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This information can be used to develop food safety and quality programs that meet the requirements of modern Regulatory, Customer and Industry Standards:
When considering the development, documentation, and implementation of Quality Management Systems within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
Quality Management systems are much more than a mechanism to meet customer expectations; they are a component of what is now considered ‘Best Practice’ for any food business. ISO is the international organization responsible for formatting, reviewing, and maintaining industry quality standards, including some related to food safety and quality. The organization is usually referred to simply as ISO. It is a common misconception that ISO is an acronym for International Standards Organization. I.S.O. originates from the Greek word isos, meaning equal. The organization’s English name is International Organization for standardization, while the French name is Organization Internationale de normalization. These initials would result in different acronyms in different languages; IOS in English and French OIN. The founders of the organization, therefore, chose ISO as the universal short form of its name, which in itself reflects the aim of the organization; to equalize or standardize across cultures. The Quality Management Systems processes within leading food businesses are strongly linked to the Continuous Improvement Process.
Quality Management Systems are based on the following principles, which are the foundation of the ISO Quality standards:
Without customers, food businesses do not survive! Food businesses must understand the rapidly changing and evolving requirements of customers, and anticipate customer requirements before they change. This process is aimed at meeting customer requirements through a strategic approach to identifying and managing customer needs.
The benefits of customer focus include:
The Senior Management of any food business must play a leading role within the management and review of the Customer Focus and Customer Complaints processes. This will ensure general awareness of product or service issues as they occur, rather than after a significant incident has occurred.
Customer Focus and Customer Complaint Management review activities must be scheduled, conducted, and recorded as elements of established Verification Activities within any food business.
Leadership is essential for any food business to meet customer and regulatory requirements and to continuously improve as a business operation. Strong leadership allows the quality objectives of the food business to be met with appropriate and sufficient support that filters from the senior management of the business through to all of the employees and contractors.
The benefits of leadership include:
A statement of commitment or quality policy statement is often used to define the business’ commitment to meeting the objectives defined by legislative, industry, customer, and moral requirements.
The involvement of people is one of the most important factors in integrating and maintaining an effective food safety and quality management system. Without the appropriate and adequate involvement of people, food safety and quality requirements cannot be met in a manner that facilitates the basic objectives of the quality management system.
The benefits of involving people include:
The organizational structure of a food business is commonly defined in a flow chart style or Organogram. This format defines positional responsibility and accountability regarding all aspects of the business, including those for financial, food safety, food quality, and occupational health and safety. Within the food safety and quality context, all job positions that have any level of food safety or quality responsibilities must be nominated within the organizational structure. These positions also should have documented positional descriptions.
Organizational structures should also include the clear designation of which positions or staff will cover other positions when they are unavailable to facilitate their required tasks. ‘Absence covering’ is commonly nominated in either the Organogram or Positional Descriptions.
Positional descriptions, also often referred to as Duty Statements, Job Descriptions, or Employee Responsibilities, generally define the scope and purpose of a positions’ interactions within the food business. It is important that all food safety and quality responsibilities and accountabilities, no matter how significant, are nominated within the positional description. This is most important within multi-sited food businesses, where the company is led by one management group, but each site or department is responsible and accountable for the food safety and quality activities within their specified scope of management.
Positional descriptions can also be used as a performance tool. This is commonly applied where the nominated requirements of the positional description are used to format Key Performance Indicators, which are used to measure the performance of that particular position.
Within smaller food businesses, it is often appropriate to list the requirements of positional descriptions within the Organizational Structure. This is often done in dot point form, to ensure simplicity and traceability regarding the responsibility for designated food safety and quality requirements.
Employee participation should be encouraged throughout all aspects of any food business’ operational food safety and systems. This not only provides a genuine sense of worth for employees but also provides an opportunity to gather insight into the working elements of the business.
Ways in which employee participation can be achieved include:
A process approach defines the efficiency and effectiveness of any business operation. Businesses that successfully implement and manage an efficient and effective process approach are traditionally market leaders within their chosen field.
The benefits of a process approach include:
The identification and management of systems within any food business are important to ensure all elements of the business are implemented and managed in a way that meets customer requirements. Individual systems are more efficiently and effectively managed, rather than attempting to manage the entire business within one system. The systemic approach allows a clearly defined inter-relation between management elements and provides a platform on which Policy, Structure, Training, Awareness, Responsibility, Communication, Documentation, and Verification can be implemented, monitored, and managed.
