Pre-Requisite Programs (PRP) & Critical Control Points (CCP)
Short Description
ISO 22000 PRP manual...
Description
STANDARD MALAYSIA – CERTIFICATION BODY FORUM 19 June 2012
Pre-Requisite Programs (PRP) and Critical Control Points (CCP)
Zahara Merican
Presentation Guide Introduction Pre-Requisite Program – PRP PRPs & oPRPs Critical Control Point (CCP) & Its Determination Summary Zahara Merican
2
Introduction
FOOD SAFETY PLAN
=
PRP/support programs (GMP, SOP, SSOP, etc.) +
HACCP + Effective training
Zahara Merican
3
HACCP = Hazard Analysis & Critical Control Point A system that identifies, evaluates & emphasize controls of hazards which are significant for food safety Other hazards are controlled under GHP/GMP (PRP) Identifies specific hazards & preventive measures for their control Consists of seven principles Zahara Merican
4
FOOD SAFETY MANAGEMENT SYSTEM PRP (GMP/GHP)
HACCP PRINCIPLES
• Design & facilities • Control of operation • Maintenance & sanitation • Personal hygiene • Transportation • Product information & consumer awareness • Training
1.Conduct hazard analysis 2.Determine Critical Control Points (CCP) 3.Establish critical limit(s) 4.Establish monitoring system 5.Establish corrective actions 6.Establish verification procedures 7.Establish documentation & records
Zahara Merican
5
References: Malaysian standards MS 1480:2007 Food safety according to HACCP MS 1514: 2009 Good Manufacturing Practices (GMP) Equivalent: Codex Food Hygiene Basic Text, Rev. 2003 Others: o ISO 22000: 2005 Food Safety Mgt Systems – Requirements for any organization in the food chain o USFDA cGMP Regulations & specific HACCP regulations o EU – legislations on Hygiene of Foodstuff, and specifics for different food products Zahara Merican
6
PRE-REQUISITE PROGRAMS (PRP)
Zahara Merican
7
PRE-REQUISITES TO HACCP Establishment is legal - food premises must be registered Operate according to relevant by-laws Products comply with appropriate regulatory requirements such as: Food Act 1983: Food Regulations 1985; Food Hygiene 2009; etc. mandatory codes of hygienic practice Products comply with: customer/importer requirements Zahara Merican
8
Prerequisites to HACCP (PRP) Practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety as described in the Codex General Principles of Food Hygiene and other Codes of Practice
Zahara Merican
9
PRPs provide foundation for effective HACCP Implementation Developed, documented and implemented before implementing HACCP Required to control factors that may or may not be directly related to the manufacturing controls, but support the HACCP Plans
Zahara Merican
10
PRP Required conditions can be achieved through: • Good Manufacturing Practices (GMP) / Good Hygienic Practices (GHP) • Sanitation Standard Operating Procedures (SSOP) Coverage depends on : regulatory requirement size of business types of product Zahara Merican
11
PRP and operational PRPs • PRP
• Operational PRP
Basic food safety conditions and activities that are necessary to maintain a hygienic environment throughout the food chain suitable for the production, handling and provision of safe end products and safe food for human consumption
Measures identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazards and/or contamination or proliferation of food safety hazards in the product(s) or in the processing environment
Ref: ISO 22000: 2005 Zahara Merican
12
SSOP – USFDA REGULATIONS Safety of water –
contact with food, food contact surfaces, or used as ice
Condition & cleanliness of food contact surfaces –
including utensils, gloves, and outer garments
Prevention of cross contamination – –
from insanitary objects to food / food contact surfaces from raw product to cooked product
Maintenance of sanitary facilities – hand washing, hand sanitizing, and toilet
Protection of food from adulteration Proper labeling, storage and use of toxic compound Control of employee health condition Exclusion of pests from the food plant Zahara Merican
13
CLEANING AND SANITATION An effective cleaning and sanitation program is important to minimize food contamination Need to consider (SSOP): • what to clean • how to clean • when to clean, and • who will clean
Need to have appropriate equipment cleaning and sanitizing facilities Cleaning of cleaning facilities/implements shall be documented & implemented Zahara Merican
14
