Subject: Control of Non-Conforming Product SOP A

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Duane Skinner
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1 - 1-1.) Scope: Policy and procedure for Control of all non-conforming product 2.) Normative References: SOP Quality Manual SOP Product Recall SOP A In Process & Final Inspection and Testing SOP A Storage, Distribution and Drainage Systems SOP G cgmp Procedures SOP C General Manufacturing Procedures SOP A Product Files SOP C Receiving SOP A Testing of Incoming Chemicals SOP B Testing of Incoming Denaturant Raw Materials SOP & A Purchase Orders, process and information SOP A & Corrective and Preventive Actions SOP B Corrective Action-Vendor Complaints SOP B Product Recall Form QA301 Corrective Action Form C003A Vendor Complaint Form Form C008 Return Goods Form C009 Return Authorization Form QA349 Quality Return Log Form QA351 Release Notification for Quality Hold material 3.) Terms and Definitions: Non-Conforming Product: Any finished product or raw material that does not comply with the stated specifications, i.e. it is off-spec. 4.) Outline of the process A.) Non Conforming Product is identified B.) Non Conforming Product is Isolated C.) Non Conforming Product is labeled as Quarantine D.) Non Conforming Product is investigated E.) Disposition of Non Conforming Product is made by QC/Production

2 - 2 - E.) Release notification is given on Form QA351. F.) QC tags material for Release. G.) All other documents are completed to satisfy ISO requirements 5.) Text: Non-Conforming Product (NCP) occurs when the following happens: I.) Production makes a product they cannot adjust during the normal production/re-working process II.) Vendor Raw Material is rejected based upon quality or packaging III.) Material is returned from a customer due to Quality issues. IV.) Material is recalled from a customer during a product recall. V.) Salvaged Product. Expired or corrupted material from inventory Since these occurrences have slightly different procedures, they will be detailed separately below: I.) Non-Conforming Product (NCP) generated from Production: 1.) This is the result of the failure of production to rework the product during the normal production-qc process. 2.) The material is isolated in quarantine and appropriately marked by QC as Quarantined. The NCR Log is filled out. 3.) A non-conformity Product report is written up by QC personnel and copied to the VP QM and VP Operations. 4.) Material will be re-worked into a low-end product (TR590) or sold off as is. 5.) If the non-conformity was the result of human failure, retraining will result and be documented.

3 - 3-6.) If the non-conformity was the result of technical failure, a corrective action will be issued. SOP A will be followed. 7.) QC will monitor the progress of the material through a product file created for that particular batch. Batch file will be included. Product File will be kept in a NCP area of QC records. 8.) Written instructions via form QA351 for the release of material for any use will be done by QC to Production. II.) Non-Conforming Product (NCP) resulting from rejection of raw material. 1.) All raw materials are in a quarantine state when it is undergoing quality review. Material is placed in the quality hold area and logged in. 2.) If the material is failing after re-testing by QC the material will be rejected. 3.) QC personnel will issue a non-conforming product form and attach to the Product File. VP Quality and VP Operations will be immediately notified. 4.) If the raw material has arrived in bulk, the vendor will be immediately notified that the truck or railcar is being rejected. 5.) If the material was being used under urgent release, the quantity of material will be pumped back into the truck or railcar. 6.) Vendor Complaint will be filed. Investigation started 7.) Material will be returned for credit or damages filed. 8.) Investigation will be completed to determine if this is a systemic problem with the vendor or an isolated non-conformity. If this is deemed a systemic problem, the vendor will be put on probation. Each lot of raw material that is received after this incident will have to undergo additional QC testing and scrutiny. If this has already occurred, the vendor can be dropped off the approved vendor list. This is done by internal communication via by the VP QM to the other Sr. Managers in the company. VP QM has the authority to reject all raw materials and drop vendors off the approved vendor list as does all Sr. Managers. 9.) Final disposition of material is communicated via form QA351to production. III.) Material is returned from a customer due to Quality issues. IV.) Material is recalled from a customer during a product recall. These two occurrences will be handled together.

