HACCP APPROACH

U K Chatterjee Oct 11

Delighted CUSTOMER & Empowered EMPLOYEE

HARDWARE

SYSTEM

PRODUCT

PEOPLE

Four Legs Of the Sound QUALITY SYSTEM

Physical Hazards
The agent causes physical damage to the consumer. (broken teeth, cuts, internal injury) Can occur during manufacture due to physical hazards such as
glass, metal, packaging residues, etc. Unstructured or lumpy product can constitute a foreign matter hazard Promotional items can become serious foreign matter hazards

Biological Hazards
The action of a biological agent harms the consumer Infection or Intoxication Mostly bacteria

Microbes are very small

1 cup of yoghurt contains 22 X this number!

Go Home

i.e. 120 000 000 000

separate living organisms.

World population is

5.5 BILLION
i.e. 5

500 000 000

Bacteria Replicate
This way: 1 -> 2 -> 4 ->

Go Home

Play Movie

8 -> 16

->

32

->

64 -> 128

->

256

->

512

Division times are typically ~20 min in the lab So, bacteria can go from 1 cell 108 cells in 18 hr!

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 of
specifications Excess addition of minor ingredients Contamination from cleaning/disinfection chemical residues

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 from anaphylaxis are due to food service and catering/restaurants, and not from industrially produced consumer goods. The WHO has produced a general list and companies have developed their Allergen policies. Some ingredients may potentially cause serious allergic reactions in sensitive consumers eg eggs, some fishes, peanut, milk( protein) and so on....Sensitivities may vary depending on target population

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
Risk-based Quality Assurance Approach Validated by Selective Application of Quality Control Techniques

HACCP =

STEP-6

The HACCP Concept

Move from QC to QA through HACCP

Identifying potential food safety problems Determining how and where these can be controlled or prevented Describing what to do and training the personnel Implementation and recording

End-product testing...
Sampling scheme: 60 units /lot Examined: 25g/unit of 250g Traditional tons end Lot size: 10 product Homogeneous testing can Assumption:

Confidence:

never guarantee distribution of products free from Salmonella contamination Lots with 800 units containing Salmonella

are accepted with 30 % probability

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...

Codex- Tasks
0. Define terms of reference 1. Assemble team 2. Describe product 3. Describe intended use 4. Construct flow diagram 5. Verify flow-diagram 6. Identify hazards and preventive measures 7. Identify CCPs 8. Set critical limits and target values 9. Assign monitoring of CCPs 10. Define corrective actions 11. Validation and Verification 12. Documentation

Definitions
Hazard
An agent*, or condition, with the potential to cause an adverse health effect * Allergen, Biological,
Chemical, Physical

Risk
The likelihood that a hazardous situation will occur

Critical Control Point

A 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.

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, chemical and physical) or explain why you dont Make it specific (e.g. under chemical: lubricants, cleaning and sanitisation materials, cooling liquids, pesticides in raw materials, pesticides used on site, heavy metals in raw materials, 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, .

Select the Team

Chairman/Sourcing Unit Head Technical Secretary Microbiologist** Production Engineer Chemist QA ** for HACCP studies on Micro hazard

 It is important that product and its use are clearly defined

Product Description and intended use

Mention storage conditions and shelf-life
Repeat the information given to consumers on the packaging- 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)

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

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

Identify Hazards and Controls

What can go wrong ? What can you DO to prevent it ? This step applies both to HACCP and dHACCP
Dont forget: Cleaning Shift Changes Breakdowns, Stoppages, TPM Training Holiday periods Rework

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 Hand wash facilities & work instructions & training Factory design & cleaning & training SHE approval & preventive maintenance & training Cleaning instructions & validation & SHE approval & training

Preventive measures for the different hazards can be as follows:

CCP vs DCP
Critical Control Point:
Specific to a factory or a process line

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.

Design Control Point:

Generic for a category

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.

Start:
Do control measures exist ? Modify step, process or product Yes

No Yes

Is control at this step necessary for safety ?

No

Not a CCP: STOP

Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level ? No

Yes

CCP: STOP

Could contamination with identified hazards occur in excess of acceptable levels, or could these increase to unacceptable levels ?

No

Not a CCP: STOP

Yes

Will a subsequent step eliminate identified hazards or reduce likely occurrence to an acceptable level ? Yes

No

CCP: STOP Not a CCP: STOP

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?

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

Target Value
The value which has been proven by practical experience to deliver the desired condition. Accounts for offset and variation ! Note
Target values are defined in operational HACCP! Not in dHACCP!!

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!

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. 2. Protect consumer safety: what will be done with the products that are potentially unsafe? Process control: what should be done to bring the process back in control? Preventive actions are not part of HACCP but are to be addressed in the quality management system (non-conformance management)

Validation
Obtaining evidence that the HACCP plan is effective.
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

Verification
Verification is the application of methods, procedures, tests and other evaluations in addition to monitoring (and at a lower 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

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

HACCP Implementation issues

UKC Oct 11

Factors affecting
pH Temperature Water activity (aw) Nutrition Presence/absence of antimicrobials or preservatives

Before HACCP Studies Review these in formulation/design

Bacterial growth & survival are dependent on:

Design Robust Product / Processes

RIGHT PRODUCT & PROCESS DESIGN

HACCP
Good Manufacturing Practice - GMP

Design Control Points - DCPs

Ensure GMP / GHP before embarking on HACCP

Bridge gaps in Hardware / Infrastructure and Implementation of GHP / GMP

Plant & Building Infrastructure Pest Proofing
Food Handling Area

Manufacturing Hygiene & Design 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

Building / Roof / Wall / Floor drain Storage and handling facilities Laboratory Personnel Hygiene Infrastructure
Hygiene Station at entrance Change room Toilet PPE

Handling of lubricants / cleaning aids / chemicals etc.

