Transcript Workshop Accreditation

Workshop on Issues relevant for the
Accreditation of the Current Quality Control
Laboratories (QCL)
III
Requirements of
the Norm
Management System
Requirements
Dieter Arnold, 24 March 2007
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No. 21
Workshop on Issues relevant for the Accreditation of the Current Quality Control Laboratories (QCL)
Structure of the Chapter „Management
Requirements“
4.1
Organisation
4.2
Management System
4.3
Document Control
4.4
Review of Requests, Tenders and Contracts
4.5
Subcontracting of Tests and Calibrations
4.6
Purchasing Services and Supplies
4.7
Service to Customers
4.8
Complaints
4.9
Control of Nonconforming Test-/Calibration Work
4.10
Improvement
4.11
Corrective Action
4.12
Preventive Action
4.13
Control of Records
4.14
Internal Audits
4.15
Management Review
Dieter Arnold, 24 March 2007
4.3.1
General
4.3.2
Document Approval and Issue
4.3.3
Document Changes
4.11.1
General
4.11.2
Cause Analysis
4.11.3 Selection and Implementation of Corrective Actions
4.11.4
Monitoring of Corrective Actions
4.11.5
Additional Audits
4.13.1
General
4.13.2
Technical Records
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4.1 Organisation
Requirements
Have technical management which has overall
responsibility for the technical operations and the
provision of the resources needed to ensure the
required quality of laboratory operations.
Demonstrate impartiality, independence of
judgement and integrity in relation to its testing.
Demonstrate that managerial and technical
personnel have the authority and resources
needed to carry out their duties in relation to the
quality management system.
Details
to ensure the protection of its customers’
confidential information and proprietary
rights;
including procedures for protecting the
electronic storage and transmission of results;
to avoid involvement in any activities that
would diminish confidence in competence,
impartiality, judgement or operational integrity.
Have policies and procedures…
Define the organization and management
structure of the laboratory, its place in any parent
organization, and the relationships between quality
management, technical operations and support
services.
Specify the responsibility, authority and
interrelationships of all personnel who manage,
perform or verify work affecting the quality of the
tests and/or calibrations.
Appoint a quality manager with defined
responsibility for the qquality management system
and direct access to the highest level of
management.
Appoint deputies for key managerial personnel.
Provide adequate supervision of testing and
calibration staff.
Ensure
Dieter Arnold, 24 March 2007
that appropriate communication processes
are established;
that personnel are aware of the relevance
and importance of their activities.
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ISO 9000 Series
President
Planning
Legal Affairs
Communication
International
Relations
Quality
Manager
IT Services
General
Services
ISO 17025:2005
ISO 17020:2004
General Manager
Laboratories
Control Laboratory
QML
Control Laboratory
QML
QML
QML
Medical Devices
Vice-President
Drugs
General Manager
Inspection Bodies
Quality Manager
Laboratories
QML
Vice-President
Foods
Quality Manager
Inspection Bodies
Inspection Body
QMI
Inspection Body
QMI
Control Laboratory
Inspection Body
QMI
Control Laboratory
Inspection Body
QMI
Control Laboratory
Inspection Body
QMI
Inspection Body
QMI
Inspection Body
QMI
QMR
Reference
Laboratory
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Note: This is a hypothetical
structure to explain principles
and not a proposal!!!
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4.1 Organisation - continued
Describe legal identity and background of parent
organisation
Describe mission of the parent organisation
Provide an organisational chart of that organisation which
indicates the lines of command, the unit having influence
on the quality of laboratory work and your QM-network!
Provide detailed chart of the laboratory concerned!
Describe the functions of the key people of the system of
the parent organisation!
Provide a business plan of the parent organisation!
Provide the Manual of procedures of the parent
organisation!
Have job descriptions of all staff!
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4.2 Management System
Requirements
Details
Top management
provide evidence of commitment to the development and implementation of
the management system and to continually improving its effectiveness;
communicate to the organization the importance of meeting customer
requirements as well as statutory and regulatory requirements.
Establish the overall objectives and review it
during management review
Issue a concise quality policy statement under
the authority of top management. It shall at
least contain:
the laboratory management's commitment to good professional practice and
to the quality of its testing and calibration;
the management’s statement of the laboratory's standard of service;
the purpose of the management system related to quality;
a requirement that all personnel familiarize themselves with the quality
documentation and implement the policies and procedures in their work;
the laboratory management's commitment to comply with ISO 17025:2500
and to continually improve the effectiveness of the management system;
the requirement that tests and/or calibrations shall always be carried out in
accordance with stated methods and customers' requirements;
Implement and maintain a management system
appropriate to the scope of activities
ensure the integrity of the management system
when changes are planned and implemented
Document to the extent necessary to assure the
quality of the test and/or calibration results:
The system’s documentation shall be ….
policies
systems
programmes
procedures
instructions
communicated to
understood by
available to
….the appropriate personnel
implemented by
Define the laboratory's
management system policies
related to quality in a quality
manual
include or make reference to the supporting procedures including technical
procedures.
outline the structure of the documentation used in the management system
define roles and responsibilities of technical management and the quality
manager, including their responsibility for ensuring compliance with this
International Standard
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4.3 Document Control
Requirements
Details
Establish and maintain procedures to control
all documents that form part of its management
system (These may be on various media, whether
hard copy or electronic, and they may be digital,
analogue, photographic or written)
regulations;
standards;
other normative documents;
test and/or calibration methods;
drawings;
software;
specifications;
instructions;
manuals;
review and approve by authorized personnel
and prior to issue all documents issued to
personnel;
use same procedure for changes;
set rules for hand made changes and for
changes on computerised documents;
uniquely identify documents (date of issue
and/or revision, page number and total number
of pages, issuing authority(ies);
establish and make readily available a
master list identifying revision status and
distribution;
make authorized editions of appropriate
documents available at all relevant locations;
review documents periodically and revise,
where necessary;
remove invalid or obsolete documents
promptly;
mark obsolete documents retained suitably
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4.4 Review of Requests,
Tenders and Contracts
Requirements
Details
requirements are adequately defined, documented
and understood;
laboratory has the capability and physical, personnel
and information resources to meet the requirements;
method selected is capable of meeting the customers'
requirements;
Establish and maintain policies and procedures for the
review of requests, tenders and contracts ensuring that
differences between request or tender and contract
are resolved before any work commences;
records of reviews and pertinent discussions with
customer are maintained;
reviews cover subcontracts;
same contract review process is used for
amendments;
customer is informed of any deviation from the
contract
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4.5 Sub-contacting of Tests
and Calibrations
Requirements
Details
Place subcontracted work with a competent
subcontractor complying with ISO 17025:2005
of all subcontractors;
of the evidence of compliance.