PERSONNEL HYGIENE – what active records are needed – which needs to be filled in every shift, every day, etc. • Hygiene and health requirements • Communicable diseases & Injuries • Attire and conduct of workers • Policy on visitors Zahara Merican
15
CHEMICAL CONTROL Documented procedures in place to ensure segregation, storage and proper use and control of non-food chemicals in the plant. Includes cleaning chemicals, fumigants, baits, etc. Chemical safety data sheets available Chemicals should be: • correctly labeled including containers for mixing • stored in designated and well ventilated area, hazardous chemicals under lock • protected from cross-contamination with food or food contact surfaces or packaging material • dispensed and handled by trained and authorized staff with procedures for receiving & issuing in place > records Zahara Merican
16
PEST CONTROL PRP
oPRP
• Pests include birds, rodents, cockroaches, flies and other insects • Effective and continuous pest control program in place prevent entry of pests elimination of breeding grounds of pests if using chemicals, get expert advice
• In-house monitoring activities – – – – –
What How Who Frequency CA
• External service provider monitoring activities
Zahara Merican
17
WASTE MANAGEMENT • Solid and liquid waste disposal – SSOP – Schedule of waste disposal from processing area and from plant – Drains to have proper flow & traps for solids • Proper covering of waste disposal containers, including those in the processing area • Cleaning of waste containers & • Central waste collection bins – away from processing area • Discharge must comply with DOE requirements Zahara Merican
18
SPECIFICATIONS • Written specifications for raw (including origin) and packaging materials and finished products • Based on regulations, standards, scientific references or own experiments Ensure raw materials meet company’s requirements Prevent / reduce hazards in raw materials Prevent unsuitable raw materials being used in production Ensure uniform products Contribute to HACCP implementation, e.g. reduce cost of analysis, etc. Meet regulatory requirements Meet customer’s requirements Zahara Merican
19
RECALL AND TRACEABILITY • Documentation of recall procedure and traceability system in place to ensure complete and rapid recall of affected lot • Do a mock recall to evaluate effectiveness • Able to trace up & down
CUSTOMER COMPLAINTS • Documented procedure for customer complaints (including auditing) • Records of complaints and actions taken. Use as feed back • Returned products isolated & appropriate action taken (destroyed, reworked or reprocessed)
X
Zahara Merican 20
Maintenance of PRP • Maintenance is essential to ensure continuous control of favourable operational conditions • The premises & equipment should be kept in good state of repair • Sanitation control should be monitored for their suitability & verified for effectiveness Good record keeping to provide evidence on continuous adherence to sanitation control Zahara Merican
21
GENERAL REQUIREMENTS All PRPs should be: - Documented (including plant lay-out for materials, equipment, workers amenities, footbaths, bait stations) - Monitored and records/checklists kept - Corrective actions taken and documented - Records and CA verified - PRPs maintained & verified where applicable, e.g. hygiene & sanitation, raw materials, clean rooms - Use results to update and improve PRPs if necessary - Reviewed before implementing HACCP Plan, to verify if all requirements have been met, and if all the necessary controls and documentation are in place Zahara Merican
22
CRITICAL CONTROL POINT & ITS DETERMINATION
Zahara Merican
23
Critical Control Point A step in the food chain where activities are carried out, or conditions prevail which can have an influence on the safety of the product, and where control can be exercised over one or more factors to prevent or eliminate a food safety hazard or reduce it to an acceptable level Zahara Merican
24
Critical Control Point (CCP) HACCP Principle 2 • CCPs are points, procedures or operational steps in the process that can be controlled to prevent or eliminate the hazard, or minimize the likelihood of its occurrence • CCPs are determined through thorough knowledge & expert judgment of team members (& specialist advisor) in Principle 1
Zahara Merican
25
PRINCIPLE 1 Conduct a hazard analysis • Prepare a list of steps of the plants’ processes • Identify where significant hazards could occur – Also identifies all possible hazards
