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Developing a class 2 food safety program template Victoria’s safe food system
Developing a class 2 food safety program template
Accessibility
If you would like to receive this publication in an accessible format, please phone 03 9096 9037 using the National Relay Service 13 36 77 if required.
The document is also available in PDF format on the Internet at www.health.vic.gov.au/foodsafety
Published by the Health Protection Branch
Edition 2
© Copyright State of Victoria, Department of Health
Authorised by the State Government of Victoria, 50 Lonsdale Street, Melbourne.
April 2011 (1008024)
Introduction 2
What is a template? 3
Who can develop a template? 3
Responsibilities of the template developer 4
How is a template developed? 4
Should I/we submit a template for registration? 4
Template assessment process 6
What are the costs of being a template developer? 7
Template assessment checklist 8
Non-standard processes 11
Registration of templates 12
Review process 14
Action taken if the food business ceases to operate 14
Amendments to a registered template 15
Revocation of a template 15
Re-assessment criteria 16
Distribution of an amended template to business users 17
Template dissemination and communication roles and responsibilities 17
How to submit a template for registration 18
How to submit a reviewed registered template 18
Form 1: Registration form for new food safety program templates 19
Form 2: Change notification form for registered food safety program templates 21
Contents
2
This package has been designed to assist template developers to develop an industry-specific class 2 food safety program (FSP) template.
A FSP is a plan for producing safe food developed by individual proprietors from a set of instructions known as an FSP template. A template is a written document containing food safety procedures that should be applied to enable food businesses to comply with the Food Act 1984. A template is customised according to specific instructions that guide a food business to create an appropriate and relevant FSP.
Businesses that elect to have their FSP compliance checked by their local council must use a template registered by the Department of Health to create their individual ‘standard’ FSP.
To assist the process of registering a FSP template with the department a checklist has been provided on pages 7, 8 and 9 to help prepare, assess and register templates. This will ensure a smooth passage of the template, as developers need to make sure every section and each item has been addressed in the submitted template.
This guide has been prepared with industry consultation. A group called the Food Safety Program Template Committee was convened to help develop the criteria and the supporting documentation for industry-based FSP templates. We thank all members of the committee and all other contributors for their hard work in creating this guide.
Introduction
3
A FSP template is a written document containing food safety procedures that are followed to ensure that food businesses comply with section 19D of the Food Act. All FSP templates must be registered by the Secretary to the Department of Health via the Food Safety and Regulation Unit’s Template Register.
A FSP is a written document that systematically identifies potential hazards, how these can be controlled and monitored, corrective action if these hazards are realised, the record-keeping requirements to monitor the hazards, and the review frequency of the program.
The template is designed to assist businesses to develop and maintain a structured approach to address all food hazards that are ‘reasonably likely’ to occur using the Hazard Analysis and Critical Control Point (HACCP) method.
Businesses can mould and customise the template in accordance with specific instructions to produce a standard FSP. Using a template is compulsory for those businesses electing to apply the standard FSP system.
Using an independent FSP will require annual audit by a Department of Health approved auditor. Businesses choosing to use an independent FSP do not need to register a template.
Who can develop a template?
Associations representing an industry that is likely to elect to be compliance checked by local council may wish to register a template for use by those businesses creating a standard FSP.
The department may commission suitable associations to develop templates.
Template developers will be those who have the ability to develop a template for a significant proportion of the food sector and represent and serve a significant constituency.
Companies with multiple class 2 business sites (more than 10) in Victoria may wish to submit a FSP template for registration.
What is a template?
4
By submitting a FSP template to the Food Safety and Regulation Unit for registration, the template developer undertakes to observe the following responsibilities:
• provide technical support to the user group for the term of the registered FSP template (this includes any support necessary to ensure the site electing to use the FSP understands and applies it correctly to site-specific business practices)
• undertake a review of the FSP template to ensure compliance with the Act and the relevant Food Standards when any changes are to be made to legislation
• undertake an annual review of content to ensure the FSP template is up to date, as required in section 19EA subsection 2 of the Act
• advise the Food Safety and Regulation Unit of any changes to the FSP template
• where a specific issue has been identified by the Food Safety and Regulation Unit, the template developer shall amend the FSP to minimise the potential risk.
