Product Recalls


Article by Janette Hughes.

 

Are you able to access batch details of every raw material you have used or every product you have produced?  No?  Why not?  What’s preventing your business from ensuring that, should a recall be necessary, you know exactly which batch is required to be removed from sale?

 

The Food Act from each State and Territory of Australia requires the food business to have in place a traceability recall system.  Having an active traceability system in place allows you to know exactly which raw materials were used in every batch of finished product manufactured.

 

Below are tips on how to develop this system.  These tips are based on the FSANZ Food Industry Recall Protocol and are compliant towards any HACCP-based and GFSI-based food safety and quality management systems.

 

An effective traceability system tests three questions:

  1. Are your raw materials or finished products identifiable?
  2. Are your raw materials or finished products traceable?
  3. Are the current systems in place effective for a 100% recall rate?

 

 

Identification

Product identification and traceability should be a very significant part of the food safety and quality management system.  Strict adherence to product identification protocol ensures that product is readily traceable from supplier to consumer or vice versa.  Product identification and traceability should be developed in the case of a physical, chemical, microbiological or allergen contamination or a quality control issue.

 

Senior management involvement is required to develop suitable identification and traceability strategies.  Below are examples of how to implement these strategies to ensure product identification and product traceability is maintained.

 

Suppliers

  • Suppliers of food items shall hold a food licence or be registered with the local authority, as applicable to their Australian State/Territory of origin and warehouse
  • All suppliers of food items and packaging shall be HACCP certified
  • For some raw materials and packaging imported, Certificates of Analysis shall be obtained to ensure quality, microbiological, chemical, or physical critical limits are met. This is applicable to the type of goods imported.  Examples of Certificates of Analysis that must be obtained for imported raw materials and packaging: herbs, spices, functional ingredients, food-contact plastic packaging
  • For raw materials and packaging used to develop our own products, supplier data sheets shall be obtained. Note: For food items, we prefer PIFs (Product Information Forms)
  • All suppliers shall have in place their own Product Identification, Traceability and Recall system and activated
  • All suppliers of food items and packaging shall be logged on the Approved Supplier Program and the following information/documentation obtained: supplier details, licence and quality certificates

 

Received Raw Materials and Food-Contact Packaging

Upon receipt of raw materials and food-contact packaging from an Approved Supplier, the following shall apply:

  • Identification of a food item is traceable by a batch code and/or expiry stamp on the product
  • Should the food item not be applicable to a batch code or expiry stamp (e.g. fresh produce), then the Date Received shall suffice, which shall match the date of the tax invoice/delivery docket
  • Should the food item be applicable to a batch code or expiry stamp, but one is not present, then we shall contact the supplier to provide a code. If a code is unobtainable, we shall allocate a Date Received, which shall match the date of the tax invoice/delivery docket
  • Product shall be checked visually for integrity and quality. Rejected product (incorrect temperature, signs of temperature abuse, damaged, underweight, crushed, or otherwise un-saleable) is either discarded or returned to the supplier.  The supplier is contacted for any rejected product to raise awareness and ensure credit is obtained
  • Should issues occur with the raw materials or food-contact packaging, the item shall be placed on hold whilst the issue is investigated in full and a satisfactory outcome is achieved. This shall be documented on a Holding Tag (example template within PDF below), and, if required, logged on the Corrective Action Register
  • Record Keeping Option 1: Handwritten on a Receival Log (example template within PDF below)
  • Record Keeping Option 2: Typed into a Microsoft Excel spreadsheet to allow for active filter usage, monitoring, and quick traceability
  • Record Keeping Option 3: All raw materials received are entered in the accounting system. Each raw material is allocated a unique product number, which in turn enables inventory levels to be monitored; traceability details are also recorded on each tax invoice/delivery docket

 

Storage

  • The FIFO | First In First Out system is used for stock rotation
  • All opened raw materials and work-in-progress MUST have the following information:
    • Product name, batch number/expiration date
    • If applicable: date opened, person’s name, date product must be used by
  • All completed production shall have the applicable best before or use by date stamp

 

Examples of Food Storage Labels

For more examples, check out:

          

 

