Decision No. 4988/QD-BYT dated September 16, 2016 of the Ministry of Health on introduction of 04 types of food safety inspection

THE MINISTRY OF HEALTH

Decision No. 4988/QD-BYT dated September 16, 2016 of the Ministry of Health on introduction of 04 types of food safety inspection

Pursuant to the Law on Inspection No.56/2010/QH12 dated November 15, 2010;

Pursuant to the Law No.55/2010/QH12 on Food Safety dated June 17, 2010;

Pursuant to the Government s Decree No. 38/2012/ND-CP dated April 25, 2012, detailing a number of articles of the Law of Food safety;

Pursuant to the Government s Decree No. 86/2011/ND-CP dated September 22, 2011, detailing and guiding the implementation of a number of articles of the Law of Inspection;

Pursuant to the Government’s Decree No.07/2012/ND-CP on authorities in charge of disciplinary inspection and disciplinary inspection activities dated February 09, 2012 by the Government;

Pursuant to the Government s Decree No.122/2014/ND-CP on organization and operation of Health authority’s inspectorates dated December 25, 2014 by the Government

Pursuant to .the Government s Decree No. 63/2012/ND-CP dated August 31, 2012 defining the functions, rights and responsibilities and organizational structure of the Ministry of Health

Pursuant to the Decision No.38/2015/QD-TTg on food safety pilot inspection in districts an communes of Ho Chi Minh and Hanoi dated September 09, 2015 by the Prime Minister

Pursuant to the Circular No.05/2014/TT-TTCP on organizational structure, operation and liaison of Inspectorates, and inspection procedures;

At request of the Chief Inspector of the Ministry of Health;

DECIDES:

Article 1.To issue 04 types of food safety inspection together with this Decision. To be specific:

1.Type 1: Standard inspection

2.Type 2: Simplified inspection

3.Type 3: Surprise inspection

4.Type 4: Independent inspection

Article 2.This Decision takes effect on the signing date.

Article 3.The Chief of the Ministry Office , Ministerial Chief Inspector, Directors of Vietnam Food Administration – Ministry of Health , Directors of Departments of Health of provinces and centrally-affiliated cities (hereinafter referred to as “province”), Heads of State regulatory authorities that are designated to pilot food safety inspection in districts and communes of Hanoi and Ho Chi Minh under the Decision No.38/2015/QD-TTg dated September 09, 2015 by the Prime Minister, and relevant entities shall be responsible for the implementation of this Decision./.

For the Minister

The Deputy Minister

Nguyen Thanh Long

TYPE 1

PROCEDURE FOR STANDARD FOOD SAFETY INSPECTION
(Issued with the Decision No.4988/QD-BYT dated September 16, 2016 by the Minister of Health)

STEP 1: PREPARATION

1.Information collection before making inspection decision

1.1. Prior to issue of inspection decision, the Heads of regulatory authorities ( such as Minister of Health and , Directors of Departments of Health), head of State inspection agency ( Chief Inspectors of Ministry of Health and Department of Health) , Heads of inspecting authorities ( Director of Vietnam Food Administration affiliated to the Ministry of health, Directors of Food Safety Department affiliated Departments of Health ), Presidents of People’s Committees of districts and communes of Hanoi and Ho Chi Minh that are designated to conduct pilot inspection under the Decision No.38/2015/QD-TTg dated September 09, 2015 by the Prime Minister shall take charge of gathering information and document for food safety inspection decision.

The designation of officers or teams for information gathering (hereinafter referred to as “information gathering team”) shall be recorded in writing. Duration of information gathering shall not exceed 15 working days.

1.2. For the purpose of information gathering, the team shall present:

a) A written designation of information gathering team, date of gathering and required information.

b) Official’s card or inspector’s card.

1.3. The information gathering team must not harass or disturb information providers nor require other information beyond the assigned mission.

1.4. The information gathering team shall research, study, analyze, assess and aggregate collected information and submit a report in writing within 05 working days.

The report covers:

a) Functions, rights and responsibilities, and laws governing the organizational structure and operation of food businesses, importers, traders, food and beverage businesses and vendors supposed to be inspected (hereinafter referred to as “ inspected food business”);

b) The current status and performance of inspected food businesses, inspection results, financial statements and investigation findings by relevant competent authorities (if any) and other relevant information such as food safety periodic inspection, food labeling and advertising; compliance with food safety requirements by food vendors, businesses and importers, etc.

c) Recognition of issues or violations, proposals for inspection scope and methods.

 1.5. Information gathering methods

a) Collect documents and information at inspected premises and State competent authorities in charge of related sectors;

b) Research, study and aggregate related information from press, complaints, appeals

c) Directly contact with involved entities, where necessary.

2.Issuance of inspection decisions

Pursuant to Article 38 of the Law on Inspection and status reports (if any), Heads of State regulatory authorities, Heads of inspecting authorities, Heads of disciplinary inspecting authorities, presidents of People s Committees of district and communes that are assigned to pilot food safety disciplinary inspection under the Decision No.38/2015/QD-TTg dated September 09, 2015 by the prime Minister have the power to make inspection decision and direct Heads of inspectorates to prepare inspection plans.

The inspection decision shall be made in accordance with Article 52 of the Law on Inspection, including:

-Legal basis:

-Scope of inspection, inspected entities and tasks;

-Duration;

- The list of inspector, head of the inspectorate and other members.

The inspection decision shall be made on the basis of:

+ Inspection plans approved by the competent authority; or

+ Violations against laws on food safety or upon request for complaint addressing or request by superior authorities.

The inspection decision shall be made using form 04/TTr - ATTP attached hereto.

3.Preparation and approval for inspection plans

Heads of Inspectorates shall prepare and submit inspection plans to the inspection decision-maker for approval within the deadline. The inspection plan shall be prepared and considered approving in accordance with Article 18 Decree No.07/2012/ND-CP dated February 09, 2012 (herein after referred to as " Decree No.07/2012/ND-CP" ). The inspection plan covers: purposes, scope and requirements of inspection, tasks, inspected entity, duration, inspection methods and progress, communication, reporting, required equipment, funding and others.

The inspection plan shall be made and approved within 05 working days from the date on which the inspection decision is signed. In case of surprise inspection, the inspection plan shall be completed and approved within 03 working days.

