Professional Documents
Culture Documents
September 3
Level 4 Award in
Food Safety
Management for
Manufacturing
2010
Staplmead Ltd.
Staplemead is a Dairy Manufacturing Company located in Frome, Somerset
From, Somerset. The main products include Custards, BA11 2NQ
Sour Cream, and Flavoured milk.
01373 457600
Changes in legislation effective from January 2006 have placed greater accountability on
anyone in the food business with supervisory responsibility. It is therefore vital they are
equipped with both the knowledge and confidence to do their job effectively. This advanced
level course is designed for those working in food businesses at a managerial level and
responsible for the planning and implementation of a cost-effective food hygiene
programme and training. From October, this will be a six day course. The course has been
developed for those who are responsible for the control and promotion of effective food
safety practice in the workplace.
Effective food safety training ensures we know WHY we must do the right things not simply
WHAT we should be doing. When food handlers get it wrong our consumers and our
business suffer.
There are rarely second chances when it comes to food safety and the reputation of our
business. Customer awareness increases daily thanks to the speed and availability of
information. Never before have had our customers had so much choice about what they
buy from where.
The Level 4 Award in Food Safety is the CIEH's higher level accredited course (formally
called "Advanced") and is designed for those whose roles require that extra knowledge
including Food Business Operators, Owners, Technical Managers, Hygiene Managers,
Production Managers and Trainers. These courses are provided to support the specialist in
our business.
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Chartered "" \, .
Institute of \
Environmental .
Heolth
Title of assignment:
Aj>?I~ I\/rvl e: I" J r
I hereby certify that the submitted assignment is my own work, I have not received unauthorised
assistance in completing this assignment and understand that it has been produced for assessment
purposes only.
1 A description of how food safety management procedures ensure effective compliance with
current legislation and codes of practice in your catering business. 10 marks
2 An explanation of how you, as a manager in your manufacturing business, can establish, monitor
and verify food safety management procedures. 15 marks
3 A critical analysis of an incident when a food safety management procedure failed - including
recommendations of the corrective actions that could be taken and an explanation of how this
information could be communicated to staff to ensure food safety in the future. 25 marks
Please note: The food safety management procedure selected for Section 3 of your report must not be
the same as the one selected for your elective assignment.
Assignment A:
1. From 1st January 2006 a number of new food hygiene regulations apply in the UK. The most
important regulations for business are:
Almost all of the requirements in the new laws are the same as the ones they replace. The main new
requirement is that we must be able to show what we do to make or sell food that is safe to eat and
have this written down.
2. The law requires us to have in place procedures to manage food safety ‘hazards’. This is similar to
previous legal requirements, but we must now write our procedures down, keep them up to date and
regularly review them.
3. These procedures can be in proportion to the size of business and the type of work we do.
A few major pieces of food safety legislation now cover all sectors of the food chain ‘from farm to
fork’, consolidating a lot of previous sector-specific and product-specific requirements. The main
legislations are below:
Regulation (EC) No. 178/2002 – this contains many of the definitions and basic principles for most
matters relating to hygiene
Food Safety Act 1990 – this deals mainly with food standards
The Food Hygiene (England) Regulations 2006 and the equivalent legislation for Wales, Scotland and
Northern Ireland – these deal with general food Hygiene requirements in the UK, offences and the
provision of enforcement powers.
Regulation (EC) No. 852/2004 on the hygiene of foodstuffs – this contains the main hygiene
requirements with which all businesses must comply, including a requirement to incorporate HACCP
principles into company procedures.
Regulation (EC) No. 2073/2005 on the microbiological criteria for foodstuffs – a perspective piece of
legislation dealing with microbiological standards in certain foods
General Food Regulations 2004 – deals mainly with legal issues, including offences under Regulation
(EC) No. 178/2002
Regulation (EC) No. 178/2002
This piece of legislation is sometimes unofficially referred to as ‘the European food safety Act’ because it
establishes the principles of food law and identifies the legal obligations of business and governments.
It includes:
It covers all stages of the food chain from
primary production to the sale (‘placing on Many of the definitions used in EU food law
the market’) o products and establishes The general principles of food law based on risk
the rights of consumers to safe food and to management and precautionary principle
accurate and honest information about it Safety requirements for food placed on the market
Procedures for dealing with food safety problems
The principle of traceability
Arrangements for the removal of unsafe food from
the market
Risk based approach required Food law must be based upon Risk assessments have been done
risk analysis, consisting of risk to all the departments and lines. All
assessment, risk management
hazards were taken into account
and risk communication. Risk
assessment must be based on like Microbiological, Chemical,
available scientific evidence Physical and Allergens. From intake
of raw materials to the delivery of
finished goods. Everything has
been recorded for traceability.
Article 14 Food safety requirements How we do it
Unsafe food defined as being Food law must be based upon risk There is a HACCP system in place
injurious to human health or unfit analysis, consisting of risk which makes sure food is safe to
for human consumption because of assessment, risk management eat.
contamination or spoilage and risk communication. Risk
It is deemed to be unsafe if it is
assessment must be based on
considered to be:
available scientific evidence
a) Injurious to health
Packaging etc must not mislead The promotion, packaging, There is a HACCP system in place
consumers labelling, display setting and so on which makes sure food is safe to
must not lead consumers eat.
Product tracing systems required All procedures and steps with At all stages of production,
throughout the food chain. materials should be traceable. processing and distribution there is
a system in place, which include
identification of documentation, to
ensure that food placed on the
market can be traced, and the
information can be made available
to the competent authorities when
requested to do so. All suppliers
are approved and identifiable.
