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Delivery: <= 8 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 19892.4-2022: Batch control - Part 4: Batch production records Status: Valid
Basic dataStandard ID: GB/T 19892.4-2022 (GB/T19892.4-2022)Description (Translated English): Batch control - Part 4: Batch production records Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: N10 Classification of International Standard: 25.040 Word Count Estimation: 70,782 Date of Issue: 2022-10-12 Date of Implementation: 2023-05-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 19892.4-2022: Batch control - Part 4: Batch production records---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Batch control - Part 4.Batch production records ICS 25.040 CCSN10 National Standards of People's Republic of China Batch control part 4.batch production records (IEC 61512-4.2009, IDT) Released on 2022-10-12 2023-05-01 implementation State Administration for Market Regulation Released by the National Standardization Management Committee table of contentsPreface VII Introduction VIII 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Batch Production Record Instructions 2 4.1 Overview 2 4.2 Overview 3 4.2.1 Batch Production Record 3 4.2.2 Business Information 4 4.2.3 Production Execution Information 4 4.2.4 Batch Production Record Specification 4 4.2.5 Batch Production Record Report 4 4.3 Purpose of batch production records 4 4.3.1 Overview 4 4.3.2 Process and/or production analysis, optimization and reporting4 4.3.3 Compliance 5 4.3.4 Production release 5 4.3.5 Deviation management 5 4.3.6 Quality Management 5 4.3.7 Material tracking and tracing 5 4.3.8 Device Tracking and Trace 5 4.3.9 People Tracking 5 4.3.10 Compliance with contract requirements 5 4.3.11 Cost accounting 5 4.3.12 Production knowledge base 6 4.4 Batch Production Record Data Management 6 4.4.1 Data retention 6 4.4.2 Data integrity 6 4.4.3 Creating batch records 6 4.4.4 Updating batch records 7 4.4.5 Life cycle state 7 4.5 Batch Record Structure 7 4.6 Production information 10 4.6.1 Overview 10 4.6.2 Business Information 11 4.6.3 Production Execution Information 11 4.6.4 Program element data 11 4.6.5 Generic (non-batch specific) data 12 4.7 Batch record element 13 5 Batch Record Object Model 16 5.1 Overview 16 5.2 Modeling information 16 5.3 Overview of the Batch Record Object Model 19 5.4 Batch Production Records 20 5.5 Batch production record entry 22 5.6 Event 23 5.7 Datasets 30 5.7.1 Dataset object 30 5.7.2 Dataset properties 32 5.7.3 Time specification 33 5.7.4 Label specification 33 5.7.5 Ordered data 34 5.7.6 Data value 34 5.7.7 Time value 35 5.8 Note 35 5.9 Sample 36 5.9.1 Sample objects 36 5.9.2 Sample properties 36 5.9.3 Sample test 37 5.9.4 Sample test results 37 5.10 Change 38 5.11 Personnel identification checklist 39 5.12 Resource Qualification Checklist 40 5.13 Product Definition 41 5.14 Production response 41 5.15 Production Request 41 5.16 Control Prescription 42 5.16.1 Controlling prescription objects 42 5.16.2 Controlling recipe attributes 43 5.16.3 Control recipe file header 44 5.16.4 Installation requirements 45 5.16.5 Constraints 46 5.16.6 Equation 46 5.16.7 Parameter 46 5.16.8 Parameter value 47 5.16.9 Program logic 48 5.16.10 Link 48 5.16.11 Step 48 5.16.12 Conversion 49 5.16.13 Other information 49 5.16.14 Other information value 50 5.16.15 Prescription elements 50 5.17 Primary prescription 52 6 Integrity, Conformity and Consistency 53 6.1 Integrity 53 6.2 Compliance 53 6.3 Consistency 53 6.4 Extended object model 53 Appendix A (Informative) Data Modeling Techniques 54 A.1 Terms and Definitions 54 A.2 UML notation 54 Appendix B (Informative) Questions and Answers 56 B.1 Overview 56 B.2 Levels of batch production record specification 56 B.3 Contents of batch production record specification 56 B.4 Format of batch production record specification56 B.5 Format of personal and computer identification in batch production records56 B.6 Reasons for recording data in the batch production record 56 B.7 How many audit trails are there for the same batch of production records 57 B.8 Recording discrete events 57 B.9 Production schedule and schedule changes 57 B.10 Material Safety Data Sheets 57 B.11 Label scanning 57 B.12 Production information 57 B.13 Device History 57 B.14 Regulated industries? 58 B.15 GB/T 19892.4 batch production records and ANSI/ISA95 standard 58 B.16 GB/T 19892.4 and ISA-95 Terminology 58 B.17 GB/T 19892.4 batch production records and ISA-95 production performance 59 B.18 What format is used for data citations? 59 B.19 Personnel conduct 59 References 60 Figure 1 Generation and use of batch production records 3 Figure 2 Batch production record component object 8 Figure 3 Batch Production Record Example 9 Figure 4 An example of an element referencing another element 10 Figure 5 Internal and Reference Data Example 10 Figure 6 Example of batch production records for recipe elements12 Fig. 7 Batch record with non-batch-specific data 13 Figure 8 Object Reference Model 18 Figure 9 Batch production record top-level model 19 Figure 10 Batch Production Record Object Model 20 Figure 11 Event Model 23 Figure 12 Example of event element relationship 24 Figure 13 Dataset model 31 Figure 14 Time series dataset example 31 Figure 15 Elements of Time Series Dataset 31 Figure 16 Cross-correlation dataset example 32 Figure 17 Element 32 of a cross-correlation dataset Figure 18 Sample model 36 Figure 19 Control Prescription Model 42 Figure 20 Sample batch production record 43 with two copies of the control recipe Figure 21 Prescription element model 51 Figure 22 Master prescription model 52 Table 1 Classification of batch production records13 Table 2 Table Example 19 Table 3 Batch Production Record Attributes 20 Table 4 Batch production record entry attribute 22 Table 5 Event attributes 24 Table 6 Alarm event attributes 26 Table 7 Standard event types 26 Table 8 Attributes of user-defined attributes 29 Table 9 Event Correlation Attributes 30 Table 10 Dataset properties 32 Table 11 Time