The inspection plan shall be made using form 05/TTr - ATTP attached hereto and shall be available for internal use only.

4.Inspection plan announcement

4.1. The heads of inspectorates shall hold an inspectorate meeting to announce inspection plans and assign tasks for specific teams and inspectors; discus inspection methods and cooperation between inspectors and inspectorates.

4.2. Inspection team leaders and inspectorate members shall submit plans for carrying out assigned tasks to the head of inspectorate.

4.3. The heads of inspectorates shall provide inspection training courses for members of the Inspectorate, where necessary.

5.Reporting request ofinspection and inspection plan

5.1. According to the scope of inspection and inspection plan, the head of inspectorate shall take charge of and direct inspectors to prepare a reporting request.

5.2.The head of the inspectorate shall inform the inspected entity in writing (enclosed with a reporting request which specifies reporting deadline and reporting methods) at least 05 days prior to announcement of inspection decision (except for surprise inspection).

The reporting request form shall be made using form 05a/TTr - ATTP attached hereto.

6.Notice of inspection decision announcement

Prior to inspection decision announcement, the head of an inspectorate shall inform inspected entities of the inspection decision announcement, date and time of announcement and attendants; or request the decision maker to give a notice in writing, where necessary.

STEP 2: INSPECTION

1.Inspection decision announcement

1.1. Within 15 days from the date on which the inspection decision is signed, the Head of the inspectorate shall inform inspected entities of the inspection decision.

1.2. Inspected entities and other attendants designated by the inspection decision maker according to the report by the head of the inspectorate shall attend the inspection decision announcement.

1.3. The head of the inspectorate shall preside over the announcement, including:

-Agenda ;

-Inspection decision;

-Inspection purposes, requirements , scope and duration, rights and responsibilities of the head of the inspectorate ( Article 53 of the Law No.56/2010/QH12), rights and responsibilities of inspectors and members of inspectorate and persons assigned to take charge of independent inspection (Article 54 of the Law No.56/2010/QH12), rights and responsibilities of the inspection decision maker (Article 55 of the Law No.56/2010/QH12); rights and responsibilities of inspected entities ( Article 57 and 58 of the Law No.56/2010/QH12); work plans; liaison between the inspectorate and inspected entity; other relevant activities.

1.4. Heads of inspected organizations or individuals shall submit reports according to the reporting request form.

1.5. Attendants may give opinions (If any)

1.6. The inspection decision announcement shall be recorded in writing and shall be signed by the head of the inspectorate and head of inspected entity.

The inspection decision announcement record shall be made using form 06/TTr - ATTP attached hereto. Inspectorates that are designated to carry out pilot inspection under the Decision No. 38/2015/QD-TTg dated September 09, 2015 by the Prime Minister shall incorporate the inspection plan announcement into the inspection record.

2.Document and information collection

2.1. The head of an inspectorate and inspectorate members have the right to request inspected entities to provide inspection-related information.

The reporting request form shall be made using form 07/TTr - ATTP attached hereto.

Transfer of documents shall be recorded in writing using form 08/TTr - ATTP attached hereto.

2.2. Documents which are not required to be kept shall be returned to the inspected entities no later than the date on which the inspection is terminated. Return of documents shall be recorded in writing as stipulated in 2.1 here above.

2.3. Documents and information shall be kept, managed and used in accordance with laws on inspection and relevant regulations of laws.

3.On-site inspection and verification

3.1. Heads of inspectorates and inspectors shall study, examine and verify provided information at the inspected entity s premise; assess the compliance with regulations of laws, policies, rights and obligations by the inspected entity; and request the inspected entity to do accountability burden .Where verification is required , inspectors shall report to the head of the inspectorate.

In case verification of provided information and documents is required, the head of inspectorate shall directly contact with the inspected entity or relevant individuals. The invitation shall be made using form 09/TTr - ATTP attached hereto.

Where it is needed clarifying, the head of the inspectorate and inspection decision maker shall request the inspected entity to give clarification in writing by using form 10/TTr - ATTP attached hereto..

3.2. On-site inspection and verification results shall be recorded in writing by inspected entities using form 11/TTr - ATTP attached hereto.

3.3. Any issue in connection to the inspection shall be recorded in writing using form 12/TTr - ATTP attached hereto.

4.Inspection procedures

Heads of inspectorates and inspection decision makers shall comply with Article 25 of Circular No.05/2014/TT-TTCP on organization, operation and liaison of inspectorates and inspection procedures dated October 06, 2014 by the Inspector General, and other relevant regulations of laws. To be specific:

4.1. Regarding document sealing

Where document status quo is required to maintain as stipulated in Article 36 of the Decree No.86/2011/ND-CP, the head of the inspectorate has the right to seal such documents. Sealing shall be carried out as follows:

a) The head of the inspectorate has the right to seal, in part or whole, relevant documents.

The sealing decision shall be made in writing which specifies name of documents, sealing duration and inspected entity s obligations. A list of sealed documents may be compiled, where necessary, and shall be signed by both inspected entity and inspectorate’s representative.

b) Sealing duration shall not exceed that of on-site inspection. Sealed documents shall be used only after obtaining the head of the inspectorate’s consent.

c) Where sealing is deemed unnecessary, the head of inspectorate shall revoke sealing decision. The sealing decision shall be made using form 13/TTr – ATTP; unsealing decision shall be made using form 14/TTr - ATTP; record of sealing and record of unsealing shall be made using form 15/TTr - ATTP and 16/TTr - ATTP, respectively.

4.2. Regarding asset and goods stocktaking

Where stocktaking of assets and goods is required as stipulated in Article 37 of the Decree No.86/2011/ND-CP, the head of inspectorate has the right to make an inventory decision. Asset and goods stocktaking shall be carried out as follows:

a) Any discrepancy between documentation and reality or appropriation is discovered, the head of inspectorate shall release an inventory decision.

b) The inventory decision shall be made in writing which specifies name of assets and goods, date and location of stocktaking, rights and obligations of persons making an inventory. The stocktaking shall be recorded in writing. The inspectorate has the right to request the competent authority to impound inspected entity’s assets and goods where necessary.

c) Where stocktaking is deemed unnecessary, the head of inspectorate shall revoke the inventory decision.

The inventory decision shall be made using form 17/TTr - ATTP; and revocation of inventory decision shall be made using form18/TTr - ATTP attached hereto.