Maintain a register
Advise the customer and gain hid approval of the
arrangement in writing
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4.6 Purchasing Services and
Supplies
Requirements
Details
Have a policy and procedure(s)
for the selection and purchasing of services
and supplies;
for purchase, reception and storage of
reagents and laboratory consumable materials;
ensuring that purchased supplies, reagents and
consumables are not used until they have been
verified as complying with specifications or
requirements;
that records of actions taken to check
compliance are maintained;
that documents describing the ordered
services and supplies are reviewed and
approved for technical content prior to
release;
that suppliers of critical consumables, supplies
and services are evaluated and records of
these evaluations and lists those approved
are maintained;
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4.7 Services to the Customer
Requirements
Details
Cooperate with customers and in relation to the
work performed, provided that the laboratory
Ensure confidentiality to other customers
Seek feedback from customers
Analyse feedback to improve
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in clarifying the customer's request;
in monitoring the laboratory’s performance;
the management system;
testing and calibration activities;
customer service;
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4.8 Complaints
Requirements
Details
Have a policy and procedure
for the resolution of complaints received
from customers or other parties;
for maintaining records of all complaints and
of the investigations and corrective actions
taken;
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4.9 Control of Nonconforming
Testing and/or Calibration
Work
Requirements
Details
Have a policy and procedures that shall be
implemented when any aspect or the results of
its testing and/or calibration work do not conform
to its own procedures or agreed requirements of the
customer. The policy and procedures shall ensure
that:
responsibilities and authorities for the
management of nonconforming work are
designated (including halting of work,
withholding of test reports, as necessary, and
resumption of work);
actions are defined and taken;
an evaluation of the significance of the
nonconforming work is made and the corrective
action procedures given in 4.11 are promptly
followed if necessary;
the customer is notified and work is recalled
where necessary.
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4.10 Improvement
Requirements
Details
Improve the effectiveness of the management
system through the use of
quality policy;
quality objectives;
audit results;
analysis of data;
corrective actions;
preventive actions;
management review.
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4.11 Corrective Action
No.
4.11
4.11.1
4.11.2
Requirements
Establish a policy and a procedure and
designate appropriate authorities for implementing
corrective action when nonconforming work or departures
from the policies and procedures in the management
system or technical operations have been identified. Use
the following sequence in the procedure.
Start with an investigation to determine the root
cause(s) of the problem.
Identify potential corrective which
4.11.3
4.11.4
4.11.5
Document and implement any required changes
resulting from corrective action investigations.
Monitor the results to ensure that the corrective actions
taken have been effective.
Audit the appropriate areas of activity in accordance
with 4.14 as soon as possible where a serious issue or
risk to the business has been identified due to
nonconformities
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Details
most likely eliminate the problem
and prevent recurrence;
are appropriate to the magnitude
and the risk of the problem.
with its own policies and procedures;
with compliance with this ISO
17025:2005.
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4.12 Preventive Action
Requirements
Details
Identify needed improvements
Technical;
concerning the management system.
Develop, implement and monitor action plans.
Identify potential sources of nonconformities
Develop, implement and monitor action plans
Draft Procedures for preventive actions including
initiation and the application of controls to
ensure that they are effective.
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Technical;
concerning the management system;
Base it on review of the operational
procedures, analysis of data, trend and risk
analyses and proficiency-testing results.
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4.13 Control of Records I
No
Requirements
Details
Establish and maintain procedures …..
identification;
collection;
indexing;
access;
filing;
storage;
maintenance;
…..for quality records
…..for technical records
disposal.
4.13
4.13
Include in the list of quality records
4.13.1
Ensure that all records (in any media,
such as hard copy or electronic media)
Have procedures to
Dieter Arnold, 24 March 2007
reports from internal audits;
management reviews;
records of corrective actions;
records of preventive actions;
are legible;
are stored and retained in facilities that provide a suitable environment to
prevent loss, damage or deterioration;
are held secure and in confidence;
are readily retrievable;
have established retention times.
protect and back-up records stored electronically;
prevent unauthorized access to or amendment of these records.
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4.13 Control of Records II
No
Requirements
Retain for a defined period technical
records (data and information resulting
from carrying out tests and/or calibrations
and indicating whether specified quality or
process parameters are achieved), such
as…
4.13.2
Provide sufficient information in test
and calibration records to enable
Include the identity of personnel
responsible for
Correct mistakes in records by
Details
Forms;
Contracts;
work sheets;
check sheets;
work notes;
control graphs;
work books;
records of original observations;
derived data;
sufficient information to establish an audit trail;
copy of each (internal and external) test report;
calibration records;
copy of each calibration certificate issued;
staff records;
customers' notes, papers and feedback;
if possible, identification of factors affecting the uncertainty;
repetition of tests or calibrations;
the sampling;
performance of each test;
performance of each calibration;
checking of results;
crossing out (not erasing, making illegible or deleting) and entering the
correct value alongside.
Ensure alterations to records are
signed or initialled by the person making
the correction and equivalent measures are
taken for electronically stored records.
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4.14 Internal Audits
Requirements
Details
Periodically (cycle of one year) conduct internal
audits of activities (to verify that operations
continue to comply with the requirements of the
management system and ISO 17025:2005
Take the following actions when audit findings
cast doubt on the effectiveness of operations,
correctness or validity of test or calibration results
Dieter Arnold, 24 March 2007
in accordance with a predetermined
schedule and procedure;
addressing all elements of the
management system, including the testing
and/or calibration activities;
under the responsibility of the quality
manager;
by trained and qualified personnel who are
wherever independent of the activity to be
audited;
take timely corrective action;
notify customers in writing if laboratory results
may have been affected;
record the area of activity audited, the
audit findings and corrective actions that arise
from them;
verify and record the implementation and
effectiveness of the corrective action taken
through follow-up audits.
