Xyz Ltd. is committed to providing products that satisfy customer and consumer requirements and are safe in design and use. Classification of incidents and management process | Incident management policy.
This commitment is described fully in the company Quality Policy. Specifically, about product recalls, XYZ Ltd. Will establish and maintain procedures and support systems to recall any suspect product from the marketplace most efficiently and effectively.
XYZ Ltd. Product Recall Procedure covers all products manufactured by XYZ Ltd. distributed through depot/retail. Incident management process.
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Triggers
Recalls may be triggered from internal or external sources,
for example:
Government authorities or
complaints.
Consumer
complaints/feedback via Care Lines or direct.
Customer/trade
complaints/feedback.
Information
from internal quality records.
Notification
of deliberate contamination (by an extortionist or other person).
Regulatory compliance.
Communication
Should
anyone become aware of a situation or information where a product or consumer
safety or quality is at risk immediately contact one of the following:
Factory
Manager
QA Head
Production
Manager
Commercial Manager
Only the Factory Manager can authorize a recall or withdrawal of any company product. Should you believe a recall/withdrawal is required please contact Company QA Head or discuss it with your Factory Manager.
UNDER NO CIRCUMSTANCES MUST A RECALL/WITHDRAWAL BE INITIATED WITHOUT THE FACTORY MANAGER AND COMPANY QUALITY ASSURANCE APPROVAL.
Note: N.B. Whilst a recall procedure has been defined, each recall is a unique event, and the exact content, execution, and assigned roles and responsibilities may vary from incident to incident.
Classification of Incidents
A Quality Incident is a Quality non-conformance that may endanger
consumer health and/or corporate or brand reputation
Category A
A non-conformance in the market that relates to a potential consumer
safety hazard. Use of or exposure to the product/information
The Could cause adverse health consequences.
Category B
A non-conformance in the market could have a significant impact on a company's brand or corporate reputation but the use of or exposure to the product
would not cause adverse health consequences. The product is noticeably
substandard AND not fit for purpose.
Category C
A non-conformance in the market that is unlikely to have a significant impact on the reputation
of the Brand AND use of or exposure to the product would not cause
adverse health consequences The product is
noticeably substandard BUT fit for purpose.
Category D
Non-conforming finished products are in company control and placed on
hold as they cannot be released to normal stock.
a). Any
HOLD at the factory on account of any analytical parameters /weight
/design or artwork / foreign matter
being out of spec
b). Any HOLD at the
factory by QC or otherwise that is greater than or equal to the production
of a shift
c). Any Depot HOLDS from the factory done by
QC or CQA
d). Any recalls by the factory provided that the
material has not been invoiced beyond depots (any material going beyond
depots is a category A, B, or C incident)
e). Any FTR failure
Risk Reduction Measure
P = Public Recall, S = Silent Recall, O = Other (includes ‘no action’)
2. Roles and Responsibilities of Factory Manager
The Factory Manager is responsible for both the decision to recall and which type of recall will take place. This decision must be based on both the QA Incident classification. The XYZ Factory Manager must:
1) Within 24 hours of receiving the QA confirmation of Incident Classification & required risk reduction measures report by email: Consult the relevant Manager to start the recall process.
Public Recalls For (A/B)
Incidents.
Silent Recalls For C
Incidents.
QA Head
The QA Head is responsible for classified Incident types
and risk reduction measure reports.
1) At the time of being informed or aware of the incident classify the
incident & risk reduction measures.
2) Conduct emergency meetings with the Incident Management team.
3) Inform Factory Manager & relevant manager &
CQA by mail.
4) If required personally visit the Depot and check that packs
about the date/shift codes are frozen.
5) Check the backward traceability to RM suppliers.
6) Check analytical test data of individual raw materials used in the soap under recall status.
Incident Management Committee
1. Quickly
collate and assess the facts that led to the incident.
2. Obtain
confirmation of incident classification and risk reduction measures from QA.
3. Make
recommendations to the Factory manager on the action required.
4. Execution
of an action plan to implement risk reduction measures that will mitigate
the impact and prevent the recurrence of the incident.
