Customer Complaint Handling Procedures

1) Purpose

The purpose of this SOP is to establish a standardized procedure for logging, investigating, and resolving customer complaints related to the quality of capsules.

2) Scope

This SOP applies to all customer complaints received by the pharmaceutical manufacturing facility.

3) Responsibilities

– Customer Service personnel are responsible for logging customer complaints.
– QC personnel are responsible for investigating complaints related to capsule quality.
– QA personnel are responsible for reviewing and approving the investigation results and ensuring appropriate corrective actions are taken.

4) Procedure

1. Logging Complaints
1.1. Record the details of the customer complaint in the customer complaint log.
1.2. Include information such as customer name, contact details, product details (e.g., batch number), nature of the complaint, and date received.
1.3. Assign a unique complaint reference number for tracking purposes.
2. Initial Assessment
2.1. Customer Service personnel should conduct an initial assessment of the complaint to determine its validity.
2.2. Forward valid complaints to the QC department for further investigation.
3. Investigation
3.1. QC personnel should conduct a thorough investigation of the complaint, including:
3.1.1. Reviewing production and quality control records for the batch in question.
3.1.2. Conducting additional testing on retained samples if necessary.
3.1.3. Interviewing relevant personnel involved in the production and quality control processes.
3.2. Document all findings and observations during the investigation.
4. Root Cause Analysis
4.1. Identify the root cause of the issue based on the investigation findings.
4.2. Use root cause analysis tools such as fishbone diagrams, 5 Whys, or failure mode and effects analysis (FMEA).
5. Corrective and Preventive Actions (CAPA)
5.1. Develop a CAPA plan to address the identified root cause.
5.2. Implement corrective actions to resolve the immediate issue.
5.3. Implement preventive actions to prevent recurrence of the issue.
5.4. Document all actions taken in the CAPA report.
6. Communication with Customer
6.1. Provide the customer with a summary of the investigation findings and actions taken.
6.2. Offer replacements, refunds, or other appropriate resolutions as necessary.
6.3. Maintain open communication with the customer until the complaint is fully resolved.
7. Documentation
7.1. Record all complaint handling activities in the customer complaint log.
7.2. Include details of the investigation, root cause analysis, CAPA, and communication with the customer.
7.3. Sign and date all entries in the log.
8. Review and Approval
8.1. Submit the completed complaint log and CAPA report to the QA department for review.
8.2. QA will review and approve the results and ensure that all necessary actions have been taken.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Customer Complaint Log
– CAPA Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ISO 10002:2018 – Quality Management – Customer Satisfaction – Guidelines for Complaints Handling in Organizations

8) SOP Version

Version 1.0