Food Handling Area must be Pest Proof

Hygienic Vessel Design

Trap in Vent Shaft Seal Spray Balls

Short Manway Hygienic Couplings For Agitator Blades To Shaft

Sloping Manifold

Angled Instrument Probe

Baffles Welded Dished Ends

Weld Seams Ground Smooth

Single Outlet at lowest point

RIGHT HYGIRNIC DESIGN OF PLANT & EQIPTS

Eliminate other possibilities of Contamination

Typical Process Water Treatment System

MAINS FEED BACK FLOW PREVENTER

Chlorination System For Process Water

Pro cess Water Sup ply and Return Piping

ACTIVATED CARBON FILTER

CATION EXCHANGER

ANION EXCHANGER

BREAK TANK

DEPTH FILTER

MAINS FEED

CATION POLISHER

Hyp och lorite Dosing System Control Panel Sod ium Hyp och lorite Sup ply Drums

Hyp och lorite Dosing Piping and Pu mps

WATER SOFTENER

De-Ionisation System For Process Water

MAINS WATER SOFTENED WATER DEMIN WATER

CHLORINATION AND STORAGE

Cationic Exchange Column

Water Source Quality

Ani onic Exchange Column

The microbial quality of water sources varies : Location to location Seasonally

System Control Panel

The main contaminants are :

Gram Negative Bacteria May also contain Moulds, Yeasts, Algae + Gram Positive Organisms Microbial CountTowns or Municipal Water 50-10 cfu/ml

Drinkable / Potable by chlorination (0.6 ppm) to eliminate enteric pathogen May be contaminated Poor chemical and microbial quality Unilever recommends 1.5 to 2 ppm available chlorine water decontamination for

Well ( or Bore Hole ) Water

Surface Water

GOOD QUALITY OF WATER & AIR

Hazard Analysis of Critical Control Point - Foreign Matter

HAZARD ANALYSIS CRITICAL CONTROL POINT ANALYSIS REPORT
Process Step Receipt of RM/PM Hazards Black specs, Foreign matter Preventative Measures QC of material before unloading the material D Tree Q2 Q3 Y CCP Q4 Critical Limit Target Value Monitoring Procedures Corrective Actions Rejection of Consignme nt

Q1 Y

CCP- No 1 Contami nation

No Checking of Contami every lot of nation RM/PM and use only if it passes

Unloading of Liquid RM/Blending & Storage

Foreign Strainers provided matter in the contamination unloading/transfer pumps Tanks are covered Ers * SS Lining to DFA storage tank from top side * Magnetic strainers to transfer lines

CCP- No FM 2

NO FM

Check Checking of condition of blend before transfer to Pan seive room

Hazard Analysis of Critical Control Point - Foreign Matter (Cont.)

HAZARD ANALYSIS CRITICAL CONTROL POINT ANALYSIS REPORT
Process Step Hazards Preventative Measures D Tree Q2 Q3 CCP Q4 Critical Target Limit Value Monitoring Procedures Corrective Actions Q1

BLS

Soap transfer to receiving Pan

Scrap addition in scrap pan

T/S Crutching

No hazards contributing to black specs/Foreign matter Open pans Soap from scrap pan added to receiving pan Pan lining Foreign matter contamination through scrap addition Open manhole Contamination while unloading of codex/EDTA in day tank Contaminated additives added to crutcher Oil leakage from gearbox

Covering of all the soap pans Strainers provided in the soap lines Sorting of scrap before adding to receiving pan Manholes covered Strainers provided to Codex/EDTA Tanks Regular preventive Maintenance of Crutcher gear box. Y Y

DCP

CCP-3

NO FM

NO FM

Visual Inspection/ sorting

Resorting/R eject

GMP

CCP
HAZARD WHO CHECKS WHAT TO CHECK HOW TO CHECK TARGET VALUE
CRITICAL LIMITS FREQUENCY OF CHECK WHERE TO RECORD WHOM TO INFORM IN CASE OF DEVIATION PREVENTIVE MEASURE
Normal Sieve

CONDITION OF SIEVE MESH

TEARING OF SIEVE MESH MIXER TEAM CONDITION OF SIEVE MESH VISUAL CHECK SIEVE MESH SHOULD BE INTACT WITHOUT ANY DAMAGE SIEVE MESH SHOULD BE INTACT WITHOUT ANY DAMAGE ONCE A SHIFT MIXER LOG BOOK

AFTER HACCP

Review& further Improve the Hardware

SHIFT OFFICER TO CHANGE THE SIEVE MESH BY NEW ONE.

Mod ified Sieve t o p revent ing res s of foreign m ateria l even w hen t he mesh screen is torn

20# screen Anti blind rings

20 # sreen Anti bl ind ri ng s 8# scr een Perfo rated sheet with 20 mm dia perfor atio ns

Perforated sheet with 20 mm dia perforations

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

LEARNINGS : HACCP
Any Change in Process / Product / Equipment should trigger HACCP 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

Review HACCP in case of any of the following changes: Change in RM or Product formulation Change in Process Change in packaging, storage and Distribution system

Receipt of market feedback.

THANK YOU