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Clause 6ISO 22000:2018 · Requirements guide

ISO 22000 clause 6: plan risks, objectives and changes coherently

Clause 6 of ISO 22000 addresses planning for the food safety management system: risks and opportunities, objectives and changes. Its purpose is to keep the system capable of achieving its intended results. This organisational planning is connected with, but distinct from, the product and process hazard analysis required in clause 8.5.

Part ofISO 22000:2018 requirements guide|Reading time 7 min

What clause 6 requires in practice

Clause 6 covers planning at the level of the management system. It has three parts. Clause 6.1 asks the organisation to consider the context, party requirements and scope it has already established and decide which risks and opportunities need attention so that the system can reach its intended results, strengthen helpful effects, limit unwanted ones and improve. It then asks for planned actions, integrated into FSMS processes, with a way to judge their effect, in proportion to the consequences. Clause 6.2 asks for objectives at relevant functions and levels, with plans for achieving them. Clause 6.3 asks that changes to the system, including changes of personnel, are carried out and communicated in a planned way.

A note in 6.1 limits risk here to the performance of the system, and keeps food safety hazard control within clause 8.

6.1: address risks and opportunities affecting the FSMS

Consider the context, interested-party requirements and scope when determining risks and opportunities that need attention. The focus is the performance and effectiveness of the management system. Examples to investigate include loss of essential competence, unreliable communication of supplier changes or growth that exceeds the capacity of existing verification arrangements.

Plan actions, integrate them into FSMS processes and evaluate their effectiveness. The response should be proportionate to its effects on food safety requirements, conformity of products and services and relevant food-chain requirements. A risk register can organise thinking, but recording a rating without assigning practical action achieves little.

Keep this work distinct from identifying and assessing biological, chemical or physical food safety hazards. A general business risk method cannot establish the adequacy of a process control. Conversely, a complete hazard analysis does not resolve a management weakness such as unclear responsibility for maintaining the information on which that analysis depends.

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6.2: establish objectives and a way to achieve them

Objectives should support the policy and take applicable food safety requirements into account. Establish them at relevant functions and levels, make them measurable where practicable, monitor and verify them, communicate them and keep them current. Retain documented information about the objectives.

Planning under 6.2.2 identifies what will be done, the resources, responsibility, timing and evaluation of results. An objective such as improving the completeness of traceability evidence becomes useful when the organisation defines the affected process, the starting position and the measure used to judge progress.

Avoid targets that discourage reporting. “No concerns reported” can look favourable while hiding problems. Consider whether the measure reflects effective control or merely the absence of recorded information. A target must not authorise departure from an applicable food safety requirement when it becomes difficult to achieve.

6.3: plan and communicate changes

Changes to the FSMS, including personnel changes, need planned implementation and communication. Consider the purpose and potential consequences, continued system integrity, available resources and allocation of responsibilities and authorities. Relevant changes may involve products, equipment, sites, providers or the people making technical decisions.

Connect business change with the food safety team before introduction. Determine whether product information, process diagrams, PRPs, hazard analysis, control validation, labels or monitoring arrangements need review. These are practical links to other clauses; they prevent an approved commercial change from bypassing the system.

Why coherent planning matters to the business

Without planning, a food safety system reacts to events and drifts from the business it is meant to serve. Clause 6 brings foresight: it asks what could weaken the system, what the system is trying to achieve and how change will be handled. This reduces surprises when a site expands, a key specialist leaves or a customer changes terms. It also gives management a basis for resourcing, because objectives and actions have owners and measures. Teams that keep management-system planning distinct from hazard analysis avoid a common trap, where a single risk list tries to serve both purposes and serves neither well.

How to plan risks, objectives and changes together

Treat clause 6 as one planning loop in which the three parts feed each other. Keep each part brief and connected to the others, because separate planning documents for risks, objectives and change tend to drift apart and be ignored by operating teams.

  1. Start from the context and party requirements and list weaknesses that could stop the system reaching its results, keeping hazards separate.
  2. Select the few that matter most and assign an action, an owner and a way of judging whether it worked.
  3. Turn the policy into a small set of objectives, each with a defined measure and population.
  4. Plan resources, responsibilities and timing for every objective and action.
  5. Add a change check to existing project and approval routes so that food safety review happens before introduction.
  6. Report progress to top management and adjust plans or resources where results fall short.
  7. Review the whole plan when scope, products or leadership change.

