QUESTION

Discuss the eight principles of quality management system according to ISO 9000
standards , Discuss documentation requirements in ISO 22000

Principles of Quality Management System and Documentation Requirements

1. Principles of Quality Management System

The first principle in the content of “Principles of Quality Management System” is “Customer Focus”. It is easy to understand this key concept, as the importance of satisfying the current and future needs of customers (also related parties, like owner and staff) is emphasized. Total customers’ satisfaction, achieved by identifying and meeting customers’ requirements, can bring the maximum benefit for the organization. Then the second principle is “Leadership”. I admire the strategic and visionary leadership of our top management and the unity of purpose and direction of our organization. Also, I find that for credible and reliable leadership, it is necessary to lead the organization with a mission and a vision, which can build up the sense of identity and the future aspiration of our organization. This principle can motivate and engage people in the organization, which complies with the next principle, “Engagement of People”. It is agreed by many different activists’ theories and also the content explains that the capability of achieving determined results is actually enhanced by involving people in the process. The principle “Process Approach” is such an essential idea introduced in the content. It represents a sequence of activities with a clearly defined input and, also, it can make sure that the given output meets the requirements. The move of “Improvement” also relates to the change of something to a better condition and it’s a never-ending philosophy for an organization. I am glad to find that the principle “Evidence-Based Decision Making” has been well executed by our organization. According to the content, the decisions are actually based on the analysis and the evaluation of facts and data. It’s a very high standard we should chase for. I am quite impressed by the last principle, “Relationship Management”. I am surprised that the content shows a well-organized chart to illustrate the different types of relationships, between the entity and its, like the inside relationship and the outside relationship. It’s easier for us to absorb different concepts. Finally, the move to “Continual Improvement” signifies a very constructive phase. The key focus of this principle is ‘substantial’ and ‘continual’. I believe the organization must be extended and improved time to time, either on a smaller scale or a larger scale.

1.1. Customer Focus

An organization which is aligning its main emphasis to customer focus will promote the effective use of the principle, its implication, and also the expected benefits to all members and stakeholders. In conclusion, customer focus is based on providing reliable and sustainable customer satisfaction and can help the organization to achieve sustainable success. This is a key factor that could help in strategic direction, especially in the area that an organization needs to differentiate and develop competitive advantages.

By having a customer-focused culture, organizations will ensure that all members understand the importance of meeting and exceeding customer expectations. This will facilitate the definition and realization of quality goals and engage every member of the organization to contribute to the process. As a result, a customer-focused organization will be able to increase effectiveness, efficiency, and flexibility. Moreover, it will result in continuous improvement in products and services, fostering innovation, capturing new markets, and enhancing reputation and building up customer loyalty.

Organizations might use different market research methods and customer satisfaction surveys to collect and understand customer needs and expectations. These commonly used methods include suggestion boxes, customer complaint and feedback systems, direct contact with customers, and sales and after-sales information and data analysis.

According to “Principles of Quality Management System,” the first principle of an effective quality management system is having a customer focus. This requires the organization to understand current and future customer needs, meet customer requirements, and strive to exceed customer expectations. In other words, all quality management initiatives and activities must be directed and shaped by the needs and expectations of customers. This is vital for the organization to ensure continuous customer satisfaction.

1.2. Leadership

Guideline 1. The section 1.2. Leadership states, “Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.” The quality management should be championed by top management. It is important that the top management should create an overall environment in which the quality management can work and thrive. For example, the top management should provide leadership and create a unity of purpose and direction. They should create and maintain the internal environment in which people can become involved in achieving the organization’s objectives. Also, they should ensure that all relevant and critical organizational issues are being addressed and that the process approach is adopted. The top management should encourage, assist, and motivate employees at all levels in order to fully utilize their abilities, skills, and knowledge for the benefit of themselves and the organization. Also, they should provide the required resources. These resources shall include human resources, facilities, and training opportunities. They should monitor and assess the performance, effectiveness, and efficiency of the quality management system, and ensure that the system can be maintained, renewed, and continually improved. This monitoring and assessing process should also cover the customers’ satisfaction, the performance of the product, as well as the performance of the employees. The top management should foster a good relationship with other stakeholders such as suppliers, partners, and society as a whole, and it will help to enhance confidence for the organization by shareholders.

