01 Compliance with Requirements for Approval

All Oiva evaluation guidelines for approved food establishments.

1.1 Approval of Facilities, Structures and Equipment

Guide/version: 2112/04.02.00.01/2021/4, valid from 1.7.2021

To be taken into consideration:

This Guideline is applied to all establishments.
Finnish Food Authority maintains a register of approved establishments. The web address to the register of the establishments is provided at the end of this Guideline
The food business operator is responsible for the compliance of the establishment with regulatory requirements and requirements for approval, also when operations are carried out in rented facilities.
The evaluation carried out in this point concerns compliance with the structural requirements for approval of the establishments, including the compliance of facilities, structures and equipment with approval documents and compliance with regulatory requirements.
In addition, this point covers the evaluation of whether the plant has applied for and been granted approval for any fundamental changes implemented in the facilities, structures or equipment.
Facilities, structures and equipment are considered to include, for example, ceilings, walls, floors, water supply points, washing and disinfection systems, systems for draining of condensation water, washing water and wastewater as well as waste disposal systems, ventilations systems, and comparable matters. In this point, attention is paid to their availability, arrangement, materials and uses as well as hygiene.
In some cases the operator may reduce the risk caused by minor structural shortcomings by means of operational arrangements, if food safety can be ensured through the arrangements (an example provided under the grade Good).
A situation where the approval procedure has not been carried out in accordance with good governance or the approval decision fails to meet the requirements laid down in Decree 315/2021 on food control shall be taken into consideration in the evaluation. The operator is not responsible for shortcomings of this kind and they must be excluded from the evaluation.
Compliance with operational requirements for approval is evaluated in point 1.2.
The compliance of water intended for human consumption with requirements is evaluated in point 1.4 and the compliance of clean water in point 1.5.
The approvals of OHSE activities (Occupational Health, Safety & Environment) are evaluated in point 1.3.

Matters to be controlled:

The availability of approval documents and reports accompanying them for control at the establishment.
The compliance of the availability, arrangement, implementation, materials and use of facilities, structures and equipment with the approval documents.
The compliance of the availability, arrangement, implementation, the materials used and the application of facilities, structures and equipment with the valid regulatory requirements.
Compliance with the structural conditions laid down in the approval decision.
Implementation of fundamental structural changes arising from changes in legislation, and approvals applied for them.
Implementation of fundamental structural changes arising from the operator, and approvals applied for them.
The adequacy and suitability of own-check activities and, where appropriate, the plans are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

Operations comply with requirements as regards the matters that are controlled. For example:

Approval documents and reports accompanying them are up-to-date and available for control at the establishment, and the valid approvals of the establishment regarding facilities, structures and equipment can be verified from them.
The arrangement and the uses of the facilities comply with approval documents.
Structures and surfaces are made from materials that are easy to keep clean.
Drain systems for condensation water and wastewater are in place and comply with requirements.
The number and arrangement of water supply points comply with approval documents and regulatory requirements.
The structural conditions laid down in the approval decision are fulfilled.
Approval has been applied and granted for fundamental structural changes prior to the start of operation.
Needs for fundamental structural changes arising from changes in legislation have been implemented.

Good: There are small issues with the operations which do not impair food safety or mislead consumers. There are small issues with the operations which do not impair food safety or mislead consumers.

For example:

There are some minor shortcomings in the availability of approval documents for control.
Structures and surfaces and in some parts made from a material that is difficult to keep clean; it is in good condition, but in order to ensure food safety, surfaces have been protected or the cleaning of surfaces is carried out especially thoroughly, for example. In a case like this, the grade Good can be awarded, depending on the nature of the shortcoming.
There is no drain for washing water in a room where one should be provided pursuant to legislation, but the draining of washing water has been implemented in a hygienic manner.
The deadlines for the conditions laid down in the approval decision have not been kept, but activities are under progress.
The layout plan of the establishment is not up-to-date, but this shortcoming does not impair food safety.

