1 - Quality Organisation

1.1 Certification

  • Is the site certified? Date?
    please photograph third party certificates
    ISO 22000
    FSSC 22000
    HACCP
    ISO 9001
    IFS
    BRC

Quality Manual

  • Does the Site have a quality policy

  • Does the Site have quality KPI's

  • How are both the quality policy and KPI's communicated

  • Does the site have a organisation chart - please attached

  • Does the site have a Quality Manual

  • Is there a document control system

  • Are there Archiving systems established - if so specify

  • Is there and Internal Audit program - if so specific (topic, frequency, auditors)

  • Does the site have an allergen policy / program

1.3: Health and Regulatory Surveillance

  • Does the site conduct a regulatory monitoring program on finished product or raw materials

  • Which regulatory department does the site surveillance monitoring

1.4: Approval Number / Government Agencies

  • Is the site registered with a government agency - if so which one and what's the number?
    Please photograph

2 - Design - Research & Development

2.1: Specifications

  • Does the site have defined specifications for all of the finished products

Human and Technical Means

  • Does the site have a technical development department

  • Write a brief summary of the technical equipment and personal on site

  • List the last 5 commercialised innovations (ensure dates are listed)

2.3: Validation of new products

  • Does the site have a formal process for developing products

  • Does the site perform shelf life validations on new products

  • how does the site communicate R&D developments to their customers

3 - Requirements and Customer Specification

3.1 Customer Requirements

  • Has the site completed and returned all Parmalat food safety documents

  • How does the site manage customer requirements

  • For packaging suppliers - Has the site conducted migration tests and have current food contact certificates

4 - HACCP

4.1 - Flow Chart, Hazard Assessments and HACCP Audit Table

  • Has the site set up a HACCP system

  • What risks have been taken into account
    * Chemical
    * Microbiological
    * Physical
    * Allergen

  • What is the scope of the study?

  • When was your HACCP study last revised?

  • Which hazards have been taken into account in your study?

  • Has the site identified the CCP, CP's and/or OPRP's

4.2 - Verification of HACCP Plan

  • Does the site Audit their HACCP plan
    if so, how often

  • What elements are included in the HACCP review

4.3 - Foreign Bodies detection and elimination

  • Does the site have metal particle detectors?
    if yes, state the number, positioning and sensitivity

  • Summaries site calibration check and recalibration schedule

  • Does the site have an foreign object reduction procedure
    if yes, summaries the site activates and corrective action procedure

  • Does the site use magnets or filters / strainers?
    if yes, summaries the site activates and corrective action procedure

5 - Production Environment & Food Defence

5.1 - Building Infrastructure

  • Does the site meet FSANZ Food Safety Standards 3.2.3

  • Are the walls and floors sealed

  • Is there logical product flow through the production environment (from raw to finished product)

  • Has the site implemented specific zoning according to the product risks

  • Does the sites waste streams manage contamination hazards

  • Does the site have a policy on wood and glass control
    if yes, summaries activities

  • Does the site have a Food defence program covering intentional hazards into food products

  • Is the site enclosed?

  • Does the site have rules in place for visitors / contractors

6 - Site Services

6.1 - Water Management

  • Does the site use water as an ingredient?

  • Does the site have access to potable water,
    if not, summaries treatment and analysis of results

  • Does the site use a cold water circuit / loop (for product cooling)
    if yes, specify site controls on risks of product contamination

6.2 - Compressed Air

  • Does the sites compressed air come in contact with the product
    if yes - is it sterile / filtered

6.3 - Ambient Air

  • Does the site use ventilation systems in the production area
    if yes. summarise the quality checks being conducted

6.4 - Steam

  • Does the site use steam in the production area
    if yes. summarise the quality checks being conducted

7 - Control of Incoming Materials

7.1 - Raw Material Selection

  • Does the site manage procurement functions

  • Is there an approved supplier program
    if so, how is it organised (supplier assessments)

  • Are the suppliers audited
    if so, what is the percentage audited

7.2 - Specification Management / Purchase Control

  • Does the site have specifications with their suppliers

  • Has the site requested data from their suppliers concerning
    - food suitability
    - allergens
    - GMO

  • Does the supplier have food contact certificates for their final packaging

7.3 - Control of Incoming Materials

  • What inspections are conducted on raw material receipt?

  • Does the site require CoA or CoC's on each delivery

  • Does the site retain samples of the raw materials

7.4 - Storage of Raw Materials

  • Does the site have a policy on stock rotation (based FIFO principles)

  • What type of storage does the site have
    * ambient
    * refrigerated
    * frozen

  • Are finished products stored external to the site
    if so, specify

7.5 - Authenticity

  • Does the site take into account food fraud risks?
    How?