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4.15 Management Reviews
Requirements
Details
the suitability of policies and procedures
Periodically (every 12 months) conduct (by top
management) a review of the laboratory's
management system and testing and/or
calibration activities in accordance with a
predetermined schedule and procedure taking
account of:
Ensure that
Dieter Arnold, 24 March 2007
reports from managerial and supervisory
personnel;
the outcome of recent internal audits;
corrective and preventive actions;
assessments by external bodies;
the results of inter-laboratory comparisons
or proficiency tests;
changes in the volume and type of the work;
customer feedback;
complaints;
recommendations for improvement;
other relevant factors, such as quality control
activities, resources and staff training.
findings from management reviews are
recorded;
arising actions are recorded and carried out
within an appropriate and agreed
timescale;
results (goals, objectives and action plans) are
fed into the laboratory planning system for
the coming year;
management review related subjects are
considered at regular management
meetings.
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Workshop on Issues relevant for the
Accreditation of the Current Quality Control
Laboratories (QCL)
IV
Requirements of
the Norm
Technical Requirements
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Structure of the Chapter „Technical Requirements“
5.1
General
5.2
Personnel
5.3
Accommodation and environmental conditions
5.4
Test and calibration methods and method
validation
5.5
Equipment
5.6
Measurement traceability
5.7
Sampling
5.8
Handling of test and calibration items
5.9
Assuring the quality of test and calibration results
5.10
Reporting the results
5.4.1
General
5.4.2
Selection of methods
5.4.3
Laboratory-developed methods
5.4.4
Non-standard methods
5.4.5
Validation of methods
5.4.6
Estimation of uncertainty of measurement
5.4.7
Control of data
5.6.1
General
5.6.2
Specific requirements
5.6.3
Reference standards and reference materials
5.10.1
General
5.10.2
Test reports and calibration certificates
5.10.3
Test reports
5.10.4
Calibration certificates
5.10.5
5.10.6
5.10.7
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Opinions and interpretations
Testing and calibration results obtained from
subcontractors
Electronic transmission of results
5.10.8
Format of reports and certificates
5.10.9
Amendments to test reports and calibration
certificates
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5.1 General
Requirements
Details
Consider and take account of all factors
influencing correctness and reliability of the tests
and/or calibrations contributing to different extent to
the total uncertainty of measurement when
developing test and calibration methods and
procedures, training and qualifying personnel, and
selecting and calibrating equipment.
human factors (see 5.2);
accommodation and environmental conditions
(see 5.3):
test and calibration methods and method
validation (see 5.4);
equipment (see 5.5);
measurement traceability (see 5.6);
sampling (see 5.7);
handling of test and calibration items (see 5.8).
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5.2 Personnel I
Requirements
Details
Ensure the competence of all who
Qualify personnel performing specific tasks on the
basis of
operate specific equipment;
perform tests and/or calibrations;
evaluate results;
sign test reports and calibration certificates;
appropriate education;
training;
experience;
demonstrated skills.
Supervise appropriately staff undergoing training.
Ensure that personnel responsible for the
opinions and interpretation included in test
reports have in addition
Management formulate the goals with respect to
the personnel’s
Have a policy and procedures for
relevant knowledge of the manufacturing
technology, the intended uses, the defects or
degradations likely occurring during service for
the items, materials, products, etc. tested;
knowledge of the general requirements
expressed in the legislation and
standards;
an understanding of the significance of
deviations found with regard to the normal
use of the items, materials, products, etc.
concerned.
Education;
Training;
Skills;
identifying training needs relevant to the
present and anticipated tasks of the laboratory
providing such training to personnel
evaluating the effectiveness of the training
Use personnel who are employed by, or under
contract to the laboratory.
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5.2 Personnel II
Requirements
Details
Maintain current job descriptions for
Define the following as part of job descriptions
Authorize specific personnel to
Maintain readily available records of …
…for all technical personnel.
Dieter Arnold, 24 March 2007
managerial personnel;
technical personnel;
key support personnel involved in tests and/or
calibrations;
responsibilities for:
Planning;
Performing;
Evaluating;
tests and/or
Reporting;
calibrations
Interpreting;
method modification;
method development;
method validation.
perform particular types of sampling, test
and/or calibration;
issue test reports and calibration certificates
give opinions and interpretations;
operate particular types of equipment.
the relevant authorization(s) and dates of its
confirmation;
competence and date of its confirmation;
educational and professional qualifications;
Training;
skills and experience….
do not adversely affect the required quality…
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5.3 Accomodations and Environmental
Conditions
Requirements
Details
Document the technical requirements for
accommodation and environmental conditions
that can affect the results of tests and calibrations
and ensure that the environmental conditions
…
facilitate and do not invalidate the results;
do not adversely affect the required quality…
…of any measurement correct performance of the
tests and/or calibrations
Monitor, control and record environmental
conditions as required by the relevant specifications,
methods and procedures or where they influence the
quality of the results (and stop tests and calibrations
when the environmental conditions jeopardize the
results of the tests and/or calibration), for example…
Separate neighbouring areas in which there
are incompatible activities to prevent crosscontamination.
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biological sterility;
Dust;
Temperature;
etc.
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5.4 Test and calibration methods and method
validation I
General
Requirements
Details
Use appropriate methods and procedures for all tests and/or
calibrations including
Have up to date and readily available instructions (deviation from test and
calibration methods shall occur only if the deviation has been documented,
technically justified, authorized, and accepted by the customer).
Sampling;
Handling;
Transport;
Storage;
preparation of items to be tested and/or
calibrated;
statistical techniques for analysis of test and/or
calibration data;
estimation of the measurement uncertainty.
on the use and operation of all relevant
equipment;
on the handling and preparation of items for
testing and/or calibration.