To be corrected: There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time. There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time.

For example:

The facilities, structures and equipment, and their arrangement and uses differ substantially from those approved according to the approval documents.
There is no drain for washing water in a room where one should be provided pursuant to legislation, and the draining of washing water has not been implemented in a hygienic manner, and the shortcoming impairs food safety.
The facilities, structures and equipment, and their arrangement and uses comply with what is indicated in the approval documents, but some essential changes of legislation have not been taken into consideration as regards them.

Poor: There are issues with the operations which jeopardise food safety or considerably mislead consumers, or the operator has failed to comply with orders that have been issued. These issues must be rectified with immediate effect. There are issues with the operations which jeopardise food safety or considerably mislead consumers, or the operator has failed to comply with orders that have been issued. These issues must be rectified with immediate effect.

For example:

The establishment uses facilities for which no approval has been applied and granted, and the risks related to operation are not under control.
It has become known since the approval was granted that the material or substance used in the structures or equipment of the establishment jeopardises food safety, and the operator has failed to take corrective actions.
The establishment has failed to fulfil the structural conditions laid down in the approval decision to verify food safety.
The operator has failed to execute the orders issued with the grade to be corrected.

Legislation and guidelines (with any amendments) pertaining to the subject:

Regulation (EC) No 178/2002 on food law
Regulation (EU) 625/2017 on official controls and other official activities
Regulation (EC) No 852/2004 on the hygiene of foodstuffs
Regulation (EC) No 853/2004 on hygiene rules for food of animal origin
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on food control 315/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021
Decree of the Ministry of Agriculture and Forestry on actions related to TSE diseases concerning slaughterhouses and cutting plants 7/EEO/2009
Evira's Guide 16033: Approval of an establishment
Finnish Food Authority's Guide “TSE actions at establishments”, 5690/04.02.00.01/2020/6
Register maintained by Finnish Food Authority of approved establishments and storage facilities in meat, fish, milk and egg business: https://www.ruokavirasto.fi/en/companies/food-sector/setting-up-a-food-business/food-establishments/approved-establishments/.

Updates in version 3:

Guideline number 2112/04.02.00.01/2021/4 en replaces Guideline number 10263/3 en
List of legislation and guides has been updated.

1.2 Approval of Activities

Guide/version: 2113/04.02.00.01/2021/4, valid from 1.7.2021

To be taken into consideration:

This Guideline is applied to all establishments.
For the purposes of this Guideline, activities refer to the activities recorded in the register of establishments maintained by Finnish Food Authority; the approval of the control authority is required for these activities. The web address to the register of the establishments is provided at the end of this Guideline.
Only matters related to the approval of activities are evaluated in this point, e.g. do the activities carried out at the establishment comply with the activities for which an approval has been granted to the establishment.
The food business operator is responsible for the compliance of the operations with regulatory requirements and requirements for approval, also when the establishment carries out in their facilities operations that are not related to its actual own food production (for example, washing of food containers that are not the establishment's own containers).
In addition, compliance with any operational conditions laid down in the approval decision is to be evaluated in this point. For example, the approval of the establishment may be granted on the condition that activities or work stages requiring different levels of hygiene that are carried out in the same production facility must be separated in time and the production facility must be thoroughly cleaned between them.
The compliance of activities with the requirements for approval laid down in valid legislation and, for example, with the limits specified for production volumes (low-capacity slaughterhouses) is also evaluated in this point. For example, even if the facilities, structure and equipment of the establishment meet requirements as such, it is possible that the production volumes of the establishment have become too high in relation to the production facilities, equipment or number of personnel, and it is no longer possible to produce foodstuffs in a hygienic manner.
In addition, this point covers the evaluation of whether the plant has applied for and been granted approval for any fundamental changes implemented in its activities.
A situation where the approval procedure has not been carried out in accordance with good governance or the approval decision fails to meet the requirements laid down in Food Control Decree 315/2021 shall be taken into consideration in the evaluation. The operator is not responsible for shortcomings of this kind and they must be excluded from the evaluation.
The compliance of practical implementation of production with requirements and the compliance of operation with requirements not related to approvals are evaluated in each specific evaluation point.
The approvals of OHSE activities (Occupational Health, Safety & Environment) are evaluated in point 1.3.

