appendix b hazard analysis and critical control point …iv+appendix+b... · step 1- frozen samosa...

APPENDIX B

Hazard Analysis and Critical Control Point

(HACCP)

Step 1- Frozen Samosa HACCP Team Assembly

Date: 27th

July’ 2011 Name Title

HACCP Team Coordinator Mr. Ajinkya Bande QA MG

HACCP Team Members Miss. Ibtisam Alzahrani Purchasing & Storage MG Miss. Lu Chen Processing MG Miss. Marilena Psylou Maintenance MG Miss. Lili Zhai Packaging MG Miss. Yushan Yang Storage & Dispatch MG

Step 2- Product Description & Intended Use

Frozen samosas are suitable for everyday family meal. Packed in LDPE packet and are sold as

frozen product in a grocery store. The product has crispy pastry parcel filled with onion, sweet potato,

coriander leaf and soya chunks cooked in a blend of Indian spices, folded in desired triangle shape and

partially fried. Finished product is to be kept frozen at -18°C or below during storage, transportation

and display in retail store. The product has an anticipated shelf-life of 6 months from the date of

manufacturing if kept frozen.

The product is intended for consumption by the general population, either at home or in a food

service environment. It is not specifically processed for high-risk populations. The frozen product

must be kept frozen at -18°C of below during storage and unused portions should be again stored at -

18°C or below. Defrosting and again freezing of product may cause changes in texture of the product.

Step 4: Process flow sheet

Preliminary Step 3.1 Frozen Samosa Raw Materials and Ingredients List and Information

Name of Raw

Material

Spec.

No.

Form: Paste,

powder, etc.

Storage: Dry/

Cool/Frozen, etc

Packaging:

Bags/drum/bulk, etc

Size of

Lots

Other

Information

Soya chunk mince 1 Mince Dry Airtight bag 1 ton “East End”

Sweet potatoes 2 Whole Cool and Dry Bulk 1 ton Trucked

Roghan josh spice 3 Paste Cool and Dry Bulk 500kg Trucked

Onions 4 Whole Cool and Dry Bags 50Kg Trucked

Yoghurt 5 Set yoghurt Refrigerator Drum 50kg Trucked

Chilli 6 Powder Cool and Dry Bags 50kg Trucked

Ginger garlic paste 7 Paste Refrigerator Drum 50kg Mothers recipe

Sunflower oil 8 Liquid Cool and Dry Drum 20ltrs “Flora”

Fresh coriander 9 Whole Refrigerated Bulk 25kg Trucked

Mint sauce 10 Paste Refrigerated Drum 10kg “Best-in”

Cumin seeds 11 Whole Cool and Dry Airtight bag 50kg “East End”

Mustard seeds 12 Whole Cool and Dry Airtight bag 50kg “East End”

Salt 13 Powder Cool and Dry Airtight bag 50 Kg Trucked

Whole meal flour 14 Flour Cool and Dry Bags 50kg “Pillsbury”

Plain flour 15 Flour Cool and Dry Bags 50kg “Morrisons”

Water 16 - Plant Water System Source: City

Step 5: Onsite verification – Plant/Factory Layout

Step 6: Conduct a Hazard Analysis (HACCP principle 1)

The aim of this step is to identify potential hazards, their significance and preventing measures which can be applied.

(1) (2) (3) (4) (5) (6)

Processing

step

Potential Hazards

Introduced,

Controlled or

Enhanced at this

step

Are any

potential food

safety hazard

significant

(Yes/NO)

Justify your decision What are preventive

measure(s) can be applied for

the significant hazards

Is this

step a

Critical

Control

Point

(CCP)?

Receiving

of Raw

material

Biological (B) Yes Ceratocystis fimbriata and pythium ultimum associated

with sweet potato (J. Woolfe, Sweet potato an untapped

food resource, p-222), Aspergillus niger, Pythium spp.

& Rogers associated with onion (H. Jones, L. Mann,

Onions and their allies, p-190), Mould growth in flour.

Ensure suppliers are credible

and have a HACCP system.

No.

GMP &

GHP 6.1.1

Chemical (C) Yes Pesticide residues on vegetables, additives in flour and

quality of soya chunks.