4.3. Regarding invitation to assessment and sampling for testing

a) Invitation to assessment:

Where professional assessment is required as the basis of inspection conclusion under Article 38 of Decree No.86/2011/ND-CP, the head of inspectorate shall request the inspection decision maker to consider making an invitation to assessment. To be specific:

a) The head of an inspectorate shall request the inspection decision maker to consider making an invitation to assessment in writing which specifies requirements, date, scope of assessment and assessing agency.

b) Assessing agencies shall be legally responsible for the accuracy, objectivity and punctuality of assessment results.

c) Assessment costs shall be paid by the inspecting authority. Any expense incurs due to the inspected entity’s faults shall be borne at the inspected entity’s account, unless otherwise stipulated.

d) Assessment costs shall be paid, managed and allocated in accordance with regulations of laws.

The assessment decision and invitation to assessment shall be made using form 19/TTr – ATTP and 20/TTr – ATTP, respectively, attached hereto.

b) Regarding sampling for testing:

Where food safety assessment is required, the head of the inspectorate shall collect samples for testing. Food shall be sampled in accordance with the Circular No.14/2011/TT-BYT on guideline for food sampling for food safety inspection and quality control dated April 01, 2011 by the Ministry of Health. The person taking samples must be a member of the inspectorate who obtained a sampling certificate. Samples shall be directly taken at the inspected entity’s premise or according to the inspectorate’s directive. The sampling record and sample transfer record shall be made using prescribed forms and shall be sealed under regulations of laws.

Expenses for sampling and testing shall be paid by the authority making inspection decision. According to testing results, any inspected entity violating food safety regulations shall pay testing and sampling expenses to the inspecting authority under Article 48 of the Law on food safety.

4.4. Regarding suspension

Any violation that should be suspended as stipulated in Article 39 of Decree No.86/2011/ND-CP is discovered, the head of inspectorate shall release a suspension decision; or request the competent person to make a suspension decision where necessary.

The suspension decision shall be made in writing which specifies reasons and duration of suspension and involved entities.

Where suspension is deemed unnecessary, the decision maker shall revoke the suspension decision.

The suspension decision shall be made using form No.21/TTr - ATTP; decision on revocation of suspension and suspension request shall be made using form No. 18/TTr – ATTP and 22/TTr - ATTP , respectively.

4.5. Regarding impoundment of cash, items and licenses

Any illegal use of cash, items or licenses that should be promptly prevented or verified as proof of inspection conclusion as stipulated in Article 40 of Decree No.86/2011/ND-CP is discovered, the head of inspectorate shall request the inspection decision-maker to consider temporarily impound such illegally-used objects, cash or licenses.

The temporary impoundment decision shall be made in writing which specifies the amount of cash, name of items and licenses, responsibilities of the competent person who makes the temporary impoundment decision and obligations of entity whose cash, items or licenses are impounded. The impoundment shall be recorded in writing. If it is required to submit impounded cash, items and licenses to the competent authority, the competent authority shall conduct impoundment.

Where impoundment is deemed unnecessary, the impoundment decision shall be revoked.

The temporary impoundment decision shall be made using form 23/TTr - ATTP; request for temporary impoundment decision shall be made using form 24/TTr - ATTP attached hereto.

4.6. Regarding confiscation of illegally-used/appropriated assets, cash and losses due to illegal acts

Where illegal use, appropriation or loss of cash, assets due to illegal acts is found as stipulated in Article 42 of Decree No.86/2011/ND-CP , the inspection decision maker shall release a decision on confiscation of such cash, asset. The confiscation decisions shall be made in writing which specifies the amount of cash or asset, responsibilities of authority that conducts confiscation and entities whose cash/ asset is confiscated.

The inspection decision maker shall conduct cash/asset confiscation in accordance with regulations of laws or upon request by the competent authority that has the power to forfeit such illegal cash/asset.

Entities whose cash/asset is confiscated shall strictly comply with the confiscation decision. In case of disobedience or failure to strictly obey with the confiscation decision, penalties such as discipline, administrative penalties or criminal prosecution shall be imposed according to the seriousness, and compensation shall be made in case of damage.

The confiscation decision maker shall supervise, inspect and expedite the decision execution.

Cash seizure decision shall be made using form 25/TTr - ATTP; asset forfeiture decision shall be made using form 26/TTr - ATTP attached hereto.

4.7. Where discipline, work allocation or retirement by members of inspecting authority or inspected entities impedes the inspection, the inspection decision maker shall request the competent person to consider suspending the implementation of discipline, retirement or work allocation. The request shall be made in writing using form 27/TTr - ATTP attached hereto.

4.8. The inspection decision maker shall request the competent person to consider suspending officials who intentionally impede the inspection or disobey inspection decisions or requests from work. The request for suspension of work shall be made using form 28/TTr - ATTP attached hereto.

5.Handling of violations

5.1. Any serious violation found shall be recorded in writing using form 28a/TTr – ATTP by the head of the inspectorate and inspectors. The administrative penalty decision shall be made using form 28b/TTr - ATTP attached hereto.

Violations shall be dealt with in accordance with laws on inspection and relevant regulations Common violations shall be dealt with as follows:

5.1.1. In case of violation against regulations on food labeling or inconformity to specifications specified in the description or label enclosed with the application for declaration shall be dealt with laws on recall and handling of unsafe foods within the jurisdiction of the Ministry of Health.

5.1.2. Offending entities shall be subjected to administrative penalties according to seriousness. Legal basis for administrative penalties are as follows:

a) Violations against food preservation conditions and periodic testing shall be dealt with in accordance with the Government’s Decree No.178/2013/ND-CP administrative penalties regarding food safety (hereinafter referred to as “Decree No.178/2013/ND-CP).

b) Violations against regulations on conformity declaration or declaration of conformity to food safety regulations; violations against State inspection of imported food , differences between sample testing results and product specifications in the declaration or label or inconformity with the applicable standards or national technical regulation or food safety regulations shall be dealt with in accordance with the Government’s Decree No.80/2013/ND-CP dated July 19, 2013 on administrative penalties in respect of standards, measurement and food quality (hereinafter referred to as “ Decree No.80/2013/ND-CP) or Decree No.178/2013/ND-CP.

c) Violations against food labeling shall be dealt with in accordance with the Decree No.80/2013/ND-CP.

d) Violations against food advertising regulations shall be dealt with in accordance with the Government’s Decree No.158/2013/ND-CP dated November 12, 2013 on administrative penalties in culture, sports, tourism, and advertising.

dd) Violations against regulations on commerce, production and trading of counterfeit and banned products shall be dealt with in accordance with the Government’s Decree No.185/2013/ND-CP on commerce, production and trading of counterfeit and banned products, and consumer rights (hereinafter referred to as “Decree No.185/2013/ND-CP”); Decree No.124/2015/ND-CP dated November 19, 2015 on amendments to a number of articles of the Decree No.185/2013/ND-CP.

