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HACCP STUDY

example of

HACCP plan
for a

Fresh Cream

and

Jam

Gateau
[1] This study was partly reproduced and adapted from Sara Mortimer and Carol Wallace; HACCP, a practical approach, Chapman & Hall, 1994

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N. Charisis WHO/MZCC
Athens, Greece

The HACCP Plan is a document prepared in accordance with the principles of HACCP to ensure control
over hazards, in the food chain under consideration.
The goal of this activity is to:
assess the compliance with product/process description,
process flow diagram,
identify the most significant hazards,
assess the most significant hazards
identify hazards sources,
identify Critical Control Points,
monitor the programme (frequency, methods, equipment etc), and
evaluate the quality of information gathered through records
The HACCP plan indicates what needs to be done, when and where. It is the basis of documentation, which can be shown to food
inspectors and auditors. Normally, a flow chart with CCPs is attached. It is the result of a HACCP study; it is specific to a production
site and product, and must be rigorously implemented. Since the HACCP plan is specific, each change and its potential impact on
safety, should be studied and the HACCP plan should be modified when necessary. The results of a HACCP study are also
presented in a condensed form in a HACCP data sheet. This sheet lists all CCPs and their associated hazards, the control
measures, the parameters assuring the control, the critical limits and target values which need to be monitored, as well as the
monitoring procedures and the corrective actions. Therefore it gives auditors and inspectors a quick insight into the decisions made
during the HACCP study.

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HACCP Plan
(is a document prepared according the principles of HACCP to ensure
control over hazards)

The goal of a
HACCP plan is:

1.

To assess compliance with product/process


description.

2.

To identify & assess the most significant Hazards


and their sources

3.

To identify all the CCPs

4.

To survey the program (methods, equipment)

5.

To evaluate the quality of information gathered


through records

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N. Charisis WHO/MZCC
Athens, Greece

From the Document HAZARD ANALYSIS AND CRITICAL CONTROL POINTS - CONCEPTS AND APPILICATION, edited as a draft in 2002, by N. Charissis, DVM - WHO/MZCC, Athens, GREECE.

a HACCP data sheet


Raw
Materi
als

CCP

Control
Measur
es

Critical
limits

Procedure

Frequency

Correcti
ve
actions

Responsib
le persons

Hazar
d

Process
step

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N. Charisis WHO/MZCC
Athens, Greece

From the Document HAZARD ANALYSIS AND CRITICAL CONTROL POINTS - CONCEPTS AND APPILICATION, edited as a draft in 2002, by N. Charissis, DVM - WHO/MZCC, Athens, GREECE.

a flow

diagram should be attached to each HACCP plan

Construct flow diagram


The flow diagram should be constructed by the HACCP team. The flow diagram should cover all steps in the operation for a specific product. The
same flow diagram may be used for a number of products that are manufactured using similar processing steps. When applying HACCP to a given
operation, consideration should be given to steps preceding and following the specified operation.

Flow diagram is a schematic representation


fromeach
rawHACCP
materials
endhave
product
WHY
Plan to
should
its ownsale
Flow Diagram?
theare absolutely specific for each product and each process.
Because CCPs

Flow
diagram
covers all steps of
production
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Change
Supplier
Chose supplier of
raw material
1

E X AM P L E

Flow Diagram in a flight catering with 21 processing steps


Acceptance of dirty dishes and trolleys

Transportation 2
Return
Washing of dirty dishes and trolleys

Acceptance
Control 3

Storage of clean dishes and trolleys


Storage of raw material 4
Meat processing 5
Fish processing 6
Vegetable processing

STORAGE 10

Cheese, sausages processing 8

Cooking

CCP 1

11
Vacuum/Pasteurization 12

Ready products processing 9

CCP 2

Cooling 13
CCP 3

CCP 4

Storage 14

CCP 5

Making portions of Cold Meals 16

Making portions of Hot Meals 15

CCP 6

Preparation of dishes 17
Preparation of trolleys 18

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Refrigeration of
ready product 19

Final Control 20

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Transportation/Delivery 21

From the

entrance of raw material to the outlet of the final product


1. List all potential hazards associated with each step,
2. Conduct a hazard analysis
3. Consider measures to control identified hazards

EXAMPLE

part of a Flow chart

List all potential hazards during:


STORAGE 10

Cooking
Cooking 11
Normal cooking
temperatures destroy
bacteria and parasites, but
hardly spores or toxins

Vacuum/Pasteurization 12

Cooling 13

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Floor Plan
1.

