KRAFT ANALYTICAL

LABORATORY QUALITY
MANUAL

Issue Date: November 2007

Supersedes:-
KRAFT Analytical Laboratory Quality Manual

Index
Page
1. Scope 3

2. Definitions 3

3. Management Requirements 6
3.1. Organization and Management 6
3.2. Document Control 6
3.3. Subcontracting / Servicing other Facilities 6
3.4. Purchasing Services and Supplies 7
3.5. Control of Non-conforming Work/Corrective Actions 7
3.6. Preventive Actions / Continuous Improvements 7
3.7. Records 7
3.8 Internal Audits 8
3.9. Waste Management 8

4. Safety 8

5. Facility and Operating Environment 9

6. Technical Requirements 10
6.1. Personnel 10
6.2. Inspection, Measuring and Test Equipment 10
6.3. Receiving, Handling and Shipping of Samples 11
6.4. Analytical Methods 12
6.5. Result Validation and Reporting 12

7. Control of Chemicals 12

8. References 13

9. Appendices (links)
9.1 Annex I:
- Assessing Compliance to the Requirements of the Quality Manual
- Laboratory Sheet
- Compliance Checklist
9.2 Annex II (Requirements for Analytical Methods)
9.3 Annex III (Requirements for Reporting of Analytical Results)
9.4 Annex IV (Guideline for Verification of Method Equivalency)
9.5 Annex V (Requirements for Organizing & Evaluating Ring/Proficiency Tests)

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1. Scope

This document specifies and officially communicates the general requirements for the technical
competence of Kraft analytical laboratories conducting chemical and physical testing, both in R&D
and operations as well as to external analytical laboratories used by Kraft. It is intended for use by
these laboratories as well as for those bodies concerned with recognizing their competence.

This set of requirements may have to be supplemented when applied to a particular laboratory. It
sets direction to all Kraft analytical laboratories to facilitate development of their own procedures and
serves as a basis for laboratory employee training programs.

The scope of this document is to set the same high requirements to all Kraft analytical laboratories,
to allow them to ensure true, precise and traceable results and by this, to have a major contribution
to product quality assurance and advancement of R&D projects.

The Kraft laboratories meeting the requirements of this document implicitly comply with the relevant
requirements of ISO/IEC 17025, 2005-05.

2. Definitions

For the purpose of this document the most relevant definitions applicable are :

• Accuracy:
Total deviation characterised by precision and trueness.

• Analysis:
Technical operation that consists of the determination of one or more characteristics of a given
product according to a specified procedure. The term “analysis” is synonymous with the term “test”
used in international standards.

• Analytical Laboratory:
Body that performs physical & chemical analysis. In all the Kraft organisations where an analytical
laboratory exists, this must be identifiable as a well defined part of the organisation.

• Analytical Method:
Specified technical procedure for performing an analysis.

• Analytical Quality Assurance:

All the planned and systematic actions and overall measures that a laboratory uses to ensure the
quality of its operations.

• Analytical Quality Control:

Operational techniques and activities that are used to fulfill requirements for quality of analytical
results of specific samples or batches of samples and that include : checking results against
repeatability limits, analysis of reference materials, analysis of blanks, analysis of spiked samples
and use of control samples and control charts.

• Analytical Report:
Document that presents analytical results and other information relevant to the analyses.

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• Calibration:
The set of operations which establish, under specified conditions, the relationship between values
indicated by a measuring instrument or measuring system and the corresponding known values of a
reference material.

• Calibration Method:
Specified technical procedure for performing a calibration. In many cases the calibration method can
be a part of an analytical method.

• Certified Reference Material (CRM):

A reference material one or more of whose properties are certified by a technically valid procedure,
accompanied by or traceable to a certificate or other documentation issued by a certifying body.

• Precision:
The closeness of agreement between independent analytical results obtained under stipulated
conditions.