How is a template developed?
Those associations that choose to develop a template must do so through: consultation with the industry; meeting the framework as per the checklist (see below); including support documentation; and being supported with back-up resources for implementation purposes.
Once businesses have expressed an interest to develop an industry template with the Food Safety and Regulation Unit’s Template Register, a template developer creates the template in line with the framework outlined in the Template assessment checklist (see pages 7, 8, 9). This framework has been designed to ensure consistency and suitability across the food sector.
Should I/we submit a template for registration?
Consider the industry sector you represent and your user group. Are these food businesses categorised as class 2 as defined in the Victorian Government Gazette? Are these businesses likely to elect to have an FSP that is audited by a Department of Health approved auditor? Are they required to be audited by legislation or by demand from the company they supply? If so, it is not necessary for a template to be developed or registered.
Responsibilities of the template developer
5
FSP template developedby business or organisation
Developer provides a copy of the registeredtemplate to all municipal councils
Submit to Food Safety and Regulation with Application Form (p. 19)
for new FSP form templates
Technical reviewTemplate developer engages an approvedtechnical review body to obtain a technical
review of the template
Template registeredThe Secretary to the Department of Health
registers templates assessed as appropriate for a particular industry
Template assessedTemplates, along with the technical compliance
reports, are submitted to Food Safety and RegulationUnit for assessment by the Template Assessment Panel
Assessedas adequate
Assessedas inadequate
Returnedfor review
Figure 1: Food safety program template development, assessment and registration process
6
Templates will be required to undergo an assessment process before being declared a registered template. The template assessment process is two-tiered, being examined by two bodies for assessment:
• a technical review body
• Template Assessment Panel.
Technical review bodies The Department of Health has approved a list of suitably appropriate and qualified technical review bodies (TRBs). These bodies report on the template’s technical adequacy and ensure that the components of the template comply with the requirements of the Food Safety Standards and the Act.
Following receipt of the template by the department, the template developer will be forwarded the list of approved TRBs from which they can select to have the template technically reviewed. Quotations for this service may vary from one TRB to another.
Upon receipt of an approved technical compliance report, the template developer will then be required to resubmit their template, along with the technical report, to the department for assessment by the Template Assessment Panel. The department has a service agreement with TRBs that technical reviews will be conducted within 10 working days.
Template Assessment Panel The Template Assessment Panel (TAP) will be established periodically at the discretion of the department. The TAP, if appointed, assesses each template for compliance with the template framework as outlined by the components of the Template assessment checklist contained in the following pages. The TAP shall also consider the technical compliance report in making a recommendation on the template.
Membership of the TAP comprises representatives from the Food Safety and Regulation Unit, industry and local government. The template developer may be requested to attend the TAP meeting to answer any queries or concerns in relation to the template to help facilitate the prompt progression of the template through the assessment and registration process.
All TAP members must agree to recommend a template for registration by the Secretary. This might be conditional upon minor amendments or additions being made to the template to satisfy all TAP members of the template’s suitability.
Templates assessed as satisfactorily meeting the components of the checklist will be recommended for registration.
Those assessed as inadequate will be returned with recommendations to the template developer via the Food Safety and Regulation Unit. Once amended, the template can then be resubmitted.
Template assessment process
7
Depending on how you initially write the document, there may be expenses associated with creating the template, for example, hiring a consultant, preparing resources and conducting trials.
The first tier of assessment, the technical review body (TRB), is a cost borne by the developer. This cost can be negotiated with one or all of the approved TRBs and will vary between them.
It is a condition of registration that the developer provides a copy of the template to each council that may have businesses that use the template to create their standard FSP.
Every 12 months the developer must review the content of the template. Should any major amendments be made or required by legislative changes, the template may be required to undergo further assessment by the TRB and/or TAP in light of those amendments.
As noted in the checklist, the developer must provide support to template users. This includes access to technical staff who are responsible for maintaining and reviewing the template. Depending on the delivery of the support, this cost needs to be considered.
The cost of providing a template to a food business is at the discretion of the developer.
What are the costs of being a template developer?
