7.

HACCP PLAN FOR RAW MATERIALS

 CCP DESIGN TREE FLOW CHART
FOR RAW MATERIALS & PACKING
Based on GMP+ Certification scheme nimal feed sector 2006 – Appendix
15 : HACCP Manual

Q1 : What type of control measureis required to he risk assessment ?

Control Control Control Specification

measurement measurement measurement control
for risk1 for risk2 for risk3 measurement
for risk4

Not CCP Are the relevant general

control measures present
and have these been
implemented ?

If required, prepare &

include in validation &
verivication process
Stop production
& change the
process or
product and start
Q2 : are the relevant specific control measures present and have these No again with Q1
been implemented ?

Yes
Q3 : is thes control measure specifically intended for eliminating this risk CCP
or reducing it to an acceptabele level during this process phase ?

No

Q4 : Will the risk be eliminated or reduced to an acceptable level during No

one of the subsequent process pkhse ?

Yes

No CCP : Include measures in validation & verivication procedures

Feed MaterialDecision tree

PFAD Calcipum Oxide (CaO)

From Physical refining From limestone (CaCO3)

1. ls the product specified in Annex lll,

No No
Chapter 1 of Reg. (EC) no. 767/2009 (List of prohibited materials)?

2. is the producttspecified in GMP+ BA : No

Minimum Requirements for the Negative List ? No

3. Does the product comply with the following definition

in reg. (EC) no.767/2009 article 3 g ? Don’t know Don’t know

4. Ins product in :
• The appendix to Reg. (EU) no. 575/2011 (Catalogue of feed materials), Yes Yes

• The register of feed materials of the European Yes No

Feed Sector according to Reg. (EC) no. 767/2009 rt. 24 section 6
(www feedmaterialsregister.eu) Yes Yes
No Yes for
• The appendix to reg. EU) no.892/2010 CaCo3
Yes Yes for
• The FSD Product list of jGMP+ FSA Scheme ?
CaCo3

Feed Material Feed Material

Feed MaterialDecision tree

Start

CV Yes Product prohibited for

ls the product specified in Annex lll,
processing in feed
Chapter 1 of Reg. (EC) no. 767/2009 (List of prohibited materials)?
No
Yes
is the producttspecified in GMP+ BA3 : Product prohibited for
Minimum Requirements for the Negative List ? (GMP+) processing in GMP+
Certofied feed
No

!!! THE PRODUCT is PERMITTED IN PRINCIPLE AS FEED / IN

FEEDINGSTUFF !!!

Does the Product comply Comply with the following The product is very probably a feed material
definition in Reg. (EC) no. 767/2009 Article 3 g?
Yes
Check this by proceeding further in this FEED MATERIAL
“Product of of vegetable or animal origin, whose principal decision tree and if necessary the FEED decision tree and
purpose is to meet animals nutrition need s, in their the PRODUCT IN FEEDS decision tree
natural state, fresh or preserved and product derived from
the industrial processing there of and organic or inorganic
substances, whether or not contain feed addictives, which
are intended for use in animal feeding either directly as
such, or after processing, or in preparation of compound 1 2
feed, or as a carrier in premixes”
No/ Dont know

Is the product in :
- The appendix to reg. (EU) No. 575/2011 (catalogue of feed materials) Yes The product
- The register of feed materials of the european feed sector according to Reg. (EC) no. 767/2009 is a feed
art section 6, see (http://www. Feedmateralsregister.eu) (note : the registry has no legal material
status.
- The apprndix to reg. (EU) no. 892/2010 (formely TVM and grey list product),
- The FSD Product list of the GMP+FSA scheme? (GMP+)

No

Is the product similiar to one of the products in the appendix to reg. (EU) no. 892/2010 Formely TVM and grey list Yes The
product) ? product is
a feed
For the answere to this question use : material
The text consideration 4 of reg. (EU) No. 892/2010
From a comparation bueetween the characteristics of the prkoducts mentioned in the repertoire of addictive for feyed and in the feed catalogue several criteria can be derived for
the division of products as feed additives and other products. Useful criteria for this function include :
1) the production and processing methode, 2.) The level of standarisation. 3) the homogenisation 4) the purity, 5) the chemical definition 6) the methode in which the products are
used.
For the benefit of coherence, product with comparable characteristics must be caegorized by analogy. With due observance of these criteria a study has been conducted with regard
to products about which there were doubts whether they were feed additives”
- Recommendation 2011/25/EU of 14 januay 2011 establishing guidelines for the distinction between
feed materials, feed additives, biocidal product and veterinary medicinal product

No/ Dont know

2
The product is very probably not a feed material.
Go Through the feed and PRODUCT IN FEED decision tree to determine the natural of the product 3

!!! THE PRODUCT IS A FEED MATERIAL !!!

