Haccp 1 Approach

8/3/2019 Haccp 1 Approach

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PEOPLE

SYSTEMHARDWARE PRODUCT

Four Legs Of the Sound QUALITY SYSTEM

Delighted

CUSTOMER

&

Empowered

EMPLOYEE


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Physical Hazards

The agent causes

physical damage to the

consumer. (broken

teeth, cuts, internal

injury)

Can occur during manufacture due to physical hazards such asglass, metal, packaging residues, etc. Unstructured or lumpy product can constitute a foreign matter

hazard

Promotional items can become serious foreign matter hazards


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Biological Hazards The action of a biological

agent harms the consumer Infection or Intoxication

Mostly bacteria


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Microbes are very small

World population is

5.5 BILLION

i.e. 5 500 000 000

1 cup

of yoghurt contains

22 X this number!

i.e. 120 000 000 000

separate living

organisms.

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Bacteria Replicate

Division times are typically ~20 min in the

lab

So, bacteria can go from 1 cell108 cells in

18 hr!

This way:

1 -> 2 -> 4 -> ->-> -> ->8 16 32 64 128 ->-> 256 512

Go Home

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Chemical Hazards

Chemical agents which may

have a toxic effect in

consumers.

These are not normally

expected to be found in the

product. (contaminants)

Can occur from ingredients that are out ofspecifications

Excess addition of minor ingredients

Contamination from cleaning/disinfection

chemical residues


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Allergens

Food allergy is an immunological reaction to a food

protein which is a normal constituent of a particular food.

Fatalities due to allergens are rare and consumers who are

aware they suffer from food allergy are careful when

purchasing foods.

The vast majority of incidents with regard to death fromanaphylaxis are due to food service and

catering/restaurants, and not from industrially produced

consumer goods.

The WHO has produced a general list and companies havedeveloped their Allergen policies.

Some ingredients may potentially cause serious allergicreactions in sensitive consumers eg eggs, some fishes,peanut, milk( protein) and so on....Sensitivities may varydepending on target population


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What is it ?

Tool for management of consumer safety in

the food industry

Based on an engineering tool FMEA

Focuses most attention on critical areas

HACCP =

Risk-based

QualityAssuranceApproach

+

Validated bySelective

Application ofQuality ControlTechniques


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Identifying potential food safetyproblems

Determining how and where thesecan be controlled or prevented

Describing what to do and trainingthe personnel

Implementation and recording

he HACCP ConceptMove from QC

to QA through

HACCP

STEP-6

60 units/lot

25g/unit of 250g

10 tons

Homogeneous

distribution ofSalmonella

Lots with 800 unitscontaining Salmonellaare accepted with 30 %probability

End-product testing...

Sampling scheme:

Examined:

Lot size:

Assumption:

Confidence:

Traditional endproduct testing can

never guarantee

products free from

contamination


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Codex- 7 Principles

Conduct a hazard analysis

Determine CCPs

Establish critical limits

Establish CCP monitoring

Establish corrective action plan

Verification Plan Documentation

These principles do not themselves contain enough detail or

structure to enable the production of a useful HACCP plan...


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Codex- Tasks

0. Define terms of reference

1. Assemble team

2. Describe product

3. Describe intended use

4. Construct flow diagram5. Verify flow-diagram

6. Identify hazards and preventive measures

7. Identify CCPs

8. Set critical limits and target values9. Assign monitoring of CCPs

10. Define corrective actions

11. Validation and Verification

12. Documentation


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Definitions

HazardAn agent*, or condition, with the potential to

cause an adverse health effect * Allergen, Biological,Chemical, Physical

RiskThe likelihood that a hazardous situation will

occur

Critical Control PointA step at which control can be applied (and is

essential), to prevent or eliminate a consumer

safety hazard or reduce it to an acceptable

level.


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Terms of Reference (1) Define what will be covered in this study

List the hazards that will be considered

Be realistic and reasonable

Cover all four hazard groups (allergens, biological, chemicaland physical) or explain why you dont

Make it specific (e.g. under chemical: lubricants, cleaning andsanitisation materials, cooling liquids, pesticides in rawmaterials, pesticides used on site, heavy metals in rawmaterials, etc)

Define the scope of the study (start & end)

Farm to fork List any related HACCP studies

Will you do a study for every product, or will you group?

List Pre-requisite Programmes / Systems

Training, pest control, personal hygiene, SEAC approval, plant

sanitation, .


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Select the Team

Chairman/Sourcing

Unit Head

Technical Secretary

Microbiologist**

Production

Engineer

Chemist

QA

** for HACCP studies

on Micro hazard


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Product Description and intended

use It is important that product and its use are clearly defined

Mention storage conditions and shelf-life

Repeat the information given to consumers on thepackaging- What do we tell people to do ?

Consider known or likely abuse- What do we know

people might realistically do ?

Mention target consumer group and any special needs

(e.g. Diabetic, High-cholesterol sufferers, Children,

Hospital patients)


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Flow Diagram

Provides the framework for hazard analysis Must be process based, and confined to

production processes within the scope given

in the Terms of Reference. Do not forget rework!