8
1 Template contact details and support material included?This section requires the template developer to demonstrate the practicality of the template for the respective industry and/or specific industry sector.
1.1 Instructions on how to use the template
• The Template Assessment Panel will assess how easily these instructions can be understood.
For example:
‘This food safety program template is to be completed by each [insert business name] store manager for the class 2 premises for which they are responsible by inserting all details that are applicable to the premises, and by applying and using the relevant parts of this template. This is to ensure that the food hazards at each particular premises are addressed using the completed program.’
1.2 Back-up resources for implementation purposes
• The template developer must support users of the template, including advising users on customising the template to their business. The template developer must demonstrate it has the resources to provide ongoing technical support, and to review the template 12 months after registration by the department.
1.3 Demonstration of industry support and industry trials for user friendliness
• The template developer must demonstrate that the template has industry support and that it has been tested to determine its user friendliness. The following may be used to ensure user friendliness.
Project management
Establish a project reference group (PRG) to provide industry or technical guidance and direction for the template development. Members with appropriate industry experience and expertise and/or technical expertise should make up the membership of the PRG.
The PRG should meet as often as necessary during the development of the template to consider issues, including reviewing:
• the template and providing guidance on the setup of testing
• the testing of the template and providing guidance on the feedback
• feedback from the testing and finalising the template and supporting material.
Testing
The PRG will seek industry support to identify a minimum of 10 appropriate businesses to test the template. Statistical issues regarding the testing, such as sample size and representativeness, should be considered. Tests should last at least four weeks. After testing, the template developer, with the PRG, should seek feedback on user friendliness, practicality and ease of customisation by users.
A copy of this evaluation should be attached to the application.
1.4 Clear description and operational scope of the template’s specific industry sector Target audience
The template developer should provide approximate figures on the number of members or franchisees that the template developer represents and an estimate of how many registered businesses the template developer expects to use the template (which may differ from membership number or franchisee numbers).
Template assessment checklist
9
2 Legislative requirementsThe template developer must adhere to all relevant regulations and legislation. Of particular note is section19D of the Food Act 1984, which defines an FSP as a written document that:
‘(a) systematically identifies the potential hazards that may be reasonably expected to occur in each food handling operation that is to be, or that is being, conducted at the premises; and
(b) identifies where, in a food handling operation, each hazard identified under paragraph (a) can be controlled and the means of control; and
(c) provides for the systematic monitoring of those controls; and
(d) provides for appropriate corrective action when that hazard, or each of those hazards, is found not to be under control; and
(e) provides for the regular review of the program by the proprietor of the food premises; and
(f) provides for appropriate records to be made and kept by the proprietor of the food premises demonstrating action taken in relation to, or in compliance with, the program.’
2.1 Reference to the need to comply with other relevant regulations, where applicable, such as meat (Victorian Standard for hygienic production of meat at retail premises 2006) and dairy legislation
2.2 List the hazards the type of food business is reasonably likely to experience
2.3 List the associated methods of control and monitoring procedures
2.4 List the corrective actions required to be taken
2.5 List the associated records
2.6 Outline the skills and knowledge of staff and the requirement for a food safety supervisor
2.7 Food recall procedures
Information about food recalls is available from the Food Standards Australia New Zealand (FSANZ) Food industry recall protocol at <www.foodstandards.gov.au>.
3 Document style and format appropriate to specific industry sectorThe template developer must ensure the template is targeted to its intended audience. Consideration should be given to appropriate style, format and language. The template developer will obtain this information during testing and in consultation with target businesses.
