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The proof is in the paperwork

By Richard F. Stier, Contributing Editor

October 4, 2012

Documentation is essential for food processors to properly maintain food safety, quality,
sanitation and food defense programs.

Without proper paperwork, food, beverage or ingredient processors cannot demonstrate they are
protecting consumers, following procedures, adhering to government regulations or complying with
standards such as ISO 22000. And the proof is in the paperwork.

A few years ago, I was conducting an audit in a meat facility. An integral part of this audit was the
companys documentation of risk assessments of not just its food safety programs, but all aspects of its

The quality manager could not find his food safety assessment, yet kept telling me, It is mandated, so we
have it. My answer was, Show me. When I returned to my hotel that evening, the client asked me to call
him. When I called him back, he wanted to know what I did to get the quality manager so angry. He also
asked me if the risk assessment was documented. My answer was no. The next morning, the quality
manager apologized, but still could not show me the assessment, even though he insisted it had been
done and was documented.

Perhaps one of the best reasons to maintain proper documentation is protection from potential liability
issues. Heres an example of the importance of documentation from a work-related injury. A member of
the cleanup crew was badly injured by getting a caustic cleaning solution in his eyes while failing to wear
proper eye protection. The accident occurred immediately after a meeting that addressed safe chemical
handling. The injured workers colleagues testified he had attended the meeting, but he had not signed
the attendance sheet. Therefore, there was no evidence he had been trained on safe chemical handling.
The courts ruled the company to be negligent in that it had failed to train the person.

Management needs to make a serious commitment to developing and implementing a program that
ensures procedures are documented, records are properly maintained, and methods are in place to verify
these activities are being carried out as described. In addition, management must clearly define how to
develop and maintain procedures and work instruction. Procedures should have a title, scope of purpose,
instructions for how to do the task, expectations, a designation of who is responsible for managing the
area or doing the work, guidelines for how the protocol should be documented and instructions for what
form or forms should be used for monitoring. They should also include copies of forms in the procedure or
work instruction. For example, any procedure that requires the use of personal protective equipment
should reference what is necessary.

Procedures also must include the proper corrective actions if a problem occurs. For instance, if a critical
control point is involved, meaning product safety is compromised, the protocol should describe not only
how the operation is to be corrected, but also define what must be done with any affected food.
Photographs can be included to make the protocols easier to understand. This is especially useful when
creating procedures for equipment startup or shutdown.

One good way to build a documentation program is to assign someone to be the document control officer.
This person is responsible for ensuring all procedures follow the correct format, have been reviewed for
accuracy and signed off by the appropriate managers, and workers are using the correct procedures and
recordkeeping forms. The document control officer is also responsible for maintaining records of revisions
to procedures and forms.

Documentation is essential for a food processor to properly maintain food safety, quality, sanitation and
food defense programs. Without good written procedures, there is no way work will be done properly,
people can be adequately trained, or a processor can prove its role in assuring the safety of its people
and products, as well as compliance with regulatory requirements.

A Pragmatic Risk Assessment
Strategy to Qualify Ingredient
and Other Suppliers
By Christian Klug, Ph.D.

In the present era of globalization, international trade in food
ingredients is growing at an unprecedented rate. Food companies are
now in a position to purchase ingredients and additives directly from an
ever-increasing range of suppliers located almost anywhere in the world.
However, this enormous degree of freedom has a very serious downside
in that food companies run the risk of purchasing ingredients that
possibly may not always satisfy quality demands or even fail to meet
international purity standards as stipulated by international food law.

In order to minimize this risk, food companies are increasingly
demanding that suppliers of ingredients install quality management
systems certified according to the EN ISO 9001:2000 standard and that
they introduce food safety systems compliant with Hazard Analysis and
Critical Control Point (HACCP) and Good Manufacturing Practice (GMP)
standards. In the European Union HACCP analysis and HACCP systems
based on such analysis are mandatory. The European Union (EU) also
requires imported products to conform to EU safety standards and that
HACCP analysis and HACCP systems must also be in place with
suppliers exporting to the EU. In response, many suppliers have
obtained these certificates. However, purchasers should not be lulled
into complacency: A rude awakening may come when the products are
analyzed and found to be contaminated in spite of any proudly presented

In view of the many ingredients and additives used nowadays by food
and beverage manufacturers, the qualification of suitable and reliable
suppliers has become a hugely important yet difficult task. Recent
advances in analytical techniques mean that many contaminants which
may have gone unnoticed in the past are now readily detectable.
Moreover, we live in a world in which consumers are becoming better
informed and are increasingly vocal in demanding safe foods. With the
frequently self-appointed mass media watchdogs waiting to pounce on
any bad news from the food industry, however trivial, it may be that the
slightest lapse in monitoring the quality of ingredients and additives
used in food production can seriously damage a companys reputation
and have a devastating effect on sales. Such adverse publicity may affect
not only the food manufacturers but also the supermarkets/retailers with
their private label products. Some retailers leave it to their private label
manufacturers to choose the supplier of the food ingredients. For
economic reasons, however, the manufacturers of private label products
might be tempted to focus their attention more on low prices than on
safe ingredients.