The benefits of a systematic approach include:
Many food businesses identify their operational systems under commonly used categories, which may include the following:
Each system within any food business should be defined regarding its scope and purpose, and responsibilities, and accountability within the context of the holistic business operation.
Continuous improvement is all about developing and maintaining systems through which the business can always improve. The term continuous improvement refers to an ongoing need to improve the effectiveness of a management system. The effectiveness of any food safety or food quality system can be continually improved through the use of communications, management reviews, internal audits, corrective actions, system updates, and verification and validation activities.
Continuous Improvement is more of a philosophy than a process or system. It requires everyone in the food business, from senior management through to operational team members to adopt a mindset of continuously looking for ways to improve processes and systems by making them efficient and effective. In most contemporary food businesses, continuous improvement usually takes the form of process improvement activities or projects. A process improvement activity or project is a planned and structured activity to improve a process so that one or more of its outcomes are replaced by a more efficient or effective outcome.
Continuous Improvement relies on the following attributes to ensure success in the intended scope and purpose of the application:
The benefits of continuous improvement include market leadership through managing and applying a commitment to continually improving business performance, ability to ensure customer requirements are met, and customer expectations are exceeded through flexibility and quick reaction to customer demand, consistency in the business approach to improving operational capabilities, increased participation from people through training in the tools and methods of continual improvement, the ability to measure continuous improvement through the establishment of goals and targets, and through the acknowledgment of improvement activities.
A factual approach to decision-making defines a business’ ability to use accurate information and data as a foundation for decision-making.
The benefits of a factual approach to decision making include:
Businesses rely on their suppliers to provide the products and services required to produce outputs. In conjunction with other inputs, this provides the business with the ability to produce income, which is the primary objective of commerce-based businesses.
The benefits of mutually beneficial supplier relationships include:
A Quality Policy or Statement of Commitment is a documented commitment to fulfilling the objectives and requirements of the food safety and quality management systems, and may also include a Scope and Purpose. The statement should define the intent to supply safe and quality products, to meet customer expectations, and should also include references to relevant legislation and industry guidelines. The Quality Policy is usually signed by the most Senior Manager or multiple Senior Managers, and displayed, so that staff, visitors, and contractors can view it.
Quality policies are commonly included in induction training routines. This ensures that all staff are aware of the objectives of the food safety and quality activities implemented and managed by the food business.
As a component of best practice, relevant legislation, and certification standards, food businesses should have adequate insurance cover for public and product liability. This is intended to provide a safety net for a situation in which an incident occurs, which may or may not have a major impact upon customers or consumers. Any insurance policy initiated by the food business must be adequate regarding the risk level of, the intended use, and scope of distribution of the foods involved.
Insurance also provides a level of confidence regarding financial liabilities that may be incurred through the production and supply of food products.
A quality hazard is a factor that has the potential to fail to meet product specifications and/or customer requirements. Quality hazards are judged by consumers as to their levels of potency and are an expression of non-fulfilled requirements in foodstuffs. Quality hazards differ from food safety hazards regarding their non-threatening status in causing food illness.
Quality Hazards may be graded as follows:
Quality issues include:
The term QMS is often used in conjunction with the term TQM or Total Quality Management. Total Quality Management is a comprehensive and structured approach to organizational management that seeks to improve the quality of products and services through ongoing refinements in response to customer feedback. TQM requirements may be defined separately for a particular business or maybe in adherence to established standards such as ISO. As with a QMS, TQM can be applied to any size or type of food business. As a current focus of business operations, TQM is based on quality management from the customer’s point of view.
TQM processes are divided into four sequential categories, which are referred to as the PDCA cycle:
Food safety is a fundamental customer requirement, and therefore, is directly related to quality management. It is expected that all foods produced and supplied to customers are safe, and of substantial quality, with the customer’s requirements and expectations.
Originally, food safety and food quality standards were maintained as separate components, both in the application and regarding certification activities. Food industry certification standards have been extremely successful in merging safety and quality system components to produce formidable auditable standards, which are now considered and applied by thousands of food businesses globally.
With increasing food safety and food quality requirements imposed upon food businesses, it is important to recognize the role that safety and quality have come to play in the operational scope of many food industry sectors. The integration of quality aspects into food industry certification standards has dramatically increased the operational capabilities of food businesses in line with other industry sectors. This has had obvious effects, especially evident for larger multinational companies, many of which are recognized as Best Practice business management experts, not only within food industries but within any global industry sector.
