Standard Operating Procedure for Product Complaint Handling

1) Purpose

This SOP outlines the procedures for receiving, documenting, investigating, and resolving product complaints to ensure timely and effective management, assessment of product quality, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in receiving, documenting, investigating, and resolving product complaints within the company, including customer service, quality assurance, and regulatory affairs.

3) Responsibilities

The Quality Assurance (QA) department is responsible for overseeing the product complaint handling process. All personnel are responsible for promptly reporting and documenting product complaints and supporting investigations and corrective actions.

4) Procedure

4.1 Receipt of Product Complaint

1. Receive product complaints through various channels, such as customer service, direct communication, or regulatory agencies.
2. Document initial complaint details, including complainant information, product name, lot number, description of the issue, and date of complaint receipt.
3. Assign a unique complaint number and notify QA and other relevant departments.

4.2 Initial Assessment

1. Conduct an initial assessment to determine the nature and severity of the complaint.
2. Classify the complaint as critical, major, or minor based on its potential impact on patient safety, product quality, and regulatory compliance.
3. Decide on the urgency and level of investigation required.

4.3 Investigation

1. Assign a cross-functional investigation team to thoroughly investigate the complaint.
2. Gather and review all relevant information, such as complaint details, batch records, testing results, and any related documentation.
3. Perform root cause analysis to identify the underlying cause(s) of the complaint.
4. Document the investigation findings in the Product Complaint Investigation Report Form.

4.4 Corrective and Preventive Actions (CAPA)

1. Develop a CAPA plan based on the investigation findings to address the root cause(s) of the complaint and prevent recurrence.
2. Implement the CAPA plan, ensuring all corrective actions are effective in addressing identified issues.
3. Monitor and document the implementation of CAPA actions.

4.5 Resolution and Follow-Up

1. Communicate the investigation findings and proposed resolution to the complainant, if applicable.
2. Ensure timely closure of the complaint once all corrective actions have been implemented and verified.
3. Follow up with the complainant, if necessary, to confirm satisfaction with the resolution.

4.6 Documentation and Records

1. Maintain complete and accurate records of all product complaints, including complaint records, investigation reports, CAPA plans, 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
CAPA: Corrective and Preventive Actions

6) Documents, if any

Product Complaint Form, Product Complaint Investigation Report Form, CAPA Plan, Closure Documentation

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q10 (Pharmaceutical Quality System), and ISO 13485 (Medical Devices – Quality Management Systems)

8) SOP Version

Version 1.0