• Describe the control/preventive measures – At all identified steps – Controlled under HACCP or PRP
Zahara Merican
26
Hazard Analysis - definition The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and should be addressed in the HACCP plan
Zahara Merican
27
Hazard Analysis • A thorough hazard analysis is the key to preparing an effective HACCP plan • When conducting a hazard analysis, safety concerns must be differentiated from quality concerns • Hazard analysis & identification of associated control measures accomplish three objectives: – Those hazards and associated control measures are identified – The analysis may identify needed modifications to a process or product so that product safety is further assured or improved – The analysis provides a basis for determining CCPs in Principle 2 Zahara Merican
28
hazard analysis involves two stages: hazard identification & hazard evaluation 1. Hazard identification –
Consider all potentially significant hazards
–
Assess likelihood of occurrence of the hazards
2. Hazard evaluation – assess severity of the hazard Use flow diagram that has been verified identify preventive measures for their control Zahara Merican
29
significant hazards = likelihood x severity reasonably likely to occur
Zahara Merican
likely to result in an unacceptable risk to consumers
30
hazards that are reasonably likely to occur Decision is based on: – Experience – Illness data – Scientific reports – Other information (e.g., Hazards and Control Guide)
Zahara Merican
31
Hazard-Analysis Worksheet • Set up the hazard-analysis worksheet • Identify the potential species-related hazards • Identify the potential process-related hazards • Complete the hazard-analysis worksheet • Understand the potential hazard • Determine if the potential hazard is significant • Identify the critical control points • (Identify the oPRPs) Zahara Merican
32
HAZARD ANALYSIS WORKSHEET (MS 1480) 1
Process Step
2
Potential hazard State whether B, C or P
3
4
Rational for inclusion or exclusion as a hazard
5
What preventive measure Is this a or control significant can be hazard? applied to prevent (Yes / No) this significant hazard?
6
Is this step a critical control point? (Yes / No)
B= CCP 1 C =
P=
Zahara Merican
33
Control Measures • Actions and activities that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level • Control measures must be validated for effectiveness • Column 5 on Hazard-Analysis Worksheet
Zahara Merican
34
Hazard Analysis Worksheet 1
Process Step
Example 1. Receiving of semi-process raw soya sauce
2
Potential hazard1 State whether B, C or P
3
Rational for inclusion or exclusion as a hazard
4
5
Is this a significant hazard? (Yes / No)
What preventive measure or control can be applied to prevent this significant hazard?
Biological
In / Ex: justify
Chemical
In / Ex: justify
Physical
In / Ex: justify
2B:
Pathogens: S aureus
In: Likely to occur
3C:
Ex: Strict control of suppliers under Approved Supplier Program
(Leave Blank)
Testing every 6 months to ensure compliance. PRP #5 Chemical Analysis Records
(Leave Blank)
(Leave Blank)
(Leave Blank)
3 MCPD (3-
chloro-1,2propanediol)
4P:
None
Yes
based on historical data
Zahara Merican
Control water activity below (aw) 0.75; salt content above 20%.
6 Is this step a CCP?5 (Yes/No)
No
35
PRP or CCP? How to know if the hazard is to be controlled under PRP or HACCP
Zahara Merican
36
Hazard Analysis Worksheet - Explanation 1
Process Step
2
Potential hazard1 State whether B, C or P
3
Rational for inclusion or exclusion as a hazard
4
5
Is this a significa nt hazard? (Yes / No)
What preventive measure or control can be applied to prevent this significant hazard?
6
Is this step a CCP?5 (Yes /No)
1
Identify potential food safety hazards introduced, controlled or enhanced at this step. Do not carry the hazard through subsequent steps 5Column
6 will be answered yes only if the step in column 1 is a critical control point. The control measure is applied at that step Zahara Merican
37
Hazard Analysis Worksheet - Explanation 1
Process Step
Example 1. Receiving of semiprocess raw soya sauce
2 Potential hazard1 State whether B, C or P 2B:
3
4
Is this a significant Rational for hazard? inclusion or (Yes / exclusion as a No) hazard
In: Likely to
Pathogen: occur based S aureus on historical data
Yes
5
6
What preventive measure or control can be applied to prevent this significant hazard?
Is this step a CCP?5 (Yes /No)
Control water activity below (aw) 0.75; salt content above 20%.
