ARIBA PLASTICANS SOP 005
Title: Quality Complaint Handling Standard Operating Procedure (SOP)
1. Purpose:
The purpose of this SOP is to establish standardized procedures for handling quality complaints in
the injection molding process, ensuring timely resolution, customer satisfaction, and continuous
improvement.
2. Scope:
This SOP applies to all personnel involved in receiving, investigating, and resolving quality complaints
within the injection molding factory.
3. Responsibilities:
3.1. Factory Management:
- Provide necessary resources, including personnel, tools, and training, to address quality
complaints effectively.
- Ensure compliance with relevant regulations, customer requirements, and quality standards.
- Review and update this SOP as needed.
3.2. Quality Assurance Team:
- Responsible for managing and overseeing the quality complaint handling process.
- Train and monitor the performance of the personnel involved in complaint resolution.
- Ensure adherence to SOP and quality management procedures.
3.3. Production and Technical Personnel:
- Assist in the investigation and resolution of quality complaints.
- Provide necessary information and expertise to support complaint handling efforts.
- Report any issues or abnormalities to the Quality Assurance Team.
4. Complaint Handling Procedure:
4.1. Complaint Receipt:
- The QMS incharge is point of contact or a complaint management system to receive and record
quality complaints.
ARIBA PLASTICANS SOP 005
- Document complaint details, including the complainant's information, product details, nature of
the complaint, and any supporting evidence or documentation.
4.2. Complaint Evaluation:
- A responsible person is assigned in consultation with Production and managment to evaluate and
classify the complaints based on severity, impact, and urgency.
- Conduct an initial assessment of the complaint to determine its validity and gather any additional
information or data required.
4.3. Investigation and Root Cause Analysis:
- Assign qualified personnel to investigate the complaint thoroughly.
- Collect relevant data, such as production records, inspection reports, and customer feedback, to
identify the root cause(s) of the complaint.
- Use appropriate problem-solving techniques to analyze the root cause(s) and determine
corrective actions.
4.4. Corrective and Preventive Actions (CAPA):
- Develop and implement appropriate corrective actions to address the identified root cause(s) of
the complaint.
- Ensure that corrective actions are timely, effective, and sustainable.
- Implement preventive actions to prevent the recurrence of similar issues in the future.
4.5. Customer Communication:
- Maintain regular communication with the complainant to provide updates on the investigation
and resolution progress.
- Ensure that communication is professional, transparent, and respectful.
- Address any concerns or questions raised by the complainant promptly and effectively.
4.6. Documentation and Reporting:
- Maintain accurate and detailed records of all quality complaints, investigations, actions taken,
and outcomes.
- Document the results of the investigation, root cause analysis, corrective actions, and preventive
measures.
- Provide periodic reports on quality complaints to management for review and analysis.
ARIBA PLASTICANS SOP 005
5. Follow-up and Closure:
5.1. Verification of Effectiveness:
- Monitor and verify the effectiveness of implemented corrective and preventive actions.
- Conduct follow-up inspections, tests, or customer feedback assessments to ensure the resolution
of the complaint.
5.2. Complaint Closure:
- Upon successful resolution and verification of effectiveness, close the complaint case.
- Document the closure details, including the date, actions taken, and any supporting evidence.
6. Training:
- Provide comprehensive training to all personnel involved in the quality complaint handling
process.
- Ensure that the Quality Assurance Team and relevant stakeholders are familiar with this SOP and
related procedures.
- Conduct periodic refresher training sessions.
7. References:
-CAPA register, Analysis register, Quality Log book