ISO 22000: The ISO 22000: 2005 Clauses

The Nomenclature of the ISO 22000 

The ISO 22000: 2005 is separated into different segments according to the impotence, complexity and uniqueness of the clauses. The ISO 22000 clauses are arranged in a way almost similar to ISO 9001 which is the key to the ISO 22000 structure. Thus it is obvious that both standards have identical clauses each other such as internal audits, management reviews etc. Here you have all the ISO 22000 clauses that is interpreted in the standard.  

The objective of the article to give you some understanding of the initial setup of the ISO 22000: 2005 standard while keeping it as a reference to some of the articles which will be published soon in the blogger. If  you thoroughly study the standard, you will realize that, there are certain words in the standard which is very important while you interpreting the technical requirements explain by these words. When you study the ISO 22000: 2005 standard, be sure to hit the words such as Shall, Document, Top Management, Documented Procedure, Implementation, Statutory and Regulatory requirements, Records, etc.

    

1.0  Scope

2.0  Normative References

3.0  Terms and Definitions

4.0  Food Safety Management System

4.1  General Requirements

4.2  Documentation Requirements

5.0  Management Responsibility

5.1  Management Commitment

5.2  Food Safety Policy

5.3  FSMS Planning

5.4  Responsibility and Authority

5.5  Food Safety Team Leader

5.6  Communication

5.7  Emergency Preparedness and Response

5.8  Management Review

6.0  Resource Management

6.1  Provision of Resources

6.2  Human Resources

6.3  Infrastructure

6.4  Work Environment

7.0  Planning and Realization of Safe Products

7.1  General

7.2  Prerequisite Programs (PRPs)

7.3  Preliminary Steps to Enable Hazard Analysis

7.4  Hazard Analysis

7.5  Establishing the Operational PRPs

7.6  Establishing the HACCP Plan

7.7  Updating of Preliminary Information and Documents Specifying the PRPs and the

HACCP Plan

7.8  Verification Planning

7.9  Traceability System

7.10 Control of Nonconformity

8.0  Validation, Verification and Improvement of the FSMS

8.1  General

8.2  Validation of Control Measure Combinations

8.3  Control of Monitoring and Measuring

8.4  FSMS Verification

8.5  Continuous Improvement

SHELF LIFE ANALYSIS PROCEDURE

Process of Shelf Life Analysis

This time we are going to talk about little bit general subject which is directly not related to the ISO 22000 food safety management system, but it is part of the system that basically required if your organization have a research and development department focusing the future. When you consider the product life cycle each and every product of your organization selling today will decline someday after earning lots of revenue for the organization due to the various factors such as preferences, awareness on food issues or change of life style etc. To explore the idea, consider the canned fish which has high salt content; our daily requirement of salt is about 2 grams, but in reality most of the people eat at least 4 grams on average and some parts of the world it is about 6 grams and lots of people now trying to avoid salt to let down the blood pressure which is a side effect of salts where the canned fish market may let down due to high salt. But people still want to eat the fish with low salts, where R & D comes to play a dominant role in your company’s survival.   Thus it is mandatory to have a research arm for a food manufacturing organizations because, human eating habits are changing everyday and there are so many new products storm the market without notice which will affect your cash flow any time.

When it comes to R & D; any organization in food chain need to test their products for shelf life, where you need to tell your customer the best before date or the life time which is safe to eat a given product. This is very difficult and time consuming process to evaluate the exact shelf life, where you need more resources and patience to complete the process. The ISO 22000 FSMS don’t require a procedure for shelf life. But your company needs it to complete the system if you have R & D arm. If you want to include a shelf life procedure here it is, which is not comprehensive, but you can customize according to your requirements. 

SHELF LIFE TESTING PROCEDURE

Guide Lines for Shelf Life Analysis

Distribution:

1.         Chairman

2.         General Manager

3.         Quality Assurance Manager

4.         Factory Manager – XYZ Factory

5.         Factory Manager – QUV Factory

6.         Sales Manager

7.         R & D Executive

1.0       Objective

To determine whether or not the existing/new products shelf life are conforms or can be extended to planned arrangements, requirements and to food safety management system, and is being effectively implemented and updated continuously.

2.0       Scope

This procedure covers product testing related to shelf life analysis and related to food safety.