4 - 4-1.) The material is quarantined upon return. Material is logged in. 2.) Return goods sheet is completed by the warehouseman and issued to the customer service manager. Forms C008 and C009 are issued or completed. 3.) QC is notified that the material has been returned and is in quarantine. 4.) QC will draw samples or request samples. QC will perform all required testing. 5.) If the material meets all required specifications, QC will authorize the return of material to inventory. QC will mark the material as approved for release. 6.) If the material does not meet the required specifications, QC will mark the material as Rejected or Unfit do not use. A non-conformity report will be issued. An investigation as to the cause of the non-conformity will ensue. 7.) The material will either be reworked or sold off as is. 8.) The investigation will be concluded. Retraining or a corrective action will be issued. 9.) A product file will be generated for that batch or lot of material to track the material through the re-working process or sale as is. This file will be kept in QC records. 10.) Final disposition of material will be communicated to production via form QA351. V.) Salvaged Product. Expired or corrupted material from inventory It is the responsibility of the Quality Management System that products that have been subjected to improper storage conditions (extremes in cold and heat etc.), or subjected to fires, accidents or equipment failure shall not be salvaged and resold as is. 1.) Salvaged product will be identified by VP Operations or VP Quality (if originating from another location). 2.) Salvaged material will be isolated and quarantined and marked as quarantined. The material will be logged in. 3.) Salvaged material will be tested. 4.) Salvaged material will either be re-worked (re-distilled etc.) or sold off as is. 5.) Product file will be issued to track the disposition of this material. 6.) If the salvaged material was the result of improper storage conditions a corrective action will be issued.

5 - 5-7.) Final disposition of material will be communicated to production by QC via form QA351. CONTROL OF NON-CONFORMING PRODUCT Non-conforming product occurs when material cannot be reworked during the quality process to conform to the finished products specifications. In these rare cases, non-conforming product is controlled by Pharmco production and quality control staff. It is labeled as such and segregated. Returned goods for quality reasons are also non-conforming product. This can be the result of damage by carrier or improper storage by the customer. More often it is due to parameters not identified in the product specifications. In all these cases, quality control must evaluate the quality of the product and complete a report on its findings. This is attached to the returns good file. See SOP on Returned Goods for additional information. The results of all returns are evaluated by Pharmco. If the cause of any returns is a breakdown of the quality management system (QC, production controls etc.), corrective actions will be issued. Care is taken that any non-conforming product is quarantined and does re-enter circulation as a finished product or raw material. All non-conforming product must be released by the quality control dept. Non-conforming product can be reworked, scrapped or sold off as a lower grade of material. Scrapped non-conforming product is used as denaturant or sold off as off-spec. material. Pharmco is a zero waste generator. Therefore, nonconforming product is never handled as hazardous waste. It is the responsibility of every Pharmco employee to immediately report any quality-related problem to the appropriate department manager. The department manager then documents the non-conformity on the Non-Conformity Report Form (Form QA304). The department manager consults with department employees and, if necessary, other department managers to minimize the immediate effects of the non-conformity. If appropriate, the department manager will determine if any materials need to be repaired, reworked or scrapped. Non-conformity reports are submitted to the ISO compliance manager for trend analysis. The ISO compliance manager is responsible for reporting on the non-

6 - 6 - conformities and apparent trends to the ISO Committees. Whenever appropriate, the ISO Subcommittee will design corrective actions to address the non-conformity. Revision History: This document was revised on 01/13/03 by PD in accordance with Q9001:2000 requirements This printed document was printed on: 3/12/2007. This printed document is valid for 5 days after the print date. All obsolete documents must be appropriately marked or discarded.

1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System

Page 1 of 8 1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System 2. Application This Standard Operating Procedure applied to the entire Quality Management System as it relevant