1.3. Engagement of People

The concept of engaging people in the quality management system is associated with creating a climate where people become fully involved in achieving the quality objectives of the organization. People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit. By implementing “Principles of Quality Management System,” focusing on customer, leadership, process approach, engagement of people, continual improvement, evidence-based decision and relationship management, and well-planned documentation in ISO 22000, an organization is able to ensure that the needs and expectations of both the employees and the customers are met. This principle encourages the power of both leadership and teamwork. It is proved that an engaged employee is more likely to help the organization succeed and being achieved in a high-quality system, which should result in much greater efficiency for the organization and a much higher level of customer satisfaction. Publicizing the quality policy and any quality objectives across the organization lets the employee know what the overall plan is and where their work fits into the bigger picture of the organization. Sharing in the benefits of quality success through, for example, personal development training for employees and recognizing and rewarding achievements is another good way to engage employees. Researches and practices are continuously conducted to improve the effectiveness of the engagement of people in the quality management system. For example, new advanced technology leads to the possibilities of working in teams across the world and to the development of a virtual reality working environment. Work design, work rotation, and job enlargement are also important parts of the practices to ensure the principle of engaging people is being achieved. This is because a well-planned and proper work design or job enlargement not only helps to reduce the repetitiveness of doing simple and monotonous jobs but also helps to make it more interesting and creates greater satisfaction for the employee. Also, different people have different levels of expectation for their work. By providing a broader type of work, it will help to stimulate the motivation and creativity for the employee. Last but not least, all the success of engagement of people in the quality management system will lead to improvement. This will direct to the achievement of the principle of continual improvement.

1.4. Process Approach

Well-run processes can be an advantage to any organization. In using a process approach, everyone, whether it be top level or bottom level, is focused on what is happening within the process. This is important to make sure the process is efficient all the time and if not, corrective action can be made. So what exactly is a process approach? And what does it mean for an organization? A process approach often emphasizes the importance of determining what the desired outcome of the process is and finding the most effective and efficient methods of achieving it. This means putting the customer first and focusing on their satisfaction. In terms of quality management system, this equates to the same thing. Quality management systems need to be effectively used as a vehicle for achieving organizational targets and to direct areas to where improvements may be necessary. In order to do this, the system must be applied and this in turn means that it needs to be focused on what actually goes on within the organization. The process approach can also be referred to as process management. This is due to the immediate impact it has in some areas of the business when these methods are implemented. If a process is overwhelmed with long waiting times or unnecessary activities, then this increases the risk of it being unproductive or costly, without there being any measures in place to prevent that. When a process is being managed and an approach is being implemented, it means that those involved can monitor the process’s efficiency. Through assessing the key activities, finding ways to optimize it and making everyone aware of their own importance, each process becomes slick and will achieve the desired results which will be shared along the total outcome of the process and the customer satisfaction overall. The application of a process approach in the audit, for example, this means the auditors and the auditee’s system can be examined by means of looking into what process or method is in place to reach a certain goal. Through comparing the expectations of the process with what is actually demonstrated, this will give an accurate view of how successful the organization’s methods are. Take for example a manager who is appointed as a responsible person when an audit is planned. By using the process approach, it enables both the manager and the auditor to come together in planning, knowing what is required and what the end objective will be. This balances out the responsibility, reduces waiting times and ultimately means the inspection will be in line with the expected criteria set out.

