Clause by Clause Requirements In Cl b Cl R i t I ISO 22000:2005

Lecture 3

ISO 22000 - Scope

Demonstrate ability to control food safety hazards, i.e. is safe at the time of human consumption Address customer satisfaction and continual improvement To demonstrate compliance with applicable statutory and regulatory food safety requirements Application to ONLY food chain (directly or indirectly involved) )

ISO22000 main scope Crop producers

Producers of pesticides, fertilizers and veterinary drugs Food chain for the production of ingredients and additives Transport and storage operators Producers of equipment Producers of cleaning agents Producers of packaging materials

Regulatory author rities

Feed producers Primary food producers Food producers Further processors

Wholesalers/Distributors

Services providers other supplying food chains

Retailers

Consumers

Requirements of ISO 22000 Standard- Clauses 4 FSMS

4.0 Food Safety Management System

4.1 General Requirements
The organization shall establish, document, implement and maintain an effective FSMS and update it when necessary Th organization is required to: The i ti i i dt
Define the FSMS scope (product categories, processes and its sites that will be address within FSMS) Ensure that food safety hazards that may be reasonably expected to occur are identified, evaluated and controlled Food safety issues are communicated throughout the food chain Internal communication re: FSMS changes Evaluate effectiveness of system

O Organization has control over outsourcing activities i ti h t l t i ti iti

4.0 Food Safety Management System

4.2 Document requirements p ISO 22000 calls for documented procedures in 7 areas 1. Control of documents ( 4.2.2) 2. Control of records (4.2.3) 3. Control of non conformity ( 7.10.1) 4. Corrective action (7.10.2) 5. Appropriate handling of potentially unsafe products (7.10.3) 6. Notification of relevant interested parties in the event of the withdrawal of unsafe products (7.10.4) 7. Internal audit (8.4.1)

4.0 Food Safety Management System 4.2 Document requirements 4.2.1 The FSMS Documentation includes: Documented food safety policies & objectives Documented procedures & records g g , p Documents covering the effective design, implementation & updating/improvement of the food safety management system 4.2.2 Control of documents Documented procedure for document control, including approval Review , update and re-approval of documents Revision control Distribution Legible and readily identifiable Control of external documents Control of obsolete documents 4.2.3 Control of records Documented procedure, defining controls for correction, identification, storage, protection, retrieval, retention time and disposition of records

Documented Procedure
Title: Internal Audit Procedure
Procedure No: Doc Issue # Authorized By: Page # Prepared By

Purpose/ Scope
ACTION FLOW CHART

WHO
1.

PROCEDURE

REFERENCE

RECORD

1.

2.

2.

3.

3.

Requirements of ISO 22000 Standard- Clauses 5 Management Responsibility

5.0 Management Responsibility

5.1 Management commitment g Food safety supported by business objectives communication of standard, statutory and legal requirements, food safety policy established management reviews availability of resources

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5.0 Management Responsibility (2)

5.2 Food safety policy appropriate to role in chain meeting statutory, regulatory and agreed (food safety) customer requirements communicated, implemented and maintained reviewed addresses communication (see 5.6) supported by measurable objectives.
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Example of Food Safety Policy (Mngmt-R2)

5.2 Food safety policy We (ABC Factory) focus on facts and results and we strive for zero defect and excellence in everything we do We provide adequate resources, equipment, procedures and systems to ensure high quality standards. We enforce full compliance and We strive for the flawless execution and improvement evaluated by TPAs

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Example of Food Safety Policy (Mngmt-R2)

5.2 Objectives Reduce scrap by 10% within the next 6 months Reduce repeat problem by 90% Increase customer satisfaction by 10% within next year Reduce NCN product by 15% Increase test accuracy through correlation test etc

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5.0 Management Responsibility (3)

5.3 Food safety management system y g y planning Planning of the FSMS is carried out to meet requirements given in 4.1 and the objectives of the organization that support food safety? The integrity of the FSMS is maintained when changes are planned and implemented?