No
2
If the group identifies a potential hazard in column 2, and is “Inclusion”, justification is required in column 3. This justification normally includes the scientific, regulatory, or historical reasons for the decision. A control measure is required in column 5. The group then determines whether the hazard is significant using the hazard matrix (Y/N in column 4) Zahara Merican
38
Hazard Analysis Worksheet - Explanation 1
Process Step
Example 1. Receiving of semiprocess raw soya sauce
2 Potential hazard1 State whether B, C or P
3C:
3 MCPD (3chloro1,2propanedi ol)
3 Rational for inclusion or exclusion as a hazard
Ex: Strict control of suppliers under Approved Supplier Program
4
5
Is this a significant hazard? (Yes / No)
What preventive measure or control can be applied to prevent this significant hazard?
(Leave Blank)
6 Is this step a CCP?5 (Yes/No)
Testing every 6 months to ensure compliance. PRP #5 Chemical Analysis Records
3
If the group identifies a potential hazard in column 2, & is “Exclusion”, justification is required in column 3. This justification normally includes PRP or procedures that manage the hazard to ensure that this step is not necessary to be controlled under HACCP. A control measure is required in column 5. Column 4 will be left blank 39
Zahara Merican
Hazard Analysis Worksheet - Explanation 1
Process Step
Example 1. Receiving of semiprocess raw soya sauce
2 Potential hazard1 State whether B, C or P
4P:
None
3
4
5
Rational for inclusion or exclusion as a hazard
Is this a significant hazard? (Yes / No)
What preventive measure or control can be applied to prevent this significant hazard?
(Leave Blank)
(Leave Blank)
(Leave Blank)
6 Is this step a CCP?5 (Yes/No)
4If
the group does not identify a potential hazard in column 2, then columns 3, 4 and 5 will be blank
Zahara Merican
40
More examples – safety alone is not sufficient 1 Process Step
1. Pasturization (soy sauce)
2
3
4
5
6
Potential hazard1 State whether B, C or P
Rational for inclusion or exclusion as a hazard
Is this a significant hazard? (Yes / No)
What preventive measure or control can be applied to prevent this significant hazard?
Is this step a CCP?5 (Yes/No)
B: 1. S aureus
Inc. Known to occur due to x cont’n from fd handler
2. A. oryzae
Exc. Quality issue (Inc.)* Exc. Quality issue (Inc)*
3. Film yeast
No
(Yes)* (Yes)*
- Testing of fd handlers every 3 months to ensure not a carrier, oPRP #7. * - Fd handlers hygiene in place. No/Yes SOP 1 Ensure time-To met Ensure time-To met
C: Nil P: Nil
* No – technically correct, but need Yes to control spoilage, so its CCP Zahara Merican
41
More examples 1 Process Step
2
3
4
5
6
Potential hazard1 State whether B, C or P
Rational for inclusion or exclusion as a hazard
Is this a significant hazard? (Yes / No)
What preventive measure or control can be applied to prevent this significant hazard?
Is this step a CCP?5 (Yes/No)
2. Pasturi- B: zation Salmonella (milk) Brucella, S. aureus
Inc. Known to occur in milk
Yes
Ensure time-To to destroy pathogens met (>65oC, >15min)
Yes
C: Nil P: Nil
Zahara Merican
42
More examples 1
Process Step
2 Potential hazard1 State whether B, C or P
3. Washing B: E coli, S. aureus, of hands Salmonella (bakery/ catering/ restaurant)
C: free chlorine
P: Nil
3
4
Is this a Rational for significant inclusion or hazard? exclusion as a (Yes / No) hazard
Inc: Happen ned before. Likely to occur from fd handlers hands
Yes
Exc: Residue validated for SOP
-
-
Zahara Merican
-
5 What preventive measure or control can be applied to prevent this significant hazard?
1. Ensure fd handlers wash & sanitize hands every h 2. Fd handlers undergo medical check every 6 month to isolate carriers Ensure correct amount used, strict adherence to SOP -
6 Is this step a CCP?5 (Yes /No)
Yes
43
HAZARD ANALYSIS WORKSHEET (US) FIRM NAME:
PRODUCT DESCRIPTION:
FIRM ADDRESS:
METHOD OF DISTRIBUTION AND STORAGE: INTENDED USE AND CONSUMER:
1
INGREDIENT/ PROCESSING STEP
2
3
IDENTIFY POTENTIAL B, C&P HAZARDS ASSOCIATED WITH THIS PRODUCT & PROCESS
ARE ANY POTENTIAL FOOD SAFETY HAZARDS SIGNIFICANT AT THIS STEP? (YES/NO)
4
JUSTIFY YOUR DECISION FOR COLUMN 3
Zahara Merican
5
6
WHAT PREVENTIVE MEASURE(S) CAN BE APPLIED FOR THE SIGNIFICANT HAZARDS?
