Purpose:
The purpose of this Standard Operating Procedure (SOP) is to establish a standard and consistent procedure for handling raw material complaints. The objective of this procedure is to ensure that all complaints made related to raw materials are investigated thoroughly, documented accurately, and resolved adequately to prevent future occurrences.
Scope:
This SOP applies to all employees who handle raw materials and is applicable to all raw materials that are used in the manufacturing process.
Responsibilities:
– Quality Assurance (QA) Department: Responsible for receiving, investigating, documenting, and resolving all raw material complaints.
– Production Department: Responsible for notifying the QA department of any raw material complaints received during the manufacturing process.
– Purchasing Department: Responsible for filing complaints with the supplier/vendor for any raw materials received that do not meet specifications.
Procedure:
1. Notification: Any raw material complaints received from any department within the company shall be documented and reported to the QA department immediately for investigation.
2. Investigation: The QA department shall investigate the complaint, including the use of any laboratory testing required for confirmation or clarification of the complaint.
3. Documentation: A complaint log shall be maintained to keep track of all raw material complaint cases. Documentation of the investigation shall be recorded in a designated complaint investigation report. Any corrective actions taken shall be recorded in a corrective action report.
4. Resolution: QA department shall notify the appropriate departments of any actions needed to resolve the complaints. It shall ensure that the resolution has been effective in preventing any reoccurrence of the complaint.
5. Communication: Upon completion of the investigation and resolution of the complaint, the QA department shall communicate the report to the complaint initiator and the relevant departments.
6. Follow-up: QA department shall ensure that the complaint resolution has been effective and shall monitor any related raw material usage for potential future complaints.
Abbreviations:
QA: Quality Assurance
Documents:
– Complaint log
– Complaint investigation report
– Corrective action report
References:
– ISO 9001:2015 Quality Management System Standard
– National Institute of Standards and Technology (NIST) Handbook 150-17 Calibration Management
SOP Version Number and Date:
Version 1.0, 01-July-2021