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5.0 Management Responsibility (4)

5.4 Responsibility and authority y y Responsibilities and authorizations defined and communicated within the organization All personnel to report problems to designated personnel with responsibility and authority to initiate and record actions

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5.0 Management Responsibility (5)

5.5 Food safety team leader y Top management must ensure that the food safety team leader has the time & training required to properly carry out all required activities Must be responsible for implementing all aspects of the FSMS, including involvement of management when required
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5.0 Management Responsibility (6)

5.6 Communication 5.6.1 External communication
Records of external communication maintained (customer feedback, comp.. Food safety related requirements from customers and regulatory authorities recorded Suppliers must also be part of the external communication plan Associations are also to be included in the external communication plan where appropriate i t Responsibility for communication of food safety related information defined. External information included as input to system updating (see 8.5.2) and management review (see 5.8.2)
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5.0 Management Responsibility (7)

5.6 Communication 5.6.2 Internal communication
Food safety team timely informed of changes, internal and external, that may inpact food safety, including changes in: Products, raw materials, ingredients, services, equipment, premises, environment, methods, personnel qualification level, responsibilities and knowledge regarding hazards, regulatory requirements, complaints, customers, sector and other external requirements Information included in system update Information included in management review (5.8.2)

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5.0 Management Responsibility (8)

5.7 Emergency preparedness response (Prvt + Crisis) Procedures for potential emergency situations and accidents established, implemented and maintained The program must contain procedures not just to handle product withdrawals, but also situations that could affect product safety, such as:
Hazardous spills Smoke/fire damage Product security during evacuations Biosecurity risks where applicable Tampering
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5.0 Management Responsibility (9)

5.8 Management review 5.8.1 General Regular reviews planned and records maintained Review output, including 5.8.2 Review i 582 R i input t Follow-up of previous reviews Analysis of verification activities Changes that effect food safety Emergencies, accidents and withdrawals Reviewing results of system updating activities Review of customer feed-back External audits or inspections Data must be presented in a manner that enables top management to relate the information to stated objectives of the FSMS 5.8.3 Review output Decisions and actions related to assurance of food safety, system improvement, resource needs Revision of (food safety) policy and objectives

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Requirements of ISO 22000 Standard- Clauses 6 Resource Management

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6.0 Resource Management

6.1 Provision of resources Top management must provide adequate resources to properly implement & maintain the FSMS 6.2 Human resources 6.2.1 General
Food safety team is competent Other personnel are provided in p p y sufficient numbers & properly trained Records of agreement or contracts defining the responsibility and authority of technical experts (e.g. if own competence is limited).

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6.0 Resource Management (2)

6.1 Provision of resources 6.2 Human resources 6.2.2 Competence, awareness, training
Competence, awareness and training Necessary competencies identified Training provided and actions taken to ensure personnel have competencies Ensure training of personnel for monitoring, corrections and corrective actions Evaluation of the above: a), b), c) Ensure personnel are aware of their relevance, importance, and contribution to food safety Ensure awareness of effective communication Training records maintained for b) and c)

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6.0 Resource Management (3)

6.3 Infrastructure Resources for the establishment and maintenance of the infrastructure are provided 6.4 Work environment Resources for the work environment are provided

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Feedback of Workshop-01

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Requirements of ISO 22000 Standard - Clauses 7 Planning and Realization of Safe Products (see another HACCP)

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Planning and realization of safe products

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ISO22000: Comparison to Other Food Standards

ISO 22000 ISO9001 HACCP BRC IFS

Principle 7 Food safety Quality Management Quality Management Quality Management (Documentation and Management system System System System record) Management reponsibility Management of Resources Planning and reailzation of safe f f products Validation, verification & improvement of the FSMS Management responsibility Management of Resources Inconsistent requirement (e.g. SGS does require this) Establish HACCP team Principle 1-3 (list all hazards, determine CCP, establish Critical Limit Principle 4-6
(Monitoring, corrective action , verification)