Do not supplement or rewrite international, regional or national standards or
other recognized specifications that they can be used as published and contain
sufficient and concise information on how to perform the tests and/or calibrations
It may be necessary to provide additional documentation for optional steps in the
method or additional details.
Selection of methods
Use only test and/or calibration methods, including methods for sampling, which
meet the needs of the customer and which are appropriate for the tests and/or
calibrations it undertakes.
Use preferably methods published in international, regional or national
standards or by reputable technical organizations, or in relevant scientific texts
or journals, or as specified by the manufacturer of the equipment.
use the latest valid edition of a standard unless
it is not appropriate or possible to do so;
only when necessary, supplement the standard
with additional details ensuring consistent
application.
Use laboratory-developed methods or methods adopted by the laboratory
only if they are appropriate for the intended use and if they are validated.
Use any method only following confirmation that the laboratory can properly
operate it and repeat this conformation if the standard/method changes.
Inform the customer as to the method chosen.
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5.4 Test and calibration methods and method
validation II
Laboratory-developed methods
Requirements
Details
Plan the introduction of test and calibration methods
developed by the laboratory for its own use and assign this
activity to qualified personnel equipped with adequate
resources. Update plans as development proceeds and ensure
effective communication amongst all personnel involved.
Non-standard methods
appropriate identification;
Scope;
description of the type of item to be tested or calibrated;
parameters or quantities and ranges to be determined;
apparatus and equipment, including technical performance requirements;
reference standards and reference materials required;
environmental conditions required and any stabilization period needed;
affixing of identification marks, handling,
transporting, storing and preparation of
items;
Develop procedures for the introduction of validated
checks to be made before the work is
methods not covered by standards and ensure that the
started;
method description contains at least the following information
description of the procedure, checks that the equipment is working
including
properly and, where required, calibration
and adjustment of the equipment before
each use;
the method of recording the observations
and results;
any safety measures to be observed;
criteria and/or requirements for approval/rejection;
data to be recorded and method of analysis and presentation;
the uncertainty or the procedure for estimating uncertainty.
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5.4 Test and calibration methods and method
validation III
Validation of methods
Requirements
Details
Confirm by examination and provision of objective
evidence that the particular requirements for a specific
intended use are fulfilled by non-standard methods,
laboratory-designed/developed methods, standard
methods used outside their intended scope, and
amplifications and modifications of standard methods:
validate as extensively as is necessary to meet the needs of the
given application or field of application and include sampling,
handling and transportation – if relevant;
record the procedure used for the validation, the results obtained,
and a statement as to whether the method is fit for the intended use.
calibration using reference standards or reference materials;
comparison of results achieved with other methods;
Inter-laboratory comparisons
systematic assessment of the factors influencing the result;
assessment of the uncertainty of the results based on scientific
understanding of the theoretical principles of the method and
practical experience.
Use one or a combination of the following
techniques for the determination of the
performance of a method
Investigate the influence on method performance of
changes later introduced into the validated method or
carry out a new validation, if appropriate
Verify that the range and accuracy of the values
obtainable from validated methods, e.g.,
uncertainty of the results;
limit of detection;
limit of quantification;
selectivity of the method;
Linearity;
limit of repeatability and/or reproducibility;
robustness against external influences;
cross-sensitivity against interference from the matrix…
…are relevant to the customers' needs.
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5.4 Test and calibration methods and method
validation IV
Estimation of uncertainty of measurement
Requirements
Establish and apply a procedure to
estimate the uncertainty of measurement for
all calibrations and types of calibrations.
Establish and apply procedures for
estimating uncertainty of measurement for
test methods (unless a well-recognized test
method specifies limits to the values of the
major sources of uncertainty of measurement
and the form of presentation of calculated
results). Take account of sources
contributing to the uncertainty, such as the
reference standards and reference materials
used, methods and equipment used,
environmental conditions, properties and
condition of the item being tested or
calibrated, and the operator:
Dieter Arnold, 24 March 2007
Details
where possible use rigorous, metrologically and statistically valid,
calculation of uncertainty of measurement (degree of rigor mainly
depending on limits on which decisions on conformity to a
specification are based;
in all other cases attempt to identify all components of uncertainty
and make a reasonable estimation, to avoid that the form of
reporting of the result gives a wrong impression of the uncertainty;
knowledge of the performance of the
method;
measurement scope;
base estimation on
use of, for example, previous experience;
validation data.
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5.4 Test and calibration methods and method
validation V
Control of data
Details
Requirements
Check calculations and data transfers
systematically and in an appropriate manner.
Ensure in all situations where computers or
automated equipment are used for the acquisition,
processing, recording, reporting, storage or retrieval
of test or calibration data that:
Dieter Arnold, 24 March 2007
computer software developed by the user is
documented in sufficient detail and is suitably
validated as being adequate for use;
procedures are established and
implemented for protecting the integrity
and confidentiality of data (e.g., during entry
or collection, storage, transmission and
processing);
computers and automated equipment are
maintained to ensure proper functioning and
are provided with the environmental and
operating conditions necessary to maintain the
integrity of test and calibration data;
laboratory specific configurations/
modifications of commercial off-the-shelf
software (e.g. word-processing, database and
statistical programmes) are validated.
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5.5 Equipment I
Requirements
Ensure that …
Ensure that …
Maintain records of each item of equipment
and its software significant to the tests and/or
calibrations performed which contain at least:
Dieter Arnold, 24 March 2007
Details
the laboratory is furnished with all items of sampling, measurement
and test equipment required for the correct performance of the tests
and/or calibrations (including sampling, preparation of test and/or
calibration items, processing and analysis of test and/or calibration data);
the requirements of ISO 17025:2005 are met in those cases where the
laboratory needs to use equipment outside its permanent control;
calibration programmes are established for key quantities or values of
the instruments where these properties have a significant effect on the
results;
equipment (including that used for sampling) is calibrated or checked to
establish that it meets the laboratory's specification requirements before it
is placed into service and before it is used;
only authorized personnel operates the equipment;
Up-to-date instructions on the use and maintenance of equipment
(including any relevant manuals provided by the manufacturer of the
equipment) are readily available;
Each item of equipment and its software is uniquely identified - where
practicable.
the identity of the item of equipment and its software;
the manufacturer's name, type identification, and serial number or
other unique identification;
checks that equipment complies with the specification;
the current location, where appropriate
the manufacturer's instructions, if available, or reference to their
location;
dates, results and copies of reports and certificates of all calibrations,
adjustments, acceptance criteria, and the due date of next calibration;
the maintenance plan, where appropriate, and maintenance carried out
to date;
any damage, malfunction, modification or repair to the equipment;
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5.5 Equipment II
Requirements
Details
Have procedures for safe handling, transport,
storage, use and planned maintenance of measuring
equipment to ensure proper functioning and in order
to prevent contamination or deterioration.
