Building a Food Safety Management System (ISO 22000:2018)
Short, concise explanation of clause 4
4 Context of the organization
4.1 Understanding the organization and its context
When developing an food safety management system, it is required that an organization understand the external environment in which it operates, its internal strengths and weaknesses, and how those internal and external factors can best be combined to achieve the intended results of its food safety management system. This requires a systematic and structured approach.
Environmental scanning and analysis, both external and internal, should not be an event that only occurs once a year, an organization must be continually monitoring factors known to be important to performance of its food safety management system, as well as be on the lookout for changes that may bring new factors into consideration.
Figure 1 highlights some of the major components considered during an environmental analysis.
Q. What tools can be used for Environmental Analysis??
A. 1. PESTLE (also called STEEP) Analysis
2. SWOT Analysis
4.2 Understanding the needs and expectations of interested parties
After understanding the context of the organization, it must be determined who therelevant interested parties are and what their needs and expectations are.
An assessment should be done to identify gaps between the objectives and plans of the organizationand the needs and interests of stakeholders, and take action to close the gaps where feasible.
Q. What tools can be used to understand the need and expectations of interested parties?
A. Stakeholder Analysis
4.3 Determining the scope of the food safety management system
Boundaries and applicability of the FSMS must be determined. The scope of the FSMS refers to the areas, locations, product or lines of products (or services), and processes or activities of the organization. It shall include the activities, processes, products or services that can have an influence on food safety of its end products. The environmental analysis and stakeholder analysis, both must serve as inputs when determining the scope of the FSMS.
Organization shall establish, implement, maintain, update and continually improve a FSMS, including the processes needed and their interactions, in accordance with requirements of ISO 22000:2018.
Clauses 4.1 and 4.2
What are the internal and external issues that are relevant to the organization’s purpose and affect its ability to achieve intended result of its food safety management system?
How does the organization review and monitor the relevant internal and external issues?
Who/what are the interested parties that are relevant to the food safety management system?
How does the organization review and monitor the requirements of relevant interested parties?
What is the scope of the food safety management system?
What are the boundaries applicable to the organization’s scope?
What manufacturing processes or services located at the site are not applicable to the organization’s scope?
How were external and internal issues and the expectations of interested parties, relevant to the organization’s requirements, considered when the organization’s scope was established?
May, 27, 2019