Matters to be controlled:

The compliance of the activities carried out at the establishment in practice with the activities approved according to the approval documents.
The legality of the approvals of activities with respect to valid legislation.
The proportioning of operations to the capacity and permitted production volumes of the establishment so as to ensure the hygiene of operations.
Compliance in practice with the operational conditions laid down in the approval decision.
Approvals applied for the implementation of fundamental changes arising from the operator.
Implementation of fundamental needs for changes arising from changes in legislation, and approvals applied for them.
The adequacy and suitability of own-check activities and, where appropriate, the plans are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

Operations comply with requirements as regards the matters that are controlled. For example:

Approval documents and reports accompanying them are up-to-date and available for control at the establishment, and the valid approvals of the establishment regarding activities can be verified from them.
The activities carried out at the establishment comply with those approved according to approval documents.
The activities carried out at the establishment comply with the requirements laid down in valid legislation.
Approval has been applied and granted for fundamental changes prior to the start of the activity.
Any operational conditions laid down in the approval decision have been complied with in practice.
Needs for fundamental structural changes arising from changes in legislation have been implemented.

For example:

The activities carried out at the establishment comply, in essence, with those approved according to approval documents.
The activities carried out at the establishment comply, in essence, with the requirements laid down in valid legislation, but there may be some minor shortcomings which do not, however, impair food safety.
Approval has not been applied and granted for a fundamental change prior to the start of the activity, but this shortcoming does not impair food safety (a fundamental change may also increase food safety).
There are some minor shortcomings in compliance with the operational conditions laid down in the approval decision, but these do not impair food safety, however.

For example:

The activities carried out at the establishment do not comply with the activities for which the establishment has approval, and this shortcoming impairs food safety. For example, the establishment only has approval for cutting meat, but the establishment also produces minced meat.
The activities carried out at the establishment do not comply with the requirements laid down in valid legislation, or the operational conditions laid down in the approval decision have not been complied with.
Approval has not been applied and granted for a fundamental change prior to the start of the activity, and this shortcoming impairs food safety.
The activities comply with those indicated in the approval documents, but the operator has failed to take notice of regulatory requirements that have changed fundamentally.

For example:

The activities carried out at the establishment do not comply with the activities for which the establishment has approval, and this shortcoming jeopardises food safety.
The activities carried out at the establishment do not comply with the requirements laid down in valid legislation, and this shortcoming jeopardises food safety.
The operational conditions laid down in the approval decision have not been complied with.
Approval has not been applied and granted for a fundamental change prior to the start of the activity, and this shortcoming jeopardises food safety. For example, the establishment only has approval to slaughter swine, but the establishment has started to slaughter also sheep, and has failed to apply for approval for this change.
The operator has failed to execute the orders issued with the grade To be corrected.

Legislation and guidelines (with any amendments) pertaining to the subject:

Regulation (EC) No 178/2002 on food law
Regulation (EU) 625/2017 on official controls and other official activities
Regulation (EC) No 852/2004 on the hygiene of foodstuffs
Regulation (EC) No 853/2004 on hygiene rules for food of animal origin
Commission Implementing Regulation (EU) No 627/2019
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on food control 315/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021
Decree of the Ministry of Agriculture and Forestry on actions related to TSE diseases concerning slaughterhouses and cutting plants 7/EEO/2009
Evira's Guide 16033: Approval of an establishment
Finnish Food Authority's Guide “TSE actions at establishments”, 5690/04.02.00.01/2020/6
Register maintained by Finnish Food Authority of approved establishments and storage facilities in meat, fish, milk and egg business:
https://www.ruokavirasto.fi/en/companies/food-sector/setting-up-a-food-business/food-establishments/approved-establishments/.