• Proficiency Testing:
Determination of laboratory analytical performance by means of interlaboratory analyses
comparisons.

• Reference Material:
A material or substance of which one or more of its properties are sufficiently well established to be
used for the calibration of an apparatus or the assessment of an analytical method.

• Repeatability (r):
Closeness of agreement between two test results* obtained with the same method on identical test
material in the same laboratory by the same operator using the same equipment and carried out
within short intervals of time.
*Note: single values or averages, depending on calculation.

• Reproducibility (R):
Closeness of agreement between two test results* obtained with the same method on identical test
material in different laboratories with different operators using different equipment.

*Note: single values or averages, depending on calculation.

• Ring Test:
Interlaboratory test assessing the analytical method performance in terms of repeatability r and
reproducibility R.

• Traceability:
The property of a result of a measurement whereby it can be related to appropriate standards
through an unbroken chain of comparisons.

• Trueness:
Closeness of agreement between the mean value obtained from a series of test results to that of a
certified reference value or accepted reference value.

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• Validation:
Totality of actions which are necessary to achieve and demonstrate that the method provides
reproducible and reliable results for the intended use (see Annex II, point II).

• Z-score:
Measure for performance in proficiency testing (for calculation and interpretation see Annex V).

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3. Management Requirements

3.1. Organization and Management

The analytical laboratory shall be organized and shall operate in such a way that it meets the
requirements as defined in the present document.

It shall be able to identify the occurrence of departures from the quality system or the procedures for
performing tests and to initiate actions to prevent or minimize such departures.

The analytical laboratory and its personnel shall be free from any internal or external pressures
which might influence their technical judgment and performance.

It shall ensure that all information relating to analytical results is kept confidential and protected
against unauthorized access.

The analytical laboratory must have a head who has overall responsibility for the laboratory and
who, in case a designated quality manager is missing, ensures the quality system is implemented
and followed at all times.

Each member of personnel shall be aware of both the extent and the limitation of their area of
responsibility.

An organizational chart showing the functional responsibilities of the laboratory staff shall be
available and kept up-to-date.

3.2. Document Control

All documents both internally generated and from external sources

(e.g. analytical methods, test reports, analytical data, specifications, instructions, manuals,
notebooks, software, drawings etc.) that form part of the quality documentation shall be controlled.
These may be on various media whether hard copy or electronic, photographic or written. Changes
to documents shall be reviewed and approved by authorized personnel.

3.3. Subcontracting / Servicing other Facilities

Where analytical work shall be performed in an external laboratory, the Kraft analytical laboratory
shall ensure and be able to demonstrate that its subcontractor is competent to perform the services
in question and complies with the Kraft general requirements for analytical laboratories as defined in
the present document.

The external laboratories shall be assessed according to the requirements and the Checklist given
in Annex I (Assessing Compliance of Kraft and External Analytical Laboratories with the “General
Requirements for Kraft Analytical Laboratories”).
The Kraft analytical laboratory shall record and retain details of its investigations into the
competence and compliance of its subcontractors and maintain a register of all subcontracting.

Where providing laboratory services to internal and/or external customers is specified in

requirements, the Kraft analytical laboratory shall establish and maintain documented procedures for
performing, verifying and reporting that the servicing meets the specified requirements. Documented
procedures would be as stated in the present document or as specified by the customer.

3.4. Purchasing Services and Supplies

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The analytical laboratory shall have procedures to ensure that only such services and supplies are
used that comply with specified requirements and are of the quality needed (e.g. shelf life,
appropriate grade used for purpose, i.e. p.a. or reagent grade.

3.5. Control of Non-conforming Work/Corrective Actions

The analytical laboratory shall ensure that responsibilities for the management of non-conforming
work (e.g. problems with testing or calibration activities) are designated and actions are defined and
taken when non-conforming work is identified. The control shall provide for identification,
documentation, evaluation, segregation, disposition of non-conforming test results and for
notification to the functions concerned.