Keep it simple


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Flow Diagram Verification

Check that your work is accurate

Introduces non-local experts to your plant

Often overlooked

Eg water lines,

side processing,

mobile storage

tanks etc


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Identify Hazards and Controls

What can go wrong ? What can you DO to prevent it ?

This step applies both to HACCP anddHACCP

Dont forget:

Cleaning

Shift Changes

Breakdowns, Stoppages,

TPM

Training

Holiday periods

Rework

Why do we need to be clear about


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Why do we need to be clear about

the hazards

Hazards need to be defined very clearly as otherwise the

preventive measure may not be effective. For example, when the hazard only mentions contamination it will lead

to assumptions being made as it can mean

Contamination from dirty hands of workers

Contamination from the factory environment

Contamination from lubricants

Contamination with residues from cleaning liquids

Preventive measures for the different hazards can be as follows: Hand wash facilities & work instructions & training

Factory design & cleaning & training

SHE approval & preventive maintenance & training

Cleaning instructions & validation & SHE approval & training


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CCP vs DCP

Design Control Point:

A step where the study of a conceptual line design, process design

or plans and layouts identified a hazard and where there is a need

for the hazard to be prevented, eliminated or reduced. DCPs will be

identified prior to HACCP studies during development/clearance of

proposed product/process designs.

Critical Control Point:

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.

Specific to a

factory or aprocess line

Generic for a

category


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Start:

Do control measures exist ?

Yes

NoIs control at this step necessary for

safety ?No

Yes

Not a CCP:

STOP

Modify step, process or

product

Could contamination with identified hazards occur in excess of

acceptable levels, or could these increase to unacceptable levels ?

Will a subsequent step eliminate identified hazards or

reduce likely occurrence to an acceptable level ?

Yes

No

Yes

No

Yes

No

Not a CCP:

STOP

CCP: STOP

CCP: STOP

Not a CCP:

STOP

Is the step specifically designed to eliminate or reduce the

likely occurrence of a hazard to an acceptable level ?
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Reality Check !

Ensure that after determining each CCP that

there is consensus within the team.

Are your CCPs sensible ?

Have you determined CCP/QCP/DCP

correctly ?

Did you include DCPs from dHACCP study

or GMP?


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Critical Limit

A value which separates the acceptable

condition, from the unacceptable.

Usually absolute or derived from science

Note

Critical limits are defined in dHACCP stage

already


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Target Value

The value which has been proven bypractical experience to deliver the desired

condition.

Accounts for offset and variation !

Note

Target values are defined in operational

HACCP! Not in dHACCP!!

M it i


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Monitoring

Must directly measure the CL/TV parameter

Must be able to detect loss of control

Should be able of detecting trends towards

loss of control

In dHACCP monitoring options for the

factory are only PROPOSED!


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Corrective Action

A clear statement to the responsible person about what must be done when

the CCP is out of control

It can make reference to other procedures if necessary- but these must be

well known and understood by all

Remember there are always two components

1. Protect consumer safety: what will be done with the products that are

potentially unsafe?

2. Process control: what should be done to bring the process back incontrol?

Preventive actions are not part of HACCP but are to be addressed in the

quality management system (non-conformance management)


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Validation

Obtaining evidence that the HACCP plan iseffective.

Are we doing the right things ?

Can we justify what we plan to do ?A critique of evidence supporting the study

Preventative measures, Critical Limits / Target

Values, Monitoring, Corrective actions

How were the Terms of Reference constructed?

Based on what?

Are acceptable (written) procedures in place.

Check references


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Verification Verification is the application of methods, procedures, tests

and other evaluations in addition to monitoring (and at alower frequency) to determine compliance with the

HACCP plan.

Trend analysis can be very powerful when applied to:

CCP monitoring data & corrective action data

Line test data

End-product testing (this is NOT monitoring)

Complaints (consumer and customer)

Hygiene test results

Increases in blocking, reworked or destroyed products

to spot deviation from our expectations


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Limitations

HACCP cannot patch gaps in basic systems e.g. GMP conformance, calibration, maintenance,

training, safe design of products

HACCP cannot prevent all possible causes

of consumer harm

Quality of the HACCP study depends of

quality of inputs and quality of

implementation


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HACCP Implementation issues

UKC Oct 11


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Good Manufacturing Practice - GMP

Design Control Points - DCPs

HACCP

Ensure GMP / GHP before embarking on HACCP


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Bridge gaps in Hardware / Infrastructure

and Implementation of GHP / GMP

Pest Proofing

Food Handling Area

Building / Roof / Wall / Floor

drain

Storage and handlingfacilities

Laboratory

Personnel Hygiene

Infrastructure

Hygiene Station at entrance

Change room

Toilet

PPE

Handling of lubricants /

cleaning aids / chemicals etc.

Process robustness

(pasteurisation, handling

of preservatives etc.)