Against this background, the issue of food safety, and thus the purity of
ingredients, is becoming more important and with regard to product
contamination food and beverage companies are increasingly adopting a
policy of zero tolerance vis--vis their suppliers. Here we outline a cost-
efficient and effective procedure with the aim of helping food safety and
quality assurance managers, product development specialists,
purchasers and auditors to identify potential risks in ingredient supplier
qualification at an early stage and to short-list the most promising
candidates as early as possible.

Risk Assessment of Food Additives
The Food and Agriculture Organization of the United Nations (FAO)
describes scientific food safety risk assessment as covering the following
four main steps: hazard identification; hazard characterization; exposure
assessment; and risk characterization of food safety hazards. Although
there are internationally accepted standards for food purity and
international policing organizations, such as the European Food Safety
Agency (EFSA) and others, it is virtually impossible to check all food
ingredients or food imported into the European Community. Therefore,
it is up to each individual purchasing company to look after its own
interests by adopting its own set of protective measures. In order to
benefit from the very real advantages of the global marketplace while
avoiding potential pitfalls, a food or beverage company should consult
with experts in drawing up its own product specifications and purity
requirements. The systematic approach adopted involves performance of
a basic and product-specific risk assessment for each individual food
additive used, followed by a supplier-specific risk assessment. With this
information in hand, a company will leave nothing to chance in reliably
identifying reputable suppliers.

Basic and Product-Specific Risk Assessment.To accomplish the task of
performing a basic and product-specific risk assessment, a company can
draw on a wealth of readily available information about international
purity requirements for food and pharmaceutical grade additives.
Appropriate sources are the Compendium of Food Additive
Specifications of the Joint FAO/WHO Expert Committee for Food
Additives (JECFA), the U.S. Food Chemicals Codex, the directives laying
down special purity criteria for food additives of the European
Commission, Japans Specifications and Standards for Food Additives,
the United States Pharmacopeia, the European Pharmacopeia, etc. The
aim of this exercise is to gather all the available information about all
international purity requirements and the impurities which may
conceivably be present in a given food or pharma ingredient. It should be
kept in mind that purity criteria laid down in legislation such as the
U.S.Code of Federal Regulations or EU purity criteria directives are
mandatory, which means that products not conforming to these criteria
are not authorized at all.

Supplier-Specific Risk Assessment. For food manufacturers, the seemingly
easy procedure might be to simply rely on a product specification sheet
and a certificate of analysis (COA) as a guarantee that legal requirements
of product purity have been fulfilled. However, this is a very risky
approach because it can very easily endanger the quality of their
products and their reputation. There is always the possibility that the
manufacturer may be using an alternative manufacturing process to
produce a given food additive, which may then contain additional or
even completely different impurities for which no regulations exist.
Whether unexpected or not, these impurities should not be present in
the final product.

It should not be overlooked that the level of expertise may vary
considerably from one potential supplier to another: some may have
state-of-the-art technologies and equipment and optimized
manufacturing and purification processes while others may not. Some
may have many years of experience while others do not.

As an example of
the discrepancies lurking in the global marketplace, variations in the
quality of real-life samples are apparent from Figure 1, which compares
potassium sorbate samples purchased in the international marketplace.
Significant differences in discoloration are immediately apparent. The
extremely long filtration time (Table 1) for the only slightly discolored
Sample II indicates the presence of almost invisible impurities in this
material, which are clogging the filter. Such clogging immediately raises
a number of important questions:

What impurities are clogging the filters
and are responsible for the discoloration?

Have toxicological risks of these impurities been evaluated?

Do these manufacturers have their manufacturing process under

Do these manufacturers have a reliable HACCP/GMP system in place?

A simple calculation will serve to demonstrate the importance of a
supplier-specific risk assessment and the dire consequences of using
contaminated ingredients: Given a usual dosage of 400 mg of potassium
sorbate per liter of beverage, one ton of contaminated potassium sorbate
could spoil 2.5 million liters of beverage. For these and other reasons it is
essential to undertake a supplier-specific risk assessment.

The tool used for conducting a supplier-specific risk assessment is a
questionnaire sent to all potential suppliers who are asked to answer
questions of the following kind:

Is the company an international supplier?

Does the manufacturer have a quality management system (QMS) and
food safety system, including HACCP, in place? Ask for descriptions of
the systems in place.

Have the systems been audited by an accredited and acknowledged
certification company? By whom? Are certificates available?

Is the product fully manufactured in this facility?

Which other products are manufactured in the facility?

Is the product manufactured and packed in a fully dedicated

Does the manufacturer have documented procedures for recording
unusual occurrences/deviations during the manufacturing process?
What were the three most common occurrences/deviations in the last

Are all international purity requirements (from above basic and
product-specific risk assessment) mentioned in the product specification
from the supplier and in the COA?

Are the values in the COA analytically determined for each delivered
batch? Can the manufacturer provide statistic evaluations/Cpk values for
these purity criteria to prove process stability?

Which manufacturing process/raw materials/chemical reactions are
used? What impurities can be introduced by raw
materials/catalysts/processing aids/process water?

What by-products/impurities are formed during the chemical reaction
and could be present in the supplied ingredient?