There is ‘one up, one down’
traceability on place.
Systems for withdrawing and In case of emergency, unsafe food System in place where if a business
recalling unsafe food. must be withdraw or recalled believes that food is unsafe,
back. immediate initiating procedures
kicked up to withdraw food from
the market and, if necessary, can
be recall food that has already
reached the consumer.
Food Safety Act 1990
The Food Safety Act 1990, is an Act of Parliament of the Parliament of the United Kingdom. It regulates the
statutory obligation to treat food intended for human consumption in a controlled and managed way.
The key requirements of the Act are that food must comply with food safety requirements, must be
"of the nature, substance and quality demanded", and must be correctly described (labelled).
Nature – food different to what All food sold must be ‘of the All products have got their Checks
was requested. nature or substance or quality before Production. Aroma, texture,
demanded by the purchaser’. Nature, pH, Colour, Viscosity, Fat
Substance – not of the correct
levels%, Weights, Sizes etc. All
composition or containing physical
approved by customers and have a
contaminants.
check sheets to make sure all
Quality – the standard expected. products meet customer demand.
Food hygiene Regulations 2006
The Food Hygiene (Northern Ireland) Regulations 2006 and subsequent amendments.
The regulation deals largely with the regulation and enforcement of food safety, plus temperature control,
and is the main British route to enforcing the main European Regulations.
Defence of due diligence. Offence Two main defences under these To demonstrate that every
committed by someone else. Regulations, either: possible reasonable step taken to
achieve safe food, we have written
That the offence was the
records to support defence. All
fault of another person
documents based on HACCP
due diligence Principles like, records of Staff
Training, Temperature
measurements, cleaning
schedules, supplier specifications,
traceability system, remedial
action where food safety problems
have arisen and pest control
measures.
Detailed temperature control High-risk foods must be kept or We have all the temperature
requirements. Chill and Hot below 8 °C or at 63 °C above. control system and records in
holding requirements. place to support HACCP.
Pasteurization Temp
Despatch Temp
Regulation (EC) No. 852/2004 on the hygiene of foodstuffs
The fundamental aim of any hygiene regulation is to create conditions in a food business that will lead to the safe
working production of food. Generally Speaking, this regulation takes a two-prolonged approach.
The management and control of the structure of food premises and the equipment used
The Regulation seeks to ensure a high level of food hygiene at all stages of the production process (production,
processing and distribution of food). A key point of the legislation is that the main responsibility for food safety
rests with “food business operators”, with a single hygiene policy applicable to all foodstuffs and all operators.
The text defines the obligations of food operators, setting out general and specific hygiene rules and requiring
the establishment, implementation and maintenance of procedures based on HACCP principles.
The regulation foresees that food businesses may use guides to good practices as an aid to comply with their
obligations. Such guides to good practices for hygiene and for the application of HACCP principles can be
developed by each sector at national or Community level.
To facilitate the implementation and interpretation of the Regulation, the European Commission issued the
following guidance documents:
Guidance document on the implementation of procedures based on the HACCP principles, and on the
facilitation
Food business must register Food business must register all Registered with the local council
premises with the competent and competent Authority.
authority.
Main requirements of the regulations
IV.2: Dedicated containers and Containers or vehicles used must be Do not use the containers or
vehicles used for bulk transport of reserved for food only and marked as vehicles to transport anything
food in liquid, granular or powder such, when there is a risk of other than food if this may result
form contamination in contamination
Foodstuffs in conveyances or
IV.5: Minimising the risk of containers must be placed so as
contamination to minimise the risk of
contamination
Everyone in a food
Food handlers must wear suitable
handling area must
VIII.1: Personal hygiene clean and, where appropriate,
maintain a high level of
protective clothing
personal cleanliness
No raw materials or
ingredients should be
accepted if known or
suspected of being
IX.1: Raw materials
contaminated and which
would still be unfit after
normal sorting or
processing
PRE REQUISITES:
Training
Waste disposal
Training How we do it
Documentation Held In
a. Jewellery
b. Hand washing
c. Fingernails
d. Perfume
e. Smoking
f. Cuts and grazes
Documentation Held In
Site Hygiene rules, PR-042 Technical
Plaster metal detection log. Log-009 Technical
Plaster Issue Log, Log-044 Technical
Lost Plaster Investigation Form, Log-045 Technical
Good Hygiene Practices How we do it
a) Wet hands
b) Apply soap
c) Rub palms and back of hands thumbs, backs of and
between fingers and repeat 5 times
d) Rinse with water
e) Dry hands
f) Apply and rub in sanitizer
Documentation Held In
Documentation Held In
Support of Management
The success of HACCP depends upon the behaviour and commitment of all plant employees to food safety.
Management must provide financial and philosophical support to HACCP because it demonstrates an awareness
of the benefits of the program. Employees will not take HACCP seriously if it does not receive visible support from
their supervisors and upper management.
Product Description
Plants are required to have a HACCP plan for each product they make. With each HACCP plan, a complete
description of the product and the raw ingredients that go into the product are required. Some of the product
description information that should
be listed for each product includes:
Product's common name
How the product will be used
Type of packaging material
Length of product's shelf-life, and at what temperature
Where product will be sold
Product's labelling instructions
Any special instructions for the product
Employee Training
All employees should be given HACCP training, but at levels relating to their responsibilities within the HACCP
plan. Extensive training of line workers is critical because these are the individuals responsible for the product.
Everyone at the facility in contact with the products should receive an overview of HACCP, as well as information
regarding the company’s HACCP policies and procedures.
