Food Safety and Control System 15

Food Safety

and

Quality Systems

HACCPISO 9001:2000

Our Food:Food Safety and Control System 1

Food Safety Systems

Safety and quality systems such as the HACCP and ISO 9001:2000 can use a lot of specific standards and guidelines. Some of these standards and guidelines are discussed here.

www.ourfood.com Karl Heinz Wilm 2

GMP and SupplementsThe vast majority of food supplements sold around the world have been manufactured according to either food or pharmaceutical Good Manufacturing Practice (GMP). In some countries, specific GMP is under development for dietary supplements.

Two different regulatory issues currently oppose the development of such legislation, the Recommended Dietary Allowance (RDA) approach and the construction of positive lists.

RDA (Recommended Dietary Allowance) 1940Some countries use the RDA approach to set the levels of dietary supplement ingredients. A major revision is under way to replace the RDA by Dietary Reference Intakes (DRI).


GMP and Supplements

● According International Alliance for Dietary Supplements Association the concept of the RDA seems to be out-dated and could prevent the market responding to nutrition science.

● Another obstacle to the innovative dietary supplement market is the development of a positive list of the ingredients that can be used in dietary supplements.


GMP and Supplements● IADSA calls for clear guidelines on health claims on vitamin and

mineral supplements.


GMP and Supplements

● IADSA calls for a guarantee of consumer safety with the establishment of a negative list. Ingredients known to be harmful to health would be placed on this list and their use in dietary supplements prohibited.


GMP and Supplements● Negative lists bear the danger that every compound which is not listed can

be seen as an allowed ingredient opening the door to an immense variety of chemicals. We do not need the total liberation of the market.


What we need is an increase of food safety achieved by careful observance of existent rules like HACCP, ISO and Guidelines.

The latest developments of Sudan I colour in foods confirm positive lists.

HACCP● HACCP: The Hazard Analysis and Critical Control Point is a system which

identifies, evaluates, and controls hazards which are significant for food safety. It is described in the following papers:

Codex: Recommended International Code of Practice General Principles of Food Hygiene CAC/RCP 1-1969,

European food regulations: Council Directive 93/43/EEC on the hygiene of foodstuffs.

● The General Principles of CAC/RCP 1 (Annex) lay a foundation for ensuring food hygiene and should be used in conjunction with each specific code of hygienic practice and the guidelines on microbiological criteria. ● The first section of this document sets out the principles of the (HACCP). ● The second section provides general guidance for the application of the

system.www.ourfood.com Karl Heinz Wilm 2

HACCP

The seven Principles of the HACCP System:PRINCIPLE 1 Conduct a hazard analysis.PRINCIPLE 2 Determine the Critical Control Points (CCPs).PRINCIPLE 3 Establish critical limit(s).PRINCIPLE 4 Establish a system to monitor control of the CCP.PRINCIPLE 5 Establish corrective actions.PRINCIPLE 6 Establish procedures for verification to confirm that the HACCP system is working effectively.PRINCIPLE 7 Establish documentation concerning all procedures.


– The successful application of HACCP requires the full commitment and involve-ment of management and the work force.

HACCP does not rely on end product testing to ensure that the food is safe. Instead, it builds food safety into the manufacturing process and relies on process controls .

HACCPApplicationThe application of HACCP principles consists of the following tasks as

identified in the Logic Sequence for Application of HACCP.

1. Assemble the HACCP team2. Describe product3. Identify intended use4.Construct flow diagram5.On-site confirmation of flow diagram6. List of potential hazards associated with each step, conduct a hazard

analysis, and consider any measures to control identified hazards. Hazard analysis should include:

● Survival or multiplication of microorganisms of concern; production or persistence in foods of toxins and chemicals or physical agents.● Existing control measures which can be applied for each hazard.


HACCP

7. Determine Critical Control Points

8. Establish critical limits for each CCP: ● Criteria often used include measurements of temperature, time,

moisture level, pH, Aw, available chlorine, and sensory parameters such as visual appearance and texture.