Does the manufacturer test for these by-products/impurities in in-
process controls and final release testing of the food additive? How
often? Are these impurities statistically evaluated? Does the supplier
provide historical data?

Does the manufacturer provide analytical methods for this impurity

Does the manufacturer test each batch for these impurities and are the
results mentioned in the COA?

Does the manufacturer undertake comprehensive testing of the
ingredient for a variety of heavy metals not mentioned in legal
requirements (to detect heavy metals originating from raw materials
and/or corrosion in the manufacturing equipment)?

Are samples checked for soluble/insoluble impurities
(discoloration/filtration test)?

What control equipment/procedures are in place for the detection of
foreign materials (e.g., metal, glass, plastics, wood, etc.)?
Food Safety Inconceivable Without Traceability
According to Regulation 178/2002 (Article 3) of EC General Food Law,
traceability is defined as: The ability to trace and follow a food, feed,
food-producing animal, or substance (e. g., food ingredient)through all
stages of production, processing, and distribution. The importance of
traceability can hardly be overstated because food safety is impossible
without it. Each food safety management system is only as safe as the
weakest link of its chain. It is essential for a food manufacturer to know
that all traceability data are quickly accessible in a crisis situation and
that no gaps exist. Otherwise, crisis management would be impossible;
product recalls may become necessary with all the ensuing brand
damage. Nobody can opt out of the traceability chain; it must be intact
along the entire supply chain.

A properly functioning traceability system provides complete
information relating to product and production process, comprising:

Raw material/packaging materials

Manufacturing records

HACCP/GMP records

Retained samples

Laboratory testing reports

Filling/packaging protocols

Logistics/transportation documentation

It is only through the availability of this complete documentation that a
food or beverage company purchasing food ingredients is assured of
complete traceability of the purchased ingredient.

Many food companies buy their ingredients from distributors rather
than directly from the manufacturers. A buyer/food manufacturer
purchasing from a distributor fulfills all legal requirements pertaining to
traceability provided that records are kept of when each batch of food
ingredient was purchased from which distributor and in which food
product it was processed. Should a problem arise, however, the food
manufacturer or the retailer then has to be able to very quickly access the
traceability data, via the distributor, all the way back to manufacture of
the ingredient for risk assessment. It is absolutely essential that this
traceability is assured and should already be tested during the
qualification process. For example, once a sample has been sent by a
manufacturer the re-traceability can be established for that sample.

Since failure to ensure traceability will be viewed as a basic and
fundamental flaw by customers/supermarkets, it is essential that a food
manufacturer has answers to the following questions:

Is the supplier a distributor or the manufacturer?

Is a distributor re-labeling the product? Make sure that a distributor
names the manufacturer and that you qualify and approve material from
just this manufacturer who is producing the product in the plant you are
approving. Get the name and address of the facility in which the product
is manufactured.

Is traceability guaranteed back to this manufacturer?

Does this manufacturer have a traceability system in place to trace
backback to raw and packaging materials?

Is the product clearly identifiable through a unique name/code
throughout the entire manufacturing process?

Within how many hours is traceability/batch information available
from this manufacturer?

Together with the data acquired for basic and product-specific risk
assessment, the answers to the above questions provide essential
information for an overall risk assessment. Consider-ation of the results
in conjunction with price information, transportation costs, and other
financial details then provides a basis for choice of a suitable supplier.

The first step in selecting a competent and reliable supplier is to consult
with experts in preparing a dossier for each of the individual food
additives that a food or beverage manufacturer may wish to purchase in
the global marketplace. This will contain information of a basic nature
and of a product-specific nature, which is readily accessible from
compilations already produced by various national and international
organizations and can be supplemented by specific items of information
obtained in-house by company experts or external specialists. The
company thus becomes aware of all the possible forms of contamination
that may be present in a given food additive and can undertake basic and
product-specific risk assessment.

In a second step, potential suppliers are then asked to fill out a
questionnaire to provide information for a supplier-specific assessment.
The responses will indicate the extent to which a possible supplier is
likely to fulfil international standards of purity. A reputable supplier will
have entire control of the production process used and will not hesitate
to fill in the questionnaire completely and truthfully and thus provide
essential information for supplier selection. Any impurities identified
can then be included in the product specification (as part of a supply
contract), analyzed during product release analysis, and indicated in the

The cost-efficient and effective approach outlined here will help to
minimize the risks involved in choosing the right food ingredient or
other food chain supplier by providing a reliable route through the
highways and byways of the global marketplace without U-turns,
deviations or disappointments.

Christian Klug, Ph.D., is Director Quality Management, Food Safety &
Security at Nutrinova, a subsidiary of Celanese. Over the past years, Dr. Klug
has held senior management positions in the food ingredients industry. He is a
qualified auditor for DIN EN ISO 9001 and DIN EN ISO 14001, as well as for
the FPA-SAFE program, and he is a qualified EFQM trainer. He has developed
and implemented an integrated system for food safety and security, covering the
supply chain from raw material purchasing, production and warehousing, to the
distribution of Nutrinovas food ingredients to the customer.
Categories: Management: Risk Assessment