ONE QUALITY MANAGEMENT SYSTEM Multiple standard compliance

Transcription

1 ONE QUALITY MANAGEMENT SYSTEM Multiple standard compliance Quality management for smallholder producer groups [May 2009]

2 ONE QUALITY MANAGEMENT SYSTEM Multiple standard compliance Quality management for smallholder producer groups [May 2009] Author: FAQ, Michiel Schoenmakers, Contributions: Fair Trade Original, Marjoleine Motz, Crecer, Benjamin Orellana, Twin, Anneke Theunissen, and coaches: Lorenzo Nigo,Teresa Blanco, Elena Marenco, Jhonny Gayoso, Doreen Chanje, Seth Gogoe, Joseph Ngubwa. Copies can be downloaded at 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

3 Table of Contents Table of Contents 3 0. Introduction Goal and target group Reading instructions Step plan Downloadable documents 6 1. Quality Quality of service Integrity of the chain quality Labour practice quality Food safety and quality 8 2. Multiple standard certification ISO 9001: ISO 22000: Other standards and guidelines 9 3. ISO 9001 basic principles Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships Plan Do Check Act Planning your quality system using the PDCA circle 15 PLAN Customer focus Customers Formation of quality team Flow charting and floor plan Flow charting Floor plans Tools for flow charting and floor plans Process identification and scope of Quality plan Basic processes at producer organisations Critical processes Support processes Scope of the quality plan Quality policy, objectives and targets Quality policy Quality objectives Quality targets Hazard and risk analysis The difference between hazards and risks Mandatory reasons for hazard and risk analysis Management reasons for hazard and risk analysis Hazard definition Hazard types Risk definition Risk analysis Risk analyses, a practical approach Risk analysis for support processes Risk analysis for organic activities Control points Definition of control point CP Control measures Critical limits Preventive Action Correction Responsibilities and working instructions Critical Control Points CCP control measures Corrective actions Responsibilities and working instructions 32 DO Monitoring and measuring Monitoring devices Monitoring and measuring Documentation and record keeping Document control system Necessary record keeping 35 Check Internal auditing Types of internal audits Compliance Audits Auditing for Continual Improvement How to audit (methodologies) How to audit (audit program sequence) When to audit (planning and scheduling) Auditor training 39 Act Management review Purpose Frequency Management responsibility Quality management system planning Responsibility, authority and communication Human resources 43 Annex 1 Terms and definitions 44

4 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 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 Best practices from all these pilots have been reworked into this Guidance Document. Presentation 0. Workshop objectives & methodologies.ppt Presentation 1. Opening presentation Puzzle pieces.ppt 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; QM Guidance document 16.docx 4/48

5 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. 8 Verification through internal audits 2 Customer identification 2A Products / Services 3 4 4A Critical Limits Control Points (CP) 4B Preventive Action 4C Monitoring 4D Correction 7 1 Management responsibility Customer requirements 2B Processes Hazard & Risk Analysis 5A 5 CCP selection Critical Control Points (CCP) Validation 2C Internal and external standards 5B Critical Limits 5C Preventive Action 5D Monitoring 5E Correction, Corrective action 6 Documentation and registration Figure 1: Basic approach towards building a risk based Quality Management System 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. QM Guidance document 16.docx 5/48

6 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 Step 6: the outcome of steps 1 5 are documented, and practical working instructions for staff are prepared, see section 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 6/48

7 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 7/48

8 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 8/48

9 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 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 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. Presentation 2. Legislation and market requirements.ppt 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. QM Guidance document 16.docx 9/48

10 3. ISO 9001 basic principles Presentation 3. Introduction to ISO 9001.ppt ISO 9001 in conjunction with ISO 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. Customer focus Mutual benefits vs. suppliers Leadership 2. Factual approach to 7. decision making 3. Involvement of people 6. Continual improvement 5. System approach to management 4. Process approach Figure 2: 8 Quality Management Principles 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. QM Guidance document 16.docx 10/48

11 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). 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. 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. QM Guidance document 16.docx 11/48

12 People openly discussing problems and issues. Presentation 4. Introduction to process management.ppt 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. QM Guidance document 16.docx 12/48

13 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 13/48

14 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 14/48

15 4. Plan Do Check Act 6. Continual improvement The most used instrument behind the continual improvement principle, see section 3.6 is the so called Plan Do Check Act circle. See below. PLAN Develop and document the sytem ACT Improve the system DO Implement the system Check Monitor the system Figure 3: PDCA Circle 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). QM Guidance document 16.docx 15/48