5 Establish corrective action to be taken if the CCP deviates from the critical limit.
Conclusion
HACCP was designed to prevent hazardous products from leaving the manufacturing or processing facility.
However, the key to the success of HACCP is employee training, behaviour and attitude. Some companies are
under the misconception that they already have a HACCP plan because they are adequately controlling all areas
where safety could be compromised. The difference is that rather than monitoring isolated processing steps, a
HACCP approach controls the entire production process as an integrated system. Although HACCP provides
insurance that product is safe, there is no way to completely eliminate all hazards. HACCP is most effective when
used with other control systems. Total Quality Management programs or ISO 9000 and Standard Operating
Procedures should be used along with HACCP to improve product safety, product quality, and plant productivity
by providing intimate knowledge of the production process, production environment and processing equipment.
Figure 1: Flow Diagram
Table 2: CCP Chart
Assignment A:
Food Safety Management Procedures
3 A critical analysis of an incident when a food safety management procedure failed –
including recommendations of the corrective actions that could be taken and an
explanation how information could be communicated to staff to ensure food safety in
future
Introduction
We produce different kind of flavoured milks. These are of different sizes from 1 litre size to 330 mil size. The
bottles came to Factory as in Pallets and covered in Plastic Bag. These are then taken inside the factory where
they are de-stacked and send to Production Line. On Production line they are then taken out from plastic bag
and put on the line. Then they go under the filler line to be filled and then caps goes on top. Labelled and then
goes in to boxes to get stacked on Pallet. From there they goes to Cold store from where they are despatched to
the Customers.
A piece of Plastic bag (Swarf) was found inside the 1 litre bottle before going to be filled.
Start of Production, when the bottles were on conveyor and before being filled with milk.
After De-canting the bottles Area and before going to the filler.
Found by operator who was looking after the bottles and also keep a visual check for any non-conformance
with the bottles.
`
Corrective Actions and Recommendations
QDA
The Quality defect Alert was raised. As it was a non-conformance and a possible food hazard with Physical
contamination it was necessary to understand the problem and find the right solution. The system was failed to
stop this kind of contamination inside the bottle and it could gone to customer.
INVESTIGATION
The investigation was done to understand and find the root cause of the problem. First of all we checked all the
following point:
The piece which was found to be in the bottle was identified. It was come from the bag inside which
bottles were packed and supplied to us. There is a safe policy and method of debagging the bottles from
the plastic bag so no swarf contaminates bottles.
To cut the bags we use Fish knives which are specifically made for industrial use and are very safe to
cut. Risk assessments have been carried out previously and it’s a safe practice to use them in
production. Before coming to production the bottles are sealed in plastic blue bags which mean no
physical contamination occurs. So how did it happen?
Staff: The person who was de-bagging the bottles was well trained and is a senior operator. He uses the fish
knife to cut the bag He did not notice anything as he was rushing the job and trying to cope with the line
speed. Everything was done according to policy and we couldn’t find any fault apart from that a swarf
might gone to a bottle after de-canting (de-bagging) of bottles.
We had a HACCP review meeting with all the HACCP team which includes the Technical Manager, QA, Engineers
and staff from Production and Planning. With HACCP Review Meeting we reviewed the whole process again.
Process Flow
All staff on the line is trained on De-canting of bottles and physical contamination hazards.
It was the first case in years and we never had this kind of contamination happened before.
There is a need of a process which eliminates this risk before filling line.
Risk Assessment
From risk assessments now it was evident that we do need more robust system in place to ensure the food
safety. As the line runs with 200 bottles per minute, it is impossible with a naked eye to control this risk.
#therefore there is a need of some automated process to eliminate this risk.
Recommendations
Few recommendations were put forward to make sure it won’t happen again:
1) Bottle Inverter : To make sure the bottles were emptied before filling
2) Staff Training : More staff training to make sure that staff understands the importance of controlling
hazards and are more vigilant
3) X-ray or Any other form of detector : To detect and foreign body inside the bottles
4) Vacuum sucked: Vacuum chamber where bottles were vacuumed making sure nothing inside the bottles.
5) Extra staff : To inspect each and every bottle
First and second option was more suitable and can be implemented in a short term. Rest of them are really costly
and long term solutions. We were sure that first 2 will almost eliminate the risk of hazard.
Corrective and preventive measures
BOTTLE INVERTER:
After HACCP meeting it was decided that there is a need of Bottle Inverter to make sure that no bottle goes to
filler with physical contamination. This machine works as turning bottles upside down to make sure whatever is
inside the bottles drop down.
After De-Bagging all the bottles goes through conveyor to Bottle inverter where they turn upside down and then
after passing this inverter goes to filler machine.
Bottle Inverter
Process Flow
Risk Assessment
Training
1. All relevant personnel including temporary staff and contractors are appropriately trained prior to commencing
work and adequately supervised throughout the working period. This is in the form of an induction either carried
out by the agency or on site. All staff should have completed induction training prior to the end of their
probationary period. An induction checklist should be signed off as confirmation this has been carried out. All new
staff to the factory should sign off first day induction training to confirm they are aware of the points documented.
A copy should be kept by employee and held on file.
2. All personnel engaged in activities relating to critical control points should have relevant training and
documented evidence will be a record made on the persons training records covering off the CCP.