The feed material may be put on the market on the following condition :
- The norm for undesirable subtance according to dir. 2002/32/EC and according to GMP+BA1 product norm are not exceeded (if exceeded then in
number of cases detoxification/ decontamination is possible (reg. (EC) no. 767/2009 art. 20, dir 202/32/EC art.8)) END
- The norm for residues of crop protection agents according to reg. (EC) no.396/2005 are not exceeded.
- If claim is attached to the feed material then this must comply with the requirements as stated in reg. (EC) no.767/2009, article 13
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA
PRODUCT DESCRIPTION
PRODUCT NAME
MAIN INGREDIENTS
ADDITIVES
PRODUCT CHARACTERISTICS
PRODUCT USE FOR FURTHER
PROCESSING / DIRECT CONSUMPTION
PROCESS / PLANT INVOLVED
PACKAGING
SHELF LIFE
WHERE WILL IT BE SOLD
LABELLING INSTRUCTION
SPECIAL DISTRIBUTION CONTROL
RISK ASSESSMENT
MegaIac® Protected Fat
PFAD and CaO
BHT and Ethoxyquin
- Dry, friable, free flowing and non-caking meal with a
granular consistency.
- Colour: beige / biscuits
- Fat 82.2% - 87%
Consumption by dairy cattle as part of energy feed ingredients
Blending / Mixing / Reacting / Cooling /
Sieving / Milling
25kg bags & 800kg Bulk Bag
1 Year
Export markets like Far East Country, Middle East, Australia, New
Zealand and African countries
No Special Instruction
NA
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

HISTORY OF THE DOCUMENT

Revision # Date Change Amendments Color code

Ver 06/5.4.11 Adding Hg test in BHT Purchase. Green
Ver 07/3.2.12 Positive Release of PFAD. Green
Ver 08/1.1.13 Review after Tank ST701 & ST702 has become fully Sky Blue
operational, i.e full implementation of Positive.
Release PFAD in VWSB.
Ver 09/21.1.13 Risk assessment of Bags Sky Blue
Review Step 1 : PFAD Purchase
Ver 10/10.1.2014 Risk assessment of Antioxidant and other raw. Red
Material about presence of Antibiotic and feed.
Medicine.
Ver 11/20.7.15 Review plan and reclassify COA and POA Purple
Ver 12/1.2.2017 Change company name Brown
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

HAZARD ANALYSIS

Process phase Raw Material Purchasing

Step Input Hazard Description of hazard, Probability Seriousness Risk Motivation Type of measure Reference
Category Cause & Justification (Pb) (S) (explaining Pb &S)
1 PFAD Oil Biological Rodent, insects and droppings Low Low 1 Pb & S = low, because PFAD Check incoming tanker QMF (SM)/002-
purchase due to unhygienic transports/ was produced in high cleanliness and hygiene Supplier
and tanker temperature and closed loop monitoring form
receiving refining process by GMP+ Loading advise from
certified suppliers. So suppliers telling us about Loading advice
present of pathogenic the past, load, presence of from supplier
microbes are unlikely residual of past load,
cleanliness and cleaning
Fungus does not grow on status.
lipids/ fat
Recommend suppliers to
use only reliable
transporters. E.g.
dedicated tangkers for
carrying PFAD or Carrying
food or Carrying food
grade palm oil product

Rodent, insect and droppings
through openings at Pump
house
Low Low 1 Pb & S = low, because the
loading pipes at pump house
are covered when not in use.
There is a filter prior to tanks
to prevent transfer of such
hazard into tanks and also ,
there is a pest controi
program in place
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

Chemical Heavy metal as lead, cadmium, Low High 3 Pb= low, because supplier General control QMQ(PQ)/003 on
mercury & arsenic like PGEO is GMP and HACCP - Get supply from PFP in supplier
certified. Also, record over GMP equivalent management
the years shows heavy metal certified supplier
level is within specifcations - Periodic heavy Certificate of
metal itest as analysis by
Contamination through S=high, because of the verivication supplier as general
external sources combined risks of heavy - This control will be QC
PFAD used in Megalac exercised under
production HACCP plan for
process
Antibiotic and feed medicine. Low Low 1 Pb & S = low. because Certificate of
Contamination through no such chemicals are analysis by 3rd
external sources used in plantation non party lab as
refining process verification