specification attributes 33 Table 12 Label identification attribute 33 Table 13 Data value attribute 35 Table 14 time value attribute 35 Table 15 Annotation attributes 35 Table 16 Sample properties 36 Table 17 Sample Test Properties 37 Table 18 Sample Test Result Attributes 38 Table 19 Change properties 39 Table 20 Person ID list attribute 39 Table 21 Qualification Checklist Attribute 40 Table 22 Control recipe attributes 43 Table 23 Control Prescription Header Attributes 44 Table 24 Device Requirements Attributes 45 Table 25 Constraint properties 46 Table 26 Parameter properties 47 Table 27 Parameter value attribute 47 Table 28 Link properties 48 Table 29 Step properties 49 Table 30 Conversion properties 49 Table 31 Other Information Attributes 50 Table 32 Other information value attribute 50 Table 33 Prescription element attributes 51 Table 34 Main prescription attributes 52 Table A.1 UML notation 54forewordThis document is in accordance with GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents" and GB/T 1.2-2020 "Guidelines for Standardization Work Part 2.Rules for Drafting Standardization Documents Based on ISO /IEC Standardization Documents" regulations drafted. This document is part 4 of GB/T 19892 "Batch Control". GB/T 19892 has issued the following parts. --- Part 1.Models and terminology; --- Part 2.Data structure and language guidelines; --- Part 3.General and field prescription models and representations; --- Part 4.Batch production records. This document is equivalent to IEC 61512-4.2008 "Batch Control Part 4.Batch Production Records". This document is proposed by China Machinery Industry Federation. This document is under the jurisdiction of the National Industrial Process Measurement Control and Automation Standardization Technical Committee (SAC/TC124). This document is drafted by. Harbin Institute of Technology Special Robot Co., Ltd., Machinery Industry Instrumentation Comprehensive Technical and Economic Research Institute, Fujian Shangrun Precision Instrument Co., Ltd., Qingdao Haier Industrial Intelligence Research Institute Co., Ltd., General Electric Power Planning Institute Co., Ltd., Shenyang Chinese Academy of Sciences Automation Research Institute, Chongqing University of Posts and Telecommunications, Rockwell (China) Co., Ltd., Yokogawa Electric (China) Co., Ltd., Shanghai Industrial Automation Instrument Watch Research Institute, Harbin Institute of Technology Robotics (Yueyang) Military-civilian Integration Research Institute, Beijing Institute of Technology, Shanghai Automation Instrument Co., Ltd., Phoenix (Nanjing) Intelligent Manufacturing Technology Engineering Co., Ltd., Hangzhou Dianzi University, Wuxi Internet of Things Innovation Center Co., Ltd. The main drafters of this document. Tang Xiaohan, Lu Tielin, Liu Xiaojing, Ge Jian, Sun Ming, Zhang Jinbin, Zhang Hualiang, Huang Qingqing, Gao Jingmei, Guan Qi, Li Minghua, Sui Guofa, Kong Lingqin, Ye Bingjin, Zhang Long, Shen Jing, Xing Hao, Zhuang Baosen, Dong Jielian, Wang Yong, Liu Heyan.IntroductionGB/T 19892 is a standard for batch process and guidance for batch control, consisting of four parts. --- Part 1.Models and terminology. The purpose is to establish the model and terminology to be followed for batch control. --- Part 2.Data Structures and Language Guidelines. The purpose is to illustrate the language's data structures and guidelines. --- Part 3.General and field prescription models and representations. The purpose is to define additional information for generic and field prescriptions. --- Part 4.Batch production records. The purpose is to provide a reference model for developing applications for storing and/or exchanging batch production records. This document is further implemented to allow retrieval, analysis and reporting of selected batch record data, and to provide Defined in detail, it consists of an object model that describes and batches the contents of records. Batch production record standards comply with GB/T 19892.2-2007 The batch data model in Chapter 4 and GB/T 19892.1. Although this document is primarily directed to batch processes, it can also be referenced for other types of processes. Batch control part 4.batch production records1 ScopeThis document defines a reference model for batch records containing information about batches or batch elements. This document is suitable for batch processing.2 Normative referencesThe contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 19892.1-2005 Batch Control Part 1.Models and Terminology (IEC 61512-1.1997, IDT) GB/T 19892.2-2007 Batch Control Part 2.Data Structure and Language Guidelines (IEC 61512-2.2001, IDT) ANSI/ISA-95.00.01-2000 Enterprise Control System Integration Part 1.Models and Terminology (Enterprise-controlsystem ANSI/ISA-95.00.02-2001 Enterprise control system integration Part 1.Object model attributes (Enterprise-controlsys-3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 batch history batchhistory Collect all execution information related to individual batches, which may include common (non-batch-specific) information. 3.2 A subset of executive and business information retained based on business requirements, identified in accordance with a batch production record specification. NOTE. This information can include prescription program element execution information, device-specific information, operator notes, batch-related alarms, batch-definition-related elements such as Control recipes, master recipes, field and/or generic recipes, batch scheduling information) and critical batch information (such as training logs, maintenance records, and environmental conditions). 3.3 Formatted information extracted from one or more batch records for printing, displaying, or sending to a collaborative system. 3.4 Data used for the generation of batch production records or contained in batch production records and specifications (if the data are used for reference or extraction) Completed execution business information requirements definition. NOTE. 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