HACCP II - Perennia

1 

GFTC 

HACCP 

SERIES 

HACCP II 

Location of bathrooms 

Location of emergency exits 

Introduction of trainer 

Snacks and breaks 

Lunch 

Phones 

Developing 

Your HACCP Plans 

2 

Our Goals for This Course 

By the end of this course you will be able to: 

• Apply the Codex 12 steps to HACCP 

• Define and explain the 7 HACCP principles 

• Identify steps to develop a HACCP plan 

• Develop an action plan to implement and 

manage the HACCP plan at your facility 

3 

© GFTC HACCP Series 

INDIVIDUAL EXERCISE 

Ask participants to introduce themselves and their goals. 

What are your goals for this course? 

Workbook page 4 

4 

Agenda 


• Overview of Food Quality & Safety Programs 

• Steps to HACCP 

• Developing a HACCP Plan 

• Successful implementation of your HACCP plan 

Agenda ‐ 3 days from 8h30 time to 4:30 time 

Breaks at 10h30 and 14h30 (approx) 

Please ask questions or make comments as we go through this. 

5 


Food Quality and Safety 

Programs 

© GFTC HACCP Series

6 

The Need for Food Safety Programs 

Health Canada and the Public Health Agency 

estimate that every year: 

• 11 to 13 million food borne illnesses occur 

• 2 to 3% of cases result in chronic health 

problems 

• Costs = $12 to 14 billion 

Retrieved from: 

http://www.canfightbac.org/cpcfse/en/safety/safety_factsheets/foodb 

orne_illness/ 

Canadian Partnership for Consumer Food Safety Education, 2009 

7 


Average Number Of Sporadic Cases Of Food borne Illness 

And Incidence Rates, By Age Group, 1998-2007* 

This study was done in Toronto 

Average annual number 

of reported cases 

Average annual reported cases 

per 100,000 population 

*Excludes 16 cases with unknown age 

Age group (years) 

8 


Average Number Of Sporadic Food borne Illness 

Cases, By Month, 1998-2007 


Jan 

Feb 

Mar 

Apr 

May 

June 

July 

Aug 

Sept 

Oct 

Nov 

Dec 

Number of reported cases 

Month 

9 


Proportion Of Sporadic And Outbreak-associated Cases Of 

Food borne Illness That Were Hospitalized, 1998-2007 


Botulism 

Listeriosis 

Typhoid fever 

Paratyphoid fever 

Verotoxigenic E. coli 

Hepatitis A 

Shigellosis 

Salmonellosis 

Cryptosporidiosis 

Amebiasis 

Yersiniosis 

Campylobacter enteritis 

Food poisoning 

Cyclosporiasis 

Giardiasis 

Overall average proportion of food attributed cases 

that were hospitalized = 6.1% 

10 


Proportion of cases hospitalized (%) 

Summary Of Selected Significant Food borne Illness 

Outbreaks 

Disease Details Critical Food Safety 

Issues 

Shigellosis 

2002, 218 

A province-wide outbreak linked to contaminated 

Greek pasta salad distributed by a Toronto-based 

Mass production of 

food 

cases 

manufacturer 

Cyclosporiasis Pasta salad containing contaminated basil Globalization of food 

2005, 16 cases imported from Central America 

supply 

Salmonellosis Salmonella enteritis PT13 contamination of mung Contamination of food 

2005, 172 cases bean sprouts resulted in 522 cases provincially during production 

Botulism 

2006, 2 cases 

Consumption of contaminated unpasteurized 

carrot juice distributed across North America. 

Globalization of food 

supply; lack of 

Four additional cases occurred in the United pasteurization 

States 

Verotoxigenic Cross-contamination between raw and cooked Food safety at large 

E. coli 

food items at a catered picnic 

events; food handler 

2007, 51 cases 

training 

Listeriosis National outbreak associated with contaminated Contamination in a 

2008, 9 cases deli meats produced by a processing plant in large-scale production 

Toronto 

plant 

The full table is provided in the workbook. Data taken from a Toronto 

study 


11 

Recalls by Commodity 

April 1, 2005 to March 31, 2006 (Total Recalls: 259) 

Egg and Egg Products 

Infant Foods 

Multiple Foods 

Non-alcoholic Beverages 

Fats & Oils 

Other 

Fresh Vegetables 

Maple 

1 

2 

2 

2 

3 

3 

5 

5 

Nuts, Grains, Seeds 

Alcoholic Beverages 

Honey 

6 

6 

8 

Processed Fruit Products 

Dairy 

13 

17 

Processed Vegetables 

21 

Spices, Herbs, Flavours, Condiments 

24 

Confectionary, Sweeteners, Snacks 

Marine Products 

27 

30 

Meat & Poultry 

Grain Derived Products 

38 

46 

0 10 20 30 40 50 

12 


Micro Recalls by Type 

April 1, 2005 to March 31, 2006 

Quality (yeasts, molds, coliform and ACC) 8 

Salmonella spp. 15 

E. coli 0157:H7 8 

Pathogenic E. coli 4 

C. botulinum 9 

Cyclospora 3 

Container integrity 11 

Other 1 

Total 78 

13 


U.S. Statistics - 2006 

• Consumers’ confidence level in the federal 

government to ensure the safety of the U.S. 

food supply. 

• A great deal of confidence 22% 

• A fair amount of confidence 60% 

• Not much confidence 15% 

• No confidence at all 3% 

14 


Purpose of Food Safety Programs 

Say what you do … Do what you say…. Prove it.. 

Say what you do 

Documentation 

Do what you say 

Activity 

Prove it 

Records 

15 


Global Food Safety Initiative 

Launched May 2000 

A non‐profit foundation 

Managed by Consumer Good Forum 

‐GFSI has become the prominent authority on food safety standards 

‐‐ GFSI board is represented by retailers, QSR’s, and manufacturers; 

Unique international stakeholder platform 

• Because food safety is top of mind with 

consumers and CEOs 

• Because industry wants to strengthen and 

maintain consumer trust 


16 

GFSI Vision 

• To be the global benchmarking organization 

delivering equivalence and driving continuous 

improvement in food safety schemes from farm 

to fork 

Once certified, accepted everywhere 


17 

FSSC 22000 

4 

Food Safety 

Management 

System 

The solid arrows reflect value‐adding activities 

The dashed arrow reflects information flow. 

8 

Validation 

and 

Improvement 

ISO 

22000 

5 

Management 

Responsibility 

4. Food safety management system 

•General requirements 

•Documentation requirements 


7 

Planning and 

Realization 

6 

Resource 

Management 

5. Management responsibility 

•Management commitment 

•FS policy 

•FS management system planning 

•Responsibility and authority 

•FS team leader 

•Communication 

•Emergency preparedness and response 

•Management review 

6. Resource management 

•Provision of resources 

•Human resources 

•Infrastructure 

•Work environment 

7. Planning and realization of safe products 

•General 

•PrP 

•Preliminary steps to enable hazard analysis 

•Hazard analysis 

•Establishing the operational PrP 

•Estalishing HACCP plan 

•Updating of preliminary information and documents specifying the 

PrP and the HACCP Plan 

•Verification planning 

•Traceability system 

•Control of nonconformity 

8. Validation, verification and improvement of the FS management 

system 

•General 

•Validation of control measure combinations 

•Control of monitoring and measuring 

•FS management system verification

18 

1 

Senior 

Mgmt. 

Commitment 

7 

Personnel 

2 

The 


Plan 

BRC 

Global 

Standard 

Food 

3 

Food 

Safety & 

Quality 

Mgmt. 

System 

4 

Site 

Standards 

Prerequisite 

Programs 

•improvement 

Format of standard 

British Retail Consortium (BRC) 

Standard Contents 

6 

Process 

Control 

5 

Product 

Control 

19 


4.8 

Identity 

Preserved 

Foods 

4.2 

Document 

Control & 

Records 

4.3 

4.1 

Commitment 

Specification 

& Product 

Development 

5 

SQF 2000 

System 

Requirements 

4.4 

Attaining 

Food Safety 

Food Safety 

Fundamentals 

Building and 

Equipment 

Design and 

Construction 

4.7 

Site 

Security 

4.6 

Product ID, 

Trace & 

Recall 

4.5 

Verification 

6 

Prerequisite 

Program 

20 


Discussion Point 

• What is the difference between Food Safety 

and Food Quality? 

• Which is more important? 


21 

FSEP Slide 

Premises 

Note that all but the HACCP Plan ball is a PRP 


plan 

Transportation 

Allergen 

FSEP 


System 

Equipment 

Recall 

Personnel 

Sanitation 

22 


Food Safety Enhancement Program 

(FSEP) 

• Canadian Food Inspection Agency’s approach 

for dairy, eggs, meats & poultry and other 

commodities 

• Based on International Codex Alimentarius 

Code 

• Prerequisite programs + HACCP analysis 

Agriculture and Agri‐Food Canada’s approach 

1. This program is based on the Canadian Food Safety Enhancement 

Program. 

The CFIA program is based on the 12 steps of HACCP under the 

international CODEX Alimentarius organization. 

2. HACCP Accreditation will be provided by the Canadian Food 

Inspection Agency. We will discuss the details of this later. 


23 

Provincial Programs 

• Advantage HACCP (Ontario) 

• Practical and feasible for all facilities, regardless of size 

or commodity. 

• Offer HACCP templates and guidebooks online at 

http://www.omafra.gov.on.ca/english/food/inspection/ 

haccp/index.html 

• Alberta HACCP Advantage 

• voluntary program to provide third party certification 

and government recognition of food safety and HACCP 

systems 

• Offer HACCP templates and guidebooks online at 

http://www1.agric.gov.ab.ca/$department/deptdocs.ns 

f/all/afs9851 

24 



A system that identifies, evaluates, and 

controls hazards which are significant for food 

safety. 

(Codex) 

Intro to a general overview of HACCP and other food safety systems. 

This definition is the official Codex definition. 

We have been running QC program and GMP for years. Each program 

focuses on a systematic process for controlling variables to meet 

identified, measurable quality and safety goals. 


HACCP Prerequisites are the foundation of the HACCP program and 

must be developed thoroughly for your operation in order for HACCP to 

be successful. HACCP Prerequisites are usually not process specific. 

HACCP Prerequisites are the support system before and after we make 

food products. 

25 

26 

The HACCP System 


Prerequisite 

Programs 


Plan 

Management 

Commitment 

Steps to 


The HACCP System 

Management Commitment 

• Business objectives 

include food safety 

• Adequate resources 

available to ensure food 

safety 

• Ensure information and 

documentation 

availability 

• Providing a letter of 

commitment 


HACCP Plan is manufacturing process specific. HACCP Plan covers the 

critical points of control during the process. Many of these items you 

may already be controlling. 

In general, it takes about 18 months to implement HACCP Prerequisites 

(75% = 12‐14 months) and HACCP Plan (25% = 4‐6 months) in a facility. 

The HACCP System includes both the preliminary steps to HACCP (select 

team, create flow chart, product description etc.) and the HACCP plan 

with its 7 principles. 