5.1.3. Where superior power is required to deal with violations, documents on violations shall be submitted to superior authority.

5.2. Where any sign of crime is found, the head of inspectorate shall request the inspection decision maker to consider transferring records investigation authorities.

6.Progress reports

6.1. According to the approved inspection decision or upon request of the head of inspectorate, every inspector or team leader (if any) shall submit a progress report to the head of the inspectorate. Any arising issue should be promptly reported to the head of inspectorate.

The head of inspectorate shall review reports and give specific directives on reporting and punctually deal with member s complaints, and request the inspection decision-maker to consider deciding where higher authority is required.

6.2. The head of inspectorate shall submit a progress report to the inspection decision-maker and supervisor according to the approved inspection decision or upon request of inspection decision-maker.

The inspection decision-maker shall review and give specific directives on reporting and punctually deal with the head of inspectorate s complaints.

6.3. Every progress reports by inspectors and heads of inspectorates shall be made in writing and cover:

+Inspection progress up to the reporting date.

+Things that have been inspected and are in inspection;

+ Incoming tasks;

+Difficulties, complaints and proposals (if any)

7.Revision to inspection plans

7.1. Where revision to the inspection plan is requested by the head of an inspectorate, the inspection decision-maker shall consider revising the inspection plan.

7.2. Where revision to the inspection plan is made by the inspection decision maker, (s) he shall send a revised inspection plan to the head of the inspectorate .

7.3. The head of an inspectorate shall inform inspectorate’s members, inspected entities and involved entities (where necessary) of revision to inspection plan and implement the amended plan.

8.Extension of inspection duration

8.1. Where it is complicated or any issue arises or multiple entities are involved, the head of an inspectorate shall submit a written request for extension of inspection duration which specifies reasons for extension and expected length of extension to the inspection decision-maker.

8.2. According to the head of inspectorate’s request, the inspection decision-maker shall consider approving the extension.

The extension decision shall be made using form 29/TTr - ATTP attached hereto.

8.3. The extension decision shall be sent to the inspectorate, inspected entity and other involved entities.

9.Document transfer to investigation authorities

In case that the inspection decision maker decides to transfer documents that reveals signs of crime to the investigation authority, the head of the inspectorate shall take charge of gathering and transferring required documents to the investigation authority. Transfer of documents which reveal signs of crime shall be recorded in writing.

The investigation authorities and competent authorities shall cooperate in detection, investigation and handling of criminal cases charged by inspecting authorities.

 Transfer of documents which reveal signs of crime to investigation authority shall be recorded in writing using form 30/TTr - ATTP attached hereto.

Document transfer between the inspecting authority and investigation authority shall be recorded in writing using form 31/TTr - ATTP attached hereto.

10.Termination of on-site inspection

10.1. Prior to termination of on-site inspection, the head of the inspectorate shall hold a meeting about incoming tasks up to the end of inspection.

10.2. The head of the inspectorate shall inform the inspection decision-maker of the expected date of termination of on-site inspection.

10.3. The head of inspectorate shall inform the inspected entity of date of termination of on-site inspection in writing using form 32/TTr - ATTP or directly (where necessary). The direct inform shall also be recorded in writing.

 Announcement of termination of on-site pilot inspection under the Decision No.38/2015/QD-TTg dated September 09, 2015 by the Prime Minister shall be specified at the end of an inspection record.

10.4. On-site inspection shall be ended at or before the end of inspection when the inspection is completed.

STEP 3. TERMINATION

1.Inspection report by Inspectorate members

1.1. Within 05 working days from the date on which the on-site inspection ends, members of Inspectorates shall submit an inspection report to the head of the inspectorate and shall be responsible for the reliability, accuracy and objectivity of the inspection report.

1.2. The inspection report covers:

a) Assigned tasks, inspection results and verification;

b) Inspection conclusion, violations (if any), specific legal basis of the conclusion;

c) Seriousness of violations causes of violations, responsibilities of offending entities;

d) Penalty proposals in case of violations; proposals for improvement of management, laws and policies, legal basis and reasons for such proposals.

1.3. In case the inspection report is incomplete or inaccurate, the head of the inspectorate shall request inspectorate members to complete the inspection report.

2.Inspection report by inspectorates

2.1. According to the inspection report prepared by inspectorate members and document research, the head of inspectorate shall take charge of preparing inspection report.

2.2. The inspection report shall be compiled in accordance with Article 25 of the Decree No.07/2012/ND-CP. To be specific:

Within 15 days from the end of inspection, the head of inspectorate shall submit an inspection report, unless where the competent authority’s conclusion is required. The inspection report shall covers:

a) Inspected entity’s information;

b) Inspection and verification results;

c) Compliance with regulations of laws on food safety by inspected entity including:

+ Application of competent authority’s technical regulations on food safety by food businesses

+ Application of relevant food safety standards that food businesses committed to apply.

+ Food advertising and labeling within the administration.

+ Certification of conformity and food safety testing.

+ Compliance with other regulations on food safety.

d) Penalties and proposals for penalties for violations;

dd) Proposals for amendments and issues or abrogation of regulations (where necessary);

e) Inspectorate members’ opinions (if any).

2.3. During preparation of inspection report, the head of the inspectorate may consult involved entities, where necessary, to ensure the objectivity and accuracy of assessment, conclusion and proposal.

The inspection report shall be made using form 33/TTr - ATTP attached hereto.

3.Review of inspection reports by inspectorates

3.1. The inspection decision-maker shall assess inspection reports or request professional authority to assess such reports.

3.2. In case supplementation to or clarification on inspection report is required, the inspection decision-maker shall hold a meeting or give written directives or make a request for inspection report.

