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HACCP Implementation Guide for Food Enterprises

Date:2013-08-16 14:30:45


Standard of Ministry of Health of P.R.C.
HACCP Implementation Guide for Food Enterprises

1.Preface
1.1 This guide stipulates the basic principle and practice instruction of Hazard Analysis and Critical Control Point (HACCP) to help food enterprises enhance the management level of food safety, guarantee the food sanitary quality and protect the interest of consumers. The HACCP shall be executed specifically according to the actual situation and concrete conditions for production and operation of food enterprises.
1.2 HACCP is applicable for the entire food supply chain from primary (raw material) production to final consumption. In addition, it shall be implemented on scientific basis of health hazard. The performance of HACCP also makes for governmental supervision over food safety and facilitating economic development by increasing credibility of food safety.
1.3 The successful implementation of HACCP requires full support and participation of the corporate management and working group. HACCP is compatible with quality management systems (such as ISO9000 Series) and is a systemic approach for controlling food safety under quality management systems.
1.4 Our country encourages all food enterprises to execute HACCP conscientiously, and instructs and appraises those acting under the HACCP management system.
2.HACCP Overview
In early 1960s, the American food manufacturers cooperated with American Space Program Planning Bureau to initially establish HACCP system. In 1993, the Codex Alimentarius Commission (CAC) recommended HACCP system as the most economic and efficient way to guarantee food safety.
HACCP is a food safety guarantee system that confirms the specific hazard and corresponding control measure in scientific and systematic way. The control system of HACCP focuses on prevention other than ensuring the food safety by finished product inspection. Any HACCP system can adapt to the innovation of equipment design and development & alteration of processing engineering or technology. HACCP is a simple, convenient, easy to implement, reasonable and efficient control system suitable for all food enterprises.
3.Definition 
Terms and definitions involved in this guide are listed as below:
3.1 Hazard Analysis: A process that collects and evaluates relevant hazards and materials leading to the hazards to confirm which hazard has material impact on food safety and shall be solved in the HACCP plan.
3.2 Critical Control Point, CCP: Steps of implementing control measures. The steps are very critical for preventing and removing the food safety hazard or diminishing the hazard to acceptable level.
3.3 Prerequisite Programs: Provide basic practice rules for implementing HACCP system, including good manufacture practice (GMP) and sanitation standard operating procedure (SSOP) etc..
3.4 Good Manufacture Practice (referred to as GMP for short): A series of measures, approaches and technical requirements through a whole process of food production in order to the food safety and quality. It requires the food manufacturers having good production equipments, reasonable production process, perfect quality management and strict test system, so as to ensure the finished products meet the quality standard.
3.5 Sanitation Standard Operating Procedure (referred to as SSOP for short): The practice rules that the food manufacturers shall abide by in food processing in order to guarantee the food sanitary quality, specifically including water quality safety, condition and cleaning of food contact surfaces, cross contamination prevention, hand washing sterilization and maintenance of restroom’s facilities, adulterant prevention, marking, storage and use of toxic chemicals, health condition of employees and killing and control of insects and murine.
3.6 HACCP Team: A working team responsible for making HACCP plan.
3.7 Flow Diagram: A continuous description of all steps for one specific process of food processing or production.
3.8 Hazard: Biological, chemical or physical factors or conditions that form potential harm to health.
3.9 Significant Hazard: The hazard that is likely to happen and can not be accepted by consumers; there is the possibility and severity of happening.
3.10 HACCP Plan: A set of documents compiled on the basis of HACCP principle, which is used to control the hazards closely related to food safety possibly incurred on any stage of food supply chain ranging from food production, processing and sale.
3.11 Step: One point, one procedure, one operation or one stage on the food supply chain from primary product processing to final consumption (raw material included).
3.12 Control (Verb): All necessary measures taken to guarantee and sustain the control standards established in HACCP plan.
3.13. Control (Noun): Condition of meeting the control standard and of correct operational procedures performed.
3.14 Control Point (CP): Any point, step or process that is capable of controlling biological, chemical or physical factors.
3.15 CCP Decision Tree: A set of diagrams that states a series of problems to judge whether a control point is a key control point.