Quality Management System Management of Resources

Management responsibility Management of Resources

Product realization

Product control

Product realization

Measurement, analysis & improvement

Product & Process control

Measurement, analysis & improvement

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PLAN-DO-CHECK-ACT SCHEMATIC

Requirement q

Plan

Do

Check

Conformity

Yes

Corrective C i Action (long term)

No Correction (immediate) Feedback Loop

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Definition of a Hazard:
A biological, chemical or physical property that may cause the food to be unsafe for consumption by the consumer
Note: Consumers may be humans, pets or livestock depending on the product & the goal to be achieved

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Micro-organisms
Can be useful or even essential:
Yeast in beer and bread Lactic acid bacteria in yogurt & cheese

Food safety programs focus on pathogenic or dangerous microorganisms, not all microorganisms

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Micro-organisms

Grow by splitting in two O O O O O O O

1 hour

OO OO OO OO To grow properly, micro-organisms need: Available food, proper pH, Temperature, Time, Suitable atmosphere, Moisture (Aw)
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Micro-organisms Micro organisms

Include harmful
Bacteria Moulds Viruses Protozoa

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Bacterial Hazards
Infection I f ti vs Intoxication I t i ti
Affect process controls used Intoxication:
Live cells need not be present Toxin may remain even when cells are killed Symptoms dramatic and rapid onset vomiting, blurred vision, paralysis, death

Infection:
Live cells are ingested for illness to occur When cells are killed, infection is reduced Slower onset nausea, headache, malaise, diarrhea

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Bacterial Hazards
Spore forming vs. non-spore forming bacteria
Different resistance Spores can germinate propagation Spores can survive adverse conditions Harder to kill off spore forming species Affects FSMS procedures/control conditions

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Bacterial Hazards example

Micro-organism (pathogenic bacteria)
Bacillus cereus Toxin producer Staphylococcus aureus Toxin producer Clostridium Botulinum Toxin producer Listeria monocytogenes Food borne disease Growth range 6-50O C aerobe* spore former Growth range 6-46O C Facultative anaerobe** Growth range 3-50O C Anerobe*** Growth range 1-45O C Facultative anaerobe** Vegetables, fruit, dairy products, red meat, poultry meat, fried rice. Raw foods of plant origin, especially cereal products, spices and milk Raw meat and poultry, dairy products, salads and canned foods Meat, vegetables, shellfish, canned food

Growth requirements

Food Commonly implicated

* Requires oxygen,** growth either with or without oxygen, *** requires the absence of oxygen

source of microbiological information e.g.

http://www.cfsan.fda.gov

Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (Bad Bug Book) Bacterial Pathogen Growth and Inactivation
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Moulds
Hazard depends on species:
Produce mycotoxins e.g. Aspergillus niger Mycotoxins include aflatoxins in nuts etc. Cannot eliminate mycotoxins easily once present Try to prevent mould growth to reduce risk of mycotoxin formation f ti Mycotoxins can be carcinogenic

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Viruses
The smallest form of life Can have a multitude of sources How can they be controlled?
prevention or sometimes by heat (thermal destruction)

Examples
Hepatitis A & E Norwalk Virus

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Parasites
Need a host to survive Thousands exist but about 100 types are known to infect people through food contamination Concern from food or water
Parasitic worms Protozoa

Fecal matter is involved in transmission

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Natural Chemical Hazards

Mycotoxins (eg. Aflatoxin) y ( g ) Scombrotoxin Ciguatoxin Shellfish toxins
Paralytic Shellfish Poisoning (PSP) Diarrheic Shellfish Poisoning (DSP) Neurotoxic Shellfish Poisoning (NSP) Amnesic Shellfish Poisoning (ASP)

Toxic plant alkaloids

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Intentionally Added Chemicals or Food Additives

