Case study 07: Pasta company

Objective:
1. To know how to approach issues on labelling, allergen, analysis plan

2. Know how to collect findings, report on evidences and evaluate IFS-requirements accordingly

Task:
1. Preparing Assessment findings on the basis of information provided by the company

2. In case of deviations and non-conformities, score and describe them against IFS Food
requirements

Documents:
Information provided by the auditor, particularly in the case study:

 CS_07_a_1_ann1_Pasta_allergen questionnaire
 CS_07_a_2_ann2_Pasta_soya validation
 CS_07_a_3_ann3_Pasta_analysis plan
 Check list IFS Food V 7

Results:

 Assessment findings on respective chapters/requirements of IFS Food

 Score against chosen IFS requirements

Steps:
First part: 30 min – working groups separately
 Read the documents
 Decide on team leader
 Establish findings and score
 Results of the working groups are presented to the plenary session and discussed

Second part: 10 min – all working groups together

 Plenary presentation/ discussion of results

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 Company: Pasta Company S.p.A.

Scope:
PRODUCTION OF LONG AND SHORT PASTA MADE OF SOFT WHEAT FLOUR, DURUM
WHEAT SEMOLINA AND WHOLEGRAIN, WITH THE POSSIBILITY TO INCLUDE OTHER
INGREDIENTS, PACKED IN PP BAGS, PET BAGS AND CARDBOARD CASES.
Product scope(s): 6
Technology scope(s): F (P11, P12)

Number of employees: 65 in 3 shifts.

Description:
The company has in place: 8 stainless steel silos for semolina storage (capacity 35 tons each, all of
them are located in a specific department inside the factory); 3 production lines (2 lines for the production
of short pasta and 1 line for the production of long pasta); 39 silos for the storage of the pasta waiting
for the packaging process and 10 packaging lines.
The company produces the following products: pasta with the possibility to include de-hydrated
ingredients such as: spinach, tomatoes, vitamins, eggs, packed in PP / PET bags or cardboard cases.
All lines can be used for all kinds of recipes.
The finished products are sold in Europe.

The manufacturing process includes the following steps: raw material and packaging receiving, storage
at room temperature, mixing, extrusion, cutting, drying and cooling with the potential for storage in silos,
packaging (CCP – metal detector), temporary storage of the finished product and dispatching. Water in
contact with the product is municipal water.

Specifications concerning raw material and packaging and declarations of conformity concerning
packaging are available.

The company handles the following allergens on site: gluten, egg.

A list of all raw materials containing allergens is available and up to date; that also identifies all blends
and formulas where such raw materials containing allergens are added. Procedures are in place to
minimize cross contamination as much as possible.
The company has carried out a specific validation (issued 17/01/2016) in order to assure that potential
presence of soya is not in the finished product, because the suppliers of semolina and wheat declared
the possible presence of soya in the raw materials.
At the moment, no client has requested the absence of “traces” of soya in the finished product.
The company has decided to label as allergens: gluten (always ingredient) and egg (ingredient or
potential presence), and, according to their validation, avoid to label the potential presence of soya.

A canteen is not available because, according to the local law, the employees can skip their meal and
work 1 hour less in their shift. If a break is needed, employees can use the break room, where a vending
machine is located. After a specific request by a client who demand nut-free products, only nut-free
snacks are allowed in the vending machine.

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The auditor looks at the site map, where the flows of raw materials, water, packaging materials, finished
product, waste, and personnel are described. Later, the Assessment team moves to the production
plant.

In the locker room, an empty nut-bar wrapper and an empty cup of yogurt are seen in the waste
container. After a request of clarification, the Quality Manager states that requirements for personal
hygiene are in place and, according to the internal regulation, it’s only possible to consume those snacks
and drinks sold in the break room.

Moving to the packaging department, the following products are in the process of being packaged: Pasta
“Fusilli” 500 g in PP bag, Pasta “Fusilli” 500 g in cardboard cases, Pasta “Spaghetti” 1 kg in PP bag.
Observing the packaging, the following data are printed:

Product Data printed on the packs

Pasta “Fusilli” 500 g in PP bag

Pasta “Spaghetti” 1 kg in PP bag

Pasta “Fusilli” 500 g in cardboard cases

After a request of clarification on printing process, the production manager answers that “sometimes the
printers must be cleaned”. He stops all the packaging lines and calls the maintenance staff in order to
clean the equipment. During the time of repairing, the workers are sent to the break room for a break.
After 10 minutes, all machines and workers start again the packaging process (without further actions
on the already packed products).

At the packaging stations, there are records about the following checks:
 Metal detector monitoring (CCP)
 Packaging sealing
 Consistency between the labelling and the product
 Batch / Best Before: correctness and readability
For all above products, no deviations are reported.