16 The Plan Do Check Act circle combined with the 8 quality management principles can be depicted as follows: Continual improvement of the Quality Management System Customers, Members Stakeholders Management responsibility Customers, Members Stakeholders Resource management Measurement, analysis and improvement Requirements Satisfaction INPUT Product realisation PRODUCT OUTPUT Figure 4: Model of a process based quality management system QM Guidance document 16.docx 16/48

17 PLAN DEVELOP & DOCUMENT THE SYSTEM

18 8. Mutual benefits vs. suppliers 1.Customer focus 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. 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. 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. QM Guidance document 16.docx 18/48

19 2. Leadership 3.Involvement of people Reference to standard ISO 22000, paragraph Food safety team: A food safety team shall be appointed. The food safety team shall have a combination of multidisciplinary 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. 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 Team 1 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. 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. 1 ISO 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. QM Guidance document 16.docx 19/48

20 7. Flow charting and floor plan Flow charts and floor plans are used as a starting point for drawing up the Quality manual. Reference to standard ISO , paragraph : 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. Action or process 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 subprocess ("make bread") within a larger process. Document A hand written or printed document or report. Decision A decision or branching point. Lines representing different decisions emerge from different points of the diamond. Input/output 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. Subroutine Database 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. QM Guidance document 16.docx 20/48

21 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. Exercise floor plans Make floor plans for all facilities that are under control of your process, see example at 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 inprocess 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. QM Guidance document 16.docx 21/48

22 8. Process identification and scope of Quality plan Reference to standard ISO 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 uses the term Food Safety System. 4. Process approach 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 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 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. QM Guidance document 16.docx 22/48

23 8. Mutual benefits vs. suppliers 1.Customer focus Reference to standard ISO 9001, 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 Exercise with the for quality top management policy. Check whether your organisation s mission statement reflects your customers requirements, and whether it is in tune with standards and legislation. If not, adjust. 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 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 QM Guidance document 16.docx 23/48

24 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). 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. QM Guidance document 16.docx 24/48

25 7. Factual approach to decision making 1.Customer focus 5. System approach to management 4. Process approach 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. 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 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 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 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. QM Guidance document 16.docx 25/48

26 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 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 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 26/48

27 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. Presentation 5. Risk analysis & critical limits.ppt Reference to standard ISO 22000, paragraph 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 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: Figure 5: Risk selection grid Hazards scoring below 3 are not significant hazards that do not need to be considered. 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. QM Guidance document 16.docx 27/48

28 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. Exercise Consult the flow charts and floor plans as developed in the previous exercises. Number the process steps, with matching criterianumbers 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 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. Figure 6: Risk selection sheet 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 Risk analysis for support processes Unless you are going for a HACCP or ISO 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. QM Guidance document 16.docx 28/48

29 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 29/48

30 7. Factual approach to decision making 5. System approach to management Note Although often used, the term Control Point is not defined in ISO 9001:2008 or HACCP or ISO ISO 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 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) CP Control measures 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. Control Points should be brought under control through different control measures: Critical limits, Preventive actions and Corrections 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 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 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 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. QM Guidance document 16.docx 30/48

31 7. Factual approach to decision making 5. System approach to management 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. 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: Q1: Have you identified significant hazards In this step? (Hazards scoring 3 to 9 are considered significant) YES This step is a CP Q2: Are preventive actions and corrections in place to prevent the risk from happening? YES Q3: Will a subsequent step prevent, eliminate or reduce the risk to the quality of the final product? YES This step is a CP NO NO NO The hazard is not relevant enough. No CP no CCP Develop preventive actions and corrections to bring this CP under control Critical Control Point CCP Figure 7: CCP decision tree 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. QM Guidance document 16.docx 31/48

32 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 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 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 retraining of staff. The corrective actions may include: Adjusting the process; Adjustment/correction of process conditions 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 32/48

33 DO IMPLEMENT THE SYSTEM

34 13. Monitoring and measuring 7. Factual approach to decision making 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. With documenting the CP s, CCP s critical limits, preventive actions corrections and corrective actions, you already started working out your monitoring system 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 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. QM Guidance document 16.docx 34/48

35 7. Factual approach to decision making 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. 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 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. QM Guidance document 16.docx 35/48

36 Check MONITOR THE SYSTEM

37 7. Factual approach to decision making 6. Continual improvement Reference to standard ISO Internal audit: The organization shall conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and b) is effectively implemented and maintained. 15. 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) 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. QM Guidance document 16.docx 37/48

38 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: 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 38/48

39 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 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 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 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 39/48

40 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 40/48

41 Act IMPROVE THE SYSTEM (= MANAGEMENT RESPONSIBILITY)