Chemical When purchase Positive
(Scenario 1) Release PFAD from
_GMP+ orGMP equivalent
certified supplier
- Dioxin compounds
- Contamination through
exeternal sources
Low High 3 Pb = Low because (a)
Because PFAD bing
purchased is positive
released
S = High, because of dioxin is
toxic and carcinogenic
General Control QMQ(PQ)/003 on
- Ensure supply of PFP in supplier
positive released PFAD management.
comes from GMP+ or
GMP equivalent Certificate of
certified supplier analysis by
- Specify dioxin as part of accredited 3rd
the quality specification party lab provided
- Must have access to cert by supplier
of analysis for dioxin
before any delivery of
the corresponding batch
is to be arranged
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA
Chemical When purchase Non-Positive Medium High 4 Pb = Medium. This is
(Scenario 2) Release PFAD from GMP+ or because CPO quality (in term
GMP equivalent certified of dioxin level) varied by
supplier region, Hence, Dioxin level in
- Dioxin compounds PFAD varies too,
- Contamination through
exeternal sources Such observations are
supparted via internal
investigation, whereby PFAD
from Johor region tend to
have higher Dioxin level than
Central region (e.g Perak) of
Peninsular Maiaysia
S = high, because of dioxin is
toxic and carcinogenic
General Control QMQ(PQ)003 on
Ensure non-positive FPF in supplier
release PFAD comes management
from GMP+ or
GMPequivalent certified
supplier s.
Specific Control Certificate of
- Must conduct dioxin test analysis by
on this non-positive accredited 3rd
release PFAD prior to party lab os the
any production use basis to release
- Batch is defined by PFAD or not.
VWSB, but volume per
batch shouid not exceed
700MT (plus &minus)
theoretically as the
maximum capacity of
storage tank of ST701 or
ST702 is around 700MT
- Such Non-positive
release PFAD can only
- be aproved for
production use based on
the ceriificate of analysis
on Dioxin issued by an
accredited laboratory,
indicating that the
Dioxin results of the
related PFAD batch
meet the GMP standart/
specification. Only then,
the related batch is
classified as Positive
Released PFAD
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA
Chemical Receiving of Non-Positive
(Scenario 3) Released PFAD into tanks that
contains Positive Released
PFAD
• Dioxin compounds
• Contamination through
errorneous uploading of
non-positive release PFAD
into tank that contains
Positive Release PFAD
Physical • None, Not possible source
of introduction
• Contmination of foreign
materials such as dust
dirt, sand & small stones,
during handling (e.g.
loading into tank) and
transportation
Low High 3 Pb = low because of : General Control QMW (SM)008 on
- Effectivr comunication & goods receipt
(1) Low prevalence to control through SOP/ procedure-PFAD &
receive Non-Positive Release workng instruction FPW(MP)012 on
PFAD from supplier, other manufacturing
than PGEO Pasir gudang, non working
purchase of such PFAD from instruction on
3rd party supplier. PFAD Blending
(2) High awareness of
producion team when such
PFAD is available and
incoming – verbal
announcement and written
notice on noticeboard in
control room.
(3) SOSP of operator getting
insjtruction and approval
from superior every time
prior to any PFAD uploading
into storage tank.
S = high, because of dioxin is
toxic and carcinogenic.
Medium Low 2 Pb = Medium because General Control QMF(SM)002-
foreign materials iike sand, - Periodic checking of supplier
smal stones, coating, plastic strainer at PFAD monitoring form
and metal particles stil found receiving and record
at the VWSB receiving observation – at least PF(MN)001 Plant
strainer This is also despite once in month equipment
supplier has strainer and - Review result during maintenance plan
filter bag at discharge point. HACCP meeting and matrix subfolder
share abnormal finding PFAD Filter
S= Low because all these with supplier. monthly
foreign materiat ar trapped
by mesh strainer during
PFAD receiving at VWSB
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA
2 CaO Purchase Biological • None, not possible sourcr
and receiving of introduction
• Microbes, insect and pest
droppings
• Contamination through
external sources /
unhygienic transportation
Chemical • Heavy Metal as Lead
• Contamination through
external / environmental
source
• Dioxin compounds
• Contamination through
external / environmental
sources
Pb & S = low, because CaO is
produced in closed loop
Low Low 1 production process, and
under high heat at supplier
factory.
Also, CaO itself dusty and
caustic. not favored by any
living organisms to infest.
Product is deliver in bulk via
tanker. is generally protected
from external sourees of
contarninetion
Low High 3 Pb = low, because records
over the years shows lead is
low
S= high, because of the
combned risks of heavy
metal and the considerable
amount CaO used in Megalac
production.
Note : Limetreat / L hoist
(formerly known as NSL
Chemicals) is the only
supplier in Malaysia that is
willing and can supply CaO
that meets our
specifications. Others failed /
refused due to small VWSB’s
purchase volume.
Low High 3 Pb = low, because test
result of Dioxin over the
years shown were low
S = high, because of dioxin is
toxic and carcinogenic
Check incoming tanker QMF(SM)/002
cleanliness and hygiene Supplier
monitoring form
Loading advise from
supplier telling us about
the past load, presence of Loading advise
residual of past load from supplier
cleanliness and clean
status
Recommend suppliers to
use only reliable
transporters, e.g.
dedicated tankers for
carrying CaO or CaOH
General Control Factor audit
- As Limetreat / L hoist report by VWSB
(formely known as NSL
Chemical) is not GMP+ QMQ(PQ)/003 on
or GMP equivalent PFP in supplier
certified, gatekeeper, management
protocol applies, i.e.
annual factory audit is Certificate of
required analysis by
- Periodic heavy metal supplier as general
test as verivication QC.
Certificate of
analysis by
accredited 3rd
party lab as
veryfication
Requested supplier to test
Dioxin once a year and give
us a copy of certificate as
evident
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

• Antibiotic and feed Low Low 1 Pb & S =low, because no

medicine such chemicais are used in
the CaO manufacturing
process

Physical • None, not possible source
of introduction Low
• Metal piece from wear
and tear of quicklime Low
factory
• Contaminaion of foreign
materials such as dust,
dirt, sand & small stones,
during handiing and
transportation
Pb & S = low. Because Monitor amount of Review result
Low 1 limestone goes through physical material trapped during HACCP
Magnetic screen before by screen/ mesh/ filter at meeting and share
processing at supplier facory VWSB’s Receiving abnormal findings
Low 1 with suppliers
QMF(SM)002 –
CaO goes through a strainer supplier
during VWSB receiving into monitoring form
silo, So far, little foreign
material is found.

3 BHT Purchase Biological • None. Not possible source Pb & S = low, because BHT is Check for transport QMF(SM)/002 –
and receiving of introduction chemicai & not a medium for cleanliness and product Supplier
micrabes growth nor condition during receiving Monitoring Form
• Microbes, Insects and pest Low Low 1 infestation of insects or pets
droppings due to
unhygienic storage at Product is protected by bags
Suppliefs end and and is feed / feed grade
transportation

Chemical • Heavy Metal as Lead & Low Low 1 Pb = Low, because record General Control QMQ(PQ)/003 on
Arsenic over the years show heavy - Get only food / feed PFP insupplier
• Contamination through metal level is within grade BHT management
external sources specification - Get supply from GMP or
• Part of product HACCP ISO or equivalent Certificate of
specification S = low because dosage certified supplier analysis by
added into PFAD is verry - Periodic Heavy metal supplier aas
small, i.e. 0.15% only, test as verivication, at general QC
supported by COA from least once a year.
supplier and 3rd party lab Certificate of
verification over the years so analysis by 3rd
far. Also, BHT bought is party lab as
food/ feed grade. verification
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