Take out of service, isolate or clearly label as
being out of service (until it has been repaired and
evidently performs correctly) all equipment that has
been subjected to overloading or mishandling, or
has been shown to be defective or outside specified
limits, or gives suspect results.
Label all equipment under the control of the
laboratory and requiring calibration to indicate,
including the and the
Verify satisfactory function and calibration
status when, for whatever reason, equipment goes
temporarily outside the direct control of the
laboratory, the laboratory.
Carry out all necessary intermediate checks of
the calibration status of the equipment according
to a defined procedure
Have procedures to ensure that copies (e.g. in
computer software) are correctly updated where
calibrations give rise to a set of correction factors.
Safeguard all test and calibration equipment
including its software from adjustments which
would invalidate the test and/or calibration results.
Dieter Arnold, 24 March 2007
examine the effect of the defect or departure from specified limits on
previous tests and/or calibrations;
institute the “Control of nonconforming work” procedure.
the status of calibration;
date when last calibrated;
date or expiration criteria when recalibration is due.
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5.6 Measurement Traceability I
General
Requirements
Details
Calibrate all equipment having a significant effect on the
accuracy or validity of the result of the test, calibration or
sampling used for tests and/or calibrations before putting
it into service and have an established programme and
procedure for the calibration of this equipment.
Specific
Have a system for selecting, using, calibrating, checking,
controlling and maintaining measurement standards, reference
materials used as measurement standards, and measuring and
test equipment used to perform tests and calibrations.
requirements
establish traceability of own measurement standards and
measuring instruments to the SI by means of an unbroken
chain of calibrations or comparisons linking them to relevant
primary standards of the SI units of measurement (may be
achieved in several steps carried out by different laboratories that
Design and operate calibration laboratories and have a
can demonstrate traceability);
programme for calibration of equipment so as to ensure
achieve the link to SI units by reference to national
that calibrations and measurements made by the laboratory
measurement standards (primary or secondary) or
are traceable to the International System of Units (Système
use calibration services from laboratories issuing calibration
international d'unités, SI).
certificates that can demonstrate competence, measurement
capability and traceability. In this case ensure that certificates
contain the measurement results, including the measurement
uncertainty and/or a statement of compliance with an identified
metrological specification (see also 5.10.4.2).
use of certified reference materials provided by a competent
supplier to give a reliable physical or chemical characterization of
Establishing traceability of calibration laboratories to
a material;
appropriate measurement standards in case of
calibrations that currently cannot be strictly made in SI units use of specified methods and/or consensus standards that
by . In these cases calibration shall provide confidence in
are clearly described and agreed by all parties concerned;
measurements by such as:
participation in a suitable programme of interlaboratory
comparisons;
ensure that the equipment used can provide the uncertainty of
measurement needed;
Apply the above requirements to measuring and test
if calibration is the dominant factor, the requirements of
equipment with measuring functions of testing
traceability should be strictly followed;
laboratories depending on the contribution to the total
use certified reference materials, agreed methods and/or
uncertainty of the test result of the calibration.
consensus standards as required for calibration laboratories where traceability of measurements to SI units is not possible or
not relevant.
Dieter Arnold, 24 March 2007
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5.6 Measurement Traceability II
Reference standards and reference materials
Requirements
Details
Have a programme and procedure for the calibration of
reference standards by a body that can provide
traceability. Reference standards shall be calibrated before
and after any adjustment.
Use reference materials traceable to SI units of
measurement, where possible or to certified reference
materials and check internal reference materials as far as
is technically and economically practicable.
Have defined procedures and schedules for
intermediate checks needed to maintain confidence in the
calibration status of:
For reference standards and reference materials have
procedures for
Dieter Arnold, 24 March 2007
Use reference standards of measurement for calibration only.
reference standards;
primary standards;
transfer standards;
working standards;
reference materials;
safe handling;
transport;
storage;
use.
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5.7 Sampling
Requirements
Details
Have a sampling plan and procedures for
sampling of substances, materials or products for
subsequent testing or calibration.
Make the sampling plan as well as the
sampling procedure available at the location
where sampling is undertaken.
Base sampling plansl, whenever reasonable,
on appropriate statistical methods.
The sampling process shall address the
factors to be controlled to ensure the validity of
the test and calibration results.
Record in detail with the appropriate sampling
data and include in all documents containing test
and/or calibration results if the customer requires
deviations, additions or exclusions from the
documented sampling procedure. Communicated
these to the appropriate personnel.
Have procedures for recording relevant data and
operations relating to sampling that forms part of
the testing or calibration that is undertaken. Include
in the records:
Dieter Arnold, 24 March 2007
the sampling procedure used;
the identification of the sampler;
environmental conditions (if relevant);
diagrams or other equivalent means to identify
the sampling location as necessary;
the statistics the sampling procedures are
based upon;
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5.8 Handling of Test and Calibration Items
Details
Requirements
Have procedures for samples of test and/or calibration items covering:
Lay down provisions necessary to protect
transportation;
receipt;
handling;
Protection;
Storage;
retention and/or disposal;
the integrity of the test or calibration item;
the interests of the laboratory;
the interests of the customer.
Have a system for identifying test and/or calibration items throughout the
life of the item in the laboratory or upon transfer from the laboratory which
excludes confusion of items either physically or when referred to in records
or other documents.
