Standard Operating Procedure for Product Recall Management

1) Purpose

This SOP outlines the procedures for initiating, executing, and documenting product recalls to ensure prompt and effective management of product quality issues, protection of public health, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in initiating, executing, and documenting product recalls within the company, including quality assurance, regulatory affairs, manufacturing, and distribution.

3) Responsibilities

The Quality Assurance (QA) department is responsible for overseeing the product recall process. All relevant departments are responsible for promptly reporting and supporting recall activities as required.

4) Procedure

4.1 Recall Initiation

1. Identify a potential need for a product recall through internal quality monitoring, customer complaints, regulatory notifications, or other sources.
2. Notify the QA department immediately upon identification of a potential recall situation.
3. Document initial details, including product name, batch numbers affected, reason for recall, and severity assessment.

4.2 Recall Strategy Development

1. Convene a recall committee to assess the situation and develop a recall strategy.
2. Determine the classification of the recall (e.g., voluntary, mandatory) based on risk assessment and regulatory requirements.
3. Develop a detailed Recall Plan outlining specific actions, timelines, responsibilities, communication strategies, and regulatory notifications.

4.3 Execution of Recall

1. Initiate recall activities according to the approved Recall Plan.
2. Implement measures to retrieve affected products from customers, distributors, and other relevant stakeholders.
3. Document all recall activities, including notifications sent, responses received, and products retrieved or accounted for.

4.4 Communication

1. Communicate the recall to all affected stakeholders, including customers, distributors, regulatory agencies, and the public as required.
2. Provide clear instructions to stakeholders on actions to be taken, such as product return, disposal, or replacement.
3. Ensure all communications are timely, accurate, and comply with regulatory requirements.

4.5 Closeout and Evaluation

1. Evaluate the effectiveness of the recall process, including the timeliness and completeness of actions taken.
2. Review all documentation related to the recall, including the Recall Plan, communication records, and effectiveness evaluation.
3. Conclude the recall process and document closure activities, including final disposition of recalled products.

4.6 Documentation and Records

1. Maintain complete and accurate records of all recall activities, including the Recall Plan, communication logs, effectiveness evaluation, and closure documentation.
2. Ensure that all documentation is readily accessible for audits and regulatory inspections.

5) Abbreviations, if any

QA: Quality Assurance
SOP: Standard Operating Procedure

6) Documents, if any

Recall Plan, Communication Logs, Effectiveness Evaluation Report, Closure Documentation

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q9 (Quality Risk Management), and ISO 13485 (Medical Devices – Quality Management Systems)

8) SOP Version

Version 1.0