• Antibiotic and feed Low Low 1 Pb & S = low, because no

medicine such chemicals are used in
the preparation/
manufacturing process of
BHT

Physical • None. Not possible source Low Low 1 Pb & S = low, because BHT Check for transports QMF(SM)002 –
of introduction comes in bag, protected cleanless and product Supplier
• Contamination of foreign from contamination of condition during receiving monitoring form
material suc as dust, drt, physical foreign materials
sand & small stones,
during handling and
transportation

4 Ethoxyquin Biological • None. Not possible source Pb & S = low, because EQ is Check for transports QMF(SM)002 –
Purchase and of introduction chemicai & not a medium for cleanless and product Supplier
receiving • Microbes, Insects and pest Low Low 1 micrabes growth nor condition during receiving monitoring form
droppings due to infestation of insects or pets
unhygienic storage at
Suppliefs end and Product is protected by drum
transportation and is feed / feed grade

Chemical • Heavy Metal as Lead Low Low 1 Pb = Low, because record General Control QMQ(PQ)/003 on
• Contamination through over the years show heavy - Get only food / feed PFP insupplier
external sources metal level is within grade EQ management
• Part of product specification - Get supply from GMP or
specification ISO or equivalent Certificate of
S = low because dosage certified supplier analysis by
added into PFAD is verry - Periodic Heavy metal supplier aas
small, i.e. 0.15% only, test as verivication, i.e. general QC
supported by COA from at least once per year.
supplier and 3rd party lab Certificate of
verification over the years so analysis by 3rd
far. Also, EQ bought is food/ party lab as
feed grade verification

• Antibiotic and feed Low low 1 Pb & S = low, because no

medicine such chemicals are used in
the preparation/
manufacturing process of
BHT
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

Physical • None. Not possible source low low 1 Pb & S = low, because EQ Check for transports QMF(SM)002 –
of introduction comes in drum, protected cleanless and product Supplier
• Microbes, Insects and pest from contamination of condition during receiving monitoring form
droppings due to physical foreign materials
unhygienic storage at
Suppliefs end and
transportation

5 Portable / Biological • None. Not possible source Low Low 1 Pb & S = low, because by law Tests water quality once a Certificate of
Processed of introduction unless that protects public health, year analysis by
treated water contamination happens at the water supplier (SAJ) has laboratory
from SAJ water source or water to meet portable/ treated
treatment plant water standart/ specification
Chemical • None. Not possible source Low Low 1 set by the ministry of health
of introduction unless
contamination happens at
water source or water
treatment plant
Physical • Sediment. Dirt buy Low Low 1
unlikely source of
introduction unless piping
work maintenance/
leakage by SAJ
6 Megalac bag – Biological • Insect and dropping Low Low 1 Pb & S = low, because 25kg General Control QMQ(PQ)/003 on
25kg purchase bags are delivered to VWSB - Working PFP in supplier
(paper & BOPP almost as soon as it is nstruction to management
bags) manufactured locally and via ispect the bags
overseas. Bags are covered / before using it
wrapped with plastic during for packing
delivery

Chemical • Possible toxic chemical Low Low 1 Pb & S = low, Supplier

used to make these bags declaration about the FDA
safety of bags
Physical • Plastic pieces from detect Low Low 1 Pb & S = low because no
PP woven layer of the such defect found all these
bags year. Suppliers good past
record over the years
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

Wooden pallets Biological • Mold due to dampet & Low Low 1 Pb &s = low, moldy pallet QMQ(PQ)/ 003 on
unclean pallets unlikely to be acceptable PFP in supplier
during receiving. Supplier management
delivers pallets in lorry with
cover. Suppliers good past
records over the years.

Products are protected by

paper cloth bag as barrier to
external contaminants
Chemical • Wood treatment chemical Low Low 1 Pb &S = low, because
wooden pallet; is used in
shipping and storage of
bagged finished product has
no direct contact to Finished
product

Pallet are not chemically

treated, unless required by
importing countries

Physical • Foreign material like dust Low Low 1 Pb &S = low, moldy pallet QMC(PQ)/003 on
& dirt due to unclean unlikely to be acceptable PFP in supplier
pallets during receiving supplier management
delivers pallets in lorry with
cover. Suppliers good past
record once of the year

Product are protected by

paper cloth bag as barrier to
external contaminants

7 Slip Sheet Biological • None. Not possible source Pb & S = low, because sleep QMC(PQ)/003 on
(Laminated of introduction sheet are delivered to VWSB PFP in supplier
paper) • Insect and dropping Low Low 1 in plastic cover during management
delivery

$lip sheet is used in

shipping, does not has
any contact with bagged
finished product
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

Chemical • None. Not possible source Pb & S = low, because sleep

of introduction sheet is used in shipping,
has no direct contact to
• Possible toxic chemical Low Low 1 bagged finished product
substance used to make
the laminate

Physical • None. Not possible source Pb & S = low, because sleep

of introduction sheet are delivered to VWSB
in plastic cover during
• Foreign material like dust Low Low 1 delivery
& dirt due to unclean
pallets $lip sheet is used in
shipping, does not has
any contact with bagged
finished product