Where the situation might recur or there is doubt about compliance of the laboratory’s operations
with Kraft policies and procedures, the root causes of the problem shall be identified and corrective
actions appropriate to the magnitude of the problem shall be run. Corrective actions shall be
documented and monitored after their implementation to confirm their effectiveness.
For receiving materials at Kraft Operations, the laboratory shall have a process to document
situations where materials are used for production prior to completion of required testing. This
process may include reprioritizing testing or documenting approval for use of the materials.

Always refer to your quality systems specifications for policies and procedures related to inspection
and testing (i.e. hold and release procedures, sensitive ingredient handling procedures).

3.6. Preventive Actions/Continuous Improvements

As a preventive measure, opportunities for needed improvement and potential sources of non-
conformances, either technical or with the quality system shall be identified. For instance by review
of operational procedures, analysis of data including trend analysis, appropriate sources of
information such as processes and work operations which affect laboratory testing quality, audit
results, quality records, service reports and customer/consumer comments to detect, analyze and
eliminate potential causes of nonconformities. When needed, preventive actions shall be taken and
subsequently controlled with regards to their effectiveness.

As a continuous improvement measure, appropriate functions shall pass customer/consumer

feedback (complaints, comments, inquiries) for analysis to other parts of the business as appropriate
for identification and problem solving.

3.7. Records

The analytical laboratory shall have procedures for identification, collection, indexing access
(including regulatory agencies) and storage of quality and technical records. The laboratory records
may be in the form of any type of media such as hard copy, electronic media (including Laboratory
Information Management System).Quality records also include reports from assessment of external
laboratories as well as corrective and preventive actions taken. Technical records are accumulation
of data and information which result from carrying out tests or calibrations. They shall contain
sufficient information to enable the particular test or calibration to be repeated under conditions as
close as possible to the original.

All analytical reports and supporting records shall be held secure and appropriately stored for a
period of time as specified by local policies or for at least 3 years. Laboratory quality records shall be
maintained to demonstrate conformance to specified requirements and the effective operation of the
laboratory quality system.
The analytical laboratory shall ensure that all corrections / amendments made in hard copy records
are authorized and enable identification of original data (i.e. no use of correction fluid) and of
corrector as well as loss or unauthorized change of original data held on computers is prevented.
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3.8 Internal Audits

The analytical laboratory shall periodically (recommended once a year; minimum once every 2
years) conduct internal audits of its activities to verify that its operations continue to comply with the
requirements of the management system and the present document. Such audits shall be carried
out by trained and qualified personnel who are, wherever resources permit, independent of the
activity to be audited. Audit findings and corrective actions that arise from them shall be recorded.
Follow-up audit activities shall verify and record implementation and effectiveness of the corrective
action taken.
3.9 Waste Management

Solid and liquid analytical laboratory waste, containing inorganic and organic compounds such as
solvents, reagents, reaction products etc. and gaseous waste, shall be handled according to the
local legal requirements as well as the Kraft Foods environmental & safety plans. Where applicable,
waste shall be collected by classes, labelled and stored in appropriate containers and a specialized
company entrusted with the disposal. Laboratories should minimize their waste wherever possible.

4. Safety

Legal Aspects
All applicable legal directives with regard to personnel safety and equipment safety have to be
implemented. All staff must strictly adhere to governmental and company policies regarding work
safety and health protection by implementing the necessary programs (e.g. defined responsibilities,
training programs, procedures/work instructions, protective gear, emergency control programs,
inspections and follow up systems, chemical inventory control).

Responsibility
All employees have the obligation to actively take part in the companies health and safety process.
Lab managers (or delegates) should carry out and document safety inspections and ensure
implementation of follow ups on a regular base. Lab managers (or delegates) must ensure
compliance of laboratory safety to site specific safety requirements by cooperating with local site
safety committee.