3.3. The head of the inspectorate shall hold meeting about implementation of inspection decision-makers directives and completion or clarification of inspection report.

3.4. The head of the inspectorate shall submit a report on supplementation, clarification and members’ opinions (if any) to the inspection decision-maker.

4.Compilation of draft inspection conclusion

4.1. After receipt of inspection report and additional report (if any), the inspection decision-maker shall direct the head of the inspectorate to compile a draft inspection conclusion. The draft inspection conclusion shall be made in accordance with Article 27 of Decree No.07/2012/ND-CP.

According to the inspection report and inspected entity s explanation (if any), the inspection decision-maker shall draw an inspection conclusion in writing within 15 days from the date of receipt of the inspection report, unless where the professional authority s conclusion is required. The inspection conclusion covers:

+ Inspection and verification results;

+ Compliance with laws, policies, technical standards, rights and obligations of the inspected entity (refer to point c, 2.2 of step 3); nature, causes and seriousness of violations, responsibilities of offending entity (if any).

+ Proposed measures for tackling violations, proposals for amendments, supplement or abrogation to current regulations and issue of new regulations (where necessary);

4.2. The inspection decision-maker shall study or request a professional authority to study the draft inspection conclusion to give proposals or advices on completion of the draft conclusion. Such proposals or advices shall be made in writing and included in the inspection record.

4.3. During compilation of draft inspection conclusion, the inspection decision-maker has the right to request the head of inspectorate or members report, or inspected entity to do accountability where necessary.

4.4. In order to reach an objective and accurate conclusion, the inspection decision maker may conduct an additional inspection or invitation to assessment or consult relevant entities, where necessary.

4.5. Where the draft conclusion is sent to the inspected entity for explanation, the inspected entity shall submit a written explanation and proofs of explanations.

The head of the inspectorate shall study the explanation and request the inspection decision maker to assess and submit it to the authority that take charge of assessing draft inspection conclusion.

Inspected entity’s explanation, relevant entities and assessing authority’s opinions specified in 4.4 here above (if any) shall be reported to the inspection decision-maker in writing and shall be kept in the inspection record by the head of inspectorate.

5.Inspection conclusion signature and release

5.1. The inspection decision-maker shall study reports submitted by the head of the inspectorate and direct him/her to complete the draft inspection conclusion.

5.2. Inspection conclusion shall be sent to the inspected entity and relevant entities as stipulated in clause 4 Article 27 of Decree No.07/2012/ND-CP and other relevant regulations. To be specific:

a) For inspection conducted by the Ministry of Health, the inspection conclusion shall be submitted to the Minister of Health, Inspector-General, inspected entities, heads of inspected entities’ supervisory authorities (if any) and relevant entities;

a) For inspection conducted by Vietnam Food Administration, the inspection conclusion shall be submitted to inspectors of the Ministry of Health, inspected entities, heads of inspected entities’ supervisory authorities (if any) and relevant entities;

a) For inspection conducted by inspectors of the Department of Health, the inspection conclusion shall be submitted to the Director of the Department of Health, inspected entities, heads of inspected entities’ supervisory authorities (if any) and relevant entities;

d) For inspection conducted by Sub-Agency of Food Safety, the inspection conclusion shall be submitted to inspectors of the Department of Health, inspected entities, heads of inspected entities’ supervisory authorities (if any) and relevant entities;

dd) For pilot inspection conducted by People’s Committees of districts of Ho Chi Minh and Hanoi, the inspection conclusion shall be submitted to the Director of Department of Health, inspected entity, Heads of inspected entity s supervisory authority (if any) and relevant entities.

e) For pilot inspection conducted by People’s Committees of communes of Ho Chi Minh and Hanoi, the inspection conclusion shall be submitted to the President of People’s Committees of districts, inspected entity, Heads of inspected entity s supervisory authority (if any) and relevant entities.

The inspection conclusion shall be made in writing using form 34/TTr - ATTP attached hereto.

6.Inspection conclusion publishing

6.1. Within 10 days from the date on which the inspection conclusion is signed, the inspection decision-maker shall make the inspection conclusion publicly available in accordance with Article 39 of the law on inspection and Article 46 of Decree No.86/2011/ND- CP. To be specific:

a) The inspection conclusion shall be made public through meetings where the inspection decision-maker or, inspectorate’s representative or authorized person, inspected entities and involved entities attend.

b) Besides, the inspection conclusion shall be made public through one of the following means:

+ Means of mass media including broadcast news, Internet (at least twice) and print media (at least one issue).

+ Websites of the inspecting authority, professional inspecting authority or State regulatory authority for at least 05 consecutive days.

+ At inspected entity’s premise for at least 05 days.

The inspected entity shall be put up inspection conclusion at their premise for at least 15 consecutive days.

6.2. Within 10 days from the date on which the inspection conclusion is signed, the inspection decision maker shall inform involved entities of inspection conclusion. The inspection decision maker shall inform, in part or in whole, inspection conclusion to involved entities.

6.3. The head of inspectorate shall support the inspection decision maker in publishing of inspection conclusion.

7.Assessment of inspectorate performance

7.1. The head of an inspectorate shall hold a meeting to assess inspectorate performance. The meeting shall be recorded in writing and kept together with inspection record. 7.2. The meeting shall cover:

a) Assessment of inspection activities according to purpose and requirements of inspection;

b)Assessment of fulfillment of assigned tasks and responsibilities, compliance with inspection procedures and process, regulations on inspection and supervision, code of conduct and others;

c) Experiences;

d) Proposals for commendation to those who have outstanding performance (if any);

dd) Penalties and discipline in case of violations against inspection regulation;

e) Other proposals (if any).

7.3. After assessment, the head of the inspectorate shall submit a report to the inspection decision maker and head of inspecting authority.

8.Inspection record keeping and transfer

8.1. Every head of inspectorates shall make out and transfer inspection records to the authority that issues inspection decision.

8.2. The inspection decision maker shall direct and inspect the preparation and transfer of documents by the head of inspectorate.

8.3. Inspection documents include:

a) An inspection decision;

b) Inspection and verification records;

c) Reports and explanations by the inspected entity;

d) Inspection reports;

dd) inspection conclusion

e) Records and proposals for violation handling

g) Relevant documents.

