Professional Documents
Culture Documents
ISO22K
ISO22K
Lecture 3
Retailers
Consumers
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.
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
10
12
13
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?
14
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
15
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
16
18
20
21
22
23
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
24
Feedback of Workshop-01
25
Requirements of ISO 22000 Standard - Clauses 7 Planning and Realization of Safe Products (see another HACCP)
26
27
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)
Product realization
Product control
Product realization
28
PLAN-DO-CHECK-ACT SCHEMATIC
Requirement q
Plan
Do
Check
Conformity
Yes
29
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
30
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
31
Micro-organisms
1 hour
OO OO OO OO To grow properly, micro-organisms need: Available food, proper pH, Temperature, Time, Suitable atmosphere, Moisture (Aw)
32
Include harmful
Bacteria Moulds Viruses Protozoa
33
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
34
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
35
Growth requirements
* Requires oxygen,** growth either with or without oxygen, *** requires the absence of oxygen
http://www.cfsan.fda.gov
Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (Bad Bug Book) Bacterial Pathogen Growth and Inactivation
36
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
37
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
38
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
39
40
Nutritional Additives
Vitamins can be toxic
41
Toxic substances
eg. Lead: Zinc: Arsenic: Mercury: Cyanide
Secondary chemicals
eg. Lubricants: Cleaning compounds: Sanitizers: Paint
42
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
43
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
44
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
46
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
47
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
48
WHAT
WHO
WHEN
HOW
Cleaning
Dust, path,ba ct
Visua l
SWAB test
49
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
50
51
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
52
Hazard assessment
Assess severity and likelihood of occurrence to identify Significant hazards Select and describe control measures Validate control measures Categorize control measures
53
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
Significant hazards
Can cause illness C
Almost of no significance
Likelihood of occurrence
54
BIOLOGICAL: PROHIBITED MAT., SALM. MOULD RODENTS/INSECTS CHEMICAL: WRONG MED. IN BAG, PESTICIDE CONTAMINATION (GRAIN), CROSS CONTAMINATION MEDS IN BULK BINS, MYCOTOXINS PHYSICAL: FM
55
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.
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.
56
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.
57
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
58
59
61
62
63
NO
YES
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
64
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.
65
Inspect at regular intervals that surfaces in filling tube and auger screw are smooth
Prevent the occurrence of condensation in dry process part in connection with food
66
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
67
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
68
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
CCP
Past.
30min interval
QCO
Repasteurizer or rejected
Log book on past unit and QCO record, CCP monitoring etc
Metal Detector
CCP
MD
Tes t kits
1 hr interval
Maint.
69
(2) HAZARD
(4)
(7)
(9) VERIFICATION
(10) RECORDS
WHAT
WHO
WHEN
HOW
71
OPRP Programme
(2) HAZARD
(6)
(7)
(9) VERIFICATION
(10) RECORDS
WHAT
WHO
WHEN
HOW
72
73
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.
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.
74
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.
75
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.
76
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
77
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.
78
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)
79
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.
80