Directly added with allowed limits
Preservatives
Nitrite Sulphiting agents

Nutritional Additives
Vitamins can be toxic

Colours restrictions in some countries

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Unintentionally or Incidentally added Chemicals

Cross contaminant/undeclared allergens Agricultural chemicals
Pesticides: Fungicides: Fertilizers: Antibiotics: Growth Hormones

Toxic substances
eg. Lead: Zinc: Arsenic: Mercury: Cyanide

Secondary chemicals
eg. Lubricants: Cleaning compounds: Sanitizers: Paint

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Physical Hazards
Any potentially harmful extraneous matter not usually found in food. Conditions for hazard generation must be accurately described e.g. size, shape Examples:
Glass any is usually considered hazardous Metal limits apply (e.g. <1 mm and/or with jagged edges) Wood

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Hazards
It is not a good idea to memorize everything since hazards are dynamic and regulations change Use competent technical support people and literature to regularly (annually) review hazards

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7.0 Planning & realization of safe products

7.1 General: plan & develop process for safe product 7.2 Prerequisite programs 7.2.1 The facility shall establish, implement and maintain PRPs to assist in controlling hazards 7.2.2 The PRPs shall be appropriate to the organization, size and type of the operation and approved b th f d safety ti d d by the food f t team 7.2.3 Consider and utilize appropriate information e.g. regulations (domestic/market), customer requirement
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Prerequisite Programs
Construction and lay-out of buildings and associated utilities Lay-out of premises, including workspace and employee facilities Supplies of air, water, energy and other utilities Supporting services, including waste and sewage disposal S The suitability of equipment and its accessibility for cleaning, maintenance and preventative maintenance Management of suppliers and purchased materials (7.2.3) Storage, transportation and handling (including allergen handling) Measures for prevention of cross contamination Cleaning and sanitation Pest P t control t l Personal hygiene & training Other aspects as appropriate Document should specify how activities included in the PRP(s) are managed
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SOP or SSOP or WI

A standardized way of describing how specific tasks are y g p performed and monitored can be referred as SOP, SSOP or WI SOP: Standard Operating Procedure SSOP: Sanitation Standard Operating procedure is a procedure for sanitation WI: Work Instruction

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Document (SOP/SSOP/WI)
Benefits:

Improved consistency of implementation Efficiency (save time/money) Easier to train, understand and use Easier to monitor and verify Standardized St d di d Easier to demonstrate compliance to regulations or conformance to standards

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Sample SOP in Chart Format

(1) CCP, Operational PRP or PRP task (2) HAZARD (3) ACTION REQUIRED TO CONTROL HAZARD (4) (5) (6) (7) PROCEDURE FOR TASK & MONITORING (8) DEVIATION PROCEDURES (9) VERIFICATION (10) RECORDS

WHAT

WHO

WHEN

HOW

(CA = corrective action)

Cleaning

Dust, path,ba ct

Normal water, cl2 water, hot water etc

Cl2 conc, water temp

Clea ning super visor

Every time of cleanin g

Visua l

Again clean and training

SWAB test

Daily cleaning records, SWAB test report, training records

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7.0 Planning and realization of safe products (2) 7.3 Preliminary steps to enable hazard analysis
7.3.1 General: Relevant information needed and maintained records 7.3.2 Food safety team 7.3.3 Product characteristics raw & end (see examples) 7.3.4 7 3 4 Intended use 7.3.5 Flow diagram, Des. process steps and control measures

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Seven Principles of HACCP (fully contained within ISO 22000)

Conduct a hazard analysis & identify control measures for each hazard Identify critical control points (CCP) Establish critical limits Monitor each CCP Establish corrective actions for critical limit deviations Establish a record keeping system Establish verification procedures

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7.0 Planning and realization of safe products (3) 7.4 Hazard Analysis
7.4.1 General: F d S f t team shall conduct a 741 G l Food Safety t h ll d t hazard analysis 7.4.2 Hazard identification and determination of acceptable level 7.4.3 Hazard assessment 7.4.4 Selection and assessment of control measure