While the HACCP plan is the written document which delineates 

procedures, the HACCP system is the actual implementation of this plan 

Original Codex HACCP program did not clearly identify need for 

management commitment but it is now recognized as a necessity 

through programs like ISO 22000, SQF or BRC standards 

•HACCP approach takes isolated QC procedures at various points in the 

process and puts them together as a system 

•all points interrelate in a manner to prevent the system from going 

out of specification and causing a hazard without the information being 

picked up through the monitoring system 

Under FSEP, the responsibilities of the establishment's senior 

management are to: 

Ensure that the establishment complies with all regulatory and CFIA 

program requirements. 

Ensure that the establishment's HACCP system complies with all 

requirements of the FSEP manual. 

Ensure that food safety is fully embedded in every level of their 

business. 

Demonstrate a commitment to their HACCP system by: 

• providing the necessary resources and the time required for the 

development, implementation and effective maintenance of the 

HACCP system and for the training of appropriate staff in their

27 


• How can a company’s senior management 

demonstrate commitment to their company’s 

HACCP system? 


area(s) of responsibility; 

• providing the financial resources to ensure that the construction of 

the premises, its internal fittings, the installation of the equipment, 

the maintenance of the premises and equipment, as well as the 

supplies required to perform the above, meet all applicable 

regulatory and program requirements and support the 

implementation and effectiveness of the HACCP system; 

• designating personnel that have defined responsibilities and the 

authority to initiate, implement and record corrective actions; 

• communicating to employees the importance of meeting the 

requirements of the establishment's HACCP system, including any 

regulatory and CFIA program requirements related to food safety, 

and the importance of reporting problems to the identified 

person(s); 

• allowing designated management personnel to enforce compliance 

of the food safety procedures identified in the establishment's 

HACCP system for any person entering or working within the facility; 

• allowing the continuous improvement of the HACCP system to 

ensure its effectiveness through the validation of control measures, 

by making changes to the system as a result of corrective actions or 

reassessment activities, and through the use of HACCP team 

meetings; 

• providing sufficient time for HACCP team meetings. 

Ensure all information and documentation is accessible to the CFIA staff 

during recognition processes and subsequent verification activities. 

A letter of commitment shall be included in the HACCP System 

documentation. The letter of commitment shall be signed and dated by 

a representative of senior management at the establishment with 

authority to ensure adherence to responsibilities described in this 

section. The letter shall be signed on an annual basis and when that 

senior manager is replaced. The letter must: 

confirm senior management's full support for developing, 

implementing and maintaining an effective HACCP system; 

confirm the establishment's commitment to produce food in 

compliance with all regulatory and CFIA program requirements. 

• Providing the necessary resources and the time required for the 

development, implementation and effective maintenance of the 

HACCP system and for the training of appropriate staff in their 

area(s) of responsibility 

• Providing the financial resources to ensure that the construction of 

the premises, its internal fittings, the installation of the equipment, 

the maintenance of the premises and equipment, as well as the 

supplies required to perform the above, meet all applicable 

regulatory and program requirements and support the 

implementation and effectiveness of the HACCP system 

• Designating personnel that have defined responsibilities and the 

authority to initiate, implement and record corrective actions 

• Communicating to employees the importance of meeting the 

requirements of the establishment's HACCP system, including any 

regulatory and CFIA program requirements related to food safety, 

and the importance of reporting problems to the identified 

person(s) 

• Allowing designated management personnel to enforce compliance 

of the food safety procedures identified in the establishment's 

HACCP system for any person entering or working within the facility

28 

Food Safety Policy 

• Declaration of a company’s commitment to food 

safety 

• Requirement for ISO 22000, BRC and SQF 

• Recommended that it be supported by 

measurable objectives 

• Allowing the continuous improvement of the HACCP system to 

ensure its effectiveness through the validation of control measures, 

by making changes to the system as a result of corrective actions or 

reassessment activities, and through the use of HACCP team 

meetings 

• Providing sufficient time for HACCP team meetings. 

Measurable objectives could include: 

• reduction in recalls (yearly, monthly, by category etc.) 

• reduction in hazards (by type, over a time period etc.) 

• % adherence to policies such as record keeping or CCP monitoring 

• % CCP compliance 

• decrease in number of corrective action requests 

29 



• What are measurable objectives? 

• How can you set measurable objectives for 

your company? 


30 

Yearly Food Safety Objectives- 

Example 


• Audits by the certified body shall result in less 

than 5 minors and no major deviations 

• Corrective actions as the result of nonconformities 

from internal audits shall be 

followed up within 10 working days 

• All employees will receive a minimum of one 

hour training regarding on food safety 

Note that if objectives such as these are included in the food safety 

policy, and the policy is then signed by a senior management 

representative (e.g. Managing Director), then the policy becomes a 

template for action. 

More and more, international safety associations are requiring 

measurable objectives in a food safety policy. 

31 


GROUP EXERCISE 

Ask each group to write their policy on a flipchart. Review each policy in 

turn. 

Write a food safety policy for your 

group. 

Include measurable objectives. 

Make a note of these food safety policies. We will return to them at the 

end of the course. 



32 

33 

CFIA Responsibilities 

• Recognize HACCP systems 

• Verify implementation, effectiveness and 

maintenance 

• Verify compliance 

• Provide competent staff for recognition and 

verification 

• Ensure consistency of process and provision of 

resources 

• Maintain confidentiality 


History of HACCP 

• Developed by NASA, Pillsbury and U.S. Army in 

1960s 

• Objective of 100% food safety 

• Systematic, preventive program 

• Focuses on inputs and flow of product through 

each step of the operation 

2.1 CFIA responsibilities 

Under FSEP, the responsibilities of CFIA are to: 

Recognize federally registered establishments' HACCP systems. 

Verify the implementation, effectiveness and maintenance of the 

HACCP system in federally registered establishments. 

Verify compliance to regulations, policies and directives in federally 

registered establishments. 

Provide competent staff for the recognition and verification of 

establishments' HACCP system. 

Ensure consistency of the recognition processes and consistency of the 

verification of compliance in all federally registered establishments. 

Provide the resources to enable the timely recognition of HACCP 

systems. 

Consider any copies of the establishment HACCP system documentation 

that are obtained by an inspector on grounds that they contain 

information relevant to the administration or enforcement of 

applicable Acts and Regulations as Agency original records with 

mandatory confidentiality and maintenance requirements as stated 

under the Library and Archives of Canada Act. 

•Ensure food safety of astronauts food 

•Designed to replace finished product testing, since only testing 100% 

of the food would ensure complete food safety 

•Based on a system that looks at what could potentially go wrong at 

each stage of an operation (Failure, Mode and Effect Analysis) 

34 


HACCP Implementation Timeline 

Fisheries & Oceans QMP 

USDA Fruit Juice 

Codex 

FDA Seafood Rule 

1992 1993 1996 2002 2005 Today 

AAFC 

USDA Meat & Poultry 

CFIA Meat & Poultry 

(processing plants & 

distribution centres) 

35 



The HACCP Challenge 

Round 1 

Teams stay at their assigned table. Each team must come up with a 

name for their group. The name/logo should be placed on the flipchart 

and this should be removed and placed at the front of the room. As the 

three days progress, points earned by each team will be placed on the 

logo page. Note that one of the reasons we are introducing this exercise 

is to underline the fact that it’s important to make the whole HACCP 

experience a positive one for those who will be involved in its 

implementation back at the plant. 


Round 1: Questions concerning GMPs and HACCP 1. Use Jeopardy 

format 

Use Whiteboard to keep a running score throughout the three days.

36 

Prerequisite Programs 

A B C 

Break after this so that the lightning round exercise can be set up. 

TRANSPORTATION, 

PREMISES PURCHASING/RECEIVING/ EQUIPMENT 

SHIPPING & STORAGE 

D E F G 

PERSONNEL 

SANITATION & 

PEST CONTROL 

RECALL 

ALLERGEN 

CONTROL 


37 


Lightning Round 

You have one minute to add a 

program, rule or checklist that falls 

under the prerequisite program 

assigned. Then move to the next 

program. 


38 

Exterior Premises 

• Location 

• Risk of contamination from 

neighboring properties 

• Grounds (maintain 

perimeter for pest control) 

• Building well-constructed 

and maintained 

• Structure of other 

buildings, entrances, 

driveways 

Top photo: brewery in Chicago 

Bottom photo: standard industrial/retail building 

Ask which location is most suitable? (bottom location) What are the 

hazards shown in the top location? (risk of contamination from the 

properly on the left, grounds that could harbour rodents, etc). 

Note that the top picture shows an actually processing plant (a 

brewery). The bottom photo is a generic industrial building. 


39 

Building 

This series of slides shows different aspects of interior premises. 

Depending upon the familiarity of the group the prerequisite program, 

you can either move through these very quickly, or spend time on each 

one discussion the important details of the section. 

Hand Washing Stations 


40 

Building 

Floors & Walls 


41 

Building 

Lighting 

42 


Building 

Ventilation 

43 


Building 

Waste Disposal 

44 


Building 

Floors & Drains 

45 


Building 

Staff Areas 


46 

Building 

Storage 

47 


Building: Ventillation 

Prevent condensation 

Prevent mold and microorganism growth 

48 


Water, Steam, Ice Quality & Supply 

Filters are effective and maintained 

Adequate volume, pressure and temperature 

Stored water is covered and cleaned 

Re‐circulated water is identified and treated 

Test the feed water for your boiler 

regularly 


Chemical feed systems require 

testing and maintenance 

Water, Ice and Steam are analysed by the manufacturer at a frequency 

adequate to confirm its potability. 

•Well: monthly 

•Municipal: at least every 6 months at point of use depending on the 

industry 

•Don’t composite water samples 

Cooling towers treatment procedures: must ensure proper chemicals 

for prevention of Legionella 

As companies become more environmentally conscious they are 

looking for ways to reduce water usage or the amount of water going to 

sewer so are looking at recirculating water. If this recirculated water is 

potentially going to come into direct food contact, must insure that it is 

potable and doesn’t contain any allergen residues 

Boiler feed water and any water chemically treated, is monitored and 

controlled to deliver the desired concentration and to prevent 

contamination. Water treatment Records include: method of 

treatment, sample site, analytical result, analyst and date. 

•Use food‐grade boiler chemical 

There are no cross‐connections between potable and non‐potable 

water supplies. 

•Cooling water for compressor does not recirculate back as potable 

water. 

Where it is necessary to store water, storage facilities are adequately 

designed, constructed, and maintained to prevent contamination. e.g.. 

covered. 

•When large volume is needed but have small diameter piping.

49 

TRANSPORTATION, 

PURCHASING/RECEIVING/ 

SHIPPING & STORAGE 

Recirculated water is treated, monitored and maintained as appropriate 

for the intended purpose and has a separate distribution system which 

is clearly identified. 

