Purpose:
The purpose of this SOP is to define the procedure for dealing with raw material non-conformance in a consistent and efficient manner. The non-conformance should be identified and handled in a way that minimizes the impact on final product quality and customer satisfaction.
Scope:
This SOP applies to all raw materials used in the manufacturing process from the receipt of raw materials to final product release. It is applicable to any item that fails to conform to specifications or is otherwise determined to be non-conforming.
Responsibilities:
The Quality Department is responsible for ensuring the implementation of this procedure. The Production Department, the Procurement Department, and the Quality Control Department are also responsible for implementing the procedure as it relates to their areas.
Procedure:
1. Identification of Non-Conformance:
a. Non-conformance may be identified during incoming inspection, during manufacturing, or during final product quality control testing.
b. Any employee who suspects that a non-conformance has occurred should immediately inform the Quality Department.
2. Segregation and Disposition:
a. Non-conforming materials must be segregated and clearly labeled to prevent their use in production or shipment.
b. The disposition of non-conforming materials will be determined by the Quality Department. Options may include reworking, returning to the supplier, or
c. Any rework or repair must be properly documented and approved by the Quality Department before the material can be used in the production process.
3. Documentation:
a. All non-conforming material must be appropriately documented, including the reason for the non-conformance and the disposition of the material.
b. A Non-Conformance Report (NCR) must be issued for each non-conforming item and stored in the company’s document control system.
Abbreviations used:
NCR – Non-Conformance Report
Reference:
This procedure conforms to the requirements of ISO 9001:2015 and any applicable local regulatory requirements.
SOP Version:
This is version 1.0 of the Raw Material Non-conformance Procedure, effective as of (insert date).