Ensure suppliers are credible

and have a HACCP system

Physical (P) Yes Non vegetable material like grass, sticks, insects,

leaves, etc in vegetables and spices and insect, rodents

in flour. And damaged vegetables during transportation.

Ensure raw materials of high

grade and quality are delivered

by suppliers and

GMP&GHP 6.1.1

Storage of

raw

material

Biological (B) Yes Spore forming/ spoilage Microorganisms Proper storage on receiving

GMP&GHP 6.1.2 & 7.2

Yes

CCP1 Chemical (C) No -

Physical (P) Yes Damage due to insects and rodents and handling.

Washing

vegetables

Biological (B) Yes E. Coli, campylobacter, Vibrio cholera etc in water http://science.jrank.org/pages/7311/Water-

Microbiology.html

Ensure regular water quality

check & GMP&GHP 6.2

Yes

CCP2

Chemical (C) Yes Ensure washings drain out of the vessel to have least

chlorine left on vegetables.

Visual examination &

GMP&GHP 6.2

Physical (P) Yes Foreign material remaining even after washing. Visual examination &

GMP&GHP 6.2

Chopping

vegetables

Biological (B) Yes Use of non-sterilized cutlery and unnecessary handling

of product.

Ensure cutlery sterilized at

121°C for 20min. GMP & GHP

No

GMP&

GHP 4.2,

6.3 & 10,

Form 4

Chemical (C) No - -

Physical (P) Yes Metal contamination, uneven sweet potato cubes. Ensure GMP and Personal

training.

http://science.jrank.org/pages/7311/Water-Microbiology.html

http://science.jrank.org/pages/7311/Water-Microbiology.html

Cooking

soya

chunks

Biological (B) Yes Cooking reduces microbial load but even cooked food

more susceptible for microbial contamination.

Ensure soya chunks at least

boiled for 10min, strained and

used or stored in storage at 4°C

for future use & GMP&GHP 6.4

Yes

CCP3

Chemical (C) No - -

Physical (P) No - -

Cooking

filling

Biological (B) Yes Cooked food more susceptible for microbial

contamination.

Ensure cooked filling

immediately used for stuffing or

stored in storage if to be used

later & GMP&GHP 6.5

Yes

CCP4

Chemical (C) No - -

Physical (P) No - -

Dough

making

Biological (B) No - - Yes

CCP5 Chemical (C) No - -

Physical (P) Yes Baffle lubricants falling in dough Ensure baffle joints cleaned &

sealed properly & GMP&GHP4.2

Forming of

samosa

Biological (B) Yes Improper cleaning of machine leading to microbial

spoilage, improper handling of samosas by the workers.

Ensure proper cleaning of

machine before and after use.

GMP&GHP 6.6 & 10

Yes

CCP6

Chemical (C) Yes Detergent residue on the machine. Ensure machine cleaning. Visual

inspection. GMP&GHP 4 & 6.6

Physical (P) Yes Addition of foreign material during stuffing, metal

contamination.

Ensure closed hoppers, clean

machine & GMP&GHP 4 & 6.6

Deep

Frying

Biological (B) No - - Yes

CCP7 Chemical (C) Yes Use of oil with high peroxide value Ensure oil quality check before

using & GMP&GHP 6.7

Physical (P) No - -

Freezing Biological (B) Yes Recontamination by micro-organisms Immediate freezing of the

product to -18ºC & GMP&GHP

4.2 & 6.8

Yes

CCP8

Chemical (C) No - -

Physical (P) No - -

Packaging

Biological (B) Yes Microbial recontamination Ensure proper packaging.

GMP&GHP 6.9

Yes

CCP9

Chemical (C) No - GMP&GHP 6.9.1

Physical (P) No - GMP&GHP 6.9.1/2/4 &

Step 7: Determine the critical control points (HACCP principle 2)

The aim of this step is to identify the critical control points throughout the production process. It also shows how the decision for each CCP is made.

Process

step

Is this hazard

of sufficient

likelihood of

occurrence and

severity to

warrant its

control?

Yes: Proceed to

next question.

No :Not a CCP

Is this

hazard fully

controlled by

a

prerequisite

program?

Yes: Not a

CCP

No: Proceed

to next

question.

