NLU-02-GMP HACCP-2018

become#the#reference#for#international#food#safety#requirements 4 Asst.Prof.Dr.Suthat..Surawang.2 QA2NLU220182GMP.&.HACCP... › what#is#necessary#and#appropriate#on#the#grounds#of# the#sa

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Asst.Prof.Dr.Suthat Surawang.2 QA2NLU220182GMP.&.HACCP Asst.Prof.Dr.Suthat Surawang.2 QA2NLU220182GMP.&.HACCP

! become#the#reference#for#international#food#safety#requirements

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Asst.Prof.Dr.Suthat Surawang.2 QA2NLU220182GMP.&.HACCP

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! Outbreaks#of#food#borne#illness#can#damage#trade#and# tourism,#and#lead#to#loss#of#earnings,#unemployment# and#litigation.

! Control#of#the#General#Principles#are#recommended#to# Governments,#industry#(including#individual#primary# producers,#manufacturers,#processors,#food#service# operators#and#retailers)#and#consumers#alike.#

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› what#is#necessary#and#appropriate#on#the#grounds#of# the#safety#and#suitability#of#food#for#consumption?

› Food.hygiene.$ all#conditions#and#measures#

necessary#to#ensure#the#safety#and#suitability#of#food# at#all#stages#of#the#food#chain.##

› Hazard.$ a#biological,#chemical#or#physical#agent#in,#

or#condition#of,#food#with#the#potential#to#cause#an# adverse#health#effect.#

› HACCP.$ a#system#which#identifies,#evaluates,#and#

controls#hazards#which#are#significant#for#food#safety.#

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› avoiding#the#use#of#areas#where#the#environment# poses#a#threat#to#the#safety#of#food^#

› controlling#contaminants,#pests#and#diseases#of#

animals#and#plants#in#such#a#way#as#not#to#pose#a# threat#to#food#safety^#

› adopting#practices#and#measures#to#ensure#food#is# produced#under#appropriately#hygienic#conditions.#

› control#plant#and#animal#health#so#that#it#does#not#pose#a#threat# to#human#health#through#food#consumption,#or#adversely#affect# the#suitability#of#the#product^#

› protect#food#sources#from#fecal#and#other#contamination.#

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! equipment#and#facilities#should#be#located,#designed#and# constructed#to#ensure#that:##

› contamination#is#minimized^#

› design#and#layout#permit#appropriate#maintenance,#cleaning#and# disinfections#and#minimize#air$borne#contamination^#

› areas#subject#to#flooding#unless#sufficient#safeguards#are# provided^#

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› should#be#designed#and#constructed

› adequately#cleaned,#disinfected#and#maintained#to# avoid#the#contamination#of#food.#

› should#be#durable#and#movable#or#capable#of#being# disassembled

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4.3-Equipment

4.3.2#Food#control#and#monitoring#equipment

› harmful#or#undesirable#micro$organisms#or#their#toxins# are#eliminated#or#reduced

› where#appropriate,#critical#limits#established#in#

HACCP$based#plans#can#be#monitored^#

› temperatures#and#other#conditions#necessary#to#food# safety#and#suitability#can#be#rapidly#achieved#and# maintained.#

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› Monitoring > verification > Review

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Adapted from Taylor L (1978) An evaluation of hand washing techniques-I Nursing Times 12 January, pp 54-55.

Poor cleaning Not enough cleaning Always good cleaning

Asst.Prof.Dr.Suthat Surawang 1 QA1NLU120181GMP<&<HACCP

How to wash your hands

drying Rinse with water

Rub hand /palm / finger

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Asst.Prof.Dr.Suthat Surawang 2 QA2NLU220182GMP.&.HACCP

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!