Internal Batching

  • Internal batching is logged on the Production Logs
  • Batching details that are included: Name of batching recipe, date batch was made, raw materials used

 

Work in Progress

  • All work in progress items are recorded with a Date Made, which is also recorded on the Production Logs

 

Finished Product

  • Products manufactured/prepared are traced by the applicable best before or use by date stamp on the packaging and for internal records, documented on Production Logs

 

Despatch

  • Record Keeping Option 1: Handwritten on a Despatch Log (example template within PDF below)
  • Record Keeping Option 2: Typed into a Microsoft Excel spreadsheet to allow for active filter usage, monitoring, and quick traceability
  • Record Keeping Option 3: Can be traced via customer tax invoices, which are recorded with: tax invoice number, notes about the delivery, temperatures taken; pick up date, customer signature, and the batch details (expiry date)

 

 

Traceability

Product traceability shall be tested annually within the mock recall procedure to ensure the records retained are appropriate for our business in the event of a real product recall.   Product traceability can be conducted Forward (from Raw Materials to First Customer) or Backward (from First Customer to Raw Materials).

 

Completed records that shall be used to test the accuracy of our traceability record keep are as follows:

 

Recall Processes

A recall or withdrawal may be initiated as a result of reports from a variety of sources: distributors, suppliers, wholesalers, retailers, medical practitioners, government agencies and/or consumers.   A recall summary report shall be completed in the event of a food recall or a mock recall.  The mock recall shall be completed annually to verify the effectiveness of our identification and traceability processes.

 

The recall co-ordinator shall:

  • Evaluate the situation and assess the risk based on internal audits and daily records
  • Decide whether a recall or withdrawal is required
  • Commence the recall process
  • Notify the relevant authorities and customers
  • Monitor and conclude the recall process and final report

 

Risk Assessment Matrix

 

Evaluate the Situation

Members of the QA team and management shall gather all relevant information about the situation in order to make a well-informed decision.

 

Recall Decision

If management decides the complaint is not routine and is likely to cause harm to consumers, then the recall shall commence.  Management shall make decisions by asking the following questions:

  • Is it a Product Recall or Product Withdrawal?
  • What is the extent of the Recall: Our premises, our distributor, retailer or consumer?
  • Where to send affected product: Return to distributor or return to site?
  • Whether to stop current processing of the product

 

Notification

  • The QA team shall contact all clients via phone, followed by a facsimile and email within one hour of a recall decision. Note: All notifications shall be documented
  • The QA team shall ensure the following are contacted:
    • Company Legal Adviser
    • FSANZ and office of Consumer Affairs (www.recalls.gov.au)
    • State Health Departments and local city council
    • All Distributors/Customers

 

Recall Product Records

The information shall include:

 

The decision on whether to conduct a product recall or withdrawal must be made within 24 hours of the initial management meeting.  If the decision is made to take no further action, the complaint should be investigated, and the findings reported and filed.

 

The recall procedure must have effectively identified any food that could have been returned.  The measure used to determine this is a percentage of stock that was recovered given the amount that was potentially suspect.  This is documented in the recall summary report.

 

Final Report

The final report should include the following details:

  • Start and finish date and time of the investigation
  • Nature of the problem and how the problem was identified
  • All the data used in making the recall decision
  • Cause of the problem and proposed procedures to prevent recurrence
  • Effectiveness of recall (% affected product recovered)
  • Suggested improvements to recall procedures
  • Advertisements, letters sent and to whom
  • Difficulties experienced and how they were overcome
  • Termination of recall and the reasons
  • Costs incurred
  • Legal ramifications
  • Any other relevant information

 

Summary

  • Once all relevant documentation is retrieved, prepare a report summarising the findings
  • Note time taken to complete the real or mock recall
  • Identify any gaps in the data

 

Follow Up

  • Issues resulting from the real or mock recall summary require resolving
  • What systems need to be put into place to ensure the same errors do not occur in the next real or mock recall?
  • Consider:
    • Re-training of employees
    • Re-writing of procedures and polices
    • Elimination of product line or raw materials
    • Development of better recording systems

 

Further Reading

FSANZ Food Industry Recall Protocol

DownloadRecalls ed 01 – 27-03-19

 

 

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