Record any abnormalities of items or departures from normal or specified
conditions, as described in the test or calibration method upon receipt of the
test or calibration item.
Consult the customer for further instructions before proceeding and
record the discussion when there is doubt as to the suitability of an item for
test or calibration, or when an item does not conform to the description
provided, or the test or calibration required is not specified in sufficient
detail.
Have procedures and appropriate facilities for avoiding deterioration,
loss or damage to the test or calibration item during storage, handling and
preparation.
Dieter Arnold, 24 March 2007
follow handling instructions provided with the item;
maintained, monitor and record specified storage and
environmental conditions;
have arrangements for storage and security for test or
calibration item or a portion of an item that is to be held
secure;
provide a copy of the sampling procedure and information on
storage and transport of samples, including information on
sampling factors influencing the test or calibration result, to
those responsible for taking and transporting the samples;
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5.9 Assuring the Quality of Test and
Calibration Results
Requirements
Details
Have quality control procedures for a planned
monitoring of the validity of tests and calibrations
undertaken
use regularly certified reference materials
and/or internal quality control using secondary
reference materials;
participate in inter-laboratory comparison or
proficiency-testing programmes;
perform replicate tests or calibrations using
the same or different methods;
retest or recalibrate retained items;
correlate results for different characteristics of
an item;
record the resulting data in such a way that
trends are detectable;
apply statistical techniques to the reviewing
of the results where practicable;
take planned corrective action where
quality control data fall outside pre-defined
criteria;
Dieter Arnold, 24 March 2007
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5.10 Test Reports and Calibration
Certificates I
General
Details
Report results in a test report or a calibration certificate issued as hard copy or by
electronic data transfer and including all the information requested by the customer
Report accurately, clearly, unambiguously and
and necessary for the interpretation of the test or calibration results and all
objectively, and in accordance with any specific
information required by the method used.
instructions in the test or calibration method the
Include normally for this purpose the information required by 5.10.2, and 5.10.3
results of each test, calibration, or series of tests or
or 5.10.4 of ISO 17025:2005 (internal reports may be simplified).
calibrations carried out by the laboratory.
Have readily available all information listed in 5.10.2 to 5.10.4 including parts
not reported to the customer in the laboratory which carried out the tests and/or
calibrations.
Test reports and calibration certificates
title (e.g. “Test Report” or “Calibration Certificate”);
name and address of the laboratory, and the location where the tests and/or
calibrations were carried out, if different from the address of the laboratory;
 unique identification of the test report or calibration certificate (such as the
serial number);
 an identification on each page in order to ensure that the page is
recognized as a part of the test report or calibration certificate;
 a clear identification of the end of the test report or calibration certificate;
Requirements
Have a format for test reports or calibration
certificates that contains at least the following
information
Dieter Arnold, 24 March 2007
name and address of the customer;
identification of the method used;
unambiguous identification, description, and the condition of the item(s)
tested or calibrated;
date of receipt of the test or calibration item(s);
reference to the sampling plan and procedures used by the laboratory or other
bodies;
results with, where appropriate, the units of measurement of the test or
calibration;
name(s), function(s) and signature(s) of person(s) authorizing the test report
or calibration certificate;
where relevant, a statement to the effect that the results relate only to the items
tested or calibrated.
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5.10 Test Reports and Calibration
Certificates II
Test reports
Requirements
Details
deviations from, additions to, or exclusions from the test method, and
information on specific test conditions;
a statement of compliance/non-compliance with requirements and/or
Include the following additional information on specifications;
test methods in the format for test reports
where applicable, a statement on the estimated uncertainty of measurement;
where appropriate and needed, opinions and interpretations (see 5.10.5);
additional information which may be required by specific methods, customers
or groups of customers;
date of sampling;
unambiguous identification of the substance, material or product sampled;
the location of sampling, including any diagrams, sketches or photographs;
Include the following additional information on a reference to the sampling plan and procedures used;
sampling – where applicable - in the format for
details of any environmental conditions during sampling that may affect the
test reports
interpretation of the test results;
any standard or other specification for the sampling method or
procedure, and deviations, additions to or exclusions from the specification
concerned.
Calibration certificates
the conditions (e.g. environmental) under which the calibrations were made that
have an influence on the measurement results;
Include the following additional information in
the uncertainty of measurement and/or a statement of compliance with an
the format for calibration certificates
identified metrological specification or clauses thereof;
evidence that the measurements are traceable.
Opinions and interpretations
an opinion on the statement of compliance/noncompliance of the results
Mark clearly opinions and interpretations as such
with requirements;
in a test report and document the basis upon which
fulfilment of contractual requirements;
they have been made. Provide the following
recommendations on how to use the results;
information
guidance for improvements;
Testing and calibration results obtained from subcontractors
Identify clearly any results of tests performed by
subcontractors and use the calibration certificate of
the laboratory performing the work.
Dieter Arnold, 24 March 2007
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5.10 Test Reports and Calibration
Certificates III
Electronic transmission of results
Requirements
Details
Ensure compliance with ISO 17025:2005 in case of
electronic transmission of test or calibration results
Format of reports and certificates
Design the format to accommodate each type of
test or calibration carried out but harmonise the
layout and minimize the possibility of
misunderstanding or misuse.
Amendments to test reports and calibration certificates
Fulfil all requirements of ISO 17025:2005.
Make material amendments to a test report or
Refer to the original document and uniquely identify the new one if a complete
calibration certificate after issue only in the form
new report or certificate is to issued.
of a further document, or data transfer.
Include the statement:
“Supplement to Test Report [or Calibration Certificate], serial number... [or as
otherwise identified]”.
Dieter Arnold, 24 March 2007
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„I found 2.1 ppm of lincomycin in a chicken liver
sample from Germany. How can I transmit this result
electronically to my national data base?”
032003003407038GER154-21-22100
A
Exercise
Create an ASCII string (record) for data transmission
1
Record ID
Example:
Activity No. 03 NRP
Year
2003
Laboratory Sample No. 0034
Record ID: 0320030034
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2
Catalogue Food Commodities
....