The outcomes of merged food safety and food quality systems continue to produce positive outcomes within every food industry sector.
When applied successfully, merged safety and quality management systems offer:
Most merged certification standards employ the nomination and management of Quality Points and Quality Control Points, which are intended as the quality equivalents of Control Points and Critical Control Points within HACCP. These can be designated and implemented by using a process similar to that used within the HACCP process.
Risk Management principles can be applied throughout all sectors of all food industries and throughout all business systems, including food safety, food quality, workplace health and safety, finance, and operational management.
Risks are an unavoidable component of any business operation; Risk-taking is essential to progression and success, and failure is often a key part of learning. Although some risks are inevitable, this does not mean that attempting to recognize and manage risk will harm opportunities for creativity. It is important to keep in mind that risks are generally known by management, but are often poorly communicated. Usually, communicating risks down the chain of command is easy, but communicating risks up the chain of command is difficult. The risk management process is ongoing, and requires constant analysis, as agenda elements need to be decided, implemented, and managed.
Risk management processes are best managed by multidisciplinary teams. When risk management teams use proactive risk management, the continuous assessment creates data and information that can then be used for decision-making in all phases of the scope of the risk management activity. The team must ensure that risks are identified, managed, and resolved in a manner that is facilitative of continuous improvement for the business involved.
Contemporary risk management processes are inclusive of the following 5 elements:
Risk identification is the first step in the proactive risk management process. Risks must be identified before they can be managed. Risk identification provides the risk management team with opportunities, stimulus, and information that allow them to surface major risks before they have an impact upon the business. This risk identification step involves adequate and appropriate communication between team members and stakeholders to be successful. It is a powerful way to expose assumptions and differing viewpoints between all parties involved in the risk management process.
Risk analysis is the conversion of risk data into risk decision-making information. Thorough risk analysis ensures that the risk management team is managing appropriate risks. During this step the risk management can use a system that identifies the following:
Risk action planning is the third step in the risk management process; it turns risk information into decisions and actions. Planning involves developing actions to address individual risks, prioritizing risk actions, and creating an integrated risk management plan, which may contain the following:
Risk tracking is the fourth step in the risk management process. This step is where the risk management team monitors the status of risks and the actions it has taken to observe and control them. Risk tracking is essential to effective risk action plan implementation. This means defining the risk measures and triggering events needed to ensure that the planned risk actions are working. Tracking is the observation function of the risk action plan. Risk reviews are a recommended item to include in each program review.
Risk control is the final step in the proactive risk management process before proceeding back onto the risk analysis step. After the risk management team has chosen the risk measures and the triggering events, there is nothing defined about the risk management process – It simply becomes a component of the business management process. Risk control is intended to manage the risk action plans, correct for variations from the risk action plans, respond to triggering events, and improve the general risk management process.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Quality Management Systems Development requirements in relation to their items.
Document: A document provides guidance and/or direction for performing work, making decisions, or rendering judgments that affect the safety or quality of the products or services that customers receive.
Documented policies, procedures, work instructions, and schedules form the basis of any food safety and quality management system. The following documentation formats may be considered to ensure ongoing compliance with specified requirements for Quality Management Systems:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Quality Management Systems Documentation requirements in relation to their items.
You may wish to visit the Quality Management Systems Templates section of haccp.com for examples of Quality Management Systems documentation, record, and resource formats commonly applied within food safety and quality systems.
We have developed a methodology to ensure Food Safety and Quality Programs retain a sense of relevance among today’s vast business management systems… We call it the ‘SoLFS’ Method. SoLFS stands for Sequence of Logical Food Systems!
You’ll see the SoLFS method used throughout haccp.com, including our one-of-a-kind Food Safety and Quality Program Manual functionalities. The use of the SoLFS methodology from Development, through to the Formatting and Training of Food Safety and Quality Programs provides a consistent framework that facilitates consistent application and consistent outcomes.
We’ve defined what we believe to be the most logical manner of facilitating the Development, Formatting, and Training of Food Safety and Quality Programs:
Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation.
The implementation of Quality Management Systems within any food business requires genuine commitment from senior management, staff, and visitors to ensure the nominated goals of implementation are achievable on an ongoing basis. It is a step that requires significant planning and consideration of general and specific food business circumstances to ensure the outcomes of Quality Management Systems do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Quality Management Systems must include a clear definition of responsibilities and authorities for all levels of participation by senior management, staff, and visitors to the site.