8 Film warp/ Biological • None. Not possible source Pb & S = low, because QMC(PQ)/003 on
Stretch net of introduction Stretch net is delivered to PFP in supplier
VWSB wrapped in shrink management
• Insect and dropping Low Low 1 wrap and plastic cover

Stretch net is use in

palletizing, does not has any
contact with bagged finished
product

Chemical • None. Not possible source Pb &S = Low. Because

of introduction Stretch net is used in
palietizing, does not has any
• Possible toxic chemical Low Low 1 contact with bagged finished
substance used to make product
the laminate
Physical • None. Not possible source Pb &S = low, because Stretch
of introduction net is delivered to VWS8
wrapped in shrink wrap and
• Foreign material like dust Low Low 1 plastic cover
& dirt due to unclean
pallets Stretch net is used in
palletizirsg, does not has
any contact with bagged
finished product
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

9 Looks & Pop Biological • None. Not possible source Pb &S = low, because anti QMC(PQ)/003 on
glue / anti-slip of introduction slip agent is delivered to PFP in supplier
agent VWSB in sealed drums management
• Insect and dropping Low Low 1 during delivery

Anti-stip agent is used in

during paltetizing, does not
has any contact with bagged
finished product

Chemical • None. Not possible source Pb &S = low. Because Anti

of introduction slip agent is used in during
paltetizing, does not has any
• Possible toxic chemical Low Low 1 contact with bagged
substance used to make finished product
the laminate
Physical • None. Not possible source Pb & S = Low, because anti-
of introduction slip is used in palletizing.
Does not has any contact
• Foreign material like dust Low Low 1 with bagged finished product
& dirt due to unclean
drum surface

CCP DECISION TREE TABLE [refer flow chart FPF (MP)/003 VER 3, 13.8.09]
Step Process
1 PFAD Purchase & Receiving
2 CaO Purchase & Receiving
3 BHT Purchase & Receiving
4 Ethoxyquin Purchase & Receiving
5 Portable/ Processed water
6 Megalac bag 25kg Purchase
7 Wooden pallet purchase
8 Slip Sheet Purchase
9 Film wrap / Stretch net
10 Lock & Pop glue / Anti slip agent
HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA
Hazard Q1 Q2 Q3 Q4 CCP/ POA
- Heavy metal (chemical) 3 POA
- Dioxin compounds (supply of Positive Released PFAD) (Chemical) 3 POA
- Dioxin compounds (supply of Non Positive Released PFAD) (Chemical) 4 CCP
- Dioxin compound (Wrongly uploading of Non positive released PFAD into 3 POA
tank that contains positive release PFAD
- Antibiotic & Feed Medicine (Chemical) 1
- Biological hazard 1
- Physical hazard 2
- Heavy metal (chemical) 3 POA
- Dioxin compounds (Chemical) 3 POA
- Antibiotic & Feed Medicine (Chemical) 1
- Biological & Physical hazard 1
- Heavy metal (chemical) 1 POA
- Antibiotic & Feed Medicine (Chemical) 1
- Biological hazard 1
- Physical hazard 1
- Heavy metal (chemical) 1 POA
- Antibiotic & Feed Medicine (Chemical) 1
- Biological hazard 1
- Physical hazard 1
- Biological, Chemical and Physical hazard 1
- Biological, Chemical and Physical hazard 1
- Biological, Chemical and Physical hazard 1
- Biological, Chemical and Physical hazard 1
- Biological, Chemical and Physical hazard 1
- Biological, Chemical and Physical hazard 1
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

HACCP Plan Summary / Control Chart

POA/CCP & Hazard Control Measures Critical/ Monitoring Corrective Action fter Verification Records
Location Rejection What How When Who deviation
Limit
rd
CCP 1 PFAD Heavy metal General Control Pb = 10mg/kg Heavy Supplier’s At least once Plant Call HACCP Meeting For Lab test by 3 FPF(MP) / 008
Purchase & as lead (Pb), - Get supply from (ppm) metal as certificate of a year executive / Course Of Action And party lab, at & 009 for
Receiving cadmium GMP or GMP Pb, As, CD, analysis and / Sales Review Supplier Status least once a monitoring &
(Cd), Mercury equivalent As = 2mg/kg & Hg or lab test by (because past manager year verivication
(Hg) & certified suppier (ppm) VWSB result showed Action : plan
Arsenic (As) - Periodic heavy low - Hold Entire PFAD Lot In Responsible :
(Chemical) metal tests as Cd = 1 mg/kg incidence) Storage Tank. Draw Production Certificate of
rd
verification (ppm) Pfad Samples From Executive/ analysis by 3
Tank And Run Relevant Sales Manager party lab
Hg = 0.1 Tests.
mg/kg (ppm) - Test Megalac Stock In QMQ(PQ)/003
Warehouse For Heavy on PFP in
Metal Through supplier
Random Samples. management
- Trance Test Result Of
Megalac To Pfad
- If Megalac’s Heavy
Metal Levels Meet
Standard, No Recall/
Disposal Of End
Products, Despite Pfad
Heavy Metal Out Of
Specs
- Return Contaminate
Pfad (Whole Storage/
Blending Tanks) To
Supplier And Seek
Compensation

Responsible :
Production Executive/
Sales Manager
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

