
- evaluation of measurement uncertainty
- statistical techniques for analysis of data
• Use of “method” for activities synonymous with
“measurement procedure” in Guide 99/VIM
(International Vocabulary of Metrology)
 7.2 Selection, verification and
validation of methods
7.2.1.2 All methods, procedures and supporting documentation,
such as instructions, standards, manuals and reference data
relevant to the lab activities, shall be kept up to date and shall be
made readily available to personnel.

• Methods, procedures, supporting documentation up to date,

readily available, and use latest version
• Supplement with additional details when necessary
• When method not specified by customer:
– recommend methods published in standards by reputable technical
organizations, or in relevant scientific texts or journals, or as specified
by the manufacturer of the equipment
– lab-developed or modified methods
– methods published in scientific indexed journals
can also be used.
 7.2 Selection, verification and
validation of methods
7.2.1.3. The lab shall ensure that it uses the latest version of
a method unless it is not appropriate or possible to do so.
When necessary, the application of the method shall be
supplemented with additional details to ensure consistent
application.
• Note: International, regional or national standards or
other recognized specifications that contain sufficient
and concise information on how to perform lab activities
do not need to be supplemented or rewritten as internal
procedures if these standards are written in a way that
can be used by the operating personnel in a lab. It can be
necessary to provide additional documentation for
optional steps in the method or additional details.
 7.2 Selection, verification and
validation of methods
7.2.1.4 When the customer does not specify the
method to be used, the lab shall select an
appropriate method and inform the customer of
the method chosen. Methods published either in
international, regional or national standards or by
reputed technical organizations, or in relevant
scientific texts or journals, or as specified by the
manufacturer of the equipment, are recommended.
Lab-developed or modified methods can also be
used.
 7.2 Selection, verification and
validation of methods
7.2.1.5 The lab shall verify that it can properly perform
methods before introducing them by ensuring that it can
achieve the required performance. Records of the
verification shall be retained. If the method is revised by
the issuing body, verification shall be repeated to the
extent necessary.
• Verify proper performance of methods before
introducing them by ensuring that it can achieve the
required performance.
• Retain records of verification
• Repeat verification to the extent necessary if the
method is revised by the issuing body
 7.2 Selection, verification and
validation of methods
7.2.1.6 When method development is required,
this shall be a planned activity and shall be
assigned to competent personnel equipped with
adequate resources. As method development
proceeds, periodic review shall be carried out to
confirm that the needs of the customer are still
being fulfilled. Any modifications to the
development plan shall be approved and
authorized.
 7.2 Selection, verification and
validation of methods
7.2.1.7 deviations from methods for all lab
activities shall occur only if the deviation has
been documented, technically justified,
authorized, and accepted by the customer.
• Note: customer acceptance of deviation can
be agreed in advance in the contract.
• What if the customer requests a method that
is out of date?
 Method verification
• Is the transfer of validated methods into
laboratories working routine
• The laboratory has to
- demonstrate that the performance parameters
specified in the method have been met with the
matrices to which the method is being applied.
• Most often the critical parameter are the
– trueness and
– precision
 Method verification

Verification under conditions of use is demonstrated by meeting

system suitability specifications established for the method, as well as
a demonstration of accuracy and precision or other method
parameters. Method performance may be demonstrated by:
• blanks, or un-inoculated media (e.g. in microbiology), to assess
contamination;
• laboratory control samples (e.g. spiked samples for chemistry or
positive culture controls for microbiology) to assess accuracy;
• duplicates to assess precision;
• calibration check standards analyzed periodically in the analytical
batch for quantitative analyses;
• monitoring quality control samples, usually through the use of
control charts; and
• participation in a performance testing program provided that the
tested material is representative of the method in terms of matrix,
analytical parameters, concentration level(s), etc.
 Control chart
• A control chart—sometimes called a Shewhart chart, a
statistical process control chart, or an SPC chart—is one of
several graphical tools typically used in quality control
analysis to understand how a process changes over time.
• A visual time series graph that illustrates data points
collected at specific time intervals.
• A horizontal control line to more easily visualize variations
and trends.
• Horizontal lines, representing upper and lower control
limits, placed at equal distances above and below the
control line. These upper and lower limits are calculated
from the data that is recorded on the time series graph over
a specified period of time.
 Benefits of using a control chart
Control charts can help you:
• Understand the variations that are always present in
processes. Variations within your control limits indicate that
the process is working. Variations that spike outside of your
control limits indicate problems that need to be corrected.
• See when something is going wrong or may go wrong.
These problem indicators let you know that corrective
action needs to be taken.
• Notice patterns within plotted points. The patterns indicate
possible causes, which can help you find possible solutions.
• Predict future performance.
• Generate new ideas for improving quality based on your
analysis.
 Method Validation
• Is confirmation by examination and the
provision of the objective evidence that the
particular requirements for specific intended
use are fulfilled.
 7.2.2 Validation of methods
7.2.2.1 The lab shall validate Non-standard
methods, Lab developed methods and Standard
methods used outside their intended scope or
otherwise modified. The validation shall be as
extensive as is necessary to meet the needs of
the given application or field of application.
Note 1 Validation can include procedures for
sampling, handling and transportation of test
items.
 7.2.2 Validation of methods
• Note 2 The techniques used for, method validation can be one of, or
a combination of the flowing:
a) calibration or evaluation of bias and precision using refence
standards or reference materials;
b) systematic assessment of the factors influencing the result;
c) testing method robustness though variation of controlled
parameters, such as incubator temperature, volume dispensed;
d) comparison of results achieved with other validated method/s;
e) interlaboratory comparisons;
f) evaluation of MU of the results based on an understanding of the
theoretical principles of the method and practical experience of
the performance of the sampling or test method.
 7.2.2 Validation of methods
7.2.2.2 When changes are made to a validated
method, the influence of such changes shall be
determined and where they are found to affect
the original validation, a new method validation
shall be performed.
7.2.2.3 The performance characteristics of
validated methods as assessed for the intended
use, shall be relevant to the customers’ needs
and consistent with specified requirements.
 7.2.2 Validation of methods
• Note Performance characteristics an include, but
are not limited to
– Measurement range
– Accuracy
– Mu of results
– Limit of detection
– Limit of quantification
– Selectivity of the method
– Linearity
– Repeatability and reproductivity
– Robustness against external influences or cross-
sensitivity against interference from the matrix of the
sample or test object, and bias.
 7.2.2 Validation of methods
7.2.2.4 The lab shall retain the following records of
validation:
a) the validation procedure;
b) specification of the requirements;
c) determination of the performance
characteristics of the method;
d) results obtained;
e) a statement on the validity of the method,
detailing its fitness for the intended use.
 Exercise 07
• Group activity
Discuss and report