3.0       Responsibilities

            Overall                                                           – General Manager

            Direct                                                              – R & D Manager

            Market Requirements                                  – Sales Manager

            Maintain Sample Collection                       – Factory Manager XYZ/QUV

            Expiry Testing/External Lab Testing       – Quality Assurance Manager

            Maintaining/Updating/Documenting     – R & D Executive

            Preparation of relevant documents         

4.0       Activities

4.1       Product Shelf Life Information 

4.1.1 Any shelf life related information (requests, instructions, guidelines, and requirements) shall be communicated timely to R & D Department through General Manager, in written format (RD/MGT/FT/0XX or 0YX). The sales Manageress shall communicate with clients and contractors regarding extended or shortened shelf life.

4.1.2   The Quality Assurance Manager shall communicate with external    laboratories/ service providers for shelf life analysis testing.

4.1.3    Product information including intended use, specific storage requirements, shelf life and any other relevant information shall be communicated in due manner. This information may be included in product labels or contracts where appropriate. Approval of the General Manager shall be obtained before issuing any product shelf life related information.

4.1.4 Statutory and regulatory authorities and other organizations including clients/distributors/supermarket chains that may have an interest or impact on shelf life shall be informed as appropriate on issues concerning them. Such communication shall be done by or under the approval of General Manager.

4.1.5    Any inquiries, customer feedback or any other information from supermarket chains, including customers, suppliers and statutory and regulatory authorities regarding shelf life shall be communicated to R & D Manager. Customer complaints and related activities on shelf life also shall be communicated to R & D Manager. All above information and issues shall be documented and communicated.

4.2       Shelf Life Testing

4.2.1    Shelf life is the time period from manufacturing until reaching the “best before date” and best before date names the date until the product remains under the defined quality (quality = set standards) of the food which shall be safe at the best before date (nutritional values, appearances, colour, odour may have changed when reaching the best before date as any food undergoes permanent change during storage).

4.2.2   “Use by date” shall be used with foods that are perishes very easily and has an especially high risk of becoming unsafe due to     excessive storage. Spice & condiments with the use by date or best before/expiry date shall not be sold or put into circulation for consumption in anyway after reaching this date.

4.2.3 The shelf life test shall be conducted based on the test parameters such as microbiological, chemical (eg: chemical browning), enzymatic (eg: enzymatic browning), moisture, staling, flavour loss, light induced changes, texture changes, ERH (equilibrium relative humidity) or products with high or low:

               Water content

               Water activity

               Moisture content (free water-liquids and bound water-sugar)

               Fat/oil content – rancidity 

               Alcohol content

               Acid content

               pH

4.2.4   The products with expected shelf life to be less than one year, real time shelf life tests shall be conducted, where the product shall be monitored for the actual length of its intended shelf life.

4.2.5    If a given product has a long shelf life, then the real time testing is not likely to fit in with product development cycle. In such cases accelerated stability testing shall be used to estimate shelf life; but technical expertise is a necessity.

4.2.6   Thus the products that have an expected shelf life longer than one year shall use accelerated shelf life tests to determine the shelf life. In accelerated stability testing, there shall be different incubation chambers which can be set at different temperature and humidity levels along with various lighting conditions. By introducing stressful conditions to the given product various parameters shall be tested (clause 4.2.3), this method can accelerate testing for product quality and safety.

4.2.7    If necessary, real time testing shall be used to verify estimated best before dates after the product has been launched based on accelerated stability test. Accelerated stability testing typically involves storing products at high temperature/humidity/light intensity or similar conditions. Thus products shall be tested following storage for different times and conditions. For some products, tests other than those used for routine quality control shall be required.

4.2.8  The accelerated stability test shall be conducted in an accredited laboratory by experienced food scientist with the expert knowledge on the subject. This shall summarize the storage trial results and any required microbial growth modeling and challenge tests if necessary. The report shall justify the shelf life estimate.

4.2.9  The calculations to convert the results of testing into an estimated shelf life are complex, thus some products shall require the    services of a consulting chemist to evaluate the shelf life.

4.2.10  Expiry testing shall be conducted on retained samples from commercial batches of products which shall be tested for microbiological and chemical quality upon expiry of shelf life.

4.2.11 Newly launched products shall be tested more frequently for expiry test while proven products shall be tested occasionally. Samples for testing shall be stored under realistic rather than ideal temperature conditions. Expiry testing provides further assurance that manufacturing systems are under control.

4.2.12  There shall be reputed sensory analysis results alongside the accelerated shelf life testing which can be selected among Discrimination or difference test (this test is used to answer whether there are any differences between two types of product), Descriptive analysis (this test is used to quantify the perceived intensities of a product’s sensory characteristics and to assess how food products are similar or different from one another), Affective or hedonic test (is used to quantify the degree of preference for a product and how well products are liked or which products are preferred) with preference to descriptive analysis.