Q1. Do control

measures exist for

the identified

hazard?

Yes: Proceed to next

question.

No: Either not a

CCP or need to

modify step,

process, or product.

Q2. Is this process

step specifically

designed to eliminate

or reduce the likely

occurrence of this

identified hazard to

an acceptable level?

Yes: CCP

No: Proceed to next

question

Q3. Could

contamination with

the identified

hazard(s) occur in

excess of acceptable

level(s) or increase

to unacceptable

level(s)?

Yes: Proceed to next

question.

No: Not a CCP

Q4. Will a subsequent

step eliminate the

identified hazard(s) or

reduce its likely

occurrence to an

acceptable level?

Yes: Not a CCP

Identify subsequent

step. No: CCP

CCP

No.

Receiving

raw material

Yes No Yes Yes Yes No Form 1

& 1.1

Storage of

raw material

Yes No Yes Yes Yes No CCP 1

Washing

vegetables

Yes No Yes Yes Yes No CCP 2

Cutting

vegetables

Yes No Yes No Yes Yes -

Cooking soya

chunks

Yes No Yes No Yes No CCP 3

Cooking

filling


Dough

making


Shaping of

samosa


Frying Yes No Yes No Yes No CCP 7

GMP&GHP 9

Storage Biological (B) Yes Microbial recontamination Ensure storage below -18°C &

GMP&GHP 6.10

Yes

CCP10

Chemical (C) No - -

Physical (P) No - -

Freezing Yes No Yes No Yes No CCP 8

Packaging Yes No Yes No Yes No CCP 9

Storage Yes No Yes No Yes No CCP10

Step 8: Critical limit, monitoring action, corrective action, record keeping and verification form.

Process step Hazard

type

B/C/P

Control Point

(CCP/GMP/GHP

/PT)

And Description

Critical limit Monitoring Corrective action for

Line and Lot if limit

exceeds & *Person

responsible

HACCP Records, where

located & *Person

responsible

Verification

procedure,

frequency &

*Person

responsible

What & How Freque

ncy

Responsib

ility

Receiving

of Raw

material

B GMP1-B

Vendor pre-

certification and

pre shipment

record review

programme

Vendor monitors microbial

test programme to verify

compliance

(sweet potato, onion,

coriander, etc)

Raw material

from approved

vendor.

Form1,

Form1.1

Every

lot

Purchase

MG &

Store MG

For Line-

Withdraw vendor’s

certification. Approve

new vendor and

arrange for alternative

supply.

For Lot-

Discontinue shipping.

Reject lot(s) at

receiving department.

If in plant shift and

store in QC isolate.

*Purchase MG and

QA MG

Daily records to be taken in

receiving department.

Person designated provides

his/her initials on

monitoring documents and

on corrective action

documents.

Shift Supervisor reviews

records at end of each shift

for completeness and

accuracy, and signs and

examine date records.

*Purchase MG, Store MG

Compare

records for

completenes

s to the

HACCP

plan. Use of

HACCP

verification

procedures.

Audit every

two weeks.

Conduct

external

HACCP

verification

audit on

quarterly

basis.

*Purchase

MG, Store

MG and QA

MG

C GMP1-C

Pesticide residues

on vegetables,

additives in flour

and quality of

soya chunks

Vendor uses correct and good

fertilizers according to the

law and raw material without

adulterants

(sweet potato, onions,

coriander, etc)

Raw material

from approved

vendor.

Form1,

Form1.1

Every

lot

Purchase

MG &

Store MG

P GMP1-P

Environmental

contaminants

Vendor supplies raw material

free from foreign material.

(spices like mustard seeds,

cumin seeds, etc)

Raw material

from approved

vendor.

Form1 & 1.1

Every

lot

Purchase

MG &

Store MG

Storage

of raw

material

B CCP1-B

Spore forming

spoilage

microorganisms

Material should be stored at

temp. <4°C to reduce risk of

micro-organisms. Maintain

proper storage conditions like

cool, dry, low temperature,

humidity, ventilation (if

required)

Monitor

product

temp.,

humidity in

storage room

with

calibrated thermometer

Every

15min

during

shift

Storage

MG and

Stock MG

For Line-

If limits exceeds then

discard the undesirable

material. For Lot-

Collect the samples

and send them to QA

lab to check for

microbial load and

infestation.