Training
No personnel is allowed to carry out any work in the laboratory without safety instruction by the
laboratory manger or a delegated person.
General safety training shall be given to all laboratory personnel by lab manager or a delegated
person on a regular basis, but at least once a year. It should include at least overview about the
safety organization, disaster control, accident/incident procedures, personal safety gear and
protective equipment. Additional topics should be covered according to their relevance to
environment of workplace.
Safety training, appropriate to the specific field of work or equipment shall be given to the respective
laboratory personnel by experienced colleague and refreshed on a regular basis where necessary.

Procedures and Documentation

All safety related procedures and trainings must be documented.
Site specific safety procedures and information, required to work safely in the analytical laboratory,
must be available and easily accessible for all employees (e.g. inventory list of hazardous material,
work instructions for hazardous material, MSDS: Material Safety Data Sheets, emergency control
procedure, evacuation procedure, plan of emergency exits, contact list of first aiders etc.).
Laboratory/work relevant safety equipment/facilities must be in place and regularly checked for
functional efficiency (e.g. protective clothing, fume cupboards, adequate chemical storage facilities,
chemical spill kits).
Appropriate protective gear (e.g. laboratory coats, safety glasses etc.) must be provided to
laboratory personnel and available for visitors where necessary.
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Documentation and follow up systems must be in place for laboratory accidents and incidents.

Specific Safety Features

Specific safety features, e.g. first-aid kits, fire extinguishers, chemistry spill kits shall be conveniently
located and their locations clearly marked so that they can be found quickly in an emergency. Safety
showers and eyewash stations shall be placed at strategic locations and checked frequently for
proper functioning.
A system must be in place to continuously guarantee (i.e. defined frequent checks) all safety
features for proper functionality (e.g. fire extinguishers) and/or completeness (e.g. first aid kits).

5. Facility and Operating Environment

The operating environment of the analytical laboratory should:

• comply with local legal requirements
• facilitate the safe, reliable execution of all analytical operations.

Access to test area shall be controlled, i.e. all non-laboratory staff (includes cleaning personnel) to
be identified and appropriately supervised and/or be aware of the laboratory safety requirements.

For the laboratory design, following shall be considered, where relevant:

ƒ internal traffic pattern: to ensure efficient, ergonomic configuration of work areas.
ƒ walls, ceiling, floors: should be constructed of non-porous and easily cleanable materials. Floors
should be skid resistant and sturdy.
ƒ laboratory furniture: should be constructed of non-porous materials with acid and solvent-
resistant work surfaces where relevant to work. Storage cabinets should be corrosion-resistant.
ƒ equipment location: May affect laboratory efficiency; electrical, mechanical and ventilation
requirements to be considered; Instruments such as balances, microscopes etc. can be affected
by vibration.
ƒ chemical fume hoods and safety cabinets: If volatile, hazardous, corrosive, dusty chemicals or
other substances are handled which could affect people or environment, fume hoods have to be
available. Fume hoods should meet local policy requirements and be annually certified by a
certified vendor to ensure proper operation. Volatile and/or flammable chemicals shall be stored
in safety cabinets that are vented to the outside. Chemicals which interact explosively should be
stored separately, chemicals with high toxicity must be secured under lock, with access
restricted to authorized personnel (see point 7). Excessive quantitites may need to be kept in
exterior storage facility.
ƒ storage facilities (including cold storage): Separate storage of samples, chemicals,
volatile/flammable solvents, gas cylinders etc.
ƒ mechanical and electrical systems: Natural gas, compressed air, vacuum, water systems (i.e.
tap water, laboratory grade water) and electrical power mostly required. Quality, capacity and
location of outlets or sources need to be evaluated. Electrical power must be smooth and
protected against surges and spikes. A power backup system may be needed to protect
samples or sensitive equipment in the event of power failure. Computer systems shall be
physically and electronically protected.