Updates in version 4:

Guideline number 2113/04.02.00.01/2021/4 en replaces Guideline number 10264/3 en
List of legislation and guides has been updated.

1.3 Approval of TSE Activities

Guide/version: 2114/04.02.00.01/2021/4, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to cutting plants which are required to have specific approval as an establishment that separates TSE risk material.
The purpose of this point is to control that the cutting plant has approval for activities for which specific TSE approval is required.
The up-to-date status of the own-check activities and its compliance with the approval decision are also evaluated in this point.
The separation of material of animal origin from wastewater in the facilities of slaughterhouses and cutting plants where TSE risk material is being separated is evaluated in point 1.1.
The implementation of TSE operations in practice as well as the adequacy and suitability of the own-check activities are evaluated in point 8.1.

Matters to be controlled:

TSE approval documents are available for control at the establishment.
The establishment has applied for approval for all the TSE activities carried out at the establishment for which approval is required pursuant to legislation.
Any conditions laid down in the TSE approval decision as regards facilities, structures, utensils or equipment are complied with (compliance with operational conditions is controlled in point 8.1).

Excellent: Operations are in line with the requirements. Operations comply with requirements.

The establishment has applied for approval for all the TSE activities carried out at the establishment for which approval is required pursuant to legislation.

The facilities, structures and utensils etc. used in TSE activities comply with the approval documents and legislation.

Approval has been applied and granted for fundamental changes in operation prior to the implementation of the change.

Approval documents are available for control.

For example:

There are some minor shortcomings as concerns the availability of the approval documents of the establishment for control.

For example:

Approval documents are not available for control.
TSE activities do not comply with the approval decision or the conditions laid down in the decision.

For example:

The establishment has not applied for the specific approval required to carry out TSE activities.
The establishment has not applied for approval for a fundamental change in TSE activities.

Legislation and guidelines (with any amendments) pertaining to the subject:

Regulation (EC) No 999/2001, rules regarding TSEs
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on zoonoses 316/2021, Chapter 7
Decree of the Ministry of Agriculture and Forestry on food control 315/2021
Finnish Food Authority's Guide “TSE actions at slaughterhouses and cutting plants”
Finnish Food Authority's Guide “Guide for approval of an establishment”.

Updates in version 4:

List of guidelines has been updated.

1.4 Compliance of Water Intended for Human Consumption with Requirements

Guide/version: 2115/04.02.00.01/2021/4, valid from 2.1.2024

To be taken into consideration:

This point is to be controlled in all approved establishments that use water intended for human consumption.
Matters related to the own-check activities of water intended for human consumption are controlled in point 17.3 Own-check Testing of Water and Ice.
If part or all of the water used in production is clean water, matters related to it are evaluated in point 1.5 Compliance of Clean Water with Requirements.
The purpose of this point is to control that the water intended for human consumption used at the plant comes from a plant that supplies water intended for human consumption or from the establishment's own source of water intended for human consumption from which samples are taken on a regular basis as required by the Decree on water intended for human consumption.
It is also to be controlled that any recycled water used at the establishment does not cause any risk of contamination.

Matters to be controlled:

The source/sources of water intended for human consumption used at the establishment are a plant that supplies water intended for human consumption as referred to in the Health Protection Act, or the establishment's own source of water intended for human consumption from which samples are taken on a regular basis as required by the Decree on water intended for human consumption.
Any recycled water used at the establishment does not cause any risk of contamination. Recycled water meets the same requirements as water intended for human consumption, unless the competent authority is of the view that the quality of the water does not affect the safety of finished food products.
The adequacy and suitability of own-check activities and, where appropriate, the plan are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

The source/sources of water intended for human consumption used at the establishment are a plant that supplies water intended for human consumption as referred to in the Health Protection Act, or the establishment's own source of water intended for human consumption from which samples are taken on a regular basis as required by the Decree on water intended for human consumption. This can be demonstrated e.g. by presenting a contract related to water management, or the matter is described in own-check.
The use of recycled water is arranged so as to ensure it causes no risk of contamination.