Inspection of RM

2.

Gutting / Filleting

3.

Trimming / Inspection

4.

Brine Tank

5.

Holding Area

6.

Smoking

7.

Cooling

8.
N.TankCharisis WHO/MZCC
Brine
Athens, Greece

Packing

Cutting
and
filleting
table

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Are there any


Question 1: preventive measures
at this step?

Modify step

Rapid screening
test

The

YES
YES

NO

Decision
Tree for

Q2:

CCPs

Is control at this step


necessary for safety?

Does this step eliminate or reduce


the hazard to an acceptable level?

NO

Q3:

Q 1-a:

Not a CCP

YES

Can a contamination occur or


increase to a non acceptable level in
this step?
YES

NO

NO

CCP
Not a CCP

Q4: Can a subsequent step eliminate


the hazard or reduce it to an
acceptable level?
YES
NO

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Why a HACCP plan should change when something in product/process is

changing ?

Because CCPs usually change when process or material are changing


(even when climatic conditions are changing).

THEREFORE
There should be designed alternative Plans for predicted

changes concerning different seasons, different processes,


origin of raw material, etc.

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The HACCP Plan is very IMPORTAN but not enough!


What else we need??
the organization of the company and its working rules
a HACCP Plan should establish a record keeping concerning:
Minutes of HACCP study meetings, (decisions made and their reasons)
Records of monitoring
Records of verification
Records of deviations and corrective actions
Records of modifications to the HACCP plan
Pest Control

Raw materials,
ingredients

Process parameters
(temperature, time)

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Maintenance
and
calibration of
of equipment

Results of Internal and


Charisis
ExternalN.
Auditing

Cleaning and
Sanitizing

WHO/MZCC
Athens, Greece

Employee
training

11

the systems documentation must be chosen

On a Case

by Case basis according to the needs

What CRITERIA should be used?

Existence of a Quality
System

Complexity and
Number of Products

Quality System
Manual

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Work sheets for


quality records
Operational
Procedures

N. Charisis WHO/MZCC
Athens, Greece

Work
instructions

12

I in a HACCP plan we should establish a record keeping and documentation concerning:

- Minutes of HACCP study meetings, (decisions made and their reasons)

- Records of monitoring

- Records of verification

- Records of deviations and corrective actions

- Records of modifications to the HACCP plan


Iin other words, issuing a HACCP plan (documenting the analysis of risks, defining control points and relevant control methods,
etc) is not enough; a description of the firms organisation and its basic working rules connected to the production process
control is also necessary. The structure of system documentation must be chosen on a case by case basis, according to the
firms real needs. Main criteria used are: 1. Company Complexity and Number of Products: The HACCP Control System must
suit the firms dimensions and guarantee its effectiveness in all cases (systems documentation needed for a small firm
producing only one type of product will be minimal, while, for a large industrial Company, documentation will be more complete
and detailed for the various products/process. 2. Existence of the quality system: A quality system developed according to ISO
9000 standards includes a complete documentation, structured on 4 levels: a) Quality system manual, b) Operational
procedures, c) Work instructions, d) Worksheets for quality records. Such documentation already covers some elements of the
HACCP Control System. Therefore the problem is to integrate the HACCP control System into the Quality System. This applies
especially to medium and large firms wanting to develop a complete Quality System according to ISO 9000 Standards and
wanting to integrate the HACCP Control System into this Quality System.

Records are operative sheets regarding: Incoming materials (raw material, ingredients), Process parameters (temperature,
time), Finished product, Cleaning and sanitising, Pest control, Employee Training as well as other record-keeping document
such as microbiological/chemical test results, calibration certificate, complaints documents, finished products rejected, hours
for equipment maintenance and results of internal/external audits

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List of Possible Operational Procedures of a


HACCP
plan
Document issuing
and control

Purchasing

Premises, equipment and tools cleaning and

control: (suppliers selection, clear


definition of suppliers
requirements, and verification of purchased product).
disinfecting:

facilities, equipment and tools involved


in the
production process must be cleaned and disinfected. These activities
should be proved and documented.
Cleaning = removal of dust, undesired materials or dirt
Disinfecting = destroying or inactivating pathogens from surfaces and
4

surrounding area.
Sanitising = control of working environment conditions (e.g. cleaning,
disinfecting, pest control, improvement of: temperature,
humidity,
light,
noise
etc.)rat
to guarantee
that all
pest
and

Rat and pest control

control activities are performed according to specific given indications.

