Purpose & Scope: Procedure For Product Withdrawal & Recall

Document Code:
QS-2-004
Issue No: 01
Title: Page 1 of 3
Dept: Procedure for Product Withdrawal & Recall Issue date:
Quality System April 05, 2020
1. PURPOSE & SCOPE

1.1 The purpose of product withdrawal is the isolation and removal of unsafe product
from the food chain which has been released from factory premises and is under the control
of others in the storage, distribution and customer end.
1.2 The purpose of a product recall is to protect customer product / public health by
facilitating the efficient, rapid identification, communication and removal of unsafe products
from the distribution chain.
1.3 This procedure is applicable to all end products that are not in the direct control of
an organization.
2. RESPONSIBILITIES
2.1 The authority to initiate recall lies with the top Management. Head of Quality
System is responsible to give withdrawal call after consultation with the top management &
Head of marketing & sales.
2.2 Head of Quality Assurance execute the procedure and coordinates with the cross
functional department / team(s) and external agencies.
3. PROCEDURE
3.1 Product Recall

3.1.1 In the event that a food safety issue arises with our products protects public health
by facilitating the efficient, rapid identification and removal of unsafe food from the
distribution chain and, by informing customers for potentially hazardous product.
3.1.2 There is a documented recall/ withdrawal procedure in place and this will be
periodically tested to ensure that it is comprehensive and fit for purpose in its ability to
remove unsafe product from consumers and/ or distribution chain".
3.1.3 Product mock recall / withdrawal would be planned at least once in a fiscal year,
subject to management decision.
3.2 Product Recall Planning & Executi on
3.2.1 A Product recall plan is made as Appendix-2 where the flow of the activities is
defined. When any customer complaint investigation reveals that the product has serious
health hazard and its presence in the food chain may affect public health.
Head of QA / Management Representative conducts a preliminary meeting at earliest. The
decision of recall is illustrated in the Recall Decision Tree appendix 1.
Document Code:
QS-2-004
Issue No: 01
Title: Page 2 of 3
3.2.2 QA conducts reliable tests on the product samples and confirm the hazard presence.
The results are discussed in the recall meeting chaired by Head of QA / Quality System.
3.2.3 The extent of infected quantities is estimated based on the sales data. Product
existence is located through the traceability system of sales module. The distribution chain
is contacted through warehouse and logistic team and a formal notification is released as
deem essential.
3.2.4 Quality System / QA analyze the whole food safety system particularly the HACCP &
OPRP plans and verify ingredients quality through the traceability system in place.
3.3 Regaining Control of Aff ected Stock

3.3.1 If essential requests customers to destroy the affected product.
3.3.2 If affected product is recovered either by; direct returns from customer; returns via
the distribution chain, or product already in stock then the following considerations are in
view:
a. The unsafe product is returned to one central site or, in the case of a widely
distributed product, to major recovery sites and handled through CPA procedure,
MR/2/003.
b. The recovered product is stored in an isolated area.
c. Accurate records are kept of the amounts of recovered product and the codes of
that product.
d. If the recovered product is unfit for human consumption, it may be destroyed or
denatured under the supervision of the company management and/ or the relevant
regulatory authority where legally required.
e. If the food safety risk can be safely removed from the recovered product through re
label or reprocessing this is carried out under QA supervision.
3.4 Reviewing the safety system

3.4.1 The plan needs to define the process for formally notifying all parties that the
incident has ended. The MR ensures that the activities are documented.
3.4.2 Every product recall is viewed as opportunity to learn and improve the systems used
in the food business. The Head of Quality System initiate a formal review procedure
involving the product recall team. Some of the elements that should be included in a review
are:
a. A review of the cause of the issue identifying the real issue (not the symptoms) and
immediate and long term actions that will rectify the problems.
b. A review of company policies, procedures and actions to update them in light of the
issue.
Document Code:
QS-2-004
Issue No: 01
Title: Page 3 of 3
c. A review of training plans to improve awareness of the problem and ensure it is not
repeated.
d. A review of management structures, if reporting or lack of clarity on responsibilities
contributed to any problems with the product recall.
e. A review of investigations and analysis carried out on product returns.
f. A review of stock reconciliation.
4. RELATED DOCUMENTS
4.1 Mock Recall Report QS-4-012
4.2 Recall Decision Tree
4.3 Plan for Product Recall
5. DOCUMENT APPROVAL
Document Designation Signature
Prepared by Consultant
Reviewed by Operation Manager
Approved by Director

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1. PURPOSE & SCOPE

3.1 Product Recall

3.2 Product Recall Planning & Executi on

3.3 Regaining Control of Aff ected Stock

3.4 Reviewing the safety system

Document Designation Signature

Reviewed by Operation Manager

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