For example:

The source/sources of water intended for human consumption used at the establishment are a plant that supplies water intended for human consumption as referred to in the Health Protection Act, or the establishment's own source of water intended for human consumption from which samples are taken on a regular basis as required by the Decree on water intended for human consumption, but the establishment is unable to demonstrate this e.g. by presenting a contract related to water management, or it has not been described in own-check.
There are some minor shortcomings in the use of recycled water which do not impair food safety.

For example:

There are some shortcomings in the use of recycled water which impair food safety.

For example:

The water intended for human consumption used at the plant does not come from a plant that supplies water intended for human consumption or from the establishment's own source of water intended for human consumption from which samples are taken on a regular basis as required by the Decree on water intended for human consumption.
The recycled water used at the establishment jeopardises food safety.

Legislation and guidelines (with any amendments) pertaining to the subject:

Regulation (EC) No 178/2002 on Food Law
Regulation (EC) No 852/2004 on the Hygiene of Foodstuffs
Decree of the Ministry of Social Affairs and Health on Quality Requirements and Surveillance Studies for Household Water 1352/2015
Decree of the Ministry of Social Affairs and Health on Quality Requirements and Surveillance Studies for Household Water of Small Units 401/2001
Health Protection Act 763/1994
Finnish Food Act 297/2021
Finnish Food Authority’s Guide 8014/04.02.00.01/2021: Control of Water and Ice in Food Establishments (available in Finnish and in Swedish).

Updates in version 4:

Guideline 10591 is replaced by guideline 8014/04.02.00.01/2021.

1.5 Compliance of Clean Water with Requirements

Guide/version: 2116/04.02.00.01/2021/4, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to approved establishments in the fish sector.
Matters related to the sampling of clean water (clean seawater or comparable fresh water) at the establishment are controlled in point 17.3 Own-check Testing of Water and Ice.
If part or all of the water used in production is water intended for human consumption, matters related to it are evaluated in point 1.4 Compliance of Water Intended for Human Consumption with Requirements.
The purpose of this point is to control that the intake of clean water has been arranged in a manner and from a source that makes it possible to assess the use of water to be safe.
It is also controlled in this point that the areas of production and the activities in which clean water is used are suitable for it and food safety is not compromised.
It is also controlled in this point that the microbiological and chemical quality of the source of clean water complies with regulatory requirements and recommendations.

Matters to be controlled:

The intake of clean water, and the purification of the water, if any, is technically arranged in a manner that ensures risks are under control.
The quality of the source of clean water has been assessed to allow it to be used in the specified activities at the relevant establishment in fish sector.
- The water must not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the safety of food.
The adequacy and suitability of own-check activities and, where appropriate, the plan are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

The quality of the source of clean water has been assessed to allow it to be used, purified or non-purified, in the specified activities at the relevant establishment.
The purification of water, if any, is technically arranged in a manner that ensures the safety of foodstuffs is not impaired.

The grade can be Good e.g. in cases where:

The quality of the source of clean water has been assessed to allow it to be used, purified or non-purified, in the specified activities at the relevant establishment.
The activities in which clean water is used have been deficiently defined in some respects, but the use of the water in them does not impair food safety.
The technical suitability of the water purification system, if any, has been deficiently assessed, but the use of the system does not impair food safety.

The grade can be To be corrected e.g. in cases where:

The quality of the source of the clean water used has been assessed to allow it to be used in the activities permitted by legislation at an establishment in the fish sector, but variations in the quality of non-purified water, for example, may impair food safety.
The activities in which clean water is used have been deficiently defined, or the use of the water in them may impair food safety.
The technical suitability of the water purification system, if any, has been deficiently assessed, and the use of the system may impair food safety.