1.5. Improvement

Improvement is an ongoing activity that is focused on increasing the effectiveness and efficiency of the quality management system and its processes. The current state of the quality management system is assessed through data such as internal audit results, monitoring and measurement results, and audit results of the food safety management system. The analysis and evaluation of this data can lead to a number of different “improvement opportunities,” such as the existence of a new customer need or expectation, a change in local regulations, or new technology that could be used to improve a process. These opportunities could be focused on individual processes or on the quality management system as a whole. Common improvement tools include the Plan-Do-Check-Act model that forms the basis for most food safety management system standards, and the wider use of quality tools such as “Six Sigma,” which aims to improve business processes by identifying and removing the causes of defects and minimizing variability in manufacturing and business processes. When selecting an “improvement opportunity,” consideration should be given to the prioritization of such opportunities so that the resources required for an improvement can be prioritized and focused on the most important improvements needed. There should be a clear program for implementing improvements, which can vary from simple changes to documented methods or procedures, or the introduction of new equipment or IT systems. All changes should be subject to some form of review to demonstrate that the change has resulted in the improvement it was supposed to achieve. The state of the quality management system is re-assessed after an implementation to ensure that the improvement has actually been delivered. For example, if the improvement concerned reducing the number of non-conformities in the supplier approval process then the number of such non-conformities would be monitored after the improvement has been implemented. Also, different processes use their own monitoring techniques to check that the process is effective. For example, critical control points in the food safety management system will have monitoring and measurement so that, if it goes out of control, the output of the process can be invalid and corrective actions can be implemented before a defective product is produced. All of these monitoring results are also forms of input to the improvement process and the food safety management system is carefully designed to build in the use of objective, factual data to assist with the continual improvement of the system.

1.6. Evidence-Based Decision Making

This means that you make a decision based on evidence that something is the case. You need to have evidence to prove that your decision is either right or wrong because without evidence anybody might dispute your decision. There are many forms of evidence such as experience which can be the most powerful form of evidence to have confidence in a decision. Data can be another powerful form of evidence to support decision making. It has long been said that ‘deeds matter, not words.’ ISO 22000:2018, the international standard specifying requirements for a food safety management system, also emphasizes the importance of evidence-based decision making in its latest edition. This risk-based standard requires the adoption of a systemic approach to evidence-based decision making in order to meet its stringent Food Safety Management System (FSMS) requirements. It not only insists that an organization shall ‘base decisions on the analysis and evaluation of data and information’ but also mandates that ‘the organization shall determine, provide and maintain the resources, including trained and competent personnel…’ to support such decision making. This clear focus on having the right resources to drive effective, evidence-based decision making reinforces the message that this is a senior management-led, proactive activity that is fundamental to the ongoing success of the FSMS. All departments and levels within an organization, including outside parties or suppliers, need to contribute to the process of evidence-based decision making. When taking decisions affecting the FSMS, ISO 22000:2018 requires that ‘the organization shall ensure that the integrity of the FSMS is maintained’ and ‘data and information…shall be analyzed and evaluated.’ I hope you have another clear view of evidence-based decision making. Nowadays, in the modern and ever-more complex organizational environment, practising evidence-based decision making is considered a key element of successful management. ISO 22000:2018 secures its leading role in food safety management by requiring a structured and systemic approach based on clear leadership, the right resources and a culture that allows decisions to be verified and evaluated through evidence. Well-designed sections of information in ISO 22000:2018 such as this help users of the standard to understand its natural flow and the underlying synergy between different components of a food management system, making the ultimate aim of ensuring food safety and compliance more achievable. So be careful when you make decision and choose the right approach, ask for evidence when necessary. Keep on asking yourself do you have enough evidence for your decision.

