Qm Guidance Document 16

ONE QUALITY MANAGEMENT

SYSTEM Multiple standard compliance

Quality management for smallholder producer groups

[May 2009]

ONE QUALITY MANAGEMENT SYSTEM

Multiple standard compliance

Quality management for smallholder producer groups

[May 2009]

Author: FAQ, Michiel Schoenmakers, www.fa2q.nl

Contributions: Fair Trade Original, Marjoleine Motz, www.fairtrade.nl

Crecer, Benjamin Orellana, www.crecer.org.gt, Twin, Anneke Theunissen, www.twin.org.uk, and coaches:

Lorenzo Nigo ,Teresa Blanco, Elena Marenco, Jhonny Gayoso, Doreen Chanje, Seth Gogoe, Joseph

Ngubwa.

Copies can be downloaded at www.qms4s.org/downloads/eng

This document was produced with the support of 42 smallholder producer groups in Africa and Latin

America, Café Direct, Twin, Fair Trade Original, Hivos and Comic Relief.

8 quality management principles flower designed by: Teresa Blanco

http://www.fa2q.nl/

http://www.fairtrade.nl/

http://www.crecer.org.gt/

http://www.twin.org.uk/

http://www.qms4s.org/downloads

Table of Contents

Table of Contents 3

0. Introduction 4

0.1 Goal and target group 4 0.2 Reading instructions 4 0.3 Step plan 5 0.4 Downloadable documents 6

1. Quality 7

1.1 Quality of service 7 1.2 Integrity of the chain quality 7 1.3 Labour practice quality 7 1.4 Food safety and quality 8

2. Multiple standard certification 9

2.1 ISO 9001:2008 9 2.2 ISO 22000:2005 9 2.3 Other standards and guidelines 9

3. ISO 9001 basic principles 10

3.1 Customer focus 10 3.2 Leadership 11 3.3 Involvement of people 11 3.4 Process approach 12 3.5 System approach to management 12 3.6 Continual improvement 13 3.7 Factual approach to decision making 13 3.8 Mutually beneficial supplier relationships 13

4. Plan Do Check Act 15

4.1 Planning your quality system using the PDCA circle 15

PLAN 17

5. Customer focus 18

5.1 Customers 18

6. Formation of quality team 19

7. Flow charting and floor plan 20

7.1 Flow charting 20 7.2 Floor plans 21 7.3 Tools for flow charting and floor plans 21

8. Process identification and scope of Quality plan

22

8.1 Basic processes at producer organisations 22 8.2 Critical processes 22 8.3 Support processes 22 8.4 Scope of the quality plan 22

9. Quality policy, objectives and targets 23

9.1 Quality policy 23 9.2 Quality objectives 23 9.3 Quality targets 24

10. Hazard and risk analysis 25

10.1 The difference between hazards and risks 25 10.2 Mandatory reasons for hazard and risk analysis 25 10.3 Management reasons for hazard and risk analysis 25 10.4 Hazard definition 26 10.5 Hazard types 26 10.6 Risk definition 27 10.7 Risk analysis 27 10.8 Risk analyses, a practical approach 28 10.9 Risk analysis for support processes 28 10.10 Risk analysis for organic activities 29

11. Control points 30

11.1 Definition of control point 30 11.2 CP Control measures 30 11.3 Critical limits 30 11.4 Preventive Action 30 11.5 Correction 30 11.6 Responsibilities and working instructions 30

12. Critical Control Points 31

12.1 CCP control measures 32 12.2 Corrective actions 32 12.3 Responsibilities and working instructions 32

DO 33

13. Monitoring and measuring 34

13.1 Monitoring devices 34 13.2 Monitoring and measuring 34

14. Documentation and record keeping 35

14.1 Document control system 35 14.2 Necessary record keeping 35

Check 36

15. Internal auditing 37

15.1 Types of internal audits 37 15.2 Compliance Audits 38 15.3 Auditing for Continual Improvement 38 15.4 How to audit (methodologies) 39 15.5 How to audit (audit program sequence) 39 15.6 When to audit (planning and scheduling) 39 15.7 Auditor training 39

Act 41

16. Management review 42

16.1 Purpose 42 16.2 Frequency 42

17. Management responsibility 43

17.1 Quality management system planning 43 17.2 Responsibility, authority and communication 43 17.3 Human resources 43

Annex 1 Terms and definitions 44

QM Guidance document 16.docx 4/48

0. Introduction

Fair Trade Original and Twin in association with FAQ carried out two

Quality Management pilot implementations with smallholder producer

groups in Africa and Central America in early 2006. Goals of the pilots

were:

Ensure present and future position of fair trade food marketing, and

bring it from a niche market to full compliance with national and

international food legislation, standards and code of conducts.

Strengthen producers/exporters from the South to continue access to

premium markets, fair trade and conventional outlets, thus ensuring

their economical position.

Support producer groups in establishing cost effective and efficient

management processes, improving quality of produce, services and

efficient management of different certification schemes.

Facilitate, utilise and upscale of working methodologies, especially

targeted at disadvantaged producer groups.

Raise local capacity to set up and maintain quality management

systems.

The materials from the two pilots were further tested with producer groups

in Latin America and West Africa in 2006. Best practices from all these

pilots have been reworked into this Guidance Document.

0.1 Goal and target group

This Guidance Document is intended as a reference book for coaches,

trainers and senior staff of producer organisations.

This Guidance Document gives a model and provides guidance in setting

up and controlling an integrated Quality Management System for producer

organisations against multiple market requirements.

The system approach is taken from ISO 9001:2008 and ISO 22000:2005.

Explanations, examples and supporting workshops are designed to suit the

reality of producer organisations.

A certifiable integrated Quality Management System is not aimed for.

However if producer groups wish to obtain an ISO certification, the system

provides a good basis for such.

0.2 Reading instructions

This guidance document is accompanied with workshop presentations,

exercises and examples. The following references are made in the left

margin:

Presentations in Power Point. These presentations were made for the

QMS coaches of FTO and Twin in Latin America and Africa as a support

tool to explain the basics of the joint quality management program, and

introduce the different exercises. Presentations can be downloaded at

qms4s.org;

Exercises that follow step by step the theoretical chapters (chapters 3 to

17). These exercises form the step plan for the quality team to design a

documented quality manual for their own organisation

Reference to standard, which help the reader to find the respective section

in the ISO 9001:2008 or ISO 2200:2005 standards;

Presentation

0. Workshop objectives &

methodologies.ppt

Presentation

1. Opening presentation Puzzle

pieces.ppt

http://www.qms4s.org/downloads/eng


Examples as developed by different producer organisations can be

downloaded at qms4s.org.

0.3 Step plan

This document follows a step plan as depicted in Figure 1 below.

Step 1: Starting point of building a quality management system is

commitment of the management to develop a QMS and continually improve

its effectiveness. The importance of leadership is explained in section 3.2,

and further explanation on the role of top management in QMS is given in

chapter 16 and 17.

Top management shall, amongst others, communicate to the organization

the importance of meeting customer as well as statutory and regulatory

requirements, see step 2.

Step 2: The importance of an organisation’s customer focus is explained in

section 3.1. How to identify customers and customer- requirements, as well

as which statutory and regulatory requirements to meet is explained in

chapter 5.

Based on step 1 and 2, the organisation develops its Quality Policy and

Quality Objectives. Explanation in chapter 9.

Step 2A, B and C: the identification, analysis and selection of products,

services, processes and standards to bring under control of the QMS are

explained in chapters 7 and 8.

Step 3 and 4: via a hazard and risk analysis it is determined which

activities minimally need to be captured in the Quality Management

System. Explanation in chapter 10.

Step 4 A, B, C and D: Hazard and risk analysis result in Control Points that

are associated with Critical Limits, Preventive Action, Monitoring and

Correction. Explanation of all these terms and practical guidelines can be

found in chapter 11.

Figure 1: Basic approach towards building a risk based Quality Management System

Verification through internal audits

Management

responsibility

Customer

identification

Customer

requirements

Validation

CCP selection

Products /

Services

Processes

Internal and

external

standards

Hazard &

Risk

Analysis

Control Points (CP)

Critical Control Points (CCP)

Critical

Limits

Preventive

ActionMonitoring

Documentation and registration

1

2A

2B

2C

3 4

4C4A

5

5A

6

8

7

Critical

Limits

Preventive

ActionMonitoring

5D5C5B

Correction

4D

Correction,

Corrective

action

5E

2

4B



Step 5 A, B, C, D and E: out of the Control Points, the Critical Control

Points (CCP) are selected. CCP selection is explained in chapter 12. In

addition to the Critical Limits, Preventive Action, Monitoring and

Corrections, a CCP is also associated with Corrective action, see

paragraph 12.2.

Step 6: the outcome of steps 1 – 5 are documented, and practical working

instructions for staff are prepared, see section 12.3.

Step 7: Quality Management System preparation is team work. It is

important for top management and Quality team to validate the

documentation before distribution and implementation. See chapters 6 and

14

Step 8: verification of the organisation’s compliance with the (internal and

external) standards is done through internal audits. Compliance audits and

Continual improvement audits are explained in chapter 15.

Step 1: the Quality Management System approach is based on continual

improvement. Information from the internal audits is feedback to

management which allows management again to take responsibility in

adapting and improving the management plan.