Coming back to the office, the following documents are requested:

 Allergens questionnaire concerning the semolina and wheat flour (Annex 1)
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 Validation concerning the amount of vitamins in “Pasta with vitamins”
 Validation concerning the absence of soya in the finished product (Annex 2)
 Analysis Plan (Annex 3)

The auditor requests if the analysis plan had been reviewed lately. The quality manager confirms that
the document has been confirmed in the last management review. The parameters were defined in
accordance with the consultant who works at the external Accredited Laboratory and the frequency of
sampling were decided by the Plant Manager taking into account the available budget.

While the auditor checks the documentation, the Quality Manager records the previously identified non-
conformity in the “non-conformity register” writing the following description: “the printers didn’t work
properly; the workers at the packaging lines notified the episode and the maintenance staff cleaned
them up. The out of specification product was segregated, checked and packaged again with the same
data”.

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IFS Food V 7 checklist
Score Findings
N° IFS Requirement
Product development / Product modification /
4.3
Modification of production processes
A procedure shall be in place to ensure that labelling *Compulsory field
4.3.4* complies with current legislation of the destination
country /ies and customer requirements.
4.5 Product packaging
Based on hazard analysis, assessment of associated
risks and intended use, the company shall define the key
parameters for the packaging materials in detailed
specifications complying with the current relevant
legislation and other relevant hazards or risks.
The company shall check and verify the suitability and
4.5.1* existence of functional barrier(s) of the consumer unit
packaging material for each relevant product test /
analysis, such as:
• organoleptic tests
• storage tests
• chemical analyses *Compulsory field
• migration test results.
For all packaging materials which could have an impact
on products, certificates of conformity shall exist which
attest conformance with legal requirements. In the event
that no specific legal requirements are applicable,
4.5.2
evidence shall be available to demonstrate that
packaging materials are suitable for use. This applies for
packaging materials which could have an influence on
raw materials, semi-finished and finished products
The company shall ensure that the used packaging and
labelling corresponds to the product being packed and
4.5.3
comply with agreed customer product specifications.
This shall be regularly checked and documented.
4.19 Allergen risk mitigation

Raw material specifications that identify allergens

requiring declarations relevant to the country of sale of
the finished products shall be available. The company
4.19.1 shall maintain a continuously up-to-date listing of all raw
materials containing allergens used on the premises.
This shall also identify all blends and formulas to which
such raw materials containing allergens are added.

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 Score Findings
N° IFS Requirement

Based on hazard analysis and assessment of associated

risk, preventive and control measures shall be in place
from receipt to dispatch, to ensure that potential cross
contamination of products by allergens is minimized. The
potential cross contamination risks related to:
4.19.2*
- environment
- transport
- storage
- raw materials shall be considered
Control measures shall be verified.
*Compulsory field
Finished products containing allergens that require
declaration shall be declared in accordance with legal
requirements. Accidental or technically unavoidable
cross-contaminations of legally
declared allergens and traces shall be labelled. The
4.19.3
decision shall be based on a hazard analysis
and assessment of associated risks. The potential cross-
contamination with allergens from raw
materials processed in the company shall also be taken
into account on the product label.
5.6 Product and process analysis
Testing plans, for internal and external analysis shall be
justified by risk assessment to ensure that product safety,
quality, safety, legal and specific customer requirements
are met. The plans shall cover topics, such as:
- raw materials
5.6.1* - semi-finished products
- finished products
- packaging materials
- contact surfaces of processing equipment
- relevant parameters for environmental monitoring
All test results shall be recorded. *Compulsory field
Analyses, which are relevant for food safety, shall
preferably be performed by laboratories with appropriate
accredited programs/ methods (ISO/IEC 17025). If the
analyses are performed internally or by a laboratory
5.6.2*
without the appropriate accredited programs/ methods,
the results shall be verified on a regular basis by *Compulsory field
laboratories accredited to these programs/ methods
(ISO/IEC 17025).
Procedures shall exist which ensure the reliability of the
internal analyses results, based on officially recognized
5.6.3
analysis methods. This shall be demonstrated by ring
tests or other proficiency tests.
For verification of the quality of the finished product,
internal organoleptic tests shall be carried out regularly.
These tests shall be in accordance with specifications
5.6.6
and related to the impact on respective parameters of
product characteristics. The results of these tests shall
be documented.

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 Score Findings
N° IFS Requirement

Management of non-conformities and non-

5.10
conforming products

Where non-conformities are identified, immediate actions

5.10.3 shall be taken to ensure that food safety and product
quality requirements are complied with.

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