When implementing Quality Management Systems within a food safety and quality system, you may wish to consider the following requirements before completion:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Quality Management Systems Implementation requirements in relation to their items.
Monitoring: Monitoring is the act of reviewing and confirming measurable parameters of a defined process or product status.
Monitoring requirements within food industry sectors are generally identified against limits of acceptability defined within HACCP plans, implementation procedures, and work instructions. Monitoring usually includes some element of record-keeping, which may be maintained manually or through digital systems. It is important to consider that advancements in technology have spawned many systems and processes which are self-monitored and or self-adjusted when variances are identified. Regardless of the system used; The goal of any monitoring activity is to provide sufficient evidence that any limit of acceptability has been met.
Traditional Quality Management Systems monitoring requirements include manual recording and the application of corrective actions when the results of monitoring are found to be outside acceptable limits. Corrective Actions should also generally be strongly linked to the monitoring process where applied to ensure full traceability of the applied actions.
Common monitoring activities and record formats may be applicable to Quality Management Systems:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Quality Management Systems Monitoring requirements in relation to their items.
You may wish to visit the Quality Management Systems Templates section of haccp.com for examples of Quality Management Systems documentation, record, and resource formats commonly applied within food safety and quality systems.
Corrective Action: Corrective action is mandatory action to be taken when a deviation to the Quality System occurs, particularly in relation to a Critical Control Point.
Preventative Action: At any step in the process where a hazard has been identified, preventative action must be put into place to prevent re-occurrence.
Corrective Action and Preventative Action is implemented to ensure that any identified non-conformance issues are documented, investigated, and rectified within appropriate time-frames. Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as being non-conforming outside nominated limits of acceptability. Preventative action is any action applied to prevent any identified non-conformance from reoccurring.
The outcomes of corrective and preventative actions should result in regained process control after effective application. Specified corrective actions are commonly linked to the HACCP Plans and the food business certification process.
Below are Corrective Action and Preventative Action examples which may be associated with Quality Management Systems related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Quality Management Systems Corrective Action requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action section of haccp.com for examples of best practice applications for this food safety and quality system element.
Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
Verification is the detailed review of all food safety and quality system elements to confirm that they are effectively developed, documented, implemented, monitored, and reviewed. All food safety and quality system elements, including documented policies, procedures, training, HACCP plans and their operational applications must be verified on an ongoing scheduled basis. The verification process commonly includes a defined schedule for which verification activities are required, how often they are conducted, who is responsible, and detailed documented procedures for each nominated verification activity.
The general goal of an established verification process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
The following examples of verification activities may be applicable to Quality Management Systems:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Quality Management Systems Verification requirements in relation to their items.
You may wish to visit the Verification Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Quality Management Systems Verification Key Points
Validation: The process of gathering evidence to provide a scientific basis for the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
Validation is the provision of evidence to support the limits of control or acceptability for food safety or quality parameters nominated within systemic elements. Limits of control or acceptability are commonly included within documented food safety and quality systems elements such as procedures, HACCP plans, and specifications.
Common sources of validation include regulatory and legislative standards, finished product specifications and customer requirements, industry codes of practice and guidelines, verified and validated research, historical product, and process control outcomes, and analytical testing.
The general goal of an established validation process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
Validation activities are commonly defined within the verification schedules and procedures of established food safety and quality management systems.
The following examples may be applicable to the validation of the limits of control or acceptability for Quality Management Systems:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Quality Management Systems Validation requirements in relation to their items.
You may wish to visit the Validation Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Skills and Knowledge; Skills and knowledge are attributes of human interactions commonly linked to competency within any specific job-related task.
Training and competency requirements for Quality Management Systems must be ongoing, including regular scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Quality Management Systems should have knowledge including:
Team members who have defined responsibilities regarding Quality Management Systems should have skills including:
Team members who have defined responsibilities regarding Quality Management Systems should have access to resources including:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Quality Management Systems Training, Competency, and Resources requirements in relation to their items.
You may wish to visit the Training, Competency, and Resources section of haccp.com for examples of best practice applications for this food safety and quality system element.
haccp.com was created to support food businesses and food industry professionals in achieving and maintaining the stringent requirements of food industry compliance.