Immediate isolation of

infested material. *Storage MG and Stock

Storage temperature

records for intervals of

15min are to be taken &

visual inspection after

every hour.


his/her initials on



documents. Supervisor

reviews records at end of

each shift for completeness

and accuracy, and signs and

P CCP1-P

Damage due to

insects & rodents

during storage GHP1-P

Raw material remains in sound

condition during storage WRT

pest’s infestation.

Least damage to raw material

Extent of

damage by

visual

examination

Every

hour

during

shift.

During

Storage

MG and

Stock MG

Improper handling

during handling (loading &

unloading)

Handling by

workers

handlin

g.

MG examine date records. *Storage MG and Stock MG

Washing

vegetable

B CCP2-B E. Coli < 50cfu,

Campylobacter<100cfu

Vibrio cholera<100cfu

http://whqlibdoc.who.int/publications/2011/9789241548151_

eng.pdf

Water sample

testing of

water source

in QC lab

Every

30min.

*QA MG

&

Processing

MG

For Line-

If microbial limit

exceeds then discard

the product. If ppm

fluctuates then send

sample for analysis.

For Lot-

Check water source.

Collect the samples

and send them to QA

lab to check for

microbial load and

chlorine ppm.

* Processing MG

Record sample collected

for microbial examination

for every 30min, Record

chlorine ppm every 15min,

Record visual examination

done or not and result.


his/her initials on







examine date records. *Shift in-charge & Processing

MG

Compare

records for

completenes

s to the

HACCP

plan. Use of

HACCP

verification

procedures

Audit every

two weeks.

Conduct

external

HACCP

verification

audit on

quarterly

basis.

*HACCP

team for

internal

audit.

Corporate

Quality

Assurance,

HACCP

team from

another

plant or

consultant

C CCP2-C Maintain 20-25ppm chlorine in

water and washing drained out.

http://whqlibdoc.who.int/publications/2011/9789241548151_

eng.pdf

Maintain

proper

chlorine

dosage and

check ppm

with litmus

paper.

Every

15min.

*QA MG

&

Processing

MG

P CCP2-P Complete draining of foreign

material with water.

Visual

inspection.

Every

15min.

*QA MG

&

Processing

MG

Choppin

g

vegetable

B GMP2-B & PT Cutlery sterilized at 121ºC for at

least 20min

Time and

temp. of

sterilization

For

every

batch

cutlery

steriliza

tion

*Shift in-

charge &

Processing

MG

For Line-

Collect sample and send

to QC lab for microbial

exam and specification

check.

For Lot-



exam and specification

check.

*Shift in-charge &

Processing MG

Record process completeness

for each batch of sterilization

and average size of 10 cubes

measured every 30min.


his/her initials on








MG

P GMP2-P & PT Cubes of sweet potato

5-7mm

Measure dice

size with

vernier caliper.

10

cubes

every

30min

*Shift in-

charge &

Processing

MG

Cooking

soya

chunks

B CCP3-B Boiling in water for at least

10min.

Time and

temp. of

boiling with

stop watch and

calibrated

thermometer

For

every

batch

boiled.

*Shift in-

charge &

Processing

MG

For Line-



exam.

For Lot-


Record that whether the

process was followed or not

for every batch and if not

report to QC MG.


his/her initials on

Compare

records for

completenes

s to the

HACCP

http://whqlibdoc.who.int/publications/2011/9789241548151_eng.pdf







exam and continue the

production with new lot.

*Shift in-charge,

Processing MG, QC MG

monitoring documents and on corrective action





examine date records. *Shift in-charge, QC MG &

Processing MG

plan. Use of HACCP

verification

procedures

Audit every

two weeks.

Conduct

external

HACCP

verification

audit on

quarterly

basis.

*HACCP

team for

internal

audit.

Corporate

Quality

Assurance,

HACCP

team from

another

plant or

consultant

Cooking

filling

B CCP4-B Immediately use cooked filling

or keep it in isolated and

refrigerated compartment.

Record for

what time

product was

on hold after

cooking with

and without

refrigeration.