0.4 Downloadable documents

This Guidance Document can be downloaded from qms4s.org .

From the same download site supporting model-documents, PowerPoint

presentations, Excel Sheets and Good Practices are made available.

The download section at this site is regularly updated with new examples

and new editions of this Guidance Document.



1. Quality

In commercial (producer) organisations, the term QUALITY is often

narrowed down to product quality only. The definition of quality however

refers to all those features of a product (or service) which are required by

the customer (see definitions Annex 1). Therefore, a commercial operating

organization deals with many different types of quality. The Quality

Management System will have to deal with all these qualities in an

integrated way, to enable the organization to properly manage overall

quality performance.

In addition to product quality, which is specific for each product, region and

or producer combination, the quality in the below paragraphs may be

important.

1.1 Quality of service

An organization may produce excellent product quality, but without

supporting service quality one is quickly out of business. Regular

communication with customers, logistics, timely deliveries, paperwork,

correct invoicing, dealing with complaints, is all part of the package deal to

stay in the market.

The same counts for the quality of services to the member producers.

Without prompt payments, regular communication, support services, the

members are easily tempted to sell to third buyers. Side-selling affects the

quality of the external service again because contracts may not be fulfilled.

In the FairTrade standards many requirements deal with the quality of

service that a cooperative or cooperative union delivers to the members.

1.2 Integrity of the chain quality

FLO, Utz Certified, GlobalGap, Organic, RainForest Alliance are all process

certifications that require a minimal quality of chain management. When the

integrity of the chain is affected, or product traceability is lost or external

non controlled product enters the system, the organization may face

penalties or loss of certification. As a result contracts may have to be

cancelled.

1.3 Labour practice quality

FLO and Utz Certified/GlobalGap include criteria for labour practice. Good

quality labour practice are also in the direct interest of an organization,

because happy and involved staff feels more responsible and is more

committed to deliver quality.

Labour practices may include the recruitment and promotion of workers;

disciplinary and grievance procedures; the transfer and relocation of

workers; termination of employment; training and skills development;

health, safety and industrial hygiene; and any policy or practice affecting

conditions of work, in particular working time and remuneration.

Labour practices also include the recognition of worker organizations and

representation and participation of both worker and employer organizations

in collective bargaining.


1.4 Food safety and quality

Food safety and food quality are often found in the same texts if not the

same sentences. They sound similar and are genuinely intertwined, but

one is often mistaken for the other. Yet, they are quite different.

Behind the term food safety stands the predominant concept of consumer

health. At the heart of this concept is the responsibility of food producers

and suppliers to produce food that will not endanger the life or well-being of

those that consume it. Following the food scares of recent years, food

safety has been on top of the agenda of the European Union and the

United States. The EU General Food Law (EC/178/2002) and the US

Bioterrorism Act have been implemented in order to limit the risk to the

health of consumers.

Food quality is perhaps the least precise of the two terms as the

appreciation of the quality of a certain food can vary from one consumer to

another. Of course, quality food is also safe food.

For food producers and exporters, both food quality and food safety are

important if they wish to export.


2. Multiple standard certification

This Guidance Document gives a model and provides guidance in setting

up and controlling an integrated Quality Management System for producer

organisations against multiple market requirements. Main standards used

for this purpose are outlined in this chapter.

2.1 ISO 9001:2008

Given all the standards that an organisation must or wishes to comply with,

one may be wondering what an organization’s approach should be. In

general it is advisable to develop a quality management system based on

the ISO 9001:2008 standard. This way of working helps organisations to

control or improve the quality of its products and services, to reduce the

cost of poor quality, or to become more competitive.

This Guidance Document does not aim to add a new standard to the list of

standards to comply with, but rather helps in getting a basics understanding

of ISO 9001 and 22000, as a tool to improve management, (product and

service) quality and comply with standards.

The main principles of ISO 9001 are explained in chapter 3 of this

Guidance Document.

2.2 ISO 22000:2005

ISO 22000 was published in September 2005 and is a combination of ISO

9001 and HACCP (Hazard Analysis Critical Control Point).

The HACCP system was created in the United States. It was originally

developed and used by NASA to guarantee the safety of food products on

manned flights.

In this Guidance Document, hazard analysis on the basis of the ISO 22000

system is used as the preparatory tool to help producer organisations

analysing their operations and the hazards associated to the different

operations. This analysis helps in setting up an applied quality

management system. The hazard and risk analysis tool is described in

chapter 10.

To make the hazard analysis exercise suitable for an overall Quality

Management approach, the scope of the hazard analysis has been

expanded to not only cover food safety, but also the other qualities that an

organisation wishes to put on the market. See chapter 1.

2.3 Other standards and guidelines

In addition to ISO 9001 and 22000, the following standards and guidelines

have been taken into account while developing this Guidance Document:

Organic, EU 834/2007 and 889/2008;

FLO smallholder standards;

GlobalGap/Utz Certified;

EU General Food Law (GFL) (EC/178/2002);

US Bioterrorism Act;

ICO Code of Practice, enhancement of coffee quality through

prevention of mould formation.

Presentation

2. Legislation and market

requirements.ppt


3. ISO 9001 basic principles

ISO 9001 in conjunction with ISO 22000 form the basic foundation for the

quality management system, and ensures coherence between the

operations of the organisation’s processes.

ISO 9001 is built around eight quality management principles, see Figure 2

below.

3.1 Customer focus

Producer member organisations depend on their internal customers

(members) and external customers (who buy the products), and therefore

should understand current and future customer needs, meet customer

requirements and strive to exceed customer expectations.

Key benefits:

Increased revenue and market share obtained through flexible and fast

responses to market opportunities.

Increased effectiveness in the use of the organization's resources to

enhance customer satisfaction.

Improved customer loyalty leading to repeat business.

Presentation

3. Introduction to ISO 9001.ppt

Figure 2: 8 Quality Management Principles

Customer

focus

Continual

improvement

Leadership

Process

approach

Involvement

of people

System

approach to

management

Factual

approach to

decision making

Mutual benefits

vs. suppliers

3.

2.

5.

4.

7.

6.

8.

1.


Applying the principle of customer focus leads to:

Researching and understanding customer needs and expectations.

Ensuring that the objectives of the organization are linked to customer

needs and expectations.

Communicating customer needs and expectations throughout the

organization.

Measuring customer satisfaction and acting on the results.

Systematically managing customer relationships.

Ensuring a balanced approach between satisfying customers and other

interested parties (such as owners, employees, suppliers, financiers,

local communities and society as a whole).

3.2 Leadership

Management establishes unity of purpose and direction of the organisation.

They should create and maintain the internal environment in which people

can become fully involved in the achieving the organisation’s objectives.

Key benefits:

People will understand and be motivated towards the organization's

goals and objectives.

Activities are evaluated, aligned and implemented in a unified way.

Miscommunication between levels of an organization will be minimized.

Applying the principle of leadership leads to:

Considering the needs of all interested parties including customers,

owners, employees, suppliers, financiers, local communities and

society as a whole.

Establishing a clear vision of the organization's future.

Setting challenging goals and targets.

Creating and sustaining shared values, fairness and ethical role models

at all levels of the organization.

Establishing trust and eliminating fear.

Providing people with the required resources, training and freedom to

act with responsibility and accountability.

Inspiring, encouraging and recognizing people's contributions.

3.3 Involvement of people

People at all levels are the essence of an organisation and their full

involvement enables their abilities to be used for the organisation’s benefit.

Key benefits:

Motivated, committed and involved people within the organization.

Innovation and creativity in furthering the organization's objectives.

People being accountable for their own performance.

People eager to participate in and contribute to continual improvement.

Applying the principle of involvement of people leads to:

People understanding the importance of their contribution and role in

the organization.

People identifying constraints to their performance.

People accepting ownership of problems and their responsibility for

solving them.

People evaluating their performance against their personal goals and

objectives.

People actively seeking opportunities to enhance their competence,

knowledge and experience.

People freely sharing knowledge and experience.

Reference to standard

ISO 9001, paragraph 5.1

Management commitment:

Top management shall provide

evidence of its commitment to

the development and

implementation of the quality

management system and

continually improving its

effectiveness by:

a) communicating to the

organization the importance of

meeting customer as well as

statutory and regulatory

requirements,

b) establishing the quality policy,

c) ensuring that quality objectives

are established,

d) conducting management

reviews, and

e) ensuring the availability of

resources.


People openly discussing problems and issues.

3.4 Process approach

An activity that takes inputs and converts them to outputs can be

considered as a process. Very often the output from one process is an

input for another process.

Thus, organisations may comprise of a number of linked processes that

need to be identified and managed. The process approach therefore is the

systematic identification and management of these activities and the

interactions between activities.

Used properly, the process approach provides control over the processes,

the links between processes, and the combination and interaction of

processes.

Key benefits:

Lower costs and shorter cycle times through effective use of resources.

Improved, consistent and predictable results.

Focused and prioritized improvement opportunities.

Applying the principle of process approach leads to:

Systematically defining the activities necessary to obtain a desired

result.

Establishing clear responsibility and accountability for managing key

activities.

Analysing and measuring the capability of key activities.

Identifying the interfaces of key activities within and between the

functions of the organization.

Focusing on the factors such as resources, methods, and materials

that will improve key activities of the organization.