  • Have any risks been identified
    if so, what control are in place to verify the raw material authenticity

8 - Process - Manufacturing

8.1 - Process Stages

  • Describe the major stages of the production process (preparation - manufacturing - packaging)

  • List the main equipment used in the process

  • Are the main process steps listed in the HACCP plan

9 - In Process and Finished Product Inspection

9.1 - In-Process Inspections

  • What inspection occur during the process (type of inspection, how often).
    If yes - are there defined limits

  • What inspections are conducted on the finished product (type of inspection, how often).
    If yes - are there defined limits and record details of the monitoring plan

  • Describe how finished product is released

  • Do finished product batches get issued with a CoA
    if yes, attach and example

9.2 - Sample Retention

  • Are samples of finish product kept?
    if so:
    - how long
    - what quantities are retained
    - what are the storage conditions

9.3 - Laboratory

  • Does the site have an Internal Laboratory?
    if yes, please list activities
    - microbiological
    - pathogens
    - contaminants
    - allergens
    - physical / chemical
    - organoleptic

  • Is the internal Laboratory certified

  • Does the Laboratory participate in proficiency tests
    if yes, which ones and what tests are covered

9.4 - Management of Non-Conforming Product

  • How does the site identify non conforming product

  • Does the site have a "non-conformance product" procedure
    if yes, does it address raw materials, in-process product and finish product

10 - Storage & Shipment

10-1 - Storage of finished Product

  • How does the site protect palletised finished product

  • Which types of finished product storage does the site use

  • Is the segregation of finished product and raw material storage

  • Does the sites QMS cover storage

  • Is there a marked area for non-conforming product storage

10-2 - Transport

  • Does the site have an internal logistics department (transport their own product)

  • Does the site utilise a 3PL
    if yes, who and is there a formal contact of service

  • Does the site transport food and non-food items on the same truck

  • Are the trucks cleaned before loading and are they inspected for hygiene?

11 - Good Hygienic Practices (Cleaning)

Personal Hygiene

  • Does the site have a formal Hygiene Policy?

  • What are the site rules concerning
    - Work Clothing
    - Wearing Jewellery
    - Consumption of foods & smoking
    - Hand Washing
    - Diseases and Injury

  • how does the site review the effectiveness of the Hygiene Policy

11.2 - Staff Rooms

  • Does the site have a canteen

  • Are the catering zones independent from the production zone

  • Are the site's lockers designed to allow separation of work and personal clothing

  • describe the lay out of the production access area
    (sink, soap, footbath, boot-washer)

11.3 - Cleaning

  • Does the site have a defined cleaning plan for both the production lines and environment

  • Describe the cleaning system (CIP, COP)

  • Has the cleaning plan been validated?

12 - Pest Control

12.1 - Preventative Measures

  • Are all doors, walls and ceilings sealed

  • Are doors giving access to the production zones kept closed at all times

  • Are all windows the open to the outside screened

Preventative actions

  • Does the site use an external pest control company

  • Specify the service plan and types of pests covered

Corrective Actions

  • Who is in charge of ensuring the effective resolution of pest problems on site

  • IS a record kept of action

13 - Calibration and Maintenance

13.1 - Measuring equipment

  • How often is your equipment calibrated

  • Specify the dates of last calibration

13.2 - Maintenance

  • Does the site have a preventative maintenance plan

  • Are lubricants used in the production zone
    if yes, are they food lubricants (with food statement and allergen statement)

14 - Tractability & Crisis Management

14.2 Batch Identification

  • Describe the identification systems used on site
    - raw materials
    - work in progress
    - finished product
    - rework

  • How are these details recorded on paperwork sent to Parmalat

14.2 - Traceability

  • starting from a finished product (batch code sent to Parmalat), is it possible to:
    - trace back to the batches of raw materials
    - find the results of inspections

  • Does the site perform trace exercise
    if so, how often

14.2 - Crisis Management

  • Does the business have a crisis management plan?

  • Has the plan been tested
    if so, how many time in a year

  • Does the site have a product recall / withdrawal procedure

  • Has the plan been tested
    if so, how many time in a year

15 - Management of Customer Complaints

15.1 - Complaint management

  • Does the site have a complaint management plan

  • Who is responsible for investigating complaints

  • Does the analysis of complaints include a root cause analysis

  • Has the site set up KPI's on complaints numbers

16 - Human Resources - Training - Ethics

16.1 HR and Training

  • Do all personal on site receive HACCP training

  • Do all personal receive basic food safety training

  • Does the site have a training plan

  • Have Job descriptions been written for all positions with key skills required for certain positions

  • Does the site keep training records

16.2 - Ethics

  • Does the site have an ethics policy

  • Does the site adhere to an ethical standard
    if so has the site been audited?

17 - Allergen Controls

17.1 - Allergen Management

  • Does the site have an allergen management plan

  • Does the site hold allergenic raw materials
    if so, which ones

  • Have allergen controls been integrated into the HACCP plan

  • Does the site have established procedures for managing cross contamination

  • During storage of raw materials, is there physical separation between allergen and non-allergen materials

  • During storage of finished product, is there separation between allergen and non-allergen materials

  • Auditor Sign Off

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