3.1 Concise and simple
3.2 User friendly
3.3 Appropriate modules structure
3.4 Made available in hard copy or electronic format as applicable for particular business sites
3.5 Simple customisation
4 Elements based on preventative management of food safety risksAll these sections must be covered by the template (where those headings are applicable to the industry) to demonstrate compliance with Food Safety Standard 3.2.2 (‘Safe Food Australia’, which can be obtained from FSANZ at <www.foodstandards.gov.au>)
10
4.1 Page with individual review information
4.2 Cover page for individual food business notification to authorities
4.3 A glossary of terms
4.4 Food Safety Standard elements
4.4.1 Food handling – skills, knowledge and training options
4.4.2 Receiving food
4.4.3 Storing food
4.4.4 Dispatching food
4.4.5 Processing food
4.4.6 Displaying food
4.4.7 Food packaging
4.4.8 Transporting food
4.4.9 Disposing of food
4.4.10 Recalling food
4.4.11 Health of food handlers
4.4.12 Hygiene of food handlers
4.4.13 Health of persons who handle food – duties of food businesses
4.4.14 Hygiene of food handlers – duties of food businesses
4.4.15 Cleanliness and sanitising
4.4.16 Cleaning and sanitising of specific equipment
4.4.17 Maintenance
4.4.18 Calibration
4.4.19 Preventative maintenance
4.4.20 Corrective maintenance
4.4.21 Temperature-measuring devices
4.4.22 Single-use items
4.4.23 Animals and pests
4.4.24 Monitoring records
4.4.25 Review process
5 Sections must be covered by the template, where those headings are applicable to the industry, to demonstrate compliance with 1.2.3. Mandatory Food Allergens Information
11
Non-standard processes
11
Processes that are outside the Food Standards Code must be validated by the template developer and the procedure relevant to this process must be tested with a number of sites or repeated at one site 5–10 times. Challenge testing criteria, sample size, risk assessment and parameters must be confirmed with the department prior to commencing testing.
The report must provide a comprehensive overview of the study including duration of the study, its validation process, shelf-life testing and scientific evidence. A final report is to be provided to the department on completion of testing, comprising the proposed procedure to be included into the FSP template and an outline of ongoing validation, which will be conducted by the template developer.
Non-standard processes validation study
Validation reporting: Provided?
Report sections to include the following where applicable:
Introduction/background
Objective of study
Risk assessment
Qualitative risk assessment:
Profile of product physical characteristics (aw pH)
Product descriptions (depending on product)
Characteristics of food poisoning organisms/toxins and their potential for growth in the product
Cooking methods: time and temperature profile
Proposed usage/handling of product
Cooking to consumption timeframe
Challenge studies (before conducting the challenge studies please forward details of the proposed parameters to the Department of Health’s Food Safety and Regulation Unit)
Proposed process procedures
Ongoing validation of the process and product following implementation
12
If a TRB and the TAP have assessed a template as satisfactory, a recommendation is made to the Secretary to the Department of Health to register it. The Secretary may register a FSP template if satisfied that the template appears to be appropriate for use by the proprietors of food businesses.
It is a condition of registration that all Victorian municipal councils that have businesses utilising the template in their jurisdiction are provided with a copy of, or access to, the template by the template developer.
Notification of registered templates will be published in the Government Gazette. The notice will state that the template is registered for use and specify the classes of food businesses for which the template is suitable. Registration will be valid until revoked. Revocation will be by publication of a notice in the Government Gazette that states the template is no longer registered with the department.
A template is to be reviewed by the template developer to ensure that any legislative amendments or introduced standards are incorporated, and if there is a change in the activities carried out as per section 19EA of the Act. Any changes to the template required or identified at any time must be immediately advised by the template developer to the Food Safety and Regulation Unit’s Template Register and amendments submitted.
The Secretary to the Department of Health may revoke the registration of a FSP template if the Food Safety and Regulation Unit is not advised of changes to the template, or s/he is not satisfied that the template continues to be appropriate. Refer to Revocation of a template on page 14 for further information.
A register is maintained by the Department of Health’s Food Safety and Regulation Unit that includes: registration number; version number; developer’s name and contact details; the template’s scope; and the industry sector targeted by the template.
Registration of templates
13
Template developer reviews Food Safety Program (FSP) template content to verify if is still current,
relevant and technically accurate
Amendments required to template?
Complete Change notificationform and submit template
electronically with tracked changesNo action required
Registration continuedSubmit to Food Safetyand Regulation Unit
Technical amendments made to template
Template developer sends Template for assessment by
Technical Review Body
TRB send report to template developer
Template developerfinalises template
Template assigned new minor version (for example, V1.1
changed to V1.2)
Submit revised versionto Food Safety and Regulation
Unit with TRB assessment
Reviewed by Food Safety and Regulation Unit
Template approved by Food Safety and
Regulation Unit?