07
07038
3
Catalogue Country of Origin
BEL
…
GER
…
ITA
4
Poultry products
Poultry, edible offal
Belgium
Germany
Italy
Catalogne Residues (CAS No)
154-21-2:
Dieter Arnold, 24 March 2007
Lincomycin
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5
Content
2.1 ppm

2100
ASCII String
032003003407038GER154-21-22100
032003007807038ITA154-21-21700
032003013107038BEL154-21-20760
Dieter Arnold, 24 March 2007
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Workshop on Issues relevant for the Accreditation of the Current Quality Control Laboratories (QCL)
Element Contents of Quality Control Materials (German Food Contamination Monitoring)
Materials
Element Contents [mg/kg dry mass]
Material
Code
999930
999931
999932
999933
999934
999945
999946
999947
999948
999949
999980
999981
999982
999983
999984
999985
999990
999991
999992
999993
999994
Material
Short Description
Mussel Tissue
Bovine Liver
Pig Liver
Pig Muscle
Pig Liver
Fish Muscle
Bovine Liver
Pig Kidney
Pig Muscle
Bovine Liver
Red Cabbage
Spinach Powder
Rice Flour
Rice Flour
Lettuce Powder
Potatoe Powder
„Bowen’s Kale“
Potatoe Powder
Rice Flour
Tomatoe Powder
Wholemeal Flour
As
Cd
Cr
5.9
0.024
0.044
0.066
0.34
0.298
0.067
0.073
0.12
0.066
0.44
2.71
0.019
0.48
2.67
0.693
1.82
0.023
1.26
0.164
0.889
0.035
0.32
0.297
0.0713
0.80
0.085
0.2
2.5
0.2
1.3
2.6
0.047
0.063
0.06
0.11
0.102
0.15
0.17
0.195
0.011
0.131
0.01
0.11
0.032
0.1
0.043
0.044
0.71
0.08
0.07
3.95
0.369
0.1
0.22
1.05
Cu
9.60
189
17.2
2.43
35
4.0
158
31.9
2.9
26.3
5.5
14.6
4.1
3.5
10.18
3.0
4.89
3.87
3.3
8.24
6.4
Hg
Ni
0.188
0.044
0.011
0.003
0.003
0.47
0.004
1.97
0.023
0.37
0.031
0.005
0.004
0.029
0.171
0.003
0.001
0.001
1.4
1.61
0.230
1.1
0.4
0.062
27.4
0.56
0.3
0.19
4.28
0.532
0.895
0.19
0.39
1.29
Pb
Se
1.91
0.501
0.54
1.4
0.1
0.58
0.135
0.306
0.09
0.71
1.66
0.446
0.94
0.134
1.55
1.7
0.71
10.3
0.394
0.325
0.41
0.671
0.904
0.489
0.261
2.49
0.026
1.12
0.05
0.379
0.054
0.07
0.06
0.023
0.021
0.134
0.002
0.02
0.132
Tl
0.003
Zn
76
142
0.007
172
0.0065 144.5
0.008
150
0.004
33
0.003
123
0.01
128
0.004
101.7
162
109
0.016
49.9
0.0008
23.1
0.00055 25.2
0.038
118.0
8.2
32.29
0.007
9.0
0.002
22.3
0.002
18.4
56.5
Use
C=Calibration
P=Proficiency
Testing
P
P
P
P
P
C
C
C
C
C
P
P
P
P
P
P
C
C
C
C
C
Values given in bold characters are certified values
Dieter Arnold, 24 March 2007
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Workshop on Issues relevant for the Accreditation of the Current Quality Control Laboratories (QCL)
Results of the 8th Test Round: Lettuce Powder CRM
Zinc
Element:
Param.Set
A
B
122.5
 [mg/kg]: 118
9.208 11.41
 [mg/kg]:
RSD:
0.078 0.093
LNo nNQ
2
1
-0.15
-0.52
3
2
1.26
0.52
4
2
2.50
1.62
8
2
1.09
0.48
9
1
1.55
0.86
10
1
1.30
0.66
11
1
-0.33
-0.66
12
2
-2.15
-2.13
13
2
0.91
0.34
14
5
-0.62
-0.89
15
2
0.76
0.22
17
2
-0.43
-0.75
18
4
0.00
-0.39
20
1
-1.46
-1.57
22
2
-1.26
-1.41
24
1
1.06
0.46
25
3
2.24
1.41
26
2
0.33
-0.13
28
2
1.39
0.73
29
2
2.72
1.00
30
4
0.58
0.08
31
2
-0.87
-1.10
32
2
-0.22
-0.57
33
4
0.49
0.00
34
2
0.30
-0.15
6
3
-0.61
-0.89
19
2
0.87
0.31
27
2
0.65
0.13
35
2
-0.16
-0.53
n(results)
29
29
25
28
n(z 2)
Copper
Nickel
Chromium
Cadmium
A
B
A
B
A
B
A
B
10.18 10.30
4.280 2.573
3.95
3.195 1.260 1.186
1.149 0.929 0.550 0.513 0.514 0.824 0.195 0.169
0.113 0.090 0.129 0.199 0.130 0.258 0.155 0.143
Uncorrected Z-Scores
-0.13
-0.29
-3.53
-0.45
0.08
0.97
-0.05
0.38
0.70
0.73
-2.84
0.29
-1.73
-0.16
-0.62
-0.27
-1.52
-2.51
-2.24
0.93
-1.85
-0.24
-0.67
-0.33
0.10
0.00
-3.60
-0.53
-0.49
0.61
0.00
0.44
-1.80
-2.36
-3.18
-0.08
0.45
1.20
-0.64
-0.30
0.03
-0.09
-2.22
0.94
-1.47
0.00
-0.15
0.26
-1.72
-2.26
-4.51
-1.51
-5.55
-2.54
-1.29
-1.04
0.19
0.11
-3.09
0.01
-0.64
0.52
0.56
1.09
0.71
0.75
