What could be the root cause for a non-conformance related to scope determination and documentation in an ISO 22000 Stage 1 audit?

one of my client got below non-conformities for there ISO 22000 stage 01 audit

NC - Scope was not determined and documented 

What would be the root cause for this NC ?

That sounds pretty straight forward to me - they need to define the scope and document it - which should have been done already at the the time the audit was even ordered.

Hi senarath,

Given this from ISO 22000:2018 Food safety management systems — Requirements for any organization in the food chain Section 4 Context of the Organization this is quite a fundamental regquirement and a shocker to fall down on in a document audit:

4.3 Determining the scope of the food safety management system

The organization shall determine the boundaries and applicability of the FSMS to establish its scope. The scope shall specify the products and services, processes and production site(s) that are included in the FSMS. The scope shall include the activities, processes, products or services that can have an influence on the food safety of its end products.

When determining this scope, the organization shall consider:

a) the external and internal issues referred to in 4.1 (Understanding the organization and its context)

b) the requirements referred to in 4.2 (Understanding the needs and expectations of interested parties)

The scope shall be available and maintained as documented information.

Determining the root cause can be done using the popular 5 Whys method. This involves asking why five times to get to the root cause of the problem.

Without knowing the organization there could be a number of possible root causes; incompetence, lack of knowledge, lack of management commitment and/or lack of resources.

Kind regards,

Tony