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Personal hygiene:
Personnel should have a health register, renewed every year.

In case of illness employees are suspended from work until recovery.

No eating, smoking, spitting, or chewing in the working areas.

Clothes should be washed regularly or whenever necessary,

wash hands using hot water and liquid antiseptic soap and dry with paper
towels.

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Personnel training

Machinery and equipment maintenance:

relevant to the operators tasks

Register and list all equipment


Define specific maintenance requirements and responsible personnel
for each equipment
Use a form to register every preventive/corrective maintenance performed
8
9

Calibration of measuring equipment:

It is essential

to

guarantee the
proper control of the product.

Product identification and trace-ability


Identification = Create a mechanism to distinguish a product
from other similar
Trace-ability = To reconstruct the products history, (first material,
suppliers, process and operators involved, area of retail market, or,
according to the identification, the customers, which have bought it.

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10

Water supplies: to guarantee that the water used does not


compromise
the products hygienic and sanitary aspects.

11

Processing residues and garbage:


People responsible for these activities are also identified to all
sectors in the firm.
Waste disposal is managed according the requirements of
legislation in force.

12

Control of non-conforming product and procedures:

13

Some products may be defective. In such cases we should trace


back
and/or recall the product already distributed. We also should notify
non-conformity
cases
Corrective and
preventive actions
(i.e., Product laboratory testing, Equipment calibration, Supplier's Auditing etc)

14

Internal system audits

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VALIDATION and VERIFICATION of a HACCP plan


VALIDATION

What an Evaluator should


examine and evaluate?

= Confirms that the HACCP Plan is scientifically


correct and complies to the Legislation
The Hazard Analysis, CCPs, Critical limits, monitoring
activities, corrective actions, record keeping, verification
procedures. (e.g. if a heat treatment at 720 C for 12 seconds reduces
Salmonella a million fold on the equipment and foodas it has been
predicted!!!).

Whose responsibility is
Validation?
When Validation should
happen?

VERIFICATION

Is the responsibility of the Industry! Also of


the Authorities!
In regular intervals or when changes in
process or material, or any other change
occur!
Confirms that the HACCP plan is implemented in
every processing step.
starts

with the operator (fill out specific forms)

ends

with HACCP Manager who studies these forms and confirms


that everything is complying with the HACCP plan.

All records of Verification should be kept by the Management for future


improvements

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Athens, Greece

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Validation and Verification of A HACCP plan


Validation
A HACCP validation is the collection and analysis of data regarding the processing parameters (e.g. sampling for
microbiological and chemical test). This activity is necessary to assess the correct approach and results regarding
the identification of all significant food safety hazards as well as for the effectiveness of control measures. The
evaluation has to be conducted on scientific and specific technical basis. A HACCP plan validation programme
should include review of hazard analysis, determination of CCPs, justification of critical limits, as well as the
determination of adequacy of monitoring activities, corrective actions, record keeping and verification procedures
Validation is obtaining evidence that the elements of the HACCP plan are effective (Codex Alimentarius 1996).
Validation is mentioned in the Codex Alimentarius guidelines on the application of the seven HACCP principles, but
is not described on how to do it.
A HACCP plan contains a list of hazards, CCPs, critical limits, monitoring and verification procedures etc. All these
elements were decided upon during the HACCP study. At a certain CCP, specified hazards are controlled with
specific control measures; for instance a heat treatment to achieve a certain effect, which should ideally be
specified, (i.e. a process criterion should be set). To this specific CCP, Validation means ensuring that, e.g. a heat
treatment at 72 C for 12 seconds really reduces Salmonella a million fold (6D) on the equipment and in the food
under consideration.
If a food product should not contain more than a certain level of a hazard at the moment of consumption, challenge
studies may need to be performed to validate that under the marketing conditions, and even under slight abuse
situations, the hazard levels remain below a specified level.
Validation deals with product formulation, processes, storage conditions, preparation and use and is performed
before the results of the HACCP study are approved and implemented. For this reason validation requires highly
professional skills and may be costly and time consuming.

