Elements and Performance Criteria

retorting systems
pasteurisation systems
aseptic processing and packaging systems
hot fill systems.

obtaining evidence to confirm that a HACCP-based food safety program is complete and effective and will deliver the expected food safety outcomes.

the application of:
existing Australian legislative requirements
challenge tests
peer reviewed scientific papers
targeted scientific reports
validation already carried out in other jurisdictions and recognised by the responsible authority
mathematical modelling, e.g. predictive microbiology models
industry codes of practice (where implementation by food business is verified during audits).

methods and procedures used to carry out monitoring, including sampling and testing to provide evidence that the specifications set by relevant legislation and codes of practice continue to be met.

standards or technical specifications set by the system owner based on and in addition to regulatory requirements that relate specifically to food safety.

Relevant legislation, standards, codes of practice and technical specifications relating to heat treatment requirements may include:
relevant sections of the Australia New Zealand Food Standards Code
Validation and Verification of Heat Treatment Equipment and Processes (ANZDAC - draft)
international protocols such as Codex Alimentarius Vol 1B - 1995 Section 2, Recommended international code of hygienic practice for low-acid and acidified low-acid canned foods, CAC/RCP, 23-1979, Rev 2 1993, App III
Australian Standard for Equipment for the pasteurization of milk and other liquid dairy products - Continuous-flow systems (AS 3993:2003)
AQIS Export Control (Milk and Milk Products) Orders, 2005
code of practice for the manufacture of egg products
state and territory regulations, codes of practice and guidelines.

Factors that affect heat distribution and heat penetration may include:
raw material characteristics such as:
rheology and density
particulates and position within container
pH
heat treatment method and related equipment - process holding times and temperatures
heating systems
packaging design.

Commercial heat processing equipment may include:
pre-processing equipment
methods to achieve sterilisation of plant and packaging material (for aseptic systems)
filling equipment
heat treatment systems using both direct and indirect heating methods
packaging systems.

Packaging may include:
cans
glass containers
aluminium and plastic semi-rigid and flexible containers
bags
composite packaging
bulk packaging.

Prerequisite programs:
are also referred to as support programs, or acronyms such as good manufacturing practice (GMP), good agricultural practice (GAP) and good hygienic practice (GHP)
can be divided into two categories:
infrastructure and maintenance programs, which may include:
layout, design, construction and amenities of buildings and facilities
supplies of air, water, energy and other utilities
equipment, including sanitary design, preventative maintenance, calibration and cleaning and sanitation
support services, including waste and sewage disposal
pest control
operational prerequisite programs, which may include:
personal hygiene
measures for the prevention of cross-contamination
packaging and labelling procedures
supplier assurance
chemical storage
employee training
document control
internal audit programs
traceability programs
product integrity and security
cold chain management
inspecting and testing regimes, including analytical and microbiological testing
control of non-conforming product, processes and recall programs.

Test methods include:
conducting studies of process evaluation
conducting studies of equipment performance.

Additional reference material includes:
US Food and Drug Administration Guide to Inspections of Low Acid Canned Food Manufacturers, Parts 1, 2 and 3
US Food and Drug Administration Code of Federal Regulations. Requirements for Establishment Registration, Thermal Process Filling, and Good Manufacturing Practices for Low-Acid Canned Foods and Acidified Foods, Title 21, Vol 2, Pt 113
Campden & Chorleywood Food Research Association (1997), Guidelines for batch retort systems - Full water immersion - Raining/Spray Water - Steam/Air. Guideline no. 13
Campden & Chorleywood Food Research Association (1997), Guidelines for performing heat penetration trials for establishing thermal processes for batch retort systems. Guideline no. 16
Campden & Chorleywood Food Research Association (1997), Guidelines for establishing heat distribution in batch over-pressure retort systems. Guideline no. 17
Campden & Chorleywood Food Research Association (2000), Analysis of temperature distribution and heat penetration data for in-container sterilisation processes. Review no. 22.

Critical aspects for assessment and evidence required to demonstrate competency in this unit
A person who demonstrates competency in this unit must be able to provide evidence that they can verify food safety programs involving heat treatment processes for a range of foods, to meet regulatory, industry and business standards. They must also demonstrate capacity to confirm that appropriate validation has occurred.

Assessment must confirm that the candidate can:

identify product-specific risks and typical processing methods for a range of products, including sources of information on heat treatment requirements
participate in audits of HACCP-based food safety programs to demonstrate ability and knowledge of technical aspects of heat treatment processes.
Assessment must include the demonstration of appropriate methods, including the use of time temperature indicators (TTIs) to measure the effectiveness of a range of heat treatment. Related processes such as evaluation of raw materials, sterilisation of packaging and equipment (relevant to aseptic systems) and post-process handling will be considered where they directly impact on the effectiveness of heat treatment.
Assessment requires participation in at least two audits. Of these, at least one audit must be an in-packaging heat treatment process and one must be an out-of-packaging heat treatment process. One of these must be a heat treatment process of a low acid food.
For given scenarios where prescribed processing requirements are not met, assess adequacy of evidence used to determine response procedures.

Context of and specific resources for assessment
Competency may be assessed in an actual workplace or simulated environment that provides access to the required resources. At least one of the audit scenarios should be assessed in an actual workplace context.
Assessment is to occur under standard and authorised work practices, safety requirements and environmental constraints.

The following resources must be available:

food safety plans covering heat treatment processes
food safety-related documentation typical of commercial manufacturing businesses and used for the purpose of verification
evidence and documentation relevant to heat treatment processes that would typically be used by commercial manufacturing businesses to support validation processes
plant and equipment that would typically be used in a commercial manufacturing business.

Method of assessment
This unit only covers the technical skills and knowledge related to the specific area of risk. Generic food safety auditing skills and knowledge are covered in prerequisite units. While participation in audit processes should follow good auditing practice as specified by prerequisite units, formal assessment of generic food safety auditing competence does not need to be repeated when assessing this unit.
The audits conducted for the purpose of assessment must be witnessed by an auditor competent to audit heat treatment processes.
Assessment methods must satisfy the endorsed Assessment Guidelines of FDF03 Food Processing Industry Training Package.

Communicating ideas and information
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Collecting analysing and organising information
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Planning and organising activities
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Working with others and in teams
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Using mathematical ideas and techniques
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Solving problems
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Using technology
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