3.16 Control Measure: Any measure and action that can prevent from or remove one food safety hazard, or diminish the hazard to acceptable level.
3.17 Critical Limits: The standard value divides the acceptable level and unacceptable level.
3.18 Operating Limits: The standard that is stricter than critical limits and is used by operators to reduce the risk of deviation.
3.19 Deviation: Fail to meet the critical limits.
3.20 Corrective Action: Measures taken when the monitor of CCP indicates that the CCP is out of control.
3.21 Monitor: Continuously watch or test the control indicators under plan to evaluate whether the CCP is under control.
3.22 Validation: Prove that all elements in HACCP plan is valid.
3.23 Verification: The methods, procedures, experiments and evaluations adopted to confirm whether the HACCP plan is correctly performed, except for monitoring.
4.1 Implementation of GMP for all kinds of food shall follow the already announced or refer to relevant good manufacture rules to confirm whether the facilities, methods, operation and control of product processing is safe and whether these products are processed under sanitary conditions.
4.2 Enterprises shall check and record the GMP implementation situation and file the records for inspection.
5.Sanitation Standard Operating Procedure (SSOP)
5.1 Every enterprise shall formulate and implement sanitation standard operating procedure or similar documents to explain how it meets and practices the following sanitary conditions and regulations:
5.1.1 The safety of water contacting with food or food surface or the safety of production ice;
5.1.2 Sanitary condition and cleanliness of food contact surface (such as equipments, gloves and coats);
5.1.3 Prevent the pollution to food, food packages and other food contact surfaces caused by insanitary articles, and the cross contamination of unprocessed products and cooked food;
5.1.4 Sanitation keeping of restrooms, sterilization facilities and restroom facilities;
5.1.5 Prevent food, food packing materials and food contact surfaces from being mixed with lubricant, fuel, pesticide, detergent, disinfector, condensing agent and other chemical, physical or biological pollution;
5.1.6 Standardized label pasting, storage and use of toxic compounds;
5.1.7 Control the sanitation of employees themselves which may cause microbial pollution to food, food packing materials and food contact surfaces.
5.1.8 Wipe out the murine and insects in the plant.
5.2 Every enterprise shall check and record the SSOP implementation situation and file the records for inspection.
6.HACCP Principle
 HACCP plan includes the following 7 principles:
Principle 1: Conduct hazard analysis.
Principle 2: Confirm CCPs.
Principle 3: Work out critical limits.
Principle 4: Establish monitoring system to supervise the control status of each CCP.
Principle 5: Take corrective measures when any CCP is out of control.
Principle 6: Establish verification procedures to ensure efficient operation of HACCP system.
Principle 7: Establish necessary procedures and records concerning the foregoing principles and their application.
7.Implementation Process of HACCP Plan
7.1 Establish HACCP working team.
7.1.1 HACCP team is responsible for making HACCP plan and implementing and verifying HACCP system. The staff composition of HACCP team shall guarantee the know-how and experience about making effective HACCP plan and shall comprise leaders specifically managing the implementation of HACCP plan, productive technicians, engineering technicians, quality management staff and other necessary staff members. Some small-scale enterprises with inadequate technological strength may outsource experts.
7.1.2 Confirm the scope of HACCP plan, including the detailed implementation steps on the food supply chain and the general classes of hazards that need solution.
7.2 Describe products and confirm the predicted purposes of the products.
The primary task of HACCP is to describe the products under the management of HACCP system, with the content of description including:
7.2.1 Name of the product (Explain the type of production process)
7.2.2 Raw material and basis of the product
7.2.3 Physicochemical property of the product (Aw, p etc. Included) and sterilization (such as hot working, freezing, salt marsh and smoking etc.) of the product
7.2.4 Mode of packing
7.2.5 Conditions of storage
7.2.6 Guarantee period
7.2.7 Sales mode
7.2.8 Sales area
7.2.9 Epidemic disease material concerning food safety if necessary
7.2.10 Predicted purpose and consumers of the product
7.3 Draw and confirm the production process flow diagram.
The HACCP team shall go deep into the production line and have a full understanding of the production and processing process before drawing the production process flow diagram, and shall make on-site verification after the diagram is finished.