Validation is a responsibility of the industry


it should be undertaken initially and as needed thereafter

Whenever a change occurs, a new hazard analysis has to be carried out, because a change might induce a new
hazard, or eliminate an existing one (or reduce it to an acceptable level). Clearly the results of this hazard analysis
as well as the effectiveness of new control measures (if any) have to be validated. Validation is thus part of the
maintenance of the system.

Verification
Obviously, it is necessary to obtain evidence that the HACCP system is really working. For this purpose,
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verification procedures have to be established. Verification is the application of methods, procedures, tests and
other evaluations in addition to monitoring, Athens,
to determine
compliance with the HACCP plan. Therefore verification
Greece

Although internationally accepted definitions of the tasks of regulators or law enforcement officers have not been established yet, it is
believed that the food handler, should do verification in accordance with the HACCP plan. That activity doesnt exclude necessarily the
authorities from checking the verification procedures performed by the handler in particular or the plan in general.
Taking under consideration that Food Hygiene means all measures necessary to ensure the safety and wholesomeness of foodstuffs,
then, Food Hygiene Monitoring System is, the main tool to prevent foodborne disease. Secondary, this system permits to detect and
prevent the food spoilages causes. An inefficient monitoring system leads to economic losses, reduces credit by consumers in food
hygiene control system and also reduces credit in international trades.
In order for the monitoring system to be effective, measures shall cover all stages after primary production (the latter including, for
example, harvesting, slaughter and milking), during preparation, processing, manufacturing, packaging, storing, transportation,
distribution, handling and offering for sale or supply to the consumer. According to Article 1 , of 94/356/EC: Commission Decision of 20
May 1994, {this can be achieved by 'Own-checks', that means all those actions aimed at ensuring and demonstrating that a fishery
product satisfies the requirements of that Directive. Those actions must correspond to an approach internal to the establishment; they
must be developed and implemented by the persons responsible for each production unit, or under their management, in accordance with
the general principles set out}. The documentation must include two types of information to be kept for submission to the competent
authority:
A.
1.
2.
3.
5.
6.

A detailed and comprehensive document including:


description of the product,
description of the manufacturing process indicating critical points,
(for each critical point), identified hazards, assessment of risks and control measures,
procedures for monitoring and checking (at each such critical point), with indication of critical limits for
parameters that need to be controlled
corrective action to be taken in case of loss of control,
procedures for verification and review.

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B.

Records

1.

of the observations and/or measurements,

2.

results of the verification activities,

3.

reports and written accounts of decisions relating to corrective action when taken.

An appropriate document management system must be provided, in particular, for the easy retrieval of all documents relating to an
identified production batch.

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HACCP C A S E S T U D Y

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a.

Facility

DETAILS
(in Stockholm, Sweden)

The factory produces both chilled and frozen gateaux (cream cake) for
sale to the retail industry.

b.

Product description

- Fresh cream and jam filling between two sponges.


- Keep below 5 C through the distribution chain (=Chilled product)
- Shelf life : 3 days from date of manufacture

c.

Manufacture
1. Sponge batters are baked at 150-170 C through a travelling oven
for 18.5 minutes.
2. Then cooled to ambient (=room temperature)
3. Automatically sliced and
4. Filled with cream and jam
5. The sponges are flow-wrapped (wrapped in motion) and put into
cartons.
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d.

Hazards and Control Measures

Biological hazards:
- Potential presence of pathogens
- Cross-contamination during processing

Control measures:
- Approved suppliers (certificates of conformance),
- Sensitive ingredient testing,
- Baking and segregation

e.

Intended use

The product is targeted at the general public (including high-risk individuals)


Salmonella and Listeria control is therefore critical.