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Hazard analysis procedure Hazard identification

List all hazards that are reasonably expected to occur Describe the hazards Define acceptable levels for each hazard (if possible)

Hazard assessment

Assess severity and likelihood of occurrence to identify Significant hazards Select and describe control measures Validate control measures Categorize control measures
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Hazard assessment
Each potential hazard should be assessed if it is significant based on its its severity of health effects and likelihood of occurrence Table should be used as guidance only and other factors as nature and source of the hazard must also be taken into account
Can cause fatality A

Sever of health effects rity

Can lead to serious illness

Significant hazards
Can cause illness C

Controlled by OPRPs or HACCP/CCP

Can cause inconvenience

Almost of no significance

Not significant hazards Controlled by PRPs or may not need to be controlled

1 Unlikely 2 Rare 3 Could occur 4 Likely 5 Frequent

Likelihood of occurrence
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Hazard Analysis Form one format

(1) Ingredient or Process Step (2) Identify Potential Hazards Introduced, Controlled or Enhanced at this step (3) Are any potential hazards significant ? Yes/No* (4) Justify your decision for column 3 (5) What preventative or control measure(s) can be applied to prevent or control the significant hazard(s)? (6) Is this step a Critical Control Point? Yes/No (Use Table)

BULK RECEIVING & INGREDIENT PURCHASING

BIOLOGICAL: PROHIBITED MAT., SALM. MOULD RODENTS/INSECTS CHEMICAL: WRONG MED. IN BAG, PESTICIDE CONTAMINATION (GRAIN), CROSS CONTAMINATION MEDS IN BULK BINS, MYCOTOXINS PHYSICAL: FM

POOR PRACTICES, UNHYGIENIC CONDITIONS SAMPLING/TESTING OF GRAINS; SUPPLIER CERT.

SOP CLEANING & HIUSE KEEPING

NOT TRANSMISSIBLE THROUGH ANIMAL

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Hazard assessment Form one format

Examples of How the Stages of Hazard Analysis are used to Identify and Evaluate Hazards* Hazard Analysis Stage Stage 1 Determine potential Hazard hazards associated Identification with product Stage 2 Hazard Evaluation Assess severity of health consequences if potential hazard is not properly controlled. Frozen cooked beef patties produced in a manufacturing plant Enteric pathogens (i.e., E. coli O157:H7 and Salmonella) Epidemiological evidence indicates that these pathogens cause severe health effects including death among children and elderly. Undercooked beef patties have been linked to disease from these pathogens. E. coli O157:H7 is of very low probability and salmonellae is of moderate probability in raw meat. Product containing eggs prepared for foodservice Salmonella in finished product. Commercial frozen pre-cooked, boned chicken for further processing Staphylococcus aureus in finished product. Certain strains of S. aureus produce an enterotoxin which can cause a moderate foodborne illness.

Salmonellosis is a food borne infection causing a moderate to severe illness that can be caused by ingestion of only a few cells of Salmonella. Product is made with liquid eggs which have been associated with past outbreaks of salmonellosis. Recent problems with Salmonella serotype Enteritidis in eggs cause increased concern. Probability of Salmonella in raw eggs cannot be ruled out. If not effectively controlled, some consumers are likely to be exposed to Salmonella from this food. HACCP team determines that if the potential hazard is not properly controlled, consumption of product is likely to result in an unacceptable health risk. Hazard must be addressed in the plan.

Determine likelihood of occurrence of potential hazard if not properly controlled.

Product may be contaminated with S. aureus due to human handling during boning of cooked chicken. Enterotoxin capable of causing illness will only occur as S. aureus multiplies to about 1,000,000/g. Operating procedures during boning and subsequent freezing prevent growth of S. aureus, thus the potential for enterotoxin formation is very low. The HACCP team determines that the potential for enterotoxin formation is very low. However, it is still desirable to keep the initial number of S. aureus organisms low. Employee practices that minimize contamination, rapid carbon dioxide freezing and handling instructions have been adequate to control this potential hazard. Potential hazard does not need to be addressed in plan.