RATIONALE:-Food#may#become#contaminated,#or#may#not#reach#its#destination# in#a#suitable#condition#for#consumption,#unless#effective#control# measures#are#taken#during#transport,#even#where#adequate# hygiene#control#measures#have#been#taken#earlier#in#the#food

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! 9.1#Lot#identification

› Codex#General#Standard#for#the#Labelling of#

Prepackaged#Foods#(CODEX#STAN#1$1985,#Rev.###1$ 1991)

! 9.2#Product#information

! 9.3#Labelling

› Codex#General#Standard#for#the#Labelling of#

Prepackaged#Foods#(CODEX#STAN#1$1985,#Rev.###1$ 1991)

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› Managers#and#supervisors#of#food#processes#should#have#the# necessary#knowledge#of#food#hygiene#principles#and#practices#to# be#able#to#judge#potential#risks#and#take#the#necessary#action#to# remedy#deficiencies.#

! 10.4#Refresher#training

› Training#programmes should#be#routinely#reviewed#and#updated# where#necessary.#

› Systems#should#be#in#place#to#ensure#that#food#handlers#remain# aware#of#all#procedures#necessary#to#maintain#the#safety#and# suitability#of#food.#

How does HACCP help?

What are the benefits?

Are there any drawbacks?

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Asst.Prof.Dr.Suthat Surawang 2 QA2NLU220182GMP.&.HACCP Asst.Prof.Dr.Suthat Surawang.2 QA2NLU220182GMP.&.HACCP

1960#$ Pillsbury#+#NASA#(The#US#Army#Natick#Lab)##FMEA#concept 1971#$ USFDA#(LAF#and#Acidified#Food)

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› Sanitary#and#Phytosanitary Measures#(SPS#Agreement)

! reduces#the#reliance#on#end$product#inspection#and#testing

! enhances#the#responsibility#and#degree#of#control#at#the#level#of#the#food#industry

! enhancing#food#safety,#include#more#effective#use#of#resources,#savings#to#the#food#industry

! Can#be#capable#of#accommodating#change,#(such#as#advances#in#equipment#design,#changes#in#processing#procedures#or#technological#

developments)

! International#food#safety#standard

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! Pre-requisite program (GMP/SSOP*)

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pH 4.8 to 6.5 (low acid)

Aw > 0.85 (high moisture)

3 How the product is to be used Normally heated before serving (casseroles, garnishes, etc.) or sometimes served unheated

(salads, appetizers, etc.)

4 Packaging Hermetically sealed metal container

5 Shelf-life Two years plus, at normal retail shelf

temperatures

6 Where the product will be sold Retail, institutions and food service

7 Labelling instructions None required to ensure product safety

8 Special distribution control No physical damage, excess humidity or

temperature extremes

9 Consumer General consumers , Could be consumed by

high-risk groups (infirm, immunocompromised, elderly)

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3 Corrective#action:#Any#action#to#be#taken#when#the#results#of#

monitoring#at#the#CCP#indicate#a#loss#of#control.

4 Critical#Control#Point#(CCP):#A#step#at#which#control#can#be#applied# and#is#essential#to#prevent#or#eliminate#a#food#safety#hazard#or# reduce#it#to#an#acceptable#level.

13.#Monitor#:#The#act#of#conducting#a#planned#sequence#of#

observations#or#measurements#of#control#parameters#to#assess# whether#a#CCP#is#under#control.#

14.#Step#:#A#point,#procedure,#operation#or#stage#in#the#food#chain# including#raw#materials,#from#primary#production#to#final#

consumption 15.#Validation#:#Obtaining#evidence#that#the#elements#of#the#HACCP# plan#are#effective.