Evaluating risks, consequences and impacts of activities for customers,

suppliers and other interested parties.

The process approach forms the key to the System approach.

3.5 System approach to management

Identifying, understanding and managing a system of interrelated

processes for a given objective improves the organisation’s effectiveness

and efficiency in achieving its objectives.

Key benefits:

Integration and alignment of the processes that will best achieve the

desired results.

Ability to focus effort on the key processes.

Providing confidence to interested parties as to the consistency,

effectiveness and efficiency of the organization.

Applying the principle of system approach to management leads to:

Structuring a system to achieve the organization's objectives in the

most effective and efficient way.

Understanding the interdependencies between the processes of the

system.

Structured approaches that harmonize and integrate processes.

Providing a better understanding of the roles and responsibilities

necessary for achieving common objectives and thereby reducing

cross-functional barriers.

Presentation

4. Introduction to process

management.ppt


Understanding organizational capabilities and establishing resource

constraints prior to action.

Targeting and defining how specific activities within a system should

operate.

Continually improving the system through measurement and

evaluation.

3.6 Continual improvement

Continual improvement over the organisation’s overall performance should

be a permanent objective of the organisation.

Key benefits:

Performance advantage through improved organizational capabilities.

Alignment of improvement activities at all levels to an organization's

strategic intent.

Flexibility to react quickly to opportunities.

Applying the principle of continual improvement leads to:

Employing a consistent organization-wide approach to continual

improvement of the organization's performance.

Providing people with training in the methods and tools of continual

improvement.

Making continual improvement of products, processes and systems an

objective for every individual in the organization.

Establishing goals to guide, and measures to track, continual

improvement.

Recognizing and acknowledging improvements.

3.7 Factual approach to decision making

Effective decisions are based on the analysis of data and information.

Key benefits:

Informed decisions.

An increased ability to demonstrate the effectiveness of past decisions

through reference to factual records.

Increased ability to review, challenge and change opinions and

decisions.

Applying the principle of factual approach to decision making leads to:

Ensuring that data and information are sufficiently accurate and

reliable.

Making data accessible to those who need it.

Analysing data and information using valid methods.

Making decisions and taking action based on factual analysis, balanced

with experience and intuition.

3.8 Mutually beneficial supplier relationships

An organisation and its suppliers are interdependent, and a mutually

beneficial relationship enhances the ability of both to create value.

Key benefits:

Increased ability to create value for both parties.

Flexibility and speed of joint responses to changing market or customer

needs and expectations.

Optimization of costs and resources.


Applying the principles of mutually beneficial supplier relationships leads to:

Establishing relationships that balance short-term gains with long-term

considerations.

Pooling of expertise and resources with partners.

Identifying and selecting key suppliers.

Clear and open communication.

Sharing information and future plans.

Establishing joint development and improvement activities.

Inspiring, encouraging and recognizing improvements and

achievements by suppliers.


4. Plan Do Check Act

The most used instrument behind the continual improvement principle, see

section 3.6 is the so called Plan Do Check Act circle. See below.

4.1 Planning your quality system using the PDCA circle

Develop your quality management system, based on a hazard analysis;

Document your quality management system;

Implement your quality management system;

Monitor your quality management system;

Improve your quality management system.

This Guidance Document follows the same circle, and gives guidance in

PLANning (chapter 5 - 12), DOing (chapter 0 and 14), Check (chapter 15),

and Act (chapter 16 and 17).

Figure 3: PDCA Circle

ACT

Improve the system

PLAN

Develop and document

the sytem

DO

Implement the system

Check

Monitor the system

6. C

ontin

ual

impr

ovem

ent


The Plan Do Check Act circle combined with the 8 quality management

principles can be depicted as follows:

Figure 4: Model of a process based quality management system

Customers,

Members

Stakeholders

Requirements

INPUT

Management

responsibility

Measurement,

analysis and

improvement

Product realisation

Resource

management

Customers,

Members

Stakeholders

Satisfaction

PRODUCT OUTPUT

Continual improvement of the

Quality Management System

PLAN

DEVELOP & DOCUMENT THE SYSTEM


5. Customer focus

Core activity of a producer organisation is to jointly market the product of its members. The targets are to maximise results through external customer satisfaction, and providing the best possible services to its members (internal customer satisfaction).

Producer organisations depend on their internal customers (member

farmers) who receive the services, and external customers who receive

products and services.

Therefore, to stay in business, any commercial organisation should

understand current and future customer needs, meet customer

requirements and strive to exceed customer expectations.

Quality refers to all those features of a product and/or service

which are required by the customer.

5.1 Customers

Producer member organisations have two types of customers, internal and

external.

Internal customers

The internal customers are the members of your organisation, and the

other processes you are delivering product and information to.

The producer members have become member for certain reasons, and

expect extra benefits as opposed to selling to private buyers.

External customers

The external customers buy the product. Customers expect more than only

a good quality product. An exporter that is not able to fulfil its contracts may

have a good product quality, but will not be selling. Also the other way

round, a lousy quality product that comes with great service will not attract

much enthusiasm amongst buyers.

Quality is more than only a technical product specification. It also entails

the consistency in quality and quantities, the services delivered by the

producer organisation, or for instance maintenance of certifications.

8. Mutual

benefits vs.

suppliers

1.Customer

focus


ISO 9001, 5.2 Customer focus:

Top management shall ensure

that customer requirements

are determined and are met

with the aim of enhancing

customer satisfaction.


ISO 9001, 5.3 Quality policy:

Top management shall ensure

that the quality policy

a) is appropriate to the

purpose of the organization,

b) includes a commitment to

comply with requirements

and continually improve the

effectiveness of the quality

management system,

c) provides a framework for

establishing and reviewing

quality objectives,

d) is communicated and

understood within the

organization, and

e) is reviewed for continuing

suitability.


6. Formation of quality team

To fully understand the supply chain from production to export harbour, and

be able to identify all likely hazards and CCP’s it is important that a Quality

Team1 is formed. This team is made up of people from a wide range of

disciplines, and should include:

A team leader to convene the group and to direct the work of the team

ensuring that the concept is properly applied. This person must be

familiar with the technique, be a good listener and allow all participants

to contribute.

A specialist with a detailed overall knowledge of the supply chain is

required. This specialist will have a major role in the production of the

flow diagrams.

Management and senior staff responsible for the operational processes

are needed, to lead the Quality team for the specific process he/she is

responsible for.

People directly responsible for the operational processes, such as raw

material buyers, distribution staff or production staff, farmers. These

specialists are added to the team where and when required.

1 ISO 22000 uses the term Food Safety Team. In this Guidance Document, the term Quality

Team is used to emphasise that we do not limit our quality management efforts to food safety

only.


ISO 22000, paragraph 7.3.2

Food safety team:

A food safety team shall be

appointed.

The food safety team shall

have a combination of multi-

disciplinary knowledge and

experience in developing

and implementing the food

safety management system.

This includes, but need not

be limited to the

organization’s products,

processes, equipment and

food safety hazards within

the scope of the food safety

management system.

Exercise for top management

Form the Quality team

Inform the team about the

reason and the goals of this

quality management

exercise, and what will be

expected from them.

2. L

eade

rship

3.Involvement

of people


7. Flow charting and floor plan

Flow charts and floor plans are used as a starting point for drawing up the

Quality manual.

Depicting the operations in flow charts and floor plans is a tool that helps in

understanding and designing the necessary quality management systems.

Charts and plans depict the same information as does a written text, but in

a standardised pictorial form.

Ideally, this should make it easier to understand as the whole process can

be viewed at a glance, including the interactions between different parts of

the process. It will also help you saving money during the possible audit, as

flowcharts and floor plans enable an external auditor to quickly oversee and

understand the processes in your organisation.

7.1 Flow charting

Shapes

Flowcharts use standardized shapes to represent different types of actions

or steps in a process. Lines and arrows show the sequence of the steps,

and the relationships among them.

There are many thousands of different shapes available, ranging from

general shapes, to very specialist shapes. In the HACCP exercise, we will

mainly use the 7 shapes as shown below.

A box can represent a single step ("add two cups of flour"), or and entire sub-

process ("make bread") within a larger process.

A hand written or printed document or report.

A decision or branching point. Lines representing different decisions emerge from

different points of the diamond.

Represents material or information entering or leaving the system, such as

customer order (input) or a product (output).

Lines indicate the sequence of steps and the direction of flow.

Indicates a sequence of actions that perform a specific task embedded within a

larger process. This sequence of actions may be described in more detail on a

separate flowchart, or, long hand, in working instructions.

Indicates a list of digital data with a standard structure that allows for searching and

sorting.


ISO 222000, paragraph 7.3.5.1:

Flow diagrams shall be

prepared for the products or

process categories covered

by the food safety

management system. Flow

diagrams shall provide a

basis for evaluating possible

occurrence, increase or

introduction of food safety

hazards.

Document

Decision

Input/output

Subroutine

Database

Action or

process


7.2 Floor plans

All facilities which are part of the infrastructure of the producer or producer

organisation, such as the production lines, storage areas and staff facilities

shall be depicted in a floor plan.

