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SOP005

This document outlines a standard operating procedure for handling quality complaints at Ariaba Plasticans injection molding factory. It defines responsibilities for management, quality assurance team, and production personnel. It also describes a 6-step complaint handling process: 1) receipt, 2) evaluation, 3) investigation and root cause analysis, 4) corrective and preventive actions, 5) customer communication, and 6) documentation. The SOP aims to ensure timely and effective resolution of complaints and continuous improvement of quality management systems.

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aribaplasticans
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29 views3 pages

SOP005

This document outlines a standard operating procedure for handling quality complaints at Ariaba Plasticans injection molding factory. It defines responsibilities for management, quality assurance team, and production personnel. It also describes a 6-step complaint handling process: 1) receipt, 2) evaluation, 3) investigation and root cause analysis, 4) corrective and preventive actions, 5) customer communication, and 6) documentation. The SOP aims to ensure timely and effective resolution of complaints and continuous improvement of quality management systems.

Uploaded by

aribaplasticans
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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

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