Using information above, determine if this potential hazard is to be addressed in the HACCP plan.

The HACCP team decides that enteric pathogens are hazards for this product. Hazards must be addressed in the plan.

* For illustrative purposes only. The potential hazards identified may not be the only hazards associated with the products listed. The responses may be different for different establishments.

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7.0 Planning and realization of safe products (4) 7.5 Establishing the operational Prerequisite Programs (PRPs)
What is an operational prerequisite program? OPRPs are PRPs that are essential because the hazard analysis has shown that they are necessary in order to control specific food safety hazards OPRPs are used to reduce the likelihood that products and/or the processing environment will be exposed to hazards, will be contaminated, and that hazards will proliferate.

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Operational prerequisite programs (OPRPs) OPRPs have the following characteristics: They are usually product specific (as opposed to PRPs which are general for the whole factory) They prevent or control specific food safety hazards (identified in the hazard analysis) They are often applied prior to production (preparation for production) They control significant hazards which are not managed by the HACCP plan (CCPs) If there is a loss of control of OPRPs, products affected shall be identified and consequences on food safety evaluated
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Operational prerequisite programs (OPRPs)

Are OPRPs something new? We have been applied the concept of OPRPs since long (they are managed as CPs in the HACCP) These are the PRPs/GMPs identified in the HACCP study as measures for controlling a specific hazard (not managed by the HACCP plan) Monitoring has been by CPs in the HACCP

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Operational prerequisite programs (OPRPs)

ISO 22000 requires documentation of OPRPs Describe the hazard and the control measure What should be monitored and when Actions to take if the monitoring shows that the control measure is out of control Define a verification procedure Responsibilities The ff Th effect of OPRPs must be validated f OPRP b lid d As for CCPs, monitoring of OPRPs are included in the FSMS If there is a loss of control, products shall be identified and consequences for food safety evaluated
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Critical Control Points (CCPs)

What is a Critical Control Point? A step at which control can b applied and i essential t t t hi h t l be li d d is ti l to prevent or eliminate a food safety hazard or reduce it to an acceptable level CCPs are identified in the HACCP study When a critical limit at a CCP is violated, the product must be considered as potentially unsafe and must be blocked

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OPRP or CCP (HACCP plan)?

A decision tree has been developed to assist in the categorization of control measures Distinction is mainly based on its place in the system the possibility to establish critical limits whether corrections can be taken immediately when there is a loss of control

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Audit Report : a note on ISO 22K

Presence, validity and management of CCPs A list of all Critical Control Points should be presented listing all audited CCPs with a statement that they are correctly identified and managed Presence, validity and management of OPRPs A list of all Operational Prerequisite Programs should be presented listing all audited OPRPs with a statement that they are correctly identified and managed Presence, validity and management of PRPs The Prerequisite Programs audited need to be listed with a statement that they are correctly identified and managed

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Decision tree (1)

Answer each question for each hazard and step in the process. Q1 refers to the outcome of the hazard assessment. Q2 Q5 is used to categorize control measures, according to whether they are managed by an OPRP or in the HACCP plan at CCPs.
Q1: Based on the likelihood of occurrence (before applying the control measure) and the severity of adverse health effects, is this hazard significant (needs to be controlled)? YES Q2: Will a subsequent step ( incl. expected use by consumer) guarantee the removal of this significant hazard, or its reduction to an acceptable level? This hazard is not significant. Justify the decision, e.g. PRP, specification or MAD (Major Allergen Declaration) is in place.

NO

YES

Identify and name subsequent step.

NO Q3: Are control measures or practices in place at this step, and do they exclude, reduce or maintain this significant hazard to/at an acceptable level? YES

NO

Modify the process or the product and return to Q1.