7.4 Analyze hazards.
7.4.1 Hazard analysis is classified into two activities- free discussion and hazard evaluation. The free discussion shall cover wide and comprehensive scope, including all the raw materials, all steps and equipments of product processing, finished products and their mode of storage and distribution, and the way the consumers use the products  etc.. In this stage, all potential hazards shall be presented. The hazard without cause of occurrence shall not be included in the HACCP plan. After the free discussion, the team shall evaluate the possibility and severity of each hazard to screen out the very critical and obvious hazards (risky and serious) against food safety and involve them into the HACCP plan.
7.4.2 The hazard analysis shall divide the safety problem from the general quality problem. The considerable hazards involving safety problems include:
7.4.2.1 Biological Hazards: Including bacteria, virus and toxin, parasite and harmful biological factors.
7.4.2.2 Chemical Hazards
Chemical hazards include four categories: Natural chemical substances, chemicals put in on purpose, chemicals put in unintentionally or occasionally and hazardous chemical substances produced in the process of production
Natural chemical substances: Mycotoxin and histamine etc.
Chemicals put in on purpose: Food additive, preservatives, nutrient additive and color additive
Chemicals put in intentionally or occasionally: Agricultural chemicals, forbidden substances, toxic materials and compounds and plant’s chemical materials (lubricant and cleaning compounds etc.)
7.4.2.3 Physical hazards: Any hazardous foreign matter that is not common to be discovered in food, such as glass and metal.
7.4.3 List the working sheet of hazard analysis
The working sheet of hazard analysis is used to organize and define the train of thought of the hazard analysis. The HACCP working team shall also consider which control measure shall be taken for each hazard.
7.5 Confirm CCPs.
Apply the logical reasoning method of CCP decision tree to confirm the CCPs in HACCP system. The application of the CCP decision tree shall be flexible and other method is also permitted if it is necessary.
If it is necessary for the food safety to control a certain hazard on some step but there is not corresponding control measure set on this step or others, the production or processing technology of this step or those before and after this step must be modified so as to include the corresponding control measure.
7.6 Establish the critical limits for each CCP.
Each CCP has one or more control measures to avoid and remove the confirmed obvious hazard or relieve it to acceptable level. Each control measure shall have one or more corresponding critical limits.
The critical limits shall be confirmed on the basis of science and may originate from scientific periodicals, guide of law, experts, experiment and research etc.. The basis and references for confirming the critical limits shall be taken as a part of HACCP plan.
In general, the indicators of critical limits include: Temperature, time, humidity, p, water mobility, salt content, sugar content, physical parameter, titratable acidity, available chlorine, addictive content and sensory indexes such as appearance and smell.
7.7 Establish monitoring system for each CCP.
Monitoring can not only discover whether the CCP is out of control, but provide essential information to avoid exceeding the critical limits by adjusting the process of production timely.
Operating limits is stricter than the critical limits and is referred to by the operator to reduce the risk of deviation. Such measure as adjusting the processing procedures when the operating limits is exceeded so as to avoid violating the critical limits is called processing adjustment. By taking such measures of adjustment, the processing staff may avoid the CCPs out of control and taking corrective actions, and early discovering the out of control tendency and imposing certain measures can prevent the product from being reworked or even scrapped. No corrective measure will be taken until the CCP exceeds the critical limits.
The design of monitoring system must contain the following essential items:
7.7.1 Monitoring Content: It is general to evaluate whether one CCP is within the critical limits by observation and measurement.
7.7.2 Monitoring Approach: The monitoring measures designed must provide results rapidly. The physical or chemical test are faster than the microbiological test, and thereby is quite good monitoring approach. The common physical and chemical monitoring indicators include combination of time and temperature (generally used to monitor the effect of killing or controlling the causative agents), water activity (Aw) (the growth of causative agents is constrained by limiting the water activity, therefore, it is available to collect sample and test its water activity.), acidity or P value (certain P value can limit the growth of causative agents.) and organic inspection (an intuitive method to inspect food).
7.7.3 Monitoring Equipment: Such as hygrothermograph, timekeeper, scale, p gauge, water activity gauge and chemical analysis equipment etc.