CCP 1 Dioxin General Control Dioxin’s Dioxin in Supplier’s Every Supplier & Call HACCP Lab test by Fpf(Mp)/008
PFAD (supply of - Ensure supply Action limit PFAD certificate of corresponding plant meeting for course of accredited & 009 For
Purchase & positive of positive = 0.5ng analysis of the batch Executive / action and review
rd
3 party lab Monitoring &
Receiving Released released PFAD WHO- corresponding Sales Verivication
supplier status
(continue) PFAD) batch Must have Manager Plan
comes from PCDD/F- Verification
access to cert
GMP+ or GMP TEQ/kg Actions: frequency is
Note: of analysis for Certification
equivaient dioxin before (1) Reject PFAD if (i) based on Of Analysis By
Dioxin
certified Dioxin’s any delivery exceed 0.75ng/kg; or cumulated Accredited 3
rd
compounds
supplier Rejection of (ii) Dioxin levei is > 0.6 history of an Party Lab
Inciude :
limit = corresponding ng/kg but below supplier.
• Di0xin batch is to be Qmq(Pq)003
- Specify Dioxin 0.75 ng 0.75ng/kg when there
• Dioxin-like arranged On Pfp In
as part of the WHO- is no history
PCBs Supplier
quaiity PCDD/F- (2) If dioxin level is of deviation ,
• Non- specification TEQ/kg management
between 0.5 to veruvication
Dioxin like
0.6ng/kg, we can is in fact not FPF(HM)015
PCBS - Must have Internal exercise the options of needed PFAD Batch
access to Cert accepted taking (2a) or (2b) positive
Based on of analysis for Dioxin Verification Release
COA results Dioxin before level = 0.6 tracking
Action (2a) for Action
Over the corresponding ng WHO- Dilution with positive (2a)
years (since batch is to be PCDD/F- releaase PFAD, should The diluted
2012), only arranged TEQ/kg, we have access to batch can be
Dioxin is During other batches of verified by
“critical emergency positive release PFAD laboratory
hence only case (see with Dioxin level ≤ Dioxin test, if
Dioxin is Note** at 0.5ng/kg for dilution need to.
targeted for Corrective
CCP Action The new diluted / If and when
coloumn blended batch must the blending
have a lower dioxin formula is
level. Arround 0.5ng/kg verified later
or <ng/kg idealy and proof to
be reliable,
The new diluted/ the biended
blended batch can be PFAD does
HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

released 24 hours after not need to

blending) for be tested for
production use Dioxin again
based on dilution afier
formulation (see blending.
QMQ(SP)/G17), with
the preceding
condition that the
dioxin lavel of the
source PFAD is
known.

Action (2b) Verification

in cases of emergency, for Action
like shortage of PFAD (2b)
in the market or Finished
prolonged delay of product of
PFAD supply to VWSB; such batch
even dioxin level at would have
≤0.6ng/kg can be to be
accepted internally and verified for
PFAD can be positive Dioxin
release by VWSB for compliance
direct Production use. (i.e.
<0.75ng/kg)
N0te**:
lnternailly accepted Responsible
Dioxin level (0.6ng/kg) :
is based on the Production
following assumptions Executive /
: Sales
- PFAD Maneger
Contributes 75% of
0.6ng/kg =
0.45ng/kg
HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

- CaO & Other

Contribute 0.1ng/kg
Dioxin into finished
product

Responsible :
Production Executive /
Sales Maneger
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

POA/CCP Hazard Control Measures Critical/ Monitoring Corrective Action fter Verification Records
& Location Rejection What How When Who deviation
Limit
CCP 1 PFAD Dioxin General Control Dioxin’s Action Dioxin in certificate of Every Plant Call HACCP No verification is FPF(MP) / 008
Purchase & (supply of - Ensure supply limit = 0.5ng PFAD analysis of the corresponding Executive / meeting for course of in fact needed & 009 for
Receiving Non-positive of positive WHO- corresponding batch Sales action and review since the monitoring &
(Continue) Released released PFAD PCDD/FTEQ/kg batch Manager “Positive verivication
supplier status
PFAD) ReleaseExcercise” plan
comes from
Dioxin’s is conducted at
GMP+ or GMP PFAD become “Positive
Note: Rejection VWSB Certificate of
equivaient release” if dioxin level is rd
Dioxin limit = analysis by 3
certified below Action limit. If
compounds party lab
supplier’s 0.75 ng not, taken either Action
Inciude : WHO- (1) & (2)
QMQ(PQ)/003
• Di0xin PCDD/F- on PFP in
Specific Control
• Dioxin- TEQ/kg Action :
supplier
- Must conduct (1) if ‘results’
like management
Dioxin test on Exceed Rejection limit
PCBs Internal
this non-
• Non- positive accepted (0.75ng/kg the FPF(HM)015
Dioxin like Dioxin releated PFAD PFAD Batch
release PFAD, batch is to be positive
PCBS prior to any level = 0.6
downgraded as release
production ng WHO-
“Non-feed use”. tracking
Based on use. PCDD/F-
COA results TEQ/kg, Such PFAD would
- Batch is be either (i) rejected
Over the defined by During
years (since emergency & returned to the
VWSB, but supplier or (ii) resell
2012), only volume per case (see
Dioxin is Note** at it to other buyer for
batch cannot “'non- feed use”.
“critical exceed 700MT Corrective
hence only theoretically, Action
Dioxin is coloumn (2) if results fall
as the capacity between Action limit
targeted for of storage
CCP (0.5ng/kg) and
tank of ST701 Rejection limit
or ST702 is (0.75ng/kg), VWSB
700MT has the options of
maximum taking either action
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