Approved supplier list 

Receiving 

Storage (raw materials and finished goods) 

Shipping 

Non‐Food Chemical handling 

Returns 

Product holds 

50 


Equipment 

Design & Installation 

Preventive Maintenance 

Calibration 

Design & 

Installation 

Calibration 

Preventive 

Maintenance 

51 


Personnel 

• Training 

• Orientation, on‐going and at regular intervals 

• Hygiene and Health requirements 

• Controlled Access 

• Staff & visitors 

Training 

Controlled Access Hygiene & Health 

52 


Sanitation 

• Dedicated tools and tool carts to avoid crosscontamination 

• Cleaning Schedules 

• Effectiveness checks 

Daily cleaning (detailed or ‘deep’ cleaning) 

Non‐daily cleaning 

• Tasks must be scheduled (Master Cleaning Schedule) 

Mid‐shift cleaning 

• Short, quick and product‐specific 

Effectiveness Checks 

53 


Pest Control 

• Elements of a pest 

control program 

• Using an outside firm 

• Pest control device 

map 

• Trend analysis of pest 

evidence 

Different colored brushes used for different operations (prevent cross 

contamination). Picture on right shows mixture of brushes (e.g. black 

for floor drains, blue for allergen, white for food contact surfaces) 

which could lead to cross contamination 

Insect Light Trap 


54 

Recall 

The removal from sale or use, or correction, of 

a marketed product that poses a health risk or 

is non-compliant with respect to legislation 

administered by the Canadian Food Inspection 

Agency. 

CFIA 

Note that there is no accessible definition for Recall in Codex 

Alimentarius 

55 

Reasons for Product Recalls 

• Hazards 

• Physical, chemical, biological, allergenic 

• Non Health and Safety Issues 

• Deceptive practices 

• Misrepresentation 

• Quality 

• Spoilage/taint 

• Tampering 


Q Who should be responsible for this program? 

A – sales, senior management. 

56 


Traceability is Key 

From raw material to 

finished product 

Tracing from raw material (including packaging materials) to finished 

product 

Product to customer 

• Product by lot number 

Ingredient by lot number 

And from finished 

product to raw material 


Bioterrorism legislation demands traceability of one forward one back 

within a specified period of time 

Traceability is now a regulatory requirement for product security 

Use mock recalls to test ability to trace product 

Use incident simulation exercises 

57 

Type of recall 

Legislation 

Steps to a recall 

Components of a recall plan 

Traceability and mock recalls 

Testing the recall plan 

These are the top allergens identified internationally 

Allergen list, starting in the top left corner and moving from left to right 

• gluten, sesame seeds, shellfish, soy, molluscs, 

• Egg, Dairy/Milk, celery, peanuts, mustard, lupins 

• Sulfites, buckwheat, fish, wheat, tree nuts 

• • Sulfites (labeling required if >10 ppm in finished product) 

Top Top Allergens Identified Internationally by USDA CFIA 

Note: this list includes all minor ingredients containing any of these 

elements (Soy lecithin). 

Processing aids containing any of these elements. 

Those with an aqua box around them indicate the top allergens in the 

U.S. 

On first click: the remaining photos represent those foods on the CFIA 

Allergen list 

On second click: these are the top 8 allergens in the U.S.

Key Teaching Notes: 

In your procedure it is important to identify the key allergens and at 

what level they will be controlled. 

CFIA Priority Allergen List ‐ this list account for 90‐95% of all food 

allergies. However, over 200 known food allergies (any food protein 

can potentially cause an allergic reaction) 

Sulphites are not a food allergen (not protein) but appears on the list as 

a results of a high incidence of sensitive individuals 

58 

Note: Peanuts are a legume, not a nut. Individuals allergic to nuts are 

usually not allergic to peanuts. This is important if using the “may 

contain” statement. Can not use the generic term “may contain nuts” if 

it also contains peanuts 

Getting Started with HACCP 

59 

The Codex HACCP 12 Steps 


1. Assemble HACCP Team 

2. Describe Product 

3. Identify intended use 

4. Construct process flow diagram and plant schematic 

5. On-site verification of flow diagram and plant schematic 

6. List hazards associated with each step 

7. Apply HACCP decision tree to determine CCP 

8. Establish critical limits 

9. Establish monitoring procedures 

10.Establish deviation procedures 

11. Establish verification procedures 

12. Establish record keeping and documentation 

Briefly review the 12 steps. Steps 1 to 5 are the pre‐steps to HACCP, and 

we will look at these first. 

60 


1. Assemble the Team 

Leadership is key 

• Senior management 

champion 

• Clear values & vision 

statement 

• Clear objectives and 

targets with 

responsibilities assigned 


Visionary Leader / CEO is Champion 

Part of Corporate Identity 

Part of Governance Structure of Company 

Vision statement must be Aligned with Code of Conduct, Objectives, 

Targets 

Accountability 

• Built‐into Business Plans 

• Part of Senior Management & Board‐Level Accountability Systems 

• Senior Management Signs‐Off on Codes of Conduct

61 

62 

HACCP Team Coordinator 

• Ensure that the HACCP system is developed, 

implemented, maintained and reassessed; 

• Taskmaster 

• Resource person 

• Ingredient and product specifications 

• Process data 

• Databases 

• Meeting chairperson and facilitator 

• Main HACCP related contact with CFIA staff 


HACCP Team 

• Personnel with knowledge and experience 

• Represent various areas within the facility 

• Meet on a regular basis to discuss the 

effectiveness of their HACCP system 

• Evaluate information logically 

• Ensure HACCP program works for the long-term 

(audit) 


Keep in mind that your HACCP team leader is critical 

•select this person carefully 

•there are some tools to make your HACCP Team go smoothly, i.e.. Use 

of good brainstorming methods is critical during the HA stage of your 

HACCP Plan 

•During Brainstorm session ‐ make sure everyone takes a turn and no 

criticism around peoples ideas. 

Meeting chairperson/facilitator 

• get everyone involved 

• ensure everyone attends 

• accomplish a lot, set standards high 

• use brainstorming 

• encourage 

The team coordinator must not only be knowledgeable of HACCP 

processes, but must have the dedication and leadership abilities 

required to shepherd the process through to implementation. 

Follow‐up question: True of false: the QA/QC manager is the best 

candidate for the position of HACCP team coordinator. 

The HACCP team consists of assigned personnel that have adequate 

knowledge and or experience. Representing various areas within an 

establishment such as production, sanitation, quality control, food 

microbiology and equipment maintenance, they are responsible for 

assisting the HACCP team leader in developing, implementing and 

maintaining the HACCP system. 

The number of people on the HACCP team may vary based on the 

complexity of the process and the number of employees at the 

establishment. In small plants with a limited number of staff, the HACCP 

team may be made up of a few people that have a good understanding 

of the facility and its products, as well as HACCP. 

The HACCP team should meet on a regular basis to discuss, among 

other points: 

Changes in the HACCP System 

Deficiencies in the HACCP System 

Root causes 

Action plans 

CFIA concerns 

It is recommended that representatives from senior management 

participate periodically in HACCP team meetings to be aware of the 

HACCP system performance within their facility. 

Senior Management shall appoint a HACCP team leader who, 

irrespective of other responsibilities, shall have the responsibility and 

authority: 

to ensure that the HACCP system is developed, implemented, 

maintained and reassessed; 

to be the main HACCP related contact with CFIA staff. 

Note: It is recommended that the HACCP team leader be on the 

premises on a regular basis. Where the HACCP team leader is not at the 

establishment on a regular basis, an on‐site liaison person must be

63 

64 

System Performance Report 

• Procedure for communicating the HACCP 

system performance to the senior mgmt. 

• Purpose: communication between HACCP team 

and senior management 

• Should include: 

• Name of personnel responsible for communication 

• Frequency of communication 

• Method of communication 


Build a Working Team 

• Identify candidates 

• List responsibilities 

• Identify resources 

• Provide training 

identified to take on these responsibilities and authorities. 

•Knowledge and experience/ multi‐disciplined 

• hazards, prevention of hazards 

• know the processes, the day‐to‐day operation 

• equipment, facility with respect to cleanability 

• know when to ask others for help 

•Evaluate information logically ‐ good decisions 

•Solve problems, not short term fixes but long term 

•Be creative and get things done 

•Be able to teach others (lead by example) 

•Lead 

•Ensure HACCP program is working long term, by auditing & improving 

the system constantly. 

A documented procedure shall be established which defines how the 

HACCP system performance is communicated to the senior manager 

who has signed the letter of commitment (see section 2.2.1). 

The procedure shall include as a minimum: 

The name or title of personnel responsible to communicate the HACCP 

system performance and CFIA verification results. 

The frequency of communication. 

The method used to communicate the information. 

The method used to demonstrate to the CFIA that the communication 

took place. 

The main objectives of the communication process are to: 

Make establishment senior management aware of the overall HACCP 

system performance within their facility. 

Convey the information required for senior management to provide 

support and supply resources to the HACCP team to ensure issues are 

corrected. 

65 


Dealing with Opposers and Visionaries 

Opposers 

Recognize that there will be resistance 

Ask for their criticisms with moving this 

forward 

Visionaries 

Draw on their energy and 

commitment 


66 

67 


From the choices provided to you, 

select your HACCP team. 

Defend your choices and your 

omissions. 



• What training is needed for the HACCP 

team? 


Hand out the HACCP Team Trading Cards. There is no set number of 

people that should be on the team – that is up to each group to decide. 

If the plant already has a HACCP team, ask them to review the current 

make‐up of the team and indicate what other positions would 

strengthen the team. Also ask them how they assign activities and 

responsibilities within the team (who is in charge of documentation, 

who is in charge of communication, what can you do if there is no one 

from upper management? etc.) 

• Production 

• Technical 

• Engineering 

• Sanitation 

• Purchasing 

• Plant Manager 

• R&D 

• Warehouse 

Train HACCP Team (managers & supervisors) : 

Benefits, steps, timing, process, B,C,P, hazards 

Training required: GMP training, personal hygiene, HACCP updates, CCP 

training and retraining 


Don’t forget to mention that HACCP IV, V and VI are also available. 

68 

Training 


• Senior management: HACCP principles and 

management’s role in managing risk 

• HACCP Team members: consistent knowledge 

regarding potential biological, chemical or physical 

risks 

• Supervisory staff: verification and corrective 

action procedures; training of line staff 

• Line Staff, especially process owners: critical 

training of the risks in their area and how to 

manage them (Critical limits, monitoring, deviation 

procedures, etc.) 

Discuss the type and frequency of training required, not just for the 

HACCP team, but for all employees and most specifically for process 

owners. 

Personnel should be trained to understand the importance of the 

critical control points for which they are responsible, the critical limits, 

the procedures for monitoring, the action to be taken if the limits are 

not met and the records to be kept. 

69 


Effective Training 

• Use staff to help develop the HACCP Plan 

• Train everyone so they understand the 

relevancy 

• Integrate HACCP instructions/requirements with 

formulas 

• Translate into relevant languages 

• Use pictures and flow charts 


70 

71 

HACCP Meetings 

• Planning is vital 

• Know the road ahead 

• HACCP plan 

development: 

1. Training, concepts, flow 

diagram 

2. Hazard Analysis 

3. Determine CCP 

4. Determine monitoring, 

validation, verification 


Time Commitment of Team 

Hours Per Week 

• Team members: 2 

hours per week to 

start; 3 hours per 

month once plan is 

established. 