In the floor plan the following items shall be indicated:

The routing of products, personnel and air flows (in the case of 'high

care' rooms);

The areas where cross contamination of and incidental contact with in-

process and finished products by raw materials, additives, lubricants,

cooling agents, personnel, packaging, pallets and containers, cannot

be excluded;

The areas and facilities for personnel use.

7.3 Tools for flow charting and floor plans

Suggested is that the flow charts and floor plans are manually drawn in

close collaboration with staff responsible for the different processes, as to

ensure ownership and recognition, and to ensure that all steps, are

included.

Flow charts and floor plans can be copied digitally in Microsoft Word or

Excel, where the shapes are available in the drawing section. Excel works

better than Word, as the cells give some certainty about placing the shapes

in line with each other.

However, MS Word and Excel were not designed for graphic designs and

easier is to use MS Visio for that purpose.

Exercise floor plans

Make floor plans for all

facilities that are under

control of your process, see

example at

www.qms4s.org/downloads

Exercise general chart

Make a general flow chart,

see example annex 2, which

oversees the entire process

under control, from

production to shipping. Don’t

be too detailed now, this

chart is used as an

introduction, with reference

to more detailed processes

and belonging charts, see

exercise 4.

Use the shape “subroutine”

for those processes that are

further detailed later.

In the Remarks column,

make a reference to the

detailed flow charts that you

are making later.


8. Process identification and scope of Quality plan

8.1 Basic processes at producer organisations

Most producer and export organisations minimally operate and control the

following basic processes:

1. Export management (including customer needs communication

process);

2. Top management

3. Human resource management

4. Finance

5. Fair Trade process

6. Farm production process

7. Post harvest operations

8. Quality system coordination

A complete example overview of the basic processes in producer

organisations, with their respective goals, activities, inputs and outputs can

be downloaded at www.qms4s.org/downloads.

The eight processes are operated in close connection to each other (they

are part of one system). Each process has its own requirements (internal

quality standards, external standards and legislation), and ideally the

different processes are controlled in one coherent quality system; one

quality system multiple standard compliance.

8.2 Critical processes

The processes that handle the product are referred to as Critical

processes. First concentration of most Twin/FTO partners will be on

bringing the critical processes under the quality management system, and

optimising these processes.

8.3 Support processes

The processes that support the organisational aspects, such as finances,

and human resource management, are referred to as Support processes.

All eight (and more) processes play an equally important role in the

performance of the organisation.

8.4 Scope of the quality plan

The next activity of the Quality team is to identify the scope of the study.

For example, will the whole supply chain, all processes be covered or only

selected components? This will make the task more manageable and

specialists can be added (temporarily) to the team as and when required.

Exercise scope of study

In a joint session of

management and Quality

team, determine the different

process and product that

your organisation is

handling.

Jointly make a first overview

from all activities from

production to export, using

the flow chart exercises in

chapter 6.


ISO 22000 4.1 General

requirements:

The organization shall define the

scope of the quality management

system*. The scope shall specify

the products or product

categories, processes and

production sites that are

addressed by the food safety

management system.

* ISO 22000 uses the term Food Safety

System.

4. Process

approach


9. Quality policy, objectives and targets

Based on the customers and customer requirements, the Quality Policy

and Quality Objectives for the organisation and its processes are defined.

This information will help the Quality team to analyse the supply chain, and

to determine the necessary processes to safeguard quality.

9.1 Quality policy

A quality policy is a public statement that describes WHAT the organisation

aims to achieve in terms of quality. The quality policy is overarching and

sets the objectives for the different processes that the organisation

operates and for the objectives of these processes.

Most producer organisations have a mission statement that may serve as a

starter for the quality policy. See www.qms4s.org for example missions,

visions, policies and objectives.

9.2 Quality objectives

HOW the organisation goes about, is described in the quality objectives

and quality manual of the different processes.

Quality objectives are defined for each process separately, and describe

WHAT the objectives are of the processes, and HOW the process

contributes to reaching the organisation’s quality policy.

Before you determine the objectives for your process, determine:

What the position of your process is towards fulfilling the organisation’s

quality policy,

What the role of your process is towards your fellow processes (internal

customer expectations),

What the external standards require from your process (product quality,

product safety, traceability, chain integrity etcetera).

Each department or process may summarise the above information in a

process summary form. Examples are available for download at

www.qms4s.org.

Exercise for top management

Check whether your

organisation’s mission

statement reflects your

customers’ requirements,

and whether it is in tune with

standards and legislation. If

not, adjust.


ISO 9001, 5.4.1 Quality

objectives:

Top management shall

ensure that quality

objectives, including those

needed to meet

requirements for product,

are established at relevant

functions and levels within

the organisation. The quality

objectives shall be

measurable and consistent

with the quality policy.

8. Mutual

benefits vs.

suppliers

1.Customer

focus



9.3 Quality targets

Most organisations work with an annual work plans, containing annual

targets. Following the quality policy and quality objective methodology, it is

a good idea to include annual quality targets per process that support the

continual improvement of the processes.

Exercise for processes

For the Export Management

process:

determine the quality

expectations of the external

customers;

determine the quality

objectives for the processes

you are responsible for;

determine the product

characteristics for the export

product.

Farm production and supply

chain management:

determine the product

characteristics for the

product that you are

handling.

All processes:

Verify the quality objectives

with your colleagues and

have them accorded with

your management;

Verify the quality objectives

with your internal and

external customer(s).


10. Hazard and risk analysis

Now that a definition of quality has been laid down, and all production and

handling processes have been identified, hazards and risks to quality

should be identified at each process step.

10.1 The difference between hazards and risks

Although the words hazard and risk are used in the same context and have

the same meaning in daily language, a distinct difference is made in the

scientific (food safety) world. The difference between the two words can be

captured with the elements frequency (how often does a hazard occur) and

impact (what is the impact of the hazard on quality).

Not every hazard is a risk. A hazard is a potential risk. Only by determining

frequency and impact of the hazard, the Quality Team determines whether

a hazard is a risk or not.

Or in other words, when the frequency of the hazard and/or the impact has

little relevance to quality, the hazard is not considered a risk. When the

frequency and/or impact of the hazard is relevant to quality, the hazard

becomes a risk.

10.2 Mandatory reasons for hazard and risk analysis

Hazard and risk analysis (or assessment) is becoming compulsory in more

and more regulations and voluntary standards.

In April 2004, the European Parliament and the Council adopted new

hygiene rules, which regulations entered into force on 1 January 2006

General Food Law (GFL). The new hygiene rules take particular account of

the general implementation of procedures based on the HACCP principles.

Imported foods have to be of at least the same hygienic standard as food

produced in the Community or of an equivalent standard. The HACCP

system is also mandatory in the US.

GlobalGap, Utz Certified, many Organic Certification bodies and FLO

require hazard and risk analysis for (part of) standard compliance or as an

analytical instrument to base management on.

10.3 Management reasons for hazard and risk analysis

Mandatory or not, this Quality Management Program considers hazard and

risk analysis as a powerful tool for the Quality team to:

Jointly assess their processes, and communicate about the identified

hazards and risk in a uniform and systematic manner;

Come to a common internal understanding, that makes the internal and

external communication about processes and process control a lot

easier;

To separate processes and activities that need to be brought under

control from low risk activities that do not need a formal control system;

To enable prioritization of controls.


ISO 22000, paragraph 7.4.1:

The food safety team shall

conduct a hazard analysis

which shall result in the

determination of those

hazards that need to be

controlled to the necessary

degree, and by which

combination of control

measures.

1.Customer

focus

4. Process

approach5. System

approach to

management

7. Factual

approach to

decision making


10.4 Hazard definition

In this paragraph we start with identifying the hazards to quality.

Hazard is the potential to jeopardise quality.

All real or potential hazards that may occur at each stage of the commodity

system should be considered.

10.5 Hazard types

Four types of hazards can be distinguished: food safety hazards, hazards

jeopardising the integrity of the chain, hazards to the quality of the product,

and hazards to the level of service provided.

Food safety hazards

Food safety hazards can be classified into three types of hazards:

Biological: typically food borne bacterial pathogens such as

Salmonella, Listeria, also viruses, algae, parasites and fungi.

Due to the nature of the product and its use, this is not a likely hazard

to green coffee.

Chemical:

o Naturally occurring chemicals, not applicable in coffee.

o Toxins produced by micro organisms, such as mycotoxins

produced in mouldy coffee (ochratoxin) or edible nuts (aflatoxin).

o Chemicals added in the production chain.

Physical: contaminants such as broken glass, metal fragments, insects

or stones.

Please consult www.qms4s.org/downloads for more background

information on mycotoxins:

Hazards to product quality

Food safety hazards and product quality are sometimes closely

interrelated.

A too high moisture content in coffee stimulates mould and fungi which

effects the cupping quality. The fungi produce ochratoxine, a toxic that is a

potential food safety hazard.

In nuts mould and fungi produce aflatoxin. Where the moulds and fungi in

coffee are detected through cupping, and diminished in the roasting

process, the aflatoxins in nuts are not automatically recognised or

eliminated in the nut chain. The food safety hazard is therefore much more

severe in nuts as compared to coffee.

A full hazard analyses on product quality can only be based upon a

detailed product specification and should cover the entire production and

post harvest chain. Factors potentially effecting mould and fungi range

from;

soil conditions

climate

variety of planting materials

pests and diseases

farm management

unripe picking (coffee)

inappropriate drying

inappropriate grading

inappropriate storage

mixing specialties from defined regions or altitudes

inappropriate transport (time, humidity)

etcetera.