For

every

batch

*Shift in-

charge &

Processing

MG

For Line-

Continuous product

testing after every

30min.

For Lot-

Isolate the filling from

other batches and send

the samples to QC

*Shift in-charge,

Processing MG, QC MG

Record for what time product

was on hold after cooking

with and without

refrigeration.


his/her initials on







examine date records. *Shift in-charge, QC MG &

Processing MG

Dough

making

P CCP5-P The baffle joint are cleaned and

sealed properly

Seal of the

baffle joints

before and

after dough

making to be

tightened with

spanner

For

every

batch

*Shift in-

charge &

Processing

MG

For Line-

Stop the line and reject

the raw material.

For Lot-

Discard the lot.

*Shift in-charge &

Processing MG

Record if there is presence of

lubricant and appearance of

dough.


his/her initials on








MG

Forming B CCP6-B Machine free from microbial

spoilage

Visual

inspection of

Before

starting

*Shift in-

charge &

For Line-

Stop the production

Record the stoppage of due to

such reason particularly and

of samosa the machine every

shift

Processing

MG

clean the machine and

again start production

and discard previous

products.

For Lot-

Stop the line clean

machine and start

production again and

send samples in QC lab

for microbial and

chemical analysis.

*Shift in-charge, QC

MG & Processing MG

report to Production MG.


his/her initials on







examine date records. *Shift in-charge, Production

MG & Processing MG

C CCP6-C No detergent residue after

cleaning

Thoroughly

rinse all metal-

food contact

surfaces with

water.

Before

starting

every

shift

*Shift in-

charge &

Processing

MG

P CCP6-P No addition of foreign material

during stuffing

Ensure closed

hopper and

After

the

filling

is

topped

in the

hopper.

*Shift in-

charge &

Processing

MG

Frying C CCP7-C Peroxide value of oil less than

25meq/lit

(>0.7meq/lit for fresh oil)

Continuous

addition of

fresh oil to

tank &

collecting

samples to

check peroxide

value of oil in

QC lab

Every 4

hours

(at start

and

mid of

every 8

hour

shift)

*Shift in-

charge,

QC MG &

Processing

MG

For Line-

Stop the line put new oil

if needed let the oil heat

and check for peroxide

value again and fry.

For Lot-

Stop the line & replace

whole oil if peroxide

value is too high.

(>13meq/lit)

Record the peroxide value in

QC lab and inform the

Processing department.


his/her initials on







examine date records. *Shift in-charge, QC MG,

Production MG & Processing

MG

Compare

records for

completenes

s to the

HACCP

plan. Use of

HACCP

verification

procedures

Audit every

two weeks.

Conduct

external

HACCP

verification

audit on

quarterly

basis.

*HACCP

team for

internal

audit.

Corporate

Quality

Assurance,

HACCP

Freezing B CCP8-B Product should be frozen

immediately after frying to

-18°C.

Measure

temperature by

a calibrated

thermometer

Every

30min

*Pcakagin

g MG &

Processing

MG

For Line-

Slower all the previous

lines. May be the freezer

takes more time to reach

-18°C.

For Lot-

Slower the line and send

the samples for

microbial analysis. If

suitable then send ahead

or discarded.

*Shift in-charge, QC

Record the temperatures of

the freezer every 30 minutes.


his/her initials on








MG, Packaging MG &

Processing MG

*Shift in-charge, QC MG,

Production MG & Processing

MG

team from another

plant or

consultant

Packagin

g

B CCP9-B Proper 3-seal packaging Visual

inspection of

packets

Every

50th

packet.

*Packagin

g MG

For Line-

Stop and repair the line

and start packaging.

For Lot-

Discard all improper

packets.

*Storage MG and

Packaging MG.

Record the number of faulty

pieces of packet per hundred

packets and report to the

Packaging MG.


his/her initials on








* Storage MG and Packaging

MG.

Compare

records for

completenes

s to the

HACCP

plan. Use of

HACCP

verification

procedures.

Audit every

two weeks.

Conduct

external

HACCP

verification

audit on

quarterly

basis.

*HACCP

team for

internal

audit.