3. Personnel holds each person’s training records to provide evidence what training is required to carry out the
role and signed off documentation on the status of the training carried out. Internal audits and monitoring of
Quality Defect Alerts are used as a method of reviewing the implementation and effectiveness of training and
competency of trainer. All staff complete a 13 week probationary period which is monitored by departmental
heads and personnel department.
a. Name of employee
e. Training provider
f. A copy of the contents of the course should be held with training/personnel department
5. A yearly review of the competencies of staff is carried out and where necessary relevant training is carried out
as deemed necessary by the departmental head. The review will take into consideration any finding following
internal audits, quality defect alerts or changes that have arisen within the department. The review should be
documented by the departmental head and signed off on the training log. Relevant training can be either by
formal training, on the job experience or refresher training.
Food Safety refresher training should be carried out on average every 3 – 4 years.
Verification
Objective to ensure that the hazards identified in the study are complete and correct and that the
selected controls for these Hazards are suitable.
Validation
Chartered
~
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Institute of \
Environmental
Health
Title of assignment:
MSSir4.N (III€N T 8 - Al..LE:f<.f;,eN GJN m-n~'NI'I710N
I hereby certify that the submitted assignment is my own work, I have not received unauthorised
assistance in completing this aSSignment and understand that it has been produced for assessment
purposes only.
3 A critical analysis of the corrective actions you could take in the event of a failure of an allergen
contamination control, with your recommendations of the most appropriate corrective actions,
and an explanation of how you would communicate this information to staff to ensure food safety
in the future. 25 marks
Assignment B:
Allergen Contamination
1. Description of how allergen contamination controls, including with
current legislation and codes of practice, contributes to food safety in
your manufacturing business.
Allergen Controls
There are both criminal and civil legal regimes relevant to the sale of foods containing allergens and the
provision of ‘allergen-free’ lists. It is essential that these are given careful consideration. The following is a
brief outline of the main provisions to assist manufacturers in identifying their legal obligations and the
appropriate courses of action in respect of Good Manufacturing Practice and the provision of information to,
or for communication to, consumers. Also with respect to those regulations I will point out how we abide
those regulations at our work place to make food safe and better.
This piece of legislation is sometimes unofficially referred to as ‘the European food Safety Act’ because it
establishes the principles of food law and identifies the legal obligation of food business and governments.
Risk based approach required Food law must be based upon Risk assessments have been done
risk analysis, consisting of risk to all the departments and lines. All
assessment, risk management hazards were taken into account
and risk communication. Risk like Microbiological, Chemical,
assessment must be based on Physical and Allergens. From in-
available scientific evidence take of raw materials to the
delivery of finished goods.
Everything has been recorded for
traceability.
Unsafe food defined as being Food law must be based upon There is a HACCP system in place
injurious to human health or unfit risk analysis, consisting of risk which makes sure food is safe to
for human consumption because assessment, risk management eat.
of contamination or spoilage and risk communication. Risk
It is deemed to be unsafe if it is
assessment must be based on
considered to be:
available scientific evidence
a) Injurious to health
Packaging etc. must not mislead The promotion, packaging, There is a HACCP system in place
consumers labelling, display setting and so which makes sure food is safe to
on must not lead consumers eat.
The Food Safety Act 1990 is an Act of Parliament of the Parliament of the United Kingdom. It regulates the
statutory obligation to treat food intended for human consumption in a controlled and managed way.
The key requirements of the Act are that food must comply with food safety requirements, must be "of the
nature, substance and quality demanded", and must be correctly described (labelled).
Offence to sell food for human It is an offence for a food business Every step of the process makes
consumption if it is injurious to to sell food for human sure that food is safe to consume.
health. consumption if it has been made Everything is declared on
injurious to health by: ingredients information on
packaging so consumer can easily
Adding any article or see what product is constituted of.
substance to a food that
renders it injurious to
health
Abstracting any
constituent from the food
that renders it injurious
to health
Nature – food different to what All food sold must be ‘of the All products have got their Checks
was requested. nature or substance or quality before Production. Aroma, texture,
demanded by the purchaser’. Nature, pH, Colour, Viscosity, Fat
Substance – not of the correct
levels%, Weights, Sizes etc. All
composition or containing physical
approved by customers and have a
contaminants.
check sheets to make sure all
Quality – the standard expected. products meet customer demand.
The Food Hygiene (Northern Ireland) Regulations 2006 and subsequent amendments.
The regulation deals largely with the regulation and enforcement of food safety, plus temperature control,
and is the main British route to enforcing the main European Regulations.
Defence of due diligence. Offence Two main defences under these To demonstrate that every
committed by someone else. Regulations, either: possible reasonable step taken to
achieve safe food, we have written
That the offence was the
records to support defence. All
fault of another person
documents based on HACCP
due diligence Principles like, records of Staff
Training, Temperature
measurements, cleaning
schedules, supplier specifications,
traceability system, remedial
action where food safety problems
have arisen and pest control
measures.
Regulation (EC) No. 852/2004 on the hygiene of foodstuffs
The fundamental aim of any hygiene regulation is to create conditions in a food business that will lead to the safe
working production of food. Generally Speaking, this regulation takes a two-prolonged approach.
The management and control of the structure of food premises and the equipment used
The Regulation seeks to ensure a high level of food hygiene at all stages of the production process (production,
processing and distribution of food). A key point of the legislation is that the main responsibility for food safety
rests with “food business operators”, with a single hygiene policy applicable to all foodstuffs and all operators.
The text defines the obligations of food operators, setting out general and specific hygiene rules and requiring
the establishment, implementation and maintenance of procedures based on HACCP principles.
The regulation foresees that food businesses may use guides to good practices as an aid to comply with their
obligations. Such guides to good practices for hygiene and for the application of HACCP principles can be
developed by each sector at national or Community level.
