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Course: ISO 22000 2018 Food Safety Management Sy...
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ISO 22000 2018 Food Safety Management System - Lead Auditor Course

Evaluation - ISO 22000 2018 - Lead Auditor Course

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ISO 22000 Context of the organization

Understanding the organization and its context

The intent of this clause is to provide a high‐level, conceptual understanding of the important issues that can affect, either positively or negatively, the way the organization manages its food safety responsibilities. There are a variety of techniques that can be used to determine context. The most popular ones are the;

  • Competitive Profile Matrix (CPM)
  • Strengths, Weaknesses, Opportunities and Threats Analysis (SWOT)
  • Political, Economic, Socio-Cultural and Technological Analysis (PEST)

Issues identified should include positive and negative factors or conditions for consideration. Understanding the external context should be facilitated by considering,

  • Issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
  • Issues related to values, culture, knowledge and performance of the organization.
  • Issues arising from conditions related to climate, air quality, water quality, land use, existing contamination etc that can affect the organisation’s purpose
  • Issues from introduction of new competitors, contractors, subcontractors, suppliers, partners and providers, new technologies, new laws and the emergence of new occupations
  • New knowledge on products and their effect on food safety
  • Key drivers and trends relevant to the industry or sector having impact on the organization
  • Governance, organizational structure, roles and accountabilities
  • Policies, objectives and the strategies that are in place to achieve them
  • The capabilities, understood in terms of resources, knowledge and competence (e.g. capital, time, human resources, processes, systems and technologies)
  • Information systems, information flows and decision-making processes (both formal and informal)
  • Introduction of new products, materials, services, tools, software, premises and equipment
  • Relationships with, as well as perceptions and values of workers
  • Working time arrangements and working conditions

These external and internal issues should be monitored and reviewed from time to time. Understanding of context shall be used to establish, implement, maintain and continually improve FSMS. Some of the issues that can be considered while deciding the context are

Example

Political factors – Unstable political conditions, high taxation rate, change in policies whenever a new Government comes to the office Economic factors – High cost of raw materials and manpower, currency fluctuations Social factors – Lack of skilled work force, frequent strikes and shutdowns Technological factors – Requirement for automation to improve efficiency and productivity, security threats from hackers

Understanding the needs and expectations of interested parties

“Interested parties” are those stakeholders who receive an organisation’s services, who may be impacted by them, or those parties who may otherwise have a significant interest in the organisation. The interested parties include both internal and external parties. Interested parties to be considered shall include but not limited to,

  • Legal and regulatory authorities
  • Suppliers
  • Contractors and subcontractors
  • Employees
  • Workers’ representatives
  • Owners
  • Shareholders
  • Clients
  • Visitors
  • Local community
  • Neighbours
  • General public
  • Non-governmental organizations (NGOs)
  • Certification bodies

For each interested party, an action plan to meet the needs and expectations shall be identified.  Interested party requirements are not necessarily requirements of the organization. Some interested party requirements reflect needs and expectations that are mandatory because they have been incorporated into laws, regulations, permits and licenses by governmental or even court decision. The organization may decide to voluntarily agree to or adopt other requirements of interested parties (e.g. entering into a contractual relationship, subscribing to a voluntary initiative). Once the organization adopts them, they become organizational requirements (i.e. compliance obligations) and are taken into account when planning the food safety management system. Needs and expectations may be either internal or external, depending on whether the interested party is internal or external. In addition, a certain type of party may have both internal and external concerns. When attempting to identify internal needs and expectations technological concerns, employee concerns, etc should be considered. When attempting to identify external needs and expectations, concerns arising from competition, society and culture, labour relations, statutory and regulatory issues, supply chain, food safety issues, economic issues, etc. should be considered.

Example

Employees expect satisfactory equipment, facilities, a safe environment and working conditions. The action plan to meet this is to identify the requirements, provide them, conduct internal verification audits etc. Collecting periodical feedback from employees will also help to know whether their requirements have been met. Regulatory bodies are another interested party who cannot be ignored. They expect the organisation to comply with the regulatory requirements such as obtaining regulatory license to operate, following pollution control norms and filing periodical returns.  Action plan is to identify the regulatory bodies in each market where the organisation operates and list all the requirements. Then assign responsible persons to procure licenses and timely renewal of those licenses.

Determining the scope of the food safety management system

The scope of the food safety management system is intended to clarify the physical and organizational boundaries to which the FSMS applies, especially if the organization is a part of a larger organization. An organization has the freedom and flexibility to define its boundaries. It may choose to implement the food safety standard throughout the entire organization, or only in a specific part of the organization, as long as the top management for that part has authority to establish a food safety management system. In setting the scope, the credibility of the food safety management system depends upon the choice of organizational boundaries. The organization considers the extent of control or influence that it can exert over activities, products and services considering a food safety perspective. Scoping should not be used to exclude activities, products, services, or facilities that have or can have significant food safety hazards, or to evade its compliance obligations. The scope is a factual and representative statement of the organization’s operations included within its food safety management system boundaries that should not mislead interested parties. The certification audit will cover only the products and boundaries specified in the scope of FSMS. The certificate issued will also have the scope mentioned in it.

Food safety management system

The organization retains authority and accountability to decide how it fulfils the requirements of the food safety standard, including the level of detail and extent to which it:

  • Establishes one or more processes to have confidence that it is controlled, carried out as planned and achieve the desired results
  • Integrates food safety management system requirements into its various business processes, such as product development, procurement, human resources, sales and marketing
  • Incorporates issues associated with the context of the organization and interested party requirements within its food safety management system.

If the standard is implemented for a specific part of an organization, policies, processes and documented information developed by other parts of the organization can be used to meet the requirements of the standard, provided they are applicable to those specific parts. Examples include corporate FSMS policies, education, training and competency programmes, and procurement controls.

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