The grade can be Poor e.g. in cases where:

The clean water used does not meet quality criteria and may jeopardise food safety.
Clean water is used in activities in which its use jeopardises food safety.
The water purification system, if any, jeopardises food safety.

Legislation and guidelines (with any amendments) pertaining to the subject:

Regulation (EC) No 178/2002/EC on food law
Regulation (EC) No 852/2004 on the hygiene of foodstuffs
Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin, Annex III, Section VIII
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on Food Hygiene 318/2021, 43 §
Finnish Food Authority’s Guide 3039/04.02.00.01/2022: Control of Fishery Products (available in Finnish and in Swedish)
Finnish Food Authority’s Guide 8014/04.02.00.01/2021: Control of Water and Ice in Food Establishments (available in Finnish and in Swedish).

Updates in version 4:

Guideline 16023 is replaced by guideline 3039/04.02.00.01/2022.
Guideline 10591 is replaced by guideline 8014/04.02.00.01/2021.

1.6 General Compliance of Own-check with Requirements

Guide/version: 2117/04.02.00.01/2021/7, valid from 2.1.2024

To be taken into consideration:

The purpose of this point is to assess on a general level the controllability, basic structure, coverage and up-to-date status of the own-check system, the prerequisite programmes, the hazard analysis and any other HACCP procedures included in it.
The own-check and its execution, adequacy and suitability are evaluated specifically for each topical area and the evaluation is included in the grade of the topical area.
A separate written own-check plan is not necessarily required. The operator shall have a system in place to manage the food safety risks.
The own-check system can be part of the quality system. In some cases, a good practical guideline evaluated by Finnish Food Authority or the operator´s own work instructions can be used as own-check system.
In small companies (1-2 employees) or in low-risks activities, the descriptions of all the programmes included within the scope of the prerequisite programmes need not be in written form.
In some cases, a good practical guideline evaluated by Finnish Food Authority can replace the operator's own hazard analysis. If the company’s hazards can be managed with plans included within the pre-requisite program, the company is not required to carry out a hazard analysis or implement other HACCP procedures.
Critical control points are not necessary, if the decision on their exclusion has been made based on a hazard analysis.
The own-check system shall be readily available for control, either in written form or by interviewing the operator.
Control of own-check system should, if necessary, be carried out in co-operation with personnel familiar with the plan.

Matters to be controlled:

Availability of the own-check system for control
Coverage of the prerequisite programmes
Hazard analysis
Critical control points, if any, critical limits, monitoring procedures and corrective actions
Verification practices
Up-to-date status of the own-check plan, and the initial assessment, and if necessary re-assessment (validation)
The laboratory (laboratories) and the methods used for the analysis of own-check samples required by legislation to be tested.

Excellent: Operations are in line with the requirements. Operations comply with requirements.

The own-check system is available for control.

The prerequisite program covers all the required programmes.

The own-check system covers all the facilities and activities of the establishment.

A hazard analysis has been carried out for all processes and product groups.

Control points and good practices have been defined.

Critical control points, if any, and critical limits have been defined.

Monitoring procedures and corrective actions have been defined.

Verification practices have been defined.

The own-check system has been updated after any fundamental changes, the effectiveness of own-check has been validated before adoption and has been re-validated, where necessary.

Own-check samples required by legislation to be tested are analysed by a laboratory approved by Finnish Food Authority, and with a method included in the scope of the approval.

For example:

There are some minor shortcomings in the prerequisite programmes.
There are some inaccuracies in the descriptions of monitoring procedures or corrective actions.
There are some minor shortcomings in the updating of the own-check system after fundamental changes.