16.#Verification#$ The#application#of#methods,#procedures,#tests#and# other#evaluations,#in#addition#to#monitoring#to#determine#

compliance#with#the#HACCP#plan

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› Brain#storming#/Scientific#&#Rationale

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Sa#– Satisfactory#(negligible) Mi – Minor

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› Hazards#will#vary#among#firms#making#the#same#products#because#of#differences#in:#

› All#biological,#chemical#and#physical#hazards#should#be#considered

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- Hard foreign objects in food

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Asst.Prof.Dr.Suthat Surawang $ QA$NLU$2018$GMP#&#HACCP

Microbiological Hazards

- Bacteria

- Fungi , Yeast & Mold

- Protozoa and parasites

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Reduce Cross Contamination

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• Clostridium perfringen

• Sources: meat, spices

• Symptom: Headache, diarrhea

• Prevention: heating, low temperature

• Sources: canned food

• Symptom: Vomit, neurotoxin, muscle paralysis,

• Prevention: Thermal process, acidified

• Prevention: thermal process, low temperature

• Escherichia coli O157:H7

• Sources: raw beef, milk, salad

• Symptom: Diarrhea, nausea, renal failure

• Prevention: Personal hygiene, hand washing, thermal process

• Infection

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https://en.wikipedia.org/wiki/Escherichia_coli_O157:H7

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!Prevention:##Thermal# process,#GMP,#pest# control

!Prevention: Thermal process, GMP

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• Histamine#(decaboxylation of#histidine)

• Aflatoxin (Aspergillus flavus)

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Q4 Q3 Q2

Q1a

Process-or-Product

Modify-steps-in-the-Stop*

Y Y

Y

Y N Y

N

N N

N

*-Proceed-to-the-next-step

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!Is the step specifically designed to

eliminate or reduce the likely occurrence

of the identified Hazard to an acceptable

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!Could#contamination#with#identified#hazard(s)#

occur#in#excess#of#acceptable#level#or#would# these#increase#to#unacceptable#levels#?

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! For#example:#CCP$1#(C)#?

!CCP$2#(B,C)#?

!If#not#a#CCP#(fully#controlled#by#GMP/GHP)

› GMP/GHP#(equipment,#personal,#premises,#storage,#transport)

› For#hazards#for#which#the#answer#to#Question#3#is#"no",#write#"not#applicable"#(N/A)

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Process#adjustment Corrective#action

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!Establish a#monitoring#system#for#each# CCP

! Monitoring#may#mean#measuring#a#characteristic#of#the#product#or#of#the#process#to#determine#

compliance#with#a#critical#limit#(CL)

! Monitoring#may#also#mean#observing#whether#a#control#measure#at#a#CCP#is#being#implemented

! The#monitoring#procedures#must#be#able#to#detect#loss#of#control#at#the#CCP.#

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" Serial#no.

" Due#date

" Calibration#date

" Calibrated#by

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• Records:

– CCP#monitoring#activities– Deviations#and#corrective#actions#record

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01 8/6/2016 Change temperature to 100 O C 8/6/2016 Martin

Disposition

Purchase orders

Purchasing Purchasing 1 year Archive 3 yrs.;

Destroy Calibration

records

Quality Assurance

QA manager 2 years Destroy

Traceability records

Food safety Food safety 1 year Destroy

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› HACCP team leader and staff

› List of HACCP team and experiences

7 Chemical control procedure

9 Water, ice and steam control procedure

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10 Incoming materials control procedure

11 Transportation control procedure

12 Waste disposal control procedure

13 Training procedure

14 Product Traceability procedure

15 Hold and release procedure

16 Product recall procedure

17 Document and record control procedure

18 Verification procedure

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1 Preliminary step of HACCP team

1.1 Official promotion of HACCP team leader

1.2 List of HACCP team

2.1 Product description and intended use

2.2 Flow diagram and detail of each processing steps

2.3 On-site verification of flow diagram

2.4 Determination of Hazard analysis 2.5 Determination of Critical Control Point (CCP) 2.6 Determination of Critical limit (CL)

2.7 Determination of Monitoring procedure 2.8 Determination of corrective action 2.9 Verification procedure

2.10 Documentation and record keeping 2.11 Training record

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Auditor certification

Scheme Auditor Certification Auditor Training

! http://www.tisi.go.th http://www.fao.org http://www.codexalimentarius.net

Asst.Prof.Dr.Suthat Surawang - QA-NLU-2018-GMP & HACCP

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