A document handover record shall be made using form 35/TTr - ATTP attached hereto as it is transferred. /.

TYPE 2

PROCEDURE FOR SIMPLIFIED INSPECTION
(Issued together with the Decision No.4988/QD-BYT dated September 16, 2016 by the Minister of Health)

STEP 1: PREPARATION

1.Release of inspection decisions

Pursuant to Article 38 of the Law on Inspection and inspection status reports (if any), Head of State regulatory authorities, Heads of inspecting authorities, Heads of disciplinary inspecting authorities, presidents of People s Committees of district and communes that are assigned to carry out food safety pilot inspection under the Decision No.38/2015/QD-TTg dated September 09, 2015 by the prime Minister have the power to make inspection decision and direct the Head of inspectorates to prepare inspection plans. The inspection decision shall be made using form 04/TTr - ATTP attached hereto and in accordance with Article 52 of the Law on Inspection.

2.Preparation and approval for inspection plans

Heads of Inspectorates shall prepare and submit inspection plans to the inspection decision-maker for approval within a deadline. Inspection plans shall be compiled and approved in accordance with Article 18 Decree No.07/2012/ND-CP dated February 09, 2012 (herein after referred to as “Decree No.07/2012/ND-CP" and form 05/TTr - ATTP attached hereto. The inspection plans shall be made for internal use only.

3.Inspection plan announcement

3.1. The heads of inspectorates shall hold an inspectorate meeting to announce inspection plans and assign tasks for specific teams and inspectors; discus inspection methods and cooperation between inspectors and inspectorates.

3.2. Inspectors and members shall submit plans for carrying out assigned tasks to the head of inspectorate.

3.3. The heads of inspectorates shall provide inspection training courses for inspectorate members, where necessary.

4.Reporting request

4.1. According to the scope of inspection and inspection plan, the head of inspectorate shall take charge of and direct inspectors to prepare a reporting request.

4.2.The head of the inspectorate shall inform the inspected entity in writing (enclosed with a reporting request which specifies reporting deadline and reporting methods) at least 05 days prior to announcement of inspection decision (except for surprise inspection).

The reporting request form shall be made using form 05a/TTr - ATTP attached hereto.

5.Notice of inspection decision announcement

Prior to inspection decision announcement, the head of an inspectorate shall inform inspected entities of the inspection decision announcement, date and time of announcement and attendants; or request the decision maker to give a notice in writing, where necessary.

STEP 2: INSPECTION

1.Inspection decision announcement

Within 15 days from the date on which the inspection decision is signed, the Head of the inspectorate shall inform inspected entities of the inspection decision.

The inspection decision announcement record shall be made using form 06/TTr - ATTP attached hereto.

Inspectorates that are designated to carry out pilot inspection under the Decision No. 38/2015/QD-TTg dated September 09, 2015 by the Prime Minister shall incorporate the inspection plan announcement into the inspection record.

2.Document and information collection

2.1. The head of an inspectorate and inspectorate members have the right to request inspected entities to provide inspection-related information.

The reporting request form shall be made using form 07/TTr - ATTP attached hereto.

Transfer of documents shall be recorded in writing using form 08/TTr - ATTP attached hereto. The document handover record shall be made using form 08/TTr - ATTP attached hereto.

2.2. Documents which are not required to be kept shall be returned to the inspected entities no later than the date on which the inspection is terminated. Return of documents shall be recorded in writing as stipulated in 2.1.

2.3. Documents and information shall be kept, managed and used in accordance with laws on inspection and relevant regulations of laws.

3.On-site inspection and verification

3.1. The Head of inspectorate and inspectors shall study, examine and verify provided information at the inspected entity s premises; assess the compliance with regulations of laws, policies, rights and obligations by the inspected entity; request the inspected entity to do accountability .Where verification is required , inspectors shall report to the head of the inspectorate .

In case verification of provided information and documents is required, the head of inspectorate shall directly contact with the inspected entity or relevant individuals. The invitation shall be made using form 09/TTr - ATTP attached hereto.

Where it is needed clarifying, the head of the inspectorate and inspection decision maker shall request the inspected to clarify in writing by using form 10/TTr - ATTP attached hereto. The reporting request form shall be made using form 10/TTr - ATTP attached hereto.

3.2. On-site inspection and verification results shall be recorded in writing.

The document handover record shall be made using form 11/TTr - ATTP attached hereto.

3.3. Any issue in connection to the inspection shall be specified in writing using form 12/TTr - ATTP attached hereto.

4.Inspection procedures

Heads of inspectorates and inspection decision makers shall comply with Article 25 of Circular No.05/2014/TT-TTCP on organization, operation and liaison of inspectorates and inspection procedures dated October 06, 2014 by the Inspector General, and other relevant regulations of laws. To be specific:

5.Handling of violations

5.1. Any serious violation that requires to be promptly dealt with shall be recorded in writing using form 28a/TTr – ATTP by the head of the inspectorate and inspectors. The administrative penalty decision shall be made using form 28b/TTr - ATTP attached hereto.

5.2.5.2. In case of detection of signs of crime, the head of inspectorate shall report to the inspection decision maker.

6.Document transfer to investigation authorities

In case that the inspection decision maker decides to transfer documents that reveals signs of crime to the investigation authority, the head of the inspectorate shall take charge of gathering and transferring required documents to the investigation authority. Transfer of documents which reveal signs of crime shall be recorded in writing.

The investigation authorities and competent authorities shall cooperate in detection, investigation and handling of criminal cases charged by inspecting authorities.

Document transfer shall be recorded in writing using form 30/TTr - ATTP attached hereto.

Document transfer between the inspecting authority and investigation authority shall be recorded in writing using form 31/TTr - ATTP attached hereto.

7.Termination of on-site inspection

7.1. Prior to termination of on-site inspection, the head of the inspectorate shall hold a meeting about incoming tasks up to the end of inspection.

7.2. The head of inspectorate shall inform the inspected entity of date of termination of on-site inspection in writing using form 32/TTr - ATTP or directly (where necessary). .

 In case date of termination of on-site inspection is directly informed to the inspected entity, it shall be specified at the end of the inspection record.