IS THIS STEP A CRITICAL CONTROL POINT? (YES / NO)
44
Relationship between a significant hazard and a CCP • CCPs are steps in the process where HACCP control activities will occur • For every significant hazard identified during the hazard analysis (principle 1) there must be one or more CCPs where the hazard is controlled Zahara Merican
45
DETERMINING CCP • CCP - step where control can be applied & is essential to prevent, eliminate or reduce a food safety hazard to acceptable levels • CCPs can be determined through the Use of the CCP Decision Tree • Caution - CCP must be correctly identified – too many CCPs will dilute effort – too few could result in unsafe food
Zahara Merican
46
use of a CCP decision tree • Application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identified hazard • It is merely a tool and not a mandatory element of HACCP • A CCP decision tree is not a substitute for expert knowledge Zahara Merican
47
CCP Decision Tree (MS/Codex) Questions to be answered for each potential hazard for each step Q1. Are there preventive measure(s) for the identified hazard?
Modify process step, Process or product?
YES
YES
Is control at this step necessary for product safety?
NO
Q2. Is step specifically designed to eliminate or reduce likely occurrence of a hazard to an acceptable level?
NO
Not a CCP
STOP
YES
NO Q3. Could contamination occur at unaccept. levels or increase to unaccept. levels?
YES
NO
Not a CCP
YES Q4. Will a subsequent step eliminate or reduce hazard to an acceptable level?
NO
STOP
CCP
CCP DECISION TREE (US) Q1.
DOES THIS STEP INVOLVE A HAZARD OF SUFFICIENT RISK AND SEVERITY TO WARRENT ITS CONTROL?
YES
Q2.
NO
NOT A CCP
DOES CONTROL MEASURE FOR THE HAZARD EXIST AT THIS STEP?
YES
NO IS CONTROL AT THIS STEP NECESSARY FOR SAFETY?
Q3 Zahara Merican
NO
MODIFY THIS STEP, PROCESS OR PRODUCT
YES
NOT A CCP
STOP* 49
CCP DECISION TREE Q3.
IS CONTROL AT THIS STEP NECESSARY TO PREVENT, ELIMINATE OR REDUCE THE RISK OF THE HAZARD TO CONSUMERS?
YES
NO
NOT A CCP
STOP*
CCP
This decision tree is derived from one that was developed by the National Advisory Committee on Microbiological Criteria for Foods, USA 50 Zahara Merican
HAZARD A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect
Zahara Merican
51
SUMMARY HACCP is not a stand alone system depends on management commitment depends on a solid foundation of PRPs: GMP/ GHP; SSOPs & relevant codes of practice HACCP does not replace nor diminish PRP attention must be focused on basic hygienic practices before embarking on HACCP The effectiveness of PRP has to be assessed during the development & implementation of the HACCP Plan Zahara Merican
52
Pre-requisite Programs PRPs must be developed, documented and implemented They have to be effectively monitored and controlled, including proper record keeping, validation and verification They are required to control factors that may or may not be directly related to the processing controls, but support the HACCP Plan
Zahara Merican 53
CCP – HACCP Principle 2 determined from hazard analysis in Principle 1 Principle 1 – identifies hazards associated with food production at all stages from raw materials to point of consumption – The first most important step, wrong hazard analysis results in faulty HACCP plan – Identifies steps to be controlled as CCPs or oPRPs – Significant hazard = likelihood x severity – Identify control measures for hazard elimination/ reduction/ prevention in the HACCP Plan
Zahara Merican
54
Zahara Merican
55
View more...
Comments