• Team coordinator: 

10 hours per week 

to start. 

Options for achieving a HACCP Program through group interaction 

without excessive meeting time: 

HACCP Plan Development meetings: ( 4‐5 meeting total) 

1/ Training, concepts, flow diagram 

2/ HA 

3/ Determine CCP 

4/ flush out CCP and HACCP Plan 

When individuals come together as a work group for the first time, 

there is a certain dynamic to the interaction of members which affects 

the group’s effectiveness. Sometime, groups of individuals can not 

perform together. Other times the group will proceed through the 

stages of group development quickly 

Ask participants if they agree with this estimate. 

Discuss how to best use the time: have agendas, action items, 

management commitment to keep things on track etc. 

72 


Celebrate Success 

73 

74 



Getting Started 

• Which process line do you start with? 

Justify your answer. 

How Many HACCP Plans? 



• Scope of Plan: from receiving to warehouse 

• Unitizing (identifying common processes) 

Receiving 

Sauce Meat Pasta 

Place participants in their dot groups 

If there is more than one line in your process, choosing which line to 

work on first can depend on a number of variables. 

• Has a client requested HACCP implementation for any line? 

• Is one line simpler than the other, so that you can quickly implement 

a successful HACCP plan? 

• Does one line cause more problems than the other? 

• Which line has the most volume and so could generate the most 

problems? 

• Which line can generate the most risk? 

This is a very important concept: the purpose of unitizing is to identify 

those processes common to all lines. 

Once again, there is no right answer for this. The only right answer is 

that every product that comes out of the plant is assigned to a HACCP 

plan. 


Assembly 

Each establishment should conduct a complete hazard analysis for all of 

its processes and products in order to identify and control all hazards 

effectively. At this point you may determine that several of your 

products share similar hazards, processing steps or equipment. In this

75 


• Would you develop all plans and then roll 

them out or develop one first and then roll it 

out? 

• Why? 

case, you may group these products or processes into one HACCP plan. 

One of the benefits of breaking up the plan is that you can have a core 

HACCP team and then a number of smaller HACCP teams (for receiving, 

packaging, line processing etc.) This can makes it easier to manage, 

document and maintain. 

Large group discussion – 5 minutes 


76 

77 

Charting Your Progress 

Task 

Start of project 

GMP team meeting 

Train GMP team 

Baseline audit and gap analysis 

Establish goals 

Set actions and timetables 

Create documentation templates 

Assign responsibilities 

Develop standard procedures 

Train staff 

Test procedures 

Implement procedures 

Monitor progress 


Codex 12 Steps 

JA 

N 

FE 

B 

M 

AR 

AP 

R 

MA 

Y 

JU 

N 

JLY 














AU 

G 

SE 

P 

OC 

T 

NO 

V 

DE 

C 

Sample progress document. 

Posting process charts in a public place allows everyone to follow the 

success of the team and encourages the team to work towards the final 

plan. 

The process chart can also be used as part of your documentation 

(document that different people are on your team; document that all 

the steps in the process have been allocated 

Using color to specify different individuals responsible for the task is a 

also common and effective. 

78 


2. Describe the Product 

• Complete and 

detailed 

description of 

the product 

Product Description 

Facility: 

HACCP Plan Author: 

Approved by: 

Revision: 

Date: Page of 

Product name 

Important characteristics 

How it is to be used 

Packaging 

Shelf life 

Where it will be sold 

Labelling Instructions 

Special distribution control 


79 

80 

Product Name(s) 

Product Description 


Beef Stew 

Process/product type name: BEEF STEW 

Important product 

characteristics (a w pH, N/A 

preservatives, etc.) 

How the product will 

be used 

For further processing. Will be used in a prepared meal. 

Bulk product packaged in food grade plastic pails. Pail lined 

Packaging 

with food grade plastic liner and sealed with tamper‐evident 

tape 

Shelf life of product 

Frozen product: 12 months @ ‐18 o C or colder 

Refrigerated product: “X” number of days @ 4 o C or cooler 

Where will it be sold Food processing establishment 

(Frozen product)‐Keep frozen 

Production code, date 

Labeling instructions (Refrigerated product)‐ Keep refrigerated, “Best before” 

date 

“Ready‐to‐eat” identified on the label 

Special distribution 

control 


Frozen product‐ Refrigerated truck @‐18 o C or colder 

Refrigerated product‐ Refrigerated truck @ 4 o C or less 

Use the Product Description 

Template in your workbook to 

complete the product description for 

your chosen product. 


This is a sample of a portion of a product description form. 

Important characteristics: remind participants that what are wanted 

here are food safety characteristics, not simply overall description or 

marketing benefits. 

How it is to be used: if others will further process the food product (e.g. 

by cooking it), then we are not fully responsible for its food safety. 

For packaging description: Include primary, secondary and tertiary 

materials 

Place participants in dot groups. Each group must invent a food 

product, name the product and name the company. Bonus points go to 

any group that incorporates HACCP into their business. Ask each group 

to use the flipchart to introduce their company and product. This 

should be taped to the wall. They can then write their product 

description on the flipchart. 

Form 1 

81 


Identify Product Ingredients and 

Incoming Material 

• Ingredients 

• Packaging 

• Processing aids 

Discuss possible ingredient hazards for each category. (Specific 

ingredient lists can be provided for each product.) 


82 

List of Product Ingredients and Incoming Material Form 2 

Product Name: Beef Stew 

Meat Non‐meat ingredients Packaging materials 

Beef meat 

Product rework 

Frozen vegetables 

Dried Oregano 

Salt 

Pepper 

Dried gravy preparation (dehydrated 

vegetables, onion, garlic, salt, wheat 

flour, potato starch, corn syrup solids, 

MSG, sugar, natural flavors, canola oil, 

color, spice, modified milk ingredients, 

sulphites) 

Water 

Plastic food grade 

pails 


liner 

83 


• What other categories might a Form 2 

include? 

Be sure to include processing aids as a category. Example: dry ice, antimicrobial 

substances for meat or poultry, anti‐foaming agents, ion 

exchange resins, enzymes, reactive gases for MAP systems and oven 

belt spray. 



84 


Use the Product Ingredient 

Template in your workbook to 

complete the product ingredient 

and incoming material categories 

for your assigned product. 

Each group will place ingredients on the flipchart 

Form 2 


85 

3. Identify Intended Use 


• Identify the end user or consumer 

• Purpose is to identify any vulnerable population 

• e.g. sugar-free gum for diabetics 

Guideline 3 is included in the product description 

template 

86 


4. Construct Process Flow Diagram 

• Identify each step in the process 

• Use interviews, observations and blueprints 

87 


Returns 

1 Receiving @ Gate 1 

Dry ingredients Cool vegetable Cold meat 

Packaging 

2 storage 3 storage storage 4 material storage 5 

Storage 3 Cooler 1 Cooler 2 Material storage 1 

2a Sieve 

7 Cut into cubes Slicer 2 for meat 

Gravy 

Mix meat with sauce 

6 

8 

preparation 

Gravy Kettle 

9 Cook Kettle 1 & 3 for meat 

Cooler 1 & 3 for 

6aWater distribution 

10 Cool 

finished product cooling 

11 Metal Detector 

Line and code 

Code/Label & Package 

packing material 13 

12 

14 15 

Freezer 1 Cooler 4 

Finished frozen 

Finished refrigerated 

product storage 

product storage Returns 

16 Shipping/Distribution@ Gate 2 

When creating a process flow, there is no need for complicated charts, 

but there is a need to be sure that every step in the process is included, 

and that the flow from one step to the next is clearly indicated. 

Provide details of: 

• Activity: what is being done 

• Equipment 

88 


Sub-Processes and Offshoots 

• Danger lies in not including steps that are 

separate from the main flow of the process 

• Examples: rework, holding and additional 

irregular steps 

The omission of sub‐processes and offshoots is common to many 

learners, especially when new to flow‐charting. (Chances are some or 

all of the groups will have omitted at least one sub‐process or offshoot) 

Ask the group: where do sub‐processes and offshoots occur in your 

line? Did you adequately capture them in the flow chart exercise? 


Provide time for participants to return to their flow chart diagram and 

make any necessary corrections. 

Direct food contact: air, steam, gasses

89 



Packaging 



2a Sieve 


Gravy 


6 

8 

preparation 

Gravy Kettle 



6a Water distribution 

10 Cool 


11 Metal Detector Rework 

Rework 

Line and code 

Code/Label & Package packing material 13 

12 

14 15 




Returns product storage 



90 

91 


Process Flow Checklist 

Raw material receiving & storage 

Additional ingredients, pre-mix, intermediate product 

Use of air or other gases 

Filters, screens, metal and magnet detectors 

Process equipment 

Tanks and continuous systems 

Filing and packaging equipment 

Recirculation, overflow 

Rework, holdover, reclaim 

Transfer of product from one step to another 

Storage 



Form 3 

Create the process flow for your 

product. 

Use sticky notes for this exercise. Once they happy with their flow, they 

can put it up on the flipchart. 


92 



Form 4 

Using the plant schematic template, 

indicate the location of rooms and 

the flow of personnel and product. 

End of Day 1. 


93 

Plant Schematic 

Change rooms & 

Washrooms 

Cooking 

Operation 



Frozen 

Office Shipping Refrigerated 

Storage Cooler 

Packaging 

Finished product employees 

Raw product employees 

Frozen Storage 

Dry 

Storage 

Receiving 

Tempering room 

Chemical 

Storage 

Raw product flow 

Finished product flow 

Your primary tool for identifying where allergen ingredients, food 

additives or raw ingredients could come into unplanned contact. 

Highlight areas of potential contamination due to employee practices. 

Both people movement and waste movement should be tracked here 

as well. 

Note that employees from the raw product area can only enter other 

production areas once they change into appropriate external gear. 

Otherwise, they risk cross‐contamination.

94 

5. Conduct On-Site Confirmation 

of Flow Diagram 

• On-site verification of process flow and plant 

schematic to ensure their accuracy and 

completeness 

• Confirm the processing operation against the 

flow diagram during all stages and hours of 

operation and amend the flow diagram where 

appropriate 

The HACCP team member responsible for each area of the process line 

should be tasked with confirming the accuracy and completeness of the 

process flow for that area. 

95 


Verified by: P. Person and J. Smith 


Date: May 3, 2009 


Washrooms 

Frozen 



A verified plant schematic and flow diagram would show a signature 

and date. 

Dry 

Storage 

Cooking 

Operation 

Packaging 

Packaging 


Receiving 




Chemical 

Storage 



96 



Teams return to their original HACCP table. 


Round 2 

Round 2: Questions concerning anything taught that day. Use Jeopardy 

format 

97 


HACCP Program 

Day 2 

98 

Day One Review 














Review the first five steps and Forms 1 to 4. 


99 

The Codex HACCP 12 Steps 













Briefly review the 12 steps. Steps 6 to 12 are the 7 principles of HACCP. 

100 


Hazard 

“A biological, chemical or physical agent in, or 

condition of, food with the potential to cause 

an adverse health effect. 

