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Document Type: Subject: Doc No.

: QAD-FBC-003

GUIDELINES QA MANUAL Revision Number: 0


Document Title: Release Date:
Page1 of 5
PRODUCT RECALL Date Effective: AUGUST 2018

1.0 PURPOSE

This program aims to:

1.1. Stop the distribution and sale of the affected product


1.2. Effectively notify customers and appropriate authorities of the recall
1.3. Effectively and efficiently remove any potentially unsafe product from the
marketplace
1.4. Effectively retrieve product from customer warehouses, retail stores and/ or
consumers
1.5. Effectively dispose of the unsafe recalled product
1.6. Conduct a post recall; and
1.7. Implement a corrective and preventive action plan to prevent a recurrence of
the problem

2.0 SCOPE

2.1 . This product recall plan will be applied in the event it is necessary to
recall or withdraw stocks from customer S, stores or even from the
consumers.

3.0 DEFINITION OF TERMS

3.1 Product Recall – an appropriate alternative method for removing or


correcting marketed consumer products, their labeling, and/or promotional
literature that violate the laws administered by the Food and Drug
Administration (FDA).

Prepared By: Approved By:

CrissaBongalosa Dante N. Valdez

QA Specialist Vice President, Food Baskets Corporation


Disclaimer: This document is issued to Production Department on the effectivity date stated above. Any comments pertaining to this document should be raised to PD within 48 hours upon receipt, otherwise, this shall be
considered as FINAL. This document is the Intellectual Property of Food Baskets Corporation and is governed by all applicable laws pertaining to the Intellectual Property rights. Possession of an unauthorized copy in any
form (handwritten, photocopy, etc.) of this document is punishable according to the company rules and regulations and by law.
Document Type: Subject: Doc No.: QAD-FBC-003

GUIDELINES QA MANUAL Revision Number: 0


Document Title: Release Date:
Page2 of 5
PRODUCT RECALL Date Effective: AUGUST 2018

4.0 DUTIES AND RESPONSIBILITIES

4.1 The ultimate responsibility for ensuring the correct application of this recall
plan rests with the Senior Commissary Manager who will act as a Recall
Coordinator.

4.1.1 Below are the specific Recall Team composition and their
responsibilities:

DEPARTMENT TEAM MEMBER POSITION RESPONSIBILITIES


Commissary Thomas Commissary (Recall Coordinator)
Operations Macabagdal Manager - Oversee the whole recall
process
- Determine if a recall is
necessary or whether further
information and advice is
needed in order to make a final
decision
-Communicate with the
customer/FDA
Production Laurencia Production (Recall Team Member)
Operations Tellosa Supervisor -Lead on the whole traceability
process at the production
Sales SalvacionForteza Warehouse (Recall Team Member)
Distribution Manager -Determine the distribution
(STAM) store list/ routes
MD Marketing Carol Bulilan Key Accounts (Recall Team Member)
Manager -Coordination with FDA

5.0 GUIDELIINES

1.7.1. Initial Information


Food Baskets may be informed of a problem with any of its existing
products via the following mechanisms:
4.1.1.1 Customer complaints/ feedback (e.g. phone call, letter,
facsimile, and e-mail informing sales/marketing/operations
department by stores or customers).

Prepared By: Approved By:

CrissaBongalosa Dante N. Valdez

QA Specialist Vice President, Food Baskets Corporation


Disclaimer: This document is issued to Production Department on the effectivity date stated above. Any comments pertaining to this document should be raised to PD within 48 hours upon receipt, otherwise, this shall be
considered as FINAL. This document is the Intellectual Property of Food Baskets Corporation and is governed by all applicable laws pertaining to the Intellectual Property rights. Possession of an unauthorized copy in any
form (handwritten, photocopy, etc.) of this document is punishable according to the company rules and regulations and by law.
Document Type: Subject: Doc No.: QAD-FBC-003

GUIDELINES QA MANUAL Revision Number: 0


Document Title: Release Date:
Page3 of 5
PRODUCT RECALL Date Effective: AUGUST 2018

4.1.1.2 A supplier of a raw material that is used in making its products


informs management that there is a problem with the ingredient;
and
4.1.1.3 Government authorities, such as police, local council or health
departments indicate that there may be a problem with the
particular product.

1.7.2. Determine whether a recall or withdrawal is necessary


4.1.2.1 The Recall Coordinator shall assess whether the product is safe
or unsafe.
4.1.2.2 If the product is not safe, it shall only be handled as complaint.
4.1.2.3 If the product is deemed unsafe or potentially unsafe, he/she
must initiate the recall plan, and convene the recall committee as
soon as possible.

1.7.3. Carrying out a recall


1.7.3.1.Upon convening the Recall team, the Recall Coordinator shall
discuss the objective and necessary actions needed on the recall
process. The team shall then perform based on their designated
duties and responsibilities.

