Parmalat Supplier Quality Audit

• Document No.

• Client / Site

• Personnel

• Conducted on

  Date

• Prepared by

• Location
  Address

1.1 Certification

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

  Yes

  No

  N/A

Quality Manual

• Does the Site have a quality policy

  Yes

  No

  N/A

• Does the Site have quality KPI's

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does the site have a organisation chart - please attached

  Yes

  No

  N/A

• Does the site have a Quality Manual

  Yes

  No

  N/A

• Is there a document control system

  Yes

  No

  N/A

• Are there Archiving systems established - if so specify

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does the site have an allergen policy / program

  Yes

  No

  N/A

1.3: Health and Regulatory Surveillance

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

  Yes

  No

  N/A

• Which regulatory department does the site surveillance monitoring

  Yes

  No

  N/A

1.4: Approval Number / Government Agencies

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

  Yes

  No

  N/A

2.1: Specifications

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

  Yes

  No

  N/A

Human and Technical Means

• Does the site have a technical development department

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

2.3: Validation of new products

• Does the site have a formal process for developing products

  Yes

  No

  N/A

• Does the site perform shelf life validations on new products

  Yes

  No

  N/A

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

  Yes

  No

  N/A

3.1 Customer Requirements

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

  Yes

  No

  N/A

• How does the site manage customer requirements

  Yes

  No

  N/A

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

  Yes

  No

  N/A

4.1 - Flow Chart, Hazard Assessments and HACCP Audit Table

• Has the site set up a HACCP system

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• What is the scope of the study?<br>

  Yes

  No

  N/A

• When was your HACCP study last revised?<br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

4.2 - Verification of HACCP Plan

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

  Yes

  No

  N/A

• What elements are included in the HACCP review

  Yes

  No

  N/A

4.3 - Foreign Bodies detection and elimination

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

  Yes

  No

  N/A

• Summaries site calibration check and recalibration schedule

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

5.1 - Building Infrastructure

• Does the site meet FSANZ Food Safety Standards 3.2.3

  Yes

  No

  N/A

• Are the walls and floors sealed

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does the sites waste streams manage contamination hazards

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is the site enclosed?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

6.1 - Water Management

• Does the site use water as an ingredient?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

6.2 - Compressed Air

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

  Yes

  No

  N/A

6.3 - Ambient Air

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

  Yes

  No

  N/A

6.4 - Steam

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

  Yes

  No

  N/A

7.1 - Raw Material Selection

• Does the site manage procurement functions

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are the suppliers audited<br>if so, what is the percentage audited

  Yes

  No

  N/A

7.2 - Specification Management / Purchase Control

• Does the site have specifications with their suppliers

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.3 - Control of Incoming Materials

• What inspections are conducted on raw material receipt?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does the site retain samples of the raw materials

  Yes

  No

  N/A

7.4 - Storage of Raw Materials

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.5 - Authenticity

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

8.1 - Process Stages

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

  Yes

  No

  N/A

• List the main equipment used in the process

  Yes

  No

  N/A

• Are the main process steps listed in the HACCP plan

  Yes

  No

  N/A

9.1 - In-Process Inspections

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Describe how finished product is released

  Yes

  No

  N/A

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

  Yes

  No

  N/A

9.2 - Sample Retention

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

  Yes

  No

  N/A

9.3 - Laboratory

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

  Yes

  No

  N/A

• Is the internal Laboratory certified

  Yes

  No

  N/A

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

  Yes

  No

  N/A

9.4 - Management of Non-Conforming Product

• How does the site identify non conforming product

  Yes

  No

  N/A

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

  Yes

  No

  N/A

10-1 - Storage of finished Product

• How does the site protect palletised finished product

  Yes

  No

  N/A

• Which types of finished product storage does the site use

  Yes

  No

  N/A

• Is the segregation of finished product and raw material storage

  Yes

  No

  N/A

• Does the sites QMS cover storage

  Yes

  No

  N/A

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

  Yes

  No

  N/A

10-2 - Transport

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Personal Hygiene

• Does the site have a formal Hygiene Policy?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

11.2 - Staff Rooms

• Does the site have a canteen

  Yes

  No

  N/A

• Are the catering zones independent from the production zone

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

11.3 - Cleaning

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

  Yes

  No

  N/A

• Describe the cleaning system (CIP, COP)

  Yes

  No

  N/A

• Has the cleaning plan been validated?

  Yes

  No

  N/A

12.1 - Preventative Measures

• Are all doors, walls and ceilings sealed

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are all windows the open to the outside screened

  Yes

  No

  N/A

Preventative actions

• Does the site use an external pest control company

  Yes

  No

  N/A

• Specify the service plan and types of pests covered

  Yes

  No

  N/A

Corrective Actions

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

  Yes

  No

  N/A

• IS a record kept of action

  Yes

  No

  N/A

13.1 - Measuring equipment

• How often is your equipment calibrated

  Yes

  No

  N/A

• Specify the dates of last calibration

  Yes

  No

  N/A

13.2 - Maintenance

• Does the site have a preventative maintenance plan

  Yes

  No

  N/A

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

  Yes

  No

  N/A

14.2 Batch Identification

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

  Yes

  No

  N/A

• How are these details recorded on paperwork sent to Parmalat

  Yes

  No

  N/A

14.2 - Traceability

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

14.2 - Crisis Management

• Does the business have a crisis management plan?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does the site have a product recall / withdrawal procedure

  Yes

  No

  N/A

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

  Yes

  No

  N/A

15.1 - Complaint management

• Does the site have a complaint management plan

  Yes

  No

  N/A

• Who is responsible for investigating complaints

  Yes

  No

  N/A

• Does the analysis of complaints include a root cause analysis

  Yes

  No

  N/A

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

  Yes

  No

  N/A

16.1 HR and Training

• Do all personal on site receive HACCP training

  Yes

  No

  N/A

• Do all personal receive basic food safety training

  Yes

  No

  N/A

• Does the site have a training plan

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does the site keep training records

  Yes

  No

  N/A

16.2 - Ethics

• Does the site have an ethics policy

  Yes

  No

  N/A

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

  Yes

  No

  N/A

17.1 - Allergen Management

• Does the site have an allergen management plan

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Have allergen controls been integrated into the HACCP plan

  Yes

  No

  N/A

• Does the site have established procedures for managing cross contamination

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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