Hazards to the integrity of the chain

Hazards jeopardising the integrity of the chain mostly refer to possible

deviations from the standards that the producer or producer organisation

wishes to comply with.

Hazards to the level of service provided

Examples of hazards that affect the level of service provided to customers

are:

Late or no reaction to orders, contract proposals.

Lack of communication during (pre) shipment

Lack of internal communication.

10.6 Risk definition

After having identified all potential hazards, a risk analysis must be

conducted to understand the relative risk to quality.

The risk analysis refers to the frequency in which a hazard may occur and

the impact on quality;

Risk: the probability that a hazard

will occur and jeopardise quality.

Formula:

Risk = Frequency x Impact

Frequency

For each hazard, consider:

the likely occurrence of the hazard

the likely duration and conditions required for the hazard to persist.

Impact

For each hazard, consider:

the severity and/or magnitude of the hazard

risk to consumer health,

regulatory risk (risk of not respecting food safety regulations or

certifications),

risk of deteriorated quality of product,

risk to operator's health (Occupational Health and Safety)

10.7 Risk analysis

The step from hazard to risk can be summarized in the following risk

selection grid:

Only real risks, i.e. significant hazards that may reasonably be expected to

occur, will be taken into account for the quality manual. Not significant

hazards do not need to be considered.

Presentation

5. Risk analysis & critical

limits.ppt


ISO 22000, paragraph 7.4.3

Each food safety hazard

shall be evaluated according

to their severity of adverse

health effects and likelihood

of their occurrence. The

methodology used shall be

specified and results of the

food safety hazard

assessment shall be

recorded.

Figure 5: Risk selection grid

Hazards scoring below 3 are not significant hazards that do not need to be considered.


Steps in the supply chain that have been identified with risks (3 – 9), are

referred to as Control Points (CP). Control Points should be brought under

control, see the next chapter.

10.8 Risk analyses, a practical approach

Experience shows that the risk selection grid is difficult to handle for many

staff members. In the pilots it turned out that many people are not used to

work with cross tables. Also the difference between hazard and risk is

difficult to understand.

Where it is important for the coaches to understand the differences

between hazard and risk and the background methodology, it is advised to

use another methodology during the workshops.

Pilot experience shows that it is not necessary to understand the selection

grid in all detail to come up with workable results. In most cases the risk

assessment model as shown in Figure 6 is used (Ms Excel sheet).

With this model most groups are well capable of assessing their risks, if

they know that results 3 and more are considered as significant hazard or

risk.

Qms4s.org contains different examples of completed risk assessment

sheets. Some groups developed creative ways of risk categories using

colours, others copied their flow charts into the sheets for easier reference,

see www.qms4s.org/downloads.

10.9 Risk analysis for support processes

Unless you are going for a HACCP or ISO 22000 certification, risk

assessment is a tool, not a goal or a requirement.

For critical processes, risk assessment is a very useful tool for a quality

team to jointly analyse their processes and design control measures. For

support processes the risk assessment tool seems less relevant at first

sight. It is however suggested that the quality teams responsible for the

support processes give the risk assessment tool a serious try. The above

risk selection grid has proven helpful for a common understanding of

support processes as well, and for the design of preventive measures,

corrections in support processes. In most cases, the critical limits are

difficult or impossible to set for support processes, and can better be

ignored.

At all times, coach and Quality Team need to judge whether the risk

assessment tool is helping or whether it is complicating. See also the

remarks on the management and human resource processes in Chapter 16

Management review.

Exercise

Consult the flow charts and

floor plans as developed in

the previous exercises.

Number the process steps,

with matching criteria-

numbers in the hazard lists.

Identify the hazards in your

situation.

Make the risk analysis per

hazard.

Mark the risks in the far right

column of the risk assessment

list.

Check all and floor plans and

hazards lists on site with

responsible staff.

Make sure all steps are

mentioned.

Make sure all hazards are

mentioned.

Figure 6: Risk selection sheet



10.10 Risk analysis for organic activities

More and more organic certification bodies make risk assessment

compulsory in their certification scheme.

The EU organic regulation of 2007/2008 states that Organic production

shall be based on, amongst others, risk assessment, and the use of

precautionary and preventive measures, when appropriate (EC 834/2007

Article 4 IV). EC 889/2008 Article 63 1b hooks on to this risk assessment,

and makes reference to “a quality system as set up by the operator”.

At qms4s.org a compilation of hazards collected from different operators in

the organic sector can be downloaded. Please use this list as reference, it

is not complete and you may well find irrelevant or missing hazards in your

case.

Because of the nature of organic certification, most organic hazards are

automatically risks and need to be brought under control. Risk assessment

may help in analysing risks and prioritising designing preventive actions

and corrections.



11. Control points

11.1 Definition of control point

Steps in the supply chain that have been identified with risks, are referred

to as Control Points (CP)...

A Control Point (CP) is a step which has been

identified as carrying a risk of non conformity

with the quality objectives of the process.

11.2 CP Control measures

Control Points should be brought under control through different control

measures: Critical limits, Preventive actions and Corrections.

11.3 Critical limits

A critical limit is that moment from which on the hazard takes such

proportions that it cannot be accepted in the process as such anymore. It is

necessary to establish and validate the limits to each control point to

determine as of when or where the risk must be controlled.

Different limits can be established at each step of the process, e.g. limits to

temperature, timing, moisture level, PH, as well as flavour or visual aspects

and consistency.

It is suggested that the critical limits are written down in the Risk

assessment lists, as developed in chapter 10.

11.4 Preventive Action

Preventive Actions should be designed to prevent or eliminate any risk or

reduce such risk to an acceptable level.

It is suggested that a summary of the Preventive Actions are written down

in the Risk assessment lists, as developed earlier. Preventive actions are

documented in further detail in the form of working instructions to staff

responsible for keeping the risks under control.

11.5 Correction

A correction is an action to eliminate a detected non conformity. A

correction can be for example rework or re-grade, re-dry or even destroying

the product.

In case of organic certification, many of the corrections are described in the

ICS, for instance, taking the non conformity product out of the organic chain

in case of doubts about the integrity of the producer or contamination.

11.6 Responsibilities and working instructions

It is time now to identify staff that is responsible for the control measures

and monitoring. Note the names or the initials of staff members in the risk

analysis lists.

For the continuity of the organisation and for safeguarding that different

staff members carry out the same tasks in a comparable way, it is

recommended that control measures and monitoring activities (see chapter

0) are documented in the form of working instructions.

Note

Although often used, the term

“Control Point” is not defined in

ISO 9001:2008 or HACCP or ISO

22000.

ISO 22000 does not speak about

CP’s, but uses the term

Operational PreRequisite

Program (Operational PRP), see

definition.

As the above terms cannot

specifically be connected to

individual steps in the process,

and as HACCP and ISO22000

concentrate on food safety only,

the author of this manual thought

it best to work with the term CP

in conjunction with Quality

Management Plan. See the

respective remarks in Annex 1.

5. System

approach to

management

7. Factual

approach to

decision making


12. Critical Control Points

For each CP, measurements have been developed to keep the risks under

control. In principle some risks can be brought controlled in different steps

in the supply chain under control of the organisation. The last step where a

risk can be brought under control is a crucial one. This control point is a

Critical control point, beyond which the organisation can no longer bring the

risk back under control, and which is the final performance check of all

earlier control measures.

This chapter helps in selecting the so called Critical Control Points from the

list of Control Points.

A Critical Control Point is a step at which control can be applied

and is essential to prevent or eliminate a quality hazard

to the final product or reduce it to an acceptable level.

For the identification of CCP’s, the following decision tree may be used:

Important considerations when using the decision tree:

The decision tree is used after the hazard analysis.

The decision tree is used at the steps where a "significant hazard" has

been identified, the so-called Control Points (CP). These are hazards

that may reasonably be expected to occur.

Non-significant hazards (i.e., of low risk and unlikely to occur) have

been excluded.

Exercise

Convene with the complete

quality team again.

Use the CCP selection

tree, and identify the

CCP’s of your

organisation, from the

respective risk

assessment lists of the

different processes.

Mark the identified CCP’s

in the risk assessment list

with CP.

Copy the CCP’s to a

separate list of your

organisation’s CCP’s, see

model CCP list.

Establish the corrective

actions for the CCP’s, and

summarise in the CCP list.

Note who is responsible

for controlling the CCP’s

and the CA.

For CCP’s, add in the

working instructions for

staff the instruction that in

case of non conformities,

the CCP responsible

should be informed.

Make working instructions

for the CA.

Figure 7: CCP decision tree

Q1: Have you identified significant hazards

In this step?

(Hazards scoring 3 to 9 are considered significant)

Q2: Are preventive actions and corrections in place to

prevent the risk from happening?

YES

NO

Q3: Will a subsequent step prevent, eliminate or

reduce the risk to the quality of the final product?Critical Control Point

CCP

YES

NO

YES

NO

This step is a CP

Develop preventive actions and

corrections to bring this CP

under control

This step is a CP

The hazard is not

relevant enough.