HACCP8. Establish critical limits for each CCP (See Principle 3): ● Criteria often used include measurements of temperature, time,

moisture level, pH, Aw, available chlorine, and sensory parameters such as visual appearance and texture.

9. Establish a monitoring system for each CCP ● Physical and chemical measurements are often preferred to

microbiological testing because they may be done rapidly and can often indicate the microbiological control of the product.

10. Establish corrective actions


HACCP11. Establish verification procedures

Examples of verification activities include

● Review of the HACCP system and its records;● Review of deviations and product dispositions;● Confirmation that CCPs are kept under control.●

12. Establish Documentation and Record Keeping

Training


Logic Sequence for Application of HACCP Diagram 1

Assemble HACCP Team

Describe Product

Construct Flow Diagram

On-site Confirrmation of Flow Diagram

Determine CCPs (See Diagram 2)

Establish a Monitoring System for each CCP

Establish Corrective Actions

Establish Verification ProceduresList all Potential Hazards

Conduct a Hazard AnalysisConsider Control Measures

Identify Intended Use

Establish Documentation and Record Keeping

Establish Critical Limits for each CCP

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Do control preventative measure(s) exist?

Yes No Modify step, process or ProductIs control at this stepnecessary for safety? Yes

No Not a CCP Stop (*)

Is the step specifically designed to eliminate or reduce thelikely occurrence of a hazard to an acceptable level (**)

Yes

No

Could contamination with identified hazards occur in excess ofacceptable level(s) or could these increase to unacceptable levels? (**)

NoYes Not a CCP Stop (*) Will a subsequent step eliminate identified hazard(s) or reduce likely occurrence to an acceptable level? (**)

Yes No Critical Control PointStop (*) Not a CCP

(*)Proceed to the next hazard in the described Process.

(**) Acceptable and unacceptable levels need to be defined within the overall objectives in identi-fy ing the CCPsof HACCP plan.

Q1

Q2

Q3

Q4

Diagram 2 Example of Decision tree to identify CCPs

Diagram 3 Example of a HACCP Worksheet


LI STStep Hazard(s) Control CCPs Critical Monitoring Corrective Record(s)

Measure(s) Limit(s) Procedures Action(s)

HACCP Implementation● Since 1995, all proprietors of food businesses in the EU have been required to

carry out a hazard analysis to identify the food safety hazards within their businesses.

● It has been found that over half of all premises surveyed were not cleaning and disinfecting correctly.


HACCP Implementation

Recommendations

The authors of the UK study recommend that all food businesses should be licensed, with the application of HACCP linked to the licensing requirements.

The licensing in two stages with a provisional licence being granted to those businesses that have the necessary prerequisites in place. A full licence would be granted when the business had successfully implemented HACCP.


HACCP Implementation

Situation in Australia

● The same situation is found in Australia. Change in larger companies has been primarily customer driven (the large supermarket chains) but this has had little impact on smaller operations where the customer is often the end-user.

● The typical owner/manager has yet to be convinced that HACCP is either practical or effective in the context of his business.


HACCP Implementation● Small food businesses face special problems when trying to

implement HACCP. This is possibly even more pronounced in catering rather than processing or retail situations.

www.ourfood.com Karl Heinz Wilm 13Kitchen backside of fine restaurant

HACCP in the Food Chain

● The Conference on Mycotoxins recommends to implement HACCP principles taking special attention in the control of risks associated with mycotoxin contamination of feed.

● Other hazards include dioxin, nitrofen, MPA (progesterone) in feed in Netherlands , and BSE prions.


HACCP in the feed chain

HACCP concept should be implemented in the feed chain as this in-dustry has been on the headlines in food scandals.

HACCP in the Food ChainPublications

The “Codex Guidelines” has published several guidelines regarding feedstuffs such as:

● Code of Practice for the Reduction of Aflatoxin B1 in Feedingstuffs for Milkproducing Animals

● Draft Code of Practice for the Prevention of Mycotoxin Contamination in Cereals

● A HACCP system should be built on sound GAPs and GMPs.