7.7.4 Monitoring Frequency: The monitoring may be either continued or discontinued and continued monitoring is preferred if possible. Continued monitoring is feasible for many physical or chemical parameters. If the monitoring is not continuous, it shall be ensured that the CCPs are within the monitoring quantity or frequency.
7.7.5 Monitoring Staff: CCP monitoring staff include staff on the production line, equipment operators, supervisors, repairers and quality guarantee staff etc.. The staff members responsible for CCP monitoring must accept the training relevant to CCP monitoring technology, fully understand the importance of CCP monitoring, conduct monitoring activities timely, accurately report the monitoring result each time, report the condition of exceeding the critical limits and take corrective measures timely.
7.8 Establish corrective measures.
7.8.1 As per the HACCP plan, the corrective measures corresponding to each CCP shall be prepared in advance for immediate implementation in case of deviation.
7.8.2 Corrective measures shall include: (1) Ascertain and correct the cause of deviation; (2) Ascertain the method of disposal against the product involved in the deviation, such as separation and storage with safety evaluation, raw material withdrawal, reworking or product destroy; (3) Record the corrective actions including product confirmation (such as product disposal and number of detained products), description of deviation and corrective measures taken covering the final treatment to the impacted product, name of the staff involved in corrective measures and essential result of evaluation. 
7.9 Establish verification procedures.
Verification, inspection and test (random sampling test included) can confirm whether the HACCP is operating normally. The verification procedures include verification of CCP and that of HACCP system.
7.9.1 Verification of CCP
7.9.1.1 Calibration: CCP verification includes calibration of the monitoring equipments to guarantee the accuracy of measuring method adopted.
7.9.1.2 Recheck of Calibration Record: The recheck of calibration record involves check date, method of calibration and result of experiment. The record of calibration shall be kept for recheck.
7.9.1.3 Targeted Sampling Test
7.9.1.4 Recheck of CCP Record
7.9.2 Verification of HACCP System
7.9.2.1 Frequency of Verification: The frequency of verification shall be enough to confirm whether the HACCP system is operating normally at a rate of at lease once a year or when the system falls in trouble, or when there is obvious change to the raw material or processing procedures, or when new hazard is found.
7.9.2.2 Verification Activities: Check the accuracy of production description and production flow chart; check whether CCP is monitored as per the requirement of HACCP; check whether the monitoring activities are carried out in the area stipulated in HACCP plan; check whether the monitoring activities are carried out at the frequency as regulated in HACCP plan; check whether corrective measures are taken when the monitor indicates deviation of critical limits; check whether equipments are calibrated at the frequency regulated in HACCP plan; check whether the technological process is operated within the set critical limits; check whether the record is accurate and completed within the required time limit.
7.10 Establish documents and recording files
Generally speaking, HACCP system must store the following records:
7.10.1 Brief Summary of Hazard Analysis: Include written hazard analysis working sheet and any information record for hazard analysis and critical limits establishment. The supportive documents may also include the sufficient materials used for working out methods to control growth of bacterial causative agents, materials used for confirming service life of product safety shelves and those used for confirming the heating intensity for killing bacterial causative agents. Apart from datum, the supportive documents may also be the letters of consultation to relevant consultants and experts.
7.10.2 HACCP Plan: include name list of HACCP working team and their relevant responsibilities, product description, recognized production technological process and brief summary of HACCP. The brief summary of HACCP shall include product name, CCP located step and name of hazard, critical limits, monitoring measures, corrective measures, verification procedures and record keeping procedures.
7.10.3 All records occurred in implementation process of HACCP plan.
7.10.4 Other supportive documents, for example, the verification record and revision of HACCP plan.
8.Promotion and Training
8.1 The sanitary administrative department conducts propaganda and education work on HACCP knowledge for the social public.
8.2 The sanitary technicians and food enterprises shall organize routine HACCP training for relevant staff in the system.
9.Others
9.1 Food enterprises shall combine the execution of HACCP with reconstruction of infrastructures and technologies.
9.2 As HACCP targets specific product and production technology, if the production technology changes, the enterprise shall modify HACCP with choice based on the actual situation.
9.3 The appendix to this guide provides a series of tables about HACCP plan as reference for enterprises in implementation. The specific format of the tables can be either flexible or integrated efficiently into the concrete implementation documents of the enterprise’s existing quality management system.
 

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