Food Safety and Quality Systems

HACCP ISO 9001:2000

Our Food:

Food Safety and Control System

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.

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Karl Heinz Wilm

GMP and Supplements

The 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) 1940 Some 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).
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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.

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Karl Heinz Wilm

GMP and Supplements

IADSA calls for clear guidelines on health claims on vitamin and mineral supplements.

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Karl Heinz Wilm

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.

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Karl Heinz Wilm

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.
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GMP and Supplements

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.

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Karl Heinz Wilm

HACCP

The successful application of HACCP requires the full commitment and involvement 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 . 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.
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HACCP
Application The application of HACCP principles consists of the following tasks as identified in the Logic Sequence for Application of HACCP. 1. Assemble the HACCP team 2. Describe product 3. Identify intended use 4.Construct flow diagram 5.On-site confirmation of flow diagram 6. 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.
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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.

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Karl Heinz Wilm

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HACCP
8. 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
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HACCP
11. 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

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Logic Sequence for Application of HACCP

Diagram 1

Assemble HACCP Team Describe Product Identify Intended Use Construct Flow Diagram On-site Confirrmation of Flow Diagram List all Potential Hazards Conduct a Hazard Analysis Consider Control Measures
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Determine CCPs (See Diagram 2) Establish Critical Limits for each CCP Establish a Monitoring System for each CCP
Establish Corrective Actions Establish Verification Procedures Establish Documentation and Record Keeping

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Diagram 2

Example of Decision tree to identify CCPs

Do control preventative measure(s) exist? No Is control at this step necessary for safety? No Not a CCP Modify step, process or Product Yes Stop (*) Yes
(*)Proceed to the next hazard in the described Process. (**) Acceptable and unacceptable levels need to be defined within the overall objectives in identify ing the CCPsof HACCP plan.

Q1 Yes

Q2 Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level (**) No Q3 Could contamination with identified hazards occur in excess of acceptable level(s) or could these increase to unacceptable levels? (**)

Stop (*) Yes Not a CCP No Will a subsequent step eliminate identified hazard(s) or reduce Q4 likely occurrence to an acceptable level? (**) No Stop (*) Not a CCP Yes Critical Control Point www.ourfood.com 15

Diagram 3

Example of a HACCP Worksheet

LIST Step Hazard(s) Control Measure(s) CCPs Critical Monitoring Corrective Record(s) Limit(s) Procedures Action(s)

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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.

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Karl Heinz Wilm

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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.
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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.

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Karl Heinz Wilm

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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.

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Kitchen backside of fine restaurant

Karl Heinz Wilm

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HACCP in the Food Chain

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

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.
Karl Heinz Wilm

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HACCP in the Food Chain

Publications 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.

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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.
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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.

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Karl Heinz Wilm

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HACCP, Guidelines and Agreements

The 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.
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ISO 15161:2001
Guidelines 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

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Karl Heinz Wilm

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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.

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Karl Heinz Wilm

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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.

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Karl Heinz Wilm

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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.

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Karl Heinz Wilm

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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.

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Karl Heinz Wilm

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22000:200x
Food 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.
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ISO 22000:200x
Food 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

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Karl Heinz Wilm

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BRC/IoP Packaging Standard

Comparision 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
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BRC/IoP Packaging Standard

Comparision with ISO 22000:200x
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.
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BRC/IoP Packaging Standard

Comparision with ISO 22000:200x
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.
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BRC/IoP Packaging Standard

Comparision with ISO 22000:200x
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.
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BRC/IoP Packaging Standard

Comparision with ISO 22000:200x
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.
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BRC/IoP Packaging Standard

Comparision with ISO 22000:200x

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.

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Karl Heinz Wilm

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BRC/IoP Packaging Standard

Comparision with ISO 22000:200x
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.
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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. www.ourfood.com Karl Heinz Wilm 40

Quality Control
Demingers Management-Program
W. Edwards Deming influenced worldwide quality control. Deming cycle, or PDSA cycle:
PLAN: DO: STUDY: ACT: plan ahead for change. Analyze and predict the results. execute the plan, taking small steps in controlled circumstances. CHECK, study the results. take action to standardize or improve the process. Plan Act Study Do 41

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Quality Control
Demingers Management-Program

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.

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Karl Heinz Wilm

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Quality Control
Demingers Management-Program
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.
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Quality Control
Deminger The seven deadly diseases

On basis of his fourteen points to quality he developed the Demings Demingers Chain Reaction:

Improved quality Improved productivity Costs decrease greater market share solid company structure secure working places.

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Karl Heinz Wilm

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Quality Control
Arman 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: COST of QUALITY
1. 2. 3. 4.

(Feigenbaum)

Quality planning Costs of inspection Internal failure costs ( scrap and rework ) External failure costs (warranty costs, complaints)

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

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Karl Heinz Wilm

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Quality Control
Interoperability of Standards
The main Producers of National Standards Instituition UK Germany France EUROPE EUROPE EUROPE EUROPE America Canada British Standard Instituition Deutsches Institut fr Normung Association Franais de Normalisation European committee for Electrotecnical Standardisation European Committee for Standardisation Electronic Components Committee European Standard Harmonized Document American National Standards Institute Canadian Standars Association
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BSI DIN AFNOR CENELEC CEN CECC EN HD ANSI CSA

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Quality Control

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

ISO International Standard Organisation NSO National Standard Organisation

IEC International Electrotechnical Organisation

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Quality Control
International Standards ANSI ISO NSOS CENELEC EN HD CECC
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IEC

CEN

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Quality Control
International Standards

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 Internationl Organisation for Standardisation International Electrotechnical Commission International Telecommunications Union National Standards Organisation
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Subject Industrial Standards Electrical equipment Global telecom networks Link to international standards
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ISO IEC ITU NSO

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Quality Control
International Standards
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.

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Karl Heinz Wilm

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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.
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ISO 9001:2000
Structure 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
Karl Heinz Wilm

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ISO 9001:2000
Structure

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 documents Provides detailed procedure for the control of documents

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ISO 9001:2000
Structure

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
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ISO 9001:2000
Structure Review 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. www.ourfood.com Karl Heinz Wilm 56 Work environment.

ISO 9001:2000
Control of monitoring and measuring devices Planning of product realisation Product Realisation Production and services provision Design and Development Customer related processes

Customer communication Determination of requirements Review of requirements Planning Inputs Outputs Review Verification Validation Change control

Control of production Validation of processes Identification and traceability Customer property Preservation of product
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Purchasing

Purchasing Verification Information Purchasing of purchased Process Product

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ISO 9001:2000
Continual improvement Corrective action Preventative action
The activities are defined to measure and monitor product conformity and Product improvement. Measurement Analysis and Improvement

Customer satisfaction Improvement

General

Monitoring and measuring

Internal audit Monitoring and measuring of procedures

Measurement analysis and improvement

Monitoring and measurement of product

Control of non-conforming product
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Analysis of data
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ISO 9001:2000

Structure

Quality 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.
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ISO 9001:2000
Structure
Purchaser

General specifications

Overall performance specifications General description

Standard specifications BS 9000, CECC IECQ or similar

Detailed written description

Manufacturer
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Product

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ISO 9001:2000
Structure
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.
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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 nonconformity 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.
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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.

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