HACCP, Guidelines and Agreements

Regional Programs for Food Security (RPFS)

FAO broadened its partnership with 12 Regional Economic Organizations in Africa, the Caribbean and South Pacific, providing assistance to address regional constraints.

● Strengthening the agrarian structure of developing countries open the way for a later introduction of safety systems and guidelines.

● Without a substantial aid, the implementation of these systems are not realistic.


HACCP, Guidelines and Agreements Multilateral trade negotiations on agriculture

● The Agreement on Agriculture (AoA): Fairer competition and a less distorted sector.

● The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS): Food safety and animal and plant health measures in the WTO.

● The Agreement on Technical Barriers to Trade (TBT): Technical regulations and product standards may vary from country to country.

If regulations are set arbitrarily, they could be used as an excuse for protectionism.


HACCP, Guidelines and AgreementsThe Agreement on Trade-Related Aspects of Intellectual Property

Rights (TRIPS) Makes it easier for poorer countries to import cheaper generics made

under compulsory licensing.

The treaties, agreements, guidelines are hurting sometimes even powerful nations, like recent problems of the food chain:

The bird flu outbreak in Texas in February 2004 is hurting poultry producers. Shares in a number of US chicken processors have already fallen.

The loss of poultry export markets came together with the first US case of mad cow disease resulting in a near-global ban on US beef loosing the export of about 10 per cent of its beef production. www.ourfood.com Karl Heinz Wilm 25

ISO 15161:2001Guidelines on the application of ISO 9001:2000 for the food and drink

industry

● ISO 15161:20002 combines ISO 9001:2000 and HACCP. It is a useful model for the business improvement in the food industry. It makes special reference to:

- A food safety risk assessment programme - Maintaining emergency procedures and response - Maintaining operational risk control, monitoring and measurement - The continuous improvement of food safety management system.- The effectiveness of corrective and preventative actions


ISO 15161:2001

● HACCP ensures the safety.

● ISO 9001 system ensures the quality.

The application of HACCP within an ISO 9001 quality management system can result in a food system that is more effective than the application of either ISO 9001 or HACCP alone.


ISO 15161:2001

● ISO 15161:2001 includes sourcing, processing and packaging food and drink products and explains the possibility to link the common interests and the communication between the two systems.

● It is important to consider, that ISO 15161 is not a HACCP standard and cannot be a reference document at certification, but these guidelines are intended to provide a clear management system supporting HACCP controls for an effective food safety system, under the recognized framework of an ISO 9000 Quality Management System.


ISO 15161:2001

List of acceptable Alternative Standards to ISO 15161:2001:

IRCA (International Register of Certified Auditors) has determined that the Code of Practice Food Hygiene CAC/RCP 1 is considered to be acceptable alternatives to ISO 15161:2001.


ISO 15161:2001 and 22000:200x

At the end of 2004, ISO will publish the standard ISO 22000 “Food safety management systems- Requirements”. These two standards are quite different.

ISO 15161 has a wide scope dealing with all aspects of food quality and shows how the HACCP system can be integrated into a quality management system.

ISO 22000 concentrates exclusively on food safety and will instruct food producers how they can build up the food safety system itself.


22000:200xFood Safety Management Standard

● The idea of harmonizing the relevant national standards on the international level was initiated by the Danish Standards Association (DS). ISO 22000 aims to harmonize all of these standards.

● ISO 22000 will be international and will define the requirements of a food safety management system covering all organizations in the food chain from farmers to catering, including packaging.

The standard has the following objectives:● Comply with the Codex HACCP principles.● Harmonize the voluntary international standards● Provide an auditable standard that can be used either for internal

audits, self-certification or third-party certification● The structure is aligned with ISO 9001:2000 and ISO 14001:1996● Provide communication of HACCP concepts internationally.


ISO 22000:200xFood Safety Management Standard

The ISO 22000 gives definitions on related terms, describes a food management system.