Codex 

101 


Hazard Analysis 

The process of collecting and evaluating 

information on hazards and conditions 

leading to their presence to decide which 

are significant for food safety and 

therefore should be addressed in the 

HACCP plan. 

Codex 

102 

Types of Hazards 


Biological: caused by microorganisms, can increase and spread, invisible 

Chemical:normally added accidentally 

Physical: anything that can be seen, objects 

Biological Chemical Physical 

103 


Biological Hazards and 

Controls 

•The predominant focus of HACCP is on biological bec of the incidence 

of food borne illness 


104 

Effect of Microorganisms 

• Inert 

• Beneficial 

• Spoilage 

• Pathogenic 

Which of these three is our focus for HACCP: Pathogenic 


105 

Food borne Pathogens 

• Food borne pathogens are 

transmitted to man by food 

• Food-poisoning symptoms 

include vomiting, diarrhea, 

and abdominal pain 

• Proper sanitation protocols 

are essential to prevent the 

spread or growth of food 

borne pathogens 


106 

Biological Hazards 

Yeast 

and 

Mould 

Parasite 

Virus 

Bacteria 

This shows the relative sizes of the different biological hazards. 

Introductory slide. 

Bacteria: Very small, seen only under microscope 

Yeast and mould: most are harmless, some moulds can produce toxins, 

(aflatoxin, associated with grains & peanuts) 

Viruses: the tiniest of all microorganisms, very specific (dogs cannot 

catch you cold) 

Parasites: one or multi‐celled, sometimes worm‐like 

107 


Sources of Biological Hazards 

Bacteria 

• Salmonella spp, E.coli O157:H7, Listeria, 

• C. perfringens… 

Yeast & mould 

Viruses 

• Hepatitis, Norwalk virus… 

Parasites 

• Trichinella spiralis, cryptosporidium… 

Personnel hygiene practices 

Dirty equipment 

Inadequate cooking 

Slow cooling 

Recontamination during packaging 

High storage temperatures 

Hot‐holding temperatures too low 

Dirty 

Equipment 

Holding or Storage 

Temperatures 

Recontamination 

During Packaging 

Hygiene 

Practices 


108 

Controlling Biological Hazards 

• Destroy, eliminate or reduce the hazard 

• Thermal processing, freezing, drying, irradiation 

• Prevent re-contamination 

• If hazard cannot be totally eliminated, inhibit 

microbial growth (and toxin production) 

109 


Inhibition of Microbial Growth 

• Characteristics of the food 

• pH, Aw (water activity) 

• Addition of inhibitors 

• Salt, other preservatives 

• Conditions of packaged 

food 

• Aerobic or anaerobic 

• Storage temperatures 

• Refrigeration or freezing 

110 


Chemical Hazards, Allergens 

and their Control 

111 

Chemical Hazards 


Naturally Occurring Added Agricultural 

Food Additives 

112 


Naturally Occuring 

Patulin Aflatoxin Vomitoxin 

Mushroom 

toxins 


Shellfish 

toxins 

Scombrotoxin 

& Ciguatoxin 

•If formal limits have been established ‐ found in the regulations under 

• Food and Drug Act 

• Agriculture Products Act 

•If informal limits have been established (aflatoxins, paralytic shellfish 

toxin) ‐ 

• maximum allowable limits found in Food and Drug Administration 

Compliance Policy guidelines 

•If formal limits have been established ‐ found in the regulations under 

• Food and Drug Act 

• Agriculture Products Act 

•If informal limits have been established (aflatoxins, paralytic shellfish 

toxin) ‐ 

• maximum allowable limits found in Food and Drug Administration

113 

Added chemicals 

• Agricultural Chemicals 

• Pesticides 

• Fertilizers 

• Antibiotics 

• Chemicals not allowed in 

Canada 

Compliance Policy guidelines 

•Potential hazards that can be added to some foods during growing 

and harvesting or through food processing, storage, distribution 

•Chemicals which are not allowed include lead, arsenic, mercury 

114 


Food Additives 

Allowable limits under GMPs 

• Preservatives (nitrite and sulfiting agents) 

• Flavour enhancers (MSG) 

• Nutritional fortifiers (niacin) 

• Colour enhancers 

115 


Secondary Direct & Indirect 

Chemicals 

Paints and Other Non-Food 

Grade Chemicals 

Packaging Materials 

A secondary chemical is one that is not directly involved in the process 

operation. Secondary chemicals, however, can pose a serious threat if 

not carefully monitored. 

Insufficiently cured flexible packaging materials 

Machinery Care Products 

Residual Cleaning 

Products 

116 


Industrial and Environmental 

Contaminants 

Chemical Source Food 

PCBs Transformers Fish, animal fat 

Dioxins By-product Fish, animal fat 

Mercury Chlor – alkali Fish 

Lead 

Smelting, paint, glazes, 

solder, vehicle emissions 

Canned food, acidic 

foods, drinking water 

Cadmium Sludge, smelting Grains, molluscs 

Nitrate/nitrite Fertilizers Vegetables, drinking 

water 

117 


Acceptable Chemical Limits 

Some countries provide lists of acceptable 

maximum residue limits 

Some countries provide guidelines or informal 

limits 

The CODEX GENERAL STANDARD FOR FOOD ADDITIVES (GSFA) ONLINE 

DATABASE, 

http://www.codexalimentarius.net/gsfaonline/index.html?lang=en, is a 

database that provides, in a searchable format, all the provisions for 

food additives that have been adopted by the Codex Alimentarius 

Commission. 


118 

Sources of Food Allergens 

• Component of food being prepared* 

• Mis-formulation and rework* 

• Improper clean-up 

• Cross-contamination* 

• Mislabelling* 

Follow‐up questions: which of these sources would be most likely to 

occur at your plant? 

* These can be controlled during processing 

119 


Danger of Undeclared Allergens 

• A hazard exists when an 

allergen is not declared 

on the label 

• Only way to avoid allergic 

reaction is to avoid the 

food 

• Allergic individuals read 

labels 

120 


Control Of Chemical Hazards 

1. Control before receipt 

• Raw material specifications 

• Vendor certification/guarantees 

• Spot checks - verification 

2. Control before use 

• Review purpose for use of chemical 

• Ensure proper purity, formulation and labeling 

at receiving. 

• Control quantities to be used 

121 


Control Of Chemical Hazards 

3. Control storage and handling conditions 

• Prevent conditions conducive to production of 

naturally occurring toxicants 

4. Inventory all chemicals in facility 

• Review uses 

• Records of use 

122 


Physical Hazards and Controls 


123 

Physical Hazards 

Objects not normally found in the food which may 

cause illness, trauma or injury. 

Glass, wood, stones, twigs, pests, jewellery, metals 

Physical hazards are the most readily identified by consumers. 

The majority of all complaints 

124 


Sources of Physical Hazards 

Incoming Materials 

Facility 

Ask for personal stories: do learners know of situations where physical 

hazards entered the line? What was the source? What was the 

outcome? 

125 

Employee Practices 


Equipment 

Sources of Physical Hazards 

Glass 

Wood 

Metal shavings 

Metal 

Insulation 

Stones 

Hard Plastic 

Jewellery or 

personal effects 

Insects 

Filth 

Bottles, jars, light fixtures, utensils, gauge covers, 

containers, maintenance 

Splinters from pallets, boxes, buildings, sheeting trays 

Processing equipment 

Wire, employees, fields, machinery, maintenance 

Building materials 

Fields, buildings 

Containers, packaging materials, pallets, employees 

Employees 

Fields, plant 

Fields, plant, distribution 

• extraneous matter or foreign objects, which could include physical 

matter not normally found in the food which may cause illness 

(including trauma) or injury. 

•A physical hazard occurs when you get and object in food that later 

causes harm to the person consuming that food. 

•Ex ‐ glass, wood, stones, twigs, pests, jewelry, metals 

126 


Control of Physical Hazards 

• Equipment used to control foreign material 

• Optical sorters 

• Inspection 

• Bone separator 

• X ray 

• Metal detector, magnets 

• Screens & filters 

127 


Filters, Screens and Sieves 


Documented program includes: 

Ingredient and process physical hazard assessment. 

Identification of elements of the program (document basis for the 

application and location of filters). 

Procedures for: 

• Verification that filter is in place and not damaged at start up. 

• Inspecting, removing and evaluating collected material. 

• Establishing limits on material to determine when to take action. 

• Tracking the type, size and quantity of material collected. 

• Verification that ingredient filtering program is effective. 

• Corrective action for when filter breaks during production. 

Preventive maintenance program for filtering equipment. 

Training and verification of training.

128 

Hazard Analysis 


129 

Information Sources 

• Product history 

• Consumer complaints 

• CFIA Database 

• Scientific literature / 

Journals 

• Generic models 

• Textbooks 

• Association 

• Internet 

• Inspections 

130 


What hazards are out there 

the following list was put together by the NACMCF in 1982 

Questions to be considered by the HACCP team 

when deciding about potential hazards 

131 


A. Raw Materials 

• What hazards are likely 

to be of concern to the 

process or product? 

• Are any of the raw 

materials hazardous in 

excess amounts? 

132 


A. Incoming Materials 

• Hazards that could 

occur before you receive 

the product 

• Who should be part of 

this review process ? 

• Purchasing 

• Receiving 

• R&D 

• QA 

• Batch Makers 


133 

Approved Supplier Lists 

• Is there an approved 

supplier list for every 

item? 

• Is it available across the 

business? 

• Are like products grouped 

together? 

• Do sub-components have: 

• Correct labelling 

• Allergen declaration if 

needed? 

134 


B. Design Of Plant 

And Equipment 

Where could crosscontamination 

occur? 

• Consider 

microbiological, 

chemical and physical 

safety issues 

Consider all steps in the process at all holding stages 

135 


B. Design Of Plant And Equipment 

• Where could contamination build up or 

microbiological or allergen hazards grow to 

dangerous levels? 

• Can the equipment be effectively controlled 

within the required tolerances for safe food 

production? 

• Can effective cleaning be carried out? 

• Are there any hazards associated with 

particular equipment? 

136 


C. Intrinsic Factors 

1. Do the product's integral factors (pH, Aw, etc.) 

control microbiological hazards in raw 

materials or that could enter during the 

process? 

2. Which intrinsic factors must be controlled to 

ensure product safety? 

3. Can microbiological hazards survive or grow in 

the product formulations? 

Remember there are different types of microorganisms which react in 

different ways ‐ what will control one might not control another. 

137 


Factors Affecting Microbial Growth 

Source of third bullet: USFDA Bad Bug Book 

Organism Temp °C pH a w 

Salmonella spp. 6.5 – 47 4.5 - ? >0.95 

Staph. aureus 7 – 45 4.2 – 9.3 >0.86 

Listeria 

0 – 45 4.4 – 9.4 >0.92 

monocytogenes 

• Microbes need food (high protein is preferred) to 

survive 

• Some microbes need oxygen as well 

• Some microbes survive only in the absence of 

oxygen 


138 

D. Process Design 

1. Will microbiological hazards survive any 

heating step? 

2. Does the use of reworked or recycled product 

cause a potential hazard? 

3. Is there a risk of recontamination between 

process stages? 

