Upload
doannhi
View
220
Download
0
Embed Size (px)
Citation preview
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
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
QM Guidance document 16.docx 5/48
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
QM Guidance document 16.docx 6/48
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.
QM Guidance document 16.docx 7/48
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.
QM Guidance document 16.docx 8/48
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.
QM Guidance document 16.docx 9/48
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
QM Guidance document 16.docx 10/48
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.
QM Guidance document 16.docx 11/48
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.
QM Guidance document 16.docx 12/48
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
QM Guidance document 16.docx 13/48
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.
QM Guidance document 16.docx 14/48
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.
QM Guidance document 16.docx 15/48
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
QM Guidance document 16.docx 16/48
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
QM Guidance document 16.docx 18/48
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
Reference to standard
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.
Reference to standard
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.
QM Guidance document 16.docx 19/48
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.
Reference to standard
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
QM Guidance document 16.docx 20/48
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.
Reference to standard
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
QM Guidance document 16.docx 21/48
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.
QM Guidance document 16.docx 22/48
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.
Reference to standard
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
QM Guidance document 16.docx 23/48
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.
Reference to standard
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
QM Guidance document 16.docx 24/48
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).
QM Guidance document 16.docx 25/48
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.
Reference to standard
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
QM Guidance document 16.docx 26/48
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.
QM Guidance document 16.docx 27/48
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
Reference to standard
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.
QM Guidance document 16.docx 28/48
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
QM Guidance document 16.docx 29/48
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.
QM Guidance document 16.docx 30/48
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
QM Guidance document 16.docx 31/48
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
QM Guidance document 16.docx 32/48
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.
QM Guidance document 16.docx 34/48
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.
Reference to standard
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
QM Guidance document 16.docx 35/48
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
QM Guidance document 16.docx 37/48
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
Reference to standard
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.
QM Guidance document 16.docx 38/48
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.
QM Guidance document 16.docx 39/48
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;
QM Guidance document 16.docx 40/48
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.
QM Guidance document 16.docx 42/48
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
Reference to standard
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.
QM Guidance document 16.docx 43/48
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.
QM Guidance document 16. 45/48
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.
QM Guidance document 16. 46/48
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.
QM Guidance document 16. 47/48
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.
QM Guidance document 16. 48/48
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.