For laboratory equipment and supplies, following shall be considered:

ƒ clean glassware, apparatus & supplies to ensure analytical data are not compromised.
ƒ distilled water system: delivery system must ensure requested quality and must be non-
contaminating. Regular checks to be performed on conductivity. If required other parameters to
be included (e.g. TOC (Total Organic Carbon) for HPLC analyses)

Other requirements to be considered:

ƒ Adequate housekeeping shall be ensured (clean and organized).
ƒ Environmental conditions to be monitored, as required by relevant specifications or where may
influence the quality of results (e.g. temperature of refrigerators).
ƒ A floor plan shall be available, detailing specifications, content, location of safety equipment,
duties performed etc.
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6. Technical Requirements

6.1. Personnel

The analytical laboratory personnel shall have appropriate education and experience relating to their
function as defined in the job descriptions.

Specific personnel shall be trained to operate particular types of equipment, to perform particular
types of test and calibration etc.
Information on the relevant competence, qualification and training of the laboratory personnel shall
be maintained.

When using staff undergoing training or personnel additionally contracted, appropriate supervision
shall be provided.

Training of the laboratory personnel shall be planned with respect to present and anticipated tasks
and kept up-to-date.
Appropriate records of training, including refresher training, shall be maintained.

6.2. Inspection, Measuring and Test Equipment

The analytical laboratory shall be furnished with all items of equipment required for correct
performance of the analyses which it claims to be competent to carry out. In the exceptional case
where the laboratory is obliged to use outside equipment, it shall ensure the quality of that
equipment.

Equipment and its software used for testing and calibration shall be capable of achieving the
accuracy required and shall comply with specifications relevant to the tests or calibrations
concerned.

6.2.1. Maintenance and Calibration

Equipment shall be operated by trained personnel, be properly registered & listed and maintained.
Quality relevant equipment shall be calibrated. Up-to-date instructions on the use, maintenance and
calibration of equipment shall be available.

Records on instrument calibration indicating the status of calibration and the date when recalibration
is due shall be maintained as well as details of maintenance carried out and history of any damage,
modification or repair. Recalibration shall be scheduled at intervals that are likely to prevent the
instrument going out of calibrationat any moment.

Calibration must be performed using suitable reference material, or if available, a certified reference
material (see definitions). The analytical laboratory shall ensure safe handling, transport, storage
and use of reference materials to prevent contamination and deterioration and to protect their
integrity.

A procedure must be available to deal with instrument being out of calibration.

Following frequencies shall be applied:

6.2.1.1 Weight based Equipments

All equipment/supplies used for measuring weight (i.e. balances, scale based oven) should be
regularly verified with calibrated weights (minimum quarterly) and calibrated (minimum annually) by
either qualified external services or in-house using certified standards and documented. Balances
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should be always leveled and calibrated/adjusted by automatic function before use (internal weight
applied automatically).

6.2.1.2 Volume based Equipments

All equipment/supplies used for critical volume (i.e. pipettors, dispensor) should be regularly verified
against a material of known density (depending on usage, monthly to annually) and calibrated
(minimum annually) by qualified external services or qualified in-house staff and documented.

6.2.1.3 Temperature / Heat based Equipments

All equipment/supplies used for critical temperature (i.e. thermometer, ovens)
should be regularly verified against calibrated thermometer (minimum quarterly) and calibrated
(minimum annually) by qualified external services or qualified in-house staff.
For ovens recommended monthly check program should be implemented; less frequent checks
maybe applied where data demonstrate sufficient control (minimum quarterly). For furnaces, a yearly
check on temperature variation on working space is recommended.

6.2.1.4 Others
pH-meters should be calibrated before use, utilizing minimum 2 standards and checking then after
accuracy against a third standard; Slope must be between 93-107% (based on mV reading). pH
instrument should allow automatic compensation for temperature. Since this does not correct for all
the variables, pH should be measured close to 20°C. Actual temperature of sample should be
recorded and reported with pH.