Use of reworked or recycled product: consider carefully both 

microbiological hazards and their toxins and allergen hazards. 

139 


E. Facility Design 


Frozen 

1. Washrooms Are there hazards Office associated Shipping with the 

Refrigerated 

Storage 

layout or 

Cooler 

environment? 

Dry 

Storage 

2. Is segregation adequate between raw and 

Cooking 

Operation ready-to-eat? 

3. Is positive-pressured filtered air necessary? 


Receiving 

4. Do movement Packaging patterns for personnel and 

equipment cause hazards? 


Chemical 

Storage 





140 

141 




Washrooms 

Cooking 

Operation 


Frozen 



Packaging 



F. Personnel 

1. Could personnel practices 

affect the safety of the 

product? 

2. Are all food handlers 

adequately trained in food 

hygiene? 

3. Are occupational health 

procedures in place? 

4. Do employees understand 

the aims of the HACCP 

system, along with how their 

role affects the process? 


Dry 

Storage 

Receiving 


Chemical 

Storage 



Your primary tool for identifying where allergen ingredients, food 

additives or raw ingredients could come into unplanned contact. 

Highlight areas of potential contamination due to employee practices. 

Both people movement and waste movement should be tracked here 

as well. 

Note that employees from the raw product area can only enter other 

production areas once they change into appropriate external gear. 

Otherwise, they risk cross‐contamination. 

142 


G. Packaging 

• How does packaging 

influence the growth or 

survival of microbiological 

hazards? 

• Are there labels and 

instructions for safe 

handling and use, and can 

these be easily 

understood? 

• Is the package damageresistant 

and are tamperevident 

features in place if 

required? 

Examples of packaging environment: aerobic or anaerobic? 


143 

H. Storage and Distribution 

1. Could the product be 

stored at the wrong 

temperature? 

2. Will this affect safety 

during the shelf-life? 

3. Could the product be 

used in an unsafe 

manner by the 

customer? 


144 




Beef meat 

Product rework 

Frozen vegetables 

Dried Oregano 

Salt 

Pepper 






sulphites) 

Water 


pails 


liner 

This is reproduced as a reminder as to what should be included in the 

flow diagram on the next slide. 

145 



Packaging 



2a Sieve 


Gravy 


6 

8 

preparation 

Gravy Kettle 



6a Water distribution 

10 Cool 


11 Metal Detector Rework 

Rework 

Line and code 

Code/Label & Package packing material 13 

12 

14 15 




Returns product storage 



146 



The workbook used the combined form (5, 6 and 7) 

Using the ingredient form, the plant 

schematic and the process flow 

diagram, conduct a hazard analysis. 

Use this to complete the hazard 

analysis form. 


147 





Beef meat‐ BCP 

Product rework‐ BP 

Frozen vegetables BCP 

Dried Oregano BCP 

Salt CP 

Pepper BCP 






sulphites) BCP 

Water BC 


pails B 


liner BC 

Once hazards are identified, return to your product ingredient form and 

enter location of B,C and P hazards

148 

1.Dry ingredients 

storage 

BP 

2.Cool 

BP vegetable 

storage 

Receiving 

3.Cold meat 

storage 

Cut into cubes 

BP 

BP 

4.Packaging 

material storage 

B 

Once hazards are identified, return to your process flow and enter 

location of B,C and P hazards 

BC 5.Gravy 

preparation 

BC 

Water distribution 


Cook 

BP 

BPC 

Rework Cool B 

BC 


Line and code B 

packing material 

Returns 

BP 



BP 



BP 

Returns 

Shipping/Distribution 


149 


Series of lightning‐round questions on what was covered so far today. 


Round 3 

150 


Critical Control Points 

151 

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. 

Codex 

152 

Critical Control Point 


If I lose control , is it LIKELY that a health risk will 

occur? 


153 

Processing CCPs 

• Acidity, water activity or 

any other characteristic 

essential to food safety 

• Time and temperature 

during thermal processing 

• Sifter for sorbitol (nonmetallic 

contamination) 

• Filters for glycerine 

Ask for other examples from the group, or provide examples from your 

own experience. 

154 


Packaging CCPs 

• Metal detectors & X-rays 

• Tamper-evident 

packaging 

• Labelling for 

declaration of 

allergens 

Ask for other examples from the group, or provide examples from your 

own experience. 

155 


Distribution & Dispatch CCPs 

• Time (e.g. time on loading dock) 

• Temperature (e.g. product temp. before loading, 

loading dock temperature) 

• Handling at Foodservice/Consumption: 

• Some factors are uncontrollable 

• If critical, steps can be taken (e.g. education, selfpurchased 

refrigerators) 

156 


The HACCP Decision Tree 

• A sequence of questions to help you determine 

determining whether a hazard is a CCP 

• New FSEP pre-question: 

Is this hazard fully controlled by the prerequisite 

programs? 

157 



• How do you decide if it’s fully controlled by 

the PRPs? 

• Who is responsible for deciding this? 



158 

CCP Decision Tree 

Q1. Could a control measure be used by the operator at any process step? 

Yes 

Proceed to the next hazard 

No 

Q2. Is it likely that contamination with the identified hazard could occur or increase in 

excess of the acceptable level or could increase to an unacceptable level? 

Note: Question 5 is an FSEP requirement. It is not required by GFSI 

standards. 

Yes 

No 


Q3. Is this step designed to eliminate or reduce the likely occurrence of a hazard to an acceptable 

level? 

No 

Yes Stop here. THIS IS A CCP 

Q4. Will a subsequent step eliminate or reduce the hazard to an acceptable level? 

Yes 

No Stop here. THIS IS A CCP 

Q5. Does this step provide partial control of the identified hazard? 

Yes 

No 


Stop here. THIS IS A PC 

159 


Question 1 

Could a control measure be used by the 

operator at any process step? 

Note the highlighting of the word process: this question asks learners to 

think about the process steps only – not at steps controlled by 

Prerequisite or by supplier agreements. 

Yes: Describe the control measure, then go to 

question 2 

No: If you can’t control it, you can’t have a 

critical control point. You must find a way to 

control the hazard either before or after 

processing. Proceed to the next hazard 

160 


Hazards Not Controlled by Operator 

Hazards Not Controlled By Operator 

Facility: 

HACCP Plan Author: 

Approved by: 

Revision: 

Date: Page of 

Product Name: 

Form 9 

This form is provided in the workbook. Time permitting portions of this 

form will be completed (though these hazards should be addressed in 

the prerequisite program.) 

Hazard 

How Could the Hazard Be Addressed? 

Provide examples of hazard not controlled by operator 

161 


Question 2 

Is it likely that contamination with the 

identified hazard could occur or increase to 

an unacceptable level? 

Remind participants of the health risk assessment matrix 

• No: No critical control needed 

• Yes: Go to question 3 

162 


Health Risk Assessment Matrix 

Controls put in place should match the degree of risk . 

Explain model as an aid to objective assessment of risks. 

LIKELIHOOD 

High 

Medium 

Low 

Minor 

Risk 

Minor 

Risk 

Minor 

Risk 

Major 

Risk 

Major 

Risk 

Minor 

Risk 

Critical 

Major 

Risk 

Minor 

Risk 

Low Medium High 

SEVERITY 


163 


Case Study: 

Use the health risk assessment 

matrix to determine the likelihood 

and severity of the hazards 

mentioned in the assigned case. 


There are 4 case studies in the workbook. One for physical and chemical 

hazards and 2 for biological hazard. Assign one case study to each 

table/group and let them work through the case study using the risk 

assessment matrix. The trainer is provided with an answer sheet for the 

case studies. 

164 


Question 3 

Is this step designed to eliminate or reduce 

the likely occurrence of a hazard to an 

acceptable level? 

If the answer to this question is yes, then a CCP has already been put in 

place, even if it has not been identified as such. As learners for 

examples of where or when this may have occurred. 

• Yes: Stop here, you have a CCP 

• No: Go to question 4 

165 


Question 4 

Will a subsequent step eliminate or reduce 

the hazard to an acceptable level? 

Remind learners of the importance of control points as well as critical 

control points. (This will be discussed in greater detail in a later slide.) 

• No: Stop here, you have a CCP 

• Yes: This might be a control point, but it is not a 

critical control point because it is not the last 

possible control measure. Proceed to the next 

hazard 

166 


Question 5 

• Does this step provide partial control of the 

identified hazard? 

• Yes: Stop here. This is a Process Control (PC) 

• No: Proceed to the next hazard 

167 


Example Scenario 

• Metal shavings have been found in your 

finished product. Further investigation pinpoints 

the source of the contamination from the meat 

cutter. 



168 

Receiving 

Dry ingredients 

storage 

Cool 

vegetable 

storage 

Cold meat 

storage 


Packaging 


Gravy 

preparation 



Cook 

Cool 

Metal Detector 


Line and code 


Returns 





Returns 


169 


Hazard Decision Tree 

Receiving 


storage 

Cool 

vegetable 

storage 

Cold meat 

storage 


Packaging 


Gravy 

preparation 


Cook 

• Is there a prerequisite program that will fully control this 

hazard? 

• No. It is only partially controlled by the preventative 

maintenance program 

170 


Question 1 

Receiving 


storage 

Cool 

vegetable 

storage 

Cold meat 

storage 


Packaging 


Gravy 

preparation 


Cook 

• Could a control measure be used by the operator at any 

process step? 

• Yes. A metal detector can be used 

171 


Question 2 

Receiving 


storage 

Cool 

vegetable 

storage 

Cold meat 

storage 


Packaging 


Gravy 


preparation 

Cook 

• Is it likely that contamination with the identified hazard 

could occur or increase in excess of the acceptable level or 

could increase to an unacceptable level? 

• Yes. Customer complaints show that this continues to be a problem 

172 


Question 3 

Receiving 


storage 

Cool 

vegetable 

storage 

Cold meat 

storage 


Packaging 


Gravy 

preparation 


Cook 

• Is this step designed to eliminate or reduce the likely 

occurrence of a hazard to an acceptable level? 

• No 


173 

Question 4 

Receiving 


storage 

Cool 

vegetable 

storage 

Cold meat 

storage 


Packaging 


Gravy 

preparation 


Cook 

• Will a subsequent step eliminate or reduce the hazard 

to an acceptable level? 

• Yes. A metal detector has been installed further down the line. 


174 

Question 5 

Receiving 

Make sure to include the comment that Question 5 is an FSEP 

requirement. It is not required by the GFSI standards. 


storage 

Cool 

vegetable 

storage 

Cold meat 

storage 


Packaging 


Gravy 


preparation 

Cook 

• Does this step provide partial control of the identified 

hazard? 

• Yes. This is a Process Control 

175 


FSEP Process Control 

• Where several steps in the process contribute 

to the reduction of a hazard, process controls 

are developed for those early steps where the 

hazard cannot be fully controlled 

• The final step that results in the elimination or 

reduction of the hazard is the CCP 

Just because they’re not critical does not mean 

they’re not important 

176 



Forms 8 and 9 

CCP Determination 

Review each of the hazards to determine 

• Which hazards are controlled by 

prerequisite programs 

• Which hazards are PCs 

• Which hazards become CCPs 



177 

1.Dry ingredients 

storage 

BP 

BP 

2.Cool 

vegetable 

storage 

Receiving 

3.Cold meat 

storage 

BP 

Cut into cubes BP 

4.Packaging 


B 

Once the decision tree has been applied, return to your process flow 

and identify PCs and CCPs. 