Template registered as new major version
(for example, V1.0 changed to V2.0 via
Government Gazette.) Certificate issued
Food Safety and Regulation Unit
upload new electronic version
of the FSP on local EHO extranet
Templatedeveloper
sendscopies to
localcouncils
All businesses using the
registered FSP template must transfer to new
version as agreed
Food Safety and Regulation Unitupload new electronic version
of the FSP on local EHOextranet site
Yes No
No
No
Yes
Figure 2: Annual review process for registered food safety programs
14
The template developer is required to review the registered template to ensure that any legislative amendments or introduced standards are incorporated, and other necessary improvements in formatting, technical or grammatical amendments to the registered template’s content are made.
Note: The revised template with changes should not be distributed until confirmation is received from the Food Safety and Regulation Unit.
Where changes are required, the notification form (Form 2, page 20) must be accompanied by a draft revised FSP template with ‘tracked’ changes showing the proposed amendments and where they will occur in the document.
Action taken if the food business ceases to operate
If a template developer ceases to operate, the Food Safety and Regulation Unit must be notified immediately to ensure food businesses utilising the template are informed. In order to keep the template updated, responsibility will be assigned to another template developer. Alternatively, the template shall be deregistered.
Food businesses using a template developed by a business that has ceased to operate may utilise the template for a negotiated period up to 12 months. The Food Safety and Regulation Unit will notify local councils of this through extranet facilities, and local councils will then notify each food business registered with a standard FSP created by that template that another registered template will need to be obtained.
Review process
15
Should bodies other than the template developer identify any matters that relate to the integrity of the template, such as a food business or a local council, those bodies must notify the Food Safety and Regulation Unit of their concern. The Food Safety and Regulation Unit is responsible for coordinating the notification of the problem to the template developer.
Should the issue impact on public health and safety, the template developer must review their template in relation to this issue and advise the Food Safety and Regulation Unit about how they will address this issue within 14 days.
The template developer may choose to provide evidence to the Food Safety and Regulation Unit that this issue is adequately covered by the FSP and is in line with their organisation’s risk analysis, and is therefore not a risk to public health. The Food Safety and Regulation Unit will consider this information and, where it is deemed an appropriate response, the template developer assumes responsibility for monitoring this risk.
Where a template developer has not provided any information to the Food Safety and Regulation Unit in relation to an identified issue, and does not provide any evidence to support their decision to not consider changes to the template, the Food Safety and Regulation Unit will prepare a report and forward it to the Secretary to revoke registration. A notification will be published in the Government Gazette.
Any amendments made to the template during annual review, or at any other time, must be submitted to the Food Safety and Regulation Unit. The amended content of the template will then be considered for reassessment.
Revocation of a template
The Secretary to the Department of Health may, under the Act, revoke (deregister) an FSP template where deemed necessary. The department will seek to communicate with the template developer prior to revocation; however, where this is unsuccessful, revocation will proceed.
The registration of a FSP template for some businesses may no longer be appropriate. For example, following changes to the Food Act, a business may now be categorised as class 3. As registered FSP templates are applicable to class 2 businesses only, the template registration will be revoked.
Note: The FSP can continue to be used by the business; however, it is the responsibility of the business to ensure the records used meet the minimum requirements for the business classification.
To seek revocation of a template, the developer must submit a written request to the Food Safety and Regulation Unit that states the template is no longer required and should be deregistered.
A template is formally revoked when the Gazette notice is published.
Amendments to a registered template
16
Modifications of a grammatical, wording, readability, layout, presentation, content or format nature will be required to be reviewed by the Food Safety and Regulation Unit only.
For identification purposes templates amended by the above nature will be required to be identified by the same version number, but with an updated identifier. For example: version 1.1. Both version 1 and version 1.1 of a template will be valid document, available to all suitable businesses targeted by that particular template. Those businesses wishing to obtain the new version may do so, however, it will not be mandatory.
Note: A certificate for continuation of registration will not be issued in the case of a minor version alteration.
Modifications of a technical nature, being anything that impacts on a process in the business or changes the way something is done, will be required to undergo technical assessment by a TRB prior to being considered by the Food Safety and Regulation Unit. The Food Safety and Regulation Unit will determine the extent of re-assessment required, amounting to a whole or partial technical review of the revised template.