To facilitate the implementation and interpretation of the Regulation, the European Commission issued the
following guidance documents:
Guidance document on the implementation of procedures based on the HACCP principles, and on the
facilitation
Procedures must exist based upon Food business operators must put 1: Conduct a hazard analysis.
Allergen Contamination
2. An explanation of how you, as a manager in your manufacturing
business, can establish, monitor and verify allergen contamination
controls.
In order to avoid the unintentional presence of allergenic foods in products it is necessary to evaluate the
likelihood of unintentional allergen cross-contamination across the supply chain, from raw materials through to
the finished product. Following completion of such a risk analysis, manufacturers can then determine whether
or not allergen advisory labelling is appropriate on the finished product as sold to consumers.
Risk analysis is made up of four stages:
Is the food manufactured from any of the allergenic foods specified in the current UK legislations or their derivatives?
YES NO
What is the likelihood, under normal operating conditions, of cross-contamination of the food by specified allergens?
PROBABLE REMOTE
St e p 2 a – C h ec k a g ai n s t i n g r e di e n t l a b elli n g
YES NO
St e p 3 – C h e c k a g ai n s t ex e m p t i o n s lis t
YES NO
Identify the physical form and the characteristics of the potential cross-contaminating allergenic material
YES NO
St e p 6
St e p 7 – C h e c k o t h e r r el e v a n t a ll e r g e n s
YES NO
Processing Raw
Aid Storage Transport
Material
Handling
Packaging People
Cross-
Contamination
Whether manufacturing individual ingredients or complex food products, consistency in risk assessment and
application of risk management measures is always done.
The ‘visually and physically clean’ standard can in principle be applied to each stage in the supply chain.
General Pronciples
Allergens should be managed to avoid their unintentional presence in products wherever possible. This
management involves evaluation of the likelihood of allergen cross-contamination associated with every step of
the food production process, from sourcing raw materials through to marketing of a finished product.
Our business already has Good Manufacturing Practice (GMP) in place. These require a commitment and
discipline to ensure products meet food safety, quality and legal requirements, using appropriate
manufacturing operations, including effective food safety systems (using hazard analysis principles) and quality
assurance systems. Existing GMP controls will assist with allergen management, for example avoiding cross-
contamination by segregation, cleaning, using separate utensils etc. However, it should be noted that unlike
microbiological risks, heating does not necessarily destroy food allergens and may actually increase their
potency, for example roasting peanuts.
The introduction of allergen management into a food business can be seen as an extension of existing food
safety management rather than a completely new system.
Manufacturing
The key aspects of our businesses to be considered in the management of allergens are illustrated in figure 3,
which are then discussed in more detail in the following sections.
All staff (including temporary staff and contractors) involved in handling ingredients, equipment, utensils,
packaging and products are all aware of food allergens and the consequences of their ingestion by sensitive
individuals. They are trained in avoiding cross-contamination of foods by the major food allergens. Appropriate
procedures on the management of allergens have also be available and/or posted wherever they need to be
observed in pursuit of the company’s management policy. Additionally, it is important to ensure awareness of
these procedures on the part of both workers and visitors by posting in the reception and production areas at
least a summary of the critical aspects. Training and awareness procedures include:
There is an appropriate and proportionate policy for assessing the allergen status of ingredients for use within
our own manufacturing processes and premises, and if appropriate, by their suppliers or co-packers. Any
change in supplier must be accompanied by the appropriate checks.
We are all aware of the presence of the major allergens in all raw materials, particularly the potential for
allergen cross contamination from manufacturing and handling activities on the raw material suppliers’ sites, as
well as earlier in the food chain during harvesting and transport. This is done through audits or from asking
suppliers to provide the required information. We ensure that materials are ordered against a clear
specification and that we ask appropriate questions of our suppliers.
Steps have been taken to ensure that non-allergenic ingredients do not come into contact with allergens in
subsequent handling and storage. Allergenic raw materials should be stored in clearly identified areas where
possible, for example, using colour-coded boxes or demarcation of storage areas using painted lines on the
floor.
Where allergenic raw materials are de-bagged or de-boxed, they are placed in dedicated lidded and labelled
containers and made easily identifiable. Such containers are only used for storage of other raw materials after
appropriate cleaning.
(i) Dedicated or
(ii) Thoroughly cleaned after sieving allergenic ingredients.
In summary, practices ensures that the allergen status of all ingredients (including flavourings, additives,
carriers and processing aids), as well as other materials that might come into contact with the food such as
baking release agents, are known:
Check the allergen status of all ingredients with suppliers and review regularly.
Ask suppliers to notify changes in the allergen status of the materials they supply.
Clearly identify allergenic raw materials and segregate where possible.
Ensure the handling of allergenic ingredients does not cause contamination of other ingredients.
Check implications of any change of ingredient supplier.
Manufacturing Premises, Equipment and Processes
Whilst the ideal approach to avoiding cross-contamination with allergens is to dedicate production facilities to
specific allergenic products, it is recognised that food manufacturing premises and product ranges vary greatly
and that this is not always an option particularly in small and micro businesses. Where dedicated production
facilities are not possible, there are a number of ways of separating the production of allergen containing
products from those that do not contain the allergen. These can include separation:
Shared Equipment
Consideration has been given to the dedication of equipment within production facilities.
For example, weighing equipment, scoops and utensils are dedicated and the weighed product placed in
dedicated, lidded and labelled containers.
Consideration also been given to colour coding equipment.