For example:

The own-check system is not available for control.
The prerequisite program does not include all the required programmes.
A hazard analysis has not been carried out for all processes and product groups and the shortcomings may impair food safety.
Corrective actions have not been defined for deviations from critical limits.
Verification practices have not been defined.
The own-check system has not been updated after fundamental changes, and is not consistent with current operations.
An initial validation and/or re-validation, where necessary, of the effectiveness of the own-check system has not been conducted.
Own-check samples required by legislation to be tested are analysed by a laboratory that is not approved by Finnish Food Authority, or the method is not included in the scope of the approval.

For example:

Most of the required parts of the prerequisite programmes are missing.
A hazard analysis has not been carried out for processes or product groups of such a nature that shortcomings in them may jeopardise food safety.
Critical limits have not been defined for critical control points.

Legislation and guidelines (with any amendments) pertaining to the subject:

Regulation (EC) No 178/2002/EY on food law
Regulation (EC) No 852/2004 on the hygiene of foodstuffs, Articles 4 and 5
Commission Notice on the implementation of food safety management systems covering Good Hygiene Practices and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses 2022/C 355/01
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on Food Hygiene 318/2021, 22 §, 36 §
Evira's Guide 16043: Risk-based control of the own-check of food establishments (in Finnish and Swedish).

Updates in version 7:

Commission Notice 2016/C 278/01 is replaced by Commission Notice 2022/C 355/01.

Annex 1.6, Adequacy and Suitability of Own-check Activities

Guide/version: Annex 1.6/2, valid from 1.7.2021

General evaluation

To be taken into consideration:

The Guideline pertains to the evaluation of the adequacy and suitability of the own-check of each topical area, i.e. the plan and the execution (including the prerequisite program and HACCP, if any).
The Guideline also covers the evaluation of the records related to own-check activities and the storage of such records.
The grade based on this Guideline is NOT included in point 1.6 General Compliance of Own-check with Requirements.
The evaluation is included in the grade of each specific topical area.
The evaluation is primarily carried out on the basis of execution and the records; the plan is to be controlled, as appropriate.

Matters to be controlled:

Adequacy, suitability and up-to-date status of the plan.
Suitability and adequacy of corrective actions.
Records of monitoring and execution related to the prerequisite program.
Records of the monitoring of critical control points, if any.
Records of deviations and corrective actions (e.g. temperature deviations, shortcomings in chain information, deviations in sampling results).
- a deviation refers to a monitoring result that is outside the set limit, an unacceptable monitoring result
- monitoring refers to observations or measurements made according to plans to assess if the matter to be monitored is under control.

Excellent: Operations are in line with the requirements. Operations comply with requirements.

The risks related to the topical area are under control through the execution of own-check activities.

The execution of own-check activities complies with the plan.

The plan is adequate and suitable in relation to operations, and it is up-to-date.

Records have been made of the monitoring of critical control points.

Corrective actions have been adequate and appropriate. Deviations and corrective actions have been recorded.

For example:

There are some minor shortcomings in the execution of own-check activities.
The execution of own-check activities does not comply with the plan in all respects.
As a rule, records have been made of the monitoring of critical control points, but in some individual cases a record has not been made.
Corrective actions have been adequate and appropriate. There are some minor shortcomings in the records of deviations and corrective actions related to the prerequisite program.

For example:

The risks related to the topical area are not under control through the execution of own-check activities and food safety is impaired. There are major shortcomings in the monitoring of critical control points, for example.
The execution of own-check activities deviates significantly from the plan.
There are major shortcomings in the plan, or there is no plan for managing a topical area. Evaluation depends on the topical area.
There are major shortcomings in the monitoring of critical control points.
Corrective actions related to the support system have not been made or they have been inadequate. Food safety is impaired.
There are major shortcomings in the records of deviations and corrective actions related to the prerequisite program.

For example:

The risks related to the topical area are not under control through the execution of own-check activities and food safety is jeopardised. Critical control points are not monitored, for example.
There is no plan for managing a topical area. Evaluation depends on the topical area.
Corrective actions related to critical control points have not been made or they have been inadequate.
Corrective actions related to the support system have not been made or they have been inadequate. Food safety is jeopardised.