Contents:
Flour, Milk powder, Pasteurized Liquid egg, Water, Ingredients
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Fresh Cream and Jam Gateau


PROCESSING METHOD
Mix Flour + Milk powder + Pasteurized liquid eggs + Water + Ingredients

Put batter in tins

Bake in traveling oven in


150-1700 C for 18.8 minutes

Depan and cool sponge in


ambient temperature

Automatic sliced & filled


with cream and jam

blast chilled, metal detector


dispatched
Chilled product - shelf life 3
days under 50 C

Sponges are flow


wrapped in
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motion

Charisis WHO/MZCC
Athens, Greece

25

Raw
material

CCP
No.

Incoming
Flour

Not
a
CCP
Incoming Milk
powder

Not a
CCP
only

Incoming
Liquid egg

if we doubt
with

suppliers
HACCP

Water

Hazard to be
controlled

Control
measures

CCP
parameters

Critical
limits

MONITO
Method

ING
Frequency

Corrective
actions

Biological
(B.controlled
cereus) by
Aflatoxins are
the supplier.
bodies
Foreign

Obtain Cerf.of
Analysis/Testing

Aflatoxin = mg /kg

Aflatoxin <10
mg/kg
B. Sereus
< 1000/g

Inspect certif. of

Every batch
B. sereus,

Reject batch
Reject batch

2 by 2 mm

Inspect
filters

1 inspection x
per hour

Re-sieve

< 10mg/kg

ISO
method

Every
delivery

Rejection

Every
delivery

Rejection

investigation
for chemicals
Weekly
weekly is not
recommended
in small
business

Filtration and
chlorination
Filtrate
&
control
biological
Chlorinate
hazards but do
not control
chemical
contamination

Every
delivery

Rejection

Baked Insects
are no
(Insects,
glass, wire,
wood)
hazard.
Chemical
dangers
Foreign bodies
detected at
(Aflatoxin,
packaging
metal detector
after chilling,
material,
painting)
Sieving is a GMP
Antibiotics, Salmonella
Is controlled
by suppliers
Brucella,
Campylobacter,
E.coli, Listeria, Sstaphylococci
HACCP
(QA)
Dioxines,
Aflatoxins,

no
need for
testing
Salmonella
? Listeria?
Shigella?
in theStreptococcus?
plant
Other?

Chemical
contamination
and
/ or
Baking of the
final
Not a
CCP

product destroys

Microbial
bacteria and
Contamination
parasites
from
(usually
Giardia,
or the
Cryptosporidium)
water

Incoming &
processing

Cream

Not a
CCP

Listeria
& Salmonella
Possibly
a CCP
Etc.

but practically
impossible

No
control
Sieving
measures
needed

X X XX X
X

B. Sereus = No / g

Sieving = Pore size

Supplier= QA
AUDIT
InspectionAflatoxin
of Suppliers

to verify
suppliers
Supplier QA
premises

HACCP

mg/kg

Coliforms
count

B. sereus,
ISO method

ISO
method
Investigating the water
Regulatory
Testing to
forChemical
microorganisms
requirements
or
include
toxic
isMicrobiolo
not a usual
substances
gical
procedure
for
contamina Giardia/
Cryptosporidi
tion
um
small
business

There
is no need
Carry out on-site
microbiological
for
checks and
obtain Certificate
microbiological
of Analysis of
samples from
Water Authority
tests.
No control
measures
needed

Analysis

< 10/g

(national

Every delivery

Inspect

Anyway,
Chemicals
Regulatory
Certificates
compliance)
remain
in waterof Analysis
from Water
Authority

Optimal hygiene
and
time/temperature
control along the
food chain are
required.

Absence / 25 g

Ask for
Supplier QA

Regulatory
requirements

Testing 5
samples of
10 g found
negative

ISO
method

Testing takes 2 days,

shelf life is only 3 days = no Practical

Incoming

Jam

Not a
CCP

Packing
material

Not a
CCP

Possibly a CCP but


Pesticides
practically
impossible

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Moulds
Is quality problem, not
safety

Regulatory
requireme
nts

N. Charisis WHO/MZCC
Testing
Aerobic count < 100/cm2
X Greece
X
X
Athens,

Supplier
audit

Yearly

Rodac
plate

Every
delivery

Sanctions

26

Rejection
X

Process
step
Storage of
raw
material

CCP
No.