BC 5.Gravy 

preparation 

BC 


Mix meat with sauce BPC 

Cook BP 

Rework Cool B 

BC 


Line and code B 


Returns 

BP Finished frozen 



BP 




BP 

Returns

178 

HACCP Program 

Day 3 

179 

Review of Day Two 






5. On-site verification of flow diagram & plant schematic 





10. Establish deviation procedures 



Note for those who are CFIA registered. You must return to forms 5,6, 

and 7 to identify where each hazard is controlled 

180 


Critical Limits 

181 

Critical Limits 


A criterion that separates acceptability 

from unacceptability. 

Codex 

182 

Critical Limits: 

Must be based on sound 

science 

• Regulatory requirements 

• Industry guidelines 

• Studies, research 



183 

Information Sources 

• Product history 

• Consumer complaints 

• CFIA Database 

• Scientific literature / 

Journals 

• Generic models 

• Textbooks 

• Association 

• Internet 

• Inspections 

Note that participants have already seen this slide: they must do 

research for both hazard analysis and setting critical limits. 

184 



Temperature is one processing parameter 

that is used to set critical limits. What other 

parameters can be used to establish critical 

limits? 

Each group stands at a flip chart and has one minute to come up with as 

many processing parameters as possible. The team with the most 

correct answers wins 100 points. 

Lightning round: You have 1 minute 


185 

Critical Limit Criteria 

• Time 

• Temperature 

• Weight/Size 

• Humidity 

• Water activity (Aw) 


• pH 

• Acidity 

• Preservative level 

• Salt level 

• Pressure 

What is missing from this list? 

Micro results. The reason is that the results come back too slowly. Too 

slowly for the operator to use the results to control the line. 

186 


Examples of Critical Limits 

• Pasteurization of milk destroys non-sporeforming 

pathogens 

• Acidifying canned foods to pH 4.6 or below 

prevents pathogen growth 

• Drying foods to a water activity of 0.86 or below 

prevents bacterial pathogen growth 

187 


Microbiological Limits 

Problem: 

• Microbiological defect rate: 0.1% 

• Probability of detection: 0.1-5.8% 

Cost: 

• To get the 5.8% chance requires 60 samples 

Result: 

• Cost prohibitive and ineffective 

Microbiological Sampling (based on ICMSF 1986, using 

2 or 3 class plan) 

Http://www.icmsf.iit.edu/main/home.html 

This shows that micro testing is not 100% and can be used to confirm 

but not to use as CL. 


188 

Physical Limits 

Capability of machine 

• E.g. Metal Detector. No foreign material greater 

than: 

• 1.5mm ferrous 

• 2.0mm non-ferrous 

• 2.5mm stainless steel 

Size of screen 

• E.g. Screen 

• No foreign material greater than the mesh size. 

189 


Chemical Limits 

• Regulatory requirements 

• Supplier specifications 

190 



Select one of your CCPs. 

What is its critical limit? 

Defend your limit. 


191 

Operating Limits 


• A built-in margin of safety 

• Based on the capability of the process 

• Can be related to quality (e.g. setting of starches, 

inactivating enzymes) 

Operating limits are often set up to meet a quality objective. For 

examples, with our beef stew, need to reach a temperature of at least 

70 C internal for food safety but to get the gravy to set up, you need an 

internal temperature of 72 C. Companies may assume that because 

they have more a more stringent limit that everything is okay. But is it? 

In the next few slides will take the group through the thought process 

behind validating CCP critical limits. 

192 


Discussion Beef Stew Case Point Study 

• Critical limit has been established at 

internal temperature of meat at 72°C for 15 

seconds 

• In order to properly set the gravy, it must 

reach a temperature of 75° for 15 seconds 

• With 75° as our operating limit, does this 

mean our product is always safe? 

Our operating limits will have variation as well. Is this variation large 

enough that it is possible to exceed the critical limit? We need to 

confirm this (validate). 



193 

Determining Safety of Operating Limits 

What variables would affect our ability to cook 

consistently? 

• Thickness of sauce 

• Temperature at start of process (equipment, 

product and environment) 

• Condition of the kettle 

• Ratio of meat to vegetables 

• Automated vs. manual process 

Equipment may need time to fully reach its temperature so at end of 

day may overcook product. In summer, room may be warmer. Product 

coming out of cooler at beginning of day will need longer to heat up. 

194 


Determining Safety of Operating Limits 

What is the effect of each variable on your ability to 

meet the critical limit? 

• Thickness of sauce: heat transfer may be easier in 

a thin sauce 

• Temperature at start: sauce left in cooler overnight 

will require longer to reach required cook temp. 

• Condition of kettle: surface volume or age of kettle 

can affect cook time 

• Ratio of meat to vegetables: more meat could 

require longer cook time 

• Automated vs. manual: method of stirring can 

effect how heat is distributed 

195 


Current Operating Range 

• Variable kettle temperature (170-180°C) 

• Stew temperature variation at start of cook time 

(2-10°C) 

• Exposure of meat to highest temperature in 

kettle due to manual stirring (varies from 9-12 

min) 

Could run the worst case scenario and provide that can still get the beef 

stew cooked. …. 

How would you test this to ensure we could still 

safely cook? 

196 


Test the Worst Case Scenario 

• Coldest kettle temperature = 170° C 

• Coldest stew at start of cook time = 2° C 

• Shortest time at maximum temperature = 9 

minutes 

To calculate sigma we need a good volume of data. 60 data points is a 

minimum, 200‐300 is best. 

197 



• Measures of Variation 

• Average 

• Standard Deviation 

We need to determine 

‐Average 

‐SD which is max and min 

‐So you need to understd these two in order to underst process… 


‐Story there is variation in size of shoes here but the larger variation 

would be observed if we were at the mall… 

‐So if add all shoe size in class and find average it is x=10 … 

‐So if find SD comparise each size to the SD… so get x‐SD… so next have 

to get rid of the negatives in the comparision…. So do the formula in the 

next slide…

198 


• Standard Deviation 



s 

( x x) 

n 1 

2 

THIS WAS HARD TO TYPE UP 

The n‐1 is to err in the area of safety… and the bigger the denominator 

the less 1 effects… 

199 



• Beef stew cooking example 

• Minimum cook temp. = 72°C 

• Average cook temp. = 75°C 

• Standard Deviation(S) = 2°C 

So if we look at our data sheets and get these number 

CL =70 

X= 72 

SD = 1 

200 


Normal Distribution Curve 

Not all data falls into a normal distribution curve. However a significant 

portion of things that vary randomly do. 

Discuss al of the feature of the normal curve. (mean range, standard 

deviations, shape of curve (bell)) 


Story – 

What to do with SD and what it means? ‐‐‐‐ if cut out curve and weigh 

Than cut into 6 section …. Most of the temperatures will be in 1SD 

We should be able to control at least to 4SD.. Which is 100‐ 99.95= .5 /2 

= 2.5 of 10,000 meat balls would be under cooked SOOOOO raise 

temperature to 2C 

201 




• Standard Deviation(s) = 1°C 

• Average + 3S = 72 + 3(1) = 75°C 

• Average – 3S = 72 – 3(1) = 69°C 

Recommend you go to 4DS 

Sooo now deal with the variability… SD means you are driving an old 

Ford…. Try to fix all the variables listed a few slides prior i.e., size, onion 

distribution, temp, etc…. 

Q= what could do now to ensure better cooked number meatball. 




202 




• Standard Deviation(s) = 2°C 

• Average + 3S = 75 + 3(2) = 81°C 

• Average – 3S = 75 – 3(2) = 69°C 

• THE CRITICAL LIMIT HAS BEEN VIOLATED 

• What is the next step? 

So now…. 

Average = ?? 

SD=.5 

minCL is 70 

…now average 72 ???? 

This is how toyota makes cars… so can have safe food at low cost and 

good quality….. 

203 




• Average + 3S = 75 + 3(2) = 81°C 

• Average – 3S = 75 – 3(2) = 69°C 

• SHORT TERM 

• Move average cooking temperature up 1°C 

• LONG TERM 

• Reduce the standard deviation 

• HOW? 

So set 



204 


Monitoring 

205 

Monitoring 


The act of conducting a planned sequence of 

observations or measurements of control 

parameters to assess whether a CCP is under 

control. 

Codex 

Ensuring that the product is 

manufactured safely from day to day 

206 



• What would you consider to be a monitoring 

activity in your facility? 

• Who is responsible for monitoring? 



207 

Monitoring Methods 

1. Observation 

• Qualifiable 

• Training is key 

• Checklists are a handy 

format 

• Interpretation can be a 

weakness 

Discuss each of the points listed on the slide. 

Follow up questions: 

What type of training is most valuable when teaching observation 

methods? 

What tactics can be used to ensure more consistent interpretation? 

208 


Monitoring Methods 

2. Measurement 

• Quantifiable 

• Calibration of 

equipment is essential 

• The preferred 

monitoring method due 

to its pass/fail outcome 

• Physical, chemical or 

microbiological eg. pH, 

Aw, time, temperature, 

E.coli 

Follow up questions: 

What measurements are taken on the line today? 

Who is responsible for the calibration of equipment? How often is the 

equipment calibrated? 

209 


Basic Types of Monitoring 

1. On-floor: 

• Critical factors are monitored during the 

process 

• Continuous 

• Discontinuous 

2. Off-line: 

• Samples are taken elsewhere for measurement 

210 


Frequency of Monitoring Checks 

• How should this be 

determined? 

• There must be a sound 

basis 

• Statistical sample size 

• Based on risk 

• Sample very frequently 

for a period of time to 

spot patterns 

Determination of frequency of checks is a balance between: 

• The business risk that a company is willing to assume 

• The time and labour required to perform the monitoring activity 

211 


Sample Monitoring Procedure 

(1) (2) (3) (4) (5) (6) (7) 

CCP Significant Critical Limit Monitoring Corrective Verification Records 

Hazard 

Action(s) 

CCP 1: Metal 

Metal from 

Detector process 

1.2 mm 

ferrous 

1.5 mm nonferrous 

1.8 mm SS 

Reject device 

operational 

Who: Line 

Operator 

Where/ 

How: 

When/Fre 

quency: 

Who 

Frequency 

Equipment required 

• Is it accurate enough? 

Steps (detail is important) 

Important criteria 

Records to be filled out 

Signature of company official: Title: Date: 


212 


Return to your chosen CCP 

1. Who is responsible for monitoring the CCP? 

2. What are the steps in the monitoring 

process? 

3. How will the task be performed? 

4. What are the important criteria? 

5. When will the task be performed? 

6. What records must be filled out? 



Monitoring procedure template in workbook. 

The concept of the process owner is important when developing a 

successful HACCP plan. 

