SAMPLE COMPANY Page 1 of 5 SOP # 14-1 Revision: 0 Prepared by: _ Effective Date: Approved by: _ Title: CORRECTIVE ACTION AND FOLLOW-UP Policy: The causes for nonconforming product will be investigated and appropriate corrective action will be implemented to prevent their recurrence. Adequate follow-up will be performed to ensure that the corrective action(s) have been effective. Purpose: This procedure outlines the responsibilities and methods for identifying causes of nonconforming product, initiating corrective action(s) and performing follow-up to ensure that the corrective action(s) have been effective in preventing the reason for the nonconforming product. Scope: This procedure applies to all causes of nonconforming product discovered during production, post-sale or during internal quality audits. Procedures: 1.0 Identifying Causes of Nonconforming Product Nonconforming product or their causes can be discovered during production, after the sale through customer contact/service or during internal quality audits. 1.1 The underlying cause or causes for nonconforming product occurring in the production phase is to be determined at the time of discovery or during subsequent evaluation for disposition of the items. Refer to the procedure "Nonconforming Components and Products." 1.2 The underlying cause or causes for nonconforming product occurring after the sale that is discovered through customer contact or service is to be determined by performing trend analysis of product defects or customer complaints. Refer to the procedure "Customer Service Contact/Complaint Handling." 1.3 The underlying cause or causes for nonconforming product discovered during the review of quality records or during an internal quality audit is to be determined as part of the audit review process. Refer to the procedure "Quality Assurance Audits." CORRECTIVE ACTION AND FOLLOW-UP Page 2 of 5 2.0 Corrective Action 2.1 To initiate an internal corrective action, a Corrective Action Request form (Exhibit 1) should be prepared and forwarded to the Quality Assurance Manager who will initiate the appropriate action with the applicable department manager or managers. This action should include review and verification of the underlying cause of nonconforming product and appropriate correction action to be taken with an implementation plan including necessary changes to procedures and documentation. 2.2 To initiate a corrective action with a vendor/supplier, a Supplier Corrective Action Request form (Exhibit 2) should be prepared and forwarded to the appropriate personnel for the vendor. 3.0 Documentation and Follow-Up 3.1 The Quality Assurance Manager will assign a sequential corrective action number to all requests and maintain a Corrective Action Status Log (Exhibit 3) to record disposition of all corrective action requests. 3.2 The Quality Assurance Manager is responsible for performing a follow-up review to ensure that the corrective action has been effective in preventing or eliminating the cause for nonconforming product. The Quality Assurance Manager will determine the appropriate timing or schedule for performing the follow-up review according to the nature of the cause and/or corrective action taken.