7.3. On-site inspection shall be ended as at or by the end of inspection when the inspection is completed.

STEP 3. TERMINATION

1.Inspection report by Inspectorates

Within 05 working days from the date on which the on-site inspection ends, members of Inspectorates shall submit an inspection report to the head of the inspectorate and shall be responsible for the reliability, accuracy and objectivity of the inspection report.

2.Inspection report by inspectorates

2.1. According to the inspection report prepared by inspectorate members and document research, the head of inspectorate shall take charge of preparing inspection report.

2.2. The inspection report shall be compiled in accordance with Article 25 of the Decree No.07/2012/ND-CP and form 33/TTr - ATTP attached hereto.

3.Review of inspection report by inspectorates

3.1. The inspection decision-maker shall assess inspection reports on their own or request professional authority to assess such report.

3.2. In case supplementation to or clarification on inspection report is required, the inspection decision-maker shall hold a meeting or give written directives or make a request for inspection report.

4.Compilation of draft inspection conclusion

4.1. After receipt of inspection report and additional report (if any), the inspection decision-maker shall direct the head of the inspectorate to compile a draft inspection conclusion. The draft inspection conclusion shall be made in accordance with Article 27 of Decree No.07/2012/ND-CP.

5.Inspection conclusion signature and release

5.1. The inspection decision-maker shall study reports submitted by the head of the inspectorate and direct him/her to complete the draft inspection conclusion.

5.2. Inspection conclusion shall be sent to the inspected entity and relevant entities as stipulated in clause 4 Article 27 of Decree No.07/2012/ND-CP and other relevant regulations.

The inspection conclusion shall be made in writing using form 34/TTr - ATTP attached hereto.

6.Inspection conclusion publishing

6.1. Within 10 days from the date on which the inspection conclusion is signed, the inspection decision-maker shall make the inspection conclusion publicly available in accordance with Article 39 of the law on inspection and Article 46 of Decree No.86/2011/ND-CP.

6.2. The head of inspectorate shall support the inspection decision maker in publishing of inspection conclusion.

7.Assessment of inspectorate performance

7.1. The head of an inspectorate shall hold a meeting to assess inspectorate performance. The meeting shall cover all aspects stipulated in Article 38 of Circular No.05/2014/TT-TTCP dated October 16, 2014 by Inspector-General and shall be recorded in writing and kept together with inspection records.

7.2. After assessment, the head of the inspectorate shall submit a report to the inspection decision maker and head of inspecting authority.

8.Inspection record keeping and transfer

Inspection records shall be made, stored and transferred in accordance with Article 43 Decree No. 86/2011/ND-CP and relevant provisions.

A document handover record shall be made using form 35/TTr - ATTP attached hereto as it is transferred. /.

TYPE 3

PROCEDURE FOR SURPRISE INSPECTION
(Issued together with the Decision No.4988/QD-BYT dated September 16, 2016 by the Minister of Health)

STEP 1: PREPARATION

1.Release of inspection decisions

Pursuant to Article 38 of the Law on Inspection, Head of State regulatory authorities, Heads of inspecting authorities, Heads of disciplinary inspecting authorities, presidents of People s Committees of district and communes that are assigned to pilot food safety disciplinary inspection under the Decision No.38/2015/QD-TTg dated September 09, 2015 by the prime Minister has the power to make inspection decision and direct the Head of inspectorates to prepare inspection plans. The inspection decision shall be made under Article 52 the Law on Inspection and form /TTr - ATTP attached hereto and shall apply to a number of food facilities within the administration.

2.Preparation and approval for inspection plans

Heads of Inspectorates shall prepare and submit inspection plans to the competent person for approval within a deadline. Inspection plans shall be compiled and approved in accordance with Article 18 Decree No.07/2012/ND-CP dated February 09, 2012 (herein after referred to as “Decree No.07/2012/ND-CP" and form 05/TTr - ATTP attached hereto. The inspection plans shall be made for internal use only. In case of surprise inspection that is required to carry out right after the inspection decision is released, the inspection plan is not required.

3.Inspection plan announcement

3.1. The heads of inspectorates shall hold inspectorate meeting to announce inspection plans and assign tasks for specific teams and inspector; discus inspection methods and cooperation between inspectors and inspectorates.

3.2. The heads of inspectorates shall provide inspection training courses for inspectorate members, where necessary.

STEP 2: INSPECTION

1.Inspection decision announcement

Within 15 days from the date on which the inspection decision is signed, the Head of the inspectorate shall inform inspected entities of the inspection decision.

The record of inspection decision announcement shall be made using form 06/TTr - ATTP attached hereto.

Inspectorates that are designated to carry out pilot inspection under the Decision No. 38/2015/QD-TTg dated September 09, 2015 by the Prime Minister shall incorporate the inspection plan announcement into the inspection record.

2.Document and information collection

2.1. The head of an inspectorate and inspectorate members have the right to request inspected entities to provide inspection-related information.

The reporting request form shall be made using form 07/TTr - ATTP attached hereto.

The document handover record shall be made using form 08/TTr - ATTP attached hereto.

3.On-site inspection and verification

3.1. The Head of inspectorate and inspectors shall study, examine and verify provided information at the inspected entity s premises; assess the compliance with regulations of laws, policies, rights and obligations by the inspected entity; and request the inspected entity to do accountability .Where verification is required , inspectors shall report to the head of the inspectorate .

In case verification of provided information and documents is required, the head of inspectorate shall directly contact with the inspected entity or relevant individuals. The invitation shall be made using form 09/TTr - ATTP attached hereto.

Where it is needed clarifying, the head of the inspectorate and inspection decision maker shall request the inspected to clarify in writing by using form 10/TTr - ATTP attached hereto.

3.2. On-site inspection and verification results shall be recorded in writing using form 11/TTr - ATTP.

3.3. Any issue in connection to the inspection shall be recorded in writing using form 12/TTr - ATTP attached hereto.

4.Inspection procedures

Heads of inspectorates and inspection decision makers shall comply with Article 25 of Circular No.05/2014/TT-TTCP on organization, operation and liaison of inspectorates and inspection procedures dated October 06, 2014 by the Inspector General, and other relevant regulations of laws.

5.Handling of violations

5.1. Any serious violation shall be recorded in writing using form 28a/TTr – ATTP by the head of the inspectorate and inspectors. The administrative penalty decision shall be made using form 28b/TTr - ATTP attached hereto.