1.7. Relationship Management

Relationship management refers to the identification, analysis, and management of relationships with all stakeholders in the business’s environment for the purpose of improving business performance. An organization, in its quest to deliver value to all stakeholders consistently and effectively, has to manage and align the inter-relationship between interested parties. In quality management, the focus is not only on the relationship with customers. It is also on managing the relationships with all other stakeholders of the organization such as owners or shareholders, employees, suppliers, and society. The “Principles of Quality Management Systems” places increased emphasis on the importance of relationships and a more rounded view of business as a set of interconnected entities. The adoption of a quality management system should help improve the focus on a more balanced and sustained approach to stakeholder relationships. An organization adopting this kind of system is more likely to develop and improve the relationships both now and in the future. It should help to promote a continual and iterative focus on what meets the needs of all stakeholders, rather than being managed by the shifting short-term demands of a single stakeholder with the greatest power. By adopting a more focused approach to relationship management, the organization will seek to deliver synergistic value through more integrated and effective relationships. This principle provides a framework for developing a clear understanding and recognition of the inter-dependence that exists between stakeholders and the organization. By doing this, the organization can work towards a consistent harmonious value system that recognizes the needs and expectations of all stakeholders. The customer is at the heart of the “Principles of Quality Management Systems”. However, customer loyalty, satisfaction, and the identification of new opportunities are delivered through the key processes and relationships of the management system. The emphasis on relationship management within the “Principles of Quality Management Systems” recognizes this fact. It should focus the organization on finding and maintaining the most effective and efficient ways of delivering and improving products and services in a way that meets and exceeds the reasonable expectations of all stakeholder groups. In today’s business environment, relationship management is a key ingredient to the success of any organization, no matter how big or small the entity is. Every company is concerned with its customers, suppliers, and employees. The management of these relationships is carried out by senior and line managers, but it is important for all employees to feel involved. All activities in relationship management are focused on quality and customer satisfaction. Every organization has something called the “structure” where the organization looks from the point of view of the internal culture. This is rarely the same as the organizational chart, which tends to be rather fixed with lines of power and communication. However such relationships must be managed so that there is a clear understanding of the vision from the top of the organization and how, in achieving that vision, the inter-relationships between different parts of the organization can be aligned. The adoption of a quality management system based on the “Principles of Quality Management Systems” brings greater focus and a sustained pattern of customer satisfaction and stakeholders’ loyalty. In a recent study, it has found that companies who adopt this kind of quality management system tend to perform better in the market. So it is no wonder that organizations are increasingly finding that the adoption of a quality management system based on the “Principles of Quality Management Systems”, is a formula for success in the long term.

1.8. Continual Improvement

Continual improvement, a recurring theme of ISO 22000:2018, requires organizations to develop and maintain a culture where everyone is focused on improving the organization’s processes and products. Continual improvement is essential to the success of a business since it empowers organizations to focus on the approach and adopt innovative processes. Successful continual improvement drives an organization towards improved organizational performance, operational excellence, and sustainable business success. The standard requires organizations to develop and implement a continual improvement process or processes that will be used to ensure the effectiveness of the food safety management system (FSMS). These processes must be iterative and suited to the nature and scale of the organization in that the processes must be capable of delivering results in terms of the improvement of the organization’s overall performance. The standard, in clause 8.5, also requires that these approaches to continual improvement have the aim of improving the suitability, adequacy, and effectiveness of the FSMS and enabling its processes and objectives to be achieved. The output from the continual improvement processes should be improvements to the performance of the FSMS and to the achievement of the organization’s objectives. Such improvements could include improved control of processes, improved products and services that are more consistent in meeting customer requirements, cost minimization through lower rejects and customer returns, and increased customer satisfaction through effective control of any risks to customer satisfaction. By utilizing and deploying approaches to continual improvement that adhere to the principles of ISO 22000:2018, an organization will be well positioned to realize the benefits of a quality management system through improved performance and the achievement of its objectives.

2. Documentation Requirements in ISO 22000

2.1. General Documentation Requirements

2.2. Control of Documents

2.3. Control of Records

2.4. Management System Documentation

2.5. Food Safety Management System Documentation

2.6. Records of Training, Skills, Experience, and Qualifications

2.7. Records of Communication with External Interested Parties

2.8. Records of Product Characteristics

2.9. Records of Monitoring and Measuring Results

2.10. Records of Internal Audits

2.11. Records of Nonconformities and Corrective Actions

2.12. Records of Management Reviews

2.13. Records of Supplier Evaluation and Approval

2.14. Records of Product Withdrawals and Recalls

2.15. Records of Customer Complaints and Actions Taken

2.16. Records of Verification and Validation Activities

2.17. Records of Control of Monitoring and Measuring Devices

2.18. Records of Calibration Activities

2.19. Records of Maintenance Activities

2.20. Records of Pest Control Activities

2.21. Records of Cleaning and Sanitation Activities

2.22. Records of Personal Hygiene Practices

2.23. Records of Waste Management

2.24. Records of Product Traceability

2.25. Records of Emergency Preparedness and Response

2.26. Records of Outsourced Processes and Suppliers

2.27. Records of Packaging and Labeling

2.28. Records of Allergen Control

2.29. Records of Product Preservation and Storage

2.30. Records of Product Release

principles of quality management system according to ISO 9000 standards

 

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