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Decision tree (2)

Answer each question for each hazard and step in the process. Q1 refers to the outcome of the hazard assessment. Q2 Q5 is used to categorize control measures, according to whether they are managed by an OPRP or in the HACCP plan at CCPs.

YES Q4: Is it possible to establish critical limits for the control measure at this step? YES

NO

Q5: Is it possible to monitor the control measure in such a way that corrective actions can be taken immediately when there is a loss of control?

NO

YES This hazard is managed by the HACCP plan (CCP). This hazard is managed by an OPRP.

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Examples of control measures that may be managed through OPRPs

Hazard Salmonella Increase during transport of raw meat. Control measure Chilled temperature transport of raw meat. Monitoring Temperature measurement at reception for each delivery Verification Microbiological test, for example once per week.

Listeria monocytogenes Re-contamination of refrigerated ready-to-eat product.

Controlled wet cleaning of critical equipment

Visual inspection of zoning and cleaning.

Pathogen (Listeria) monitoring. Microbiological test of end product.

Metal shavings Rovema filler

Visual checks to prevent metalto-metal contact in filling tube

Inspect straightness and concentricity of the auger screw

Inspect at regular intervals that surfaces in filling tube and auger screw are smooth

CaCl2 Leakage of cooling brine into ice cream

Regular maintenance of moulds.

Leak test with colorant.

Sensory test of end product.

Salmonella or other pathogen. Recontamination of cereal from condensation.

Prevent the occurrence of condensation in dry process part in connection with food

Visual inspection for signs of condensation.

Microbial testing of first powder being filled (line samples).

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PRP, OPRP or CCP? Pest Control Cl2 conc in can cooling waters conc. Sanitation/CIP Pasteurization Sanitation for an allergen c/o Checking seals on incoming loads Raw Material Monitoring for S Preheater Section of HTST Metal Detection
PRP PRP PRP PRP PRP PRP PRP PRP PRP oPRP oPRP oPRP oPRP oPRP oPRP oPRP oPRP oPRP CCP CCP CCP CCP CCP CCP CCP CCP CCP
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7.0 Planning and realization of safe products (5)

7.6 Establishing the HACCP Plan 7.6.1 HACCP Plan - documented for each CCP
Food safety hazards to be controlled Control measures Critical limits Monitoring procedures Actions to be taken if critical limits are exceeded Responsibility for monitoring Records of monitoring

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HACCP Plan
Example: Market Milk Process HACCP Table Step / Input: Cooking
Principle 1
Step/input Hazard CM (6)

P2
CCP/CQP/ CP/QP (7)

P3
CL (8)

P4
Monitoring (9) What Wher e Ho w When Who

P5
CA What & Who Wh (10)

P6
Verificati on Who Wh & when (11)

P7
Records (12)

Pasteurizat ion

Enzyme and Pathogenic Bact

Time and Temp of pasteurizer

CCP

72 Deg C and 3 sec

Time & temp

Past.

Sto p wat ch & tm

30min interval

QCO

Repasteurizer or rejected

Lab test and calibration

Log book on past unit and QCO record, CCP monitoring etc

Metal Detector

F. Metal at Baby Cloth

Online monitoring in against of req.

CCP

FE-1mm Non Fe-1.5 mm

Metal or foreign particle

MD

Tes t kits

1 hr interval

Maint.