Corporate

Quality

Assurance,

HACCP

team from

another

Storage B CCP10-B Storage temperature below -

18ºC

Measure

temperature by

a calibrated

thermometer

Every

30min

*Store

MG

For Lot-

Check for microbial

spoilage, etc and then

decision on it.

*Store MG & QC MG

Record the temperature every

30min and report to Store

MG.


his/her initials on







examine date records. * Storage MG and Packaging

MG.

APPENDIX

Form 1 – Supplier letter of Guarantee

Name of the Supplier Company

Address of the Supplier Company

LETTER OF GUARENTEE

Date:

To Purchase MG,

Name of the Receiving Company

Address of the Receiving Company

This letter is send to you to certify that in accordance to your purchasing order of (date), this

shipment of the (product & lot number) conforms to the specification for the hazards

specified in your purchase order.

Sincerely,

Quality MG,

Supplier Company

Reviewed By: Date:

Purchase MG of Receiving Company

Form 2 – Raw Material Inspection Report

ACCEPTABLE QUALITY LEVEL (AQL)

RAW MATERIAL INSPECTION REPORT

Quality Control Technician: ________________________ Date: ____________

Supplier: _____________________ Lot:___________ Date:___________

Product: ___________________________

Temperature: ___________________ (°C) Bacterial Sample Taken : YES NO

1) Appearance: Excellent Good Fair Poor Bad

2) Presence of Foreign matter: No Low Moderate High Unacceptable

3) Damage: No Low Moderate High Unacceptable

Inspection Comments:_________________________________________________________

_____________________________________________________________________________________

________________________________________________________________.

The raw material is Accepted Rejected *Date:________

Purchasing MG addressing to Processing MG

Raw material inward: (*Date)

Raw material to be used before: (Date)

(Signature)

Received by Processing MG

Form 3 – Instruments Calibration Records

Name of the Company

Address of the Company

TEMPERATURE INSTRUMENT CALIBRATION RECORDS

Name of the Instrument:_______________

Model No.:_______________ Serial No.:______________

Position in the Company: (Ex. Fryer, in refrigerator, cooking kettle, etc)

Calibration date:_______________

Calibration date Method of

Calibration

Performed by Next Calibration

date

Comments

Reviewed by: (Signature) Date:______________

(Name)

Form 4 – Employee Training Records

Name of the Company


EMPLOYEE TRAINING RECORD

Employee Name:______________________________

Training Course Start Date End Date

1

2

3

4

5

6

7

8

Reviewed By: (Signature) Date:______________

(Name)

Form 5 – HACCP System Deviation Report

HACCP System Deviation Report

(Failure to Meet Critical Limit)

Product:______________________________

Processing Line:_______________________

Occurred at CCP No.__________

Description:_________________________________________________________________

___________________________________________________________________________

__________________________________________________________________________.

Date:_______ Batch:_________ Shift:__________ Time: ______am/pm

Reported By:____________________

Reasons for HOLDING OF PRODUCT

Why Product was held? ______________________________________________________.

Amount of product held: _____________________________

Person placing product on held: ________________________

Reasons for DISPOSITION/RELEASE OF PRODUCT

What is decision on disposition/release of product: __________________________________

__________________________________________________________________________.

Decision made By: (Signature) Date:___________

(Name)

Corrective Action taken to avoid Deviation from Control Point

Corrective Action: ___________________________________________________________

__________________________________________________________________________.

Done By: : (Signature) Date:___________

(Name)

(Signature)

(Name)

Shift Supervisor

(Signature)

(Name)

Processing MG

(Signature)

(Name)

Quality Control MG

Form 6 – Corrective Action Form

Name of the Company


HACCP Program Records

CORRECTIVE ACTION FORM/REPORT

Date:_________ Product:_______________

Batch /Lot Id.: _________

Defect: ____________________________________________________________________

_____________________________________________________________________________________

________________________________________________________________.

Action taken: _______________________________________________________________

_____________________________________________________________________________________

________________________________________________________________.

Present Condition: ___________________________________________________________

_____________________________________________________________________________________

________________________________________________________________.

Supervisor: ____________________ Date: ___________

Reviewed By: __________________ Date: ___________

appendix b hazard analysis and critical control point …iv+appendix+b... · step 1- frozen samosa...

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