● It is a food safety management system.● Can be used for verification,validation and updating.● There is correspondence between ISO 22000:200x and ISO 9001:2000


BRC/IoP Packaging StandardComparision with ISO 22000:200x

● In recent times there has been a worldwide proliferation of third party HACCP and Food Safety Standards developed both by national standards organizations and industry groups including the UK's own BRC.

Overview of the standard● The BRC/IoP Packaging Standard dates from 17 October 2001 and was

developed by The British Retail Consortium and The Institute of Packaging , together retailers, food producers, trade associations and packaging companies.

Requirements of the standard● The adoption of a formal Hazard Analysis System.● A documented Technical Management System● The control of factory standards, products, processes and personnel



Benefits of certification: It is supported by most of the major UK Retailers

The standard is flexible and allows suppliers to operate both category A and B standards in separate 'risk areas' of the factory

Contents of the Standard

1. Scope: Whom the standard applies to and what the requirements are. 2. Organisation: Management responsibility. 3. Hazard and risk management system: Hazard analysis of the production process considering foreign object, chemical and microbiological contamination as well as packaging defects.



4. Technical management system: Quality and hygiene policy, documentation, specifications, product recall, traceability system, internal audits, complaints and supplier monitoring.

5. Factory standards: Requirements for the building infrastructure.

6. Contamination control: Glass, blade, chemical and biological and pest control.

7. Personnel: Toilets and hand washing and hygiene training.

8. Risk category determination: Classification of category A or B risk supplier.



Certification bodies

Certification bodies evaluating against the standard are formally accredited to the European standard EN45011 (General requirements for bodies operating product certification systems).

Type of standard

ISO has several types of standards. One type are auditable standards.

ISO also develops guidance standards. These standards can be used by organizations to provide an interpretation of the auditable standard.



For example ISO 9001:2000 is an auditable standard.

ISO 9000:2000 and 9004:2000 are guidance standards that are used to interpret ISO 9001:2000.

● ISO 22000:200x will be a guidance standard of a food safety system.

● BRC/IOP Packaging Standard does not completely separate the food safety issues and the quality issues.



● Detail of the standard

ISO 22000:200x appears to be less prescriptive than the BRC/IOP Packaging Standard, in that it does not address in detail the Good Manufacturing Programs (GMPs), (Good Hygiene Programs) or prerequisite programs.



Auditing Standard ISO 19011 This International Standard can be used by internal and external parties,

including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements ( audits).

Scope● ISO 22000:200x is intended to be used by organizations throughout the food

chain

● BRC/IOP Packaging Standard is intended to be used by food packaging organizations.

● Food industry organisations who trade solely within the UK may never be required to achieve certification to ISO 22000:200x, but global suppliers will have to get the ISO 22000 certificate.


New Certification System from Australia - Protection against BSE

Australian system of certification applying to each country which wishes to export bovine products to Australia To protect Australians from BSE and vCJD, Australia has announced a system of certification which will apply to each country which wishes to export bovine products to Australia.Countries will be assigned to one of four categories:

● Category A Countries with negligible risk to human health. ● Category B Countries, while not reporting cases of BSE, but have been exposed to

high risk factors such as of high-risk meat and bone meal.● Category C Countries with considerable exposure to BSE risk materials, but no

reported indigenous cases of BSE. Category D Countries, which have reported cases of indigenous BSE in their herds,

will be refused entry to Australia. Products from category B and C countries can only be imported if the national authority can certify that the product is derived from animals not exposed to BSE risk and if specific risk materials have been excluded from the food chain.


Quality ControlDeminger´s Management-Program

W. Edwards Deming influenced worldwide quality control.

Deming cycle, or PDSA cycle:

PLAN: plan ahead for change. Analyze and predict the results.DO: execute the plan, taking small steps in controlled circumstances.STUDY: CHECK, study the results.ACT: take action to standardize or improve the process.


Plan

Do

Study

Act


“Fourteen points to quality”:

He stressed the need to "drive out fear," Stop relying on inspection for insuring quality. Build cooperation and not competition within an organization.



