Product Recall and Withdrawal Procedure

1.0 Purpose

1.1 Company ABC objective is that only products which are safe for use with food products and comply with all legal requirements are delivered to the customer.

1.1 Despite all of the precautions we take it can happen that a product is distributed which is subsequently found to be unfit for use with food products. In these cases we must act quickly in order to:

protect the health of consumers and minimize the impact on the company image and the brands of our customers

2.0 Scope

2.1 For a fully functioning recall system it is essential to have implemented a well defined procedure with clearly defined responsibilities to ensure that:

Problems are identified as early as possible and follow-up actions are taken The source of the problem is identified and eliminated or minimized The implementation of the recall is fast and effective once the recall

decision is taken All responsibilities for internal and external communication are clearly

specified to assure a rapid and appropriate response

3.0 Documents

Product Recall Incident Report QD 16.24

4.0 Definitions

NONE.

5.0 Procedure

5.1 Levels of recall

5.1.1 Recalls can be operated at different levels, depending on the nature of the defect. The risk to the consumer or the risk to the brand determines the type and the depth of the recall.

Type 1 Recall (urgent): a product has a reasonable probability of causing a serious health consequence or death if used (e.g. presence of chemical toxins that could cause acute toxicity, product tampering).

Type 2 Recall: a product has a reasonable probability of causing a temporary health consequence if used e.g. presence of foreign body objects (glass, sharps, blades etc.).

Type 3 Recall: a product has no adverse health consequences but is in violation of official regulations, e.g. incorrect labeling, incorrect filling weight, inappropriate nutritional claims.

Product withdrawal is the voluntary removal of a product because it poses no hazard to health and does not violate any regulations, but does not meet own quality standards and may result in consumer dissatisfaction.

5.2 Depth of Recall

Controlled product recovery: products which have to be withdrawn are in the factory, in transit or in company warehousing. E.g. Not at customer or retail level.

Trade level removal: the suspect product is already at retail level, but there is no risk for the consumer; the product is removed from warehousing, not from retail shelves.

Retail removal: a product needs to be removed from the retail shelves, but public notification is not required.

Public recall: recall down to the consumer level; a public recall is required when the recall is assessed as type (1) or possibly type (2) as defined in 5.1. Warning through the media is necessary.

5.3 Recall Committee

5.3.1 A recall committee formed by members of different functions e.g. quality, technical, sales, marketing, logistics and at least one Manager has to be established to deal with all potential issues and guarantee a controlled recall procedure:

The recall committee:

Completes a risk assessment and recommends the type and depth of the recall or withdrawal.

Decides the necessary actions which have to be taken.

Decides the timescales for contacting all relevant stakeholders. This will not exceed 24 hours even for the lowest risk level recall.

Assures proper internal and external communication

Follows up the corrective actions

5.4 Recall Coordinator

5.4.1 The recall committee is headed by the Recall Coordinator. The Recall Coordinator is the designated Quality and Hygiene systems Manager or his direct deputy. In this capacity the person reports directly to top management.

5.5 Product recall

5.5.1 The effectiveness of the product recall procedure is tested annually and the results are recorded on Product Recall Incident Report QD 16.24.

The responsibilities include:

to coordinate all activities during the recall.

to gather all necessary information (production, stock, distribution details, details of the product defect, potential health risks etc.) and to provide the recall committee with the necessary information for the decision on the steps that have to be taken.

to forward relevant information to all parties involved in the recall (internal and external).

to document details of the product recall on Product Recall Incident Report QD 16.24 and develop action plans for improved operations.

To ensure that the recall system is reviewed regularly and that it functions in any circumstances.

5.6 Training

5.6.1 All staff that may be involved in a recall must be trained regularly in the recall procedure and related actions. The training will include being part of mock recall tests.

5.7 Training

5.7.1 The recall must be tested regularly (at least every two years) to assure the functionality of the procedure. The review process should include regular practical exercises, including a traceability exercise at internal and wholesale level. Challenging targets should thereby be set for rate of recovery within a given time frame.