4.2.13  The expiry test shall be conducted by the quality assurance department based on their retained products as well as samples collected from the market returns. The results shall be recorded and communicated on due diligence.

4.2.14  If ‘growth – no growth’ of microbes are not clear from other studies then challenge tests can be very useful. Their use shall not     be required where it is obvious that either growth won’t occur or growth will occur. Challenge tests shall be used to clarify areas of uncertainty and verify growth models for products with chemical characteristics near to the growth – no growth border.

4.2.15  Challenge test – A challenge test is similar to the microbiological testing used in storage trials mentioned. The difference is that specific different temperature (atmospheric/cold) tolerant pathogens are added to the product prior to packaging which shall not be done inside the manufacturing premises. Storage tests on products, where pathogenic bacteria are only occasionally present are likely to be misleading. The design and evaluation of challenge tests shall be done by an expert food microbiologist.

4.3       Product Development

4.3.1  Product development shall be well advanced before the company can have confidence in shelf life estimates. The company shall        be able to reliably produce homogeneous product with consistency from batch to batch.

4.3.2    Physical and chemical factors that impact on the capacity of bacteria to grow, such as pH, water activity and evenness of mix (distribution of moisture, salt, preservative or food acid) shall be well controlled.

4.3.3  The physical, chemical and microbiological profile of several batches of finished product shall be established. The potential for product contamination shall be evaluated. The packaging materials shall be correctly identified.

4.3.4    Company shall establish reliable commercial batch sample storage with a catalogue for each every batch manufactured and collected samples from different batches shall be stored separately while keeping them until expiry date is reached where expiry test shall be conducted. The sample room shall have the limited access to authorized persons.  

4.4       Product Stability and Food Safety

4.4.1    Initial studies are likely to consist of storage trials under the recommended storage conditions. Refrigerated storage trials shall be run at 5°C and under conditions of mild temperature abuse equal to what might be encountered in the commercial cold chain.

4.4.2    Products shall be inspected at suitable times and samples tested for stability of the critical physical and chemical characteristics. These trials also provide an opportunity to commence microbiological tests for both spoilage organisms and the cold-tolerant pathogens.

4.4.3    The trials shall continue beyond the targeted shelf life unless the product fails earlier.

4.5       Product Specification

4.5.1 The product specification document shall list the physical, chemical and microbiological characteristics of the product. In some cases document shall specify both manufacture (start of shelf life) and expiry (end of shelf life) criteria.

4.5.2    The specified criteria shall be traceable by formulation/recipe/ lock code to product development records.

4.5.3    Even seemingly minor changes to ingredients, manufacturing procedures, packaging or distribution can have adverse affects on product safety and use by dates. Therefore the shelf life of the revised product shall be verified, for example, by expiry testing of trial batches.

4.5.4    For the same reason, similar precautions shall be taken when applying the same use by date to a family of products with very similar characteristics. For a given product, where growth is least restricted shall be used in the shelf life study.

4.5.5  The specification shall also be correlated with quality assurance test results for manufactured batches.

4.5.6   The specification shall include recommended storage conditions and the shelf life. This shall be traceable to the shelf life study.

4.6       Test Results

4.6.1    The test result shall include the answers to the questions such as:

            Does pH change (eg: due to microbial growth or failing buffering systems)?

Is water redistributed within the product (eg: due to syneresis, condensation or a broken emulsion)?

            Is the preservative system stable?

            Are there any signs of surface growth of microorganisms?

            Does any modified atmosphere persist for required times?

            Do chemicals migrate from the food contact materials into the food?

            Are there any unforeseen changes to the product?

4.6.2    The trials shall lead to an understanding of target levels and ranges for the critical physical and chemical characteristics of the product over the intended shelf life.

4.6.3   The specific test results shall include microbiological, physical and chemical tests results including but shall not limited to (microbial) Total aerobic count, Coli form bacteria/E. coli, Lactic acid bacteria, L. monocytogenes, Salmonella, Staphylococcus aureus, Yeast and mold etc., (physical) Water activity (AW value), Viscosity, Determination of atmosphere inside the packaging (oxygen, nitrogen, CO2-content), Decreasing or increasing pressure inside the packaging, Turbidity etc., and (chemical) Acid value, Free fatty acids, Aldehydes, External moisture, Peroxide value etc.