Deminger : Seven Deadly Diseases

1. Lack of constancy of purpose to plan product and service that will have a market and keep the company in business, and provide jobs.

2. Emphasis on short-term profits: short-term thinking (just the opposite of constancy of purpose to stay in business), fed by fear of unfriendly takeover, and by push from bankers and owners for dividends.

3. Personal review systems, or evaluation of performance, merit rating, annual review, or annual appraisal, by whatever name, for people in management, the effects of which are devastating.

4. Mobility of management; job hopping. 5. Use of visible figures only for management, with little or no consideration of figures that are unknown or unknowable. 6. Excessive medical costs. 7. Excessive costs of liability.


Quality ControlDeminger → The seven deadly diseases

● On basis of his fourteen points to quality he developed the Deming´s

Deminger´s Chain Reaction:


Improved quality → Improved productivity → → Costs decrease → greater market share→

→ solid company structure → secure working places.

Quality ControlArman Feigenbaum and Total Quality Control The concept of "Total Quality Control": He claimed that quality

requires a "total" effort of management and not simply the inspection department. He defined the costs of quality as having four key components:

● The European Union did not encourage the adoption of total quality management. It created instead, the ISO system.


COST of QUALITY (Feigenbaum)1. Quality planning 2. Costs of inspection 3. Internal failure costs ( scrap and rework ) 4. External failure costs (warranty costs, complaints)

Quality ControlKaoru Ishikawa ● Kaoru Ishikawa later developed the Cause-and-Effect Diagram (also

called Fishbone Graph), and the Seven Tools of Quality Control. Ishikawa criticized authors for putting too much emphasis on worker attitudes as a cause of poor quality. Worker attitudes will improve as the systems improve.


Quality ControlInteroperability of Standards


The main Producers of National StandardsInstituition

UK British Standard Instituition BSIGermany Deutsches Institut für Normung DINFrance AFNOREUROPE European committee for Electrotecnical Standardisation CENELECEUROPE European Committee for Standardisation CEN EUROPE Electronic Components Committee CECCEUROPE European Standard Harmonized Document EN HDAmerica American National Standards Institute ANSICanada Canadian Standars Association CSA

Association Français de Normalisation

Quality ControlInternational Standards

● International Standards themselves are drawn up by international technical committees which have been approved by ISO or IEC member countries


International Standards

ISOInternational Standard

Organisation

IEC InternationalElectrotechnical

Organisation

NSO National Standard Organisation



ANSI

ISO IEC

NSOS

CENELEC CEN

EN HD

CECC


● Quality is today seen by a customer when a product always meets the quality standard that was initially offered and/or recommended.

● Other countries such as Japan and Saudi Arabia develop their own Standards, but European and North American standards are the most widely used ones.


International Organisation Subject

Internationl Organisation for Standardisation Industrial Standards ISOInternational Electrotechnical Commission Electrical equipment IECInternational Telecommunications Union Global telecom networks ITUNational Standards Organisation Link to international standards NSO


● A good management philosophy is to associate ISO 9001:2000 with complementary systems such as BS 8800 Health and Safety and the ISO 14001:1996 Environmental Management.

● The 2000 revision is an attempt to harmonise the common quality management of ISO 9000 with those contained in the ISO 14001 (environment) and to some degree, the health and safety requirements of standards such as BS 8800 with the intention to enable an organisation to run one management system that addresses quality, environment as well as health and safety.


ISO 9001:2000● The ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 family os standards

have been consolidated into a single revised ISO 9001:2000 which contains a single quality management `requirements´ standard that is applicable to all organisations, products and services.

Only three main standards subsisted:● ISO 9000:2000: Includes a description approach to quality Management as

well a revised vocabulary.

● ISO 9001:2000: Includes the quality management system, requirements.

● ISO 9004:200: Includes guidelines for performance improvement moving toward Total Quality Management. It is not intended for certification or contractual use.