No CP no CCP

5. System

approach to

management

7. Factual

approach to

decision making


For Control points there should be Preventive Actions and Corrections

in place.

More than one step in a process may be involved in controlling the

same hazard.

More than one hazard may be controlled by a specific preventative

action.

A subsequent step in the process under your control may be more

effective for controlling a hazard and may be the preferred CCP.

12.1 CCP control measures

As the CCP’s are selected from the list of CP’s, you have already

developed a set of control measures in the form of critical limits, preventive

action, corrections and working instructions.

Monitoring and measuring of CCP’s is however bound to stricter monitoring

requirements, and for CCP’s additional Corrective Actions (CA) apply.

12.2 Corrective actions

The difference between correction and corrective action is, that correction

is aimed at taking away the nonconformity, while corrective action is aimed

at identifying the cause of the non conformity and preventing recurrence. In

other words, a correction is a concrete and physical activity, while

corrective action is re-defining of a procedure/working instruction and re-

training of staff.

The corrective actions may include:

Adjusting the process;

Adjustment/correction of process conditions.

12.3 Responsibilities and working instructions

Data derived from monitoring of CCP’s shall be evaluated by (a)

designated person(s) with sufficient knowledge and authority to initiate

corrective actions.

DO

IMPLEMENT THE SYSTEM


13. Monitoring and measuring

With documenting the CP’s, CCP’s critical limits, preventive actions

corrections and corrective actions, you already started working out your

monitoring system.

13.1 Monitoring devices

It is a good idea to further design and document your monitoring system

now, by taking into account the following suggestions from ISO 22000:

The monitoring system may consist of relevant procedures, instructions

and records that cover the following:

o Measurements or observations that provide result with an adequate

time frame;

o Monitoring devices used;

o Applicable devices used;

o Applicable calibration methods;

o Monitoring frequency;

o Responsibility and authority related to monitoring and evaluation of

results;

o Record requirements and methods.

The monitoring methods and frequency shall be capable of determining

when critical limits have been exceeded in time for the product to be

isolated before it is used or consumed.

13.2 Monitoring and measuring

The results of the monitoring shall be documented by means of records

and the practices shall be described in the process control plans. The

records shall include:

Monitoring reports (dated and signed);

Records of deviations which have occurred critical limits and corrective

actions taken.


ISO 22000, paragraph 7.6.4:

A monitoring system shall be

established for each CCP to

demonstrate that the CCP is

in control. The system shall

include all scheduled

measurements or

observations relative to the

critical limits.

7. Factual

approach to

decision making


14. Documentation and record keeping

Through the exercises in chapter 1 to 11, much of the needed QMS

documentation has been developed already. It is now time to further

(re)design and control the documentation and record keeping of all

operations. Documents required by the Quality Management System shall

be controlled.

14.1 Document control system

Documented procedures shall be established to define the controls

needed:

to approve documents for adequacy prior to issue,

to review and update as necessary and re-approve documents,

to ensure that changes and the current revision status of documents

are identified,

to ensure that relevant versions of applicable documents are available

at points of use,

to ensure that documents remain legible and readily identifiable,

to ensure that documents of external origin are identified and their

distribution controlled,

to prevent the unintended use of obsolete documents, and to suitably

identify them if they are retained for any purpose

14.2 Necessary record keeping

Efficient and accurate record-keeping is essential to a Quality Management

System Records shall be established and maintained to provide evidence

of conformity with requirements and with the effective working of the

Quality Management System. Records shall remain legible, readily

identifiable and retrievable. A documented procedure shall be established

to define the controls needed for identification, storage, protection, retrieval,

retention time and disposal of records.

Records that shall be available are:

Records to demonstrate that the members of the QUALITY team have

adequate knowledge, expertise and different disciplines available

Records concerning management reviews and, if needed, related

actions

Records of the hazard analysis and information sources (standards,

literature, hygiene codes, GMP, Codex) used by the QUALITY teams to

identify and evaluate the hazards and risks

Records of the assessment of every step in the process and the

reasons for establishing the Critical Control Points (CCP's) and General

Control Measures (GCM's).

Monitoring reports (dated and signed) per CCP to demonstrate their

control

Records of deviations occurred (action limits and critical action limits)

per CCP and corrective actions taken

Records related to the verification program (including internal audit)

and their evaluation.

Records that are relevant to ensure traceability of food stuffs. During

the Quality Management exercise, you already made a start with

documenting the processes you are operating.

Presentation

6. Summary QMS manual and

working instructions.ppt

Exercise

Collect existing procedures

and working instructions,

and see whether these

reflect the CCP’s as found

during the hazard/risk

analysis exercises.

7. Factual

approach to

decision making

Check

MONITOR THE SYSTEM


15. Internal auditing

Internal audits are important because they are the feedback loop in the

quality system. Internal audit outcomes keeps management informed about

the performance of the organisation, and about the organization’s

compliance with its own documented system.

Listed below are some of the major internal benefits of internal auditing:

Internal audits help determine the effectiveness of the quality system.

Internal audits help to determine the adequacy of the quality system.

Internal audits help to determine the organization’s compliance to the

established quality system.

Internal audits provide a record of the state of an organization, and can

be used to trend its progress.

Internal audits help to uncover areas that need improvements.

Internal audits measure products and processes and verify contractual

requirements and corrective actions.

Internal audits may also be organised for external reasons:

FLO, Organic, Utz, GlobalGap and others require an organisation to

perform internal audits against the standard requirements.

Internal audits are used to prepare for external audits in order that no

surprises occur, and an external audit can be run efficiently (lower

costs).

15.1 Types of internal audits

Many different types of internal audits exist, dependant of the management

goals that are to be achieved. Some examples are;

Product Audit is an in-depth examination of a particular product to

evaluate whether it conforms to product specifications, performance

standards, and customer requirements.

Process Audit is performed to verify that processes are working within

established limits. It examines an activity to verify that the inputs,

actions and outputs are in accordance with defined requirements.

Compliance Audits are performed to verify that applicable elements of

the quality system are appropriate and have been developed,

documented, and effectively implemented in accordance to the

organization’s quality policy and quality objectives of the processes.

Auditing for Continual Improvement is performed to evaluate how the

individual processes contribute to the continual improvement of the

quality management system.

In this chapter the concentration is on auditing for internal reasons. The

chapter highlights the most important features of internal auditing. In depth

training is provided by FTO and Twin, and the training program can be

downloaded in the second half of 2009 from qms4s.org. More background

material on internal auditing is compiled by QMS coach Joseph Ngubwa,

downloadable via the same site.

In the paragraphs below, guidance is given to organising Compliance

Audits, with the goal to work towards Audits for Continual Improvement.

Concentration is on purpose, what, how and when of internal auditing.

7. Factual

approach to

decision making

6. C

ontin

ual

impr

ovem

ent


ISO 9001 8.2.2 Internal audit:

The organization shall conduct

internal audits at planned

intervals to determine whether

the quality management

system

a) conforms to the planned

arrangements (see 7.1), to the

requirements of this International

Standard and to the

quality management system

requirements established by the

organization, and

b) is effectively implemented and

maintained.



15.2 Compliance Audits

Purpose

The first internal audit that most organizations organize is a Compliance

audit, to verify that applicable elements of the quality system are

appropriate and have been developed, documented, and effectively

implemented in accordance to the organization’s quality policy and quality

objectives of the processes.

Compliance audits aim to:

Help determine the organization’s compliance to the established quality

system.

Help to determine the effectiveness of the quality system.

Help to determine the adequacy of the quality system.

Provide input for management decisions (so that, safety, quality

problems and costs can be prevented or rectified).

Provide visible management support of the quality program

What to audit

The first step is to audit the Compliance of the developed quality

documentation to verify:

Adequacy and completeness of documentation – are procedures in

place for each category, department or operations and their

requirements in place.

Compliance with regulations and private standards that the

organizations must or wishes to comply with.

Compliance to the documented procedures, preventive action,

correction, working instructions and registration. Is staff actually

working according to procedures?

The effectiveness of the procedures towards reaching the quality

objectives of the respective process.

After the first draft of the quality manual has been compiled, and internal

auditors trained, an internal auditor can start his/her round of audits. For

the Twin/FTO QMS program example audit checklists are available at:

www.qms4s.org/downloads.

15.3 Auditing for Continual Improvement

Purpose

Auditing for Continual Improvement forms the core of the Check in the P-D-C-A

improvement cycle. Purposes of Continual Improvement Audits are:

To serve as improvement tool.

To help to uncover areas that need improvements.

Internal audits provide a record of the state of an organization, and can

be used to trend its progress.

What to audit

To audit effectively, the internal auditor will have to evaluate the

performance of individual processes, and how processes contribute to the

continual improvement of the quality management system. Continual

improvement audits are based on:

The quality policy;

Quality objectives;

Previous audit results;

Analysis of data;

Corrective and preventive actions;

Previous management review.


The performance of particular processes may be analysed through the

monitoring and/or measurement of factors such as:

accuracy;

timeliness

reaction time of processes and people to special internal and external

requests;

effectiveness and efficiency of processes;

cost reduction.

15.4 How to audit (methodologies)

Compliance and Continual Improvement use (combinations of) different

assessment methods such as interviews, questionnaires, observation, and

selective review. Auditing is work of (wo)man, and therefore very much

dependant on the qualifications, experience and skills of the auditor. The

audit goal and the auditor’s experience determine the combination of

methodologies to be applied.