1.7.4. Notifying customer


1.7.4.1.The Recall Coordinator shall inform the customer regarding the
recall and instruct to put all remaining affected products ‘ON
HOLD’.
1.7.4.2.The Recall Coordinator shall also notify FDA regarding the recall.
4.1.3.3.1
4.1.3.3.2 The FDA Recall Coordinator will confirm the type of recall
required under the circumstances.
4.1.3.4.1.1 Class 1 Recall – a situation in which there is a
reasonable probability that the use or exposure to a violative
product will cause serious adverse health consequences or
death.
4.1.3.4.1.2 Class II Recall – a situation in which use or exposure
to a violative product may cause temporary or medically
reversible adverse health consequences or where the probability
of serious adverse health consequences is remote.

Prepared By: Approved By:

CrissaBongalosa Dante N. Valdez

QA Specialist Vice President, Food Baskets Corporation


Disclaimer: This document is issued to Production Department on the effectivity date stated above. Any comments pertaining to this document should be raised to PD within 48 hours upon receipt, otherwise, this shall be
considered as FINAL. This document is the Intellectual Property of Food Baskets Corporation and is governed by all applicable laws pertaining to the Intellectual Property rights. Possession of an unauthorized copy in any
form (handwritten, photocopy, etc.) of this document is punishable according to the company rules and regulations and by law.
Document Type: Subject: Doc No.: QAD-FBC-003

GUIDELINES QA MANUAL Revision Number: 0


Document Title: Release Date:
Page4 of 5
PRODUCT RECALL Date Effective: AUGUST 2018

4.1.3.4.1.3 Class III – a situation in which the use or exposure to


a violative product is not likely to cause adverse health
consequences.

1.7.5. Hazard/ Risk Assessment

1.7.5.1. The recall team shall collect all available information. They shall
fill-up product/hazard risk assessment form (Q. Indicate below
details:
4.1.4.1.1 Product name and description, including pack size and type
4.1.4.1.2 Batch numbers affected and Best before date
4.1.4.1.3 Manufacturer/contact number
4.1.4.1.4 Name and contact number of the person reporting the
problem
4.1.4.1.5 Nature of the problem
4.1.4.1.6 Indicate whether the problem is related to the raw material
used in the product (state the manufacturer
4.1.4.1.7 Number of similar reports received
4.1.4.1.8 Results of tests and other investigations on the suspect of
other samples
4.1.4.1.9 Other relevant information (type of problem and possible
reason of occurrence)

1.7.6. Trade Recall – Stopping further distribution and sale of the food being
recalled
1.7.7. Traceability at the plant level
1.7.7.1. Plant manager shall lead the traceability process.
1.7.7.2. He/she shall check all the documents related to the product
affected.
1.7.7.3. In case the problem is Media Release:
1.7.8. Consumer Recall – Informing the public about the recall
1.7.8.1. In the event that it is necessary to conduct a consumer recall,
all steps outlined in Section 4.15 shall be followed. In addition, the
general public shall be informed through media.

Prepared By: Approved By:

CrissaBongalosa Dante N. Valdez

QA Specialist Vice President, Food Baskets Corporation


Disclaimer: This document is issued to Production Department on the effectivity date stated above. Any comments pertaining to this document should be raised to PD within 48 hours upon receipt, otherwise, this shall be
considered as FINAL. This document is the Intellectual Property of Food Baskets Corporation and is governed by all applicable laws pertaining to the Intellectual Property rights. Possession of an unauthorized copy in any
form (handwritten, photocopy, etc.) of this document is punishable according to the company rules and regulations and by law.
Document Type: Subject: Doc No.: QAD-FBC-003

GUIDELINES QA MANUAL Revision Number: 0


Document Title: Release Date:
Page5 of 5
PRODUCT RECALL Date Effective: AUGUST 2018

Food Baskets Marketing Officer shall coordinate the YUM


Marketing Officer regarding the possible media release to ensure
rapid and wide information dissemination.
1.7.8.2. The media release shall contain a clear instruction to the
consumers on what to do with the product (return the product to
the store they have purchased for a full refund) or how to safely
dispose the product. A contact person and number shall also be
included to allow access on further information.
1.7.9. Retrieving the recalled product and product disposal
1.7.9.1. The Recall Coordinator shall take all the reasonable measures
to retrieve stock in the market place and have it returned to the
company.
1.7.9.2. The Recall Coordinator shall communicate with Marketing
Officer to retrieve affected stock from customers, warehouses and
distribution centers and to encourage cooperation from all links in
the distribution chain to ensure the recall is effective.
1.7.9.3. Records of the product identification details and the amount of
product returned from the customer and distribution center must be
kept.
1.7.10. Disposal of returned product

REVISION HISTORY
Revisio Effectivity
Description of Change Author
n Date
00 New L. Catindig May 2018

Prepared By: Approved By:

CrissaBongalosa Dante N. Valdez

QA Specialist Vice President, Food Baskets Corporation


Disclaimer: This document is issued to Production Department on the effectivity date stated above. Any comments pertaining to this document should be raised to PD within 48 hours upon receipt, otherwise, this shall be
considered as FINAL. This document is the Intellectual Property of Food Baskets Corporation and is governed by all applicable laws pertaining to the Intellectual Property rights. Possession of an unauthorized copy in any
form (handwritten, photocopy, etc.) of this document is punishable according to the company rules and regulations and by law.

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