Water management

Air

Valves

Pumps

Pipeline / fittings

Heat Exchangers/Vessels Generic CCPs

Cleaning & Disinfection

Rework Handling

Offline Processing

Plant & Building Infrastructure Manufacturing Hygiene & Design


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Food Handling

Area must be

Pest Proof

Hygienic Vessel Design


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Hygienic Vessel Design

Sloping Manifold

Angled Instrument

Ground Smooth

Short

Manway

Trap in Vent

Probe

Baffles

Welded

Single Outlet at lowest point

Shaft

Seal

Spray

Balls

Dished Ends

Weld Seams

Hygienic CouplingsFor Agitator Blades

To Shaft

RIGHT HYGIRNIC DESIGN OF PLANT & EQIPTS


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Eliminate other

possibilities ofContamination


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HAZARD ANALYSIS CRITICAL CONTROL POINT ANALYSIS REPORT

D TreeProcess Step Hazards PreventativeMeasures Q1 Q2 Q3 Q4

CCP Critical TargetLimit Value

MonitoringProcedures

CorrectiveActions

Receipt ofRM/PM

Black specs,Foreignmatter

QC of materialbefore unloadingthe material

Y Y CCP-1

NoContamination

NoContamination

Checking ofevery lot ofRM/PM anduse only if itpasses

Rejection ofConsignment

Unloading ofLiquidRM/Blending& Storage

Foreignmattercontamination

Strainers providedin theunloading/transferpumps

Tanks are coveredErs

* SS Lining to DFAstorage tank fromtop side

* Magnetic strainersto transfer lines

Y Y CCP-2

No FM NO FM Checking ofblend beforetransfer to Panroom

Checkcondition ofseive

Hazard Analysis of Critical ControlPoint - Foreign Matter


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HAZARD ANALYSIS CRITICAL CONTROL POINT ANALYSIS REPORT

D TreeProcess Step Hazards PreventativeMeasures Q1 Q2 Q3 Q4

CCP CriticalTargetLimitValue

MonitoringProcedures

CorrectiveActions

BLS No hazardscontributing toblackspecs/Foreign

matterSoap transferto receivingPan

Open pans Soap from scrap

pan added toreceiving pan

Pan lining

Covering of all thesoap pans

Strainers providedin the soap lines

DCP

Scrap additionin scrap pan

Foreign mattercontaminationthrough scrapaddition

Sorting of scrapbefore adding toreceiving pan

Y Y CCP-3 NOFM

NO FM VisualInspection/sorting

Resorting/eject

T/S Crutching

Open manhole Contamination

while unloading ofcodex/EDTA inday tank

Contaminatedadditives added tocrutcher

Oil leakage fromgearbox

Manholes coveredStrainers providedto Codex/EDTATanks

Regular preventiveMaintenance ofCrutcher gear box.

N N GMP

Hazard Analysis of Critical ControlPoint - Foreign Matter (Cont.)

AFTER HACCP


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CCP CONDITION OF SIEVE MESHHAZARD TEARING OF SIEVE MESHWHO CHECKS MIXER TEAMWHAT TO CHECK CONDITION OF SIEVE MESHHOW TO CHECK VISUAL CHECKTARGET VALUE SIEVE MESH SHOULD BE INTACT

WITHOUT ANY DAMAGECRITICAL LIMITS SIEVE MESH SHOULD BE INTACT

WITHOUT ANY DAMAGEFREQUENCY OF CHECK ONCE A SHIFTWHERE TO RECORD MIXER LOG BOOKWHOM TO INFORM INCASE OF DEVIATION SHIFT OFFICERPREVENTIVE MEASURE TO CHANGE THE SIEVE MESH BY NEW ONE.

Modified Sieve t o prevent ing ress of

foreign m ateria l even when t he mesh

screen is torn

20# sreen

Anti bl ind rings

8# screen

Perforated sheet w ith

20 mm dia

perforations

Normal Sieve

20# screen

Anti blind rings

Perforated sheet with 20

mm dia perforations

Review&

further

Improvethe

Hardware

AFTER HACCP


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LEARNINGS : HACCP

Restore the basic condition of Plant & equipment - AM step 1 &2

Address the DCPs first

Make the shopfloor Pest Proof as part of GMP implementation

One day inhouse training capsule to everyone by QA

Active participation by QA as HACCP Team member

Designate QA manager / officer as Consumer Safety Manager

with responsibility of HACCP implementation


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LEARNINGS : HACCP

Any Change in Process / Product / Equipment should triggerHACCP Review

Visual Display Boards at Workplace means Thousand Words

Involve operators while designing CCP monitoring Sheets

Include QCCP & CCP Trend Monitoring in monthly

Factory Review

Above all Top mgt commitment & build in Key Tasks;

use OPLs for workers training/appreciation

Always focus on results after HACCP impl &

review effectiveness of implementation

REVIEW OF HACCP PLAN


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REVIEW OF HACCP PLAN

Review HACCP in case of any of thefollowing changes:

Change in RM or Product formulation

Change in Process

Change in packaging, storage and

Distribution system

Receipt of market feedback.


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T H A N K Y O U

Haccp 1 Approach

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