Physical Separation
Physical separation has been considered for ‘high risk’ ingredients and the implications of changes to the layout
of the food production area have been assessed. Consideration has also been given to the ease of cleaning of
equipment. Avoiding the crossover of production lines and allowing adequate space for effective cleaning has
helped minimise the risk of allergen cross-contamination.
Storage
Consideration has been given to the temporary labelling of work in progress. This is, for instance, a half-finished
product that is held-over. Care should be taken that the product is not mistaken for another product with a
different set of allergens. Similarly, care should be taken to label and store packaging materials that are unused
at the end of a production run. Co-products are misshapes and broken products, which for quality reasons are
not acceptable as finished product but could still be consumed by employees or sold through factory shops.
Such products should be subject to the normal allergen labelling controls.
Re-work
Re-work that contains allergenic ingredients should be re-worked only into products that contain that allergen,
for example chocolate that contains nuts or nut fillings should only be re-worked into other nut containing
chocolates. Re-work should be clearly identified in order that it may be tracked in the manufacturing process.
Oils used for cooking allergenic foods (for example, shellfish, fish and breaded or battered products) should not
be used subsequently for cooking products not containing that allergen.
In summary
Is it possible to have dedicated production lines or areas?
Is it possible to erect physical barriers between production lines or areas?
Is it possible to dedicate utensils and equipment?
Is it possible to clean between production runs?
Is it possible to schedule production runs to minimise possible cross-contamination?
Is re-work managed?
Is it possible to manage airflow?
Are held-over products suitably labelled?
Is there a procedure for removing packaging and labelling it before returning it to the stores?
Cleaning
Very small amounts of some allergens, such as nuts, can cause adverse reactions, including potentially fatal
anaphylactic shock. Therefore, thorough cleaning that is effective in reducing the risks of allergen cross
contamination should be used where appropriate. A ‘visually and physically clean’ standard is not just a casual
visual inspection of the production line or area, it also requires that all of the trouble spots are sought out and
inspected. Cleaning practices that are satisfactory for hygiene purposes may not be adequate for removing
some allergens and their validity for such a purpose should be assessed, for example, via residue/environmental
swab testing. Equipment may need to be dismantled and manually cleaned to ensure hard to clean areas are
free from allergen residues. Particular food materials (for example, powders, seeds, pastes and particulates)
present significant cleaning problems and any relevant industry guidance, where this has been developed,
should be followed. Adequate procedures should be in place for cleaning both production and packaging
machinery. Where adequate cleaning is not possible, then the risk of allergen cross-contamination should be
assessed and advisory labelling used, if appropriate.
Care is needed in cleaning to ensure that the cleaning of one line does not contaminate another (for example,
by use of compressed air cleaning), or an area which has already been cleaned (for example, clean dry mix areas
from the top down).
Any spillage that occurs during production, storage and transportation should be cleaned up immediately to
ensure that there is no subsequent allergen cross-contamination. Where known allergen contamination has
occurred, the contaminated material should be labelled and physically moved away from the non-contaminated
ingredients and work-in-progress.
Consideration should be given to maintenance activities, such as the use of dedicated tools or adequate
cleaning procedures where tools are not dedicated.
Where adherence to a cleaning regime is part of a separation system, it should be validated as ‘fit for purpose’
and compliance should be monitored.
Investment in developing and following appropriate cleaning regimes will help to minimise food allergen cross-
contamination and can reduce the likelihood of needing costly product recalls. Ensure that cleaning equipment
itself is cleaned after use to minimise the risk that it may carry and transfer allergen traces.
Establish appropriate cleaning regime including laundering of protective clothing.
Validate cleaning regimes.
Monitor that cleaning is being done properly.
Keep records of cleaning.
Packaging
Incorrect packaging and/or labelling is a major cause of allergen related product recalls. Procedures for checking
that the correct labels are applied to products should be implemented and audited regularly, so that accurate
information is provided to allergic consumers. Checks should be in place between processing and packing to
ensure the correct packaging is used, for example the use of automated label verification systems.
It is important that, following recipe changes or the introduction of a new allergen cross-contamination risk etc,
the old packaging is not only withdrawn from use but is physically destroyed, so that it cannot be used in error.
There are systems to ensure packaging is removed at the end of a run, including any packaging that may be
within the wrapping machine. This will help to avoid packaging mix-ups when the product to be packed is
changed and, therefore, reduce the number of instances in which misleading information is passed to the
consumer.
It is important to ensure that the correct outer packaging is used for multi-pack products and that allergen
information appears on, or is visible through, both the inner and outer wrappers.
Product Formulation
Whenever possible, it is good practice not to include an allergenic ingredient in a product unless necessary. For
example, manufacturers could consider using corn (maize) flour instead of wheat flour or using vegetable oil,
for example sunflower oil, instead of butter. By using allergenic ingredients only when they are essential
components of a food product, one element of the risk from unintentional allergenic cross contamination will
be minimised.
Reformulating Products
Reformulation of a product with the introduction of a new allergenic ingredient may lead to accidental
contamination of other lines produced in the same premises, for which advisory labelling might then become
appropriate. Businesses can benefit from simplification programmes and these might provide opportunities to
discontinue minor lines that bring allergen complexity in manufacturing, as well as reformulating products to
avoid allergenic ingredients.
Extending Brands
If it is decided to extend a brand name into a different product sector (for example, an established
confectionery product giving its name to a dessert product or ice cream), care should be taken that the
presence of any allergen not associated with the original product is clearly indicated. The approach to allergen
labelling across a brand should be as consistent as possible.