15.5 How to audit (audit program sequence)

1. Establish the audit type and purpose;

2. Establish audit scope and limits, i.e. what activities to be audited;

3. Establish the personnel to be involved;

4. Establish audit basis, i.e. determine what to audit against;

5. Review the audit basis documentation, e.g. review the documentation

against internal (progress) requirements;

6. Prepare an audit plan, i.e. activity sequence and timing;

7. Prepare an audit checklist (see example at qms4s.org);

8. Notify auditee.

15.6 When to audit (planning and scheduling)

For audits to be effective, they should:

Be planned systematically – preview of documents/system etc prior to

audit. Good planning lead to good audit results, poor planning leads to

poor audit results.

Cover all the activities and elements of the quality system as defined in

the objectives and the scope of the audit.

Have specific audit arrangements for pre-audit work, times for audit,

meetings and interviews.

Follow internal audit schedules

15.7 Auditor training

For an audit to be meaningful it must be deemed credible. Using

knowledgeable, experienced, skilled, capable and well-trained auditors is

the most effective way to enhance the credibility of the audit.

Principles of auditing

To ensure that auditing is an effective and reliable management tool,

auditing is based upon a number of fundamental principles. Understanding

and following these principles will ensure that audit conclusions are

relevant and sufficient, and that auditors working separately from each

other will reach similar conclusions in similar circumstances. Three of the

principles relate to the personal characteristics of auditors:

Ethical conduct: the role of the auditor is one of trust integrity,

confidentiality and discretion;

Fair presentation: audit findings, audit conclusions and audit reports

reflect truthfully, accurately and completely the audit activities. Any

unresolved or diverging opinions between the auditor and the auditee

and any obstacles encountered are reported;



Due professional care: auditors must exercise a degree of care

appropriate to the importance of the task and to the confidence placed

in them by management and auditees. Having the necessary

competence is an important part of this.

Two further principles concern the audit process:

Independence: auditors must be independent of the organisation or

activity being audited. They must remain free from bias and conflicts of

interest.

Evidence: audit evidence is verifiable. It is based on samples of the

information available.

Act

IMPROVE THE SYSTEM (= MANAGEMENT RESPONSIBILITY)


16. Management review

We have arrived at the final and the first step of the P-D-C-A circle, the

ACT of management review.

16.1 Purpose

A management review is an opportunity for top management of an

organization to review the performance of their organization’s management

system. It’s more than just a meeting however, as a management review

includes the collection, analysis and review of performance data, and any

decisions and actions related to the results. The review should assess

opportunities to improve and the need to change the QMS, quality policy

and quality objectives.

16.2 Frequency

Aim to do management review at least once per year or more often if

appropriate. Little and often is best - there is nothing to say that you have to

go through the full agenda each time, nor is there any need to duplicate

effort if you cover certain aspects as part of other management meetings.

2. L

eade

rship

7. Factual

approach to

decision making

6. C

ontin

ual

impr

ovem

ent


ISO 9001 5.6 Management

review:

Top management shall review

the organization's quality

management system, at planned

intervals, to ensure its continuing

suitability, adequacy and

effectiveness. This review shall

include assessing opportunities

for improvement and the need for

changes to the quality

management system, including

the quality policy and quality

objectives. (...)

The input to management review

shall include information on:

a) results of audits,

b) customer feedback,

c) process performance and

product conformity,

d) status of preventive and

corrective actions,

e) follow-up actions from

previous management reviews,

f) changes that could affect the

quality management system, and

g) recommendations for

improvement.

The output from the management

review shall include any

decisions and actions related to:

a) improvement of the

effectiveness of the quality

management system and its

processes,

b) improvement of product

related to customer

requirements, and

c) resource needs.


17. Management responsibility

ISO 9001 and ISO 22000 are based on the assumption of commercially

operating companies with a central management. The management in

most smallholder producer groups is divided over a daily management

(General Manager) under supervision of a democratically chosen board

and general meeting.

This chapter contains an interpretation of the ISO top management

requirements, to help the board, general management and quality team

with an easy set up of the management process, procedures, and prepare

for management review (see chapter 16).

17.1 Quality management system planning

Management must ensure that:

The planning is carried out to meet quality objectives;

The integrity of the systems is maintained when changes to the system

are planned and implemented.

Management must plan implement quality planning for the activities and

resources needed to satisfy the quality policy, objectives and requirements.

17.2 Responsibility, authority and communication

Top management must ensure that responsibilities and authorities are

defined and communicated within the organization.

In practice, management delegates most activities to the Quality Team.

That sounds simple, but the experience of the Twin/FTO program is, that

most Quality Teams get the task, but not the authority or the resources

(budget, time) to set up a quality management system. Result is that this is

not perceived as a high priority with staff involved, and that in some cases

little progress is booked with setting up quality management systems.

17.3 Human resources

Although human resource management is often delegated to a department

office, it remains a key duty of top management to see to it that staff be

competent on the basis of:

Appropriate education

Training;

Skills;

Experience.

Competence, training and awareness

To ensure competency of staff, an organization must:

Determine competencies for different positions;

Provide training or other actions to satisfy competence needs;

Evaluate the effectiveness of actions taken;

Ensure awareness of the relevance and importance of activities and

contribution to achievement of objectives;

Maintain appropriated records of education, training, skills and

experience.

2. L

eade

rship

QM Guidance document 16. 44/48

Annex 1 Terms and definitions

Definitions and notes in this annex are copied from ISO 9000:2000 and ISO 22000.

Where necessary the author of this guidance document has added additional editorial notes.

Acceptable level: The level of a safety hazard which is considered to present an acceptable,

low risk to the consumer. The acceptable level of the final product, sometimes referred to as a

target level, should be stated in the product description and would normally be set at, or

below, any regulatory limits. An acceptable level for a hazard at an intermediate step in the

commodity flow diagram can be set higher than that of the final product, provided that the

acceptable level in the final product will be achieved.

Competence: demonstrated ability to apply knowledge and skills (see also the definition for

qualification).

Control (verb): To take all necessary actions to ensure and maintain compliance with criteria

established in the Quality Management Plan.

Control (noun): The state wherein correct procedures are being followed and criteria are

being met.

Control measure: Any action and activity that can be used to prevent or eliminate a food

safety hazard or reduce it to an acceptable level.

EDITORIAL NOTE 1: Control measure is a collective noun referring to preventive action

Correction and Corrective Action.

EDITORIAL NOTE 2: The term “Control Measure” is not used in this guidance document

because the author thinks is clearer to use the distinct terms “Preventive action”, “Correction”

and “Corrective action”.

Control Point: A step which has been identified as carrying a risk of non conformity with the -

quality objectives of the process.

EDITORIAL NOTE 1: Although often used, the term “Control Point” is not defined in ISO

9000:2000 or HACCP or ISO 22000.

EDITORIAL NOTE 2: Control Points are identified with the help of the hazard selection grid

see section 10.7 and 10.8of this document. All activities carrying potential hazards with an

result of 4 and more (or in the old hazard selection grid section 10.8 combination above LL,

LM and ML), are considered as risks. Steps carrying risks should be brought under control by

the organisation through control measures.

EDITORIAL NOTE 3: ISO 22000 does not speak about CP’s, but uses the term Operational

PreRequisite Program (Operational PRP), see definition.

EDITORIAL NOTE 3: As the above terms cannot specifically be connected to individual steps

in the process, and as the programs concentrate on food safety only, the author of this

manual thought it best to work with the term CP in conjunction with Quality Management Plan.

See the respective definitions.

Correction: action to eliminate a detected nonconformity.

NOTE 1: A correction can be made in conjunction with a corrective action.

NOTE 2: A correction can be, for example, rework or re-grade or re-dry.

Corrective action: Any action to be taken when the results of monitoring at the CCP indicate

a loss of control.

NOTE 1: there can me more than one cause of a non conformity.

NOTE 2: Corrective action is taken to prevent recurrence, whereas preventive action is taken

to prevent occurrence.

NOTE 3: there is a distinction between correction and corrective action.

EDITORIAL NOTE 1: Corrections are associated with Control Points ánd with Critical Control

Points, whereas Corrective Actions are only associated with Critical Control Points.

EDITORIAL NOTE 2: “Correction” is usually a physical action (rework, regrade, redry) and

“Corrective Action” is usually action on paper (revise procedures or working instruction

prevent recurrence).

Critical Control Point (CCP): A step at which control can be applied and is essential to

prevent or eliminate a quality hazard to the final product or reduce it to an acceptable level.


EDITORIAL NOTE 1: This guidance document concentrates on quality compliance instead of

food safety only. Therefore the term “quality hazard” replaces the term “food safety hazard”

(ISO 22000).

EDITORIAL NOTE 2: to stress the difference between CP and CCP, the words “to the final

product” have been added.

Critical limit: A criterion which separates acceptability from unacceptability, when monitoring

a CP or CCP.

Customer: organisation or person that receives a product.

Example: customer, client, end-used, retailer, exporter, beneficiary, purchaser.

NOTE: a customer can be internal or external to the organisation.

EDITORIAL NOTE: in cooperatives, the members are important customers of the

organisation’s services. See for instance most mission statements of the cooperatives.