Hazard to be
controlled

Physical
Not a Physical
contamination/

CCP

contamination can
Biological
growth
occur!
Growth of
(what can grow in
what? i.e. fermentation
high temperatures
bacteria
are needed!
and humidity?)
Keep raw material cold
GHP and GMP are
enough

Ingredient
weighing
Sponge
baking

Not a

Critical
limits

Procedure

Frequency

Corrective
actions

Store
as specified,
No physical,
checks
Hold and
Bacteria
should beVarious
specified and all risks
should beAutomatic
taken under Daily
consideration.
(i.e. cream < 5C,
chemical
temperature
continue
inform QA
egg
Most
forraw
specified
powder material have beencontamination
filtered already
recorder.
(also, thereduring
is a metal
use. detector
Manager
at the
Maintain
max.
batch
Responsible
end time)
of the line. Storage of raw material
is covered Visually
by GMP/GHP,Every
& Final
Product
is
temperature
Keep covered
inspect label
person=Wareh
Cooked! Therefore there is no need <for
control measures
only prerequisites =
i.e. GMP
5C
to ensure
ouse
+ GHP
stock rotation
manager+Ope
rator

Too much salt?

Weighing

Weight/batch

0.2%

Testing

Each batch

Reprocess

CCP

Survival of
Salmonella & Listeria will
pathogens?
be killed but but Spores
Give
examples!
of B. Cereus or

Time

150-170C

Temperature

18 min

Automatic
chart
recorder

Continuous

No 1

C. Perfrigens

Bake sponge
at specified
time/
temperature

Stop
production.
Reject product.
Adjust oven
temperature/ti
me

Keep cooling area

Observe working

No residues

Visual

After every

Clean again

cleaning

before start

CCP

Cooling

Not a
CCP

Listeria,
Cream
Salmonells

Cream
whipping

Not a
CCP

Salmonella

Filling

Not a
CCP

Flow
Wrapping

Not

Metal
detecting

CCP
parameters

Is a quality, not a safety problem

may survive baking

Chilling

Control
measures

a CCP

for

whipping,
hygienic area.
No other before
heat start
cleanfiling and wrapping
surfaces for take place
visible in high Inspection
cleaning
treatment is possible, thereforeresidues
CONTAMINATION against Listeria spp., Salmonella spp.,
etc should be avoided
by any means!
Listeria,
Clean machine
Visible residues
No residues
Observation
After every
Clean again
visible

Salmonella in cream may cause illness, but product is kept at low temperatures and its self
Salmonella
Keep line clean
Visible residues
No residues
After every
Clean again
life is 3 days, therefore
the hazard
to develop Salmonella
isObservation
extremely low.
If it does,
visible
cleaning
before start
Salmonella will turn the cream rancid the cake will not be eaten; however if eaten, it might
Biological
Hermetic seal
No holes
Intact seal
Visual
Every 15
Re-sealing
cause harm to sensitive persons!
contamination
inspection
min.

(GMP)

Growth of
pathogensThe

Blast chilling
hr./ 5 C
Temperature
Rework
pathogens
should beTime/temperature
mentioned and risk
analyzed,
otherwise
it is
not a CCP
recorder
Each
batch

CCP

the
Metal
contamination

Metal

Metal detector
Metal size
Absent
Metal
Every 30 min
Stop line,
Detector
should be programmed to detect
of certain size (not metal objects)
ferrous needles
2.0
detection
recalibrate,

No 2

Also to detect needles by their length -not by their weighnon-ferrous


(ferrous or non
test ferrous)
pieces.

mg,

01/02/16

2.5 mg
N. Charisis WHO/MZCC
Athens, Greece

check using

notify QAM.
Hold stock

27

verification
What?

Why?

Cream taste testing

Acceptance

When?

How?

Action in
case of
deviation

Every batch

Triangle test

Reject

Every batch

ISO method

Reprocessing

Finished product
B. cereus testing

Check safety,
< 100/g

Finished product
Listeria testing

Check conformity
with criterion
Absence in 5 x 10g

1/week

ISO method

Find cause,
Improve HACCP
plan

Check adherence
to HACCP plan

1/week

Inspection

Correct, Train,
Improve

Monitoring records
review

01/02/16

N. Charisis WHO/MZCC
Athens, Greece

28