Templates with technical amendments will be required to be identified as a new version number, for example, version 2. This version will then replace the previous version.
Notification of registered templates will be published in the Government Gazette. The notice will state the template name, template number and version registered for use, and specify the classes of food businesses for which the template is suitable.
Note: A new certificate of registration will be issued to the template developer following publication of the Gazette notice.
Re-assessment criteria
17
It will not be mandatory for template developers who have modified their template in terms of format, content or other minor changes to forward the modified template to all businesses registered with a standard FSP created by that template. These modifications will be identified in a new version of the document and will be obtained by new businesses obtaining a template or existing templates requiring a replacement to their current template.
Templates with technical modifications will be required to be adopted by food businesses registered with a standard FSP created by that template. Where a technical change impacts on public health and safety, immediate adoption by users will be required.
Food businesses utilising a template that has been technically amended will be informed as promptly as possible of the change. Once the template developer has submitted the amendments to the Food Safety and Regulation Unit and those amendments have been assessed and accepted, the Food Safety and Regulation Unit will request that the template developer provide details of when the businesses using the template will change over to the new version.
The Food Safety and Regulation Unit will notify local councils of this version change through extranet activity and advise a date when businesses will be expected to move across to the new version. The template developer is responsible for communicating to businesses in relation to the version changes, in line with best practice document control processes.
Template dissemination and communication roles and responsibilities
Template dissemination is to be the responsibility of the template developer. The template developer needs to provide each local council with a hard copy of the FSP template on registration and inform councils when reviewed editions are available.
If the changes have been of a technical nature the template developer must provide the Food Safety and Regulation Unit with a date by which all sites will have received a copy of the new version of the template.
Distribution of an amended template to business users
18
1. The template developer creates a template in accordance with the framework outlined in the Template assessment checklist to ensure all required components are included within the template.
2. The developer submits one copy of the template in electronic format along with the appropriate completed form (Form 1, page 19) to the Food Safety and Regulation Unit at the below address.
3. The Food Safety and Regulation Unit’s Template Registrar reviews the contents of the template for any significant exclusion and forwards the list of approved TRBs to the template developer.
4. The template developer selects and contracts the service of a TRB to obtain a technical compliance report on the template.
5. On receipt of an approved technical compliance report, the template developer sends the template and the technical compliance report to the Food Safety and Regulation Unit.
6. All communication is directed to:
Template Registrar Food Safety and Regulation Unit Department of Health 15/50 Lonsdale Street MELBOURNE VIC 3000
Please include an electronic copy with all paper submissions.
7. The Food Safety and Regulation Unit assesses the document, and if fit for purpose, registration is undertaken.
8. Registration is complete when the template developer is issued a registration certificate and the template is published in the Victorian Government Gazette.
How to submit a reviewed registered food safety program template
1. The template developer completes Form 2 (page 21).
2. The template developer sends the FSP with tracked changes, associated documents and changes the log identifying what changes have made and where.
3. A Technical review report with any/all items is closed out.
4. All communication is directed to:
Template Registrar Food Safety and Regulation Unit Department of Health 15/50 Lonsdale Street MELBOURNE VIC 3000
Please include an electronic copy with all paper submissions.
How to submit a new food safety program template for registration
19
Form 1: Registration form for new food safety program templates
Submission of an industry template for registration under the Food Act 1984
Applicant details
Registered name of association
Address of association
Name of contact
Telephone
Business/mobile
Signature of applicant
Date
Please attach any additional information that will support your template application.
Application form
20
Form 2: Change notification for registered food safety program templates
Food Safety and Regulation Unit Department of Health 15/50 Lonsdale Street MELBOURNE VIC 3000
Dear Sir/madam
I hereby declare that the following template:
insert name of the template and version no.
registered as the Department of Health Registered Food Safety Program Template
No.
has been reviewed as required by the conditions of template registration and declare that the above named food safety program template
Does not require any modifications
Does require modifications
If yes, please attach modifications for review and indicate proposed new version number
Developer:
Signed:
Date:
Change notification
Heading level 1 line one Subheading level 1