4.6.4    The worst case or least restrictive values (maximum or minimum as the case may be) of the key chemical characteristics shall be compared to published values to evaluate the opportunity for microbial growth and organoleptic changes.

4.6.5    Shelf life of a given product shall be extended or reduced based on the test results and parameters tested in shelf life analysis.

4.6.6    A series of linked documents and records shall be used to provide objective evidence that “Use by Date”/”Best Before”/”Expiry Date” is reliable.

5.0       References

5.1       Company data base on product keeping quality and market returns

5.2       Company sample collections

5.3       R & D New Product Development Request – RD/MGT/FT/0XX 

5.3       R & D Product Improvement Request – RD/MGT/FT/0YX  

6.0       Records

6.1       Shelf life analysis reports – RD/MGT/RT/0X0  

6.2       Externally available data on shelf life of the concerned products

6.3       Expiry test analysis of company products

ISO 22000: How to Write an ISO 22000 Supplier Selections and Evaluation Procedure?

What is  ISO 22000 Supplier Evaluation Process?

ISO 22000 is developed based on ISO 9001 management system elements where quality comes first. On the other hand good manufacturing practices as well as HACCP systems all depend of the material quality of supply. Thus it is mandatory to have a proper supplier evaluations and selection system which is also a major concern for ISO 22000 food safety management system too. Even in the FSSC 22000 it has became more concerned where it is basically a prerequisite program, but it can also be considered as a food safety procedure due to the importance of the ISO 22000 FSMS. In addition, Supplier evaluation is not only a requirement of ISO 22000  compliance, but it also guarantees the food safety and traceability throughout the food chain. The given procedure is based on ISO 22000 FSMS requirements which is not comprehensive but you can customize it in to your requirements by addition and removal of specific supplier compliance process.

 ISO 22000 - FOOD SAFETY PROCEDURE

FSP 11 – Supplier Evaluation and Selection 

Distribution:

1.         Director/General Manager

2.         Administration Manager

3.         Purchasing Manager

4.         Factory Manager

5.         Stores Manager

6.         Stores Executive

7.         Consultant – FSMS

1.0       Objective

To provide a transparent methodology with uniform consistency for the purchase of products or services, which shall ensure the fulfillment of relevant food safety/quality assurance requirements while establishing appropriate control measures to eliminate food safety hazards through incoming materials or services.

2.0       Scope

This procedure applies to all material purchases and services including sourcing, supplier selection and evaluations, maintaining purchasing up-to-date, development of alternative sources of purchasing while establishing, maintaining and upgrading the purchasing system.

3.0       Responsibility

3.1       General Manager           – Guidance and compliance with requirements

3.2       Purchasing Manager     – Selection & evaluation of new suppliers

                                                      – Periodical review of existing suppliers

                                                      – Inventory control, procurement planning & follow-ups  

3.3       Factory Manager            – Identification of materials & Service requirements

3.4       Consultant                       – Compliance with FSMS

3.5       Stores Manager               – Maintaining & updating inventory controls

                                                       – Receiving, inspection & documentation of correct items

                                                       – Storage & issue of materials according to FIFO principles

                                                       – Supervision of inventory and record keeping

Stores Executive                          – Collection of samples, supervision of material storing

                                                        – Record keeping and issuing of materials   

4.0       Activities

4.1       Supplier Evaluation & Selection

4.1.1   The material and service requirements shall be planned according to the production planning.  The forecasted raw material requirements shall be categorized and listed while calling suppliers based on company registered list of suppliers or by tendering.  

4.1.2  The suppliers shall provide all the relevant details including but not limited to; material safety data sheets, product descriptions, specific certifications (ISO 22000, ISO 9001, GMP, etc.) samples and other relevant data which may be specified by the production team time to time.  

4.1.3  The factory visits or external audits shall be performed as to the criticality of the materials where supplier shall responsible for third party audits if required while letting the purchasing team to make observations on their production facilities as well as up to the primary raw material receiving of any specific product manufactured by a given supplier.

4.1.4  Suppliers shall be selected based on previous ratings, capacity and quality of the materials supplied and the cost.

4.1.5  The each item shall be furnished with best suppliers or when material scarcity or cost is too high, alternative suppliers and temporary suppliers shall be contacted according to the list of suppliers.

4.2       Purchasing of Materials 

4.2.1  After selection and evaluation, the new suppliers shall be given with trial orders and their performances are evaluated, the second and further continuation of their service shall be based on the performance of the given orders.