- Such non- (2a) or (2b) or (2c) or

positive a combination.
release PFAD
can only be Action (2a)
approved for Dilution with pesitive Verification for
production release PFAD, shculd Action (2a)
use based on we have access to the diluted
the certificate other batches of batch. should
of analysis on positive released be verified
Dioxin, issued PFAD with Dioxin by either (i)
by an level ≤0.5ng/kg for laboratory
accredited dilution purpose. Dioxin test of
laboratory, the blended
indicating that The new diluted / PFAD or (ii)
the Dioxin blended batch must Dioxin
results of the have a lower Dioxin verification
related PFAD level, ideally on the finished
batch meet ≤0.5ng/kg; or at products made
the GMP internally acceptable from such
standard Dioxin level, i.e. blended PFAD.
/specification. maximum 0.6ng/kg Targeted dioxin
compliance of
- Only then, the The new diluted / the finished
related batch blended batch can be product should
is classified as released (24 hours be < 0.75 ng/kg
“Positive after blending) for
Release PFAD” production use lf and when the
based on dilution blending
formulation (see formula is
QMQ(SP)/017) with verified later
the preceding and proof to be
condition that the reliable the
dioxin level of the blelended does
source PFAD is not need to be
known. tested for
Dioxin again
HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

after blending.
Likewise, its
finished
product.

Verivication for
Action (2b) action (2b)
In cases of Finished
emergency; like product of such
shortage of PFAD in batch can be
the market or verified for
prolonged delay of Dioxin
PFAD supply to compliace (i.e
VWSB:even Dioxin <0.75ng/kg)
level at ≤0.6ng/kg
can be accepted Responsible:
internally and such Producailon
PFAD can be positive Executive
released by VWSB for Sales
direct production use. Manager

Note** :
- PFAD
Contributes 75% of
0.6ng/kg =
0.45ng/kg
- CaO & Other
Contribute
0.1ng/kg Dioxin
into finished
product

Action (2c)
To be rejected &
Returned to the
HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

supplier or resell it to
other buyers for as
“downgraded PFAD
or for “non-feed use”

Responsible :
Production Executive
/ Sales Maneger
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

POA/CCP Hazard Control Measures Critical/ Monitoring Corrective Action fter Verification Records
& Location Rejection What How When Who deviation
Limit
CCP 1 PFAD Dioxin General Control Dioxin’s Action Dioxin in Certificate of Related & Plant Call HACCP No verification is FPF(MP) / 008
Purchase & (Wrongly - Effective limit = 0.5ng PFAD analysis of the Affected Executive / meeting for agreed in fact needed & 009 for
Receiving uploading of comunivcation WHO- corresponding batch Sales course of action since the monitoring &
(End) incoming & control PCDD/FTEQ/kg batch Manager “Positive verivication
non-positive ReleaseExcercise” plan
through SOP/ Hold the affected
release PFAD Dioxin’s “Positive is conducted at
working batch until the dioxin
into tank that Rejection urelease” if VWSB Certificate of
contain instruction dioxin level level is ascertained analysis by 3
rd
limit =
positive meets the party lab
0.75 ng
Released GMP+standart PFAD become “Positive
WHO-
PFAD) release” if dioxin level is FPF(HM)015
PCDD/F- below Action limit. If not, PFAD Batch
Note: TEQ/kg taken either Action (1) & positive
Dioxin (2) release
compounds Internal tracking
Inciude : accepted Action :
• Dioxin Dioxin (1) if results
• Dioxin-like level = 0.6 Exceed Rejection limit
PCBs ng WHO- (0.75ng/kg the
PCDD/F- releated PFAD
• Non-
TEQ/kg, batch is to be
Dioxin like
During downgraded as
PCBS
emergency “Non-feed use”.
case (see Such PFAD would
Based on
Note** at be either (i) rejected
COA results
Corrective & returned to the
Over the
Action supplier or (ii) resell
years (since
coloumn it to other buyer for
2012), only
“'non- feed use”.
Dioxin is
“critical
(2) if results fall
hence only
between Action limit
Dioxin is
(0.5ng/kg) and
targeted for
Rejection limit
CCP
HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

(0.75ng/kg), VWSB has

the options of taking
either action (2a) or
(2b) or (2c) or a
combination. Verification for
Action (2a)
Action (2a) the diluted
Dilution with pesitive batch. should
release PFAD, shculd be verified
we have access to by either (i)
other batches of laboratory
positive released PFAD Dioxin test of
with Dioxin level the blended
≤0.5ng/kg for dilution PFAD or (ii)
purpose. Dioxin
verification
The new diluted / on the finished
blended batch must products made
have a lower Dioxin from such
level, ideally blended PFAD.
≤0.5ng/kg; or at Targeted dioxin
internally acceptable compliance of
Dioxin level, i.e. the finished
maximum 0.6ng/kg product should
be < 0.75 ng/kg
The new diluted /
blended batch can be lf and when the
released (24 hours blending
after blending) for formula is
production use verified later
based on dilution and proof to be
formulation (see reliable the
QMQ(SP)/017) with blelended does
the preceding not need to be
condition that the tested for
Dioxin again
HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

dioxin level of the after blending.

source PFAD is known. Likewise, its
finished
product.