Factory Trials and Consumer Testing
If conducting factory trials of allergen-containing products, measures should be taken to avoid allergen cross-
contamination with existing products. Information on the presence, or potential presence, of allergens should
be made available to those involved in factory trials and in taste testing and that information should be clearly
conveyed with products presented for wider test and marketing purposes.
However clearly they are labelled, care should be taken if sample products containing the major food allergens
are distributed or offered where they can be taken by unsupervised children (for example through letterboxes,
in stores or other public places).
Managing Changes
Any changes to one production process within the food production area or the introduction of a new product
line can affect the risks of allergen cross-contamination of other products. Moving production of a product to
another site may also result in a different allergenic risk that needs to be relayed to the consumer. Following
any such changes, it will be necessary to conduct a new assessment of the risks of allergen cross contamination
of a product, including an evaluation of any advisory labelling that might be necessary.
Consumers may unknowingly consume allergen-containing products where changes have been made to the
recipe of a familiar product and allergenic ingredients have been introduced. Any changes to the allergen status
of a product (for example, recipe changes) need to be made obvious to the consumer, for example, by using
prominent labelling flashes, preferably on the front of the pack, in addition to the amended ingredients list.
Suitable warnings might be, for example, ‘New Recipe’ and ‘Now Contains’. It may also be possible to use other
methods such as websites to inform consumers of recipe changes. This is important, as allergic consumers, who
may have been consuming the product for some time, need to be informed of a new potential hazard. In
addition, food manufacturers and retailers are strongly advised to provide updated information to consumer
support organisations such as the Anaphylaxis Campaign and Coeliac UK as they have systems in place for
informing their members about changes.
Allergen Risk Review
Allergen Management Systems should be monitored and reviewed to provide assurance that they are working
correctly. The most effective way of doing this is by carrying out routine checks on manufacturing operations
including an audit or ‘health check’ of the system. An overall ‘health check’ can find any weaknesses in the
system and then corrective actions can be taken. A key benefit of auditing the system is to provide evidence of
due diligence in managing allergens.
The ‘health check’ should as a minimum encompass compliance with GMP requirements, including:
Review and verification of the hazard analysis and hazard management system.
Product and ingredient specifications.
Operating procedures.
Cleaning procedures.
Training records – demonstration of competence.
Analysis of customer complaints.
Internal Audits and External Audits to make sure everything is verified and in place
For example, any changes to one process within a food production area, or introduction of a new product, can
affect the risks of allergen cross contamination of other products manufactured at the same site. Moving
production of a product to another site may also result in a different allergenic risk, which needs to be relayed
to the consumer.
Following any such changes, it will be necessary to conduct a new assessment of the risks of allergen cross-
contamination of a product, including an evaluation of any advisory labelling that might be necessary.
Assignment B:
Allergen Contamination
3 A critical analysis of the corrective actions you could take in the event of a
failure of an allergen contamination control, with your recommendations of
the most appropriate corrective actions, and an explanation of how you
would communicate this information to staff to ensure food safety in the
future.
Introduction
In our company we produce two kinds of Custards. One is normal custard without Allergens and one with
Allergens with eggs in it. To make sure we do have control we have policies defined in our HACCP Plan how to
make sure that cross contamination does not occur.
As we have same line running both products, there is a Cleaning Procedure between Non Allergen Products and
Allergen Products. The line is clean with Caustic and then later disinfects it. This is to make sure there are no
remains of Allergens left on the line and it is safe to run non Allergen Product. There is a physical clean and also
visual check to make sure that cleaning happens.
After running an Allergen Product, the line was not cleaned and we packed non Allergen Product afterwards.
In the early morning when we had a plan to run a new fresh non Allergen Product. It was a normal day with no
Issues or break downs on the line.
On the Custard line where we produce fresh custards (free from allergens) and Luxury Custard (with Allergens).
While going through traceability paperwork, QA found out that the line was not cleaned after running last
Allergen Product. As normal routine of doing traceability, QA found out at the end of run that the product might
be contaminated with Allergens as the line was not cleaned.
Corrective Actions and Recommendations
PRODUCT ON HOLD
The entire product which was made last hour was put on hold. Line was put on clean and the samples were
taken to send external Laboratory
INVESTIGATION
When the Allergen Product ran last time, as it was the last run of production the line was not cleaned
thoroughly instantaneously. It was cleaned by Operator with normal cleaning but as with Allergen it should have
cleaned with Caustic called as CIP. As the day gone by, the operator on the cleaning department forgot to clean
the line as he was busy cleaning other lines. The next day Operator checks visually and found nothing dirty on
top and started the run. There was no check for operator to make sure that line was really cleaned and free of
Allergens.
There was a need of HACCP Review as the system failed and it did not guarantee our Food Safety system.
We had a HACCP review meeting with all the HACCP team which includes the Technical Manager, QA, Engineers
and staff from Production and Planning.
RECOMMENDATIONS:
The cleaning Procedure was fine, but there was no check for operator to make sure the line is clean,
safe and ready to start production.
Protein Swab Checks need to be implemented which can detect trace of Allergens
The lab result came back with some traces of Allergens and we have to destroy the entire product.