Illustrative example: manufacturing capacity increases

Illustrative example 1

A hypothetical food manufacturer adds a second shift. The organisational risk is not simply “more production”; it includes whether competent supervision, verification and escalation remain available. Management checks the proposed responsibilities and resources before treating the existing daytime arrangement as sufficient.

Illustrative example 2

The food safety team also assesses any changes in process conditions and information relevant to hazard control. The two planning levels interact. After introduction, management reviews evidence from the new shift instead of assuming that a staffing schedule proves the expanded system works.

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Illustrative example: a construction catering contract expands

A hypothetical caterer adds several construction-site service points. It plans communications, transport interfaces, staff competence and the resources needed to maintain its FSMS. A useful objective could concern the reliability of specified traceability information, provided the measure and required performance are clearly defined.

When the customer changes a delivery location, the caterer checks the implications before updating the route. It communicates relevant decisions to the food safety team and service personnel. This illustrates change management for the catering activity, not certification of the construction work.

Evidence and common planning weaknesses

What counts as evidence

Objective information is specifically documented. Other evidence can include action plans, decisions, reviews and records showing that changes were communicated and evaluated. The format should make responsibilities and follow-up clear. ISO 22000 does not prescribe a particular risk matrix or project-management tool.

Common weaknesses

An auditor may follow a relevant organisational issue into an action and ask how effectiveness was judged. Common weaknesses include objectives unrelated to actual priorities, repeated overdue actions without management decisions and changes reviewed only after implementation. Another is combining every food hazard and business concern into one list without explaining their different evaluation methods.

Explore each numbered part

6.1 · plan for risks and opportunities affecting the FSMS

Clause 6.1 addresses risks and opportunities affecting the performance of the food safety management system. This guide separates that work from operational hazard analysis, explains proportionate action and effectiveness evaluation, and uses food-manufacturing and catering examples to connect business changes with competence, resources, information and accountable follow-through.

6.2 · set food safety objectives that support decisions

Food safety objectives turn policy and requirements into results that the organisation can pursue and evaluate. This guide covers objective selection, communication, monitoring, verification and achievement planning. Manufacturing and food-distribution examples explain how to define a useful measure, preserve its meaning and avoid declaring success solely because an action or training session was completed.

6.3 · keep food safety arrangements coherent during change

A change can make existing food safety arrangements unsuitable even when the final product appears unchanged. This guide explains planning and communication under clause 6.3, including personnel changes, resources and reassigned authority. Food-manufacturing and catering examples show how to manage transition conditions and check that revised arrangements work before considering the change complete.

Frequently asked questions

Must all objectives be numerical?

They should be measurable where practicable and capable of meaningful monitoring and verification. Even where a simple number is unsuitable, define the intended result and the evidence that will demonstrate achievement.

Can planned change use an existing project process?

Yes, if it includes the necessary food safety considerations, responsibilities and communication. The effectiveness of the review matters more than the title of the form used.

Does a new supplier always require the same level of review?

Review should reflect the provision and its potential effects. Apply provider controls and involve the food safety team where the change could affect product information, hazards or existing control assumptions.

Turn planning into assigned, useful work

Sterling can support planning workshops, practical documentation and implementation follow-up. Agreed Effivity ISO & GRC automation software can help organise the management workflow alongside employee learning. Request a free consultation on your planned expansion or system priorities. Review Risk Management for organisational decision skills and ISO 22000 Food Safety Awareness for the FSMS foundation.

Return to leadership or the hub, and continue to clause 7 support.

Source basis and reading note. This is original practical guidance for ISO 22000. Use an authorised copy for definitive requirements. Illustrative examples describe hypothetical situations, not client results. Implementation methods are distinguished from requirements; independent bodies decide management-system certification outcomes. Issuer standard record: iso.org.
Disclaimer. This guide is provided for general information only. It is not the text of the standard, not legal or professional advice, and not a representation of how any certification body will assess your organisation. Sterling International Consulting accepts no liability for any loss arising from reliance on it. Requirements are applied to each organisation's own context through an engagement; contact us to implement ISO 22000 in your organisation.