Customer satisfaction: customer’s perception of the degree to which the customer’s

requirements have been fulfilled.

NOTE 1: Customer complaints are a common indicator of low customer satisfaction, but their

absence does not necessarily imply high customer satisfaction.

NOTE 2: Even when customer requirements have been agreed with the customer and

fulfilled, this does not necessarily ensure high customer satisfaction.

Decision tree: A series of questions linked diagrammatically to be answered with Yes or No.

The answers determine which path is followed and which decision this leads to.

Deviation: Failure to meet a critical limit.

Document: Information and its supporting medium.

EXAMPLE: record, specification, procedure document, drawing, report, standard.

NOTE 1: the medium can be paper, magnetic, electronic or optical computer disc, photograph

or master sample, or a combination thereof.

NOTE 2: A set of documents, for example specifications and records, is frequently called “

documentation”.

NOTE 3: Some requirements (e.g. the requirement to be readable) relate to all type of

documents, however there can be different requirements for specifications (e.g. the

requirement to be revision controlled) and records (e.g. the requirement to be retrievable).

Flow diagram: A systematic representation of the sequence of steps or operations used in

the production or manufacture of a particular food item.

Food safety: Freedom from environmental and other contaminants and sources of toxicity

(physical, chemical and/or biological) injurious to health.

NOTE 1: Definition (EU) “Food shall be deemed to be unsafe if it is considered to be (a)

injurious to health; (b) unfit for human consumption.” Regulation (EC) 178/2002, Article 14

gives a further detailed definition of food safety requirements.

Scope (EU) “Food safety is a result of several factors including the respect of mandatory

requirements, the implementation of food safety programmes established and operated by

food business operators and the implementation of the HACCP system.”

Food safety hazard: biological, chemical or physical agent in, or condition of, food with the

potential to cause an adverse health effect.

See also Hazard.

HACCP: A system that identifies, evaluates, and controls hazards which are significant for

food safety.

Hazard: the potential to jeopardise quality.

See also Food safety hazard

Monitor: Conducting a planned sequence of measurements to assess whether control

measures are operating as intended and meeting specified limits.

Mycotoxin: refer to toxic substances produced by certain moulds and fungus during their

metabolic cycles. Mycotoxins can be both harmful (Ochratoxin) and useful (penicillin) when

ingested.

Ochratoxin A (OTA): is a mycotoxin produced by several species of the mould genera

Aspergillus and Penicillium. It is acknowledged to be responsible for certain kidney

pathologies in pigs and is suspected of causing some human kidney pathologies. It has been

shown in rats that OTA has carcinogenic and immunotoxic properties.


Prerequisite Program (Operational PRP): food safety basic conditions and activities that

are necessary to maintain a hygienic environment throughout the food chain suitable for the

production, handling and provision of safe end products and safe food for human

consumption.

EDITORIAL NOTE: PRP is a term used in ISO 22000 to refer to the control measures to bring

food safety hazards under control. With that, PRP is a hotchpotch of CP’s, Critical Limits,

Preventive Actions and Corrections. The HACCP methodology works with the term, General

Control Measures, or for specific sectors the terms GAP GMP. These terms are synonymous

to Operational PRP of ISO 22000.

As the above terms cannot specifically be connected to individual steps in the process, and

as the programs concentrate on food safety only, the author of this manual thought it best to

work with the term CP in conjunction with Quality Management Plan. See the respective

definitions.

Preventive action: action to eliminate the cause for a potential nonconformity or other

undesirable potential situation.

NOTE 1: There can be more than one cause for a potential nonconformity.

NOTE 2: Preventive action is taken to prevent occurrence whereas corrective action is taken

to prevent recurrence.

Procedure: specified way to carry out an activity or a process.

NOTE 1: procedures can be documented or not.

NOTE 2: when a procedure is documented, the term “written procedure” or “documented

procedure” is frequently used. The document that contains a procedure can be called a

“procedure document”.

Process: Set of interrelated or interacting activities which transforms inputs to outputs.

NOTE 1: Inputs to a process are generally outputs of other processes.

NOTE 2: Processes in an organisation are generally planned and carried out under controlled

conditions to add value.

Product: result of a process.

NOTE 1: there are four generic product categories, as follows: - services (to internal and external customers); - software (computer program, dictionary); - hardware (coffee, cocoa beans, tea, nuts, engine mechanical parts) - processed materials (grind coffee, chocolate bars)

Qualification: an official record showing that you have finished a training course or have the

necessary skills (Cambridge English dictionary) (see also the definition of competence).

Qualified: having finished a training course, or having particular skills (Cambridge English

definition).

Quality: refers to all those features of a product (or service) which are required by the

customer.

NOTE 1: Quality today embraces in addition to product quality also: - the service, organisational, management and in particular process quality; - the compliance with third-party specifications; - the perception of its excellence at a competitive price;

NOTE 2: Quality is associated with all the activities related to - Standardisation; - quality management/assurance as a strategic discipline in company

management; - quality control, certification and accreditation; - quality marks and labels etc.

NOTE 3: Quality has changed its notion: - from product quality that needed to be inspected; - through process quality that needed to be controlled; - to quality assurance systems as a behaviour or mode of thinking being an

essential element of the company strategy.

Quality is thus integrated in the management strategy of an organisation/company based on

the overall commitment of the whole management staff and labour force to continuously

improve value for their customers, for the organisation/company itself, and the society as a

whole.


Quality Assurance System (QA): QA Systems enable the application and verification of

measures intended to assure the quality and safety of food. They are required at each step in

the food production chain to ensure safe food and to show compliance with regulatory and

customer requirements.

NOTE 1: Quality Assurance Systems are part of the Quality Management. They define the

organisational structure, the processes and procedures necessary to providing confidence

that quality requirements will be fulfilled.

NOTE 2: QA systems are generally not mandatory but increasingly adopted in the production

and processing of food products. Selection and application of a QA system can vary

according to the stage within the food chain, the size and capacities of the company, type of

product etc. QA systems may include: - Good Agricultural Practices (GAP); - Good Manufacturing Practices (GMP); - Good Hygiene Practices (GHP); - Good Distribution Practices (GDP); - Hazard Analysis and Critical Control Point (HACCP) systems.

Quality Management Plan: A document prepared in accordance with the principles of

HACCP to ensure control of hazards which are significant for food safety in the segment of

the food chain under consideration.

Quality Management System (QMS): "Quality management" means what the organization

does to ensure that its products or services satisfy the customer's quality requirements and

comply with any regulations applicable to those products or services.

NOTE 1: Please note the difference with Quality Assurance Systems above.

NOTE2: Food quality can only be maintained if all activities/processes related to food

production are subject to a systematic approach, i.e. integrated into a management system.

Since the beginning of the 1990s, QM Systems have proved good as systematic approach for

steering companies.

NOTE 3: Whereas the introduction of QM Systems is voluntary, product (food) safety

constitutes a legal requirement. Thus, the EU General Food Law (GFL) formulates vast

requirements regarding hygiene in the food industry. Furthermore, it stipulates the need to

establish traceability systems. An internal QM System offers an ideal frame for the

implementation of hygiene and traceability requirements. A comprehensive and systematic

HACCP-System can as well constitute the nucleus for a future QM System.

Quality objective: something sought, or aimed for, related to quality

NOTE 1: Quality objectives are generally based on the organisation’s quality policy.

NOTE 2: Quality objectives are generally specified for relevant functions and levels in the

organisation.

Quality policy: overall intentions and direction of an organisation related to quality as

formally expressed by top management.

NOTE 1: generally the quality policy is consistent with the overall policy, of the organisation

and provides a framework for the setting of quality objectives.

EDITORIAL NOTE: most smallholder organisations have a mission/vision statement in their

legal papers and can be used to base the quality policy upon.

Record: document stating results achieved in providing evidence of activities performed.

NOTE 1: records can be used, for example, to document traceability and to provide evidence

of verification, preventive action and corrective action.

Requirement: Need or expectation that is stated, generally implied or obligatory.

NOTE 1: “Generally implied” means that it is custom or common practice for the

organisations, its customers and other interested parties, that the need or expectation under

consideration is implied.

NOTE 2: A qualifier can be used to denote a specific type of requirement, e.g. product

requirement, quality requirement, customer requirement.

NOTE 3: Requirements can be generated by different interested parties.

Risk: is expressed as the probability that a hazard will occur and jeopardise quality. Formula:

Risk = Probability x Impact

With that, risk refers to both the probability that a hazard will occur and to the seriousness of

its impact on quality.


Safe moisture content: the moisture content at or below which toxigenic moulds cannot

grow. Relates to a minimum water activity for mould growth and toxin production.

Specification: document stating requirements.

Note: a specification can be related to activities (e.g. procedure document, process

specification and test specification), or products (e.g. product specification, performance

specification).

Step: A point, procedure, operation or stage in the food chain including raw materials, from

primary production to final consumption.

System: set of interrelated or interacting elements.

Target level: The acceptable level of a hazard in the final product, such as the regulatory

level of mycotoxins in a product description.

Validation: Obtaining evidence that the elements of the Quality Management Plan are

effective.

Verification: The application of methods, procedures, tests and other evaluations, in addition

to monitoring to determine compliance with the Quality Management Plan.

Qm Guidance Document 16

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