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Production ProcedureTable of Contents - Click here for PDF demo - opens in new tab 1.0 Purpose 1.0 PURPOSE NOTE: The Production process includes all QC inspections and tests within it. Quality is not a separate process. 2.0 THEORY
3.0 PROBLEM RESOLUTION It is understood that the appropriate responsible authority will...
4.0 REQUIREMENTS
5.0 PRODUCTION DOCUMENTATION Documented information that defines characteristics of products and services includes... The Company ensures all documented information required to accompany the products and services are present at delivery. 5.1 All revision controlled production documents are... 5.2 In addition to this process procedure, additional production documentation may be required for a given order or production operation. Where required, these are... 5.3 Such documentation includes... 5.4 Records that are created for temporary retention of miscellaneous information are not... 6.0 PRODUCT IDENTIFICATION The Company controls acceptance authority media, such as... 6.1 Product is identified in shop areas by any of the following methods:
6.2 Lot traceability or individual serialization of parts is to be maintained on the paperwork (travelers, routers, etc.) as required. Supervisory staff will... Traceability requirements include:
6.3 Bad (nonconforming) product that has failed an inspection or test and cannot be reworked to comply with requirements is... 6.4 Any parts or product not marked with a tag are... 6.5 IDENTIFICATION OF TRANSFER CONTAINERS 6.5.1 Whenever a portion of chemical is transferred from its original container to a smaller temporary container... 6.5.2 Whenever a portion of chemical is transferred from its original container to a smaller permanent container... 7.0 PRODUCT HANDLING 7.2 In all cases, Operators are... 7.3 The Company provides suitable safety and personal protection equipment for handling hazardous or toxic materials. Operators are... 8.0 PRESERVATION 8.2 Operators will... 8.3 Operators will... 8.4 Operators will... 8.5 FOD: Foreign Object Damage, Prevention, Detection and Removal: Work instructions and training methods ensure that handling and preservation practices reduce the introduction of foreign objects (FOD) into products. 8.6 ... 8.7 ... 9.0 EXTERNAL PROVIDER PROPERTY CONTROL 9.1 External Provider Property (Property) means... Hardware property includes:
9.2 All External Provider furnished hardware property shall... 9.3 Property shall be identified... 9.4 Sensitive material, as defined by the External Provider, shall... 9.5 Property shall only be used as instructed or required by External Provider contract and... 9.6 External Provider equipment shall... 9.7 The Responsible Authority investigates... 9.8 Requirements for the control of External Provider property shall... 10.0 VALIDATION OF PROCESSES 10.2 Validation and verification activities include...:
11.0 PRODUCTION PROCESS VERIFICATION 11.1 Control of Equipment, Tools, and Software Programs 12.0 INSPECTION AND TEST OF PRODUCT OR SERVICE 12.1 Receiving inspection is performed according to the Receiving Procedure. 12.2 First Article Inspection 12.2.1 First article inspections are... 12.2.2 The Company will... 12.2.3 Where not provided, the Company will... 12.2.4 Complete the first article inspection form according to its format and submit to CCB. 12.2.5 Calibrated tools shall be used for first article inspection; however,...under the following conditions:...
12.2.6 ... 12.2.7 Any item failing first article inspection must be processed according to the Control of Nonconformities Procedure. 12.3 In Process Inspections 12.3.1 In-process inspection is performed by... 12.3.2 In-process inspections are performed... The Company ensures documented information for monitoring and measurement activity for product acceptance includes:
When sampling is used as a means of product acceptance, the sampling plan is... 12.3.3 Calibrated tools shall be used for in-process inspection; however,... under the following conditions:
12.3.4 When applicable, complete the production inspection form according to its format. 12.3.5 ... 12.3.6 Any item failing in-process inspection must be processed according to the Control of Nonconformities Procedure. 12.4 Final Inspection 12.4.1 Final inspection is performed by Responsible Authority(s) prior to release of product for packaging and shipping. 12.4.2 100% sampling is required for final inspection unless otherwise specified by Customer contract. When sampling is permitted by Customer contract,... 12.4.3 Calibrated equipment is used for final inspection and documented information provides traceability to specific monitoring and measurement equipment; however,... under the following conditions:
12.4.4 Complete the production inspection form according to its format. Prior to final acceptance, confirm... 12.4.5 Any item failing final inspection must be processed according to the Control of Nonconformities Procedure. 12.4.6 Prior to product delivery to Customer, the Responsible Authority... 13.0 SHELF LIFE EXTENSION 13.1 Items that are subject to expiration may...: 13.1.1 ... 13.1.2 ... 13.1.3 ... 13.1.4 ... 13.2 Chemicals that are purchased or prepared by the chem-lab are... 13.3 Raw material components whose shelf life has... ... 15.0 REVISION HISTORY AND APPROVAL RECORD Quality System Procedure Copyright © JnF Specialties, LLC. All rights reserved worldwide. PROPRIETARY INFORMATION - UNCONTROLLED IF PRINTED UNLESS OTHERWISE MARKED |