Action (2b) Verivication for

In cases of emergency; action (2b)
like shortage of PFAD Finished
in the market or product of such
prolonged delay of batch can be
PFAD supply to VWSB : verified for
even Dioxin level at Dioxin
≤0.6ng/kg can be compliace (i.e
accepted internally <0.75ng/kg)
and such PFAD can be
positive released by Responsible :
VWSB for direct Producailon
production use. Executive
Sales
Note** : Manager
- PFAD
Contributes 75% of
0.6ng/kg =
0.45ng/kg
- CaO & Other
Contribute 0.1ng/kg
Dioxin into finished
product

Action (2c)
To be rejected &
Returned to the
supplier or resell it to
other buyers for as
“downgraded PFAD or
HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

for “non-feed use”

Responsible :
Production Executive /
Sales Maneger
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

POA/CCP & Hazard Control Measures Critical/ Monitoring Corrective Action fter Verification Records
Location Rejection What How When Who deviation
Limit
rd
POA 1 Heavy metal General Control Pb = Heavy Supplier’s At least Plant Call HACCP Lab test by 3 FPF(MP) / 008
CaO as Lead (Pb) - As limetreat 10mg/kg(ppm) metal as Pb Certificate once a year Executive / meeting for course of party lab, at & 009 for
Purchase & (Chemical) NSL Chemical is Of Analysis Sales action an review supplier least once a monitoring &
Receiving not GMP or And / Or (because Manager year verivication
status
Lab Test By past result plan
GMP equivalent
VWSB showed Responsible :
certified, Action :
low Production Certificate of
annual factory Action : rd
incidence) Executive/ analysis by 3
audit is - Hold Entire CaO Lot In
Sales Manager party lab
required Storage Tank. Draw CaO
Samples From Tank And rd
- Periodic heavy Same 3 party QMQ(PQ)/003
Run Relevant Tests.
metal tests as lab’s cert of on PFP in
- Test Megalac Stock In
verivication analysis for supplier
Warehouse For Heavy
diocin shared management
Metal Through Random
by supplier
Samples.
whould serve
- Requested - Trance Test Result Of
Dioxin in the purpose of
supplier to test Megalac To CaO
Dioxin Dioxin’s Action CaO Supplier To At least Supplier. verivication
Dioxin once a - If Megalac’s Heavy
limit = 0.5ng Provide once a year Monitored
year and give Metal/ Dioxin Levels
WHO- Cert Of By Plant
Meet Standard, No
us a copy of PCDD/FTEQ/kg Analysis Executive/
Recall/ Disposal of end
certificate as For Dioxin Technical/
rd Products, Despite CaO
evident Dioxin’s from 3 Sales
Heavy Metal/ Dioxin Out
Rejection party lab Manager
Of Specs
limit = - Return Contaminate CaO
0.75 ng (Whole Storage/
WHO- Blending Tanks) To
PCDD/F- Supplier And Seek
TEQ/kg Compensation

Responsible :
Production Executive /
Sales Maneger
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

POA/CCP & Hazard Control Measures Critical/ Monitoring Corrective Action fter Verification Records
Location Rejection What How When Who deviation
Limit
rd
POA 2 Heavy metal General Control Pb = Heavy Supplier’s Every NEW Plant Call HACCP Lab test by 3 FPF(MP) / 008
CaO as Lead (Pb) - Get only food 4mg/kg(ppm) metal as Certificate batch upon Executive / meeting for course of party lab, at & 009 for
Purchase (Chemical) grade BHT Pb, As & Hg Of Analysis receiving or Sales action an review supplier least once a monitoring &
- Get Supply As = 1 And / Or at least Manager year verivication
status
mg/kg(ppm) Lab Test By once a year plan
from GMP / ISO
VWSB Responsible :
or Equivalent Action :
Hg = 0.1 (because Production Certificate of
certified Action : rd
mg/kg(ppm) past result Executive/ analysis by 3
supplier - Hold affected BHT
showed Sales Manager party lab
- Periodic heavy batches
low
- Test affected Megalac
metal test as incidence) QMQ(PQ)/003
Stock For Heavy Metal
verivication r on PFP in
- If Megalac’s Heavy Metal
supplier
Levels Meet Standard,
management
No Recall/ Disposal of
end Products, Despite
BHT Heavy Metal Out Of
Specs
- Return affected BHT to
supplier (Whole Storage/
Blending Tanks) To
Supplier And Seek
Compensation

Responsible :
Production Executive /
Sales Maneger
 HACCP PLAN FOR RAW MATERIALS
Megalac/ CaSPFA

POA/CCP & Hazard Control Measures Critical/ Monitoring Corrective Action fter Verification Records
Location Rejection What How When Who deviation
Limit
rd
POA 3 Heavy metal General Control Pb = 0.0002 % Heavy Supplier’s Every NEW Plant Call HACCP Lab test by 3 FPF(MP) / 008
CaO as Lead (Pb) - Get only food of weight metal as Certificate batch upon Executive / meeting for course of party lab, at & 009 for
Ethoxyquin (Chemical) grade BHT Pb, Of Analysis receiving or Sales action an review supplier least once a monitoring &
Purchase - Get Supply And / Or at least Manager year verivication
status
Lab Test By once a year plan
from GMP / ISO
VWSB Responsible :
or Equivalent Action :
(because Production Certificate of
certified Action : rd
past result Executive/ analysis by 3
supplier - Hold affected EQ
showed Sales Manager party lab
- Periodic heavy batches
low
- Test affected Megalac
metal test as incidence) QMQ(PQ)/003
Stock For Heavy Metal
verivication r on PFP in
- If Megalac’s Heavy Metal
supplier
Levels Meet Standard,
management
No Recall/ Disposal of
end Products, Despite
EQ Heavy Metal Out Of
Specs
- Return affected EQ to
supplier (Whole Storage/
Blending Tanks) To
Supplier And Seek
Compensation

Responsible :
Production Executive /
Sales Maneger