-4.29
-1.27
-1.60
-0.08
-0.34
0.04
-0.60
-0.87
-2.95
0.16
-1.13
0.21
-4.09
-4.27
0.37
0.32
-2.74
0.38
-1.50
-0.02
0.62
1.15
-0.30
-0.51
-3.42
-0.34
-0.21
0.78
-1.37
-1.14
0.31
0.26 -99
-99
-3.41
-1.21
-0.08
0.35
1.24
1.40
-2.34
0.81
-1.63
-0.10
-0.46
-0.09
0.37
0.32
-5.11
-2.15
-4.03
-1.60
-0.87
-0.57
1.25
1.42
-4.00
-0.96
-4.05
-1.61
-1.84
-1.69
1.15
1.29
-3.12
-0.01
-0.68
0.49
-0.38
0.00
0.57
0.58
-2.38
0.77
-2.74
-0.80
-2.51
-2.46
1.10
1.23
-0.67
2.60
-0.66
0.50
0.56
1.09
0.10
0.00
-1.84
1.36
0.10
0.98
0.15
0.62
-0.47
-0.70
-3.22
-0.13
0.64
1.32
-0.03
0.40
-0.52
-0.77
-2.71
0.42
-0.51
0.60
-0.62
-0.27
1.24
1.40
-4.14
-1.12
0.10
0.98
-1.34
-1.10
-0.31
-0.52
-3.27
-0.18
-5.23
-2.35
-0.21
0.20
-0.19
-0.37
-3.34
-0.25
-3.93
-1.54
-2.21
-2.11
0.10
0.00
-1.71
1.49
-3.54
-1.29
2.21
2.98
-0.65
-0.94
-2.56
0.56
-0.56
0.56
-0.77
-0.46
1.15
1.29
-4.43
-1.43
-3.39
-1.20
-0.05
0.38
0.19
0.11
-2.58
0.56
-1.32
0.09
-0.22
0.19
29
29
29
29
29
29
29
29
29
26
3
26
20
27
25
25
Parameter Set A: Certified (or Reference) Value/Horwitz SD
Parameter Set B: Calculated Parameters (Qn/Median, PROLAB-Software)
Dieter Arnold, 24 March 2007
[email protected]
No. 77
Workshop on Issues relevant for the Accreditation of the Current Quality Control Laboratories (QCL)
Comparison of the Element Contents of Quality Control Materials and the Median Concentrations of
Monitoring Samples
The original monitoring data were given on a fresh weight basis. They were re-calculated for comparison with the QCM´s
Materials
Type
QCM
QCM
QCM
Monitoring
Monitoring
QCM
QCM
QCM
Monitoring
QCM
QCM
Monitoring
QCM
Monitoring
QCM
QCM
Monitoring
QCM
Monitoring
Monitoring
QCM
Monitoring
QCM
QCM
Monitoring
Description
Mussel Tissue
Pig Muscle
Pig Muscle
Pig Muscle
Bovine Muscle
Bovine Liver
Bovine Liver
Bovine Liver
Bovine Liver
Pig Liver
Pig Liver
Pig Liver
Pig Kidney
Pig Kidney
Red Cabbage
„Bowen’s Kale“
White Cabbage
Spinach Powder
Spinach, fresh
Spinach, frozen
Lettuce Powder
Lettuce
Potatoe Powder
Potatoe Powder
Potatoe
[mg/kg dry mass]
As
5.9
0.066
0.06
0.047
0.024
0.11
0.025
0.044
0.025
0.063
0.09
0.131
0.102
0.195
0.011
0.01
Dieter Arnold, 24 March 2007
Cd
0.34
0.073
0.019
0.007
0.065
0.44
0.298
0.48
0.25
0.067
0.12
0.15
2.71
1.1
2.67
0.889
0.064
0.693
0.67
0.89
1.26
0.48
0.164
0.035
0.077
Cr
0.80
2.5
0.043
0.05
0.06
0.085
0.044
0.04
0.2
0.2
0.04
0.1
0.369
0.71
0.82
0.75
3.95
0.34
0.1
0.045
Cu
9.60
2.43
2.9
2.7
2.3
158
189
26.3
100
17.2
35
32
31.9
13.5
5.5
4.89
2.94
14.6
10.7
10.1
10.18
8.0
3.0
3.87
3.6
Hg
0.188
0.003
0.023
0.004
0.044
0.37
0.008
0.011
0.003
0.01
1.97
0.015
0.171
0.031
0.029
[email protected]
Ni
1.61
0.062
0.07
0.05
1.4
0.04
0.230
0.4
27.4
0.895
0.56
0.95
0.71
4.28
0.5
0.532
0.19
Pb
1.91
1.4
0.09
0.05
0.03
0.135
0.501
0.71
0.2
0.54
0.1
0.085
0.306
0.55
Se
1.66
0.134
0.394
0.4
0.19
0.71
0.446
0.325
0.5
0.94
1.55
1.8
10.3
3.9
Tl
0.003
0.0065
0.004
2.49
0.134
0.41
0.62
0.51
0.489
0.5
0.261
0.026
0.072
0.054
0.016
0.023
0.038
0.021
0.002
0.007
0.005
0.003
0.008
0.007
0.008
0.01
0.01
0.02
Zn
76
144.5
101.7
110
200
123
142
162
125
172
150
210
128
65
109
32.29
20.5
49.9
76.2
66.6
118.0
56.0
8.2
9.0
12.6
No. 78
Workshop on Issues relevant for the Accreditation of the Current Quality Control Laboratories (QCL)
Arsenic
Type of Matrix:
A
P
Classification
Excellent
Satisfactory-1
Satisfactory-2
5
7
Unsatisfactory-2 2
8
Unsatisfactory-1 26
14
Cadmium
A
P
16
5
4
15
7
6
8
5
Chromium
A
P
1
20
12
Dieter Arnold, 24 March 2007
11
12
7
Copper
A
P
12
11
4
10
7
9
6
8
Mercury
Nickel
A
P
A
P
Number of Results
3
14
17
7
13
10
9
16
8
[email protected]
2
22
5
Lead
A
P
6
8
2
5
13
1
9
6
8
6
Selenium
A
P
5
4
3
2
19
Thallium
A
P
2
31
30
3
2
28
Zinc
A
P
14
11
4
1
4
8
8
8
2
8
No. 79