Those on the line who are in day‐to‐day contact with the CCP must fully 

understand its importance to food safety before they can be motivated 

to assume responsibility for its consistent monitoring. Process owners 

must also be fully trained in monitoring techniques, and most have 

clear guidelines to follow when monitoring results show that the CCP 

risks being out of control. 

213 

10. Establish Deviation Procedures 





5. On-site verification of flow diagram & plant schematic 





10. Establish deviation procedures 



If time permits, screen the HACCP video 

Deviation procedures can also be called corrective actions 


214 

Deviation 

A failure to meet a critical limit. 

Codex 

Note that a deviation procedure is a set of actions, not a single step or 

process. Note also that deviation procedures must be documented. 

Examples 

Failure of the metal detector to detect a test wand 

Wrong label on package 

Follow up questions: what should you do if deviations occur more 

frequently your stated food safety objectives for the year? 

215 

Deviation Procedure 


A pre-determined and documented set of 

corrective actions (immediate and preventive) 

which are implemented when a deviation 

occurs. 

CFIA 

Follow up questions: why is it essential to document deviation 

procedures? 

216 


Deviation Procedure Corrective Actions 

Regain control of the process 

• If necessary, stop the operation 

• Determine and implement 

short-term solution 

• Record what happened and 

1action taken 

The next four slides address the types of corrections that can be 

implemented when a deviation occurs. 

Provide examples of short‐term solutions. 

Discuss: who is responsible for stopping an operation when a deviation 

occurs? (lead hand or line supervisor). This must be immediately 

communicated to the QA manager. 


Who is responsible for resuming operation? (lead hand or line 

supervisor upon approval from QA manager)

217 


Deal with the non-complying 

product 

• Destroy 

• Rework into new products 

• Release into less-sensitive 

channels 

• Release after 

2 testing/evaluation 

The amount of non‐complying product is determined by the frequency 

of monitoring checks. 

Provide examples of reworking into new products and releasing into 

less‐sensitive channels. 

218 



3 


Maintain control of the process 

• Identify and correct root cause of 

problem 

• Record what happened and 

action taken 

• If necessary, review and improve 

plan 

Note that recording what happened occurs both short and long‐term 

Follow up question: what methods can be used to determine the root 

cause of the problem. 

Provide examples of short‐term and long‐term solutions to a problem. 

219 



Record the corrective action 

4• What product was involved ? 

• How much was involved?? 

• How it was handled? 

• How the situation was 

corrected? 

220 



Describe the deviation and its 

cause 

5 

221 



Verify effectiveness of corrective 

actions taken 

6 


222 

Deviation Procedure Example 

Metal Detector Failure 

1. Stop production and fix problem 

2. Re-calibrate metal detector to standard 

3. Re-test metal detector before line start-up 

4. Hold all product back to last good check and 

advise supervisor. Supervisor will promptly 

notify Q.A. 

5. Follow non-conforming product procedure 

6. Document non-conformance on HACCP 

corrective action report 

223 


Corrective Action Report 

• Documented evidence that the company corrected an 

critical failure identified during an audit 

• Points to be covered: 

• Nature of non-conformance 

• Date and time on which failure occurred 

• Time since last good check 

• Amount of product compromised 

• Short-term and long-term corrective actions 

• Preventative measures 

• People involved 

• Disposition of compromised product 

• Verification of corrective actions and preventative 

measures 

224 


Sample Corrective Action Report 

Plant name:_________________________________________________ 

Plant location:_______________________________________________ 

Date:__________ Time:__________ Signature:____________________ 

Step 1. Record the actual event or circumstance that lead to a corrective action. 

Step 2. Record what corrective action you performed to control the hazard or event, and its outcome. 

Step 3. If the corrective action was a result of a food safety hazard, a review of the HACCP plan must occur. 

Description of problem: __________________________________________________________________ 

______________________________________________________________________________________ 

______________________________________________________________________________________ 

Corrective action taken: __________________________________________________________________ 

______________________________________________________________________________________ 

______________________________________________________________________________________ 

Date problem was solved: _______________________ Time:___________________________ 

Verification signature: ________________________________ Date: ___________________________ 

Note: Verification of record must occur within 7 days of entry. 

Discuss that there may be a further requirement for detailed root cause 

analysis and preventative measures. The extent and complexity of your 

Corrective Action Report will depend upon the extent and severity of 

the deviation. 

Ask the group: how do you manage your corrective action system? 

225 



• Who is responsible for ensuring the 

completion of a corrective action report? 

• How do you verify? 


226 


Deviation Procedure Challenges 

• Thorough investigation and follow-up 

• Documentation 

• Close the loop 

• Corrective action report form 

• Frequency 

• Deviations should occur infrequently (maximum 

1.35 times/1000 checks if capable to 3 Sigma !) 

• Track it 

CAR or CAPA (corrective action preventive action)…. So if had a D than 

usually complete a CAR in many industry.. So can investigate and ensure 

it does not happen again. 

So have a % CCP compliance…. The goal is 100%.. If statistically 3SD 

than should only have non conformance every 1.3 for 1000… 


227 


Write the corrective action 

procedure for your chosen CCP 


228 


Verification, Validation and 

Reassessment 

229 

230 

Verification 


The application of methods, procedures, tests 

or other evaluations, in addition to monitoring, 

to determine whether a control measure is or 

has been operating as intended. 

Codex 

Confirm and record 


Record and On-site Verification 

The act of applying methods, procedures, tests and other evaluations, 

to determine if monitoring tasks are in compliance with the HACCP 

system. 

2009, Government of Saskatchewan 

A confirmation of double‐check of the Operator’s critical limits, 

monitoring checks and corrective actions 

E.g. Review the cook temperature sheet at the end of each production 

day to ensure it has been filled out completely, correct temperatures 

have been met and, if required, corrective actions and preventive 

measures were carried out appropriately. 

This is an FSEP requirement 

231 


Who Verifies? 

• Verifiers should not be 

peers, because they 

must have the authority 

to correct the behaviour 

• Verifiers must be 

competent in the activity 

that they are verifying 

• Monitoring and 

verification tasks cannot 

be performed by the 

same person 


232 

Validation 

Obtaining evidence that control measures, if 

properly implemented, are capable of 

controlling the hazard. 

Codex 

Obtaining confirmation that the elements of the HACCP system are 

effective in controlling biological, chemical and physical hazards. 

• It may include but is not limited to literature searches, validation 

studies and review of regulations. 

Government of Saskatchewan 

233 

Validation 

Justify and record 

• Validation occurs throughout the process 

1 

prerequisite 

Programs 

3 

The HACCP 

Plan 

VALIDATION 

2 

Steps to 



E.g. if you are cooking a product you will have to validate that your 

equipment is capable of cooking the product evenly and consistently. 

Morning Break after this slide 

• prerequisites 

• Preliminary steps of HACCP 

• Hazard Analysis 

• CCPs 

• Critical Limits 

• Monitoring 

• Corrective Action 

234 


Tools for Validation 

• Regulations 

• Experimental trials to simulate process 

conditions; mathematical modelling 

• Use of a guide approved by competent 

authorities 

• Internal and external testing 

• Review of records 

235 


Reassessment of the HACCP 

System 

• Recommended at least annually and whenever 

any changes occur that could affect the hazard 

analysis or alter the HACCP system 

• A requirement of CFIA’s FSEP program, BRC, 

SQF 

Where re‐validation is almost always triggered by a change in the 

hazards associated with food or ingredient the annual reassessment of 

the HACCP system is mandatory. It could or could not be triggered by 

the deficiencies encountered during the re‐validation activity. 

Validation can be apart of the reassessment procedure. Validation 

studies are used in case of reassessment of the CCP’s (microbiological 

data etc.) 

236 


HACCP System Reassessment 

• HACCP Team must review HACCP System 

• Includes the revalidation of all HACCP Principles 

• Ensure all forms are up-to-date 

• Reassess hazard analysis and CCP’s 

• Review the facility, process and science regarding 

Monitoring, Deviation Procedures, Verification & Records 

• When 

• Change in the product, process or plant design 

• Science change (emerging pathogens) 

• Once per year to allow for subtle process changes 

Be sure to let everyone know about HACCP IV: Verification and 

Validation of your HACCP System. 


237 

Records 

238 

Record Keeping 


Establish documentation concerning all 

procedures and records appropriate to these 

principles and their application. 

239 

Records 

• Record retention 

• Shelf-life plus 1 year 

• No stated shelf-life, 2 

years 

• (plus legal issues) 

• Changes Log 

• Records must be up-todate, 

legible, accurate 

and properly filed 


Follow‐up question: how do participants manage their records? Who 

files them? Where are they kept? Who knows how to access them? 

How can they guarantee the security of the records? 

240 


Each Record Must Indicate 

• Record title 

• Results of monitoring, deviation or verification 

• Corrective actions and preventative measures 

as required 

• Name of the person completing the record 

• Date and exact time of activity 

• Signature or initials of person completing the 

record 

241 


The Value of Records 

• Confirms conformance to written HACCP plan 

• Proof that the CCPs were implemented 

effectively 

• Constitute an important element of an 

auditable system 


242 


• What CCP records do you keep? 

• How long do you keep them? 


243 



Complete Your HACCP Plan 


244 

CFIA Generic Models 


• 19 generic models representing dairy, meat and 

poultry, and some processed products 

• Federally registered facilitates must review 

generic model against their own HACCP plan 

and be able to defend differences 

• Non-federally registered facilities can use these 

models as a reference when creating or 

reassessing their plan 

• Canadian Food Inspection Agency - FSEP / 

HACCP Generic Models 

Advise participants that these generic models are not necessarily up‐todate 

with the FSEP changes. They are a guide only. 

245 


HACCP is not a static process. 

Act 

Continual Improvement 

Plan 

Do 

Check 

Edwards Deming’s “Continual Improvement Loop” is the basis of all ISO 

management systems 

Most organizations understand the benefits of this simple model but 

lack the mechanisms and discipline to adhere to it 

Consequently they do not achieve continual improvement 

246 


Changes to the HACCP System 

• New HACCP plan 

• Changes to a HACCP system 

• Changes in ownership 


If a new plan is added, this must be communicated to the CFIA 

inspector prior to start of new process. A review of the new HACCP plan 

will be conducted. 

If changes are made to a recognized HACCP plan, these must be 

entered in the log book and made available for future review by the 

CFIA 

If there is a change in facility ownership and the original HACCP system 

is intact, the new owner will be required to submit a letter of 

commitment to the CFIA coordinator. The letter will confirm that the 

originally recognized HACCP system is intact and will not be changing. 

The letter will also confirm the commitment of the new owner. 

If changes to the HACCP system are made by the new owner, a new 

letter of commitment and list of changes must be submitted to CFIA. 

CFIA will evaluate the impact of the changes and determine if the 

facility must undertake a new recognition process.

247 

Course Review 

How have we met the course objectives? 

By the end of this course you will be able to: 

• Apply the Codex 12 steps to HACCP 

• Understand the 7 HACCP principles 

• Develop a HACCP plan 

• Know how to implement and manage the 

HACCP plan 

248 


Team Challenge Winner

HACCP II - Perennia

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