Date prepared: 04/11/08 Revision: 2 Prepared by: S. Hudd
Risk assessment for cross contamination of non egg containing products with sugared egg yolk ingredient and custard containing egg
contamination
Probability of
Overall risk
to non egg
Severity
cross
Hazards (Cross contamination to final packed
Step Control Document reference
product)
Spillage during transfer/ storage Spillage kit GEN-033 Sugared egg yolk spillage 3 1 3
Receipt of incoming egg to cold store, put into
storage
Agreed packaging format with supplier and to R-004 Handling of sugared egg yolk and
Wrongly labelled, used in wrong product 3 1 3
be clearly identified as egg. custard containing egg
Transfer/ Storage to processing dept Spillage during transfer/ storage Spillage kit GEN-033 Sugared egg yolk spillage 3 1 3
Red over sleeves and apron to be worn when R-004 Handling of sugared egg yolk and
Cross contamination via operator overalls 3 1 3
mixing egg mixes custard containing egg
Direct purge of product to floor where line Procedure for deep cleaning mix room post R-004 Handling of sugared egg yolk and
3 1 3
purges last 250L of skim to mix tank egg mixes custard containing egg
End of mix purges to floor
Red over sleeves and apron to be worn when R-004 Handling of sugared egg yolk and
Cross contamination via operator overalls 3 1 3
filling custard egg custard custard containing egg
Cross contamination via cleaning equipment R-004 Handling of sugared egg yolk and
Designated red cleaning equipment 3 0 0
when cleaning up egg custard spillage custard containing egg
Transferred to cold store/ stored prior to being
picked and despatched (all product is sealed at
this point)
Red over sleeves and apron to be worn when R-004 Handling of sugared egg yolk and
Cross contamination via operator overalls 3 0 0
filling custard egg custard custard containing egg
To make sure we don’t produce any more contaminated product, there was a check included in start-up checks
for an operator to check before Start. To verify that manual cleaning of the filler has been sufficient in removing
traces of egg protein the filler must be swabbed with protein swabs and pass, post CIP prior to being disinfected.
THIS IS A CCP.
Work Instruction
Work Instruction was created to make sure that it is communicated to all the staff properly and they are properly
trained on it.
To verify that manual cleaning of the filler has been sufficient in removing traces of egg protein the filler must be
swabbed with protein swabs and pass, post CIP prior to being disinfected. THIS IS A CCP.
(NB: It is critical swabs are done post CIP and prior to chemical disinfection as the chemicals used in disinfection
step interfere with the swab reagents).
1. Take a sample by swabbing a 10cm square area. For uneven surfaces try to swab the equivalent size surface area.
2. Put swab back into tube.
3. Activate by bending bulb until ‘snap valve’ breaks. Squeeze bulb twice to expel liquid reagent down swab shaft.
4. Gently shake swab in an upright position (Swab tip facing down) for 5 seconds.
5. Compare colour of reagent against the Pro-clean colour swab label.
Interpreting results – (NB: Colour chart is also shown on side of swab stick for easy reference)
6. PASS - Go ahead and put filler on for a chemical disinfection. (The swab must be retained and checked after 10
minutes in order for the swab to have time to pick up any faint traces of protein. If this is the case then the machine
must go back through a manual clean)
FAIL – Where a swab has failed, manually re-clean filler and then re-swab. If the re-swab passes you can then
continue with putting filler on for a chemical disinfection.
7. It is critical that all swabs results and any re-swabs are recorded on log sheet (RL-016 or RL-017) along with any
action taken i.e. re-cleans etc.
START UP CHECK:
There is a check included in Operator Start-up check sheet. This sheet is confirmed and sign by Team Leader or
Manager.
Process Flow
Start-up Checks:
1) Hygiene Swabs
2) Nut & Bolts
Checks
3) Visual Cleaning
Checks
4) Protein Swab
Protein Swab was included in the checks to make sure that there is no trace of any Allergens left on the line.
Training
There was staff brief at that time which made sure that all the staff now aware of new process and systems.
Why we introduce the Protein Swabs and what is the Importance of the Protein Swabs.
1. All relevant personnel including temporary staff and contractors are appropriately trained prior to
commencing work and adequately supervised throughout the working period. This is in the form of an
induction either carried out by the agency or on site. All staff should have completed induction training
prior to the end of their probationary period. An induction checklist should be signed off as
confirmation this has been carried out. All new staff to the factory should sign off first day induction
training to confirm they are aware of the points documented. A copy should be kept by employee and
held on file.
2. All personnel engaged in activities relating to critical control points should have relevant training and
documented evidence will be a record made on the persons training records covering off the CCP.
3. Personnel holds each person’s training records to provide evidence what training is required to carry
out the role and signed off documentation on the status of the training carried out. Internal audits and
monitoring of Quality Defect Alerts are used as a method of reviewing the implementation and
effectiveness of training and competency of trainer. All staff complete a 13 week probationary period
which is monitored by departmental heads and personnel department.
5. A yearly review of the competencies of staff is carried out and where necessary relevant training is carried
out as deemed necessary by the departmental head. The review will take into consideration any finding
following internal audits, quality defect alerts or changes that have arisen within the department. The
review should be documented by the departmental head and signed off on the training log. Relevant
training can be either by formal training, on the job experience or refresher training.
Food Safety refresher training should be carried out on average every 3 – 4 years.
Verification
Objective to ensure that the hazards identified in the study are complete and correct and that the
selected controls for these Hazards are suitable.
Validation
Coeliac UK
www.coeliac.org.uk
LACoRS
www.lacors.gov.uk
http://www.cip.ukcentre.com/food1x.htm
http://books.google.co.uk/books?id=GLu142ovTu4C&lpg=PR20&ots=qDgASt49
Xk&dq=how%20to%20establish%2C%20monitor%20and%20verify%20the%20f
ood%20safety%20management%20system&pg=PP1#v=onepage&q&f=true