Hold and re-check then reject for sale

Maint inchrage, monitoring & calibration records a

Log book, yearly calibration on standard one

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7.0 Planning and realization of safe products (6)

7.7 Updating preliminary information and documents related to prerequisite programs and FSMS procedures 7.8 7.9 Verification planning Traceability system 7.10.1 Correction 7.10.2 Corrective action 7.10.3 Handling of potentially unsafe product (Release & Disposition) 7.10.4 Withdrawals (top management shall appoint personnel)
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7.10 Control of nonconformity

FSMS Procedures Form

(1) CCP STEP (#)

(2) HAZARD

(3) CRITICAL LIMIT TO CONTROL

(4)

(5) (6) MONITORING

(7)

(8) DEVIATION PROCEDURES

(9) VERIFICATION

(10) RECORDS

WHAT

WHO

WHEN

HOW

(CA = corrective action)

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OPRP Programme

(1) OPRP STEP (#)

(2) HAZARD

(3) CONTROL Limit

(4) (5) MONITORING

(6)

(7)

(8) DEVIATION PROCEDURES

(9) VERIFICATION

(10) RECORDS

WHAT

WHO

WHEN

HOW

(CA = corrective action)

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Requirements of ISO 22000 Standard- Clauses 5 Management Responsibility

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8.0 Validation, verification & improvement of the food safety management system
8.1 General: plan and implement
Processes for validation of control measures and verification and improvement of the system planned. Prior to implementation and after any change validate that:
control measures are capable of achieving intended control of hazards control measures are effective in obtaining end products that meet acceptance levels.

8.2 Validation of control measure combinations

If negative: modification and reassessment of control measures. Changes include: process parameters, raw materials, manufacturing technology, end product characteristics, distribution method and/or intended use.
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8.0 Validation, verification & improvement of the food safety management system (2)
8.3 Control of monitoring and measuring
Monitoring and measuring methods and equipment must be adequate. Ensure equipment and methods (including critical software programs) are:
calibrated or verified to traceable standards adjusted and re-adjusted identified to enable calibration status to be determined, safeguarded from adjustments which might invalidate measurement results (e.g. lock out switches) (e g protected from damage and deterioration

Records maintained Reassessment of validity of previous measurement when equipment is nonconformant to requirements. Ability of software used in monitoring confirmed prior to use and recorded.
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8.0 Validation, verification & improvement of the food safety management system (3)
8.4 Food safety management system verification
8.4.1 Internal audit: Conducted at planned intervals to verify that the FSMS system:
conforms to planned arrangements is effectively implemented and updated

Plan considers importance of processes and areas and results from previous audits Audit criteria, scope, frequency and methods defined Auditors independent of tasks audited Documented procedure for planning conducting reporting and recording audits Prompt actions taken to correct non-conformities and their causes by management responsible for area.

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8.0 Validation, verification & improvement of the food safety management system (4)
8.4 Food safety management system verification 8.4.2 Evaluation f individual 8 4 2 E l ti of i di id l verification result ifi ti lt
Evaluation of results of planned verification by food safety team Action in case of nonconformity including review of:
procedures and communication channels conclusions of hazard analysis, operational PRPs and the FSMS procedures p The PRPs Effectiveness of managing personnel and training activities

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8.0 Validation, verification & improvement of the food safety management system (5)
8.4 Food safety management system verification 8.4.3 Analysis of results of verification activities
Results of verification activities, including internal and external audits analysed, recorded and reported to top management as input for management review and updating the system.

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8.0 Validation, verification and improvement of the food safety management system (6)
8.5 Improvement 8.5.1 Continual improvement 8 5 1 C ti li t
Top management must ensure continual improvement of the effectiveness of the FSMS through use of:
communication (see 5.6) management review (see 5.8) internal audit (see 8.3.1) evaluation of individual verification results (see 8.3.2) ( ) analysis of verification activities (see 8.3.3) validation of control measure combinations (see 8.4) food safety management system updating (see 8.5.2)

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8.0 Validation, verification and improvement of the food safety management system (7)
8.5 Improvement 8.5.2 Food safety management system updating
Top management to ensure that the FSMS is updated in a timely manner to ensure food safety Evaluation of system must be performed by food safety team at planned intervals to consider review of hazard analysis, operational PRP and FSMS procedures Evaluation and updates based on:
inputs from communication (internal and external) other inputs concerning suitability adequacy and effectiveness of the system output of verification activities output of the management review

System updating activities recorded and reported as inputs to the management review.
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