5. Identify
staff that would play an essential role in an incident investigation or recall.
6. Institute
a recall, follow it through, analyze the effectiveness of execution, and
recommend any changes. This includes
timely reporting and communication to the Head Office and all relevant authorities.
7.
Appropriately document all aspects of the incident.
8.
Stock Reconciliation
9. Product Recall Close
10. Prepare an improvement plan for the gaps
Each member of the Recall Committee must have a deputy. Given the serious nature of a recall, this responsibility should be delegated upwards.
The Recall Committee is made up of managers from key operations within the business, along with appropriate deputies to fulfill their specific responsibilities should they be absent. The Core Members are a mandatory part of the team. Other personnel may be seconded to the Recall Committee as required to provide specialist knowledge of the product or situation involved.
Commercial Manager
1. Send a mail to freeze the stock to the Depot
manager with a copy to the Logistic Manager / Executive.
2. Get a confirmation mail from the Depot Manager.
3. Send a Freeze release mail.
3. Definitions
Quality Safety Incident
A situation where a company has produced and/or distributed products that may endanger consumers’ health and/or the Brand's reputation.
Classifies consumer quality and safety incidents according to their potential to endanger public health and violate consumer expectations and satisfaction. The three incident categories are Category A, B, and C.
Category A Incident
A non-conformance in the market that relates to a potential consumer safety hazard. Use of or exposure to the product/information could cause adverse health consequences.
Category B
A non-conformance in the market could have a significant impact on a company's brand or corporate reputation but the use of or exposure to the product would not
cause adverse health consequences. The product is noticeably substandard AND
not fit for purpose.
Category C
A non-conformance in the market that is unlikely to have a significant
impact on the reputation of the Brand AND use of or exposure to the
product would not cause adverse health consequences The
product is noticeably substandard BUT fit for purpose.
PUBLIC RECALL
Withdrawal of products/services by notification to consumers through media such as television, radio, newspapers10, websites, email, or through in-store announcements. Any product withdrawal enforced by regulatory authorities.
SILENT RECALL
Withdrawal of
products/services without the use of any public-facing media, withdrawal of
products from distribution and/or shop shelves, collection/buy-back of products
by field sales representatives, withdrawal of products from professional
users without public notification.
4. Documentation and Incident Reporting
Documentation
An accurate, precise, and structured log must be kept of all communications, decisions, incoming information, etc. Written reports must be factual and, for liability reasons, any opinions carefully drafted. Such information must be treated as highly confidential due to risks associated with uncontrolled publicity and in case it is needed to defend Unilever against possible claims. All documents should be marked “Confidential”.
All
documentation relating to a recall (e.g. traceability details of products or
materials, distribution or warehousing records, or internal paperwork generated
as part of the recall) must be in line with document control requirements i.e.
date.
Documentation must be appropriately filed by the Recall Coordinator after a recall. Corrective Action Records.
All
corrective action and verification records must be available.
Reporting
Reports must be prepared by the Recall Co-ordinator to meet company requirements. Copies of these reports may also be circulated to others if considered appropriate.
5. Dummy Recalls and Traceability
The product recall procedure must be tested at least annually. If a site or the company has been involved in an actual recall, whether public or silent, this can substitute the test that was planned.
Objectives of Product Recall
Each year a
dummy product recall must be undertaken to:
Test upstream and downstream traceability, documentation, and
recovery of product from incoming raw/packaging material and rework through to the finished
product including the status of CCPs
Check the availability and working conditions of communication
systems
Timely availability of key personnel
Increase knowledge and training of those likely to be
involved with a real recall.
Check the
performance and effectiveness of a potential recall.
Test that
the procedure (incl. site procedures and contact lists) will give the desired
final outcome.
Identify any weaknesses which need to be improved.
Rules of Product Recall
No product is physically moved
All reports
and documents are clearly labeled “Dummy Recall”
The scenario
must not be based on a consumer safety issue, as misinterpretation of the
information may have a large impact on the hands of people not directly
involved.