4.2.2  Each such suppliers are evaluated after some time till sufficient information shall be collected before them become regular suppliers.

4.2.3  Each supplier shall be rated according to their performance and the status of the supplier ( priority, secondary, alternative or temporary) shall be offered according to the ratings.

4.3       Approved Supplier List  

4.3.1  The approved supplier list shall be maintained and updated continuously for each item and service required.

4.3.2  Each item shall be listed with relevant specific requirements to be fulfilled by the supplier and the relevant chemical, microbiological and physical hazards associated with and their maximum levels and testing reports to be attached.

4.3.3  Each such item supplies are closely monitored and relevant suppliers are educated according to the requirements and the understanding of the suppliers.

4.3.4  The check lists shall be maintained with verification for specific criteria for each item with food safety hazards, supplier control measures, product specifications and the communication on such parameters with suppliers. 

4.3.5  The key suppliers shall be selected based on their capacity to comply with specific requirements, on time delivery, material quality, effectiveness of service delivery, and specially food safety. 

4.4       Supplier Rating

4.4.1  The supplier evaluation and review shall comply with; in-terms of their production facilities, customer lists, capability of for on time delivery of specific product comply with procurement parameters. 

4.4.2  Trail order performance on given supplies and the evaluation of the product quality.

4.4.3  Market leadership, reputation and dealerships for safe and sound food product or raw materials supplies over sufficient period of time.

4.4.4  Any other parameters such as monopolistic suppliers who dominate the markets. 

4.4.5  All the suppliers and contractors who filtered through above selection criteria shall be given appropriate ratings and shall be included in the approved supplier list with adequate priority based on the ratings.

4.4.6  If a new supplier has to be appointed he shall come through the same procedure passing all the set parameters to be listed in approved supplier list. 

4.5       Purchasing Data

4.5.1  Raw material specification data sheets shall be prepared according to the ISO 22000 requirements. The same specifications shall be utilized for the purchasing requirements and provided to suppliers as a form of purchase order requirements. 

4.5.2  Following requirements shall incorporate in to the purchase orders according to the type of product or materials purchased.

• The product name, type, brand name,or any other specific product identification
• Material specification sheets, packaging, quantity, mode of dispatch
• The specifications documented for all raw materials and ingredients
• Requirements of the food grade materials, source of raw materials and food safety requirements specified. 
• Regulatory requirements where applicable
• Delivery requirements and costs where necessary 
• Product specifications for test reports, relevant certifications, method of product approvals  

4.5.3  The purchasing data shall document as described to ensure that all purchase data such as quantity, quality, food safety requirements, and delivery methods with dates. It is clearly documented and reviewed before approval of purchase order. If any guarantee certificate is required, the same requirement shall be communicated to the supplier.

4.6       Purchasing of Services 

4.6.1 Purchase of services such as calibration of equipment, instruments, maintenance equipment, pest control, fumigation, testing of products, shelf life, transportation, including air fright and marine, insurance, etc. shall be carried out through approved and accredited service providers. 

4.6.2  In such events, instead of issuing purchase orders, relevant heads of departments directly deal with relevant approved service provider, while purchasing manager shall maintain selection and evaluation with the help of relevant department heads for selection and evaluation of their services. 

4.7       Control of Suppliers

4.7.1   The type of the extent of control shall depend on the type of product or raw material purchased. The supplier's performance of the previous deliveries, impact of the products/materials being procured on the quality of the final product,  the quality  and food safety compliance records supplied with the delivery. 

4.7.2  The control measures shall be specified in the purchase order or in the contract.

4.7.3  All the raw materials/products/ingredients shall be tested at the factory after delivery according to the illustration given. If any material is rejected due to the failure of compliance to given specifications, the product shall be delivered to the supplier through his own cost of transportation. 

4.7.4  The external or internal laboratory test shall be conducted by the company as a main control measure for all chemicals, raw materials, ingredients etc.

4.7.5  All the necessary records related to purchasing and individual suppliers as well as service providers shall be prepared and maintained up to date.  

5.0       Reference 

5.1   Raw material Specifications  

6.0       Records  

6.1   Supplier Registration Form

6.2   Indent and Incoming Material Inspection Report 

6.3   Approved supplier/Contractor List

             1. Raw Materials & Ingredients 

             2. Services 

6.4  Supplier Performance Records

6.5  Supplier Ratings

6.6  Product Hygiene Records and Supplier Performance Check List