For other equipment (e.g. HPLC, GC etc) refer to manufacturer’s recommendation, Kraft Official
method as available and document procedure.

6.3. Receiving, Handling and Shipping of Samples

The laboratory shall establish and maintain documented procedures for receiving, handling, storage,
packaging and delivery of laboratory samples and supplies.

The sample submitter is ultimately responsible for ensuring representative sampling according to
sampling plans if appropriate. Providing advise on appropriate sampling techniques is one of the
core responsibilities of the laboratory.

A system for uniquely identifying and appropriate labeling of the samples to be analyzed shall be
applied to ensure that there can be no confusion regarding the identity of the samples and the
results of the measurements made.
At all stages of receiving, storage, handling, preparation of samples for analysis and shipping,
precautions shall be taken to prevent damage to the samples, for example contamination, spoilage
and temperature abuse, any of which could invalidate the results. Any relevant instructions provided
with the samples or items shall be observed.

There shall be clear rules for the receipt, retention and disposal of samples or items.

6.4. Analytical Methods

All analytical methods in use must be registered, appropriately validated, approved by the
appropriate competent person and documented according to the criteria in Annex II (“Requirements
for Analytical Methods”). The Official Kraft Methods Manuals for Confectionery, Food, Coffee, Salty
Snacks and Refreshment Beverages serve as an example for such a documentation.

For the purpose of method validation and assessment of laboratory performance, as well as for
assessment of the reproducibility of methods, the analytical laboratories shall take part in ring tests
and / or proficiency tests as required and available.

The laboratory head is responsible for demonstrating Analytical Quality Control for each method.
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For the control of critical parameters in raw materials and finished products the analytical
laboratory shall use methods and procedures which are required by the specification against which
the samples are to be analyzed.
Where Kraft Offical methods and / or international methods are specified but other local
methods are used, it shall be demonstrated that either:
- key method differences are identified/documented and are not judged to have an influence on
the test results from a chemistry perspective
- validation data are available (see approach Annex IV) which prove method equivalency or that
accuracy of the applied method is sufficient to cross-check against target value in specification.
For critical parameters and in case supplier methods are specified but local methods are used,
a formal verification of method equivalency of local to supplier method is not required, provided both
methods are based on same principle and key data as given in the specification.

The analytical laboratory shall reject requests to perform analyses according to analytical methods
that may endanger an objective result or have a low validity.

Where it is necessary to employ analytical methods which are non-standard, these shall be fully
documented, for example in laboratory notebooks.

6.5. Result Validation and Reporting

Analytical results that are to be released from the lab shall be documented in a test report which
accurately, clearly, unambiguously and objectively presents the analytical results and all other
information relevant for the interpretation of the results (see Annex III “Requirements for Reporting
of Analytical Results” for details).

Each result must be traceable to the related sample. All results must be validated by an authorized
person.

7. Control of Chemicals

Laboratory chemicals with high toxicity and solvents not in immediate use must be secured, with
access restricted to authorized personnel.

A secured laboratory (access controlled, locked when not occupied) is adequate for the storage of
chemicals used on a routine basis. It is recommended that those chemicals used only periodically,
or general inventory supplies, should be stored under lock, with access restricted to authorized
personnel.

Inventory of hazardous and high toxicity materials must be routinely monitored, using paper or
electronic data systems. A Physical inventory of hazardous and high toxicity materials must be taken
annually.

Where there are local regulations regarding inventory management of hazardous or toxic materials,
these must also be met.

8. References

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8.1. ISO/IEC 17025, 2005-05

8.2. ISO 5725 1994, Accuracy (trueness and precision) of measurement
methods and results - Part 1 and 2
8.3 OECD Principles of good laboratory practice, 1983.
8.4 Commission Decision of 12 August 2002 implementing Council Directive
96/23/EC concerning performance of analytical methods and the
interpretation of results

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