ISO 9001:2000Structure

They rely on the following eight principles:

● Customer focused organisation● Leadership● Involvement of people● Process approach● System approach to management● Continual improvement● Factual approach to decision making● Mutually beneficial supplier relationship



● Documentation of the system should include● Quality Manual.● Specific statement regarding quality policy and quality objectives.● Documented procedures that describe the sequence of processes necessary to ensure the conformity of the product.● Documented instructions to ensure the effective operation and control of the processes.● Quality records.

Control of documentsProvides detailed procedure for the control of documents



● Control of records

● Management commitment: Management should conduct regular management reviews, ensure the availability of necessary resources and ensure that everyone is aware of the importance of meeting customer, regulatory and legal requirements.

● Customer focus: The customer needs and expectations must be determined, converted into requirements and fulfilled.

● Quality policy● Quality management system planning● Responsibility, authority and communication


ISO 9001:2000StructureReview input

The input to management reviews shall include results from:● Customer feedback.● Process performance.● Product conformance.● Preventive and corrective actions

Review output● The review output should:

● Improve the overall QMS and its process.● Improve the product.● Enhance customers satisfaction.● Confirm the resources required.

Resource management ● Resource Management should include:

● Human resources on regard of competence, awareness and training.● Provision of resources.● Work environment.


ISO 9001:2000

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ProductRealisation

Purchasing

Design and Development

Production and services

provision

Control ofmonitoring and

measuringdevices

Planning ofproduct

realisationCustomer

relatedprocesses

Customercommunication

Determination ofrequirements

Review of requirements

PurchasingInformation Purchasing

Process

Verification of purchased

Product Change control

Validation

VerificationReviewOutputsInputs

Planning

Preservationof product

Customerproperty

Identification and traceability

Validation of processes

Control ofproduction

ISO 9001:2000Measurement Analysis and Improvement


Measurementanalysis andimprovement

ImprovementGeneral Monitoring

and measuring

Analysis of data

Control of non-conforming

product

Monitoring andmeasurement

of product

Monitoring andmeasuring ofprocedures

Internalaudit

Customersatisfaction

Continualimprovement

Correctiveaction

Preventative action

The activities are defined to measureand monitor product conformity and Product improvement.

ISO 9001:2000 StructureQuality control Quality control resides on surveillance of specifications along the whole product

line.

Types of specifications There are three ways to establish the proper specifications when product

requirements are settled:General specifications: Are overall specifications of the product written by

the purchaser.Overall performance specifications: Here the purchaser tells the

manufacturer what he is looking for. He leaves the design of the product up to the manufacturer. Later complaints are difficult to argue about.

● Standard specifications: Standard specification is a list that describes in detail the items or materials that are to be used in the manufacture of the product.www.ourfood.com Karl Heinz Wilm 59



Purchaser

General specificationsOverall

performancespecifications

Standard specifications

Detailed written description General description BS 9000, CECC

IECQ or similar

Manufacturer

Product


Monitoring and Measurement:Procedures should be available to:

● Ensure customers satisfaction● Control internal audits● Ensure effective monitoring and measurement of product and processes.

Control of non-conforming products: Procedures should be provided to avoid:

● Products which do not conform to requirements are prevented from unintended use or delivery.● Non-conforming products that have been corrected are re-verified to demonstrate conformity.


Guide to the Economics of Quality BS 6143-2:1990

The Guide to the Economics of Quality BS 6143-2:1990 provides detailed information concerning the procedures that should be adopted in case of non- conformity products.

BS 6143:Part 1:1992 Process cost model: The main purpose of this guide is to establish a method for applying quality costing to any process or service. BS 6143:Part 2:1990 Prevention, appraisal and failure model: This guide deals with the prevention, appraisal and failure (PAF) model, which is the traditional method of quality costing within manufacturing industries.


Guide to the Economics of Quality BS 6143-2:1990

● The aim of a quality cost improvement programme is to shift the costs from the failure category to prevention and reduce overall costs.

● The British Standard guides, BS 6143, make it clear it is not enough to concentrate on either human resource issues or processes: both are interrelated and should be dealt with concurrently.


Food Safety and Control System 15

Documents

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