5.2.In case of detection of signs of crime, the head of inspectorate shall report to the inspection decision maker.

6.Document transfer to investigation authorities

In case that the inspection decision maker decide to transfer documents that reveals signs of crime to the investigation authority, the head of the inspectorate shall take charge of gathering and transferring required documents to the investigation authority. Transfer of documents which reveal signs of crime shall be recorded in writing.

The investigation authorities and competent authorities shall cooperate in detection, investigation and handling of criminal cases charged by inspecting authorities.

Document transfer shall be recorded in writing using form 30/TTr - ATTP attached hereto.

Document transfer between the inspecting authority and investigation authority shall be recorded in writing using form 31/TTr - ATTP attached hereto.

7.Termination of on-site inspection

7.1. Prior to termination of on-site inspection, the head of the inspectorate shall hold a meeting about incoming tasks up to the end of inspection.

7.2. The head of inspectorate shall inform the inspected entity of date of termination of on-site inspection in writing using form 32/TTr - ATTP or directly (where necessary).

Where the date of termination of on-site inspection is directly informed to the inspected entity, it shall be specified at the end of the inspection record.

7.3. On-site inspection shall be ended as at or before the end of inspection when the inspection is completed.

STEP 3. TERMINATION

1.Inspection report by Inspectorates

Within 05 working days from the date on which the on-site inspection ends, members of Inspectorates shall submit an inspection report to the head of the inspectorate and shall be responsible for the reliability, accuracy and objectivity of the inspection report.

2.Inspection report by inspectorates

2.1. According to the inspection report prepared by inspectorate members and document research, the head of inspectorate shall take charge of preparing inspection report.

2.2. The inspection report shall be compiled in accordance with Article 25 of the Decree No.07/2012/ND-CP and form 33/TTr - ATTP attached hereto.

2.3. During preparation of inspection report, the head of the inspectorate may consult involved entities, where necessary, to ensure the objectivity and accuracy of assessment, conclusion and proposal.

The inspection report shall be made using form 33/TTr - ATTP attached hereto.

3.Review of inspection report by inspectorates

3.1. The inspection decision-maker shall assess inspection reports or request professional authority to assess such report.

3.2. In case supplementation to or clarification on inspection report is required, the inspection decision-maker shall hold a meeting or give written directives or make a request for inspection report.

4.Compilation of draft inspection conclusion

4.1. After receipt of inspection report and additional report (if any), the inspection decision-maker shall direct the head of the inspectorate to compile a draft inspection conclusion. The draft inspection conclusion shall be made in accordance with Article 27 of Decree No.07/2012/ND-CP.

5.Inspection conclusion signature and release

5.1. The inspection decision-maker shall study reports submitted by the head of the inspectorate and direct him/her to complete the draft inspection conclusion.

5.2. Inspection conclusion shall be sent to the inspected entity and relevant entities as stipulated in clause 4 Article 27 of Decree No.07/2012/ND-CP and other relevant regulations.

The inspection conclusion shall be made in writing using form 34/TTr - ATTP attached hereto.

6.Inspection conclusion publishing

6.1. Within 10 days from the date on which the inspection conclusion is signed, the inspection decision-maker shall make the inspection conclusion publicly available in accordance with Article 39 of the law on inspection and Article 46 of Decree No.86/2011/ND-CP CP.

6.2. The head of inspectorate shall support the inspection decision maker in publishing of inspection conclusion.

7.Assessment of inspectorate performance

7.1. The head of an inspectorate shall hold a meeting to assess inspectorate performance. The meeting shall be recorded in writing and kept together with inspection record. The meeting shall cover all aspects stipulated in Article 38 of Circular No.05/2014/TT-TTCP dated October 16, 2014 by Inspector-General and shall be recorded in writing and kept together with inspection records.

7.2. After assessment, the head of the inspectorate shall submit a report to the inspection decision maker and head of inspecting authority.

8.Inspection record keeping and transfer

Inspection records shall be made, stored and transferred in accordance with Article 43 Decree No. 86/2011/ND-CP and relevant provisions.

Transfer of inspection documents shall be recorded in writing using form 35/TTr - ATTP attached hereto.

TYPE 4

PROCEDURE FOR INDEPENDENT FOOD SAFETY INSPECTION
(Issued together with the Decision No.4988/QD-BYT dated September 16, 2016 by the Minister of Health)

1.Inspectors, disciplinary inspectors and officials assigned to conduct independent inspection

The Chief Inspectors of the Ministry of Health, Departments of Health, Directors of Vietnam Food Administration, heads of Agency of Food Safety, presidents of people s committees of districts and communes that are designated to pilot food safety inspection under the Decision No.38/2015/QD-TTg dated September 09, 2015 by the Prime Minister shall assign inspectors and officials to carry out the disciplinary inspection within the jurisdiction of an independent inspection. The designation covers:

a) Full name, title of inspectors and the inspector card Number.

b) The scope of inspection;

c) Date and duration of inspection

In case of regular inspection, it shall be conducted according the functions and responsibilities of the inspecting authority that take charge of disciplinary inspection under clause 3, Article 37 of the Law on Inspection.

2.Duration of independent inspection

The independent inspection shall not exceed 05 working days from the date of inspection. Where necessary, the duration of inspection may be extended but not exceeding 05 working days.

3.Rights and responsibilities of inspectors, disciplinary inspectors and officials assigned to conduct independent inspection

a) Take on responsibilities they are assigned.

b) Present the written designation, inspector or official’s cards.

c) Request inspected entities to present business certificate, business registration certificate, and practice certificate and to provide information, document and take on accountability burden.

d) Make out records of violations committed by inspected entities.

dd) Impose administrative penalties under regulations of laws, or report to the competent person to consider imposing penalty in case of lack of power.

e) Compile inspection records as the inspection is terminated.

g) Submit progress reports and legally take responsibilities for their decision towards the competent person

4.Independent inspection report

As the independent inspection ended, the inspector shall submit a written report on independent inspection. The report shall specify the inspection scope and results, administrative penalties within the jurisdiction, proposed penalties (if any) and store inspection records.

5.Inspection record keeping and transfer

Inspection records shall be made, stored and transferred in accordance with Article 43 Decree No. 86/2011/ND-CP and relevant provisions.

A document handover record shall be made using form 35/TTr - ATTP attached hereto as it is transferred. /.