Classification of Incidents, and Incident Reporting

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

Incident management process |  Incident management policy


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.

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