01 Compliance with Requirements for Approval

All Oiva evaluation guidelines for registered food premises.

1.6 General Compliance of Own-check with Requirements

Guide/version: 2117/04.02.00.01/2021/6, valid from 1.7.2021

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.

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 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.

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 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.

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:

  • 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 prerequisite programs (PRPs) and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses 2016/C 278/01
  • 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)
  • List of recommended laboratory methods:
    https://www.ruokavirasto.fi/laboratoriopalvelut/vertailulaboratoriot/ohjeita-laboratorioille/suositeltavat-menetelmat/ (in Finnish).


Updates in version 6:

  • Guideline 10268 is replaced by guideline 2117/04.02.00.01/2021.
  • The number of the Food Act has been updated.
  • Reference to the Decree of the Ministry of Agriculture and Forestry on Food Hygiene 318/2021 has been added.
  • Reference to the Decree of the Ministry of Agriculture and Forestry on Food Hygiene at Establishments 795/2014 and the Decree of the Ministry of Agriculture and Forestry on food hygiene in registered food premises 1367/2011 have been deleted.

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.

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 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.

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 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.

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 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.